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(1-lactide/glycolide Surgical Suture, is particularly useful where extended wound support (up to 6 months) is desirable.

Device Description

Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is a braided absorbable surgical suture prepared from a copolymer of lactide and glycolide and coated with a copolymer of caprolactone and glycolide.

AI/ML Overview

The acceptance criteria and study details for the Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Composition	- Made from homopolymers and copolymers of glycolide and/or L-lactide.	- Composed of a copolymer of lactide and glycolide, coated with a copolymer of caprolactone and glycolide.
Intended Use	- General soft tissue approximation and/or ligation. - Orthopedic uses, including tendon and ligament repairs and reattachment to bone. - Not for use in ophthalmic, cardiovascular, or neurological tissue.	- Intended for use in general soft tissue approximation and/or ligation. - Indicated for orthopedic uses, including tendon and ligament repairs and reattachment to bone. - Not for use in ophthalmic, cardiovascular, or neurological tissue. (Initially, the FDA letter mentioned use in ophthalmic procedures, but the "Indications for Use" statement explicitly excludes it, aligning with the "but not for use in ophthalmic, cardiovascular or neurological tissues" wording.)
Technological Characteristics	- Same as the predicate device (existing ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed).	- The modified device has the same technological characteristics as the predicate device (existing ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed).
Biocompatibility	- Biocompatible.	- Results indicated that the device was highly biocompatible.
Functionality	- Functional within its indicated uses.	- Results indicated that the device was functional within its indicated uses.
Breaking Strength Retention	- Performance comparable to predicate in terms of strength retention.	- Nonclinical laboratory testing was performed to determine breaking strength retention to assess safety and effectiveness. (Specific numerical values for retention are not provided in this summary, but the general finding of effectiveness suggests it met internal criteria.)
Wound Support	- Desirable for extended wound support (up to 6 months).	- Particularly useful where extended wound support (up to 6 months) is desirable.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided documents. The studies performed were "Nonclinical laboratory testing," "Biocompatibility and Functionality testing." The exact number of sutures or test subjects (if any animal models were used for some aspects) is not detailed.
Data Provenance: The document does not specify countries of origin for the data. The studies are described as "Nonclinical laboratory testing" by ETHICON, Inc., which implies internal corporate testing.
Retrospective or Prospective: Not explicitly stated, but typically, these types of laboratory and biocompatibility tests are conducted prospectively as part of product development and pre-market submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The studies were nonclinical laboratory and functionality tests, implying scientific and engineering experts involved in the testing and evaluation of material properties and performance.

4. Adjudication Method for the Test Set

No information on adjudication methods is provided, as the studies are "Nonclinical laboratory testing" and "Biocompatibility and Functionality testing," not studies that would typically involve expert adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The approval is for a medical device (suture), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a surgical suture, not a software algorithm.

7. The Type of Ground Truth Used

For the nonclinical laboratory testing (e.g., breaking strength retention) and functionality testing, the "ground truth" would be established through objective physical and chemical measurements according to established scientific and engineering standards and protocols.
For biocompatibility, the "ground truth" would be established through standardized in vitro and/or in vivo biocompatibility assays as per regulatory guidance (e.g., ISO 10993 series), comparing results against pre-defined safety limits or established biocompatible materials.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for the device refers to its manufacturing and processing.

9. How the Ground Truth for the Training Set was Established

Not applicable. As noted above, this is not an AI/machine learning device. The "ground truth" for the device's development and manufacturing would relate to material specifications, manufacturing process controls, and quality assurance, which are established through engineering design, material science, and quality management systems.

Summary

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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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 (800) 638-2041 or (301) 443-6597. 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. ....... . ....... . . . . . ..............................................................................................................................................................................
1. 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)Surgical Suture, Undyed
Indications for Use:	Modified ETHICON Absorbable poly(L-lactide/glycolide)Surgical Sutures, Undyed are indicated for use in general softtissue approximation and/or ligation, and orthopedic usesincluding tendon and ligament repairs and reattachment to bonebut not for use in ophthalmic, cardiovascular or neurologicaltissues. The Modified ETHICON Absorbable poly(1-lactide/glycolide Surgical Suture, is particularly useful whereextended wound support (up to 6 months) is desirable.

510(k) Number (if known):

K974299

Device Name:

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

Indications for Use:

Modified ETHICON Absorbable poly(L-lactide/glycolide)Surgical Sutures, Undyed are indicated for use in general softtissue approximation and/or ligation, and orthopedic usesincluding tendon and ligament repairs and reattachment to bonebut not for use in ophthalmic, cardiovascular or neurologicaltissues. The Modified ETHICON Absorbable poly(1-lactide/glycolide Surgical Suture, is particularly useful whereextended wound support (up to 6 months) is desirable.

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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The Counter Use
(Per 21 CFR 801.109)

(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.

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
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.(b)
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.