SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME

K100593 · Lsi Solutions, Inc. · GAW · Oct 13, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100593
• Device Name: SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME
• Applicant: Lsi Solutions, Inc.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Oct 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

These LSI SOLUTIONS® suture placement products are intended for use in the approximation of soft tissue and prosthetic materials.

Device Story

LSI SOLUTIONS® Suture Placement Devices and Accessories include the RD-180 suturing device and TK Ti-Knot® knot replacement device. These manual surgical instruments are used by clinicians to approximate soft tissue and prosthetic materials during surgical procedures. The RD-180 utilizes non-absorbable polyester and polypropylene suture load units, while the TK Ti-Knot® uses Titanium Knot® loads. These devices function as mechanical aids for suture placement and knot replacement, facilitating tissue repair and prosthetic fixation. The devices are intended for prescription use.

Clinical Evidence

Bench testing only. A "Prosthetic Fixation Study" using an ex-vivo porcine tissue model compared LSI suturing products to the Coalescent U-Clip® predicate and USP standards. Testing covered various prosthetic material types; all results met internal specifications and external standard requirements.

Technological Characteristics

Manual surgical instruments. Materials include non-absorbable polyester, polypropylene, and titanium. Devices function as mechanical suture placement and knot replacement tools. No software or electronic components.

Indications for Use

Indicated for the approximation of soft tissue and prosthetic materials.

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

• LSI Suture Placement Device and Accessories (K981531)
• LSI Flexible Suture Placement Device and Accessories (K011016)
• LSI "R" Series Placement Device and Accessories (K040232)
• LSI Suture Quick Load® Products (K031443)
• Coalescent Surgical U-Clip® (K012317)

Submission Summary (Full Text)

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# LSI SOLUTIONS® 510(k) Premarket Notification

K100593

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

| 5. Premarket Notification [510(k)] Summary | | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Submitted By: | LSI SOLUTIONS®, Inc.<br>7796 Victor-Mendon Road<br>Victor, New York 14564<br><br>Phone: [phone]<br>Fax: [phone] | 1 of 1<br><br>OCT 1 3 2010 |
| | Contact: Jude S. Sauer, M.D., President and CEO, or<br>Peter Spath, Regulatory Director | |
| Date Prepared: | February 22, 2010 | |
| Common Name: | Needle Guide | |
| Trade Name: | LSI SOLUTIONS® Suture Placement Devices and Accessories | |
| Classification<br>Name: | Manual Surgical Instrument for General Use<br>Non-absorbable Surgical Sutures<br>Non-absorbable Surgical Sutures | 21CFR Part 878.4800<br>21CFR Part 878.5000<br>21CFR Part 878.5010 |
| Predicate<br>Devices: | LSI Suture Placement Device and Accessories<br>LSI Flexible Suture Placement Device and Accessories<br>LSI "R" Series Placement Device and Accessories<br>LSI Suture Quick Load® Products<br>Coalescent Surgical U-Clip® | (K981531)<br>(K011016)<br>(K040232)<br>(K031443)<br>(K012317) |
| Description: | LSI SOLUTIONS® Suture Placement Devices, Accessories and Quick<br>Load® products, specifically the RD-180 suturing device and its 2-0 non-<br>absorbable polyester and polypropylene suture load units along with the<br>TK Ti-Knot® knot replacement device and its Titanium Knot® loads, will<br>effectively approximate tissue and prosthetic material. | |
| Intended Use: | These LSI SOLUTIONS® suture placement products are intended for use in<br>the approximation of soft tissue and prosthetic materials. | |
| Test Data: | A "Prosthetic Fixation Study" employed an ex-vivo porcine tissue model to<br>compare LSI cleared suturing products to a Coalescent U-Clip® predicate<br>device and USP standards. Multiple tests were performed covering a variety<br>of different prosthetic material types. All data fell within internal<br>specification requirements, as well as external standard requirements and<br>device performance expectations. | |
| Summary: | Included in this submission are the same devices cleared in previous LSI<br>SOLUTIONS® 510(k) submissions for the approximation of soft tissue.<br>Based on the comparison of the Coalescent U-Clip®, analysis of the<br>historic and recently developed data and our ongoing success with the<br>same already cleared products, we believe they are substantially<br>equivalent for the approximation of soft tissue and prosthetic materials. | |

CONFIDENTIAL

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

LSI Solutions, Inc. % Mr. Peter Spath Regulatory Director 7796 Victor-Mendon Road Victor, New York 14564

OCT 1 3 2010

Re: K100593

Trade/Device Name: LSI SOLUTIONS®, Inc. Suture Placement Devices and Accessories Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW, GAS, HCF, GCJ Dated: September 24, 2010 Received: September 29, 2010

Dear Mr. Spath:

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. Ilsting 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 - Mr. Peter Spath

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/ResourcesforYou/Industry/default.htm

Sincerely yours,

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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#### LSI SOLUTIONS® 510(k) Premarket Notification

## 4. Indications for Use

K100593

OCT 13 2010

510(k) Number (if known): K (00593

LSI SOLUTIONS®, Inc. Suture Placement Devices and Accessories Device Name:

Indications for Use: Approximation of soft tissue and prosthetic materials

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)

(Division Sign-Off)

510(k) Numbe

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

LSI Suture Placement Devices 510(k)

Section 4 - Page 1 of 1

CONFIDENTIAL