(16 days)
No
The summary describes a physical medical device (a catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is used to administer therapeutic agents but is not itself a therapeutic device; it's a delivery system.
No
Explanation: The device is a Peripherally Inserted Central Catheter (PICC) used to establish peripheral access to the central venous system for administration of fluids and blood specimen withdrawal. Its primary functions are therapeutic delivery and sample collection, not diagnosing medical conditions.
No
The device description clearly identifies it as a physical catheter, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for accessing the central venous system for administering fluids and withdrawing blood specimens. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic purposes, but the device itself is not performing a diagnostic test on a sample in vitro (outside the body).
- Device Description: The description is for a "Peripherally Inserted Central Catheter (PICC)," which is a medical device used for vascular access.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, detect analytes, or provide diagnostic information based on testing a sample in vitro.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This PICC catheter is a tool for accessing the body, not for performing a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC) is designed to establish peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal.
This product is effective for venous access in adults, children and infants who require intravenous therapy.
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Central Catheters (PICC) have the same intended use as our Single Lumen PICC Catheters (K963097).
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 venous system
Indicated Patient Age Range
adults, children and infants
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)
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 features a stylized depiction of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUM SERVICES - USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 MAY
Mr. Roger L. Richins Catheter Innovations Incorporated 3598 West 1820 South Salt Lake, Utah 84104-4959
Re : K981368 Trade Name: PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC) Regulatory Class: II Product Code: FOZ Dated: April 8, 1998 Received: April 15, 1998
Dear Mr. Richins:
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 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 Regulations, Title 21, Parts 800 to 895. ਰ 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 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 obligation you might have under sections 531 through 542 of
1
Page 2 - Mr. Richins
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 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
Timbthy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
510(k) Number (if known):
Device Name: PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC)
Indications for Use:
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC) is designed to establish peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal.
This product is effective for venous access in adults, children and infants who require intravenous therapy.
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Central Catheters (PICC) have the same intended use as our Single Lumen PICC Catheters (K963097).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Perscription Use_X
OR
14:13 - 1999
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)