(72 days)
Not Found
Not Found
No
The summary describes a physical sharps disposal container and contains no mention of AI, ML, or any related technologies.
No
The device is described as a disposal unit for contaminated sharps, not something that provides treatment or therapy.
No
The device is described as a disposal unit for contaminated sharps, not a tool for diagnosing medical conditions.
No
The description clearly states the device is for the "collection of contaminated disposable sharps," implying a physical container or system, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the D.N.D. is for the collection of contaminated sharps, not for analyzing biological samples.
- The device description and intended use clearly indicate a physical disposal container. There is no mention of any diagnostic testing or analysis of biological material.
The D.N.D. is a device for managing medical waste, specifically sharps, in a home setting.
N/A
Intended Use / Indications for Use
The Diabetic Needle 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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
diabetic patient at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page 1 of 1
| Labels | Values |
|---|---|
| 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)