(15 days)
Not Found
No
The provided text describes a medical device (a catheter) and its intended use, but contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality.
No
Explanation: The device is used for administering fluids and withdrawing blood specimens, which are diagnostic and supportive functions rather than direct therapeutic treatments.
No
The device is designed for administering fluids and withdrawing blood specimens, not for diagnosing conditions.
No
The device description clearly identifies it as a "PASV™ Dual Lumen Peripherally Inserted Midline Catheter," which is a physical medical device (catheter) and 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 venous system for administering fluids and withdrawing blood specimens. This is a direct interaction with the patient's body for therapeutic and diagnostic sample collection purposes.
- IVD Definition: In vitro diagnostics are devices used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
This device is a medical device used for accessing the circulatory system, not for performing tests on samples outside the body.
N/A
Intended Use / Indications for Use
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheter is designed to establish peripheral access to the venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, 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.
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
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
Not Found
Key Metrics
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1658 MAY
Mr. Roger L. Richins Catheter Innovations Incorporated 3598 West 1820 South Salt Lake, Utah 84104-4959
Re : K981382 .. . PASV™ Dual Lumen Peripherally Inserted Trade Name: Midline Catheter Requlatory Class: II FOZ Product Code: Dated: April 8, 1998 Received: April 16, 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, 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 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) 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 requlatory 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) 638-20#1 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours
J. Cilliers
Timot 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 Midline Catheter
Indications for Use:
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheter is designed to establish peripheral access to the venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, 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.
Warning: The PASV™ Dual Lumen Peripherally Inserted Midline Catheter is NOT indicated for infusion of the following:
- Hypertonic nutrition solutions with final glucose concentrations . greater than 10%
- Continuously infused Vesicant Drugs .
- Any medication contraindicated for infusion into the peripheral . system
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheters have the same intended use as our Single Lumen Midline Catheters (K963215).
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Palaich
Division of Dar, lafection Control,
and General Fiospital Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Perscription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)