(234 days)
Not Found
Not Found
No
The summary describes a standard medical catheter and does not mention any AI or ML components or functionalities.
Yes
The device is described as a catheter for TPN, fluid administration, drug infusion, and continuous therapies, which are all therapeutic interventions.
No
The device description states it is a catheter designed for administering fluids, drugs, and therapies, which are treatment-oriented functions, not diagnostic ones.
No
The device description clearly identifies it as a physical catheter, which is a hardware 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 describes a device used for direct patient care procedures (catheterization, fluid administration, drug infusion). IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health.
- Device Description: The description is of a physical catheter, not a reagent, instrument, or software used for analyzing biological samples.
- Lack of IVD-specific information: The document does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or processes associated with IVDs.
This device is a medical device used for therapeutic and supportive care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Medcomp Tri-Flow™ Triple Lumen Catheter is designed for acute central vein catheterization, TPN, fluid administration, drug infusion, and continuous therapies. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian or femoral vein, the internal jugular is the preferred site.
Product codes
FOZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central vein, internal jugular vein, subclavian or femoral vein
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/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | | 1998
Ms. Jeanne M. Cush ·Technical Submissions Coordinator Medical Components®, Incorporated 1499 Delp Drive 19438 Harleysville, Pennsylvania
Re : K973561 Medcomp Tri-Flow™ Triple Lumen Catheter Trade Name: 11.5F × 12cm II Requlatory Class : Product Code: FOZ February 6, 1998 Dated: Received: February 17, 1998
Dear Ms. Cush:
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 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. ਕੇ 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 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 obligation you might have under sections 531 through 542 of
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Page 2 - Ms. Cush
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 asboing 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,
Timothy A. Ulatowski
Timotik 1 A 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 of 1
510(K) Number (if known): K973561
Device Name: Medcomp Tri-Flow™ Soft Tip Triple Lumen Catheters
Indications for Use:
The Medcomp Tri-Flow™ Triple Lumen Catheter is designed for acute central vein catheterization, TPN, fluid administration, drug infusion, and continuous therapies. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian or femoral vein, the internal jugular is the preferred site.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cucenite
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter
(Optional Format 1-2-96)
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