VERSACLOSE, MODEL VC-200-01

K100572 · Anulex Technologies, Inc. · GAT · Mar 17, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100572
• Device Name: VERSACLOSE, MODEL VC-200-01
• Applicant: Anulex Technologies, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Mar 17, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Versaclose is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.

Device Story

Versaclose is a sterile, single-use implantable device for soft tissue approximation. It consists of a PEEK Optima (LT1) toggle-anchor connected to an adjustable 2-0 braided UHMWPE (ultra-high molecular weight polyethylene) suture loop. The device is provided preloaded on a disposable delivery instrument. It is used by surgeons in clinical settings to approximate soft tissues during general or orthopedic surgical procedures. The device functions as a mechanical anchor and suture system to hold tissue in place, facilitating healing or structural repair.

Clinical Evidence

Bench testing only. Tensile testing was performed to confirm compliance with USP suture requirements.

Technological Characteristics

Materials: PEEK Optima (LT1) toggle-anchor, UHMWPE (ultra-high molecular weight polyethylene) suture. Suture conforms to USP requirements. Form factor: Toggle-anchor with adjustable suture loop, preloaded on a disposable delivery instrument. Sterilization: Provided sterile.

Indications for Use

Indicated for soft tissue approximation in general and orthopedic surgery patients.

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

• Anchor Band Suturing System (K061386)

Submission Summary (Full Text)

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K100572_

## Section 5 – 510(k) Summary

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| Applicant: | Anulex Technologies, Inc.<br>5600 Rowland Road, Suite 280<br>Minnetonka, MN 55343 | MAR 1 7 2010 |
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| Contact Person: | Rachel Kennedy<br>Director of Regulatory and Quality Systems<br>Telephone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
| Date Prepared: | February 26, 2010 | |
| Trade Name: | Versaclose™ | |
| Product Classification<br>and Code: | 21 CFR §878.5000<br>Class: II<br>Product Code: GAT | |
| Predicate Device: | K061386 - Anchor Band Suturing System | |
| Device Description: | The Versaclose implant is comprised of one (1) Peek Optima<br>(LT1) Toggle-anchor, connected to an adjustable 2-0 braided<br>suture loop, made of ultra high molecular weight polyethylene<br>(UHMWPE) force fiber suture. The suture component<br>conforms to USP requirements. The construct is provided<br>sterile and preloaded on a disposable delivery instrument. | |
| Intended Use: | Versaclose is indicated for use in soft tissue approximation for<br>procedures such as general and orthopedic surgery. | |
| Summary of<br>Technological<br>Characteristics: | The modifications to the Anchor Band Suturing System were<br>conducted in accordance with the Anulex Design Control<br>System. Accordingly, the risk analysis identified necessary<br>design verification and validation activities. As a result of<br>this analysis, tensile testing was performed to confirm<br>compliance to USP suture requirements. | |
| Conclusion: | The modified Anchor Band Suturing System (Versaclose) is<br>substantially equivalent to the original Anchor Band Suturing<br>System in regards to the indications for use, technology and<br>the basic operating principle. | |

CONFIDENTIAL

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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird.

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

Anulex Technologies, Inc. % Ms. Rachel Kennedy Director of Regulatory & Quality Systems 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 553430

MAR 1 7 2010

Re: K100572

Trade/Device Name: Versaclose™ Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: February 26, 2010 Received: March 1, 2010

Dear Ms. Kennedy:

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 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

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Page 2 - Ms. Julie Acker, RAC Ms. Rachel Kennedy

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,

for Peta) R

Mark N. Miller

Mark N. Melkerso 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

- KIO0572 510(k) Number (if known):

## Device Name:

Versaclose™ is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane for MXM

(Division (Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K100572