SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE

K121306 · Arthocare Corporation · GAT · Jul 12, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121306
• Device Name: SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE
• Applicant: Arthocare Corporation
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Jul 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The SmartStitch M-Connector Ultra System is a handheld, manual orthopedic/arthroscopic instrument designed to deliver sutures through soft tissue. The system consists of a handle, a connector, and a suture cartridge containing MagnumWire suture. It functions as a manual suture passer; the surgeon operates the device to mechanically place sutures during arthroscopic or limited access procedures. The device is provided non-sterile (handle) and sterile (connector/cartridge) and is intended for use by trained clinicians in a surgical setting. By facilitating suture placement in confined spaces, the device assists in soft tissue repair, potentially improving surgical efficiency and patient outcomes.

Clinical Evidence

No clinical or animal data included. Bench testing only.

Technological Characteristics

Manual arthroscopic instrument; includes handle, connector, and suture cartridge with MagnumWire suture. Materials include non-absorbable synthetic polyethylene. Sterilization via ethylene oxide. Packaging includes Tyvek pouch. No electronic components or software.

Indications for Use

Indicated for placement of sutures through soft tissue during arthroscopic and 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.

Predicate Devices

• ArthroCare M-Connector System (K023843)
• ArthroCare M-Connector System (K033317)
• ArthroCare PerfectPasser Connector System (K062244)

Submission Summary (Full Text)

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K121306 Page 1/2

# 510(k) Summary

ArthroCare® Corporation SmartStitch® M-Connector Ultra System

JUL 12 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

### General Information

| Submitter Name: | ArthroCare Corporation |
|-----------------|----------------------------------------------------|
| Address | 7000 West William Cannon Drive<br>Austin, TX 78735 |
| Contact Person: | Cheryl Frederick<br>Director, Regulatory Affairs |
| Date Prepared: | April 27, 2012 |

#### Device System Names/Components

| Proprietary: | SmartStitch M-Connector Ultra | | |
|--------------|------------------------------------------------|------------------------------------------------|--|
| | Common: | Arthroscopic Instrument | |
| | Classification: | Class I | |
| | Product Code: | NBH | |
| | CFR Section: | 21 CFR 888.1100 | |
| Proprietary: | SmartStitch Handle | | |
| | Common: | Arthroscopic Instrument | |
| | Classification: | Class I | |
| | Product Code: | NBH | |
| | CFR Section: | 21 CFR 888.1100 | |
| Proprietary: | Suture Cartridge containing MagnumWire® Suture | | |
| | Common: | Suture, Nonabsorbable, Synthetic, Polyethylen- | |
| | Classification: | Class II | |
| | Product Code: | GAT | |
| | CFR Section: | 21 CFR 878.5000 | |

#### Predicate Device

The SmartStitch M-Connector Ultra System is substantially equivalent to the ArthroCare M-Connector System cleared under K023843 (February 14, 2003) and K033317 (December 30, 2003), to the ArthroCare PerfectPasser® Connector System cleared under K062244 (October 2, 2006).

#### Description

The SmartStitch M-Connector Ultra System is an orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue based on the basic design concepts of handheld, manual suture passers.

The handle is provided non-sterile. The connector and suture cartridge are sterilized by ethylene oxide. The finished products are packaged in a Tyvek® pouch inserted into a chipboard carton. Testing was performed to demonstrate the proposed device is substantially equivalent to the predicate devices.

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K121306 page 2/2

#### Intended Use/Indications For Use

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

#### Non-Clinical Data

Bench testing was performed on both the proposed and predicate devices. The test results demonstrate that the SmartStitch M-Connector Ultra System meets all design, performance, and safety specifications. Based on the test results, the proposed device is substantially equivalent to the predicate devices.

#### Clinical Data

No clinical or animal data are included in this submission.

#### Summary

All testing demonstrates that the SmartStitch M-Connector Ultra System performs as intended and has acceptable mechanical properties when used in accordance with its labeling. As the SmartStitch M-Connector Ultra System's intended use and technological characteristics are comparable to the predicate devices, we believe that the device is substantially equivalent to the ArthroCare SmartStitch M-Connector System and ArthroCare SmartStitch PerfectPasser System. The minor differences between the subject and predicate devices do not raise any new questions of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the right.

#### Public Health Service

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

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

JUL 12 2012

Re: K121306

Trade/Device Name: SmartStitch® M-Connector Ultra System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly (ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, NBH Dated: June 25, 2012 Received: June 26, 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

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Page 2 - Ms. Cheryl Frederick

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 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
Mark N. Malkerson

Mark N. Melkerson 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

## 510(k) Number (if known): K121306

Device Name: SmartStitch® M-Connector Ultra System

Indications for Use:

The SmartStitch® M-Connector Ultra 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MAY.
(Division Sign-Off)

Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K121306

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