The modified PORT-A-CATH® Low-Profile™ Systems are exactly the same in design and function as the current commercially available systems. No change to the product has been made.

AI/ML Overview

The provided document is a 510(k) summary for the PORT-A-CATH® Low-Profile™ Implantable Access Systems, dated December 29, 1997. It describes a medical device and its intended use but does not include any acceptance criteria or a study proving its performance against such criteria for AI/ML device evaluation.

The document explicitly states:

"Functional testing was not deemed necessary, since no changes were made to the product."
"Clinical studies were not deemed necessary regarding the PORT-A-CATH® Low-Profile™ Implantable Access Systems due to their similarity in materials, design and function to current commercially available product..."

Therefore, I cannot provide the information requested in your prompt because the 510(k) submission for this device did not involve performance studies against acceptance criteria in the context of AI/ML or even general functional/clinical studies, as it was deemed substantially equivalent to existing devices.

To directly answer your numbered points based on the absence of such information in the provided text:

A table of acceptance criteria and the reported device performance: Not applicable. No acceptance criteria or reported device performance data are present as no functional or clinical studies were deemed necessary.
Sample size used for the test set and the data provenance: Not applicable. No test set was used as no studies were performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established for a test set.
Adjudication method (e.g. 2+1, 3+1, none) 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. This device is an implanted port system, not an AI/ML diagnostic tool, and no such study was performed or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
The type of ground truth used (expert concensus, 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

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19973862

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

DEC 2 9 1997

PORT-A-CATH® Low-Profile™ Implantable Access Systems

October 6, 1997

GENERAL INFORMATION 1.

Applicant's Name and Address:	SIMS Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Lisa StoneManager, Regulatory AffairsTel. (612) 628-7224
Common/Usual Name:	Subcutaneously Implanted IntravascularInfusion Port and Catheter
Proprietary Name:	PORT-A-CATH® Low-Profile™Implantable Access Systems
Equivalence Device Comparison:	PORT-A-CATH® P.A.S. PORT® IIImplantable Access System(manufactured by SIMS Deltec, Inc.)BardPort™ SlimPort™ Low Profile Port(manufactured by Bard Access Systems)

II. DEVICE DESCRIPTION

The modified PORT-A-CATH® Low-Profile™ Systems are exactly the same in design and function as the current commercially available systems. No change to the product has been made.

INTENDED USE OF DEVICE III.

The indications for this device will not change [i.e. A system is indicated when a patient requires repeated vascular access for injection (bolus) or infusion therapy and/or venous blood sampling]. However, the intended use of the device will be modified to include peripheral placement of the device in large or obese patients.

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IV. DEVICE COMPARISON

	PORT-A-CATH®Low-Profile™Systems	PORT-A-CATH®P.A.S. PORT® IISystems	BardPort™SlimPort™ LowProfile Port
MANUFACTURER	SIMS Deltec, Inc.	SIMS Deltec, Inc.	Bard Access Systems
INDICATIONS FOR USE	A system is indicated when apatient requires repeatedvascular access for injection(bolus) or infusion therapyand/or venous bloodsampling.	Because of its low profile,the P.A.S. PORT system isintended for peripheralplacement in the arm. Theportal can be implanted inthe upper arm above theantecubital space below theaxilla, or below the ante-cubital space in the upperpart of the forearm. Asystem is indicated whenpatient therapy requiresrepeated venous access forinjection or infusion therapyand/or venous bloodsampling.	The BardPort ImplantedPorts are indicated forpatient therapies requiringrepeated access to thevascular system. The portsystem can be used forinfusion of medications,I. V. fluids, parenteralnutrition solutions, bloodproducts and for thewithdrawal of bloodsamples.
INTENDED USE	- Chest placement- Arm placement	- Arm placement	- Chest placement- Arm placement
PORTAL DIMENSIONS(Nominal)HeightLengthWidthSeptum Diameter	11.5 mm25.0 mm25.0 mm9.5 mm	8.9 mm23.9 mm16.5 mm9.7 mm	9.8 mm24.7 mm19.0 mm9.0 mm

SUMMARY OF STUDIES V.

Functional Testing A.

Functional testing was not deemed necessary, since no changes were made to the product.

Clinical Studies B.

Clinical studies were not deemed necessary regarding the PORT-A-CATH® Low-Profile™ Implantable Access Systems due to their similarity in materials, design and function to current commercially available product (i.e. PORT-A-CATH® P.A.S. PORT® II Implantable Access System and BardPort™ SlimPort™ Low Profile Port).

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Conclusion Drawn from the Studies C.

As noted above, no functional testing or clinical studies were deemed necessary regarding the PORT-A-CATH® Low-Profile™ Implantable Access Systems.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles incorporated into its design. The eagle and profiles are enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 29 1997

Ms. Lisa Stone Manager Requlatory Affairs Sims Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

K973862 Re : Port-A-Cath Low Profile Implantable Access Trade Name: Systems Requlatory Class: Unclassified Product Code: LTS October 6, 1997 Dated: Received: October 9, 1997

Dear Ms. Stone:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obliqation you might have under sections 531

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Page 2 - Ms. Stone

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 marketinq your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Us. Childrust

Timothy A. Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: PORT-A-CATH® Low-Profile™ Implantable Access Systems

Indications for Use:

"A system is indicated when a patient requires repeated vascular access for injection (bolus) or infusion therapy and/or venous blood sampling."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K973862

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use _

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.