SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader

K163142 · ArthroCare Corporation · GAT · Jan 6, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K163142
• Device Name: SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader
• Applicant: ArthroCare Corporation
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Jan 6, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The SpeedStitch System is a manual, handheld orthopedic/arthroscopic instrument designed for mechanical delivery of sutures through soft tissue. The system comprises a handle, a needle cassette, and a suture cartridge containing MagnumWire suture. In operation, a clinician uses the device to grasp soft tissue, insert a needle through the tissue, and capture the suture from the cartridge, pulling it through the tissue to complete a simple stitch. The device is used in clinical settings for arthroscopic or limited access procedures. It provides a mechanical means for suture placement, aiding in tissue repair. The system is provided non-sterile (handle) and sterile (needle cassette/suture cartridge) and is intended for use by trained healthcare professionals.

Clinical Evidence

No clinical or animal data included. Bench testing only. In vitro testing verified tissue grasping, needle insertion, and suture capture/delivery performance. Design verification and simulated use testing confirmed that the device meets design inputs and performance specifications.

Technological Characteristics

Manual handheld suture passer. Materials: 300/301/304/316 stainless steel, 17-4/17-7/455 stainless steel, polycarbonate, glass-filled nylon, UV adhesive. Components: handle, needle cassette, suture cartridge. Sterilization: ethylene oxide for needle cassette and suture cartridge. Mechanical operation; no energy source or software.

Indications for Use

Indicated for placement of suture(s) through soft tissue during arthroscopic and limited access 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

• SpeedStitch System (K042031)
• I M-Connector Ultra System (K121306)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

January 6, 2017

ArthroCare Corporation Ms. Laura Kasperowicz Principle RA Specialist 15285 Alton Parkway Suite 200 Irvine, California 92618

Re: K163142

Trade/Device Name: Speedstitch Suture Passer; Speedstitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; Speedstitch Needle Loader And Unloader Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT, NBH, HXK Dated: November 7, 2016 Received: November 9, 2016

Dear Ms. Kasperowicz:

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

## David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

Device Name

SpeedStitch Suture Passer System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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November 7, 2016

## 510(k) Summary

ArthroCare® Corporation

SpeedStitch® System

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, a Smith & Nephew Company |
|-----------------|----------------------------------------------------------------------------------------------------------|
| Address: | 15285 Alton Parkway, Suite 200<br>Irvine, CA. 92618 |
| Contact Person: | Laura Kasperowicz<br>Principle Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | November 7, 2016 |

#### Device System Names/Components

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

| Proprietary: | SpeedStitch Suture Passer |
|--------------|--------------------------------------------------------|
| | Common: Suture Passer |
| | Classification: Class I |
| | Product Code: NBH |
| | CFR Section: 21 CFR 888.1100 |
| Proprietary: | SpeedStitch Needle Cassette |
| | Common: Holder, Needle, Orthopedic |
| | Classification: Class I |
| | Product Code: HXK |
| | CFR Section: 21 CFR 888.4540 |
| Proprietary: | Suture Cartridge containing MagnumWire® Suture |
| | Common: Suture, Nonabsorbable, Synthetic, Polyethylene |
| | Classification: Class II |
| | Product Code: GAT |
| | CFR Section: 21 CFR 878.5000 |

#### Predicate Device

The SpeedStitch System is substantially equivalent to the following:

- SpeedStitch System (K042031, October 19, 2004)
- I M-Connector Ultra System (K121306, July 12, 2012)

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### Description

The SpeedStitch 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 needle cassette and suture cartridge are sterilized by ethylene oxide. The finished products are packaged in a Tyvek® pouch inserted into a chipboard carton.

## Intended Use/Indications For Use

The SpeedStitch 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. This in vitro testing involved grasping of a tissue model with the suture passer, insertion of needles through the tissue model and capturing suture from suture cartridges, which was successfully pulled through the tissue model using the suture passer. Design Verification testing was performed in order to verify the design outputs meet the design inputs. Simulated use testing was performed on the device and accessory devices (suture cartridges) which will be promoted for use with the SpeedStitch system in order to affirm safety and effectiveness.

The test results demonstrate that the proposed SpeedStitch meets its design, performance, and safety specifications. Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling.

#### Clinical Data

No clinical or animal data are included in this submission.

#### Summary

All testing demonstrates that the proposed SpeedStitch performs as intended and has acceptable performance when used in accordance with the labeling.

As the intended use, operating principle, materials and technological characteristics are comparable to the predicate device, the proposed SpeedStitch System is substantially equivalent. The minor differences between the proposed SpeedStitch System and predicate device do not raise any new questions of safety or effectiveness.

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# ArthroCare® Corporation Premarket Notification
SPEEDSTITCH® SYSTEM

November 7, 2016

| Comparison of Device Characteristics | | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | M-Connector Ultra<br>Predicate Device | SpeedStitch<br>Predicate Device | SpeedStitch<br>Proposed Device |
| 510(k) | K121306 | K042031 | TBD |
| Panel | General & Plastic Surgery,<br>Orthopedic | Same | Same |
| Product Code(s) | GAT & NBH | GAT | GAT/NBH/HXK |
| Classification Section | 878.5000<br>888.1100 | 878.5000 | 878.5000<br>888.1100<br>888.4540 |
| Classification Name | > Suture, Nonabsorbable,<br>Synthetic, Polyethylene<br>> Arthroscope & Accessories<br>(Suture Passer) | > Suture, Nonabsorbable,<br>Synthetic, Polyethylene | > Suture, Nonabsorbable,<br>Synthetic, Polyethylene<br>> Arthroscope & Accessories<br>(Suture Passer)<br>> Holder, Needle, Orthopedic |
| Device Classification | Class II (Sutures) &<br>Class I (Handle, Connector) | Class II | Class II (Sutures),<br>Class I (Handle),<br>Class I (Needle Holder) |
| Intended Use | For use in the placement of<br>suture(s) through soft tissue in<br>arthroscopic and limited access<br>procedures. | For use in the placement of<br>suture(s) through soft tissue in<br>endoscopic and limited access<br>procedures. | For use in the placement of<br>suture(s) through soft tissue in<br>arthroscopic and limited access<br>procedures. |
| Design Technology | Suture Passer with 2 needles | Suture Passer with 1 needle | Suture Passer with 1 needle |
| Suture Delivery<br>Method | Suture preloaded in a cartridge<br>for arthroscopic or limited<br>access delivery | Same | Same |
| Suture Specifications | USP #2 Nonabsorbable<br>Synthetic Suture,<br>Polyethylene | Same | Same |
| Suture Placement | Interrupted Mattress Stitch | Simple Stitch | Simple Stitch |
| Main Components | ■ Handle<br>■ Connector<br>■ Suture Cartridge with<br>suture | ■ Handle with Connector<br>■ Suture Cartridge with<br>suture<br>■ Needle Loader & Needle<br>Extractor | ■ Handle with Connector<br>■ Suture Cartridge with<br>suture<br>■ Needle Loader & Needle<br>Extractor |
| Main Materials | 300/301/304/316 Stainless Steel<br>17-4/17-7/455 Stainless Steel<br>Polycarbonate<br>Glass Filled Nylon<br>UV Adhesive | Same | Same |