(149 days)
The ROCAP Normal Saline Flush Syringe is indicated for use to maintain patency of indwelling venous access devices.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Normal Saline IV Flush Syringe" (ROCAP Division of Sabratek Corporation). This letter grants clearance based on substantial equivalence, which means the device is considered as safe and effective as a legally marketed predicate device.
Crucially, this document is an FDA clearance letter and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
A 510(k) clearance evaluates substantial equivalence to a predicate device, not necessarily a new study proving specific performance metrics against pre-defined acceptance criteria. While the manufacturer would have submitted data to the FDA to demonstrate substantial equivalence, this specific letter does not include the details of that data or any explicit acceptance criteria.
Therefore, I cannot provide the requested information from this document. To answer your questions, one would need access to the 510(k) submission itself or other regulatory documents that detail the performance studies and acceptance criteria.
{0}------------------------------------------------
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.
{1}------------------------------------------------
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
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 _
§ 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).