SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW

K053482 · Sutura, Inc. · GAW · Dec 27, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K053482
• Device Name: SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW
• Applicant: Sutura, Inc.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Dec 27, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SuperStitch GW is indicated for use in performing vascular stitching in general vascular closure.

Device Story

SuperStitch GW is a vascular suture delivery device designed for performing vascular stitching. It is intended for general vascular closure and is not intended for blind vascular closure. The device is used by clinicians in a medical setting to facilitate the suturing process during vascular procedures. By providing a mechanism for suture delivery, it assists in achieving vascular closure, potentially improving procedural efficiency and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence based on device design and intended use.

Technological Characteristics

Nonabsorbable polypropylene surgical suture; manual suture delivery mechanism; Class II device; Product Code GAW.

Indications for Use

Indicated for vascular stitching in general vascular closure. Patient population not specified.

Regulatory Classification

Identification

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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

• Sutura's SuperStitch Vascular Suturing Device

Submission Summary (Full Text)

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# DEC 2 7 2005

K053482

ಲ್ಲಿ 2

#### 510(k) SUMMARY

#### Sutura, Inc.'s SuperStitch GW

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Sutura, Inc. 17080 Newhope St. Fountain Valley, California 92708

[phone] Phone: Facsimile: [phone]

Anthony Nobles Contact Person: December 14, 2005 Date Prepared:

Alternate Contact:

Gerard J. Prud'homme Hogan & Hartson L.L.P. 555 Thirteenth St. NW Washington D.C., 20004 Phone: [phone]

## Name of Device and Name/Address of Sponsor

SuperStitch GW

Sutura, Inc. 17080 Newhope St. Fountain Valley, California 92708

### Common or Usual Name

SuperStitch Guidewire Vascular Suture Delivery Device

#### Classification Name

Suture, Nonabsorbable, Synthetic, Polypropolene

#### Predicate Devices

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Sutura's SuperStitchVascular Suturing Device

# Intended Use

The SuperStitch GW is indicated for use in performing vasular stitching in general
. All is and many min a many and a gain l. CW is not intended for The SuperStich GW is matcaled for about portschills. While and intended for blind vascular closure.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

DEC 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sutura, Inc. % Mr. Gerard J. Prud'Homme, Esquire Hogan & Hartson L.L.P. 555 13th Street, NW Washington, DC 20004

Re: K053482

Trade/Device Name: Superstich GW Models 06-15-04-GW; 08-15-04-GW Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: December 14, 2005 Received: December 14, 2005

Dear Mr. Prud'Homme:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bookshow on (t) personalially equivalent (for the indications for referenced above and have to legally marketed predicate devices marketed in interstate commerce use stated in the enoredure) to wgmant date of the Medical Device Amendments, or to devices that provision that 20, 1978, and cordance with the provisions of the Federal Food, Drug, and Cosmetic nave been rochassified and 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 therefore, mancer the detice, as joinements for annual registration, listing of devices, good vonufacturing 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 r your de fice is elasmod (tional controls. Existing major regulations affecting your device can be thay be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal 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 r carates and regarments, including, but not limited to: registration and listing (21 CFR Part 807), labeling (21 CFR Part 801); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will and w yours over finding of substantial equivalence of your device to a legally prematicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rryou desire specific arreliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other INISULANDING OF Telection on your responsibilities under the Act from the Division of Small Manufacturers, general information on your Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buchud
TN

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

Enclosure

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# Indications for Use Statement

510(k) Number (if known): K053482

Device Name: SuperStitch Guide-wire Vascular Suture Delivery Device

Indications for Use:

The SuperStitch GW is indicated for use in performing vascular stitching in general wascular closure.

Prescription Use __X (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Muchard

Division of General, Restorative, and Neurological Devices

**510(k) Number** K053452

. DC 8016940002 - 2203578 v1