POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING

K063536 · Tyco Healthcare Group · GAM · Jan 29, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063536
• Device Name: POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING
• Applicant: Tyco Healthcare Group
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Jan 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Polysorb* Synthetic Absorbable Suture with Modified Packaging is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Device Story

Polysorb synthetic absorbable suture; identical to predicate device (K981935) with addition of injection port to inner foil pouch. Injection port allows clinician to inject sterile saline (0.9% NaCl) into pouch for pre-wetting suture under sterile conditions prior to use. Used in clinical settings for soft tissue approximation/ligation and ophthalmic surgery. Pre-wetting facilitates suture handling; functional performance remains equivalent to predicate.

Clinical Evidence

Bench testing only. In-vitro studies conducted per Class II Special Controls Guidance Document: Surgical Sutures (2003) to verify functional performance after pre-wetting with sterile saline for up to 12 hours at room temperature.

Technological Characteristics

Material: Coated glycolide and lactide copolymer. Packaging: Foil pouch with integrated injection port for saline pre-wetting. Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for soft tissue approximation or ligation and ophthalmic surgery. Contraindicated for cardiovascular or neural tissue.

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

• Modified Polysorb* Suture (K981935)

Submission Summary (Full Text)

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635536 1/1

## United States Surgical, a division of Tyco Healthcare Group, LP

## 510(K) SUMMARY: E.

## JAN 2 9 2007

| Submitter: | United States Surgical,<br>a division of Tyco Healthcare Group, LP<br>150 Glover Avenue, Norwalk, CT 06856<br>[phone] |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Robert Zott, Program Director,<br>Regulatory Affairs |
| Date Prepared: | January 24, 2007 |
| Device Classification Name: | Absorbable poly(glycolide/L-lactide) surgical suture |
| Device Common Name: | Surgical Suture |
| Device Proprietary Name: | Polysorb* Synthetic Absorbable Suture with Modified<br>Packaging (Note: The trade name for the packaging is<br>yet to be determined.) |
| Predicate Device(s): | K981935: Modified Polysorb* Suture (manufactured by<br>U.S. Surgical, a division of Tyco Healthcare Group, LP) |
| Device Description: | Polysorb* Synthetic Absorbable Suture with Modified<br>Packaging shall remain identical to the predicate device,<br>an absorbable poly(glycolide/L-lactide) surgical suture.<br>with the addition to the packaging of an injection port to<br>the inner foil pouch. |
| Technological Characteristics: | The injection port shall enable the injection of sterile<br>saline (0.9% NaCl) into the pouch for pre-wetting of the<br>suture under sterile conditions prior to use. |
| Performance Data: | In-vitro studies were performed in accordance with the<br>Class II Special Controls Guidance Document: Surgical<br>Sutures; Guidance for Industry and FDA, issued on June<br>3, 2003 to demonstrate that the functional performance<br>of the suture is substantially equivalent to the predicate<br>device when pre-wetted with sterile saline (0.9% NaCl)<br>using the injection port for up to 12 hours at room<br>temperature prior to use. |
| Indications: | The device is indicated for use in soft tissue<br>approximation or ligation and ophthalmic surgery, but<br>not in cardiovascular or neural tissue. |
| Materials: | Coated glycolide and lactide copolymer. |
| | |

* Polysorb is a trademark of United States Surgical,
a division of Tyco Healtchcare Group, LP

- Traditional 510(k) for Polysorb* Synthetic
Absorbable Suture with Modified Packaging 510(k) Summary Revised on January 24, 2007

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tyco Healthcare Group, LP % Mr. Robert Zott Program Director, Regulatory Affairs United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856

JAN 2 9 2007

Re: K063536 Trade/Device Name: Absorbable poly(glycolide/L-lactide) Surgical suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: November 22, 2006 Received: November 22, 2006

Dear Mr. Zott:

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.

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 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); good manufacturing practice requirements as set

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Page 2 - Mr. Robert Zott

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact 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 Manufacturers, 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,

Ka. N. M.

Mark N. Melkerso Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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## D. STATEMENT OF INDICATIONS FOR USE:

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Polysorb* Synthetic Absorbable Suture with Modified Packaging (Note: The trade name for the packaging is yet to be determined.)

Polysorb* Synthetic Absorbable Suture with Modified Packaging is Indications For Use: indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(** Number L 06353x

* Polysorb is a trademark of United States Surgical, a division of Tyco Healtchcare Group, LP

Traditional 510(k) for Polysorb* Synthetic Absorbable Suture with Modified Packaging November 22, 2006