The Edwards Lifespan ePTFE Vascular Grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access.

Device Description

The subject devices are vascular grafts consisting of a base tube of expanded PTFE that is wrapped with PTFE tape for better strength. Externally supported grafts have a monofilament of PTFE wrapped over the tape for added crush and kink resistance. The stepped grafts have a 4 mm diameter end with a step up to the 7 mm diameter end. All models of the graft have a printed black orientation line consisting of "Edwards Lifesciences" printed repeatedly along the length of the qraft.

AI/ML Overview

Here's an analysis of the provided text regarding the Edwards Lifespan Reinforced Expanded PTFE Vascular Graft.

Crucially, the provided text describes a traditional medical device (a vascular graft), not a software-based AI/ML device. Therefore, many of the questions related to AI/ML device performance (like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set size") are not applicable to this type of submission.

The summary focuses on preclinical (in vitro) and biocompatibility testing for a physical product, demonstrating equivalence to predicate devices for regulatory clearance.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Mechanical Performance	Burst Pressure	Met acceptance criteria
	Suture Retention	Met acceptance criteria
	Internodal Distance	Met acceptance criteria
	Water Entry Pressure	Met acceptance criteria
Labeling/Legibility	Printing legibility	Met acceptance criteria
	(at printing, after sterilization, after aging)
Biocompatibility	Biocompatibility evaluations	Met acceptance criteria

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

Not applicable for this type of device. The testing performed was in vitro performance testing and biocompatibility evaluations of physical material properties, not an AI/ML model evaluated against a clinical dataset. The sample sizes for these specific engineering tests are not provided in this summary but would be standardized for such material characterization.

2. 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 AI/ML sense (e.g., expert labels on images) is not relevant for in vitro mechanical and biocompatibility testing of a physical graft. Performance is determined by established engineering and biological standards.

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

Not applicable. Adjudication methods are used for resolving disagreements in expert labeling of data, which is not part of this device's testing.

4. 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 vascular graft, not an AI/ML system designed to assist human readers.

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

Not applicable. This is a physical device, not an algorithm.

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

For the in vitro performance tests (burst pressure, suture retention, etc.), the "ground truth" is defined by established engineering standards and specifications for vascular grafts.
For biocompatibility, the "ground truth" is defined by regulatory standards and guidelines for biological response to materials.

7. The sample size for the training set

Not applicable. This is a physical product, not an AI/ML model that requires a training set.

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

Not applicable. See point 7.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study conducted was a non-clinical performance and biocompatibility evaluation.

Non-Clinical Tests: In vitro performance testing included:
- Burst pressure
- Suture retention
- Internodal distance
- Water entry pressure
- Legibility of printed markings (at printing, after sterilization, and after aging)
Biocompatibility Evaluations: These tests assess the biological response to the device material.
Conclusion: "All testing demonstrated that the subject device met its acceptance criteria."
Clinical Tests: "No clinical tests specific to the subject device have been conducted." The submission relies on substantial equivalence regarding risks and benefits to predicate devices.

The information primarily focuses on demonstrating that the physical properties of the Edwards Lifespan Reinforced Expanded PTFE Vascular Graft meet the required mechanical and biological standards relevant for its intended use and are comparable to its predicate devices.

Summary

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Food and Drug Administration

510(k) Summary APPENDIX I

510(k) Notification

A. Submitter Information

Daun Putnam, Regulatory Specialist Edwards Lifesciences One Edwards Way Irvine, CA 92614-5686 Phone Number: (949) 250-2217 Fax Number: (949) 250-3579 Email address: daun_putnam@edwards.com

B. Device Information

1. Trade Name:
  Edwards Lifespan Reinforced Expanded PTFE Vascular Graft

Edwards Lifespan Reinforced Expanded PTFE Externally Supported Vascular Grafts Edwards Lifespan Reinforced Expanded PTFE Stepped Vascular Graft

1. Common or Usual Name:
  Vascular Graft Prosthesis
1. Device Classification and Classification Name:
  Class II (DSY, 21 CFR 870.3460, vascular graft of 6 mm diameter or greater)

Class II (DYF, 21 CFR 870.3450, vascular graft of less than 6 mm diameter)

K032900

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Predicate Device Identification: 4.
Baxter Reinforced Expanded PTFE Vascular Graft (K933590) Baxter Reinforced Expanded PTFE Stepped Vascular Graft (K944844) Baxter Reinforced Expanded PTFE Externally Supported Vascular Grafts (K944858)
1. Device Description:
  The subject devices are vascular grafts consisting of a base tube of expanded PTFE that is wrapped with PTFE tape for better strength. Externally supported grafts have a monofilament of PTFE wrapped over the tape for added crush and kink resistance. The stepped grafts have a 4 mm diameter end with a step up to the 7 mm diameter end. All models of the graft have a printed black orientation line consisting of "Edwards Lifesciences" printed repeatedly along the length of the qraft.
1. Intended Use:
- The Edwards Lifespan ePTFE Vascular Grafts are indicated for use . as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access.
- The physician must evaluate each alternative method of treatment, . discuss the risks and benefits with each patient, and decide whether to use a prosthetic vascular graft based upon all available factors.
- Grafts with removable external monofilament support over the . length of the graft are used in bypass or reconstruction of diseased

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or occluded blood vessels, where compression or kinking could jeopardize patency.

Grafts with external monofilament supporting the middle of the graft . may be used for the creation of an arteriovenous shunt for blood access; however, the graft must not be cannulated in the area of the external monofilament support.
Stepped grafts are used for the creation of arteriovenous shunts for . blood access. Stepped configurations may reduce the risk of steal syndrome and high cardiac output.
1. Technological Comparison of Subject Device to Predicate Device:

The physical characteristics, the intended use and the mode of use of the subject device are very similar to the predicate devices.

1. Summary of Non-Clinical Tests and Conclusions:
  In vitro performance testing and biocompatibility evaluations were conducted on the subject devices. Test specific to vascular grafts included burst pressure, suture retention, internodal distance and water entry pressure. Additionally, the printing was checked for legibility at the time of printing and after sterilization and aging. All testing demonstrated that the subject device met its acceptance criteria.
1. Summary of Clinical Tests and Conclusions:
  No clinical tests specific to the subject device have been conducted. The subject devices are expected to have a risk to benefit ratio similar to the predicate devices.

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C. Submitter's Signature and Date of Summary Preparation

Daun S. Putnam only 9/15/56

Daun Putnam Regulatory Specialist

Date

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4 2003

Edwards Lifesciences, LLC. c/o Ms. Daun Putnam One Edwards Way Irvine, CA 92614

Re: K032900

Lifespan Reinforced ePTFE Straight Vascular Graft Regulation Number: 21 CFR 807.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: September 15, 2003 Received: September 17, 2003

Dear Ms. Putnam:

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 indicetions 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, Drig, 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, ilsting 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 - Ms. Daun Putnam

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) 594-4648. 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ashley B. Bevan

for

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

Enclosure

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Indications for Use

510(k) Number (if known): K032900

Device Name: Lifespan™ Reinforced ePTFE Vascular grafts

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over - The - Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashley B. Boone

510(K) Number

Page 1 of __ 1_

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.”