silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL

K153076 · Teleflexmedical, Inc. · GAT · Jun 16, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153076
• Device Name: silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL
• Applicant: Teleflexmedical, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Jun 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Deknatel nonabsorbable surgical sutures consist of five material types: polyester (coated/uncoated), polypropylene, nylon, silk, and 316LVM stainless steel. NextStitch cardiovascular valve suture is a continuous chain of linked polyester sutures for valve replacement. Gabbay-Frater suture guide acts as an accessory for organizing/counting interrupted sutures. Used in clinical settings (OR) by surgeons for tissue approximation/ligation. Sutures provide mechanical closure of wounds or tissues; guide facilitates suture management. Benefits include secure tissue approximation and organized surgical workflow. Devices are provided sterile in various lengths, with/without needles and pledgets.

Clinical Evidence

Bench testing only. Real-time aging testing performed per ISO 11607-1:2006 and USP 36-NF 31 standards (<861> Diameter, <871> Needle Attachment, <881> Tensile Strength) to verify 5-year shelf-life.

Technological Characteristics

Materials: Poly(ethylene terephthalate) (polyester), polypropylene, polyamide (nylon), silk (Bombyx mori), and 316LVM stainless steel. Polyester sutures may be uncoated or coated with PTFE. Connectivity: None. Sterilization: Not specified. Standards: ISO 10993-1 (biocompatibility), ISO 11607-1 (packaging), USP 36-NF 31 (suture performance).

Indications for Use

Indicated for soft tissue approximation and/or ligation in cardiovascular, neurological, ophthalmic, abdominal, and orthopedic procedures, depending on suture material. Contraindicated for patients with sensitivities to silk or 316LVM stainless steel components (chromium, nickel, copper, cobalt, iron). Nylon and Silk sutures not for use where permanent tensile strength retention is required.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• COTTONY' II, "silky” II POLYDEK® & TEVDEK® II Polyester Nonabsorbable Surgical Suture (K021019)
• Nextstitch™ Cardiovascular Valve Suture (K001440)
• Deknatel™ Bondek® Polyglycolic Acid Synthetic Absorbable Surgical Suture, Deknatel™ Plain and Chromic Gut Surgical Suture, Deknatel™ II Surgical Suture, Deknatel™ OpthaMend™ Ophthalmic Polypropylene Surgical Suture, Deknatel™ ‘Cottony' II Dacron® Surgical Suture, Deknatel™ ‘Silky' II Polydek® Surgical Suture, Deknatel™ Tevdek® II Surgical Suture, Deknatel™ Nylon Surgical Suture, Deknatel™ Silk Surgical Suture, and Deknatel™ Stainless Steel Surgical Suture (K930738)
• Gabbay-Frater™ Suture Guide (K802093)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being.

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 [phone] or [phone] 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 [phone] or [phone] 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.

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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: [phone] Fax: [phone]

# 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,<br>TEVDEK® II Polyester Surgical Sutures |
|---------------------|------------------------------------------------------------------------------|
| Common Name | Suture, Nonabsorbable, Synthetic,<br>Polyethylene |
| Classification Name | Nonabsorbable poly(ethylene terephthalate)<br>Surgical Suture |
| Trade Name | NextStitch® Cardiovascular Valve Suture |
| Common Name | Suture, Nonabsorbable, Synthetic,<br>Polyethylene |
| Classification Name | Nonabsorbable poly(ethylene terephthalate)<br>Surgical Suture |
| Trade Name | DEKLENE® II, DEKLENE® MAXX™<br>Polypropylene Surgical Suture |
| Common Name | Suture, Nonabsorbable, Synthetic,<br>Polypropylene |
| Classification Name | Nonabsorbable, Synthetic, Polypropylene |
| Trade Name | NYLON Surgical Suture |
| Common Name | Suture, Nonabsorbable, Synthetic Polyamide |
| Classification Name | Suture, Nonabsorbable, Synthetic,<br>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, Monofilament<br>and 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® II<br>Polyester Surgical Sutures |
| Indications for Use | Polyester Surgical Sutures are indicated for use in<br>general soft tissue approximation and/or ligation,<br>including use in cardiovascular, ophthalmic,<br>orthopedic and neurological procedures. |
| Contraindication | None known. |
| Trade Name | NextStitch® Cardiovascular Valve Suture<br>TEVDEK® II NextStitch® and "silky" II POLYDEK® |
| Indications for Use | NextStitch® cardiovascular valve suture are indicated<br>for use for soft tissue approximation and/or ligation in<br>cardiovascular valve replacement procedures. |
| Contraindication | None known. |
| Trade Name | DEKLENE® II, DEKLENE® MAXX™ Polypropylene<br>Surgical Suture<br>DEKLENE® II and DEKLENE® MAXX™ |
| Indications for Use | Polypropylene Surgical Sutures are indicated for use<br>in general soft tissue approximation and/or ligation,<br>including use in cardiovascular, and neurological<br>procedures, but not for use in ophthalmic procedures. |
| Contraindication | None known. |
| Trade Name | NYLON Surgical Suture<br>Nylon Surgical Suture is indicated for use in general |
| Indications for Use | soft tissue approximation and/or ligation including use<br>in cardiovascular, ophthalmic, and neurological<br>procedures. |
| Contraindication | Due to the gradual loss of tensile strength which may<br>occur over prolonged periods in vivo, Nylon Sutures<br>should not be used where permanent retention of<br>tensile strength is required. |
| Trade Name | SILK Surgical Suture<br>SILK Surgical Suture is indicated for use in general |
| Indications for Use | soft tissue approximation and/or ligation, including<br>use in cardiovascular, ophthalmic and neurological<br>procedures. |
| Contraindication | The use of this suture is contraindicated in patients<br>with known sensitivities or allergies to silk.<br>Due to the gradual loss of tensile strength which may<br>occur over prolonged periods in vivo, Silk Suture<br>should not be used where permanent retention of<br>tensile strength is required. |
| Trade Name | STERMOTOMY STAINLESS STEEL Suture |
| Indications for<br>Use | Stainless Steel Sutures are indicated for use in<br>abdominal wound closure, hernia repair, sternal<br>closure, and orthopedic procedures, including<br>cerclage and tendon repair. |
| Contraindication | The use of these sutures is contraindicated in<br>patients with known sensitivities or allergies to the<br>metals contained in 316LVM stainless steel, i.e.,<br>chromium, nickel, copper, cobalt, and iron. |
| Trade Name | Gabbay-Frater™ Suture Guide |
| Indications for<br>Use | Gabbay-Frater™ is a device for organizing, arranging<br>and counting multiple interrupted sutures in an orderly<br>fashion. |
| 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.
- 2. Polypropylene: DEKLENE II and DEKLENE® MAXX are the two varieties of this material.
- 3. NYLON is composed of monofilament synthetic polyamide fiber.
- 4. SILK is composed of grade 4A Chinese silk derived from the domesticated species Bombyx mori (B mori) of the family Bombycidae.
- 5. 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)<br>No. | Date<br>Cleared |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|---------------|-----------------------|
| COTTONY' II, "silky” II POLYDEK® &<br>TEVDEK® II Polyester Nonabsorbable<br>Surgical Suture | Genzyme Corp | K021019 | June 18,<br>2002 |
| Nextstitch™ Cardiovascular Valve<br>Suture | Genzyme<br>Surgical<br>Product<br>(Genzyme<br>Biosurgery) | K001440 | November<br>13, 2000 |
| Deknatel™ Bondek® Polyglycolic Acid<br>Synthetic Absorbable Surgical Suture,<br>Deknatel™ Plain and Chromic Gut<br>Surgical Suture, Deknatel™ II Surgical<br>Suture, Deknatel™ OpthaMend™<br>Ophthalmic Polypropylene Surgical<br>Suture, Deknatel™ ‘Cottony' II Dacron®<br>Surgical Suture, Deknatel™ ‘Silky' II<br>Polydek® Surgical Suture, Deknatel™<br>Tevdek® II Surgical Suture, Deknatel™<br>Nylon Surgical Suture, Deknatel™ Silk<br>Surgical Suture, and Deknatel™<br>Stainless Steel Surgical Suture | Deknatel, Inc | K930738 | July 25,<br>1994 |
| Gabbay-Frater™ Suture Guide | Howmedica<br>Corp | K802093 | September<br>26, 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.