Sofsilk™ 6/0 and 7/0 black braided silk sutures are nonabsorbable, sterile, non-mutagenic surgical sutures composed of natural proteinaceous silk fibers called fibroin. This protein is derived from the domesticated silkworm species Bombyx mori of the family bombycidae. The silk fibers are treated to remove the naturally-occurring sericin gum and braided to produce Sofsilk™ surgical silk sutures. The braided sutures are coated uniformly with silicone to reduce capillarity and to increase surface lubricity, which enhances handling characteristics, ease of passage through tissue, and knot run-down properties. Sofsilk™ sutures are colored black with Logwood extract (21CFR73.1410). Sofsilk™ sutures meet all requirements established by the United States Pharmacopeia (USP) and the European Pharmacopeia (EP) for nonabsorbable surgical sutures, Sofsilk™ Coated Braided Silk Suture. Sofsilk™ sutures are indicated for use in soft tissue approximation and/or ligation.

AI/ML Overview

The provided text is a 510(k) summary for the Sofsilk™ Coated Braided Silk Suture. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain information about an AI/ML-based device or its performance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as these aspects are not discussed in the provided document. The document describes a traditional medical device (surgical sutures) and its regulatory clearance based on substantial equivalence, primarily through bench testing for physical and mechanical performance, and biocompatibility.

The "study" mentioned refers to mechanical and physical bench tests of the suture, not a clinical or AI performance study.

Here's what the document does provide regarding the device's performance evaluation:

Acceptance Criteria (implied standards compliance):
- Meets or exceeds requirements of U.S.P. (United States Pharmacopeia) for nonabsorbable surgical sutures.
- Meets or exceeds requirements of E.P. (European Pharmacopeia) for nonabsorbable surgical sutures.
- Compliant with ISO 10993-1:2018 "Biological evaluation of medical devices-Part 1: Evaluation and testing" for biocompatibility.
- Sterility Assurance Level (SAL) of 10^-6 for ETO sterilization.
Reported Device Performance (bench tests):
- USP/EP diameter: Tested, found equivalent to predicate.
- USP needle attachment: Tested, found equivalent to predicate.
- USP tensile strength: Tested, found equivalent to predicate.
- Biocompatibility: Evaluated and confirmed compliant with ISO 10993-1 for its intended patient contact profile.
- Shelf life: Stability studies conducted, proposed 5-year shelf life demonstrated.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This further confirms that there was no clinical study, let alone one involving AI/ML performance.

Summary

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December 03, 2024

Covidien Nicole Boroumand Senior Regulatory Affairs Specialist 60 Middletown Ave North Haven, Connecticut 06473

Re: K241486

Trade/Device Name: Sofsilk™ Coated Braided Silk Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural Nonabsorbable Silk Surgical Suture Regulatory Class: Class II Product Code: GAP Dated: May 17, 2024 Received: May 24, 2024

Dear Nicole Boroumand:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tek N.
Lamichhane -S

Digitally signed by
Tek N. Lamichhane -S
Date: 2024.12.03
16:07:49 -05'00'

Tek N. Lamichhane, Ph.D.
Assistant Director
DHT4B: Division of Plastic and
Reconstructive Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241486

Device Name Sofsilk™ Coated Braided Silk Suture

Indications for Use (Describe)

Sofsilk™ Coated Braided Silk Sutures are indicated for use in soft tissue approximation and/or ligation.

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- K241486

Date Prepared:	February 14, 2024
Submitter:	Covidien II (subsidiary of Medtronic)60 Middletown AveNorth Haven, CT 06473United States
Contact:	Nicole BoroumandSenior Regulatory Affairs Specialist60 Middletown AveNorth Haven, CT 06473United StatesTelephone: (626) 375-3597Email: Nicole.boroumand@medtronic.com
Name of Device:Trade/Proprietaryname:	Sofsilk™ Coated Braided Silk Suture
Common name:	Natural nonabsorbable silk surgical suture
Classification name:	Class IIPanel number and product code: GAPRegulation Number 21 CFR 878.5030
Predicate Device:Trade/Proprietaryname:Common name:	Sofsilk™ Coated Braided Silk SutureSilk Suture
Classification name:	Natural nonabsorbable silk surgical suturePanel number and product code: GAPRegulation Number 21 CFR 878.5030
510(k) Number:	K980124
Manufacturer:	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE150 GLOVER AVENORWALK, CT 06856
Device Description:	Sofsilk™ 6/0 and 7/0 black braided silk sutures are nonabsorbable, sterile,non-mutagenic surgical sutures composed of natural proteinaceous silk fiberscalled fibroin. This protein is derived from the domesticated silkworm species
Bombyx mori of the family bombycidae. The silk fibers are treated to removethe naturally-occurring sericin gum and braided to produce Sofsilk™ surgicalsilk sutures. The braided sutures are coated uniformly with silicone to reducecapillarity and to increase surface lubricity, which enhances handlingcharacteristics, ease of passage through tissue, and knot run-down properties.Sofsilk™ sutures are colored black with Logwood extract (21CFR73.1410).
Sofsilk™ sutures meet all requirements established by the United StatesPharmacopeia (USP) and the European Pharmacopeia (EP) for nonabsorbablesurgical sutures, Sofsilk™ Coated Braided Silk Suture.Sofsilk™ sutures are indicated for use in soft tissue approximation and/orligation.
Intended users are healthcare professionals who have been trained inapplicable surgical procedures and approaches involving sutures prior toemploying this device.
Intended Use:	The intended purpose of the device is soft tissue approximation and/orligation.
Indications for use:	Sofsilk™ sutures are indicated for use in soft tissue approximation and/orligation.

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	Subject Device	Predicate Device(K980124)	Comparison
IntendedUse	Sofsilk™ sutures areindicated for use insoft tissueapproximationand/or ligation.	Modified Sofsilk™ Suturehas indications for use ingeneral soft tissueapproximationand/or ligation, includingcardiovascular,ophthalmic, microsurgeryand neural tissue.	Similar, the subject device'sintended use is morerestrictive than thepredicate device. Therefore,there is no concernregarding substantialequivalence.
Classification	Pannel number: 79Product code: GAP,per 21 CFR 878.5030Naturalnonabsorbable silksurgical suture	Pannel number: 79Product code: GAP, per 21CFR 878.5030 Naturalnonabsorbable silksurgical suture	Identical, therefore noconcern regardingsubstantial equivalence.
Materials	Suture: silk fromsilkworm dyed withLogwood extract(21CFR73.1410) witha ferrous-basedmordant and coatedwith siliconeNeedles: Stainlesssteel with siliconecoating	Suture: silk from silkwormDye: Logwood extract(21CFR73.1410) with achromium-based mordantSuture coating: MED 2245SiliconeNeedles: Stainless steelwith silicone coating	Similar, the subject deviceuses a different mordant.The new mordant does notaffect performance.Therefore, no concernregarding substantialequivalence.
Sizes	Only sizes 6-0 and 7-0are in scope for the510(k).	Sizes 5 through 9-0	Similar, the subject devicehas fewer sizes. Therefore,no concern regardingsubstantial equivalence.
ProductConfigurations	pre-cut lengths andligating reels, non-needled oraffixed to needlesusing bothpermanent andremovable needleattachmenttechniques.	pre-cut lengths andligating reels, non-needledor affixed to needles usingboth permanent andremovable needleattachment techniques: inone, two and three dozenbox quantities.	Similar, the subject devicehas fewer configurations.Therefore, no concernregarding substantialequivalence.
Sterilization	ETO sterilization witha minimum SterilityAssurance Level (SAL)of 10-6	Gamma radiation (25.1-40kGy) with a minimumSterility Assurance Level(SAL) of 10-6	DifferentThe subject device issterilized with ETOsterilization, whereas thepredicate device is sterilizedvia Gamma. The subject'ssterilization process resultsin a SAL of 10-6 and is aCategory A sterilizationmethod.
Packaging	Tyvek® and nylonpouches or Tyvek®and paper pouches	Tyvek® andnylon/polyethylenepouches or aluminumfoil/laminate packages	Similar, The subject devicecan also be packaged inTyvek® and paper pouch.This additional configurationdoes not affect sterility orshelf life. Therefore, noconcern regardingsubstantial equivalence.
Shelf life	5 years	5 years	Identical, there is no changeto shelf life between thesubject and predicatedevices.

Summary comparing the technological characteristics of the subject and predicate device:

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Sofsilk™ Coated Braided Silk Suture has been evaluated and found compliant with the following standards:

International standard, ISO 10993-1:2018 "Biological evaluation of medical devices-Part 1: . Evaluation and testing",
. Food and Drug Administration (FDA, USA) "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process' – Guidance for Industry and Food and Drug Administration Staff", issued September 8, 2023,
Performance data: The performance of the subject Sofsilk™ Coated Braided Silk Suture has been evaluated through bench tests. The following finished product physical and mechanical performance tests were conducted: USP/EP diameter, USP needle attachment, and USP tensile strength were tested, and it was found that the subject Sofsilk™ Coated Braided Silk Suture performed equivalently to the predicate and currently marketed Sofsilk™ Coated Braided Silk Suture. Both subject and predicate sutures meet or exceed requirements of U.S.P. Stability Studies were conducted, and the proposed device shelf life was demonstrated.

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Biocompatibility evaluation was performed and confirmed that Sofsilk™ Coated Braided Silk Suture is compliant with ISO Standard 10993-1 for its intended patient contact profile. This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

The evidence and testing demonstrate that the subject Sofsilk™ Coated Conclusion: Braided Silk Suture with new mordant and sterilization method is substantially equivalent to the predicate Sofsilk™ Coated Braided Silk Suture (K980124).

Regulation Number and Section

§ 878.5030 Natural nonabsorbable silk surgical suture.

(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.