ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML

K990308 · Rocap Div. of Sabratek Corp. · FOZ · Dec 10, 1999 · General Hospital

Device Facts

• Record ID: K990308
• Device Name: ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
• Applicant: Rocap Div. of Sabratek Corp.
• Product Code: FOZ · General Hospital
• Decision Date: Dec 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ROCAP Heparin Flush Syringe 100 U/mL is indicated for use to maintain patency of indwelling venous access devices.

Device Story

Heparin IV Flush Syringe 100 U/mL; pre-filled syringe containing heparin sodium solution. Used in clinical settings to flush indwelling venous access devices to prevent occlusion and maintain patency. Operated by healthcare professionals. Device provides a standardized, ready-to-use dose of heparin to reduce risk of medication errors and contamination associated with manual preparation. Output is the delivery of heparin solution into the venous access line.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pre-filled syringe containing heparin sodium 100 U/mL. Class II device (Product Code: FOZ).

Indications for Use

Indicated for maintaining patency of indwelling venous access devices in patients requiring such access.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

... . .

DEC 1 0 1999

Mr. Avia Toney, RAC Rocap Division of Sabratek Director Requlatory Affairs & Quality Assurance 1629 Prime Court, Building 100 Orlando, Florida 32809

> K990308 Re: Heparin IV Flush Syringe, 100 U/mL Trade Name: Requlatory Class: II Product Code: FOZ Dated: October 15, 1999 Received: October 18, 1999

Dear Mr. Toney:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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) 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Toney

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.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Russo

Timothy A. Ulatowski 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):

990308

Device Name:

Heparin Flush Syringe, 100 U/mL

Indications for use:

The ROCAP Heparin Flush Syringe 100 U/mL is indicated for use to maintain patency of indwelling venous access devices.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓
(Per 81 CFR 801.109)

(Posted July 1, 1998)

(Optional Format 3-10-98)

Patricia Cresente

(Division S Division of Denta and Gen 510(k) Nur