SUMMARY OF SAFETY AND EFFECTIVENESS DATA

**I. [GENERAL INFORMATION]{.underline}**

Device Generic Name: Sharps Needle Destruction Device for Insulin
Needles

# Device Trade Name: The Disintegrator Insulin Needle Destruction Unit

Applicant's Name and Address:

Mr. Joey Adkins

Safeguard Medical Devices, Inc.

403 Ken Mar Industrial Parkway

Unit \# 475

Broadview Heights., Ohio 44147

Premarket Approval (PMA) Application number: P010040

Date of Notice of Approval to the Applicant: March 15, 2002

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

> The Disintegrator is an insulin needle destruction unit for home use.
> It is a sharps needle destruction device that is designed to
> incinerate 27-30 gauge insulin needles, 5/16 to ½ inch in length,
> attached to insulin pens and disposable insulin syringes of 1/3cc to
> 1cc volume sizes.

**III.** **[CONTRAINDICATIONS]{.underline}**

> There are no known contraindications for the use of this device.

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

> The warnings and precautions can be found in the attached instruction
> sheet and device labeling for the Disintegrator.

**V. [DEVICE DESCRIPTION]{.underline}**

> The Disintegrator is a home use, portable sharps needle destruction
> device for diabetics. It uses electrical current to incinerate 27-30
> gauge insulin hypodermic needles 5/16 to 1/2 inch in length attached
> to insulin pens and disposable insulin syringes of 1/3 cc to 1 cc
> volume in size. The Disintegrator uses a rechargeable 9.6-volt battery
> to deliver an electrical current to produce an arc of electricity
> directed at the tip of the needle. This arc of electricity melts the
> tip of the needle and disintegrates the needle. Any balls of melted
> metal that fall off during the process are collected into a chamber
> where the ash or ball is sealed and does not need to be emptied. The
> remaining stub of the needle on the hub is less than 1/16^th^ inch in
> length. The device also includes a small molded port at the top, which
> is a needle straightener, for use in straightening needles that are
> bent prior to destruction.
>
> The Disintegrator uses a large button as the switch to turn on the
> device and activate the circuit that supplies the charge. There is a
> low battery charge light that is yellow, which is found at the top of
> the device. Before first use, the Disintegrator battery should be
> charged for 12 hours. A fully charged battery is indicated by a green
> light located next to the yellow light. When the green light is lit
> this device will disintegrate 30-40 needles before needing to
> recharge. The Disintegrator unit can be powered from a battery and/or
> AC current by a wall transformer. The battery can be recharged by the
> wall transformer within 45 to 90 minutes. The Disintegrator can be
> utilized when the battery is recharging. The device exterior surface
> is off-white PC/ ABS (flame-retardant) Resin with a blue needle port.
> The tear shaped Disintegrator measures 6\"X4"X 2\" and weighs 2
> pounds. The Disintegrator is to be used in closed proximity to the
> site of needle use.

**VI. [ALTERNATIVE PRACTICES AND PROCEDURES]{.underline}**

> Alternative disposal methods of insulin syringes and pen needles
> include placement in a sealed puncture proof container prior to
> discarding in the trash or transporting to a sharps collection center;
> or use of another commercially available needle destruction device.

**VII. [MARKETING HISTORY]{.underline}**

> The Disintegrator Insulin Needle Destruction Unit was introduced into
> Canada in June of 2001. Approximately 150 units are currently in use
> with no report of any customer complaints. The Disintegrator Insulin
> Needle Destruction Unit has not been withdrawn from marketing for any
> reason relating to the safety and effectiveness of the device.

**VII. [POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH]{.underline}**

> There are no anticipated adverse effects on patient health from the
> use of The Disintegrator. No adverse effects were reported during the
> clinical studies. Failure of the device to destroy the needle subjects
> the user to no greater risk than would be encountered with no use of a
> destruction device. Failure of the device to fully destroy the needle
> still results in a blunted and completely sealed needle tip.

**IX. [SUMMARY OF NON-CLINICAL STUDIES]{.underline}**

### Mechanical / Positional Stability

The device is supported with raised legs along the outer perimeter of
the bottom, resulting in extreme stability during use. Tests were
performed to determine whether the unit could be made to tip over by
activating the "button" from various angles.

> Results: The device remained stable during all tests.
>
> Conclusion: The results of stability testing indicate that The
> Disintegrator is not prone to tipping during use.

### Structural Integrity

> Independent laboratory tests were performed to test the structural
> strength of The Disintegrator according to standards outlined in
> UL-2601.
>
> Results: The device passed all tests.
>
> Conclusion: The housing strength of the device is acceptable.

### Ergonomic Considerations

> The Disintegrator is designed with the needle port, needle
> straightening aid, and actuator button all on centerline. The
> indicators are equidistant from center and are visible from a wide
> viewing angle of approximately 120 degrees. In-house tests were
> conducted with both left and right-handed individuals to determine
> comparative ease of use.
>
> Results: The device was found equally usable by both left and right
> handed individuals.
>
> The prospective clinical study protocols required representation of
> both left- handed and right handed patients.
>
> Results: There were no reports of difficulty in use attributable to
> the patient being left or right handed.
>
> Conclusion: The Disintegrator may be used with equal efficiency and
> effectiveness by either left or right handed individuals.

### Generation of Noise

Measurement of noise during the destruction cycle was taken at a
distance of 18 inches from the device.

> Results: The increase in noise level during destruction was less than
> 3 dB, the minimum change normally detectable by the human ear.
>
> Conclusion: The device poses no potential of excess noise generation.

### Generation of Heat

The temperature of the case at the port entry was monitored during the
destruction of 10 needles over a 10 minute period (much more rapid than
anticipated for a single insulin user).

> Result: A total temperature rise of less than 5 degrees F was
> measured.
>
> Independent laboratory tests were performed to determine the
> temperature rise on various internal components during both normal and
> intentional misuse, as well as in specific "failure" modes, according
> to safety standards outlined in UL-2601.
>
> Results: All tested components had a temperature rise within the
> limits of the UL-2601 standard.
>
> Conclusion: Neither external nor internal temperature rise during the
> needle destruction process poses a threat to the user.

### Formation of Sparks

During the in-house destruction of over 4,000 needles to date, no notice
was made of any sparks generated outside the unit. Although reports of
visible sparks inside the unit were recorded by some of the Study
Subjects involved in the Clinical Trials, there were no reports of
visible external sparks.

Results: There were no visible sparks generated outside the unit during
destruction.

Conclusion: As no sparks were visible outside the unit, it is concluded
that no direct user hazard exists from sparks. However, it is known that
the device uses an internal low-powered electric arc to dispose of the
metal needle body. For this reason, the unit should not be used near
flammable gases or liquids. The Disintegrator is labeled accordingly.

###  

### Electrical Shock Hazard and Electromagnetic Compatibility

The Disintegrator is powered with a rechargeable 9.6 volt Ni-Cad
battery incapable of shock hazard. The device is designed to prevent
operation in the event that the case or battery / ash door has been
opened. The AC adapter selected for recharging the battery is an
off-the-shelf sealed unit listed under both UL and CSA standards.

An independent laboratory study was conducted to evaluate the electrical
safety of The Disintegrator according to UL 2601-1 (1997 edition).

Results: The unit passed all applicable requirements for electrical
safety.

Additional laboratory testing of EMC levels was performed to EN-55011
standards. Tests were performed on a "Disintegrator" unit that contained
no added shielding for EMI, as manufactured for the consumer market.
Tests were also performed on a unit with shielding added in the form of
EMI conductive paint, as might be the case for "Disintegrator" units
intended for U.S. clinical sales.

Results: The unshielded unit showed short peaks of some radiated signals
slightly above the limits of EN-55011. Modifications were made to the
unit in the form of EMI conductive paint on the internal walls. This
unit showed reductions in all radiated emissions to well below the
limits of EN-55011.

Conclusions: Electrical safety and EMI test results are acceptable for
the device as intended for use by consumers. EMI test results show that
units intended for use in U.S. clinical settings would need to be
manufactured utilizing EMI shielding materials.

### Emission of Toxic Fumes

The Disintegrator was tested during operation to identify and qualify
airborne contaminates potentially generated by destruction of ten 27
gauge needles 1/2 inch in length. The test was designed to analyze the
components of the needles based on their potential to cause deleterious
health effects. These components were determined to be chromium, nickel,
manganese and iron. An airtight chamber with a sampling pump was
constructed to collect and filter air samples during operation of the
unit. Three trials were performed with 10 syringes, each equipped with a
½ inch by 27 gauge needle, were tested over a 10 minute period per trial
and the mass of each of these elements found in the filtered air was
measured using a Perkin Elmer Sciex, Elan 5000, ICP / Mass Spec system.
The concentration of the materials found in the sampled air were
determined, by extrapolation, to be 256 times the concentration level
which would have been found in 1 cubic meter of air.

Results: The levels found in the concentrated air were found to be less
than 0.002 (0.2%) of the safe limits established by the EPA. If the
samples had in fact been taken from a 1 cubic meter enclosure, the
concentration levels would have been below detection limits.

Conclusions: The concentrations of these metals or their oxides that are
emitted from use of The Disintegrator represent an unusual use of the
device but are within safe limits.

### Formation of Infectious Aerosols

A Disintegrator device was sent to U.S. Micro-Solutions, Inc. of
Greensburg, PA for testing to determine the potential for the formation
of infectious aerosols generated from use of the unit. An Anderson N-6
Single Stage Air Sampler was placed next to the Disintegrator inside a
Class II Biological Safety Cabinet, with a TSA plate placed into the
sampler and 4 TSA plates placed around the unit. A total of 20 sterile
insulin needles were destroyed and the plates incubated at 35 degrees
(C) for 48 hours. This process was then repeated using 20 insulin
needles contaminated with a 1 to 5 x 10^5^ suspension of *Bacillus
subtilis*. A TSA plate inoculated with the suspension of *Bacillus
subtilis* bacteria was used as the Positive Control. The air inside the
biosafety cabinet was sampled with the N-6 Sampler, before destruction
of any needles, and used as the Negative Control.

Results: All trypticase soy agar (TSA) plates had no growth of *Bacillus
subtilis* except for the Positive Control plate.

Conclusion: The Disintegrator does not appear to generate an infectious
aerosol during its use.

### Ability to Completely Destroy the Needle

Simulated laboratory tests were performed on more than 4,000 insulin
needles, ranging from 27 to 30 gauge and lengths of 5/16 and ½ inch
long, attached to syringes ranging in dosage from 3/10cc to 1cc. Insulin
pens were also similarly tested. The study evaluated adequate
destruction if the remaining "stub" was less than 1/16 inch long,
whether or not terminated by a small BB shaped ball.

Results: All needle sizes and gauges were adequately destroyed.

The prospective clinical studies also evaluated actual needle
destruction by insulin users in the home. In these studies the
destruction criteria remained the same as in the laboratory setting.

Results: In the clinical studies the worst case rate of successful
needle destruction was at least 93.3%.

Conclusion: The Disintegrator successfully demonstrated needle
destruction for 27-30 gauge insulin needles in 5/16 and ½ inch lengths.
Additional labeling instructions clarifying the battery charging
requirements were added for the second clinical study, and are now added
to all devices produced. This should help to maintain a high percentage
of successful needle destruction.

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

The objective of the clinical studies was to determine the effectiveness
of The Disintegrator when used in the home by a variety of patients who
inject insulin, following only the directions supplied by the
manufacturer.

### Study Design

The assessment of safe use and the effectiveness of needle destruction
was based on:

1)  Patients' ability to properly follow written instructions provided
    with the device;

2)  Destruction of the needle body to a "stub" of 1/16 inch or less in
    length;

3)  The number of adverse device events; and

4)  User comments regarding the use of the device.

During the clinical studies a total of 18 patients were enrolled for a
30-day study period. Patient selection criteria were based on a mixture
of patients across a wide age range, both left and right handed, who
inject insulin a minimum of 2 times per day. In addition, at least one
patient was selected who suffered from some degree of diabetes induced
visual impairment. Fourteen patients provided documentation
demonstrating completion of all tests. The patients used an adjusted
total of 905 needles. Included in the total number of needles are 169
"test syringes" representing 4 different syringe manufacturers and 11
different gauge and size combinations. These "test syringes" were
supplied to the patients in their test kits. The study was approved by
an IRB associated with the Cleveland Clinic where the patients were
obtained. The tests took place in the patient's home.

### 

### Results

Of the 905 needles tested, there were 42 reports of unsuccessful needle
destruction. Of these failures, the study subjects documented 12 as
attributable to their failure to recharge the battery, and another 7
were reported as due to improper use of the device inserts. The
remaining 23 failures are attributed to imperfect mechanism operation,
which could occur due to the manufacturing process used for the clinical
trial production units. The firm has addressed the issue of improper
battery charging by revisions in the device labeling. The issue of
mechanical imperfections is self-resolving in that all future production
of mechanical components will utilize final injection molding with much
tighter tolerances. There were no adverse events reported during the
clinical study.

### Conclusion

The device safely and successfully destroys 27-30 gauge insulin needles
when used as directed in the instructions for use.

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

The pre-clinical and clinical testing provides reasonable assurance of
the safety and effectiveness of the Disintegrator Insulin Needle
Destruction Unit device when used in accordance with the manufacturers'
instructions for use.

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

> In accordance with the provisions of section 515(c)(2) of the act as
> amended by the Safe Medical Devices Act of 1990, this PMA was not
> referred to the General Hospital and Personal Uses Devices Advisory
> Panel, an FDA advisory committee, for review and recommendation
> because the information in the PMA substantially duplicates
> information previously reviewed by this panel.

### XIII. [CDRH DECISION]{.underline}

> The applicant's manufacturing facility was inspected on [January 18,
> 2002]{.underline} and was found to be in compliance with the Quality
> Systems Regulations. FDA issued an approval order on [March 15,
> 2002]{.underline}.

### XIV. [APPROVAL SPECIFICATIONS]{.underline}

> Directions for use: See the attached labeling.
>
> Hazards to Health from Use of the Device: See Contraindications,
> Warnings, Precautions and Adverse Reactions in the attached labeling.
>
> Post-Approval Requirements and Restrictions: See approval order.