SMARTSTITCH PERFECTPASSER SYSTEM

K123268 · Arthocare Corporation · GAT · Nov 7, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K123268
• Device Name: SMARTSTITCH PERFECTPASSER SYSTEM
• Applicant: Arthocare Corporation
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Nov 7, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SmartStitch® PerfectPasser® System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.

Device Story

SmartStitch PerfectPasser System is a manual surgical instrument set for arthroscopic and limited access procedures. Components include a connector, handle, and suture cartridge containing nonabsorbable synthetic polyethylene suture. Device functions as a suture passer to facilitate tissue repair. Operated by surgeons in clinical/OR settings. Provides mechanical assistance for suture delivery through soft tissue. Benefits include simplified suture placement in constrained surgical environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of a mechanical handle, connector, and nonabsorbable synthetic polyethylene suture. Manual operation; no energy source or software. Sterilized via standard methods.

Indications for Use

Indicated for patients requiring suture placement through soft tissue during arthroscopic or limited access surgical procedures.

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.

Submission Summary (Full Text)

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## General Information 1

Submitter Name/Address

ArthroCare Corporation 7000 West William Cannon Drive Austin, TX 78735

Contact Person:

Contact Number(s) and Email Address:

Manufacturing Facilities

Cheryl Frederick

Director, Regulatory Affairs

Direct: 512-391-5751 512-895-1489 Fax:

Email: [e-mail]

3006524618

ArthroCare Corporation 15285 Alton Parkway, #200 Irvine, CA 92618

ArthroCare Costa Rica 502 Parkway, Global Park La Aurora, Heredia Costa Rica

Establishment Registration Numbers

Irvine, CA: 2032380

Austin, TX:

Costa Rica: 3003780898

Sterilization Facility

SteriGenics Corporation 7775 S. Quincy Willowbrook, IL 60527

Device Identification (System Components)

The SmartStitch PerfectPasser System is a Class II device consisting of the following components:

> SmartStitch® PerfectPasser® Connector Trade/Proprietary Name: Suture Passer Classification Name: Product Code: NBH CFR Section: 21 CFR 888.1100 Device Class: Classification Panel: Orthopedic

SmartStitch® Handle Trade/Proprietary Name: Suture Passer (Handle) Classification Name: Product Code: NBH CFR Section: 21 CFR 888.1100 Class I Device Class: Classification Panel: Orthopedic

K123268

NOV 7 2012

Page 1

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Suture Cartridge containing Suture Trade/Proprietary Name: Suture, Nonabsorbable, Synthetic, Polyethylene Classification Name: Product Code: GAT 21 CFR 878.5000 CFR Section: Device Class: Class II Classification Panel: General & Plastic Surgery

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, a symbol often associated with healthcare.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Arthrocare Corporation % Ms. Cheryl Frederick Director, Regulatory Affairs 7000 West William Cannon Drive Austin, Texas 78735

November 7, 2012

Re: K123268

Trade/Device Name: SmartStitch® Perfect Passer® System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable polyethylene terephthalate surgical suture Regulatory Class: Class II Product Code: GAT, NBH Dated: October 18, 2012 Received: October 19, 2012

Dear Ms. Frederick:

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. Cheryl Frederick

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by steeling (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please 11 you desire specific ad 1100 ter your Centers offices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Concertor Dorieted and states and ing by reference to premarket notification" (21CFR Part note to regalation interest ding 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 Tou may 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,

Peter D. Rumm -5 .

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

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Enclosure

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## Indications for Use

4-123268 510(k) Number (if known):

Device Name: SmartStitch® PerfectPasser® System

Indications for Use:

The SmartStitch® PerfectPasser® System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Komeku MM
(Division Sign Off)

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

510(k) Number K123268