MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE

K050947 · United States Surgical, A Division of Tyco Healthc · GAW · Jun 1, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050947
• Device Name: MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Jun 1, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Modified USS polypropylene sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.

Device Story

Nonabsorbable polypropylene surgical suture; used for soft tissue approximation and ligation. Applied by surgeons in clinical settings (cardiovascular, ophthalmic, neurological). Device provides mechanical wound closure; maintains tissue integrity post-surgery. Biocompatible material composition.

Clinical Evidence

Bench testing only; no clinical data provided. Performance equivalence based on established clinical history of predicate polypropylene sutures.

Technological Characteristics

Nonabsorbable polypropylene surgical suture. Biocompatible materials compliant with ISO 10993-1. Class II device (21 CFR 878.5010).

Indications for Use

Indicated for general soft tissue approximation and/or ligation in patients undergoing cardiovascular, ophthalmic, or neurological surgery. Prescription use only.

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

• USSC Polypropylene Suture (K954808)
• Modified USS Polypropylene Suture (K010909)

Submission Summary (Full Text)

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| SUBMITTER: | United States Surgical,<br>a division of Tyco Healthcare Group LP<br>150 Glover Avenue<br>Norwalk, CT 06856 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Sharon L. Murphy |
| DATE PREPARED: | April 14, 2005 |
| CLASSIFICATION NAME: | Nonabsorbable Polypropylene Surgical Suture |
| COMMON NAME: | Modified USS Polypropylene Suture |
| PROPRIETARY NAME: | To be determined |
| PREDICATE DEVICES: | USSC Polypropylene Suture (K954808)<br>Modified USS Polypropylene Suture (K010909) |
| INTENDED USE: | Modified USS polypropylene sutures are indicated for<br>use in general soft tissue approximation and/or ligation,<br>including use in cardiovascular, ophthalmic, and<br>neurological surgery. |
| MATERIALS: | Like all the devices manufactured by United States<br>Surgical, a division of Tyco Healthcare Group LP, the<br>Modified USS Polypropylene Suture is composed<br>entirely of biocompatible materials which are in<br>compliance with ISO 10993-1 for their intended patient<br>contact profile. |
| PERFORMANCE: | The performance of the Modified USS Polypropylene<br>Suture is substantially equivalent to the currently<br>marketed USS Polypropylene Suture, which has been<br>successfully used in clinical applications as a wound<br>closure device. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's emblem in the center, which consists of a stylized human figure with three heads in profile. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 - 2005

Ms. Sharon L. Murphy Director, Regulatory Affairs United States Surgical, 150 Glover Avenue Norwalk, Connecticut 06856

Re: K050947

Trade/Device Name: Modified USS Polypropylene Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: May 3, 2005 Received: May 4, 2005

Dear Ms. Murphy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to tegains and the Medical Device Amendments, or to commence prior to May 20, 1970, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvine of the general controls provisions of the Act. The 1 ou may, merclore, market the Act include requirements for annual registration, listing of general controls provisions of viactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (660 across. Existing major regulations affecting your device it may be subject to Saon additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Over ments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri bristian that your device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must of any I cuttar statutes and regainents, 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneering your mance of your device to a legally premarket notification. "The I DTP Intering circusion 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 If you desire specific advice for your aconcerner . Also, please note the regulation entitled, contact the Office of Compunation at (216) = 16 = 21 = 3 Part 807.97). You may obtain Milsoranuing by reference to promanton in the Act from the Division of Small other general information on your response at its toll-free number [phone] or Manufacturers, internet address http://www.fda.gov/cdrb/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 V.

K050947 510(k) Number (if known):

Device Name:

Modified USS Polypropylene Suture

Indications For Use:

Modified USS polypropylene sutures are indicated for use in general soft tissue Mounted OBS porypropyrent sincluding use in cardiovascular, ophthalmic, and neurological surgery.

-------------- OR Over-The-Counter Use:____ × Prescription Use: (Per 21 CFR 801.109)

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

Restorative
Surgical Devices
Ko 5094