Deknatel® Silk Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Description

Deknatel Silk Suture is a nonabsorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Silk Suture is waxed, braided or twisted, and provided dyed (black) or undyed (natural white). Silk Suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 10-0 through 5 (metric sizes 0.2 through 7). The suture is supplied sterile, waxed, and braided or twisted. The suture is provided in a variety of lengths, with and without needles, with and without pledgets, and may be supplied in a variety of cut lengths or on ligating reels. Finished suture may be packaged in cartons as single packs, multipacks or procedure packs.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "Deknatel Silk Surgical Sutures." It is not a study describing a device's performance against acceptance criteria in the typical sense of a clinical or AI performance study. Instead, it's a regulatory document demonstrating substantial equivalence to a predicate device. Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, training set details, etc.) are not applicable here.

However, I can extract the information that is present to describe the "acceptance criteria" and "study" as best as possible within the context of a 510(k) submission for a surgical suture.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (surgical suture), "acceptance criteria" are generally based on meeting recognized standards, specifically the United States Pharmacopeia (USP) requirements. The "device performance" is reported as compliance with these standards.

Acceptance Criteria (USP Standards)	Reported Device Performance
USP (United States Pharmacopeia) Nonabsorbable Sutures	Meets all requirements established by USP for Nonabsorbable Surgical Suture.
USP 36-NF 31 <861> Sutures - Diameter	Non-clinical testing performed in accordance with this standard to verify mordant material change.
USP 36-NF 31 <871> Sutures - Needle Attachment	Non-clinical testing performed in accordance with this standard to verify mordant material change.
USP 36-NF 31 <881> Tensile Strength	Non-clinical testing performed in accordance with this standard to verify mordant material change.
Biocompatibility (ISO 10993-1, G95-1) - Cytotoxicity	Testing included (Biocompatibility evaluated in accordance with relevant standards).
Biocompatibility (ISO 10993-1, G95-1) - Sensitization	Testing included.
Biocompatibility (ISO 10993-1, G95-1) - Irritation	Testing included.
Biocompatibility (ISO 10993-1, G95-1) - Systemic toxicity	Testing included.
Biocompatibility (ISO 10993-1, G95-1) - Subchronic toxicity	Testing included.
Biocompatibility (ISO 10993-1, G95-1) - Genotoxicity	Testing included.
Biocompatibility (ISO 10993-1, G95-1) - Implantation	Testing included.
Biocompatibility (ISO 10993-1, G95-1) - Haemocompatibility	Testing included.
Biocompatibility (ISO 10993-1, G95-1) - Pyrogen testing	Testing included.

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

The document does not specify exact sample sizes for the "test set" in terms of physical units of sutures. The "test set" in this context refers to the samples of the Deknatel Silk Surgical Sutures that underwent non-clinical performance and biocompatibility testing. This kind of testing is typically performed internally by the manufacturer or by a contract lab.

Sample Size: Not explicitly stated for each test, but standard statistical sampling is assumed for compliance testing.
Data Provenance: The testing was "non-clinical" and likely conducted in a laboratory setting to demonstrate compliance with USP standards and biocompatibility guidelines. The country of origin of the data is not specified but would typically be from the manufacturer's or a certified testing lab's facilities. This is retrospective in the sense that the testing was completed before the 510(k) submission.

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

This concept is not directly applicable to this type of device and regulatory submission. "Ground truth" in this context is established by the predefined specifications of the USP standards and ISO 10993 guidelines, which are universal and do not typically require expert consensus on a case-by-case basis during testing for these physical and biological properties. The "experts" would be the scientists, engineers, and toxicologists who designed and conducted the tests and interpreted the results against the established standards. Their qualifications would be expertise in materials science, biomechanics, analytical chemistry, toxicology, and regulatory compliance.

4. Adjudication method for the test set

Not applicable. Testing against USP and ISO standards involves objective measurements and predefined pass/fail criteria, not subjective interpretation requiring an adjudication process by multiple experts in the way clinical studies or AI algorithm ground truth establishment might.

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 surgical suture, not an AI-powered diagnostic device or a system designed to assist human readers.

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

Not applicable. This is a physical medical device (suture), not an algorithm.

7. The type of ground truth used

The "ground truth" for this submission are the established international and national standards for surgical sutures and biocompatibility:

United States Pharmacopeia (USP) requirements for Nonabsorbable Surgical Sutures (e.g., diameter, needle attachment, tensile strength).
ISO 10993-1 "Biological Evaluation of Medical Devices" and FDA Blue Book Memorandum #G95-1 "Use of International Standards ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a physical device like a surgical suture. This is not an AI/machine learning device.

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

Not applicable, as there is no training set.

Summary

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

November 23, 2016

Teleflex Medical, Inc Ms. Natalie Hichak Sr. Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560

Re: K162396

Trade/Device Name: Silk Surgical Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural Nonabsorbable Silk Surgical Suture Regulatory Class: Class II Product Code: GAP Dated: August 24, 2016 Received: August 26, 2016

Dear Ms. Hichak:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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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,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162396

Device Name Deknatel® Silk Surgical Sutures

Indications for Use (Describe)

Deknatel® Silk Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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

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510(k) SUMMARY

Deknatel® Silk Surgical Sutures

I. SUBMITTER

Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 Phone: 919-433-8049 Fax: 919-433-4996

Contact Person: Natalie Hichak, Senior Regulatory Affairs Specialist Date Prepared: August 24, 2016

II. DEVICE

Name of Device	Deknatel Silk Surgical Suture
Common Name	Suture, Nonabsorbable, Silk
Classification Name	Natural Nonabsorbable Silk Surgical Suture
Regulatory Class	II
Product Code	GAP
Regulation	878.5030

III. PREDICATE DEVICE

Deknatel® Nonabsorbable Surgical Sutures, K153076

IV. DEVICE DESCRIPTION

Silk Suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 10-0 through 5 (metric sizes 0.2 through 7). The suture is supplied sterile, waxed, and braided or twisted. The suture is provided in a variety of lengths, with and without needles, with and without pledgets, and may be supplied in a variety of cut lengths or on ligating reels. Finished suture may be packaged in cartons as single packs, multipacks or procedure packs.

V. INDICATIONS FOR USE

Deknatel Silk Surgical Sutures is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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The Indications for Use statement for Deknatel Silk Surgical Sutures is identical to the predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed Deknatel Silk Surgical Sutures have the same technology, indications for use and functional characteristics as the predicate system. The proposed modification is a dying process change to replace the current mordant, Sodium Dichromate with Ferrous Sulfate.

A comparison of the technological characteristics of the proposed Deknatel Silk Surgical Sutures and the predicate has been performed. The results of this comparison demonstrate that the Silk Surgical Sutures are equivalent to the marketed predicate devices in performance characteristics.

VII. PERFORMANCE DATA

Non-clinical testing has been performed in accordance USP (United States Pharmacopeia) Nonabsorbable Sutures, 36-NF 31 <861> Sutures -Diameter, <871> Sutures- Needle Attachment, and <881>Tensile Strength in order to verify mordant material change of the proposed Deknatel Silk Surgical Sutures are substantially equivalent to the predicate devices.

Biocompatibility Testing

The biocompatibility evaluation for the Deknatel Silk Surgical Suture was conducted in accordance with FDA Blue Book Memorandum #G95-1 "Use of International Standards ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standards ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA. The battery of testing included the following tests:

. Cytotoxicity
Sensitization ●
Irritation ●
Systemic toxicity ●
Subchronic toxicity
Genotoxicity ●
Implantation
Haemocompatibility
Pyrogen testing

The Deknatel Silk Surgical Sutures is considered a permanent implant (> 30 days) and the nature of body contact is tissue/bone and blood. Deknatel Silk

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Suture is composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Silk Suture is waxed with beeswax or a beeswax and paraffin mixture. Black silk suture is dyed with Logwood dye.

VII. CONCLUSIONS

Based upon the comparative test results, the proposed Deknatel Silk Surgical Sutures are substantially equivalent in performance to the predicate devices cleared to market via 510(k)s K153076.

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.