The Vital-Port® Infusion Pal™ is intended to facilitate locating and stabilizing the port body for accessing the portal septum of a Vital-Port® Vascular Access System.

Device Description

The Vital-Port® Infusion Pal™ is an open-ringed plastic disk that is intended to facilitate locating and stabilizing the port body for accessing Vital-Port® Vascular Access Systems. The Vital-Port® Infusion Pal™ is placed on the skin surface on the area overlying the port septum. The device is supplied sterile and intended for onetime use.

AI/ML Overview

This K971140 submission describes a simple, non-active medical device (Vital-Port® Infusion Pal™). For such devices, acceptance criteria and detailed study data in the format requested (especially regarding AI/ML performance, ground truth, expert consensus, and MRMC studies) are typically not included as they are irrelevant to the device's function and regulatory review. The review focuses on substantial equivalence to predicate devices based on technological characteristics and intended use.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain explicit performance acceptance criteria or reported device performance in a quantitative manner as would be expected for a complex diagnostic or therapeutic device. For a simple device like the Vital-Port® Infusion Pal™, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to existing predicate devices based on intended use and technological characteristics, and by adhering to general controls (manufacturing, labeling, etc.).

Acceptance Criteria	Reported Device Performance
Implicit: Substantial Equivalence to Predicate Devices (Vein Stabilizers) regarding:	The device is "similar to predicate vein stabilizers that are currently marketed in terms of technological characteristics and the same intended use of facilitating location and stabilization for vessel access."
- Intended Use	"Used with totally implantable vascular access systems for indirect vessel access." (Same as predicate)
- Technological Characteristics	"open-ringed plastic disk that is intended to facilitate locating and stabilizing the port body" (Similar function to predicate vein stabilizers)
- Manufacturing Process Adherence	"will be manufactured according to specified process controls and a Quality Assurance Program, undergoing manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Cook Vascular Incorporated."
- Sterility	"The device is supplied sterile and intended for one-time use." (Implies meeting sterility standards)

Notes on the absence of typical AI/ML study information:

The Vital-Port® Infusion Pal™ is a physical, non-active medical device (a locating ring/port stabilizer). Therefore, the following are not applicable and are not found in the 510(k) submission:

Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of the Study (Demonstration of Substantial Equivalence):

The "study" in this context is the 510(k) Pre-Market Notification process itself, which focuses on demonstrating substantial equivalence (SE) to a legally marketed predicate device.

Device Name: Vital-Port® Infusion Pal™ (Locating Ring, Port Stabilizer)
Predicate Device(s): "predicate vein stabilizers that are currently marketed"
Basis for Substantial Equivalence:
- Identical Intended Use: "facilitating location and stabilization for vessel access."
- Similar Technological Characteristics: "open-ringed plastic disk" performing the same function.
- Similar Manufacturing and Quality Control: "manufactured according to specified process controls and a Quality Assurance Program, undergoing manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Cook Vascular Incorporated."

The FDA's letter (K971140) confirms that they "have determined the device is substantially equivalent" based on the information provided in the submission. This determination serves as the "proof" that the device meets the regulatory requirements for market entry.

Summary

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K971140

NOV 17 1997

510(K) SUMMARY G.

Submitted By:

Neal E. Fearnot, Ph.D., E.E. President MED Institute, Incorporated P.O. Box 2402 West Lafayette, IN 47906 (765) 463-7537 March 27, 1997

Device:

Trade Name:	Vital-Port® Infusion Pal™
Common/Usual Name:	Locating Ring, Port Stabilizer
Proposed Classification Name:	Vein Stabilizer 21CFR §880.6980 (80LBJ)with intended use specific to implantedsubcutaneous intravascular catheters (80LJT)

Predicate Devices:

The Vital-Port® Infusion Pal™ is similar to predicate vein stabilizers that are currently marketed in terms of technological characteristics and the same intended use of facilitating location and stabilization for vessel access. The Vital-Port® Infusion Pal™ is used with totally implantable vascular access systems for indirect vessel access.

Device Description:

Substantial Equivalence:

The Vital-Port® Infusion Pal™ will be manufactured according to specified process controls and a Quality Assurance Program, undergoing manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Cook Vascular Incorporated. This device is similar with respect to indications for use and technology to predicate devices in terms of section 510(k) substantial equivalency.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol resembling three human profiles facing right, stacked on top of each other. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 1997

Neal E. Fearnot, Ph.D.,E.E. ·President Med Institute, Incorporated P.O. Box 2402 West Lafayette, Indiana 47906

Re : K971140 Vital-Port Infusion Pal Trade Name: Requlatory Class: Unclassified Product Code: LJT Dated: October 10, 1997 October 14, 1997 Received:

Dear Dr. 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 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 - Dr. Fearnot

through 542 of the Act for devices under the Electronic enroduct 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 diaqnostic 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 encregulation chercica, "Hibblanding by suremo" of everal 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,

Tim A. Hukari

A. Timothy 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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Page __ 1_ of ___

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

. Device Name:________________ VITAL-PORT® INFUSION PALTM

Indications For Use:

The Vital-Port® Infusion Pal™ is intended to facilitate locating and stabilizing the port body for accessing the portal septum of a Vital-Port® Vascular Access System.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Valeraci Crescenti.

I. Intention Co. arel Ho ander : 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.