NextStitch® cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement procedures.

Polypropylene Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation. including use in cardiovascular, and neurological procedures, but not for use in ophthalmic procedures.

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

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

Stainless Steel Sutures are indicated for use in abdominal wound closure, hernia repair, sternal closure, and orthopedic procedures, including cerclage and tendon repair.

Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.

Gabbay-Frater™ is a device for organizing, arranging and counting multiple interrupted sutures in an orderly fashion.

Device Description

Deknatel Nonabsorbable Surgical Sutures are available in five (5) different material options.

1. Poly(ethylene terephthalate) a polyester fiber.
- The three types of polyester sutures are 'cottony'™ II, 'silky' II POLYDEK, and ● TEVDEK II. 'cottony' II is uncoated polyester suture. 'silky' II POLYDEK® suture has a light coating of Polytetrafluoroethylene (PTFE) and TEVDEK II has a heavy PTFE coating.
- . NextStitch Cardiovascular Valve Suture is a combination of 'silky' II POLYDEK and/or TEVDEK II polyester suture. NextStitch is a continuous chain of linked sutures designed to provide an alternative suturing technique for cardiovascular valve replacement procedures.
1. Polypropylene: DEKLENE II and DEKLENE® MAXX are the two varieties of this material.
1. NYLON is composed of monofilament synthetic polyamide fiber.
1. SILK is composed of grade 4A Chinese silk derived from the domesticated species Bombyx mori (B mori) of the family Bombycidae.
1. STERNOTOMY STAINLESS STEEL sutures are composed of 316 LVM stainless steel.

All sutures are provided in a variety of lengths, with and without needles, and (if applicable) with and without pre-attached pledgets (if applicable).

An accessory that can be used with the Nonabsorbable Surgical Sutures is the Gabbay-Frater Suture Guide which is a convenient suture organizer which keeps suture ends tangle-free.

AI/ML Overview

This document is a 510(k) summary for the Deknatel Nonabsorbable Surgical Sutures. It aims to demonstrate substantial equivalence to previously cleared predicate devices, primarily focusing on a shelf-life extension and ownership transfer. Clinical performance criteria or studies in the context of device accuracy for diagnosis or treatment are not applicable here, as this is a surgical suture, not a diagnostic or AI-powered device.

Therefore, the requested information elements such as acceptance criteria, reported device performance, sample size for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training set details are not applicable or available in this submission because the device is a surgical suture, not an AI-powered diagnostic tool.

The "acceptance criteria" and "study" described in the document relate to the physical and mechanical properties of the sutures and their packaging for shelf-life extension, not to diagnostic or performance accuracy in the way an AI medical device would be evaluated.

Here's the relevant information based on the provided document regarding the substantiation of the shelf-life extension:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that non-clinical real-time aging testing was performed in accordance with specific standards. However, it does not explicitly present a table of acceptance criteria alongside reported device performance values in a comparative format for each individual suture property. Instead, it broadly states that "the proposed Deknatel Nonabsorbable Surgical Sutures are substantially equivalent to the predicate devices."

The standards referenced imply the properties that were measured and thus, the implicit acceptance criteria would be compliance with these standards within expected ranges for surgical sutures.

Acceptance Criteria (Implicit from Standards)	Reported Device Performance (Summary)
Compliance with ISO11607-1:2006 for packaging requirements for terminally sterilized medical devices.	Packaging integrity maintained for 5 years.
Compliance with USP 36-NF 31 <861> for Sutures - Diameter.	Suture diameters remained within USP specifications for 5 years.
Compliance with USP 36-NF 31 <871> for Sutures - Needle Attachment.	Needle attachment strength remained within USP specifications for 5 years.
Compliance with USP 36-NF 31 <881> for Sutures - Tensile Strength.	Suture tensile strength remained within USP specifications for 5 years.
Shelf-life claim	5-year shelf-life verified.

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

Sample Size: The document does not specify the exact sample size used for the real-time aging testing. It generally refers to "non-clinical real-time aging testing."
Data Provenance: The data is non-clinical, likely generated in a laboratory setting by Teleflex Medical, Inc. or its contractors. The document does not specify country of origin for the data, but the company is based in Morrisville, NC, USA. The testing is prospective in the sense that the sutures were aged in real-time to assess performance over 5 years.

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

Not Applicable. For the physical and mechanical testing of surgical sutures, ground truth is established by adherence to recognized international and national standards (e.g., ISO, USP) and laboratory testing protocols, not by expert consensus or interpretation of images. The "ground truth" is the objective measurement against these standards.

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective evaluations where human interpretation is involved, such as reading medical images. For physical property testing of sutures, measurements are objective and usually do not require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is not an AI-powered diagnostic device, so MRMC studies are not relevant.

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 or AI.

7. The Type of Ground Truth Used:

Objective Measurement against Recognized Standards: The "ground truth" for demonstrating the shelf-life and performance of the sutures are the established specifications and test methods outlined in ISO and USP standards for medical device packaging and surgical sutures.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI device that requires a "training set." The performance data is for physical characteristics of the manufactured product.

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

Not Applicable. As there is no "training set," this question is not relevant.

In summary, this 510(k) pertains to a traditional physical medical device (surgical suture). The "study" referenced is non-clinical real-time aging testing to support a shelf-life claim, using recognized industry standards for material properties and packaging integrity. The concepts of acceptance criteria, test sets, experts, and ground truth are applied differently in this context compared to AI/diagnostic devices.

Summary

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

June 16, 2016

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

Re: K153076

Trade/Device Name: "silky" II POLYDEK, "cottony" II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: May 18, 2016 Received: May 19, 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

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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 device-related 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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

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) K153076

Device Name

'silky' II POLYDEK®, 'cottony'™ II, TEVDEK® II,NextStitch® Cardiovascular Valve Suture,DEKLENE® MAXX™,NYLON Surgical Suture,SILK Surgical Suture,STERMOTOMY STAINLESS STEEL Suture,

Indications for Use (Describe)

NextStitch® cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement procedures.

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

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

Stainless Steel Sutures are indicated for use in abdominal wound closure, hernia repair, sternal closure, and orthopedic procedures, including cerclage and tendon repair.

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 OF SAFETY AND EFFECTIVENESS

Deknatel® Nonabsorbable Surgical Sutures

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

Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560

Phone: 919-433-8049 Fax: 919-433-4996

B. Contact Person

Natalie Hichak Sr. Regulatory Affairs Specialist

C. Date Prepared

July 10, 2015

D. Device Name

Trade Name	'silky' II POLYDEK®, 'cottony'™ II,TEVDEK® II Polyester Surgical Sutures
Common Name	Suture, Nonabsorbable, Synthetic,Polyethylene
Classification Name	Nonabsorbable poly(ethylene terephthalate)Surgical Suture
Trade Name	NextStitch® Cardiovascular Valve Suture
Common Name	Suture, Nonabsorbable, Synthetic,Polyethylene
Classification Name	Nonabsorbable poly(ethylene terephthalate)Surgical Suture
Trade Name	DEKLENE® II, DEKLENE® MAXX™Polypropylene Surgical Suture
Common Name	Suture, Nonabsorbable, Synthetic,Polypropylene
Classification Name	Nonabsorbable, Synthetic, Polypropylene
Trade Name	NYLON Surgical Suture
Common Name	Suture, Nonabsorbable, Synthetic Polyamide
Classification Name	Suture, Nonabsorbable, Synthetic,Polyamide

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Trade Name	SILK Surgical Suture
Common Name	Suture, Nonabsorbable, Silk
Classification Name	Natural Nonabsorbable Silk Surgical Suture
Trade Name	STERMOTOMY STAINLESS STEEL Suture
Common Name	Suture, Nonabsorbable, Steel, Monofilamentand Multifilament, Sterile
Classification Name	Stainless Steel Suture
Trade Name	Gabbay-Frater™ Suture Guide
Common Name	Guide, Surgical, Instrument
Classification Name	Manual Surgical Instrument for General Use
Trade Name	'silky' II POLYDEK®, 'cottony’™ II, TEVDEK® IIPolyester Surgical Sutures
Indications for Use	Polyester Surgical Sutures are indicated for use ingeneral soft tissue approximation and/or ligation,including use in cardiovascular, ophthalmic,orthopedic and neurological procedures.
Contraindication	None known.
Trade Name	NextStitch® Cardiovascular Valve SutureTEVDEK® II NextStitch® and "silky" II POLYDEK®
Indications for Use	NextStitch® cardiovascular valve suture are indicatedfor use for soft tissue approximation and/or ligation incardiovascular valve replacement procedures.
Contraindication	None known.
Trade Name	DEKLENE® II, DEKLENE® MAXX™ PolypropyleneSurgical SutureDEKLENE® II and DEKLENE® MAXX™
Indications for Use	Polypropylene Surgical Sutures are indicated for usein general soft tissue approximation and/or ligation,including use in cardiovascular, and neurologicalprocedures, but not for use in ophthalmic procedures.
Contraindication	None known.
Trade Name	NYLON Surgical SutureNylon Surgical Suture is indicated for use in general
Indications for Use	soft tissue approximation and/or ligation including usein cardiovascular, ophthalmic, and neurologicalprocedures.
Contraindication	Due to the gradual loss of tensile strength which mayoccur over prolonged periods in vivo, Nylon Suturesshould not be used where permanent retention oftensile strength is required.
Trade Name	SILK Surgical SutureSILK Surgical Suture is indicated for use in general
Indications for Use	soft tissue approximation and/or ligation, includinguse in cardiovascular, ophthalmic and neurologicalprocedures.
Contraindication	The use of this suture is contraindicated in patientswith known sensitivities or allergies to silk.Due to the gradual loss of tensile strength which mayoccur over prolonged periods in vivo, Silk Sutureshould not be used where permanent retention oftensile strength is required.
Trade Name	STERMOTOMY STAINLESS STEEL Suture
Indications forUse	Stainless Steel Sutures are indicated for use inabdominal wound closure, hernia repair, sternalclosure, and orthopedic procedures, includingcerclage and tendon repair.
Contraindication	The use of these sutures is contraindicated inpatients with known sensitivities or allergies to themetals contained in 316LVM stainless steel, i.e.,chromium, nickel, copper, cobalt, and iron.
Trade Name	Gabbay-Frater™ Suture Guide
Indications forUse	Gabbay-Frater™ is a device for organizing, arrangingand counting multiple interrupted sutures in an orderlyfashion.
Contraindication	None known.

E. Device Description

Deknatel Nonabsorbable Surgical Sutures are available in five (5) different material options.

1. Poly(ethylene terephthalate) a polyester fiber.
- The three types of polyester sutures are 'cottony'™ II, 'silky' II POLYDEK, and ● TEVDEK II. 'cottony' II is uncoated polyester suture. 'silky' II POLYDEK® suture has a light coating of Polytetrafluoroethylene (PTFE) and TEVDEK II has a heavy PTFE coating.
- . NextStitch Cardiovascular Valve Suture is a combination of 'silky' II POLYDEK and/or TEVDEK II polyester suture. NextStitch is a continuous chain of linked sutures designed to provide an alternative suturing technique for cardiovascular valve replacement procedures.
1. Polypropylene: DEKLENE II and DEKLENE® MAXX are the two varieties of this material.
1. NYLON is composed of monofilament synthetic polyamide fiber.
1. SILK is composed of grade 4A Chinese silk derived from the domesticated species Bombyx mori (B mori) of the family Bombycidae.
1. STERNOTOMY STAINLESS STEEL sutures are composed of 316 LVM stainless steel.

All sutures are provided in a variety of lengths, with and without needles, and (if applicable) with and without pre-attached pledgets (if applicable).

An accessory that can be used with the Nonabsorbable Surgical Sutures is the Gabbay-Frater Suture Guide which is a convenient suture organizer which keeps suture ends tangle-free.

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F. Indications for Use and Contraindications

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G. Substantial Equivalence

The proposed Deknatel Nonabsorbable Surgical Sutures is substantially equivalent to the predicate devices:

Predicate Device	Manufacturer	510(k)No.	DateCleared
COTTONY' II, "silky” II POLYDEK® &TEVDEK® II Polyester NonabsorbableSurgical Suture	Genzyme Corp	K021019	June 18,2002
Nextstitch™ Cardiovascular ValveSuture	GenzymeSurgicalProduct(GenzymeBiosurgery)	K001440	November13, 2000
Deknatel™ Bondek® Polyglycolic AcidSynthetic Absorbable Surgical Suture,Deknatel™ Plain and Chromic GutSurgical Suture, Deknatel™ II SurgicalSuture, Deknatel™ OpthaMend™Ophthalmic Polypropylene SurgicalSuture, Deknatel™ ‘Cottony' II Dacron®Surgical Suture, Deknatel™ ‘Silky' IIPolydek® Surgical Suture, Deknatel™Tevdek® II Surgical Suture, Deknatel™Nylon Surgical Suture, Deknatel™ SilkSurgical Suture, and Deknatel™Stainless Steel Surgical Suture	Deknatel, Inc	K930738	July 25,1994
Gabbay-Frater™ Suture Guide	HowmedicaCorp	K802093	September26, 1980

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H. Comparison To Predicate Devices

The proposed Deknatel Nonabsorbable Surgical Sutures have the same technology, indications for use and functional characteristics as the predicate system. The proposed modification is to add a stability claim of 5 years and to transfer the ownership from Genzyme to Teleflex Medical.

I. Materials

All patient contacting materials are in compliance with ISO10993-1.

J. Technological Characteristics

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

K. Performance Data

Non-clinical real-time aging testing has been performed in accordance with ISO11607-1:2006, Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and USP (United States Pharmacopeia) 36-NF 31 <861> Sutures - Diameter, <871> Sutures- Needle Attachment, and <881>Tensile Strength in order to verify addition of a 5 year shelf-life of the proposed Deknatel Nonabsorbable Surgical Sutures are substantially equivalent to the predicate devices.

L. Conclusion

Based upon the comparative test results, the proposed Deknatel Nonabsorbable Surgical Sutures are substantially equivalent in performance to the predicate devices cleared to market via 510(k)s K021019. K001440. K930738 and K802093.

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.