LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999

K040232 · Lsi Solutions · GAT · Mar 1, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040232
• Device Name: LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999
• Applicant: Lsi Solutions
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Approximation of soft tissue.

Device Story

Manual surgical instrument for soft tissue approximation or ligation; passes ligature through soft tissue. Used by surgeons in clinical settings. Device functions as a mechanical suture placement tool. Benefits include efficient tissue approximation during surgical procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison to predicate.

Technological Characteristics

Manual surgical instrument; mechanical suture placement mechanism. Materials and sterilization methods consistent with predicate device for general surgical use.

Indications for Use

Indicated for the approximation of soft tissue in patients requiring surgical closure or ligation.

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

• LSI Suture Placement Device and Accessories (K981531)

Submission Summary (Full Text)

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K040232

## MAR - 1 2004

LSI SOLUTIONS, Inc. 510(k) Premarket Notification LSI "R" Series Suture Placement Device and Accessories Product

## 11. Premarket Notification [510(k)] Summary

LSI SOLUTIONS, Inc. Submitted By: 7796 Victor-Mendon Road Victor, New York 14564 Phone: [phone] Fax: [phone] Contact: Christopher A. Klaczyk, Regulatory Compliance Manager

Needle Guide; Manual surgical instrument for general use Common Name:

LSI "R" Series Suture Placement Device and Accessories Product Trade Name:

21 CFR 878.4800; Manual Surgical Instrument for General Use Classification:

Predicate Device: LSI Suture Placement Device and Accessories (K981531)

The LSI "R" Series Suturing Device and Accessories Product, like Description: the predicate, is intended for the approximation or ligation of soft tissue by passing ligature through said soft tissue.

- Approximation of soft tissue. Intended Use:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

Mr. Christopher A. Klaczyk Regulatory Compliance Manager LSI Solutions, Inc. 7796 Victor-Mendon Road Victor, New York 14564

Re: K040232

Ro-N232
Trade/Device Name: LSI "R" Series Suturing Device and Accessories Product Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, HCF Dated: January 28, 2004 Received: February 2, 2004

Dear Mr. Klaczyk:

We have reviewed your Scction 510(k) premarket notification of intent to market the device we have reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases of the enactment date of the Medical Device Amendments, or to conniner of they 2011-12-11 accordance with the provisions of the Federal Food, Drug, de nees mat have not require approval of a premarket approval application (PMA). and Cosmetic (110) that the device, subject to the general controls provisions of the Act. The r ou may, arovisions 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 (sec 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 may be builted to been 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 1 least be device a determination that your device complies with other requirements of the Act that I Dr has Internations and regulations administered by other Federal agencies. You must or car) x 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 Cr R Part 677, aberting (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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Page 2 - Mr. Christopher A. Klaczyk

This letter will allow you to begin marketing your device as described in your Section 510(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, 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## LSI SOLUTIONS, Inc. 510(k) Premarket Notification LSI "R" Series Suture Placement Device and Accessories Product

## Statement of Indications For Use 7.

Page 1_ of _1_

510(k) Number (if known): K040232

LSI "R" Scries Suturing Device and Accessories Product Device Name:

Approximation of soft tissue Indications For Use:

X Over-The Counter Use Prescription Use AND/OR (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K040232

Section 7 - Page 1 of 1

CONFIDENTIAL