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SUMMARY OF SAFETY AND EFFECTIVENESS DATA

I. GENERAL
INFORMATION

Device
Generic Name: Sharps Needle Destruction Device for Insulin Needles   

Device Trade Name: The Disintegrator Insulin Needle Destruction Unit

Applicants
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

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

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

IV. 
WARNINGS AND PRECAUTIONS

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

V. 
DEVICE DESCRIPTION

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<sup>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"X4X 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

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

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

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

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 t