The Edwards Suture Fastening System is indicated for suture fastening in the approximation of soft tissue and prosthetic materials, including cardiovascular procedures with Edwards' surgical heart valves and annuloplasty rings.

Device Description

The Edwards Suture Fastening System is comprised of the fastening instrument and the fastener loader. These components interface together to deploy a nitinol fastener onto a suture and then cut the suture 5 mm proximal to the nitinol fastening instrument has a 3 mm (0.1 inches) diameter shaft which is available in three lengths: 15 cm (5.9 inches), 22 cm (8.7 inches) and 30 cm (11.8 inches). A handle and a trigger are located at the proximal end of the instrument. By activating the trigger, the fastening instrument deploys the nitinol fastener at the intended position and cuts the suture. Each fastener loader holds one nitinol fastener which is pre-loaded in the locking tip.

AI/ML Overview

The provided document is a 510(k) summary for the Edwards Suture Fastening System. It details nonclinical performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in the format of an AI model's performance.

The document describes tests for a physical medical device (a suture fastening system), not an AI algorithm. Therefore, many of the requested fields (like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to the content of this regulatory submission for a manual surgical instrument.

The document lists various nonclinical tests and states that "all results met acceptance criteria," but it does not quantify or specify those acceptance criteria for most tests, nor does it provide detailed performance reports for each criterion in a table format suitable for an AI model.

Therefore, I cannot fulfill the request as specified because the input document does not pertain to the evaluation of an AI-powered device or algorithm.

If you are looking for an example of how such a table and study description would be presented for an AI device, please provide a document that describes the evaluation of an AI algorithm.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 16, 2015

Edwards Lifesciences LLC Ms. Nina Brooke Regulatory Affairs Associate III One Edwards Way Irvine, CA 92614

Re: K150882

Trade/Device Name: Edwards Suture Fastening System Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: Class I Product Code: HCF Dated: April 1, 2015 Received: April 2, 2015

Dear Ms. Brooke:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

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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Indications for Use

510(k) Number (if known) K150882

Device Name

Edwards Suture Fastening System

Indications for Use (Describe)

The Edwards Suture Fastening System is indicated for suture fasteming in the approximation of soft tissue and prosthetic materials, including cardiovascular procedures with Edwards' surgical heart valves and annuloplasty rings.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (K150882)

Submitter:	Edwards Lifesciences LLC
Contact Person:	Nina Brooke, Regulatory Affairs Associate IIIOne Edwards WayIrvine, CA 92614Phone: (949) 244-6444
Fax:	(949)756-4573
Date Prepared:	April 1, 2015
Trade Name:	Edwards Suture Fastening System
Classification Name:	Instrument Ligature Passing and Knot Tying, General &Plastic Surgery Panel (21 CFR §878.4800, Product CodeHCF, Class I)
Predicate Device:	K141206, Edwards ThruPort OptiClip Knotting System,Edwards Lifesciences, LLC.

Device Description

Indications for Use

Technological Characteristics

The subject device has similar technological characteristics as the predicate device, with minor design optimizations in the disposable tip, the suture snare target, the cutter assembly, and the right handle to improve manufacturability and usability.

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Non-clinical Performance Data

The following nonclinical tests were completed and all results met acceptance criteria:

. Function testing
- Knot loader suture snare tensile strength: To demonstrate that the Knot Loader suture snare can withstand forces encountered during suture loading within the Knotting Instrument.
- । Knotting system suture loading force: To establish the forces encountered during suture loading within the Knotting Instrument
- Knotting instrument shaft stiffness: To demonstrate that the shaft of the Knotting — Instrument has adequate stiffness to perform effectively within the intended use.
- -Knotting instrument weight: To demonstrate that the weight of the assembled Knotting System allows for adequate tactile feedback.
- -Dimensional interference: To demonstrate that the components of the Knotting System (including the un-deployed nitinol knot) do not exhibit dimensional interference relative to the suture prior to deployment.
- -Pinch point area: To demonstrate that the area of the exposed Knotting System pinch point is less than that of the predicate device.
- Knotting instrument effective length: To demonstrate that the effective length of the -15cm, 22cm, and 30cm Knotting Instrument are as labeled
- -Shaft outer diameter: To demonstrate that the outer diameter of the Knotting Instrument is less than or equal to the predicate device.
- | Overall nitinol knot height: To demonstrate that the deployed nitinol knot height is less than or equal to the predicate device
- -Knot loader outer diameter: To demonstrate that the outer diameter of the Knot Loader is less than or equal to the predicate device outer diameter.
- -Knotting system deployment force: To demonstrate that the force required to fully depress the trigger and deploy a nitinol knot exceeds the weight of the Knotting System and is low enough to ensure ease of use
- -Suture tension: To demonstrate that the tension required to cut suture is less than or equal to the predicate device.
- -Knot loader disposable tip push-off force: To demonstrate that the Knot Loader locking tip will not be pushed off during the deployment of the nitinol knot.
- -Nitinol knot push-off force: To demonstrate that the Knot Loader locking tip will not be pushed off during the deployment of the nitinol knot.
- Nitinol knot suture retention strength: To demonstrate that the nitinol knot can effectively secure the suture upon deployment when used for the intended use.
- -Knotting instrument handle strength: To demonstrate that the handle of the Knotting Instrument can withstand the force of applying suture tension and pressure onto tissue or prosthetic material.
- -Knotting instrument corrosion: To demonstrate that the Knotting Instrument can function after exposure to a simulated use environment.
- | Nitinol knot corrosion: To demonstrate that the nitinol knot does not corrode.

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-Knotting instrument durability: To demonstrate that the Knotting Instrument can function for a maximum of 25 deployment cycles.
Ink adherence: To demonstrate that the ink adheres to the device. |
Nitinol knot magnetic resonance conditional testing: To substantiate the claim of magnetic resonance (MR) conditional.
-Nitinol knot durability (600 million cycles): Demonstrate that the applicable engineering requirements for nitinol knot fatigue/durability are satisfied when used with Ethibond Excel polyester (braided) suture and 2-0 Ethicon Prolene polypropylene suture.
Animal studies: To demonstrate use of the device in a cardiovascular application under worse case physiological conditions (i.e., mitral bioprosthesis) using polyester and propylene suture.
Biocompatibility testing was performed per ISO 10993-1:2009
Sterility and sterile barrier testing
. Shelf life testing
Packaging testing ●
Design validation

Conclusion

The Edwards Suture Fastening System has similar technological characteristics as the predicate device with minor design modifications. It also has the same general indications for use as the predicate device, with additional specific indications for use in cardiovascular procedures with Edwards' surgical heart valves and annuloplasty rings, which does not raise new issues of safety or effectiveness. Nonclinical performance data have demonstrated that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.