(20 days)
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Not Found
No
The summary describes a physical medical device (PICC catheter) and contains no mention of software, algorithms, AI, or ML.
No
The device is described as providing "repeated access for infusion or injection therapy" and "blood sampling," which are diagnostic and supportive functions rather than direct therapeutic treatments.
No
The device, a PICC, is used for infusion, injection therapy, and blood sampling, which are therapeutic and collection procedures, not diagnostic ones.
No
The provided text describes a physical medical device, a PICC catheter (V-Cath® PICC), which is a hardware device used for infusion, injection, and blood sampling. There is no mention of software as the primary or sole component.
Based on the provided information, the V-Cath® PICC is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as being used for infusion, injection therapy, and blood sampling directly from the patient. This involves accessing the patient's circulatory system.
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
The V-Cath® PICC is a medical device used for direct patient access, not for testing samples in a lab setting.
N/A
Intended Use / Indications for Use
The V-Cath® PICC is indicated for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 3.8FR or larger catheter is recommended.
Product codes
FOZ
Device Description
V-Cath® PICC (Peripherally Inserted Central Catheter)
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
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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)
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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/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of a bird or eagle with three wing-like shapes extending to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 23 1998
Mr. James S. Abilla Director of Quality Systems & Regulatory Affairs Management Representative HDC Corporation 2109 O'Toole Avenue San Jose, California 95131-1338
Re: K983916 V-Cath® PICC (Peripherally Inserted Central Trade Name: Catheter) Requlatory Class: II Product Code: FOZ October 30, 1998 Dated: Received: November 3, 1998
Dear Mr. Abilla:
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, qood 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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your 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.
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Page 2 - Mr. Abilla
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,
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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Appendix 3
Indications for Use Statement
| 510(k) Number | K 983916 |
|---|---|
| Device Name | V-Cath® PICC |
| Indications for Use | The V-Cath® PICC is indicated for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 3.8FR or larger catheter is recommended. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
| 510(k) Number | K983916 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | X | OR | Over-the-counter Use |
|---|---|---|---|
| ------------------------------------------ | -------------- | ---- | ---------------------- |