LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS

K031443 · Lsi Solutions · NEW · Jun 18, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031443
• Device Name: LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
• Applicant: Lsi Solutions
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Jun 18, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For polyester and polypropylene LSI SOLUTIONS® Suture Quick Load® Products: general soft tissue approximation and/or ligation. For polyglycolic acid (PGA) and polydioxanone (PDS) LSI SOLUTIONS® Suture Quick Load® Products: general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Device Story

Surgical suture products featuring ferrule attachments; designed for use with LSI SOLUTIONS® SEW-RIGHT® and PLACE-RIGHT® suture placement devices. Ferrules function similarly to traditional needle attachments to facilitate suture delivery. Used by surgeons for soft tissue approximation and ligation. Benefits include compatibility with specialized placement instrumentation for efficient suture handling.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Surgical sutures composed of polyester, polypropylene, poly(glycolide/L-lactide), or polydioxanone. Features ferrule attachments for mechanical coupling with LSI placement devices. Class II devices per 21 CFR 878.5000, 878.5010, 878.4493, and 878.4840.

Indications for Use

Indicated for general soft tissue approximation and/or ligation. PGA and PDS variants also indicated for ophthalmic procedures; contraindicated for cardiovascular and neurological procedures.

Regulatory Classification

Identification

An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for the 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

• Deknatel™ Tevdek® II Surgical Suture (K930738)
• Deknatel™ Deklene® II Surgical Suture (K930738)
• Surgisorb Absorbable Suture (K984374)
• Mono-Dox Synthetic Absorbable PDS Suture (K013274)

Submission Summary (Full Text)

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| JUN 1 8 2003 | LSI SOLUTIONS, Inc.<br>510(k) Premarket Notification<br>LSI SOLUTIONS® Suture Quick Load® Products |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 12. Premarket Notification [510(k)] Summary |
| Submitted By: | LSI SOLUTIONS, Inc.<br>7796 Victor-Mendon Road<br>Victor, New York 14564<br>Phone: [phone]<br>Fax: [phone]<br>Contact: Christopher A. Klaczyk, Regulatory Compliance Manager |
| Common Name: | Surgical Suture |
| Trade Name: | LSI SOLUTIONS® Suture Quick Load® Products |
| Proprietary Name: | 1. SEW-RIGHT® Quick Load® with 0 Polyester<br>2. SEW-RIGHT® Quick Load® with 2-0 Polyester<br>3. SEW-RIGHT® DUO™ Quick Load® with 2-0 Polyester<br>4. SEW-RIGHT® Quick Load® with 2-0 Polypropylene<br>5. QLU, SRF-5QL™ Suture, Sterile<br>6. SEW-RIGHT® Quick Load® with 2-0 STRONGSORB™<br>7. SEW-RIGHT® Quick Load® with 2-0 MONOGLIDE™ |
| Classification: | All products are Class II per the following references:<br>1. No regulation specified. Nearest reference is 21 CFR 878.5000<br>Nonabsorbable poly(ethylene teraphthalate) surgical suture<br>2. No regulation specified. Nearest reference is 21 CFR 878.5000<br>Nonabsorbable poly(ethylene teraphthalate) surgical suture<br>3. No regulation specified. Nearest reference is 21 CFR 878.5000<br>Nonabsorbable poly(ethylene teraphthalate) surgical suture<br>4. 21 CFR 878.5010<br>Nonabsorbable polypropylene surgical suture<br>5. 21 CFR 878.5010<br>Nonabsorbable polypropylene surgical suture<br>6. 21 CFR 878.4493<br>Absorbable poly(glycolide/L-lactide) surgical suture<br>7. 21 CFR 878.4840<br>Absorbable poly(dioxanone) surgical suture |

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# LSI SOLUTIONS, Inc. 510(k) Premarket Notification

K03/443 p2/2

| Predicate Device: | 1. Deknatel™ Tevdek® II Surgical Suture (K930738) |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2. Deknatel™ Tevdek® II Surgical Suture (K930738) |
| | 3. Deknatel™ Tevdek® II Surgical Suture (K930738) |
| | 4. Deknatel™ Deklene® II Surgical Suture (K930738) |
| | 5. Deknatel™ Deklene® II Surgical Suture (K930738) |
| | 6. Surgisorb Absorbable Suture (K984374) |
| | 7. Mono-Dox Synthetic Absorbable PDS Suture (K013274) |
| Description: | The LSI SOLUTIONS® Suture Quick Load® Products, like the<br>predicates, are intended for the approximation of soft tissue by<br>passing ligature through said soft tissue. The LSI SOLUTIONS®<br>Suture Quick Load® Products have Ferrule attachments, similar to<br>needle attachments, that facilitate the use of the suture with the LSI<br>SOLUTIONS® SEW-RIGHT® family and PLACE-RIGHT® family of suture<br>placement device products. |
| Intended Use: | For polyester and polypropylene LSI SOLUTIONS® Suture Quick<br>Load® Products: general soft tissue approximation and/or ligation. |
| | For polyglycolic acid (PGA) and polydioxanone (PDS) LSI<br>SOLUTIONS® Suture Quick Load® Products: general soft tissue<br>approximation and/or ligation, including use in ophthalmic<br>procedures, but not for use in cardiovascular and neurological<br>procedures. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the feathers. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 2003

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

Re: K031443 Trade/Device Name: Suture Quick Load® Products Regulation Number: 21 CFR 878.4840 21 CFR 878.4493 21 CFR 878.5000 21 CFR 878.5010 Regulation Name: Suture, surgical, absorbable, polydioxanone Absorbable poly(glycolide/L-lactide) surgical suture Nonabsorbable poly(ethylene terephthalate) surgical suture Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: NEW, GAM, GAS, GAW Dated: May 2, 2003 Received: May 8, 2003

Dear Mr. Klaczyk:

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.

If your device is classified (see 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 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.

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### Page 2 - Mr. Christopher A. Klaczyk

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); 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.

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

Muriam 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 SOLUTIONS® Suture Quick Load® Products

#### 7. Statement of Indications For Use

Page 1 1

Ko31443 510(k) Number (if known): LSI SOLUTIONS® Suture Quick Load® Products Device Name:

Indications For Use For Polyester Quick Load® Products:

The SEW-RIGHT® Quick Load® Unit with PTFE coated, polyester surgical suture is indicated for use in general soft tissue approximation and/or ligation.

Indications For Use For Polypropylene Quick Load® Products:

The SEW-RIGHT® Quick Load Unit with monofilament polypropylene surgical suture is indicated for use in general soft tissue approximation and/or ligation.

Indications For Use For Polyglycolic Acid (PGA) Quick Load® Products:

The SEW-RIGHT® Quick Load® Unit with STRONGSORB™ synthetic absorbable surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Indications For Use For Polydioxanone (PDS) Quick Load® Products:

The SEW-RIGHT® Quick Load® Unit with Monoglide™ synthetic absorbable surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number_K03/443

(Optional Format 3-10-98)

Section 7 - Page 1 of 1

CONFIDENTIAL