SUTRALENE POLYPROPYLENE SUTURES

K070243 · Visionary Medical Supplies, Inc. · GAW · Apr 17, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070243
• Device Name: SUTRALENE POLYPROPYLENE SUTURES
• Applicant: Visionary Medical Supplies, Inc.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Apr 17, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The nonabsorbable Sutralene Polypropylene Suture manufactured for Visionary Medical Supplies is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

Device Story

Sutralene Polypropylene Sutures are sterile, nonabsorbable, synthetic surgical sutures composed of polypropylene (linear polyolefin). Blue-dyed versions utilize phthalocyaninato(2-) copper. Used by surgeons in clinical settings for soft tissue approximation and ligation. Device provides mechanical closure of tissues; performance verified via USP standards for diameter, tensile strength, and needle attachment. Benefits include reliable tissue support during healing process.

Clinical Evidence

Bench testing only. Testing conducted per USP Monograph for nonabsorbable surgical sutures to evaluate diameter, tensile strength, and suture-needle attachment. Results confirmed compliance with USP standards.

Technological Characteristics

Material: Polypropylene (synthetic linear polyolefin). Blue dye: phthalocyaninato(2-) copper (21 CFR 74.3045). Uncoated. Sterile. Performance standards: USP Monograph for nonabsorbable surgical sutures.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. No specific age or gender restrictions noted.

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

• Ethicon PROLENE nonabsorbable polypropylene sutures (PMA N16374)

Submission Summary (Full Text)

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K070243

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6441 Enterprise Lane, Madison, Wisconsin 53719 USA Ph: 608 270-3880 Faz: 608 270-3882 - www.visionarymedicalsupplies.com

### 510(K) Summary

APR 1 7 2007

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92

The assigned 510(k) number is:

### Applicant:

Visionary Medical Supplies, Inc. 6441 Enterprise Lane Madison, WI 53719 Phone: [phone] Fax: [phone] Email: [e-mail]

### Contact Person:

Michael G. Price, President Visionary Medical Supplies, Inc. 6441 Enterprise Lane Madison, WI 53719 Phone: [phone] Fax: [phone] Email: [e-mail]

Date of 510(k) summary preparation: January 24, 2007

Trade name: Sutralene Polypropylene Sutures

Common name: Suture, nonabsorbable, synthetic, polypropylene

### Predicate devices:

The nonabsorbable Sutralene Polypropylene Sutures manufactured for Visionary Medical Supplies are equivalent to Ethicon PROLENE* nonabsorbable polypropylene sutures. The Ethicon PROLENE Nonabsorable polypropylene sutures were approved by PMA N16374. Subsequent to the PMA, polypropylene sutures were down classified and require clearance to market by 510(k),

File: Visionary Medical 510(k) Polypropylene 1-24-2007

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#### 1.0 Device description:

This Sutralene Polypropylene Suture is a nonabsorbable, sterile, surgical suture composed of a strand of polypropylene, a synthetic linear polyolefin. Those dyed blue are dyed with phthalocyaninato(2-) copper in accordance with Title 21 CFR Part 74.3045 and do not exceed 0.5% (w/w) suture. The sutures are uncoated.

#### 2.0 Intended use:

The nonabsorbable Sutralene Polypropylene Suture manufactured for Visionary Medical Supplies is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

#### 3.0 Performance tests to demonstrate substantial equivalency:

To establish the technical equivalency of nonabsorbable sutures manufactured for Visionary Medical Supplies with predicate devices, tests were conducted for diameter, tensile strength, and suture-needle attachment according to methods presented in United States Pharmacopoeia (USP) Monograph for nonabsorbable surgical sutures.

The test results shows that Visionary Medical Supplies' devices tested meet USP standards and are technically equivalent to the predicate devices tested.

#### 4.0 Conclusions

The intended use, technology and materials of the Visionary Medical Supplies Sutralene Polypropylene Suture are the equivalent to the predicate device. No new questions of safety or effectiveness are raised.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular pattern.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Visionary Medical Supplies, Inc. % Quality & Regulatory Associates, LLC Mr. Gary Syring Principal Consultant 800 Lavenger Lane Stoughton, Wisconsin 53711

APR 1 7 2007

Re: K070243

Trade/Device Name: Sutralene Polypropylene Sutures Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable propylene surgical suture Regulatory Class: II Product Code: GAW Dated: March 15, 2007 Received: March 19, 2007

Dear Mr. Syring:

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.

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.

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Page 2 - Mr. Gary Syring

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/industry/support/index.html.

Sincerely you Mark N. Melkerson 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Sutralene Polypropylene Sutures

Indications for Use:

The Sutralene polypropylene nonabsorbable sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular,

ophthalmic, and neurological procedures.

Pel Rmz

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

**510(k) Number** c070243

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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