**[[Summary of Safety and Effectiveness Data]{.underline}]{.smallcaps}**

# I. [GENERAL INFORMATION]{.underline}

**Device Generic Name:** Cardiac Ablation Radiofrequency Generator and

Interface Cable

**Device Trade Name:** Stockert 70 RF Generator for Cardiac Ablation

**Device Model Numbers:** S7001 (generator and accessories)

C6-MR10/MSTK-S and C10-MR10/MSTK-S (cables)

**Applicant's Name and Address:** Biosense Webster, Inc

3333 Diamond Canyon Road

Diamond Bar, CA 91765

**Date of Panel Recommendation:** None

**PMA Application Number:** P990071

**Date of Notice of Approval to**

**Applicant:** May 31, 2000

# II. [INDICATIONS FOR USE]{.underline}

The Stockert 70 radiofrequency generator and accessory cable are
indicated for use in conjunction with a Biosense Webster
Diagnostic/Ablation Deflectable Tip catheter for cardiac ablation
procedures.

# III. [CONTRAINDICATIONS ]{.underline}

Do not use this device:

-   in patients with active systemic infection;

-   via the transseptal approach in patients with left atrial thrombus
    or myxoma, or interatrial baffle or patch; and

-   via the retrograde transaortic approach in patients with aortic
    valve replacement.

# IV. [WARNINGS AND PRECAUTIONS ]{.underline}

See Warnings and Precautions in the final approved labeling (User's
Manual).

# V. [DEVICE DESCRIPTION ]{.underline}

The Stockert 70 RF Generator system consists of a radiofrequency (RF)
generator and accessories, and two reusable interface cables. The device
is intended to generate RF energy that is delivered to the heart by a
percutaneously-placed catheter for the treatment of cardiac arrhythmias.
The thermal energy at the site of application produces a lesion that
interrupts a defective electrical conduction pathway in the cardiac
wall. The Stockert 70 RF Generator is used in unipolar mode only, and
includes functions for controlling temperature at the catheter tip and
for monitoring impedance and ECG signals. Ablation parameters, such as
power, impedance, voltage, current, and temperature, can be recorded and
displayed using the optional Stockert 70 Global Port and an optional
Personal Computer (PC) system.

## A. Generator and Accessories 

The complete list of generators, accessories, and model numbers (where
applicable) are listed below:

-   Stockert 70 RF Generator, with software version 1.032

-   power cord

-   remote control foot pedal

-   global port computer interface

-   indifferent patch - electrode, 3M, package of 5

-   indifferent patch - electrode connection cable, 3M

-   grounding cable

-   software - EPWIN, version 3.010

-   ValleyLab patch cable

-   serial computer interface cable D-Type

-   global port digital - ECG connection cable

-   ECG connection cable (Redel 10-2 mm tip pin)

Below is a more detailed description of the device components and
features.

### 

### (1) [Global Port Computer Interface and EPWIN software]{.underline}

The Global Port Computer Interface provides the interface between the
generator and the external components. Five port channels (ECG distal,
ECG proximal, Temperature, RF power, and Impedance) allow for recording
of all measurement data for the system. All communication is by
electrically isolated optical fibers. An RS232 connection to a personal
computer running the EPWIN software can be used to document and display
data collected by the Global Port Interface.

### (2) [Temperature Control]{.underline}

Two modes of ablation control are provided: manual (power control) and
automatic (temperature control). In manual mode, the user controls the
power using the rotary knob on the front panel. Power can be controlled
to between 0 and 50 watts. If temperature exceeds a user-selected cutoff
value (ranging from 47°C to 95°C), the power is deactivated immediately.
In automatic mode, the power is adjusted automatically to achieve a
temperature at the catheter tip that is selected by the user. The
Stockert Generator provides temperature control for thermistor- and
thermocouple-based catheters, and is able to detect which is being used.
The set temperature ranges from 43-90°C. In automatic mode, the user can
select the rate of temperature change from 0.02 -50°C/sec.

### 

### (3) [Impedance Monitoring]{.underline}

The impedance monitoring feature allows the user to select lower (20 to
200 ohms) and upper (30 to 300 ohms) impedance cut-offs. If the
impedance falls above or below these values, power is deactivated. The
user can select a delta impedance cut-off value to monitor for rapid
changes in impedance. If the change in impedance (measured over a 3
second traveling window) exceeds this delta value, power is deactivated

### 

### (4) [ECG Monitoring]{.underline}

The device system allows for the connection of external systems for
monitoring and recording of electrograms signals obtained by the
ablation catheter. Both digital and analog interface options are
available, and a low-pass filter is activated to minimize interface due
to the RF ablation signal during the ablation procedure. The system also
allows for electrical stimulation (pacing) to aid in the diagnosis of
arrhythmias.

## B. Catheter Interface Cables

The device system may use Biosense Webster interface cables for use with
the Stockert 70 RF Generator and Biosense Webster Diagnostic/Ablation
Deflectable Tip Catheter. Cables are available in lengths of 6 feet
(model C6-MR10/MSTK-S) or 10 feet (C10-MR10/MSTK-S). The cables are
reusable and may be resterilized up to ten times using ethylene oxide.

# VI. [ALTERNATIVE PRACTICES OR PROCEDURES]{.underline}

Alternative therapy for cardiac arrhythmia includes direct surgical
ablation, use of drugs for tachycardia control, antitachycardia pacing,
and RF ablation with various market-approved catheters and generators.

# VII. [MARKETING HISTORY]{.underline}

The Stockert 70 RF Generator has not been marketed in the United States
or any foreign country.

# VIII. [ADVERSE EFFECTS OF THE DEVICE ON HEALTH]{.underline}

This section summarizes the observed and potential adverse events
associated with the use of the device.

## A. Observed Adverse Events

The Stockert 70 Generator, used with the Biosense Webster Celsius™
Diagnostic/Ablation thermocouple or thermistor catheters, was evaluated
in 210 patients, most of whom were treated for Wolff-Parkinson White
(WPW) syndrome or atrioventricular nodal re-entrant tachycardia (AVNRT).

Five patients (2.4%) were reported as having major adverse events, all
of which were reported as procedure-related. Major and minor adverse
events were classified according to the FDA's recommended definitions
for evaluating ablation safety. The major adverse events, occurring
within seven days post ablation, included pulmonary embolus/urinary
tract infection, unintentional heart block, small ecchymosis/hematoma,
deep vein thrombosis, and femoral artery pseudoaneurysm.

Thirteen minor adverse events (6.2%) were reported, including small
ecchymosis, superficial thrombophlebitis, pneumothorax, hematoma,
pulmonary embolus, pain at catheter insertion site, chest pain, groin
pain, transient 2:1 heart block, esophagitis, congestive heart failure,
right occipital stroke, and malignant lung/bronchial cancer.

Three deaths were reported for the study, all of which occurred more
than seven days post-procedure. None of these deaths were related to the
investigational device or procedure.

A summary of observed adverse events for all ablated patients is
provided in the following table:

Table 1 - Observed Adverse Events/Deaths (N=210)

+----------------+-----------+---------------+-----------+-----------+
| Adverse Event  | \%        | Number of     | 95%       |           |
| Cl             | patients  | patients      | C         |           |
| assification\* |           |               | onfidence |           |
|                |           |               |           |           |
|                |           |               | Int       |           |
|                |           |               | erval\*\* |           |
+----------------+-----------+---------------+-----------+-----------+
| Minor          | 6.2       | 13/210        | 3.3       | 10.5      |
+----------------+-----------+---------------+-----------+-----------+
| Major          | 2.4       | 5/210         | 0.8       | 5.7       |
+----------------+-----------+---------------+-----------+-----------+
| Death          | 1.4       | 3/210         | 0.3       | 4.5       |
+----------------+-----------+---------------+-----------+-----------+

\* Categories are mutually exclusive

\*\* Confidence intervals by exact (binomial) method

## B. Potential Adverse Events 

Potential adverse events may be categorized as those which were observed
in the clinical study of the device, and those which were not observed
but which may occur. Adverse events (in alphabetical order) which may be
associated with catheterization and ablation include:

+---------------------------------+------------------------------------+
| -   Air embolism                | -   Pericardial effusion           |
|                                 |                                    |
| -   Arrhythmias                 | -   Pericarditis                   |
|                                 |                                    |
| -   AV fistula                  | -   Pleural effusion               |
|                                 |                                    |
| -   Cardiac                     | -   Pneumothorax                   |
|     perforation/tamponade       |                                    |
|                                 | -   Pseudoaneurysm                 |
| -   Cardiac thromboembolism     |                                    |
|                                 | -   Pulmonary edema                |
| -   Cerebrovascular accident    |                                    |
|     (CVA)                       | -   Pulmonary embolism/tamponade   |
|                                 |                                    |
| -   Chest pain/discomfort       | -   Thrombi                        |
|                                 |                                    |
| -   Complete heart block        | -   Thromboembolism                |
|                                 |                                    |
| -   Coronary artery dissection  | -   Thrombosis                     |
|                                 |                                    |
| -   Coronary artery spasm       | -   Transient ischemic attack      |
|                                 |     (TIA)                          |
| -   Coronary artery thrombosis  |                                    |
|                                 | -   Valvular damage                |
| -   Hemothorax                  |                                    |
|                                 | -   Vascular bleeding/local        |
| -   Increased phosphokinase     |     hematomas                      |
|     level.                      |                                    |
|                                 | -   Vasovagal reactions            |
| -   Laceration                  |                                    |
|                                 | -   Ventricular tachyarrhythmia    |
| -   Local hematomas/ecchymosis  |                                    |
|                                 |                                    |
| -   Myocardial Infarction       |                                    |
+---------------------------------+------------------------------------+

# 

# IX. [SUMMARY OF PRECLINICAL STUDIES]{.underline}

Pre-clinical evaluation of the device system consisted of verification
testing of the generator, system functional testing, verification
testing of the device accessories, software validation, and
electromagnetic compatibility testing.

**A. Verification of generator features, functions, and display**

The table below summarizes the generator-related verification testing.

**Table 2 -** Verification testing of generator functions

+-----------------+------------------+----------------+---------------+
| #######         | **Methods**      | **Acceptance   | **Results**   |
|  Parameter Test |                  | Criteria**     |               |
+=================+==================+================+===============+
| **Display       |                  |                |               |
| Accuracy        |                  |                |               |
| Tests**         |                  |                |               |
+-----------------+------------------+----------------+---------------+
| impedance       | calibrate        | accuracy ± 10% | maximum       |
|                 | resistors at 50, |                | error: 6.5%   |
|                 | 100 and 150 ohms |                |               |
+-----------------+------------------+----------------+---------------+
| time            | compare to       | accuracy ± 0.5 | times within  |
|                 | stopwatch at 30, | sec            | 0.28 sec      |
|                 | 60 and 120s      |                |               |
+-----------------+------------------+----------------+---------------+
| temperature     | measure          | accuracy ± 5°C | maximum       |
| (static)        | temperature in a |                | error:        |
|                 | saline bath at   |                |               |
|                 | 37, 45, 55, 65,  |                | \< 2.4°C      |
|                 | 80, and 85 °C    |                |               |
+-----------------+------------------+----------------+---------------+
| temperature     | record last      | accuracy ± 5°C | maximum       |
| (during RF)     | reading while 50 |                | error:        |
|                 | W is generated   |                |               |
|                 | in a saline bath |                | \< 3.2°C      |
+-----------------+------------------+----------------+---------------+
| power           | measure using    | ± 10%          | maximum       |
|                 | known            |                | error:        |
|                 | resistances over |                |               |
|                 | a range of power |                | \< 5.7 W      |
|                 | settings         |                |               |
+-----------------+------------------+----------------+---------------+
| **Generator     |                  |                |               |
| Cutoff Tests**  |                  |                |               |
+-----------------+------------------+----------------+---------------+
| temperature     | 37±1^o^C         | accuracy ± 5°C | Maximum error |
|                 | temperature bath | for thermistor | 3.2^o^C       |
|                 | and system       | and            | (thermistor)  |
|                 | cutoff set at    | thermocouple   |               |
|                 |                  |                | 2.4^o^C(      |
|                 | 47^o^ C          |                | thermocouple) |
+-----------------+------------------+----------------+---------------+
| impedance       | verify that      | see methods    | pass          |
|                 | generator shuts  |                |               |
|                 | off when         |                |               |
|                 | impedance        |                |               |
|                 | exceeds max      |                |               |
|                 | value (250 ohms) |                |               |
|                 | and min value    |                |               |
|                 | (50 ohms)        |                |               |
+-----------------+------------------+----------------+---------------+
| voltage         | set limit to 50  | verify that    | pass          |
|                 | V, then 100V;    | voltage does   |               |
|                 | operate RF into  | not exceed set |               |
|                 | known load       | limits         |               |
+-----------------+------------------+----------------+---------------+
| current         | set limit to     | verify that    | pass          |
|                 | 500mA; operate   | current does   |               |
|                 | RF into known    | not exceed set |               |
|                 | load             | limits         |               |
+-----------------+------------------+----------------+---------------+

#### 

#### 

**B. System Functional Testing**

#### System functional testing consisted of simulation ablation testing, temperature accuracy testing, and temperature ramping testing.

#### 

#### (1) Simulated Ablation Testing

Simulated ablation testing was conducted using the Stockert 60 RF
generator and two commercially-available RF generators (i.e., EPT-1000
and Medtronic Atakr), along with Biosense Webster Celsius catheters (5
thermocouple and 5 thermistor catheters). Lesions were created in beef
heart tissue samples submerged in a saline bath. The length and depth of
the lesions created with the Stockert generator were consistent with
those created with the EPT-1000 and Medtronic Atakr generators for all
test conditions.

\(2\) Temperature Accuracy Testing

The Stockert and Biosense Webster Celsius catheters were tested to
determine temperature accuracy. Temperature accuracy was determined at
six temperatures ranging from 37-85°C and was shown to be within ±5°C.

#### (3) Temperature Ramp Testing

Temperature ramp testing in a simulated environment using a saline bath
with a temperature of 37°C was conducted on the Medtronic Atakr and EPT
1000 generators to confirm that the recommended lower and upper
temperature ramp rates of 12-50°C per second used in the Stockert
clinical study are comparable to those of these generators. Test data
demonstrated that the recommended ramping rates of 12-50°C per second
for the Stockert 70 RF generator was within the ramping range of the
above currently marketed generators.

**C. Verification of Accessories**

The table below summarizes the accessory-related verification testing.

**Table 3 - Verification Testing of Accessories**

+-------------------+-------------------------+-----------------------+
| **Test and        | ####                    | **Results**           |
| Methods**         | ### Acceptance Criteria |                       |
|                   |                         |                       |
| **(where          |                         |                       |
| applicable)**     |                         |                       |
+===================+=========================+=======================+
| ## Foot Switch    |                         |                       |
+-------------------+-------------------------+-----------------------+
| electrical, per   | Footswitch will         | pass: Footswitch      |
| IEC 60601-2-2,    | function and pass       | withstood 1500 VAC    |
| section 44.6      | dielectric strength     | with leakage occuring |
| addition: aa      | test after being        | at 220 VAC. No        |
|                   | actuated 50 times while | flashover or          |
|                   | completely submerged in | breakdown recorded up |
|                   | 150 mm of water.        | to 3000 VAC.          |
+-------------------+-------------------------+-----------------------+
| mechanical, per   | Footswitch will not     | pass: Footswitch      |
| IEC 60601-2-2,    | operate with a force    | operated with a       |
| section 56.101    | less than 10.0 Newton   | minimum force of 7    |
|                   | (2.25 lbs).             | lbs                   |
+-------------------+-------------------------+-----------------------+
| **Global Port     |                         |                       |
| Interface**       |                         |                       |
+-------------------+-------------------------+-----------------------+
| electrical        | normal connection \<    | pass: leakage current |
| (leakage          | 100 μA                  | = 1 μA                |
| current),         |                         |                       |
|                   | single-fault connection | pass: leakage current |
| per EN 60601-1,   | \< 500 μA               | = 4 μA                |
| section 19.3      |                         |                       |
+-------------------+-------------------------+-----------------------+
| mechanical, per   | Cable retention is a    | pass                  |
| ANSI/AAMI HF-18,  | pull force of 40 Newton |                       |
| section 4.2.5.5   | minimum. Impulse        |                       |
|                   | withstand energy        |                       |
|                   | requirement is 0.64     |                       |
|                   | joules minimum.         |                       |
+-------------------+-------------------------+-----------------------+
| **Interface       |                         |                       |
| Cable**           |                         |                       |
+-------------------+-------------------------+-----------------------+
| electrical, per   | \<549 mA                | pass: leakage current |
| ANSI/AAMI HF-18,  |                         | = 30mA                |
| section 4.2.5.4:  | \<713mA                 |                       |
|                   |                         | pass: leakage         |
| -   HF catheter   | No flashover or         | current=57mA          |
|     cable leakage | breakdown               |                       |
|     current       |                         | pass: no leakage \<   |
|                   |                         | 3000 VAC              |
| -   HF patch      |                         |                       |
|     cable leakage |                         |                       |
|     current       |                         |                       |
|                   |                         |                       |
| -   Dielectric    |                         |                       |
|     withstand     |                         |                       |
+-------------------+-------------------------+-----------------------+
| mechanical, per   | Cable retention is a    | pass                  |
| ANSI/AAMI HF-18,  | pull force of 40 Newton |                       |
| section 4.2.5.5   | minimum. Impulse        |                       |
|                   | withstand energy        |                       |
|                   | requirement is 0.64     |                       |
|                   | joules minimum.         |                       |
+-------------------+-------------------------+-----------------------+

**D. Software Validation**

Validation test activities of system performance and functionality were
conducted to determine whether the operational behavior of the Stockert
70 generator correctly implemented the software and safety requirement
specifications. All software testing passed the acceptance criteria.

**E. Electromagnetic Compatibility\
**The Stockert 70 RF Generator was tested in accordance with the
European Standard EN 60601-1-2: 1993 and other applicable International
Standards. The tests performed and the results of the testing are
detailed in the table below:

**Table 4 - Electromagnetic Compatibility Tests**

+-----------------------------------+-----------------------------------+
| **Test**                          | **Results**                       |
+-----------------------------------+-----------------------------------+
| ######### conducted emissions     | meets EN 60601-1-2: 1993          |
+-----------------------------------+-----------------------------------+
| electric field radiated emissions | meets EN 60101-1-2: 1993          |
+-----------------------------------+-----------------------------------+
| electrostatic discharge           | meets EN 60601-1-2: 1993          |
+-----------------------------------+-----------------------------------+
| electric field radiated           | meets EN 60601-1-2: 1993          |
| susceptibility                    |                                   |
+-----------------------------------+-----------------------------------+
| electrical fast transient         | meets EN 60601-1-2: 1993          |
+-----------------------------------+-----------------------------------+
| ######### surges                  | meets EN 60601-1-2: 1993          |
+-----------------------------------+-----------------------------------+
| voltage dips and interruptions    | meets EN 50082-1: 1997            |
+-----------------------------------+-----------------------------------+

# 

# X. [SUMMARY OF CLINICAL STUDIES]{.underline}

The Biosense Webster Stockert 70 Generator was studied to determine the
safety and effectiveness of the generator, global port and interface
cable in conjunction with the Biosense Webster Celsius(TM)
Diagnostic/Ablation catheter.

**A. Background and Endpoints**

The study was a prospective, multi-center study of 230 patients at 10
institutions.

Acute success was defined as complete elimination of
Wolfe-Parkinson-White syndrome (WPW) or atrioventricular (AV) condicton
pathways, inability to re-induce Atrioventricular Node Reentry
Tachycardia (AVNRT), or complete AV nodal block. Chronic success was
defined as the absence of recurrence of the arrhythmia over a 3 month
monitoring period.

**B. Results**

Of the 230 enrolled patients, a total of 210 patients were ablated and
provide the data set for which safety was evaluated.

Regarding effectiveness endpoints, the patient count included all
patients treated with the investigational device for an arrhythmia
indicated in the study. Patients who began treatment with the
investigational device but were switched to a non-investigational device
were considered failures. A total of 203 patients were treated with the
investigational device for an arrhythmia indicated in the study and were
assessed for acute effectiveness. A total of 200 patients were assessed
for chronic effectiveness (3 patients who were evaluated for acute
effectiveness died due to reasons not related to the device). Seven
patients underwent ablation to treat an arrhythmia which was not
indicated in the study. The other 20 patients were discontinued prior to
ablation for the reasons and occurrence indicated in the table below:

**Table 5 - Study** Discontinuation

  --------------------------------------------- -------------------------
  **Reason**                                    **Number of Patients**

  physician chose not to ablate due to          2
  difficult pathway, close proximity to AV      
  node, unusual location, or other              

  unable to induce protocol arrhythmia          8

  non-protocol arrhythmia                       5

  appropriate cable equipment unavailable       5

  **Total**                                     20
  --------------------------------------------- -------------------------

Of the patients enrolled in the study, 56% were female and 44% of the
patients were male. The percentages of male and female patients is
consistent with disease prevalence. The table below describes the
patient population by indication and age.

**Table 6 - Enrollment and patient age by indication (n=203)**

  ------------------ ------------ ----------- ------------ ---------------
  **Indication**     **Number of              **Age of     
                     Patients**               patients     
                                              (years)**    

                     \%           \#          Mean         Range

  WPW                25.6         52          34.0         10-71

  AVNRT              56.7         115         50.6         7-82

  AV Node Ablation   13.8         28          66.3         22-90

  WPW and other^a^   0.5          1           40.0         40

  AVNRT and other^b^ 3.4          7           50.1         20-66

  **Total**          **100**      **203**     **48.2**     **7-90**
  ------------------ ------------ ----------- ------------ ---------------

> ^a^ Sinus node reentrant tachycardia
>
> ^b^ Atrial tachycardia (n=6) and intra-atrial reentrant tachycardia
> (n=1)

A total of 1,716 RF energy applications were delivered with a mean
number of applications of 10.3 (range 1-60 per patient). The tables
below summarize success by indication.

Table 7 - Acute Success, by indication (n=203)

  -------------------- ------------ ----------- --------------------------
  Indication           \% patients  \# patients 95% Confidence Interval

  WPW                  94.2         49/52       (84.1, 98.8)

  AVNRT                94.8         109/115     (89.0, 98.1)

  AV Node Ablation     96.4         27/28       (81.7, 99.9)

  WPW & Other^a^       100          1/1         (2.5, 100)

  AVNRT & Other^b^     100          7/7         (59.0, 100)

  **Total**            95.1         193/203     (91.1, 97.6)
  -------------------- ------------ ----------- --------------------------

> ^a^ Sinus node reentrant tachycardia
>
> ^b^ Atrial tachycardia (n=6) and intra-atrial reentrant tachycardia
> (n=1)

**Table 8 - Chronic Success (freedom from Recurrence at 3 months), by
indication (n=200^c^**)

  -------------------- -------------- ------------- ----------------------
  Indication           \% patients    \# patients   95% Confidence
                                                    Interval

  WPW                  92.2           47/51         (81.1, 97.8)

  AVNRT                92.1           105/114       (85.5, 96.3)

  AV Node Ablation     92.6           25/27         (75.7, 99.1)

  WPW & Other^a^       100            1/1           (2.5, 100)

  AVNRT & Other^b^     100            7/7           (59.0, 100)

  **Total**            92.5           185/200       (87.9, 95.7)
  -------------------- -------------- ------------- ----------------------

> ^a^ Sinus node reentrant tachycardia
>
> ^b^ Atrial tachycardia (n=6) and intra-atrial reentrant tachycardia
> (n=1)
>
> ^c^ Three (3) patients who were acute successes were lost to follow-up
> due to death not
>
> related to the device.

In separate clinical studies, Biosense Webster collected the data shown
in the table below, which represents an acceptable historical control
population. The same catheters were used in the control studies as in
the Stockert RF generator study, but ablation was performed using other
RF generators.

####### Table 9. Results for Control Patient Population

+------------------------+--------------------+----------+------------+
| **Study Endpoint**     | **Ablation         | **\#     | **%        |
|                        | System**           | pa       | patients** |
|                        |                    | tients** |            |
+------------------------+--------------------+----------+------------+
| acute success          | Celsius catheter + | 676/734  | 92.1       |
|                        |                    |          |            |
|                        | Radio              |          |            |
|                        | nics/Atakr/EPT-100 |          |            |
+------------------------+--------------------+----------+------------+
| chronic success        | Celsius catheter + | 280/306  | 91.5       |
| (freedom from          | Radionics          |          |            |
| recurrence at 3 months |                    |          |            |
+------------------------+--------------------+----------+------------+
| major complications    | Celsius catheter + | 26/741   | 3.51       |
|                        |                    |          |            |
|                        | Radio              |          |            |
|                        | nics/Atakr/EPT-100 |          |            |
+------------------------+--------------------+----------+------------+

The results from a comparison of the study data to the historical data
are shown in the table below.

####### Table 10 - Device Performance Compared to Control Group

+--------+--------+-------+-----------+----------------+------------+
| **Endp | **S    |       | **D       | **One-sided    | **Window   |
| oint** | uccess |       | ifference | 95% Upper      | of**       |
|        | Propor |       | in        | Confidence     |            |
|        | tion** |       | Success   | Bound^1^ on    | **Equ      |
|        |        |       | Propor    | Difference in  | ivalence** |
|        |        |       | tions\*** | Success        |            |
|        |        |       |           | Proportions**  |            |
+--------+--------+-------+-----------+----------------+------------+
|        | **Con  | **    |           |                |            |
|        | trol** | Stock |           |                |            |
|        |        | ert** |           |                |            |
+--------+--------+-------+-----------+----------------+------------+
| acute  | 92.1%  | 95.1% | -3.0%     | 0.01%          | 5.0%       |
| s      |        |       |           |                |            |
| uccess |        |       |           |                |            |
+--------+--------+-------+-----------+----------------+------------+
| c      | 91.5   | 92.5% | -1.0%     | 3.04%          | 4.0%       |
| hronic |        |       |           |                |            |
| s      |        |       |           |                |            |
| uccess |        |       |           |                |            |
+--------+--------+-------+-----------+----------------+------------+
| safety | 96.49% | 9     | -1.13%    | 0.93%          | 4.0%       |
| s      |        | 7.62% |           |                |            |
| uccess |        |       |           |                |            |
+--------+--------+-------+-----------+----------------+------------+

\* Difference in success proportions (control minus treatment)

The safety and effectiveness results from the Stockert study were
demonstrated to be statistically equivalent to the control data. The
one-sided 95% upper confidence bound of the difference in proportions
(control minus treatment) for all three endpoints are well within the
window of equivalence with the historical control.

## C. Temperature Ramping Experience

The table below summarizes the various temperature ramping rates that
were using during ablation in a subset of 23 patients in the clinical
study. The most common temperature ramp rate used was 20°C/sec (60.9%,
14/23 patients).

####### Table 11. Temperature Ramping Experience

  ------------------------------------------- ---------------------------
  **Temperature Ramping Rate**                **\# patients (n=23)**

  12°C/sec                                    4 (17.4%)

  20°C/sec                                    14 (60.9%)

  30°C/sec                                    3 (13%)

  50°C/sec                                    1 (4.3%)

  12°C/sec and 20°C/sec                       1 (4.3%)
  ------------------------------------------- ---------------------------

**XI. [CONCLUSIONS DRAWN FROM THE STUDIES]{.underline}**

## Pre-clinical testing demonstrated that the system meets or exceeds safety, reliability and performance specifications. 

Clinical testing and statistical analyses demonstrate that the Stockert
70 RF generator is reasonably safe and effective for the stated
indications under the proposed conditions of use.

**XII. [PANEL RECOMMENDATION]{.underline}**

Pursuant to the provision of Section 515 (c) (2) of the Food and Drug
and Cosmetic Act (FD&C) as amended by the Safe Medical Devices Act of
1990 (SMDA 1990), this PMA application was not referred to the
Circulatory System Devices Panel, and FDA Advisory Panel Committee, for
review and recommendation because the information in the PMA
substantially duplicates information previously reviewed by this Panel.

**XIII. [FDA DECISION]{.underline}**

FDA determined that the device is reasonably safe and effective when
used as indicated in the labeling. CDRH issued an approval order for the
applicant's PMA, P990071, on May 31, 2000.

**XIV. [APPROVAL SPECIFICATION]{.underline}**

Directions for Use: See final approved labeling (User's Manual).

Hazards to Health from Use of the Device: See Indications,
Contraindications, Warnings and Precautions, and Adverse Events in the
final approved labeling (User's Manual).