NORMAL SALINE FLUSH SYRINGE

K984614 · Rocap Div. of Sabratek Corp. · FOZ · May 27, 1999 · General Hospital

Device Facts

• Record ID: K984614
• Device Name: NORMAL SALINE FLUSH SYRINGE
• Applicant: Rocap Div. of Sabratek Corp.
• Product Code: FOZ · General Hospital
• Decision Date: May 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ROCAP Normal Saline Flush Syringe is indicated for use to maintain patency of indwelling venous access devices.

Device Story

The ROCAP Normal Saline Flush Syringe is a pre-filled, single-use device containing sterile normal saline. It is designed for use by healthcare professionals in clinical settings to flush indwelling venous access devices. By delivering a controlled volume of saline, the device clears the catheter lumen of blood or medication residues, thereby preventing occlusion and maintaining patency. The device is manually operated by the clinician. It serves as a convenient, ready-to-use alternative to manual syringe filling, reducing the risk of contamination and improving workflow efficiency in hospital or clinic environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pre-filled syringe containing sterile normal saline. Manual operation. Single-use, disposable form factor. Designed for compatibility with standard indwelling venous access devices.

Indications for Use

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

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest wings and a head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 1999

Ms. Avia Toney Director Regulatory Affairs and Quality Assurance ROCAP Division of Sabratek Corporation 1629 Prime Court, Building 100 Orlando, Florida 32809

Re : K984614 Normal Saline IV Flush Syringe Trade Name: Requlatory Class: II Product Code: FOZ Dated: March 29, 1999 Received: March 30, 1999

Dear Ms. 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 abe beated in the enousbally, or 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 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 requlations 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.

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Page 2 - Ms. Toney

this response to your premarket notification Please note: Frease noce. Enib respension 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 first receir wir a510(k) premarket notification. The FDA debelibed in your sia equivalence of your device to a legally rinding of babbandaaise results in a classification for your markets produces and thus, pour device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regardiagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at [phone]. Also, please note ene ories or compiraed, "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 Punner

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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MAY 2 7 1999

## INDICATIONS FOR USE

The ROCAP Normal Saline Flush Syringe 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_V (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Patricio Cixent

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _