(186 days)
The Sharps Transport Tube with screw top lid is a single use or single patient use, non-sterile, disposable, sharps transportation container used in setting where traditional sharps containers cannot be conveniently accessible, such as home use, traveling, EMS, home health, etc.
Sharps Compliance Sharps Transport Tube Model 50035
The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "Sharps Compliance Sharps Transport Tube Model 50035". This document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than presenting a study demonstrating the device meets specific acceptance criteria.
Therefore, the requested information about acceptance criteria, device performance, study design (sample sizes, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set information) is not available within the provided text.
The closest information available is the intended use of the device: "The Sharps Transport Tube with screw top lid is a single use or single patient use, non-sterile, disposable, sharps transportation container used in setting where traditional sharps containers cannot be conveniently accessible, such as home use, traveling, EMS, home health, etc." This describes the function of the device but not quantifiable acceptance criteria or performance metrics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2008
Sharps Compliance, Incorporated C/O Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K073577
Trade/Device Name: Sharps Compliance Sharps Transport Tube Model 50035 Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: June 6, 2008 Received: June 9, 2008
Dear Mr. Kogoma:
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. Kogoma
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 (OS) 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylvie H. Mckain Omd.
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: Not yet assigned
Device Name: Sharps Compliance Sharps Transport Tube Model 50035
Indications for Use:
The Sharps Transport Tube with screw top lid is a single use or single patient use, non-sterile, disposable, sharps transportation container used in setting where traditional sharps containers cannot be conveniently accessible, such as home use, traveling, EMS, home health, etc.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X ____________________________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shala A.M. Murphy, KP
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073577
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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).