[SUMMARY OF SAFETY AND EFFECTIVENESS DATA]{.underline}

I.  GENERAL INFORMATION

> [Device Generic Name]{.underline}: Fiberoptic Diagnostic Analyzer
> (colon)
>
> [Device Trade Name]{.underline}: Optical Biopsy System
>
> [Applicant's Name and Address]{.underline}: *Spectra*Science, Inc.
>
> 14405 21^st^ Avenue, N. Suite 111
>
> Minneapolis, Minnesota 55447
>
> [Premarket Approval Application]{.underline}
>
> [(PMA) Number:]{.underline} P990050
>
> [Date of Panel Recommendation]{.underline}: November 19, 1999
>
> [Date of Notice of Approval to Applicant]{.underline}: November 14,
> 2000

II. INDICATIONS FOR USE

The SpectraScience Optical Biopsy System is indicated for use as an
adjunct to lower gastrointestinal (GI) endoscopy. The device is intended
for the evaluation of polyps less than 1 cm in diameter that the
physician has not already elected to remove. The device is only to be
used in deciding whether such polyps should be removed (which includes
submission for histological examination).

III. CONTRAINDICATIONS

The use of this device is contraindicated in patients who:

-   Have pre-existing abnormalities of the coagulation system which
    contraindicate endoscopic biopsy and/or polypectomy.

-   Have other conditions that prevent endoscopic biopsy or removal of
    colonic polyps.

-   Have familial polyposis.

IV. WARNINGS AND PRECAUTIONS

Warnings

-   If this device is used when the physician, absent this device, would
    remove [all]{.underline} visualized polyps, this device will lead to
    an increase in the number of potentially pre-cancerous or cancerous
    polyps that are not removed (i.e., it will decrease the physician\'s
    sensitivity).

-   If this device is used when a physician, absent this device, would
    only remove polyps that his/her visual assessment suggests are
    adenomatous, then this device will not only increase the number of
    removed polyps that turn out to be pre-cancerous or cancerous, but
    will also increase the number of removed polyps that turn out to be
    hyperplastic (i.e., while the device will increase the physician\'s
    sensitivity, it will also decrease her/his specificity).

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-   To properly use the device, the physician must move the fiber to
    three different regions of the same polyp and obtain three distinct
    spectral measurements. The accuracy of the device to distinguish
    between \"suspect\" and \"not-suspect\" polyps is dependent upon
    obtaining three distinct measurements from each polyp.

-   To properly use the device, the physician must obtain a spectral
    reading from normal tissue within the patient\'s colon. The device
    cannot provide an evaluation without this information.

Other warnings and precautions can be found in the Physician Labeling.

V.  DEVICE DESCRIPTION

The Optical Biopsy System (OBS) is a laser-operated, diagnostic system
that consists of the following main components:

-   OBS console, which provides the primary interface between the user
    and device;

-   OBS fiber, which transmits and collects laser light energy; and

-   system software, which contains the analytical algorithm.

The OBS may be used with any lower-GI endoscope with a 2.8 mm inner
diameter working channel. Accessories include biopsy forceps which are
used to obtain tissue samples of the colonic polyps.

[OBS Console]{.underline}

The OBS console is housed in a transportable self-contained cabinet. The
console includes the laser source, spectrophotometer, computer control
module, display, keyboard, and power supply. The operation of the
console is controlled by the user, who operates the keyboard and
footswitch controls. The console includes a high resolution liquid
crystal display which provides step-by-step instructions for the user to
complete the procedure. The display also provides the results of the
spectral analysis. The laser is a Class I laser device and conforms to
the regulation outlined in 21 CFR Chapter 1, Subchapter J, 1040.10
(Laser Products) and 1040.11 (a) (Medical Laser Products).

[OBS Fiber]{.underline}

The optical fiber features three main layers: a silicone core, a
silicone cladding, and a polyimide buffer. The core provides the conduit
through which light energy is transmitted to and from the target polyp.
The cladding prevents the loss of light energy through the silica core.
The buffer provides structural integrity for the silica core. The fiber
is intended for single use only.

[System Software]{.underline}

The system software includes an algorithm which analyzes the spectra
data collected by the OBS filter. Based upon the spectral data, the
algorithm classifies the polyp as \"suspicious\" or \"not suspicious.\"
This information is displayed on the console screen.

[Mechanism of Action]{.underline}

The mechanism of action of this device is based on the principle of
autofluorescence, i.e., when energy is applied to tissue, the tissue
emits light energy at a specific wavelength intensity and pattern.
Different tissues, i.e., hyperplastic and adenomatous polyps, emit this
energy at different patterns that can be distinguished from one another.
With the OBS, the energy originates with the laser source housed within
the OBS console. The laser energy is delivered to the target polyp
through the optical fiber at a pre-defined intensity and energy level.
The energy is absorbed by the target polyp, which then emits
autofluorescence back through the optical fiber. The autofluorescence is
recorded and measured by the system software. By comparing the received
spectral information to the spectra of adenomatous and hyperplastic
tissue, the device determines whether the tissue is \"suspicious\"
(adenomatous) or \"not suspicious\" (hyperplastic).

**VI. ALTERNATIVE PRACTICES OR PROCEDURES**

The evaluation of the colon for presence of colonic polyps pre-disposed
toward colon cancer takes place primarily in one of these
tests/procedures: fecal occult blood tests, and endoscopic examinations.

Fecal occult blood tests (FOBT) use chemical indicators on stool samples
to detect the presence of blood (or its derivatives) not otherwise
visible. A positive result may indicate the need for further diagnostic
procedures. Possible medical conditions associated with a positive FOBT
include colorectal and gastric cancer, ulcers, hemorrhoids, and
inflammatory bowel disease.

Two types of endoscopic procedures are performed to evaluate the colon:
sigmoidoscopy and colonoscopy. In sigmoidoscopy, the lower third of the
colon is visually examined, whereas in colonoscopy, the entire length of
the colon is examined.

**VII. MARKETING HISTORY**

The OBS has not been marketed in the United States or any foreign
country.

VIII. **POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH**

There were no adverse effects observed or documented during the clinical
evaluation of the OBS. Potential complications which were not seen
during clinical evaluation include inadvertent perforation of colon with
the optical fiber or components; excessive exposure of the patient to
laser energy due to device malfunction; excessive bleeding; other risks
associated with sigmoidoscopy or colonoscopy.

**IX. SUMMARY OF PRE-CLINICAL TESTING**

The pre-clinical information submitted for the Optical Biopsy System
consisted of laser safety, electrical safety/electromagnetic
compatibility, biocompatibility, sterilization, *in vitro* bench testing
, and software validation and verification information.

**Laser Safety**

The laser safety information consisted of a computational evaluation of
the maximum laser energy that may be delivered from the optical fiber.
Based on the 337 nanometer (nm) pulsed nitrogen laser, the maximum laser
energy delivered to the optical bulkhead per pulse was determined to be
40.7 microjoules (μJ) with a peak power of 8.14 kilowatts (kW) (minimum)
and 10.85 kW (maximum). The total laser energy delivered to the tissue
for one tissue examination (six pulses) was calculated to be 3.178
millijoules (mJ)/mm^2^. This value is an order of magnitude below the
threshold limit value for chemical substances, physical agents, and
biological exposure indices, as specified by the American Conference of
Government Industrial Hygienists (ACGIH). Although this threshold limit
is specifically intended to address skin exposure to laser energy, FDA
determined that this limit provided an adequate safety margin for
exposure to mucosal tissue. It was concluded that the ultraviolet (UV)
radiation exposure generated from the OBS does not pose an unacceptable
risk for mutagenicity or carcinogenicity if used as intended.

**Electrical Safety/Electromagnetic Compatibility**

The electrical safety/electromagnetic compatibility information
consisted of testing performed by an independent laboratory to evaluate
the electrical safety of the OBS. The laboratory tested the device for
compliance with these standards: International Electrotechnical
Commission (IEC) 60601-1, IEC 60601-1-2 and European Commission for
Standardization CEN EN 55011. This evidence provides adequate
characterization of electrical safety and electromagnetic compatibility
of the device.

**Biocompatibility**

The only patient-contacting component of the device is the optical
fiber, composed of fused silica and polyimide. This fiber was cleared
for marketing under a prior marketing application, K973611 for a
duration and placement of use similar to its use with the OBS.
Therefore, the biocompatibility of these materials was previously
established for this intended use.

***In Vitro* Bench Testing**

The bench testing for the OBS focused on the integrity of the optical
fiber when inserted into the endoscope. The specific tests conducted
were assembly friction test, fiber fatigue test, pull test of the
connector and optical fiber jacket, clamp force test, and energy
transmission test. Five samples of the OBS fiber were used for each
test. These tests are described in more detail below.

A. [Assembly Friction Test]{.underline}

The purpose of this test was to assess whether the optical fiber could
be passed through the endoscope without excessive resistance. In the
test, the optical fiber was inserted into the biopsy forceps and was
advanced until the end of the fiber slightly extended from the forceps.
All 5 samples successfully passed this test.

B. [Fiber Fatigue Test]{.underline}

The purpose of this test was to determine whether the optical fiber
would retain its mechanical integrity and light transmission properties
when subjected to axial movement through a 25 mm-radius tube. This test
was intended to simulate movement of the fiber through an endoscope. In
the test, the fiber was subjected to 50 cycles of movement through the
length of the tube. All five samples successfully passed this test.

C. [Pull Test of SMA Connector and Optical Fiber Jacket]{.underline}

The purpose of this test was to determine whether the joint between the
SMA connector and optical fiber jacket will stay intact when subject to
a pull force of 10 lb., an acceptable specification given the device\'s
intended use. The results of the test showed that the force at which
separation occurred was 85.1 lb. Thus, the device successfully passed
this test.

D. [Clamp Force Test]{.underline}

The purpose of this test was to determine that the clamp force on the
tubing was greater than 1 lb., an acceptable specification given the
device\'s intended use. The results of the test showed that the force of
the clamp was 6.45 lb. Thus, the device successfully passed this test.

E. [Energy Transmission Test]{.underline}

The purpose of this test was to determine how efficient the optical
fiber was in transmitting the energy delivered from the laser source. In
this test, the optical fiber was connected to the laser source at one
end. The other end was connected to a calibrated Molectron JD2000
Joulemeter. A series of 15 laser pulses were sent through the fiber and
the energy input and output were measured. The pass criterion was that
the energy loss from the optical fiber is less than 30% of the initial
energy output sent from the laser source. The results of the test showed
that the energy loss from the fiber was 17%. Thus, the device
successfully passed this test.

**Sterilization**

The sterilization information was provided on the OBS optical fiber,
which is the only component provided sterile. The fiber is sterilized
with 100% ethylene oxide (EtO) to a sterility assurance level of 10^-6^.
The sterilization method was validated in accordance with International
Organization for Standardization (ISO) 11135: 1994 \"Medical devices \--
Validation and routine control of ethylene oxide sterilization.\" The
residual levels for EtO, ethylene chlorohydrin, and ethylene glycol were
within acceptable limits as specified in the 1978 Proposed Rule for
maximum residual levels. The device is packaged in a Tyvek/Mylar pouch
and heat sealed. The package integrity was validated in accordance with
ANSI/AAMI/ISO 11607:1998 \"Packaging of terminally sterilized medical
devices.\" The device was tested for and successfully passed the
shipping and handling durability test requirements of ASTM D4169-96
\"Standard Practice for Performance Testing of Shipping Containers and
Systems.\"

**Shelf Life**

The only component of the OBS which required a shelf life was the
optical fiber, which was previously cleared for marketing under K973611
with a 1-year shelf life. Since no changes in product package,
materials, or design were made from the device cleared under K973611, no
changes in shelf life for the optical fiber were required.

**Software**

The software of the device was considered to present a moderate risk,
given that the software controls the delivery of energy from a 337 nm
laser, which, if not properly controlled, may cause injury to the
patient. Software validation and verification information included
software description, hazard analysis, software requirements
specification, architectural design chart, design specification, and
traceability analysis. The verification and validation testing confirmed
that the device software performed as designed.

**X. SUMMARY OF CLINICAL STUDIES**

The clinical studies of the OBS system were conducted in two phases.

***Phase I***

In the first phase (Phase I), data were collected to develop the
diagnostic algorithm to be validated in the Phase II study. A total of
183 specimens from 86 subjects at three investigational sites were
evaluated in the Phase I study. Background information on these study
participants is listed in Table 1. Complete spectral characterization,
the endoscopist\'s visual assessment, and consensus pathology diagnoses
were obtained for 97 polyps and 86 \"normal\" control tissue samples.

Table 1 - Background Information from Phase I Study

+------------------------------+----------+-------------+-------------+
| **Characteristic**           | **Male** | **Female**  | **Total**   |
+==============================+==========+=============+=============+
| Number of subjects           | 56       | 30          | 86          |
+------------------------------+----------+-------------+-------------+
| Age, range (years)           | 45-86    | 40-86       | 40-86       |
|                              |          |             |             |
| mean + SD                    | 63.39 ±  | 64.86 ±     | 63.89 ±     |
|                              | 9.52     | 15.93       | 12.06       |
+------------------------------+----------+-------------+-------------+
| Number of polyps evaluated   | 64       | 33          | 97          |
+------------------------------+----------+-------------+-------------+
| true adenomas biopsied       | 35       | 21          | 56          |
+------------------------------+----------+-------------+-------------+
| true hyperplastic polyps     | 19       | 8           | 27          |
| biopsied                     |          |             |             |
+------------------------------+----------+-------------+-------------+
| polyps classified as         | 10       | 4           | 14          |
| \"normal\"                   |          |             |             |
+------------------------------+----------+-------------+-------------+

The \"true\" status of each polyp, as classified above, was determined
by histological examination. Polyps were classified as adenomatous,
hyperplastic, or \"normal\" and ranged in size from 3 - 25 mm. The
\"normal\" classification refers to those tissue samples which during
endoscopic evaluation were thought to be polyps, but were determined to
be normal tissue during the histological exam.

Based on the data obtained from this study, an algorithm was developed
that evaluated the spectral characteristics to distinguish between
adenomatous and hyperplastic polyps.

***Phase II***

The purpose of the Phase II study was to validate the algorithm
developed from the Phase I study, i.e., to measure the ability of the
OBS device during colonoscopy to discriminate between adenomatous and
hyperplastic polyps by classifying them as \"suspect\" and \"not
suspect,\" respectively.

[Study Design]{.underline}

The Phase II trial was a prospective, non-randomized, multi-center study
of 101 subjects at 5 sites. Patients who participated in the study had
been previously referred to colonoscopy and had at least one polyp
identified. The patient\'s participation in the study was limited to the
single colonoscopy procedure where the device was used (i.e., the
patient was not followed after the completion of the procedure). The
results of the OBS analysis were not known to the physician; therefore,
patient treatment was not affected.

[Patients Studied]{.underline}

Characteristics of the patients studied, stratified by sex, are
presented in Table 2.

Table 2 - Background Information from Phase II Study

+--------------------------------+-------------+----------+----------+
| **Characteristic**             | **Male**    | **       | *        |
|                                |             | Female** | *Total** |
+================================+=============+==========+==========+
| Number of subjects             | 61          | 40       | 101      |
+--------------------------------+-------------+----------+----------+
| Age, range (years)             | 30-91       | 50-83    | 30-91    |
|                                |             |          |          |
| mean + SD                      | 60.99 ±     | 67.22 ±  | 63.57 ±  |
|                                | 6.53        | 4.36     | 6.12     |
+--------------------------------+-------------+----------+----------+
| Number of polyps identified    | 107         | 70       | 177      |
+--------------------------------+-------------+----------+----------+
| Number of polyps evaluable^†^  | 79          | 56       | 135      |
+--------------------------------+-------------+----------+----------+
| true adenomas biopsied         | 45          | 36       | 81       |
+--------------------------------+-------------+----------+----------+
| true hyperplastic polyps       | 20          | 15       | 35       |
| biopsied                       |             |          |          |
+--------------------------------+-------------+----------+----------+
| polyps classified as           | 14          | 5        | 19       |
| \"normal\"                     |             |          |          |
+--------------------------------+-------------+----------+----------+

-   The number of polyps evaluable is defined as those polyps for which
    a complete spectral analysis was performed and for which a normal
    tissue biopsy was obtained. The number of subjects is based on the
    number of polyps evaluable, and not the total number of polyps
    identified.

The inclusion criteria for the study included:

-   presence of at least 1 polyp on prior endoscopic examination.

The exclusion criteria included:

-   coagulopathy or other conditions contraindicating endoscopic biopsy
    or polypectomy;

-   other conditions which prevent the removal or biopsy of colonic
    polyps;

-   presence of familial polyposis.

[Methods]{.underline}

Patients were prepared for a standard colonoscopy procedure according to
the practice at each investigational site. The optical fiber and forceps
were inserted through the working channel of the colonoscope.

When a polyp was identified, the physician documented: (1) whether they
believed the polyp was adenomatous (or pre-cancerous, pre-malignant) or
hyperplastic based on their visual assessment; and (2) whether they
would remove the polyp. The OBS probe was then applied to the polyp.

The \"test\" spectral measurements were obtained in the following
manner: The optical fiber was placed on a region of the polyp; the OBS
pedal was depressed, triggering the release of laser energy to the
polyp; the tissue\'s autofluorescence was reflected back through the
fiber and evaluated by the analytical software. This step was repeated
twice, such that spectral information from three different locations on
the polyp were obtained. If the OBS was unable to decipher all three
measurements, then the diagnostic procedure was not completed and the
polyp was considered unevaluable. A \"normal\" control spectral
measurement was obtained on a region of \"normal\" mucosa near the
location of the target polyp. Once three spectral polyp readings and a
\"normal\" reading were obtained, the data were processed through the
system algorithm. During the study, the physician performing the
procedure was blinded to the system results. The polyp was then
biopsied.

All tissue samples were evaluated by two pathologists to confirm
histology. This included a \"reference\" pathologist who evaluated all
specimens, as well as the institutional pathologist who regularly
evaluated specimens at that site. If the diagnoses by the pathologists
differed, then the tissue sample was reevaluated by each pathologist. If
the diagnoses differed a second time, then the specimen was excluded
from further analysis.

[Effectiveness Results]{.underline}

The effectiveness of the OBS was characterized by its ability to
correctly identify adenomatous polyps as adenomatous (characterized as
sensitivity of the machine) and to correctly identify hyperplastic
polyps as hyperplastic (characterized as the specificity of the
machine). The data presented below include those polyps which were 1 cm
or smaller in size that were evaluable in the Phase II study. Polyps
were considered \"evaluable\" if a complete spectral data set was
obtained on both the target polyp and the adjacent \"normal\" tissue,
and if all documentation was complete.

***Sensitivity/Specificity Results***

The sensitivity and specificity of the device alone (OBS), physician
alone (based on visual assessment), and combined device and physician
are presented in Tables 3, 4, and 5, respectively.

> **[Table 3 - Sensitivity/Specificity of Device Alone]{.smallcaps}**
>
> **n = 135 evaluable polyps ≤ 1 cm**

+---------------+-------------------+------------------+--------------+
|               |                   | Pathology        |              |
+---------------+-------------------+------------------+--------------+
|               |                   | adenomatous      | hyperplastic |
+---------------+-------------------+------------------+--------------+
| > Device      | adenomatous       | 64               | 24           |
+---------------+-------------------+------------------+--------------+
| > Alone       | hyperplastic      | 17               | 30           |
+---------------+-------------------+------------------+--------------+
| > Sensitivity |                   | 79.0%            |              |
|               |                   | (68.5-87.3)      |              |
+---------------+-------------------+------------------+--------------+
| > Specificity |                   | 55.6%            |              |
|               |                   | (41.4-69.1)      |              |
+---------------+-------------------+------------------+--------------+
| > False       |                   | 44.4%            |              |
| > Positive    |                   |                  |              |
| > Rate        |                   |                  |              |
+---------------+-------------------+------------------+--------------+
| > False       |                   | 21.0%            |              |
| > Negative    |                   |                  |              |
| > Rate        |                   |                  |              |
+---------------+-------------------+------------------+--------------+

> **[Table 4 - Sensitivity/Specificity of Endoscopist\'s Visual
> Assessment Alone]{.smallcaps}**
>
> n = 135 evaluable polyps ≤ 1 cm

+---------------+-------------------+------------------+--------------+
|               |                   | Pathology        |              |
+---------------+-------------------+------------------+--------------+
|               |                   | adenomatous      | hyperplastic |
+---------------+-------------------+------------------+--------------+
| > Physician   | adenomatous       | 67               | 27           |
+---------------+-------------------+------------------+--------------+
| > Alone       | hyperplastic      | 14               | 27           |
+---------------+-------------------+------------------+--------------+
| > Sensitivity |                   | 82.7%            |              |
|               |                   | (72.7-90.2)      |              |
+---------------+-------------------+------------------+--------------+
| > Specificity |                   | 50.0%            |              |
|               |                   | (36.1-63.9)      |              |
+---------------+-------------------+------------------+--------------+
| > False       |                   | 50.0%            |              |
| > Positive    |                   |                  |              |
| > Rate        |                   |                  |              |
+---------------+-------------------+------------------+--------------+
| > False       |                   | 17.3%            |              |
| > Negative    |                   |                  |              |
| > Rate        |                   |                  |              |
+---------------+-------------------+------------------+--------------+

**[Table 5 - Sensitivity/Specificity of Combined OBS and Endoscopist\'s
Visual Assessment^†^]{.smallcaps}**

> **n = 1**35 evaluable polyps ≤ 1 cm

+-----------------------+----------------+---------------+------------+
|                       |                | Pathology     |            |
+-----------------------+----------------+---------------+------------+
|                       |                | adenomatous   | hy         |
|                       |                |               | perplastic |
+-----------------------+----------------+---------------+------------+
| > Combined Device     | adenomatous    | 78            | 36         |
+-----------------------+----------------+---------------+------------+
| > and Physician       | hyperplastic   | 3             | 18         |
+-----------------------+----------------+---------------+------------+
| > Sensitivity         |                | 96.3%         |            |
|                       |                | (89.6-99.2)   |            |
+-----------------------+----------------+---------------+------------+
| > Specificity         |                | 33.3%         |            |
|                       |                | (21.1-47.5)   |            |
+-----------------------+----------------+---------------+------------+
| > False Positive Rate |                | 66.7%         |            |
+-----------------------+----------------+---------------+------------+
| > False Negative Rate |                | 3.7%          |            |
+-----------------------+----------------+---------------+------------+

-   For Table 5, if [either]{.underline} the device classified the polyp
    as \"suspect\" or the physician classified the polyp as adenomatous,
    then the combined classification for that polyp was adenomatous.
    Thus, the only case where the polyp was classified as hyperplastic
    was when the device classified the polyp as \"not suspect\"
    [and]{.underline} the physician classified the polyp as
    hyperplastic.

The results presented above demonstrated a statistically significant
improvement in sensitivity when the OBS was used in conjunction with the
physician\'s visual assessment during colonoscopy, according to the
approved Indications for Use.

[Safety Results]{.underline}

No adverse events (i.e., patient complications) were observed by study
investigators or reported by study subjects.

XI. **CONCLUSIONS DRAWN FROM THE STUDIES**

The pre-clinical studies included laser safety, electrical safety,
electromagnetic compatibility, biocompatibility, and functional testing.
The bench tests validated the safety of the device for the proposed
intended use. The software documentation validated that the device
algorithm performs according to its set specifications.

The pivotal (Phase II) clinical study demonstrated that the combined
discriminatory ability of the OBS device and physician was improved over
the discriminatory ability of the physician alone.

The effectiveness of the OBS device was demonstrated for the clinical
setting in which the physician bases the decision to remove a polyp on
his/her discriminatory ability. In this setting, the physician\'s
sensitivity to remove adenomatous polyps is less than 100%. As a result,
when labeled as an adjunctive tool, this device will increase the number
of adenomatous polyps that are biopsied (i.e., increase the physician's
sensitivity). However, the device will also increase the number of
hyperplastic polyps that are biopsied (i.e., decrease the physician's
specificity).

In contrast, the effectiveness of the OBS device was not demonstrated
for the clinical setting in which the physician removes
[all]{.underline} polyps which are visualized. In this setting, the
physician\'s sensitivity to identify adenomatous polyps is 100% (with a
specificity of 0%). As a result, the device cannot improve this
physician\'s sensitivity. The risk of not removing an adenomatous polyp
outweighs the benefit of reducing the number of hyperplastic polyps that
are biopsied. The risk of removing a polyp \< 1 cm is minimal.

Regarding device safety, the clinical study suggested that the device
will not expose patients to an unreasonable or significant risk of
illness or injury, as the most likely adverse events would not be
directly associated with the use of this device, but with the lower GI
endoscopic procedure.

Overall, the pre-clinical and clinical studies provide reasonable
assurance that, when used in a manner consistent with the indications,
contraindications, warnings, and precautions specified in the labeling,
the OBS device is safe and effective.

XII. **PANEL RECOMMENDATION**

At an advisory meeting held on November 19, 1999, the Gastroenterology
and Urology Devices Advisory Panel recommended that *Spectra*Science\'s
PMA for the Optical Biopsy System be approved, subject to submission of
and approval by the Center for Devices and Radiological Health (CDRH) of
a post-approval study. This post-approval study would evaluate the
performance of the OBS device in the context of sigmoidoscopy and by
physicians who are less experienced and skilled than those who
participated in the Phase II clinical study.

**XIII. CDRH DECISION**

CDRH concurred with the Panel\'s recommendation regarding device
approval. However, CDRH determined that a post-approval study was not
required to evaluate the performance of the device when used in a
different clinical setting. CDRH determined that the sponsor submitted
sufficient safety and effectiveness data on the device\'s performance
and that the performance of the device during the conditions described
by the Indications for Use statement can be reasonably extrapolated from
the existing clinical data.

FDA inspection determined the manufacturing facility to be in compliance
with the device Quality System regulations.

XIV. **APPROVAL SPECIFICATIONS**

Directions for use: See the labeling.

Hazards to Health from Use of the Device: See Indications,
Contraindications, Warnings, Precautions, and Adverse Events in the
labeling.