PANACRYL

K974299 · ETHICON, Inc. · GAM · Feb 13, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974299
• Device Name: PANACRYL
• Applicant: ETHICON, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Feb 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Sutures, Undyed are indicated for use in general soft tissue approximation and/or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular or neurological tissues. The Modified ETHICON Absorbable poly(l-lactide/glycolide Surgical Suture, is particularly useful where extended wound support (up to 6 months) is desirable.

Device Story

Braided absorbable surgical suture; composed of poly(L-lactide/glycolide) copolymer; coated with caprolactone and glycolide copolymer. Used by surgeons for soft tissue approximation, ligation, and orthopedic repairs (tendon/ligament). Provides extended wound support up to 6 months. Device is a sterile, single-use implantable material.

Clinical Evidence

Bench testing only. Testing included breaking strength retention, biocompatibility, and functionality assessments. No clinical data provided.

Technological Characteristics

Braided absorbable suture; material: poly(L-lactide/glycolide) copolymer; coating: caprolactone and glycolide copolymer. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone. Contraindicated for ophthalmic, cardiovascular, or neurological 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

• Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed (K974299)

Reference Devices

• Johnson & Johnson Absorbable Suture
• Coated VICRYL II (Polyglactin 910) suture

Submission Summary (Full Text)

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### FEB 1 3 1998

K974299

### SECTION 7

# SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as as Information supporting clailis of Drug and Cosmetic Act,
defined under the Federal Food, Drug and Cosmercized below defined under the Federal 1 600, Dreg ---------------------------------------------------------------------------------------------------------------------------------------the convenience of the Reviewer, this summary is formatted in the convenience of the Review.org annual ".... 510(k) Summaries
accordance with the Agency's final rule con be used to accordance with the Agency of CFR 807) and can be used to and 510(K) Statements... (21 CFR 807) and 14 to anyone requesting it from the Agency.

Modified DEVICE NAME: Modified ETHICON Absorbable poly(Llactide/glycolide) Surgical Suture, Undyed

PREDICATE DEVICE: Existing Cleared Device - Absorbable
PREDICATE DEVICE: Existing Cleares Unduced PREDICATE Descolide) Surgical Suture, Undyed.

REFERENCE DEVICE NAMES: Johnson & Johnson Absorbable
Stature DEVICE NAMES: Johnson & Johnson & Market REFERENCE DEVICE NAMES. Veally Productin 910) suture.
Tendon Suture and Coated VICRYL* II (Polyglactin 910) suture.

510(k) SUMMARY

Device Description

Modified ETHICON Absorbable poly(L-lactide/glycolide) Modified ETITCON reserceders peric braided absorbable Surgical Suture, Chayes form a copolymer of lactide and surgical suture propares coated with a copolymer of caprolactone and glycolide.

Continued on next page

Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed ETHICON, Inc.

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### SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

510(K) SUMMARY, Continued

Modified ETHICON Absorbable poly(L-lactide/glycolide) Intended Use Surgical Suture, Undyed is intended for use in general soft tissue approximation and/or ligation as is the predicate device ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed. Modified Absorbable poly(L-lactide/glycolide Surgical Suture, Undved is indicated for orthopedic uses including tendon and ligament repairs and reattachment to bone. Modified ETHICON Absorbable poly(L-lactide/glycolide) Indications Statement Surgical Suture, Undyed is indicated for soft tissue approximation and/or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular, or neurological tissue. The modified device has the same technological characteristics Technological as the predicate device (existing device) ETHICON Absorbable Characteristics poly(L-lactide/glycolide Surgical Suture, Undyed. Nonclinical laboratory testing was performed to determine Performance Data breaking strength retention. Biocompatibility and Functionality testing was conducted to assess the safety and effectiveness of Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed. Results indicated that the device was highly biocompatable and was functional within its indicated uses. Continued on next page

Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed ETHICON, Inc.

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## SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Cancerasses

Based on the 510(k) summaries and 510(k) statements (21 CFR Based on the information provided herein, we conclude that the 007) and the miormation pequivalent to the Predicate Devices new device is seal Food, Drug, and Cosmetic Act.

Contact

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Gregory Jones Director, Regulatory Affairs ETHICON, Inc. ಿ.t. #22, West ිංහerville, NJ 08876-0151

November 14, 1997

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Modifico FTHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed ETHICON, Inc.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle. The seal is black and white and has a simple, clean design. The eagle is stylized and abstract, and the overall impression is one of authority and trustworthiness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 1998

Mr. Gregory Jones Director, Regulatory Affairs Ethicon. Inc. P.O. Box 151 Somerville, New Jersey 08876-0151

K974299 Re:

> Panacryl Absorbable poly (L-lactide/glycolide) Surgical Suture, Undyed Regulatory Class: II Product Code: GAM Dated: November 14, 1997 Received: November 17, 1997

Dear Mr. Jones:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Friday, May 31, 1991 (Vol. 56, No. 105, Pages 24684 and 24685). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at [phone] or [phone]. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- 1. The Panacryl Absorbable poly (L-lactide/glycolide) Surgical Suture, Undyed is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. ....... . ....... . . . . . ..............................................................................................................................................................................
- 2. This device may not be manufactured from any material other than homopolymers and copolymers made from glycolide and/or L-lactide. Any deviation of the polymer composition or processing as described in this 510(k) notification must be submitted to FDA in a new premarket notification at least 90 days prior to implementation of the proposed changes. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the Panacryl Absorbable poly

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(L-lactide/glycolide) Surgical Suture, Undyed surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.

The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.

Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR). Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control Provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the

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Page 3 - Mr. Gregory Jones

Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

**Sincerely yours,**

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

| 510(k) Number (if known): | K974299 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Modified ETHICON Absorbable poly(L-lactide/glycolide)<br>Surgical Suture, Undyed |
| Indications for Use: | Modified ETHICON Absorbable poly(L-lactide/glycolide)<br>Surgical Sutures, Undyed are indicated for use in general soft<br>tissue approximation and/or ligation, and orthopedic uses<br>including tendon and ligament repairs and reattachment to bone<br>but not for use in ophthalmic, cardiovascular or neurological<br>tissues. The Modified ETHICON Absorbable poly(1-<br>lactide/glycolide Surgical Suture, is particularly useful where<br>extended wound support (up to 6 months) is desirable. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block;">✓</div> | OR | Over-The Counter Use |
|----------------------|--------------------------------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |

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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number: K974299
(Optional Format 1-2-9G)
Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed ETHICON, Inc.