(301 days)
The American Medical Manufacturing, Inc. Sharps Collection Container is to be used for collection and disposal of medical sharps in hospitals and doctors' offices.
The American Medical Manufacturing, Inc. Sharps Collection Container is an accessory to a single lumen hypodermic needle. The proposed device functions in the same manner as predicate devices in that they provide safe collection of sharps such as svringes, needles, and blades.
Device Design/Materials Used/Physical Properties: The proposed device is comprised of polypropylene plastic.
The provided text is a 510(k) summary for a Sharps Collection Container. It describes the device, its intended use, and a technological comparison to predicate devices. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.
Therefore, I cannot provide the requested table and detailed information as it is not present in the given text.
The document focuses on establishing substantial equivalence to legally marketed predicate devices based on design, materials, and intended function, rather than presenting a performance study with acceptance criteria.
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4/6/99
American Medical Manufacturing, Inc. SHARPS COLLECTION CONTAINER
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
NAME: American Medical Manufacturing ADDRESS: 9410 DeSoto Avenue, Bldg. J Chatsworth, CA 91311
TELEPHONE: CONTACT: DATE OF PREPARATION:
(818) 701-7171 Mike Hoftman April 4, 1998
DEVICE NAMES
NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known):
AMMI - Sharps Collection Container - SAF-T-ShellTM Sharps Collection and Disposal Systems Accessory: Hypodermic Single Lumen Needle
PREDICATE OR LEGALLY MARKETED DEVICES
Baxter Becton Dickinson Pro-Tec Sage Products Devon Industries
DEVICE DESCRIPTION
The American Medical Manufacturing, Inc. Sharps Collection Container is an accessory to a single lumen hypodermic needle. The proposed device functions in the same manner as predicate devices in that they provide safe collection of sharps such as svringes, needles, and blades.
Device Design/Materials Used/Physical Properties: The proposed device is comprised of polypropylene plastic.
DEVICE INTENDED USE
The American Medical Manufacturing, Inc. Sharps Collection Container is intended for use in any situation where the disposal of medical sharps is required, such as in hospitals, doctors' offices.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | AMMI | Other Devices |
|---|---|---|
| Lid | Translucent/Clear | Same |
| Mounting Brackets | Yes | Yes |
| Sizes | 1 Quart | Multiple |
| Disposable | Yes | Yes |
| Sterility | Non-sterile | Non-sterile |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1999 APR
Mr. Mike Hoftman President American Medical Manufacturing, Incorporated 9410 DeSoto Avenue, Unit J Chatsworth, California 91311
Re: K982029
Sharps Collection Container - SAF-T-Shell™ Trade Name: Requlatory Class: II Product Code: FMI January 22, 1999 Dated: Received: January 28, 1999
Dear Mr. Hoftman:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Hoftman
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,
Timothy A. Ulatowski
Timothy ਮੁ 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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510(k) Number (if known):
: 今
.
Device Name:
American Medical Manufacturing, Inc. Sharps Collection Container
Indications for Use:
The American Medical Manufacturing, Inc. Sharps Collection Container is to be used for collection and disposal of medical sharps in hospitals and doctors' offices.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qiu S. Lìn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number
Prescription Use (Por 21 CFR & 801.109) OR
Over-The-Counter Use
§ 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).