(304 days)
Not Found
Not Found
No
The summary describes a pre-filled syringe for maintaining patency of venous access devices, which is a standard medical product and does not mention any AI/ML components or functionalities.
No
The ROCAP Heparin Flush Syringe is indicated for maintaining patency of indwelling venous access devices, which is a maintenance function for a medical device, not a therapeutic treatment for a disease or condition.
No
Explanation: The device is a heparin flush syringe used to maintain patency of venous access devices, which is a therapeutic/maintenance function, not a diagnostic one.
No
The device description clearly states "Heparin Flush Syringe, 10 U/mL", indicating a physical syringe containing a solution, which is a hardware component.
Based on the provided information, the ROCAP Heparin Flush Syringe 10 U/mL is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "maintain patency of indwelling venous access devices." This is a direct therapeutic or preventative action performed on a patient's body (maintaining the function of a medical device within the body).
- Device Description: It's a syringe containing a heparin flush solution. This is a drug delivery device, not a device used to examine specimens from the human body.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents for testing
- Measuring analytes
IVDs are devices used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ROCAP Heparin Flush Syringe does not fit this definition.
N/A
Intended Use / Indications for Use
The ROCAP Heparin Flush Syringe 10 U/mL is indicated for use to maintain patency of indwelling venous access devices.
Product codes
FOZ
Device Description
Heparin IV Flush Syringe, 10 U/mL
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure, with three curved lines representing the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1999
Mr. Avia Toney, RAC Rocap Division of Sabratek Director Regulatory Affairs & Quality Assurance 1629 Prime Court, Building 100 Orlando, Florida 32809
Re: K990390 Trade Name: Heparin IV Flush Syringe, 10 U/mL. Requlatory Class: II Product Code: FOZ Dated: October 15, 1999 Received: October 19, 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, 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 aqainst 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) regulation (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 requlation may result in requlatory 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
1
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 requlation (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 the regulacion Chilibica, "Hibbidnang by Sther 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
Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name:
Heparin Flush Syringe, 10 U/mL
.
Indications for use:
The ROCAP Heparin Flush Syringe 10 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)
Prescriptim Use
(Per 21 CFR 801.109)
(Posted July 1, 1998)
Patricia Vicente
(Optional Format 3-10-98)
(Division Sian Division of Dental, Infe and General Hospital I 510(k) Number