(200 days)
The Fitpack® DS-128 and DS-130 Fit Tank Products are intended to be used for the collection, transportation and disposal of hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used hypodermic needles and syringes.
The Fitpack® DS-047 Disposa Safe Clean Up, DS-091 Disposa Safe Products are intended to be used for the collection, transportation and disposal of 1 ml insulin hypodermic needles and syringes in health care arcas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml insulin hypodermic needles and syringes.
The Fitpack® DS-046 mini fit tube Product is intended to be used for the collection, transportation and disposal of 1 ml and 2 ml hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml and 2 ml hypodermic needles and syringes.
Not Found
I am sorry, but the provided text does not contain detailed information about the acceptance criteria for the ASP HealthCare FITPACK® PRODUCT LINE or a study proving its performance against these criteria. The document is a 510(k) premarket notification letter from the FDA, indicating that the device has been deemed substantially equivalent to a predicate device.
The letter mentions:
- Trade/Device Name: ASP HealthCare FITPACK® PRODUCT LINE
- Regulation Number: 880.5570
- Regulation Name: Hypodermic Single Lumen Needle
- Regulatory Class: II
- Product Code: MMK
The "Indications for Use" section describes how the various Fitpack products are intended to be used (for collection, transportation, and disposal of hypodermic needles and syringes) but does not provide specific performance metrics, acceptance criteria, or details of a study with sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for the table of acceptance criteria, device performance, study details, sample sizes, expert qualifications, or adjudication methods based on the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol associated with medicine and health. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 2006
ASP Plastics Pty Limited C/O Dr. Albert Rego Scientific Consultant 2700 La Paz Road, Suite 314 Mission Viejo, California 92691
Rc: K060037
Trade/Device Namc: ASP HealthCare FITPACK® PRODUCT LINE Regulation Number: 880.5570 Regulation Name: Hypodernic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: June 30, 2006 Received: July 5. 2006
Dear Dr. Rego:
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 - Dr. Rego
Please be advised that FDA's issuance of a substantial equivalence determination does not mcan 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 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.
Clive Liu, Ph.D.
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): K060037
Device Name: ASP HealthCare FITPACK@PRODUCT LINE
Indications for Use:
The Fitpack® DS-128 and DS-130 Fit Tank Products are intended to be used for the collection, transportation and disposal of hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used hypodermic needles and syringes.
The Fitpack® DS-047 Disposa Safe Clean Up, DS-091 Disposa Safe Products are intended to be used for the collection, transportation and disposal of 1 ml insulin hypodermic needles and syringes in health care arcas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml insulin hypodermic needles and syringes.
The Fitpack® DS-046 mini fit tube Product is intended to be used for the collection, transportation and disposal of 1 ml and 2 ml hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml and 2 ml hypodermic needles and syringes.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule P. Murphy, R.D. 2/25/06
Sign-Off
: Number. KOioo37
§ 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).