The Mini Polyurethane Catheter is intended for use with single-chamber Vital Port" reservoirs for use in patient therapy requiring long-term vascular access for infusion therapy sampling sampling.

Device Description

The Mini Polyurethane Catheter is for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling. The device is supplied sterile and is intended for one-time use. The construction materials comprising the Mini Polyurethane Catheter are identical to those used in predicate Vital-Port® system catheters. Reasonable assurance of biocompatibility of the materials comprising this device is provided by their established history of use in medical product manufacturing.

AI/ML Overview

This document, a 510(k) Premarket Notification for a Mini Polyurethane Catheter, is a regulatory submission for a medical device and describes its intended use and similarity to existing devices. It is a not a study that proves the device meets acceptance criteria but rather a notification of intent to market based on substantial equivalence. Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable or cannot be extracted from this document.

Here's the breakdown of why and what information can be inferred:

1. A table of acceptance criteria and the reported device performance

Not applicable. This document does not describe specific acceptance criteria or performance data from a study. It focuses on demonstrating substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No test set or data provenance is mentioned as part of a performance study. The submission relies on the established history of the predicate device and the materials used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no mention of a test set requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical catheter, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI-related effectiveness is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. Ground truth for a performance study is not discussed. The "ground truth" for this regulatory submission is the established safety and efficacy of the predicate device and the biocompatibility of the materials.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device or a study involving data training.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary of Extracted Information relevant to the prompt (though not fitting the direct questions due to the nature of the document):

Device Name: Mini Polyurethane Catheter
Intended Use: For use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.
Predicate Devices: Catheters supplied with Vital-Port® systems manufactured by COOK Vascular™ Incorporated.
Reason for Substantial Equivalence Claim:
- Same intended use, design, and materials of construction as predicate catheters.
- Biocompatibility of materials is established by their history of use in medical product manufacturing.
- Will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to predicate devices.
Regulatory Outcome: FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing its market entry.

Summary

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510(k) Premarket Notification Mini Polyurethane Catheter

SEP 1 6 1998

I. 510(k) SUMMARY

Submitted By:

Neal E. Fearnot, President MED Institute, Incorporated West Lafayette, Indiana 47906 (765) 463-7537 July 16, 1998

Device:

Trade Name:	Mini Polyurethane Catheter
Common/Usual Name:	Implanted Subcutaneous Intravascular Catheter
Proposed Classification:	Implanted Subcutaneous Intravascular Catheter

Predicate Devices:

The Mini Polyurethane has the same intended use, design, and materials of construction as predicate catheters supplied with Vital-Port® systems manufactured by COOK Vascular™ Incorporated.

Device Description:

Substantial Equivalence:

The Mini Polyurethane Catheter will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by COOK. Vascular™ Incorporated. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 1998

Mr. Neal E. Fearnot President MED Institute, Incorporated A Cook Group Company P.O. Box 2402 West Lafayette, Indiana 47906

Re : K982507 Mini Polyurethane Catheter Trade Name : Regulatory Class: Unclassified Product Code: LJT July 16, 1998 Dated: Received: July 20, 1998

Dear Mr. Fearnot:

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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or ro 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 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 not affect any obligation you might have under sections 531

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Page 2 - Mr. Fearnot

through 542 of the Act for devices under the Electronic Chrough 542 OF the nee to: revisions, 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 described in your 31011 plemance of your device to a legally marketed predicate device results in a classification for your marketed predicate anits 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 Other general ** premarket notification" (21CFR 807.97). 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/dsma/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

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Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use:

The Mini Polyurethane Catheter is intended for use with single-chamber Vital Port" reservoirs for use in patient therapy requiring long-term vascular access for infusion therapy
sampling sampling.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Labrita Crescente
(Division Sign-Off)

ivision Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number 4982507

Prescription Use
(Per 21 CFR 801.109)

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Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.