DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950

K990371 · Post Medical, Inc. · FMI · Apr 21, 1999 · General Hospital

Device Facts

• Record ID: K990371
• Device Name: DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950
• Applicant: Post Medical, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Apr 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Indications for Use

The Diabetic Syringe Disposal (D.N.D.) is to be used by the diabetic patient at home for the collection of contaminated disposable sharps at the point of use.

Device Story

Device is a sharps container for home use by diabetic patients. Collects contaminated disposable needles/syringes at point of use. Provides safe disposal mechanism for sharps to prevent injury or contamination. Operated by patient in home setting. No electronic or mechanical processing involved.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sharps collection container for home use. Mechanical device with no energy source, software, or complex materials specified.

Indications for Use

Indicated for diabetic patients for home collection of contaminated disposable sharps at the point of use.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 1999

Mr. David R. Thead Regulatory Affairs Post Medical, Incorporated P.O. Box 29863 Atlanta, Georgia 30359

Re : K990371 Diabetic Needle Disposable (D.N.D.) Model# Trade Name: PMSM - 950 Requlatory Class: II Product Code: FMI February 4, 1999 Dated: February 8, 1999 Received:

Dear Mr. Thead

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Thead

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at
its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|------------------------------------------|
| 510(k) Number (if known): | K990371 |
| Device Name: | Diabetic Needle Syringe Disposal (D.N.D) |

Indications For Use:

Needle
(D.N.D.)
The Diabetic Syringe Disposal (D.A.D.) is to be used by the diabetic patient at home for
the collection of contaminated disposable sharps at the point of use.

(PLEASE DO NOT WRITE SELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!

Concurrence of CORH, Office of Device Evaluation (ODE)

Olin S. Làn

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number

Preseription Use_ (fer 21 CFR 801.103) ਾ ਜ

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-98)