(238 days)
Not Found
Not Found
No
The device description is a sterile heparin flush syringe, and there is no mention of AI, ML, or any related technologies in the provided summary.
No
A therapeutic device is used to treat a disease or condition. This device, a heparin flush syringe, is used to maintain patency of IV access devices, which is a maintenance function, not a treatment.
No
The device is described as a "Sterile Heparin I.V. Flush Syringe" used "TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)". This indicates a therapeutic or maintenance function, not a diagnostic one.
No
The device description explicitly states "Sterile Heparin I. V. Flush Syringe," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)". This describes a therapeutic or maintenance function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a "Sterile Heparin I. V. Flush Syringe". This is a medical device used for flushing IV lines, which is a direct interaction with the patient's circulatory system.
- 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
Therefore, this device falls under the category of a general medical device used for patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)
Product codes
FOZ
Device Description
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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 (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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the words "Public Health Service" in bold, black font. The text is horizontally aligned and appears to be a title or heading. The background is plain white, providing a clear contrast for the text.
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2000
Mr. Pradeep Aggarwal President-CEO Medefil's, Incorporated 492 Lunt Avenue Schaumburg, Illinois 60193
K993518 Re : Medefil's Heparin I.V. Flush Syringe, In Trade Name: Various Fill Size Regulatory Class: II Product Code: FOZ March 20, 2000 Dated: Received: March 21, 2000
Dear Mr. Aggarwal:
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 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 Regulations, 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 Please note: this response to your the Federal Register. premarket notification submission does not affect any 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.
1
Page 2 - Mr. Aggarwal
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 labelinq 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 gener 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,
Timothy A. Ulatowski
Timothy A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Medefil, Inc. October, 1999 Sterile Heparin I. V. Flush Syringe Indications For Use
:
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____Pending
Heparin I. V. Flush Syringe Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricio Cucenita
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K993578
(Optional Format 3-10-98)