VITAL SUTURES, SUTUREX, CIRUGIA PERUANA

K100780 · Unilene Sac · NEW · Dec 14, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100780
• Device Name: VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
• Applicant: Unilene Sac
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Dec 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The absorbable sutures (Polydioxanone, Polyglactin and Polyglycolic Acid) are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. The absorbable sutures (Polyglecaprone) are indicated for use in soft tissue approximation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures.

Device Story

VITAL SUTURES, SUTUREX, and CIRUGIA PERUANA are absorbable surgical sutures composed of Polydioxanone, Polyglactin, Polyglycolic Acid, or Polyglecaprone. Used by surgeons for soft tissue approximation. Devices function as mechanical fasteners to hold tissue edges together during healing; material eventually absorbs. Used in clinical settings; operated by physicians. Benefits include wound closure and tissue support.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Absorbable surgical sutures composed of Polydioxanone, Polyglactin, Polyglycolic Acid, or Polyglecaprone. Class II device under 21 CFR 878.4840. Mechanical fixation device. Sterilization method not specified.

Indications for Use

Indicated for soft tissue approximation. Polydioxanone, Polyglactin, and Polyglycolic Acid sutures are indicated for ophthalmic procedures. Polyglecaprone sutures are contraindicated for ophthalmic procedures. All variants are 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.

Submission Summary (Full Text)

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

Unilene, S.A.C. % Regulatory Insight, Inc. Mr. Kevin Walls, RAC 5401 S. Cottonwood Court Greenwood Village, Colorado 80121

DEC 1 4 2.30

Re: K100780

Trade/Device Name: VITAL SUTURES, SUTUREX, CIRUGIA PERUANA Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW, GAM, GAN Dated: November 5, 2010 Received: November 8, 2010

Dear Mr. Walls:

·

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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Page 2 - Mr. Kevin Walls, RAC

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 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 Pan 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ODRHOffices/ucm1 LS800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Alease note the regulation entitled, "Misbranding by reference to premarket notification" (21 (CFR Preu 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kij B. Rute
Bnxn

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

DEC 1 4 2010

510(k) Number (if known): ূ≤100780

Device Names: VITAL SUTURES, SUTUREX, CIRUGIA PERUANA

Indications for Use:

The absorbable sutures (Polydioxanone, Polyglactin and Polyglycolic Acid) are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

The absorbable sutures (Polyglecaprone) are indicated for use in soft tissue approximation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR
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(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Kicre for MXM
(Division Sign Off)

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

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510(k) Number K100780