SUTRAZORB

K102592 · Visionary Medical Supplies, Inc. · GAM · Feb 3, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K102592
• Device Name: SUTRAZORB
• Applicant: Visionary Medical Supplies, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Feb 3, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sutrazorb Absorbable Surgical Sutures USP / EP are indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of Sutrazorb sutures in cardiovascular and neurological procedures have not been established.

Device Story

Sutrazorb Absorbable PGA Suture is a sterile, surgical suture composed of polyglycolic acid monofilaments and braids; dyed violet with D&C Violet #2. Used by surgeons for soft tissue approximation and ligation during ophthalmic procedures. Device provides mechanical support to tissue during healing; material is absorbable. Performance verified through USP 32:2009 monograph testing for diameter, tensile strength, and needle attachment.

Clinical Evidence

Bench testing only. No clinical data provided. Performance established via compliance with USP 32:2009 monographs for absorbable surgical sutures, including diameter, tensile strength, and needle attachment testing.

Technological Characteristics

Material: Polyglycolic acid (PGA); dyed with D&C Violet #2 (21 CFR 74.3602). Form: Monofilament and braided absorbable suture. Standards: USP 32:2009 monographs for diameter <861>, needle attachment <871>, and tensile strength <881>.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in ophthalmic procedures. Not indicated for cardiovascular or neurological procedures.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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

• DEXON II (K951352)
• Surgisorb (K984374)

Submission Summary (Full Text)

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FEB-3 2011

VISIONARY MEDICAL SUPPLIES, INC.
OPHTHALMIC SUTURES, IOL S AND MORE

6441 Enterprise Lane, Madison, Wisconsin 53719 USA Ph: 608 270-3880 Fax: [phone] www.visionarymedicalsupplies.com

### 510(K) Summary

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: September 3, 2010

Trade name: Sutrazorb Absorbable PGA Sutures

Common name: Absorbable Poly(glycolide/I-lactide) Surgical Suture

## Predicate devices:

Trade Name: DEXON II Manufacture: Davis & Geck PMA Number: K951352

Trade Name: Surgisorb Manufacture: Samyang Corporation 510(k) Number: K984374

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#### 1.0 Device description:

The Sutrazorb Absorbable PGA Suture (Sutrazorb Suture) is a sterile, surgical suture composed of monofilaments and braids of polyglycolic acid. The suture is dyed violet. The violet sutures are dyed with D&C Violet #2 in accordance with CFR Title 21 Part 74.3602, reference Section 6.0.

The Visionary Medical Supplies' Sutrazorb Suture meets all requirements established by the United States Pharmacopoeia for absorbable surgical sutures. Testing to the following USP 32:2009 Monographs for Absorbable Sutures is discussed in Section 6.0:

- t Sutures - Diameter <861>
- Sutures Needle Attachment <871> .
- Tensile Strength <881> t

#### 2.0 Intended use:

Sutrazorb Absorbable Surgical Sutures USP / EP are indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of Sutrazorb sutures in cardiovascular and neurological procedures have not been established.

### 3.0 Performance tests to demonstrate substantial equivalency:

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

Absorption profile and shelf life tests were also performed. The test results shows that Sutrazorb Sutures 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 Sutrazorb Sutures are the equivalent to the predicate device. No new questions of safety or effectiveness are raised.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Visionary Medical Supplies, Inc. % Quality and Regulatory Associates, LLC Mr. Gary Syring 800 Levanger Lane Stoughton. Wisconsin 53589

FEB - 3 201

Re: K102592

Trade/Device Name: Sutrazorb Absorbable PGA Sutures Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: January 18, 2011 Received: January 21, 2011

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. 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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and the country of the country of the county of

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Page 2 - Mr. Gary Syring

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 hillp://www.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1118001.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, nease 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 regultiven (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 is coll free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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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# Indications for Use

510(k) Number (if known): _ K 102592

Device Name: Sutrazorb Absorbable PGA Sutures

Indications for Use:

Sutrazorb Absorbable Surgical Sutures USP / EP are indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of Sutrazorb sutures in cardiovascular and neurological procedures have not been established.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kume for Mxing

(Division Sign Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K102592