(312 days)
Not Found
Not Found
No
The 510(k) summary describes a heparin flush syringe, a simple medical device for maintaining patency of venous access devices. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The intended use and device type are not typically associated with AI/ML applications.
No
The device is used to maintain the patency of venous access devices, which is a maintenance function rather than a direct therapeutic intervention for a disease or condition.
No
The device, a Heparin Flush Syringe, is indicated for maintaining patency of indwelling venous access devices, which is a therapeutic or maintenance function, not a diagnostic one.
No
The intended use describes a physical syringe, which is a hardware device, not software.
Based on the provided information, the ROCAP Heparin Flush Syringe 100 U/mL is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "maintain patency of indwelling venous access devices." This is a therapeutic or preventative action performed on the patient, not a diagnostic test performed on a sample taken from the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The ROCAP Heparin Flush Syringe is a medical device used to prevent blockages in venous access lines, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The ROCAP Heparin Flush Syringe 100 U/mL is indicated for use to maintain patency of indwelling venous access devices.
Product codes
FOZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 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 (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 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 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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Page 1 of 1
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