AESCULAP® Absorbable Surgical Gut Sutures and Softcar® Absorbable Surgical Gut Sutures are indicated for use in all types of gencral soft tissue approximation and/or ligation, including ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Device Description

The subject device is an absorbable, flexible suture thread, available in both plain and chromicized forms, which is supplied sterile. It is manufactured from the serosal connective tissue layer of bovine intestine or the submucosal layer of ovine intestine. It is indicated for general soft tissue approximation and/or ligation, including ophthalmic tissues, but not including cardiovascular or neural tissues. It is undyed, and is available with and without needles attached. In the Softcar® form, both plain and chromic sutures are treated with glycerol.

AI/ML Overview

The provided text is a 510(k) summary for the AESCULAP® Absorbable Surgical Gut Suture. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving performance through a detailed study in the manner of an AI/medical device performance evaluation.

Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) is not applicable or cannot be extracted from this type of regulatory submission. The document primarily highlights physical property testing to ensure compliance with U.S.P. standards and biosafety/implant studies to demonstrate equivalency to existing sutures.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Compliance to USP XXIII)	Reported Device Performance
<861> Sutures -- Diameter	Conforms in all respects to requirements of USP XXIII
<871> Sutures -- Needle Attachment	Conforms in all respects to requirements of USP XXIII
<881> Tensile Strength (Knot Pull, Straight Pull)	Physical properties substantially equivalent to predicates
Flexibility	Physical properties substantially equivalent to predicates
Knot Security	Physical properties substantially equivalent to predicates
Shelf Life Validation	Demonstrated substantial equivalence
Sterilization Validation	Demonstrated substantial equivalence
In vitro and in vivo biosafety (biocompatibility)	Demonstrated substantial equivalence
Implant studies (tensile strength and mass loss) in animals	Demonstrated substantial equivalence
Manufacturing process (materials and methods)	Equivalent to predicate devices
Packaging and labeling claims (indications, contraindications, warnings, cautions, precautions)	Same or equivalent to predicate devices

Explanation: The acceptance criteria are essentially derived from the requirements of the Official Monograph for Absorbable Surgical Suture in U.S.P. XXIII and equivalence to the predicate devices. The reported device performance is a general statement of compliance and substantial equivalence, without specific numerical results in this summary.

2. Sample sized used for the test set and the data provenance

Sample Size for Test Set: Not specified in the document. The document refers to "testing of physical properties" and "in vitro and in vivo biosafety studies" without detailing sample sizes for each.
Data Provenance: The studies were non-clinical (in vitro, in vivo animal implant studies), with physical property testing likely conducted in laboratories. The country of origin for the data is not specified, but the submission is to the U.S. FDA.

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

Not applicable. This is a medical device (suture) submission focusing on physical properties and biocompatibility, not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. This type of adjudication method is relevant for studies involving human interpretation (e.g., medical imaging), which is not the case here.

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 study type is for AI-assisted diagnostic devices.

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

Not applicable. This refers to AI algorithm performance.

7. The type of ground truth used

The "ground truth" for this device is based on:

USP XXIII Standards: These are established physical, chemical, and performance specifications for absorbable surgical sutures.
Predicate Device Characteristics: Benchmarking against existing, legally marketed similar devices (Davis & Geck, Ethicon, U.S. Surgical Corporation) established the expected performance and safety profile.
Animal Study Outcomes: In vivo studies in animals provided empirical data on tensile strength retention and mass loss, which were compared to expected performance based on predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this traditional medical device submission.

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

Not applicable.

Summary

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4/30/95

AESCULAP®

K991223

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, Director of Regulatory Affairs & Quality Assurance Date Prepared: April 6, 1999

B . Device Name

Trade or Proprietary Name:	Absorbable Surgical Gut Suture, plain andchromic; Softcat® Absorbable Surgical GutSuture, plain and chromic
Common or Usual Name:	Absorbable Surgical Gut Suture, plain andchromic
Classification Name:	Absorbable Surgical Gut Suture

C. Predicate Devices

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

Plain and Chromic Absorbable Surgical Suture (Davis & Geck)) .
Plain and Chromic Absorbable Surgical Suture (Ethicon, Inc.) .
. SOFTGUT® Plain and Chromic Absorbable Surgical Suture (Davis & Geck)
SURGIGUT® Plain and Chromic Absorbable Surgical Gut Suture (U.S. . Surgical Corporation)

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D. Device Description

E. Intended Use

F. Comparison to Predicate Devices

The subject Absorbable Surgical Gut Suture is composed of processed strands of bovine serosa or ovine submucosa, materials equivalent, if not identical, to those comprising the predicate sutures. The subject device is offered both plain, and chromicized to prolona its in vivo strength retention. In addition, the Softcar® plain and chromic forms of the subject device have been treated with a glycerol solution to enhance handling properties, in the same fashion as the predicate Davis & Geck SOFTGUT® suture.

The subject device has the same design as do the Ethicon and Davis & Geck predicate devices, being a sterile, flexible thread available in sizes 6-0 (1 Metric) through 4 (8 Metric), being offered with or without one of a selection of standard needles attached, and conforming in all respects to the requirements of the Official Monograph for Absorbable Surgical Suture in U.S.P. XXIII, including <& 1> Sutures -- Diameter, <871> Sutures -- Needle Attachment, and <881> Tensile Strength. .

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As is also the case with the predicate devices, the sutures are offered either plain, or treated with a chromic salt and cross-linked to increase resistance to degradation in vivo, thereby prolonging tensile strength retention. Both plain and chromic sutures are offered in traditional packaging containing an alcohol solution to prevent spruing caused by drying during storage.

Alternatively, as is the case with the predicate Davis & Geck SOFTGUT® sutures, Softcat® plain and chromic sutures are treated with a glycerol solution before packaging to prevent spruing and to preserve handling properties.

Physical properties of the subject device are substantially equivalent to those of the Ethicon and Davis & Geck predicate devices, including fiber diameter, knot pull tensile strength, straight pull tensile strength, flexibility, 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 bovine serosa or ovine submucosa are harvested from healthy animals, cut into long strips which are cleaned mechanically and chemically to remove non-collagenous materials, twisted together to form monfilament-like strands, dried, polished to uniform diameter, cut to length, and attached to needles to make finished sutures. A series of chromicizing and cross-linking baths are added to the process to make chromic sutures, and both plain and chromic sutures are either packaged in an alcohol solution to prevent fiber drying during storage, or treated with a glycerol solution to condition the fibers before packaging. Given that the subject device is made from the same materials, and in essentially the same fashion, as the Ethicon and Davis & Geck predicate devices, the subject device can be expected to have the same or equivalent chemical characteristics, physical properties, biocompatibility, and 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.

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G . Summary of Non-Clinical Tests

Non-clinical testing conducted on the subject device to demonstrate its substantial cquivalence to predicate devices included testing of physical properties to prove conformance to the requirements of U.S.P., in vitro and in vivo biosafety studies, implant studies in animals to demonstrate rates of tensile strength and mass loss, and shelf life and sterilization validation studies.

H . Summary of Clinical Tests

(Not applicable)

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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three birds in flight, depicted with curved lines to suggest movement and freedom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1999

AESCULAP c/o Mr. Steve Reitzler, RAC 13221 Maricotte Place San Diego, California 92130

Re: K991223

Trade Name: Absorbable Surgical Gut Suture, and SOFTCAT® Absorbable Surgical Suture

Regulatory Class: II Product Code: GAL Dated: April 6, 1999 Received: April 12, 1999

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 Monday, December 11, 1989 (Vol. 54, No. 236, Pages 50737 and 50738). 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:

The Absorbable Surgical Gut Suture and SOFTCAT® Absorbable Surgical Suture is 1. 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 serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine. 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 manufacturing of the Absorbable Surgical Gut Suture and SOFTCAT® Absorbable Surgical Suture. 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 change(s).

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Page 2 - Mr. Steve 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 registration, listing of The general controls provisions of the Act include requirements of regioned in the problem in the adulteration.

Existing major regulations affecting your device can be found in the Code of Federal
. Existing major regulations arrecting your avversion and Drug Administration
Regulations, Title 21, Parts 800 to 895. In addition, the Federal Regis Regulations, Title 21, Parts 800 to 893, 111 addition, more ance in the Federal Register.
(FDA) may publish further announcements concerning your device in the Federal any (FDA) may publish further announcements contribution submission does not affect any Please note: this response to your premarker nontrol for Health and Safety Act of 1968, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k)
. In the may and on the collected as a few interceiple on wour dcyice to This letter will allow you to begin malicoling of substantial equivalence of your device to a
premarket notification. The FDA finding of substition for vour device and thus, premarket notification. The FDA finding of substantial equiration of 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)
Carties of the same and since in the income includes contract the Office of If you desire specific advice for your ucvace on on our accessions of the Office of
and additionally 809.10 for in vitro 41 love of excellence the promotion and and additionally 809.10 for in Milly diagnolic de rocs), product on the promotion and Compliance at (301) 594-4392. Aduntonally, NY (405.70mpliance at (301) 594-4595.
advertising of your device, please contact the Office by Compliance to premarket advertising of your device, piease contact the oranding by reference to premarket.
Also, please note the regulation entitled, "Misbranding on your responsibility Also, please note the regulation entitled, "Misoration on your responsibilities under the
notification" (21 CFR 807.97). Other general information on your responsibilities u notification" (21 CFR 807.97). Outler gench internations veers Assistance at its toll-free
Act may be obtained from the Division of Small Manufacturers Act may be obtained none 1701) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia 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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Draft Labeling v.

A . Indications for Use

510(k) Number (if known): K991223

Device Name: AESCULAP® Absorbable Surgical Gut Suture

Indications for Use:

Absorbable Surgical Gut Suture is indicated for use in general soft rissue approximation and/or ligation , including use in ophthalmic nssac upproximation and in cardiovascular or neural tissues.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)
Division of General Restorative Devices
510(k) Number	K991223

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use ______
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Regulation Number and Section

§ 878.4830 Absorbable surgical gut suture.

(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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.