K Number

Device Name

Manufacturer

JOTEC GMBH

Date Cleared

2003-01-24

(259 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Standard Wall FlowLine Bipore ePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.

Device Description

The Jotec FlowLine Bipore ePTFE Vascular Graft is a tube composed of pure expanded polytetrafluoroethylene (ePTFE). The graft may also have an external line or other orientation mark and may also have an external FEP double helix support.

The Jotec FlowLine Bipore ePTFE Vascular Graft is composed of pure expanded polytetrafluoroethylene (ePTFE), as are the predicate devices. Like the predicate devices, the Jotec FlowLine Bipore ePTFE Vascular Graft may have an external support, and an external line or other orientation mark.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Jotec® FlowLine™ Bipore ePTFE Vascular Graft. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data from studies directly comparing the device against acceptance criteria in the way a diagnostic AI device would.

Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device submission.

Here's the information that can be extracted or deduced from the provided text:

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

Acceptance Criteria	Reported Device Performance
Material Strength	Demonstrated substantial equivalence through mechanical testing and material analysis
Chemical Identification of Materials	Demonstrated substantial equivalence through chemical testing

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

Not Applicable: This was not a study involving human subjects or a "test set" in the context of device performance in patients. Performance was assessed through non-clinical bench testing.
Provenance: The non-clinical bench testing was "as prescribed by the FDA Guidance Document for Vascular Graft Prostheses 510(k) Submissions." The location of the testing is not specified, but the submitter is Jotec GmbH, located in Hechingen, Germany.

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: "Ground truth" in the context of expert consensus on diagnostic interpretations is not relevant here. The evaluation involved mechanical and chemical compliance with standards, likely interpreted by engineers and material scientists.

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

Not Applicable: No adjudication of interpretations was performed as this was not a diagnostic study. Compliance was evaluated against specified test methods and criteria.

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 vascular graft, not an AI-assisted diagnostic tool. An MRMC study is irrelevant to its evaluation.

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

Not Applicable: This device is not an algorithm. Its performance is inherent to its physical and chemical properties.

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

Ground Truth: The "ground truth" for this device's substantial equivalence was established by adherence to FDA Guidance Document for Vascular Graft Prostheses 510(k) Submissions, which outlines mechanical and chemical test requirements, and comparison to the properties of legally marketed predicate devices (Impra and Gore-Tex® ePTFE vascular grafts).

8. The sample size for the training set

Not Applicable: There is no training set as this is not a machine learning or AI device.

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

Not Applicable: As above, no training set.

Summary

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K621547

JAN 2 4 2003

510 (k) Summary

Submitter:	Jotec GmbHLotzenacker 23 Hechingen, Germany 72379Phone: 49-7471-922-0Fax: 49-7471-922-100
Contact Person:	Dr. Ralf Kaufmann
Date Summary Prepared:	May 9th, 2002
Trade or Proprietary Name:	Jotec® FlowLine™ Bipore ePTFE Vascular Graft
Common or Usual Name:	ePTFE Vascular Graft
Classification Name:	Prosthesis, vascular graft of 6 millimeters or greaterdiameter
Predicates:	Impra and Gore-Tex® and ePTFE vascular grafts.

Device Description:

Non-clinical bench testing, as prescribed by the FDA Guidance Document for Vascular Graft Prostheses 510(k) Submissions demonstrated through mechanical testing and material analysis that the Jotec FlowLine Bipore ePTFE Vascular Graft is substantially equivalent to the predicate devices.

Statement of Intended Use:

The Jotec FlowLine Bipore ePTFE Vascular Graft is indicated in cases of arterial vasoreconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstruction - femorofemoral and axillofemoral. Standard wall FlowLine BiporeePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.

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Substantial Equivalence Conclusion:

Mechanical and chemical tests, including material strength and chemical identification of the materials demonstrate that the FlowLine Bipore ePTFE Vascular Graft and predicate Gore-Tex® and Impra, Inc, ePTFE vascular grafts are substantially equivalent.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

JAN 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jotec GmbH c/o Mr. Bruce Ruefer Bridger Biomed 2430 N. 7th Avenue, Suite 4 Bozeman, MT 59715

Re: K021547

Jotec GmbH Flowline™ Bipore ePTFE Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: November 5, 2002 Received: November 6, 2002

Dear Mr. Ruefer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Bruce Ruefer

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the text "510(K): K 021547" written in black ink on a white background. The text appears to be handwritten. The "K" in "510(K)" is in parentheses. The number following the second "K" is "021547".

10 Statement of Indication for Use

Indication for Use:

Standard Wall FlowLine Bipore ePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.

ason Devices

510(k) Number: K021547

Prescription Use_X (Per 21 CFR 801.109)

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.”