XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01

K091432 · Anulex Technologies, Inc. · GAT · Jun 12, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091432
• Device Name: XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01
• Applicant: Anulex Technologies, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Jun 12, 2009
• 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 is a surgical device for soft tissue approximation. It consists of two non-absorbable braided 3-0 UHMWPE suture and PET T-anchor assemblies, connected by a green 2-0 PET suture loop. The loop facilitates tightening and drawing the anchor assemblies together to re-approximate tissue. The system is provided sterile and preloaded on a disposable delivery instrument. It is used by surgeons in clinical settings (general or orthopedic surgery). The device functions as a mechanical suture-anchor construct to secure tissue, aiding in healing or structural repair.

Clinical Evidence

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

Technological Characteristics

Non-absorbable braided 3-0 UHMWPE suture; PET T-anchors; 2-0 PET suture loop. Provided sterile, preloaded on disposable delivery instrument. Suture components conform to USP requirements.

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

• Xclose Tissue Repair System (K062307)

Submission Summary (Full Text)

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### Section 5 - 510(k) Summary

Anulex Technologies, Inc. Applicant: JUN 1 2 2009 5600 Rowland Road, Suite 280 Minnetonka. MN 55343 Rachel Kennedy Contact Person: Senior Regulatory Affairs Manager Telephone: [phone] Fax: [phone] e-mail: rkennedy(@anulex.com May 13, 2009 Date Prepared: Xclose™ Tissue Repair System Trade Name: 21 CFR §878.5000 Product Classification and Code: Class: II Product Code: GAT Predicate Device: K062307 - Xclose Tissue Repair System The modified Xclose™ Tissue Repair System consists of two (2) Device Description: non-absorbable braided surgical 3-0 suture (Ultra High Molecular Weight Polyethylene, UHMWPE) and T-anchor (polyethylene terephthalate, PET) assemblies, connected together with a loop of green 2-0 suture (PET). The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture/anchor assemblies together, thereby re-approximating the tissue. The suture components conform to USP requirements The construct is provided sterile and preloaded on a disposable delivery instrument. The Xclose™ Tissue Repair System is indicated for use in soft Intended Use: tissue approximation for procedures such as general and orthopedic surgery. The modifications to the Xclose Tissue Repair System were Summary of conducted in accordance with the Anulex Design Control System. Technological Accordingly, the risk analysis identified necessary design Characteristics: verification and validation activities. As a result of this analysis, tensile testing was performed to confirm compliance to USP suture requirements. The modified Xclose™ Tissue Repair System is substantially Conclusion: equivalent to the original Xclose Tissue Repair System in regards to the indications for use, technology and the basic operating principle.

CONFIDENTIAL

Special 510{k} for the Anulex Xclose Tissue Repair System

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized eagle emblem. The eagle is depicted with three prominent wing strokes, conveying a sense of strength and national identity. The overall design is simple, yet recognizable, representing the HHS's role in public health and human services.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 2 2009

Anulex Technologies, Incorporated % Ms. Rachel Kennedy Senior Regulatory Affairs Manager 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343

Re: K091432

Trade/Device Name: Xclose™ Tissue Repair System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(ethylene terephthalate) Surgical Suture Regulatory Class: II Product Code: GAT Dated: May 13, 2009 Received: May 14, 2009

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 agninst 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 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

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Page 2-Ms. Rachel Kennedy

practice requirements as set forth in the quality systems (OS) 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/cdrh/mdr/ 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/cdrl/industry/support/index.html.

Sincerely yours

Mark N. Melkerson Division of Surgical, Orthopedic and Restorative 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): K

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)

Daniel Krone

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091432