Safil® Synthetic Absorbable Surgical Sutures are indicated for use in all types of general soft tissue approximation and ligation, including use in ophthalmic surgery, but not in cardiovascular surgery, microsurgery or in neural tissue.

Device Description

The subject device is an absorbable, flexible multifilament or monofilament suture thread which is supplied sterile. It is composed of synthetic polyglycolic acid polymer, and is indicated for soft tissue approximation and/or ligation. It will be offered undyed, and dyed with the FDA approved colorant D&C Green No. 6 in accordance with Title 21 CFR, §74.3206. It will be available uncoated, and coated with an absorbable magnesium stearate-based coating. It will be available with and without standard needles attached.

AI/ML Overview

This 510(k) summary describes a traditional medical device (surgical sutures), not an AI/ML powered device. As such, many of the requested categories related to AI/ML device studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.

However, I can extract the information relevant to the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.

Acceptance Criteria and Device Performance for Safil® Synthetic Absorbable Surgical Suture

The study described is a non-clinical study demonstrating substantial equivalence to predicate devices, rather than a prospective clinical trial with specific performance metrics against an established ground truth in the context of AI.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (from USP XXIII or manufacturing standards)	Reported Device Performance / Method of Proof
Material Composition	- Composed of 100% polyglycolic acid polymer	- Demonstrated: FTIR spectroscopy to show substantial equivalence of identity and purity to predicate DEXON® suture.
Colorant	- Undyed, or dyed with FDA approved D&C Green No. 6 (21 CFR §74.3206)	- Demonstrated: Offered undyed and dyed with D&C Green No. 6 at compliant concentration.
Design	- Sterile, flexible multifilament (sizes 8-0 and larger) or monofilament (sizes 9-0 and smaller) thread. - Offered uncoated or coated with absorbable magnesium stearate-based coating. - With or without standard needles attached.	- Demonstrated: Same design as predicate devices (DEXON®, POLYSORB®, VICRYL®). Conforms to USP XXIII requirements for absorbable surgical suture.
Physical Properties	- Conformance to U.S. Pharmacopeia (U.S.P.) XXIII, including: - <861> Sutures --Diameter - <871> Sutures -- Needle Attachment - <881> Tensile Strength - Other properties: fiber diameter, knot pull tensile strength, straight pull tensile strength, elongation at break, knot security, and needle attachment strength.	- Demonstrated: Extensive physical testing to prove conformance to U.S.P. XXIII requirements and substantial equivalence to predicate devices for all listed physical properties.
Biocompatibility	- Safe for in vivo use.	- Demonstrated: In vitro and in vivo biosafety studies.
In Vivo Performance	- Appropriate rates of tensile strength and mass loss (absorption).	- Demonstrated: Implant studies in animals.
Manufacturing Process	- Typical industry processes for polymer synthesis, extrusion, spinning, drawing, braiding/cutting, coating, and attachment to needles.	- Demonstrated: Manufacturing process described as identical to DEXON® and equivalent to POLYSORB® and VICRYL® predicate devices.
Packaging & Sterilization	- Same or equivalent methods as predicate devices.	- Demonstrated: Sterilization validation and evaluation of sterilant residues. Shelf-life testing.
Labeling Claims	- Same or equivalent indications, contraindications, warnings, cautions, and precautions as predicate devices.	- Demonstrated: Labeling claims are same or equivalent to predicate devices.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated as a single "test set" analogous to an AI/ML validation data set. The non-clinical tests involved various samples of the Safil® suture for physical, chemical, and biological testing. The specific number of sutures or batches tested for each parameter is not provided in this summary.
Data Provenance: The data comes from internal non-clinical testing conducted by Aesculap®, the manufacturer, and potentially third-party labs for specific tests (e.g., sterilization validation). The country of origin for the data is not specified beyond it being conducted by the manufacturer. The data is retrospective in the sense that it's generated as part of product development and submission, not a prospective study on a patient population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. For this traditional medical device (suture), "ground truth" is established by adherence to recognized standards (e.g., USP XXIII, FDA CFR) and established scientific/engineering principles for material properties and performance. There isn't an "expert consensus" model for interpreting results in the way there would be for image-based diagnostic AI. The experts involved would be materials scientists, engineers, and regulatory specialists designing and evaluating the tests against these standards.

4. Adjudication method for the test set:

Not Applicable. Without "experts" establishing a "ground truth" in the context of subjective interpretation, there is no adjudication method like 2+1 or 3+1. Testing results are objective measurements against established specifications or comparisons to predicate device measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is not an AI-powered device, and thus no MRMC study comparing human readers with and without AI assistance was conducted.

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

Not Applicable. This is not an AI-powered device.

7. The type of ground truth used:

The "ground truth" (or more accurately, the reference standard) used for this device is primarily:
- Regulatory Standards/Specifications: U.S. Pharmacopeia (U.S.P.) XXIII monographs for absorbable surgical sutures, and Title 21 CFR regulations (e.g., for colorants).
- Predicate Device Performance: The performance characteristics (physical, mechanical, chemical properties) of the legally marketed predicate devices (DEXON®, VICRYL®, POLYSORB®). The goal was to demonstrate "substantial equivalence" to these devices.
- Biological Response: In vitro and in vivo biosafety studies, and animal implant studies, to assess biological compatibility and degradation, referenced against established safety profiles for similar materials.

8. The sample size for the training set:

Not Applicable. This is not an AI-powered device, so there is no "training set."

9. How the ground truth for the training set was established:

Not Applicable. No training set exists for this traditional medical device.

Summary

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Aesculap®

K 98004

VII.510(k) Summary

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

A . Submitted By

Aesculap® 1000 Gateway Boulevard South San Francisco, California 94080-7030 Telephone: (415) 876-7000 Contact: Victoria MacKinnon, Manager of Regulatory Affairs Date Prepared: February 19, 1998

B . Device Name

Trade or Proprietary Name:	Safil® Synthetic Absorbable Surgical Suture
Common or Usual Name:	Absorbable Poly(Glycolide/L-lactide) Surgical
	Suture
Classification Name:	Absorbable Poly(Glycolide/L-lactide) Surgical
	Suture

C . Predicate Devices

The subject device is substantially equivalent to the following predicate devices:

DEXON® Synthetic Absorbable Surgical Suture (Davis & Geck)) ●
VICRYL® Synthetic Absorbable Surgical Suture (Ethicon, Inc.) .
POLYSORB® Synthetic Absorbable Surgical Suture (U. S. Surgical Corp.) ●

D . Device Description

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offered undyed, and dyed with the FDA approved colorant D&C Green No. 6 in accordance with Title 21 CFR, §74.3206. It will be available uncoated, and coated with an absorbable magnesium stearate-based coating. It will be available with and without standard needles attached.

E. Intended Use

F. Comparison to Predicate Devices

The subject Safil® Synthetic Absorbable Surgical Suture is composed of 100% polyglycolic acid, a material identical to that comprising the predicate DEXON® suture, and equivalent to the material comprising the predicate POLYSORB® and VICRYL® devices. Further, the subject device is offered undyed, and dyed with the same colorant as the DEXON® predicate device, that being D&C Green No. 6 at a concentration that conforms to the requirements of Title 21 CFR, §74.3206.

The subject device has the same design as do the DEXON®, POLYSORB® and VICRYL® predicate devices, being a sterile, flexible thread available in a braided multifilament form in sizes 8-0 and larger, and a monofilament form in sizes 9-0 and smaller. Braided multifilament sutures are offered either uncoated, or treated with an absorbable magnesium stearate-based coating to enhance handling characteristics and reduce tissue drag. It is offered in a variety of lengths and a range of diameters conforming with the requirements of U. S. Pharmacopeia (U.S.P.) XXIII, and is offered with or without one of a selection of standard needles attached. Further, as is the case with the predicate devices, the subject device conforms in all respects to the requirements of the Official Monograph for Absorbable Surgical Suture in U.S.P. XXIII, including <861> Sutures --Diameter, <871> Sutures -- Needle Attachment, and <881> Tensile Strength.

Physical properties of the subject device are substantially equivalent to those of the DEXON®, POLYSORB® and VICRYL® predicate devices, including fiber

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diameter, knot pull tensile strength, straight pull tensile strength, elongation at break, knot security, and needle attachment strength, among others.

The subject device is manufactured in a manner typical of the industry and equivalent to that used to produce predicate devices, wherein: Polyglycolic acid polymer is synthesized via condensation reaction; the polymer is melt extruded and spun to form fine filaments of specified diameter and are then drawn to enhance tensile properties; the fibers are either cut to length and attached to needles to make monofilament sutures, or braided to produce multifilament suture fiber, coated, and then cut to length and attached to needles. Given that the subject device is made from the same material as the DEXON® predicate device, and in the same manner as the DEXON®, POLYSORB® and VICRYL® predicate devices, the subject device has the same or equivalent chemical characteristics, biocompatibility, and/or in vivo performance properties as do the predicate devices.

The subject device is packaged and sterilized in the same or equivalent manner, and has the same or equivalent labeling claims as do the predicate devices, including indications, contraindications, warnings, cautions and precautions.

G . Summary of Non-Clinical Tests

Non-clinical testing conducted on the subject device to demonstrate its substantial equivalence to predicate devices included physical testing for all parameters identified above, sterilization validation and evaluation of sterilant residues, and shelf-life testing. Testing conducted by the manufacturer included Fourier Transform Infrared Spectroscopy assays to demonstrate substantial equivalence of identity and purity, testing of physical properties to prove conformance to the requirements of U.S.P., in vitro and in vivo biosafety studies, and implant studies in animals to demonstrate rates of tensile strength and mass loss.

H . Summary of Clinical Tests

(Not applicable)

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I. Conclusions of Non-Clinical and Clinical Tests

The results of all testing demonstrated the substantial equivalence, if not superiority, of the subject device to one or more predicate devices.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY III ପ୍ରିପିଟି

Mr. Steve Reitzler Vice President, Regulatory Affairs AESCULAP c/o Advanced Bioresearch Associates One America Plaza, Suite 900 600 West Broadway San Diego, California 92101-3302

Re: K980704
Safil Synthetic Absorbable Surgical Suture Regulatory Class II Product Code: GAM Dated: February 19, 1998 Received: February 23, 1998

Dear Mr. Reitzler:

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 Safil Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery but not in cardiovascular surgery, neurological procedures and microsurgery.
1. This device may not be manufactured from any material other than homopolymers of glycolic acid. 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 Safil Absorbable Synthetic 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

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Page 2 - Mr. Reitzler

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 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,

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

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510(k) Number (if known): K980704

Device Name: Safil® Synthetic Absorbable Surgical Suture

Indications For Use:

Safil® sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not in cardiovascular surgery, microsurgery or neural tissue.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign-Off) ാന്ദ്രീപ്പി Sign-Om
Division of General Restorative Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.