Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch

K192490 · Teleflex Medical · GAT · Mar 30, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K192490
• Device Name: Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
• Applicant: Teleflex Medical
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Mar 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures. Polyester Surgical Suture Tapes are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures. TEVDEK® II NextStitch® and 'silky' II POLYDEK® NextStitch® cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement procedures.

Device Story

Non-absorbable surgical sutures composed of twisted or braided Polyethylene Terephthalate (PET) fibers; available undyed or dyed green; offered with or without stainless steel needles and PTFE pledgets. Configurations include uncoated 'cottony' II, lightly PTFE-impregnated 'silky' II/Polydek, and heavily PTFE-impregnated Tevdek II. NextStitch variant provides continuous chain of linked sutures for cardiovascular valve replacement. Used by surgeons in OR settings for tissue approximation/ligation. Device provides mechanical closure of surgical sites; benefits patient through secure tissue approximation. Subject device represents a change in source of PET resin and PTFE coating materials compared to predicates.

Clinical Evidence

Bench testing only. Performance verified per USP 40-NF 35 <861> (Diameter), <871> (Needle Attachment), and <881> (Tensile Strength). Biocompatibility assessed per ISO 10993-1. Stability and MR safety testing performed.

Technological Characteristics

Non-absorbable braided/twisted PET fibers. PTFE coating (varying density). 300/400 series stainless steel needles. USP sizes 7-0 to 9. Sterilization via Ethylene Oxide (EO) to SAL 10^-6. Compliant with ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in cardiovascular, ophthalmic, orthopedic, and neurological procedures; cardiovascular valve replacement procedures for NextStitch variants. No contraindications known.

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

• silky II POLYDEK, 'cottony' II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL (K153076)
• 'cottony' II Polyester Suture Tape (K153089)

Reference Devices

• SUTURES POLYPROP., POLYETHYLENE, NYLON & SILK (K930739)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

March 30, 2020

Teleflex Medical Robin Haden Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560

Re: K192490

Trade/Device Name: Tevdek II, "Silky" II Polydek, 'Cottony' II, NextStitch Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: February 21, 2020 Received: February 24, 2020

Dear Ms. Haden:

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. 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 located 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.

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 803) for

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devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic 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) K192490

Device Name

"silky" II POLYDEK®, 'cottony' II, TEVDEK® II Polyester Surgical Suture

Indications for Use (Describe)

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

| 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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# Indications for Use

510(k) Number (if known) K192490

Device Name

'cottony' II Polyester Surgical Suture Tape

Indications for Use (Describe)

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

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# Indications for Use

510(k) Number (if known) K192490

Device Name

TEVDEK® II NextStitch® and "silky" II POLYDEK® NextStitch® Cardiovascular Valve Suture

Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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#### 510(k) SUMMARY

## Deknatel® Polyester Surgical Suture

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

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

Phone: [phone] Fax:

# B. Contact Person

Robin Haden Surgical Business Unit Tel – [phone] Fax - [phone] Email – [e-mail]

# C. Date Prepared

March 18, 2020

### D. Device Name

| Trade Name(s) | Deknatel® Polyester Surgical Sutures, including: | | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | – "silky" II POLYDEK® Polyester Surgical Suture<br>– 'cottony' II Polyester Surgical Suture and Tape<br>– TEVDEK® II Polyester Surgical Suture<br>– TEVDEK® II NextStitch® Cardiovascular Valve Suture<br>– "silky" II POLYDEK® NextStitch® Cardiovascular<br>Valve Suture | | |
| Product Code | GAT (Suture, Nonabsorbable, Synthetic, Polyethylene) | | |
| Regulation | 21 CFR 878.5000 | | |
| Classification Name | Nonabsorbable poly(ethylene terephthalate) surgical suture | | |

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# E. Device Description

The Deknatel® Polyester Surgical Suture is a non-absorbable surgical suture composed of twisted or braided Polyethylene Terephthalate fibers. Deknatel® Polyester Surgical Suture is available undyed (white) or dyed (green) and is offered in a variety of cut lengths, with or without needles, and with or without pledgets. Product labeling carries the following specific information on the suture: material (including color, number and length of sutures in the package); USP size (diameter, including any difference in diameter); the number, profile and size of any attached needles; and the number, size and density of pre-attached pledgets.

The Deknatel® Polyester Surgical Suture meets all nonabsorbable surgical suture requirements established by the United States Pharmacopeia (USP) for tensile strength, diameter and needle attachment, except for suture size 7-0 which differs from USP in diameter only.

Deknatel® Polyester Surgical Suture is available in USP sizes 7-0 to 9 in the following configurations:

- . 'cottony' II: Uncoated (Not PTFE impregnated)
- "silky II" or Polydek®: Lightly coated (PTFE impregnated) .
- Tevdek® II: Heavily coated (more PTFE impregnated than "silky")) .

The Deknatel® Polyester Surgical Sutures are also available in the following productspecific configurations with or without needles, and with or without pledgets:

- Surgical Suture Tape as uncoated 'cottony' II in flat braid sizes of 1/8", 1mm, 2 mm, ● 3mm, 4mm and 5mm.
- . NextStitch® Cardiovascular Valve Suture is comprised 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. NextStitch Sutures are available in USP Sizes 4-0, 3-0, 2-0 and 0 (metric sizes 1.5 through 3.5).
- Readi-Cut TEVDEK® II Bulk Non-Sterile Polyester Surgical Suture is bulk, non-● sterile Tevdek® II polyester suture available in USP Size 2.

# F. Indications for Use and Contraindications

### Sterile Deknatel® Polyester Suture, previously cleared under K153076 and K153089. carries the following indications and contraindications:

# "silky" II POLYDEK®, 'cottony' II, TEVDEK® II Polyester Surgical Suture and Tape

#### Indications:

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

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Contraindications: None known.

# TEVDEK® II NextStitch® and "silky" II POLYDEK® NextStitch® Cardiovascular Valve Suture

#### Indications:

TEVDEK II NextStitch and "silky" II POLYDEK NextStitch cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement procedures.

Contraindications: None known.

Non-sterile Deknatel® Polyester Suture, previously cleared under K930739, carries the following indications and contraindications:

#### READI-CUT TEVDEK® II Non-Sterile Polyester Surgical Suture

Indications:

Deknatel Polyester Surgical Sutures (i.e. Dacron®, Polydek, and Tevdek) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

Contraindications: None known.

#### G. Substantial Equivalence

The proposed Deknatel Polyester Surgical Suture is substantially equivalent to the predicate devices cleared below:

| Predicate Device | Manufacturer | 510(k) | Clearance<br>Date |
|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------|-------------------|
| "silky" II POLYDEK, 'cottony' II,<br>TEVDEK II, NextStitch, DEKLENE<br>II, DEKLENE MAXX Gabbay-Frater,<br>NYLON, SILK, STAINLESS STEEL | Teleflex Medical,<br>Inc. | K153076 | June 16, 2016 |
| 'cottony' II Polyester Suture Tape | Teleflex Medical,<br>Inc. | K153089 | July 15, 2016 |

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The following reference device information is included to support the inclusion of the nonsterile Deknatel® Polyester Surgical Suture. The proposed non-sterile device is substantially equivalent to the reference non-sterile Deknatel® Polyester Surgical Suture cleared below:

| Reference Device | Manufacturer | 510(k) | Clearance Date |
|--------------------------------------------------|---------------------------|---------|----------------|
| SUTURES POLYPROP.,<br>POLYETHYLENE, NYLON & SILK | Teleflex Medical,<br>Inc. | K930739 | July 26, 1994 |

# H. Comparison To Predicate Devices

The proposed sterile Deknatel® Polyester Surgical Suture is substantially equivalent in intended use and fundamental scientific technology to the Deknatel® Polyester Surgical Suture predicate devices cleared under K153076 on June 16, 2016 and K153089 on July 15, 2016. The proposed non-sterile Deknatel® Polyester Surgical Suture is substantially equivalent in intended use and fundamental scientific technology to the non-sterile Deknatel® Polyester Surgical Suture devices cleared under reference K930739 on July 26, 1994. Nonclinical testing on functionality, stability, biocompatibility, and MR safety was conducted to confirm that the supplier changes did not negatively impact device performance. The testing results concluded that the only difference between the subject and predicate sutures are the sources for the PET resin and the PTFE impregnation/dispersion coating materials.

The following tables contain the technological characteristics of the proposed devices in comparison to the predicate and reference devices.

| Comparative<br>Characteristics | Predicate Device | Proposed Device | Explanation<br>of Differences |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|---------------------------------------------|
| Manufacturer | Teleflex Medical | | Identical |
| 510(k) Number | K153076, K153089 | K192490 | N/A |
| Product Code | GAT | | Identical |
| Regulation | 878.5000 | | Identical |
| Device Class | 2 | | Identical |
| Indications for<br>Use<br>('cottony' II,<br>"silky" II<br>POLYDEK,<br>TEVDEK II<br>Sutures) | Polyester Surgical Sutures are indicated for use in general soft<br>tissue approximation and/or ligation, including use in<br>cardiovascular, ophthalmic, orthopedic and neurological<br>procedures. | | Identical |
| Comparative<br>Characteristics | Predicate Device | Proposed Device | Explanation<br>of Differences |
| Indications for<br>Use<br>('cottony' II<br>Suture Tapes) | Polyester Surgical Suture Tapes are indicated for use in general<br>soft tissue approximation and/or ligation, including use in<br>cardiovascular, ophthalmic, orthopedic and neurological<br>procedures. | | Identical |
| Indications for<br>Use<br>(NextStitch) | TEVDEK II NextStitch and "silky" II POLYDEK NextStitch<br>cardiovascular valve suture are indicated for use for soft tissue<br>approximation and/or ligation in cardiovascular valve<br>replacement procedures. | | Identical |
| Contraindications | | None known. | Identical |
| Trade Names | "silky" II POLYDEK®<br>'cottony' II, TEVDEK® II, NextStitch® | | Identical |
| USP Size<br>('cottony' II,<br>"silky" II<br>POLYDEK,<br>TEVDEK II) | 9-0 to 9 | 7-0 to 9 | Equivalent,<br>within cleared<br>size range |
| USP Size<br>(NextStitch) | 4-0 to 0 | | Equivalent |
| Size<br>'cottony II'<br>Suture Tape | 1/8", 1mm, 2mm, 3mm, 4mm, 5mm | | Equivalent |
| Suture Diameter | All sizes meet USP <861> requirements for nonabsorbable<br>surgical suture except tape which does not conform to USP<br>Diameter | | Identical |
| Suture Tensile<br>Strength | All sizes meet USP <881> requirements for nonabsorbable<br>surgical suture | | Identical |
| Needle<br>Attachment<br>Strength | All sizes meet USP <871> requirements for nonabsorbable<br>surgical suture | | Identical |
| Material | Polyester<br>[Poly(ethylene terephthalate)] | | Identical |
| Suture<br>Construction | Braided | | Identical |
| Impregnated/Coat<br>ed | Yes ("silky" II POLYDEK or TEVDEK II) with<br>Polytetrafluoroethylene | | Identical |
| Uncoated | Yes ('cottony' II) | | Identical |
| Undyed White | Yes | | Identical |
| D&C Green No. 6 | Yes | | Identical |
| Co-braid<br>(White/Green) | Yes | | Identical |
| Impregnated | Yes | | Identical |
| Comparative<br>Characteristics | Predicate Device | Proposed Device | Explanation<br>of Differences |
| PTFE Pledget | | | |
| Pledget Material | polytetrafluoroethylene (PTFE) | | Identical |
| Needle Material | 300 or 400 Series Stainless Steel | | Identical |
| Package Materials | Solid Sulfite Board (SBS)/ Uncoated Tyvek Pouch | | Identical |
| Sterility Method | Ethylene Oxide (EO);<br>SAL 10-6 | | Identical |
| Biocompatibility | Per ISO 10993-1 | | Identical |
| Shelf Life | 5 Years | | Identical |

#### Substantial Equivalence Summary Table (Sterile Product)

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# Substantial Equivalence Summary Table (Non-Sterile Product)

| Comparative<br>Characteristics | Reference Device | Proposed Device | Explanation<br>of Differences |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------------------|
| Manufacturer | Teleflex Medical | Teleflex Medical | Identical |
| 510(k) Number | K930709 | K192490 | N/A |
| Product Code | GAT | GAT | Identical |
| Regulation | 878.5000 | 878.5000 | Identical |
| Device Class | 2 | 2 | Identical |
| Indications for<br>Use<br>TEVDEK® II | Polyester Surgical Sutures are indicated for use in general soft<br>tissue approximation and/or ligation, including use in<br>cardiovascular, ophthalmic, and neurological procedures. | | Identical |
| Contraindications | None known. | | Identical |
| Trade Names | TEVDEK® II | | Identical |
| USP Size<br>TEVDEK® | 2 | | Identical |
| Suture Diameter | All sizes meet USP <861> requirements for nonabsorbable<br>surgical suture except tape which does not conform to USP<br>Diameter | | Identical |
| Suture Tensile<br>Strength | All sizes meet USP <881> requirements for nonabsorbable<br>surgical suture | | Identical |
| Needle<br>Attachment<br>Strength | All sizes meet USP <871> requirements for nonabsorbable<br>surgical suture | | Identical |
| Material | Polyester<br>[Poly(ethylene terephthalate)] | | Identical |
| Suture<br>Construction | Braided | | Identical |
| Impregnated/Coat<br>ed | Polytetrafluoroethylene | | Identical |
| D&C Green No. 6 | Yes | | Identical |
| Package Materials | Solid Sulfite Board (SBS)/ Uncoated Tyvek Pouch | | Identical |
| Sterility Method | N/A- Sold Non-Sterile | | Identical |

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| Comparative<br>Characteristics | Reference Device | Proposed Device | Explanation<br>of Differences |
|--------------------------------|-----------------------|-----------------|-------------------------------|
| Biocompatibility | Per ISO 10993-1 | | Identical |
| Shelf Life | N/A- Sold Non-Sterile | | Identical |

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# I. Materials

All patient contacting materials are in compliance with ISO10993-1. The proposed modification is replacing the source of the polyester resin and polytetrafluoroethylene (PTFE) coating used to manufacture the Deknatel® Polyester Surgical Sutures.

### J. Technological Characteristics

A comparison of the technological characteristics of the proposed Deknatel® Polyester Surgical Suture and the predicate has been performed. The results of this comparison demonstrate that the Deknatel Polyester Surgical Sutures are equivalent to the marketed predicate devices in performance, stability, biocompatibility and MR safety characteristics.

### K. Performance Data

Non-clinical testing has been conducted in accordance with USP (United States Pharmacopeia) 40-NF 35 <861> Sutures – Diameter, <871> Sutures- Needle Attachment, and <881>Tensile Strength in order to verify the new polyester suture resin and polytetrafluoroethylene (PTFE) coating of the proposed Deknatel Polyester Surgical Sutures are substantially equivalent to the predicate devices in performance Additional non-clinical testing was conducted to confirm substantial equivalence with regards to stability, MR safety and biocompatibility (per ISO 10993-1).

#### L. Conclusion

Based upon the comparative test results, the proposed Deknatel Polyester Surgical Sutures are substantially equivalent in performance, stability, biocompatibility and MR safety to the predicate devices cleared to market via 510(k)s K153076, K153089, and reference 510(k) K930739. The proposed new sources of polyester resin and PTFE coating are the only changes to the product and do not introduce any new issues of safety and effectiveness.