XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS

K062307 · Anulex Technologies, Inc. · GAT · Sep 1, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062307
• Device Name: XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS
• Applicant: Anulex Technologies, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Sep 1, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Xclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.

Device Story

Xclose™ Tissue Repair System consists of two non-absorbable braided 3-0 polyethylene terephthalate (PET) surgical sutures with T-anchor assemblies, connected by a 2-0 suture loop. Device provided sterile, preloaded on disposable delivery instrument. Used by surgeons in general and orthopedic procedures to re-approximate soft tissue. Operator uses 2-0 loop to tighten and draw 3-0 suture assemblies together, securing tissue. System facilitates mechanical tissue approximation; no electronic or software components.

Clinical Evidence

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

Technological Characteristics

Materials: Polyethylene terephthalate (PET) conforming to USP requirements. Form factor: Two 3-0 braided sutures with T-anchors and 2-0 suture loop, preloaded on 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

• Anulex Anchor Band Suturing System (K061386)

Submission Summary (Full Text)

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SEP 1 2006

## Section 5 – 510(k) Summary

| Applicant: | Anulex Technologies, Inc.<br>5600 Rowland Road, Suite 280<br>Minnetonka, MN 55343 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tim Miller<br>Vice President, Regulatory and Clinical Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared: | August 7, 2006 |
| Trade Name: | Xclose™ Tissue Repair System |
| Product Classification<br>and Code: | 21 CFR §878.5000<br>Class: II<br>Product Code: GAT |
| Predicate Device: | K061386 - Anulex Anchor Band Suturing System |
| Device Description: | The Xclose™ Tissue Repair System consists of two (2) non-<br>absorbable braided surgical 3-0 suture and T-anchor assemblies,<br>connected together with a loop of green 2-0 suture. The 2-0 suture<br>loop is used to facilitate tightening, drawing the 3-0 suture<br>assemblies together, thereby re-approximating the tissue. The<br>device construct is composed of polyethylene terephthalate (PET)<br>and conforms to USP requirements. The construct is provided<br>sterile and preloaded on a disposable delivery instrument. |
| Intended Use: | The Xclose™ Tissue Repair System is indicated for use in soft<br>tissue approximation for procedures such as general and orthopedic<br>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 System.<br>Accordingly, the risk analysis identified necessary design<br>verification and validation activities. As a result of this analysis,<br>tensile testing was performed to confirm compliance to USP suture<br>requirements. |
| Conclusion: | The Xclose™ Tissue Repair System is substantially equivalent to<br>the Anchor Band Suturing System in regards to the indications for<br>use, the basic operating principle, materials, sterilization, packaging<br>and shelf-life. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2006

Anulex Technologies, Inc. % Mr. Tim Miller VP Regulatory and Clinical Affairs 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343

Re: K062307

Trade/Device Name: Xclose™ Tissue Repair System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: August 7, 2006 Received: August 8, 2006

Dear Mr. Miller:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA

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Page 2 - Mr. Tim Miller

finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,


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

Enclosure

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## Section 4 - Indications For Use Statement

510(k) Number (if known): Ko CQ 30 7

Device Name: Xclose™ Tissue Repair System

## Indications for Use:

The Xclose™ Tissue Repair System 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)

**Division Sign-Off**

Division of General, Restoral : and Neurological Devices

510(k) Number L062307

CONFIDENTIAL