(56 days)
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No
The summary describes a simple medical device (extension sets with a valve) for fluid delivery and does not mention any computational or analytical capabilities that would suggest the use of AI/ML.
No
The device is an extension set for delivering fluids intravenously, which is a supportive function rather than a direct therapeutic intervention. It facilitates the delivery of therapeutic fluids but is not inherently therapeutic itself.
No
The device description and intended use indicate it is an extension set for intravenous fluid delivery, not for diagnosing medical conditions.
No
The device description clearly states "Extension Sets," which are physical medical devices used for intravenous fluid delivery. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the intravenous delivery of fluids directly into a patient's bloodstream. This is an in-vivo (within a living organism) application.
- Device Description: The description refers to "extension sets" and "indwelling vascular access catheters," which are components used for administering substances directly to a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information about a physiological state, health, or disease.
IVD devices are used to test samples like blood, urine, or tissue in a laboratory setting to diagnose or monitor conditions. This device's function is entirely focused on delivering substances into the body.
N/A
Intended Use / Indications for Use
These extension sets are indicated for needle-free use in the intravenous delivery of fluids, including but not limited to, hydration fluids, chemotherapy, antibiotics, analgesics, and nutritional therapy. The sets are commonly connected to the external portion of indwelling vascular access catheters.
Product codes
FPA
Device Description
Catheter Innovations, Inc. Extension Sets with PASV™ Valve
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Roger L. Richins Vice President Technology and Requlatory Affairs MAR 11 1998 Catheter Innovations, Incorporated 3598 West 1820 South Salt Lake City, Utah 84104
Re : K980127 Trade Name: Catheter Innovations, Inc. Extension Sets with PASV™ Valve Regulatory Class: II Product Code: FPA Dated: January 12, 1998 Received: January 14, 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 Regulations, Title 21, Parts 809 to-895. A ---------substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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
1
Page 2 - Mr. Richins
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 requlations.
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) 594-4618. 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 qeneral 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
Timot Ulatowski A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
*980127
Page 1 of 1
510(k) Number (if known): K980127
Device Name: Catheter Innovations, Inc. Extension Sets with PASV™ Valve
Indications For Use:
These extension sets are indicated for needle-free use in the intravenous delivery of fluids, including but not limited to, hydration fluids, chemotherapy, antibiotics, analgesics, and nutritional therapy. The sets are commonly connected to the external portion of indwelling vascular access catheters.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CHRH, Office of Device Evaluation (ODE) Division Sign-
Division of Dontal, In and General Hos 510(k) Numbe
Prescription Use V
OR
Over-The-Counter Use
(Optional Format 1-2-96)