This document is a 510(k) clearance letter from the FDA for a medical device: "Medefil's Heparin I.V. Flush Syringe". It grants permission to market the device based on its substantial equivalence to a legally marketed predicate device.

Therefore, this document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a regulatory approval document, not a scientific study report.

The request asks for specific details about acceptance criteria, device performance, study design (sample sizes, data provenance, expert involvement, adjudication), MRMC studies, standalone performance, ground truth establishment, and training set information. None of this information is present in the provided text.

To answer your request, you would need a scientific or clinical study report for the "Medefil's Heparin I.V. Flush Syringe", not this FDA clearance letter.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2000

Mr. Pradeep Aggarwal President-CEO Medefil's, Incorporated 492 Lunt Avenue Schaumburg, Illinois 60193

K993518 Re : Medefil's Heparin I.V. Flush Syringe, In Trade Name: Various Fill Size Regulatory Class: II Product Code: FOZ March 20, 2000 Dated: Received: March 21, 2000

Dear Mr. Aggarwal:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. 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. Aggarwal

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 labelinq regulation (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 gener 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

Timothy A. 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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K993518

Medefil, Inc. October, 1999 Sterile Heparin I. V. Flush Syringe Indications For Use

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____Pending

Heparin I. V. Flush Syringe Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricio Cucenita
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K993578

(Optional Format 3-10-98)

000020

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).