POLYPROPILENE SURGICAL SUTURES

K043330 · Demetech Corp. · GAW · May 16, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043330
• Device Name: POLYPROPILENE SURGICAL SUTURES
• Applicant: Demetech Corp.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: May 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DemeTECH Polypropylene Surgical Suture is indicated for use in general soft tissue approximation and/or litigation including use in cardiovascular, ophthalmic, and neurological procedures.

Device Story

DemeTECH Polypropylene Surgical Suture is a sterile, non-absorbable, synthetic surgical suture composed of isotactic crystalline stereoisomer of polypropylene. Device is pigmented blue for visibility. Used by surgeons in clinical settings for soft tissue approximation and ligation during cardiovascular, ophthalmic, and neurological procedures. Suture is single-use only.

Clinical Evidence

bench testing only

Technological Characteristics

Material: Isotactic crystalline stereoisomer of polypropylene (synthetic linear polyolefin). Form: Monofilament suture. Sizes: 10-0 to 8-0 and 6-0 to 2. Sterilization: Ethylene Oxide. Single-use.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in cardiovascular, ophthalmic, and neurological procedures.

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

• Pronova Non-Absorbable Suture - Ethicon (K001625)

Submission Summary (Full Text)

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MAY 16 2005

## K043330

## 510(K) SUMMARY (as required by 807.92(c))

| Submitter of 510(k): | DemeTECH<br>3530 NW 115th Ave.<br>Miami, FL 33178<br>U.S.A |
|-------------------------|------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Luis Arguello |
| Date of Summary: | November 1, 2004 |
| Trade/Proprietary Name: | DemeTECH Polypropylene Surgical Sutures |
| Classification Name: | Suture, nonabsorbable, synthetic, polypropylene |
| Product Code: | GAW |
| Predicate Device: | Pronova Non-Absorbable Suture - Ethicon K001625 |

Intended Use:

The DemeTECH Polypropylene Surgical Suture is indicated for use in general soft tissue approximation and/or litigation including use in cardiovascular, ophthalmic, and neurological procedures.

## Device Description:

The DemeTECH polypropylene sutures are inert, non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polylefin. The suture is pigmented to enhance visibility.

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| | | | K043330 Pg. 2 of 2 |
|--------------------------------|---------------------------|--------------------------|--------------------|
| Size Range | 10-0 to 8-0 and 6-0 to 2 | 10-0 to 8-0 and 6-0 to 2 | |
| Thread Diameter<br>U.S.P sizes | 10-0 to 8-0 and 6-0 to 2 | 10-0 to 8-0 and 6-0 to 2 | |
| Metric sizes in mm | 0.2 to 0.4 and 0.7 to 5.0 | 0 - .350 to .399mm | |
| Packaging | Cartons of 12, 24 and 36 | Cartons of 12, 24 and 36 | |
| Thread Length | 45 -100 cm | Variety of Lengths | |
| Thread Color | Pigmented Blue | Pigmented and Clear | |
| Sterilization | Ethylene Oxide | Ethylene Oxide | |
| Application | Single Use Only | Single Use Only | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned inside a circle, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 6 2005

Demetech Corporation C/o Mr. Arthur J. Ward AJW Technology Consultants Incorporated 962 Allegro Lane Apollo Beach, Florida 33572

Re: K043330

Trade/Device Name: DemeTech Polypropylene Surgical Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: April 27, 2005 Received: April 28, 2005

Dear Mr. Ward:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nevers forced your your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered prior to 1125 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmette (110) the elevice, subject to the general controls provisions of the Act. The r ou rakyontrols 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 r louse be advisou alla i hat your device complies with other requirements of the Act that I Drivias Intatutes and regulations administered by other Federal agencies. You must or any 1 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. Arthur J. Ward

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and no your finding of substantial equivalence of your device to a legally promation in the 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 In you 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 other general 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 yours,

Signature

Miriam C. Provost, Ph.D. Acting 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): _K043330_

Device Name: DemeTECH Polypropylene Surgical Suture

Indications for Use:

The DemeTECH Polypropylene Surgical Suture is indicated for use in general soft tissue The Demor LOTT For Proportion including use in cardiovascular, ophthalmic, and neurological procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)