V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE

K103052 · Covidien, LLC · GAT · Nov 10, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K103052
• Device Name: V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
• Applicant: Covidien, LLC
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Nov 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

V-Loc™ Nonabsorbable Wound Closure Device is indicated for soft tissue approximation.

Device Story

V-Loc™ Nonabsorbable Wound Closure Device is a monofilament polybutester suture featuring unidirectional barbs along its axis. Designed for soft tissue approximation, the device eliminates the need for knot tying due to its barbed design. It is supplied in various USP/EP sizes, either undyed or dyed with [Phthalocyaninato(2-)] copper, and comes pre-cut with attached needles. Used by surgeons in clinical settings, the device functions by anchoring into tissue via barbs to maintain wound closure tension. The device provides a mechanical means of approximating tissue edges, facilitating healing by maintaining apposition. It is intended for use by healthcare professionals in surgical environments.

Clinical Evidence

Evidence includes bench testing and an in-vivo porcine model. Bench testing verified needle attachment, diameter, tensile strength, and barb holding strength against USP/EP specifications. A 21-day chronic porcine study compared the burst pressure of incisions closed with the subject device versus the predicate V-Loc™ 180. Results showed no statistical difference in burst pressure between the test and control devices.

Technological Characteristics

Monofilament polybutester suture (copolymer of butylene terephthalate and polytetramethylene ether glycol). Features unidirectional barbs. Sizes USP 3-0 to 1. Materials compliant with ISO 10993-1. Dyed with [Phthalocyaninato(2-)] copper (21 CFR 74.3045). Mechanical fixation via barbs.

Indications for Use

Indicated for soft tissue approximation in patients requiring surgical wound closure.

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

• Syneture™ Novafil™ Synthetic Absorbable Suture (K990952)
• V-Loc™ 180 Absorbable Wound Closure Device (K090348)

Submission Summary (Full Text)

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| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | Surgical Devices, a global business unit<br>of Tyco Healthcare Group LP (d/b/a Covidien)<br>60 Middletown Avenue<br>North Haven, CT 06473 |
| | NOV 10 2010 |
| CONTACT PERSON: | Jennifer Brennan<br>Manager, Regulatory Affairs<br>Tel. No.: [phone] |
| DATE PREPARED: | September 30, 2010 |
| TRADE/PROPRIETARY NAME: | V-Loc™ Nonabsorbable Wound Closure Device |
| COMMON/USUAL NAME: | Synthetic Nonabsorbable Suture |
| CLASSIFICATION NAME: | Nonabsorbable poly(ethylene terephthalate) surgical suture |
| PREDICATE DEVICE(S): | Syneture™ Novafil™ Synthetic Absorbable Suture (K990952)<br>V-Loc™ 180 Absorbable Wound Closure Device (K090348) |
| DEVICE DESCRIPTION: | The V-Loc™ Nonabsorbable Wound Closure Device is a polybutester<br>suture prepared from a copolymer of butylene terephthalate and<br>polytetramethlyene ether glycol. Each device has unidirectional barbs<br>along the axis of the monofilament.<br><br>The V-Loc™ Nonabsorbable Wound Closure Device will be offered<br>both Undyed (clear) and Dyed with [Phthalocyaninato(2-)] copper (21<br>CFR 74.3045) at a level not exceeding 0.5% by weight of the suture in<br>sizes USP (EP) 3-0 (Metric 3), 2-0 (Metric 3.5), 0 (Metric 4) and 1<br>(Metric 4.5). They will be supplied in pre-cut lengths affixed to various<br>needle types. |
| INDICATIONS: | V-Loc™ Nonabsorbable Wound Closure Devices are indicated for soft<br>tissue approximation. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | V-Loc™ Nonabsorbable Wound Closure Device is substantially<br>equivalent to the predicate devices with regards to use in soft tissue<br>approximation. |
| MATERIALS: | All components of the V-Loc™ Nonabsorbable Wound Closure Device<br>are comprised of materials that are in compliance with ISO standard<br>10993-1. |
| PERFORMANCE DATA: | Performance testing was conducted to verify that the V-Loc™<br>Nonabsorbable Wound Closure Device is safe and effective and<br>performs as intended.<br>The following is a description of tests performed and associated<br>conclusions: |

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K103052

## COVIDIEN™ V-LOC™ NONABSORBABLE WOUND CLOSURE DEVICE

Page 2/2

## In-vitro performance evaluation (bench testing) .

- Needle Attachment meets USP/EP specification. .
- Diameter (non-barbed suture) Maximum Overage of ■ USP/EP specification as stated in the Instructions for Use.
- l Tensile Strength (T=0 straight pull evaluation)- Pass
- . Barb Holding Strength (T=0 simulated barb holding of felt medium) - Pass
- · In-vivo performance evaluation

## Product safety and efficacy in porcine model ●

Chronic 21 day study with biomechanical testing at T=3, T=7, and T=21 days to compare the burst pressure of the sutured incision of the control (predicate V-Loc™ 180 Absorbable Wound Closure Device) and the test (V-Loc™ ).

Results: No statistical differences in burst pressure between the barbed control (V-Loc™ 180) and test device (V-Loc™ Nonabsorbable).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Covidien LLC % Ms. Jennifer Brennan Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

NOV 1 0 2010

Re: K103052

Trade/Device Name: V-Loc " Nonabsorbable Wound Closure Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: October 12, 2010 Received: October 14, 2010

Dear Ms. Brennan:

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

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Page 2 - Ms. Jennifer Brennan

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

510(k) Number (if known): __ 长 ١٥3052

NOV 1 0 2010

Device Name: V-Loc™ Nonabsorbable Wound Closure Device

Indications For Use:

V-Loc™ Nonabsorbable Wound Closure Device is indicated for soft tissue approximation.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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 (ODE)

David Krane for MCM
(Division Sign Off)

(Division Sign-6 Division of Surgi al Orthopedic, and Restorative L. . vices

510(k) Number K103052