The Perma-Pass™ Vascular Graft is intended for bypass or reconstruction of occluded or diseased arterial blood vessels, or the creation of subcutaneous arteriovenous conduits for blood access. The Graft is intended for use as a vascular prosthesis only.

Thinwall Perma-Pass Grafts are not indicated for blood access. .
Perma-Pass Grafts are not indicated for applications involving: pulmonary arteries; . ascending aorta; coronary arteries; common, external, or internal carotid arteries; cerebral arteries; brachiocephalic trunk; cardiac veins; pulmonary veins; or the inferior or superior vena cava.

Device Description

The Perma-Pass™ Vascular Graft is manufactured from the following materials; polytetraflouroethylene (PTFE) resin, lubricant used as a manufacturing aid, and a black pigment used to create the orientation line. These grafts are available in a straight configuration with an internal diameter of 5mm, thin wall, and lengths sufficient to satisfy most vascular graft applications. The Perma-Pass Graft is constructed from the same materials used in manufacturing the tubing for the Perma-Flow® Coronary Bypass Graft, manufactured by Possis Medical, Inc. and approved under HDE H970005 dated 30 April, 1998. These grafts are supplied in the same packaging as the Perma-Flow Graft and are packaged, labeled and sterilized in the same manner.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Perma-Pass™ Vascular Graft, comparing it to an existing predicate device (IMPRA ePTFE Vascular Graft). The core of the submission is to demonstrate substantial equivalence, rather than to establish new safety and effectiveness criteria through a standalone study with defined acceptance criteria and performance metrics.

Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not explicitly available in this document. This document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device based on material, design, and performance characteristics, rather than proving performance against specific acceptance criteria for a new clinical claim.

However, I can extract the relevant information regarding the comparison and the non-clinical tests that implicitly serve as the "study" for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission seeking equivalence, explicit "acceptance criteria" for clinical performance are not stated in the traditional sense of a clinical trial. Instead, the acceptance is based on demonstrating that the Perma-Pass Graft's physical and functional properties are comparable to and exceed physiological requirements like the predicate device.

Characteristic	Acceptance Criteria (Implied: Comparable to/Better than Predicate & Exceed Physiological Requirements)	Predicate Device Performance (IMPRA Graft)	Perma-Pass Graft Performance
Physical Properties
Pore volume	Comparable	69%	67%
Internodal distance (Inner)	Comparable	21 um	21 um
Internodal distance (Outer)	Comparable	24 um	21 um
Water entry pressure	Comparable to/Better than 276 mmHg	276 mmHg	309 mmHg
Kink diameter	Comparable to/Better than 14mm	14mm	13mm
Pressurized burst strength	Comparable to/Better than 325 kPa	325 kPa	381 kPa
Tensile Strength
Longitudinal	Comparable	126 N	121 N
Circumferential	Comparable to/Better than 3.10 N/mm	3.10 N/mm	3.50 N/mm
Suture Retention Strength
Longitudinal	Comparable to/Better than 283 g	283 g	535 g
Oblique	Comparable to/Better than 285 g	285 g	553 g

Study Proving Device Meets Acceptance Criteria:

The "study" conducted for this 510(k) submission consisted of Non-Clinical Tests. The document states:
"Extensive testing of in vitro, functional, physical, and biocompatibility tests have been performed on the Perma-Pass Graft. These tests have shown that the Graft performs comparably to the predicate device. All performance results for the Graft and the predicate device exceed physiological requirements for the intended clinical use of the device. Where applicable, tests were conducted using USP or AAMI guidelines and standards. The results were acceptable in all cases."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the document. The testing involves "extensive testing of in vitro, functional, physical, and biocompatibility tests," implying multiple samples of the Perma-Pass Graft and the predicate device were tested for each characteristic. The exact number of units per test or batch size is not reported.
Data Provenance: The tests are "in vitro, functional, physical, and biocompatibility tests." This indicates laboratory-based testing, likely conducted by the manufacturer (Possis Medical, Inc.) in the USA. It is prospective testing designed to evaluate the properties of the manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This submission relies on objective physical and functional measurements, following established standards (USP or AAMI guidelines). There are no human "experts" establishing a subjective "ground truth" for the test results described. The "ground truth" is the measured value itself, derived from the test methodology.

4. Adjudication method for the test set:

Not applicable as the tests are objective measurements, not subjective evaluations requiring adjudication.

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 is a medical device (vascular graft), not an AI diagnostic tool. No MRMC studies were conducted as part of this submission.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used:

The "ground truth" for the performance claims in this submission is objective, quantitative measurements of physical properties (e.g., pore volume, water entry pressure, tensile strength) and functional performance, compared against the known properties of a legally marketed predicate device and physiological requirements. This is data derived from laboratory testing, not expert consensus, pathology, or outcomes data in the usual clinical sense.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning model. The device itself is manufactured using established processes.

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

Not applicable. There is no training set for this type of medical device submission.

Summary

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FEB 1 1999

Image /page/0/Picture/1 description: The image shows the logo for Possis Medical Inc. The logo features a stylized "M" inside a square, followed by the company name in bold, sans-serif font. The words "MEDICAL INC" are stacked below "Possis" in a smaller font size.

9055 Evergreen Blvd. N.W. Minneapolis, Minnesota 55433-8003 USA K984183 (612) 780-4555 Fax (612) 780-2227

PERMA-PASS™ VASCULAR GRAFT 510(K) SUMMARY

NOVEMBER 1998

SUBMITTER'S INFORMATION

CONTACT

Possis Medical, Inc. 9055 Evergreen Boulevard N.W. Minneapolis, MN 55433

Tel: (612) 780-4555 Fax: (612) 780-2227

Primary

Timothy J. Kappers Sr. Regulatory Affairs Associate

Alternate

James D. Gustafson Vice President of Quality Systems and Regulatory/Clinical Affairs

November 20, 1998

Perma-Pass™ Vascular Graft

Vascular Graft

Vascular Graft prosthesis of less than 6 mm diameter (74DYF, 21 CFR 870.3450)

IMPRA ePTFE Vascular Graft Straight; 5 mm x 50 cm K791810 IMPRA, Inc. 1625 West Third Street Tempe, Arizona 85281

SUMMARY DATE

DEVICE TRADE NAME

COMMON NAME

DEVICE CLASS

The Comments of Children

LEGALLY MARKETED PREDICATE DEVICE

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DEVICE DESCRIPTION

The Perma-Pass Graft is constructed from the same materials used in manufacturing the tubing for the Perma-Flow® Coronary Bypass Graft, manufactured by Possis Medical, Inc. and approved under HDE H970005 dated 30 April, 1998. These grafts are supplied in the same packaging as the Perma-Flow Graft and are packaged, labeled and sterilized in the same manner.

INTENDED USE

The Perma-Pass Graft is intended for bypass or reconstruction of occluded or diseased arterial blood vessels, or the creation of subcutaneous arteriovenous conduits for blood access. The Graft is intended for use as a vascular prosthesis only.

. Thinwall Perma-Pass Grafts are not indicated for blood access.
. Perma-Pass Grafts are not indicated for applications involving: pulmonary arteries; ascending aorta; coronary arteries; common, external, or internal carotid arteries; cerebral arteries; brachiocephalic trunk; cardiac veins; pulmonary veins; or the inferior or superior vena cava.

COMPARISON TO PREDICATE DEVICE:

Table 1 summarizes key technical characteristics and physical properties of the Perma-Pass Graft and the predicate device.

	IMPRA Graft	Perma-Pass Graft
Materials	PTFE: No additives	PTFE: No additives
Markings	Longitudinal orientation	Longitudinal orientation
Clinical application	Bypass or reconstruction ofoccluded or diseased arterialblood vessels, vascularaccess and others	Bypass or reconstruction ofoccluded or diseased arterialblood vessels
Fabrication	Paste extrusion, expansion,sintering	Paste extrusion, expansion,sintering
Structure
Configuration	Straight, isodiametric	Straight, isodiametric
Dimensions
Length (all sizes)	50cm	70cm

TABLE 1 Comparison of Technical Characteristics

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	IMPRA Graft	Perma-Pass Graft
Internal diameter	5.17mm	5.01mm
Wall Thickness	0.420mm	0.453mm
Physical properties
Pore volume	69%	67%
Internodal distance	Inner: 21um	Inner: 21um
	Outer: 24 um	Outer: 21 um
Water entry pressure	276mmHg	309mmHg
Kink diameter	14mm	13mm
Pressurized burst strength	325kPa	381kPa
Tensile Strength
Longitudinal	126N	121N
Circumferential	3.10N/mm	3.50N/mm
Suture retention strength
Longitudinal	283g	535g
Oblique	285g	553g

NON-CLINICAL TESTS

Extensive testing of in vitro, functional, physical, and biocompatibility tests have been performed on the Perma-Pass Graft. These tests have shown that the Graft performs comparably to the predicate device. All performance results for the Graft and the predicate device exceed physiological requirements for the intended clinical use of the device. Where applicable, tests were conducted using USP or AAMI guidelines and standards. The results were acceptable in all cases.

CONCLUSION

The Perma-Pass Vascular Graft is a 5mm straight vascular prosthesis, intended as a permanent implant for bypass or reconstruction of occluded or diseased arterial blood vessels. The present 510(k) compares the Perma-Pass Graft to a legally marketed predicate device. The intended use, graft configuration, material, labeling, method of use, intended anatomical sites, and the target population of the Perma-Pass Graft are the same as those of the predicate device.

The Perma-Pass Graft is manufactured from PTFE, well known to the market with a long history of successful implantation in the human body. There are no known technological differences between the subject device and the predicate device. Extensive testing has shown the subject device is equivalent to the predicate device.

As summarized above, this 510(k) notification provides adequate information to support a determination of substantial equivalence between the Perma-Pass Graft and its predicate device.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 1999

Mr. Timothy J. Kappers Sr. Regulatory Affairs Associate Possis Medical, Inc. 9055 Evergreen Boulevard, N.W. Minneapolis, MN 55433-8003

Re: K984183 Perma-Pass™ Vascular Graft, 5T Graft, Model 31451 Regulatory Class: III (Three) Product Code: 74 DYF Dated: November 20, 1998 November 23, 1998 Received:

Dear Mr. Kappers:

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 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 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 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Timothy J. Kappers

This letter will allow you to begin marketing your device as Info iceeer wire as 0 ( ) premarket notification. The FDA finding a burnatantial equivalence of your device to a legally marketed or babbandante device 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 Additionally, for questions on the promotion and (301) 594-4648. 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 Other general information on your responsibilities CFR 807.97). under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 Mandracturers Inbibox or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html."

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

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PERMA-PASS™ VASCULAR GRAFT INDICATION FOR USE STATEMENT

NOVEMBER 1998

Thinwall Perma-Pass Grafts are not indicated for blood access. .
Perma-Pass Grafts are not indicated for applications involving: pulmonary arteries; . ascending aorta; coronary arteries; common, external, or internal carotid arteries; cerebral arteries; brachiocephalic trunk; cardiac veins; pulmonary veins; or the inferior or superior vena cava.

(Division Sign-Off) Division of Cardiovascular, R and Neurological Devices 510(k) Number

Prescription only

Regulation Number and Section

§ 870.3450 Vascular graft prosthesis.

(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”