(54 days)
The Sharps Compliance Container is a disposable infectious waste container in 1 gallon, 2 gallon and 3 gallon sizes, intended for use by laypersons or health professionals, in small usage areas in clinical and non-clinical settings, such as: phlebotomy, nursing homes, homes, isolation, doctors office, clinics, labs, or school nurses office. The Sharps Compliance Container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations.
The Sharps Compliance Container is a sharps container (disposable infectious waste container) in 1 gallon, 2 gallon and 3 gallon sizes designed to meet Occupational Safety and Health Administration ("OSHA") regulations on bloodborne pathogens (29 C.F.R. 1910.1030).
The provided text is for a Sharps Compliance Container (K083129), which is a physical medical device (a sharps container). The 510(k) summary and FDA letter clearly indicate that this submission is for a physical product and its intended use, rather than a diagnostic AI/ML device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, and comparative effectiveness for an AI/ML device is not applicable to this document.
The submission focuses on demonstrating substantial equivalence to a predicate device (Sage 2 Gallon Alternate Care Sharps Container K973911) based on design and intended use, following guidelines for sharps containers. The device does not involve AI, ML, or any diagnostic algorithms.
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K083129
510(k) Summary
Submitted by Sharps Compliance, Inc. DEC 1 5 2008 Address: 9220 Kirby Drive, Suite 500, Houston, Texas 77054 (800) 772-5657 or (713) 432-0300 Telephone: Facsimile: (713) 660-3586 Al Aladwani, Senior Vice President of Operations Contact Name:
Date Submitted: December 4, 2008
Trade Name: Common Name: Sharps Compliance Container Sharps Container
Product Code / Regulation: MMK / 21 C.F.R. 880.5570
Description: The Sharps Compliance Container is a sharps container (disposable infectious waste container) in 1 gallon, 2 gallon and 3 gallon sizes designed to meet Occupational Safety and Health Administration ("OSHA") regulations on bloodborne pathogens (29 C.F.R. 1910.1030).
Intended Use: The Sharps Compliance Container is a disposable infectious waste container in 1 gallon. 2 gallon and 3 gallon sizes, intended for use by laypersons or health professionals, in small usage areas in clinical and non-clinical settings, such as: phlebotomy, nursing homes, homes, isolation, doctors office, clinics, labs, or school nurses office. The Sharps Compliance Container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations.
Substantial Equivalence:
The Sharps Compliance Container is similar in design and intended use to the Sage 2 Gallon Alternate Care Sharps Container (K973911). Substantial equivalence to the predicate device was evaluated according to the criteria identified in the FDA guidance document "Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers," issued in October 1993.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Al Aladwani Senior Vice President of Operations Sharps Compliance, Incorporated 9220 Kirby Drive, Suite 500 Houston, Texas 77054
DEC 1'5 2008
Re: K083129
Trade/Device Name: Sharps Compliance Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: December 4, 2008 Received: December 5, 2008
Dear Mr. Aladwani:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Aladwani
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clars
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KO83129
Device Name: Sharps Compliance Container
Intended Use:
The Sharps Compliance Container is a disposable infectious waste container in 1 gallon, 2 gallon and 3 gallon sizes, intended for use by laypersons or health professionals, in small usage areas in clinical and non-clinical settings, such as: phlebotomy, nursing homes, isolation, doctors office, clinics, labs, or school nurses office. The Sharps Compliance Container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shade A Murphy MD
(Division Sign-Off)
Division of Anesthesiology General Hospital Infection Control, Dental Devices
510(k) Number: K083129
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§ 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).