Dekna-lok™ is indicated for use in general soft tissue approximation and/or ligation, but not for cardiovascular, neurological or ophthalmic procedures.

Device Description

Dekna-lok™ is Deknatel® Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture supplied with two integral acetal polymer buttressing components designed to spread the pressure of the suture across tissue.

AI/ML Overview

This document is a 510(k) summary for the Dekna-lok™ Polyglycolytic Acid Surgical Suture. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed acceptance criteria, specific device performance metrics in a quantitative table, or an elaborate study description with the requested details beyond general statements about testing for materials and design.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The document mentions that the device was evaluated through "recognized consensus standards as outlined in USP 28:2005 Absorbable Surgical Sutures and biological qualification safety tests as outlined in ISO 10993 Part 1 'Biological Evaluation of Medical Devices'." It also states that "Verification and Validation testing was performed according to the risk analysis."
Reported Device Performance: The document concludes, "The design and materials were found to be acceptable for the intended use."

However, specific quantitative acceptance criteria (e.g., minimum tensile strength, degradation rates) and corresponding quantitative performance results for the Dekna-lok™ device are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The summary only mentions "Verification and Validation testing," implying internal testing by the manufacturer (Teleflex Medical).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable/Not specified. This type of information (expert review for ground truth) is typically relevant for diagnostic or AI-driven devices, not a surgical suture which is evaluated based on material standards and physical/biological properties.

4. Adjudication Method for the Test Set:

Not applicable/Not specified. As mentioned above, this is generally for interpretation-based studies.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study is not mentioned. This type of study is typically for evaluating the effectiveness of diagnostic tools, often imaging-based, with human readers involved.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a surgical suture, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for a surgical suture would be established through material property testing (e.g., tensile strength, knot security, degradation profile) against established standards (USP, ISO) and biological compatibility testing. The document refers to "USP 28:2005 Absorbable Surgical Sutures" and "ISO 10993 Part 1 'Biological Evaluation of Medical Devices'" as the standards used for evaluation.

8. Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established:

Not applicable. This device does not involve a "training set."

Summary of Study Information Provided in the Document:

The study described is a set of verification and validation (V&V) tests to demonstrate that the Dekna-lok™ suture's materials and design comply with relevant consensus standards and internal risk analysis requirements for its intended use.

Scope of Testing: Materials used in fabrication and biological qualification safety tests.
Standards Referenced: USP 28:2005 Absorbable Surgical Sutures and ISO 10993 Part 1 "Biological Evaluation of Medical Devices".
Conclusion: "The design and materials were found to be acceptable for the intended use."
Primary Study Goal: To establish substantial equivalence to a legally marketed predicate device (Teleflex Medical's Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture, K992088) with respect to functionality, design, intended use, and performance characteristics.

In essence, the document serves as a regulatory submission demonstrating compliance with established standards for a medical device rather than a detailed scientific study report with quantitative performance data.

Summary

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060801

Image /page/0/Picture/1 description: The image shows the logo for Teleflex Medical. The word "Teleflex" is in a bold, sans-serif font, with a stylized "T" that resembles a right angle. Below "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is in black and white.

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v + 7 0006

Teleflex Medical 2917 Weck Drive RTP. NC 27709 USA 919-544-8000 Phone: Fax: 919-361-4061 www.teleflex.com

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dekna-lok™

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-361-8000 Fax: 919-361-4061

B. Contact Person

Kimberly Edgerton Regulatory Affairs Specialist

C. Date Prepared

March 23, 2006

D. Device Name

Trade Name: Dekna-lok™

Common Name: Polyglycolytic Acid Surgical Suture

Classification Name: Absorbable poly(glycolide/l-lactide) surgical suture

Product Code: GAM

Regulation Number: 21 CFR 878.4493

Class: Il

E. Device Description

A Division of Teleflex Incorporated

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F. Intended Use

Dekna-lok™ is indicated for use in general soft tissue approximation and/or ligation, but not for cardiovascular, neurological or ophthalmic procedures.

G. Substantial Equivalence

Dekna-lok™ is substantially equivalent to Teleflex Medical's Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture (K992088) with respect to functionality, design, and intended use and performance characteristics.

H. Summary of Testing

All materials used in the fabrication of Dekna-lok™ were evaluated through the recognized consensus standards as outlined in USP 28:2005 Absorbable Surgical Sutures and biological qualification safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices". Verification and Validation testing was performed according to the risk analysis. The design and materials were found to be acceptable for the intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2006

Teleflex Medical % Ms. Kimberly Edgerton Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709

Re: K060801

Trade/Device Name: Dekna-lok™ Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: March 23, 2006 Received: March 24, 2006

Dear Ms. Edgerton:

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.

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.

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

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Page 2 - Ms. Kimberly Edgerton

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 (240) 276-0115. 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.

Hubert Werner ws

Mark N. Melkerson Director Division of General, Restorative and.Neurological 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 logo for Teleflex Medical. The logo is in black and white, with the word "Teleflex" in a bold, sans-serif font. Below the word "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is simple and modern.

K060801

Teleflex Medical 2917 Weck Drive RTP, NC 27709 USA Phone: 919-544-8000 Fax:919-361-4061 www.teleflex.com

、中国人民共和国际

Indications for Use

510(k) Number (if known):

Device Name: Dekna-lok TM

Indications For Use:

Dekna-lok™ is indicated for use in general soft tissue approximation and/or ligation, but not for cardiovascular, neurological or ophthalmic procedures.

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (Of

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uation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K060801

A Division of Teleflex Incorporated

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(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.