VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED

K123034 · Unilene Sac · GAR · May 28, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123034
• Device Name: VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
• Applicant: Unilene Sac
• Product Code: GAR · General, Plastic Surgery
• Decision Date: May 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The nonabsorbable sutures (Monofilament Nylon, Polypropylene and Silk) are indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Story

Vital Sutures, Suturex, Cirugia Peruana, and Sutumed are nonabsorbable surgical sutures composed of Monofilament Nylon, Polypropylene, and Silk. Used by surgeons for soft tissue approximation and ligation in cardiovascular, ophthalmic, and neurological procedures. Devices function as mechanical fasteners to hold tissue edges together during healing. No electronic, software, or algorithmic components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nonabsorbable surgical sutures; materials include Monofilament Nylon, Polypropylene, and Silk. Classified under 21 CFR 878.5020 (Product Codes: GAR, GAW, GAP). Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for soft tissue approximation and/or ligation in cardiovascular, ophthalmic, and neurological procedures. Applicable to patients requiring nonabsorbable sutures (Monofilament Nylon, Polypropylene, and Silk).

Regulatory Classification

Identification

Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a human figure in motion.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: May 28, 2013

Unilene S.A.C. % Regulatory Insight, Inc. Kevin Walls, Principal Consultant 33 Golden Eagle Lane Littleton, Colorado 80127

Re: K123034

Trade/Device Name: Vital Sutures, Suturex, Cirugia Peruana, Sutumed Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: Class II Product Code: GAR, GAR, GAW, GAP Dated: April 25, 2013 Received: April 29, 2013

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 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

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### Page 2 - Kevin Walls, Principal Consultant

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 Nighterson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): K123034

#### Device Names:

- Vital Sutures a)
- b) Suturex
- Cirugia Peruana C)
- d) Sutumed

#### Indications for Use:

The nonabsorbable sutures (Monofilament Nylon, Polypropylene and Silk) are indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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 Krause S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123034

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