ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB

K061386 · Anulex Technologies, Inc. · GAT · Jul 5, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061386
• Device Name: ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB
• Applicant: Anulex Technologies, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Jul 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anchor Band Suturing System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.

Device Story

Anchor Band Suturing System facilitates soft tissue approximation; consists of non-absorbable braided polyethylene terephthalate (PET) surgical suture and T-anchor; provided sterile and preloaded on disposable delivery instrument; instrument needle places T-anchor in tissue sub-layer; used by clinicians in general and orthopedic surgical procedures; provides mechanical fixation of soft tissue.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: Polyethylene terephthalate (PET) suture and T-anchor. Suture size: U.S.P. 2-0. Delivery: Disposable instrument with preloaded suture/anchor assembly. Sterilization: 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

• ArthroCare Speedstitch (K042031)
• AutoSuture SurgiStitch (K972911)
• Teleflex Medical Polyester Nonabsorbable Suture (K021019)

Submission Summary (Full Text)

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Ko61386 1/1

:

## Section 5—510(k) Summary

| Submitter: | Anulex Technologies, Inc.<br>5600 Rowland Road, Suite 280<br>Minnetonka, MN 55343 | JUL - 5 2006 |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Tim Miller<br>Vice President, Regulatory and Clinical Affairs<br>Anulex Technologies, Inc.<br>Direct: 952.224.4003<br>Fax: [phone]<br>E-Mail: [e-mail] | |
| Date Prepared: | May 17, 2006 | |
| Trade Name: | Anchor Band Suturing System | |
| Classification: | II | |
| Product Code: | GAT | |
| | 21 CFR 878.5000 | |
| Predicate Device(s): | The subject device is substantially equivalent to the following<br>predicate devices: | |
| | ArthroCare Speedstitch<br>(K042031 cleared October 19, 2004)AutoSuture SurgiStitch<br>(K972911 cleared April 25, 1998)Teleflex Medical Polyester Nonabsorbable Suture<br>(K021019 cleared June 18, 2002) | |
| Device Description: | The Anchor Band Suturing System consists of a non-absorbable<br>braided surgical suture and T-anchor, both of which are composed<br>of polyethylene terephthalate (PET). The suture, which conforms<br>to U.S.P. 2-0, and T-anchor assembly are provided sterile and<br>preloaded on a disposable delivery instrument. The instrument's<br>needle facilitates placement of the suture by positioning the T-<br>anchor in the sub-layer of the tissue. | |
| Indications for Use: | The Anchor Band Suturing System is indicated for use in soft tissue<br>approximation for procedures such as general and orthopedic<br>surgery. | |
| Functional and<br>Safety Testing: | Biocompatibility and bench testing were completed and support the<br>safety and effectiveness of the Anchor Band Suturing System. | |
| Conclusion: | The Anchor Band Suturing System is substantially equivalent in<br>intended use, technological characteristics, materials and<br>performance to the predicate devices. | |
| Anchor Band Suturing System<br>Anulex Technologies, Inc.<br>Confidential_ | Traditional 510(k) Premarket Notification<br>Page 18 | 5/17/2006 |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is written around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 5 2006

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

Re: K061386

Trade/Device Name: Anchor Band Suturing System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: May 17, 2006 Received:, May 18, 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. EDA way 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 not incl net or any Federal statutes and regulations administered by other Federal agencies. Youndation 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

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## Page 2 - Mr. Tim Miller

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 100-1050. This letter will allow you to begin marketing your device as described in your Section 10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, perrorts 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 von ; } pos "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon vibtain other general information on your responsibilities under the Act from the Division of Voall Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/suport/i03e20ml.

Sincerely yours.

Huker Lernerius

Radiological Health

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

Enclosure

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## Section 4 - Indications for Use Statement

Device Name: Anchor Band Suturing System

## Indications for Use:

The Anchor Band Suturing 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulen Lemmer

Division of General, Restorative, and Neurological Devices

510(k) Number k061386

Anchor Band Suturing System Anulex Technologies, Inc. Confidential

Traditional 510(k) Premarket Notification

Page 17

5/17/2006