Silkam® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Description

The subject device is a nonabsorbable, sterile, flexible, braided multifilament thread composed of an organic protein called fibroin. It is derived from the domesticated silkworm species Bombyx mori, of the family Bombicidae, and is indicated for general soft tissue approximation and/or ligation. It meets all applicable requirements of the U. S. Pharmacopeia Official Monograph for Nonabsorbable Surgical Sutures (Class I). It will be offered undyed, and dyed with the FDA listed colorant Logwood extract in accordance with Title 21 CFR, §73.1410. It will be offered uncoated, or with a coating to enhance certain characteristics. It will be available with and without standard needles attached.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the AESCULAP® Silkam® Nonabsorbable Silk Surgical Suture:

Key Takeaway: This 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing novel acceptance criteria for a new device type and proving its performance through distinct studies with defined metrics like sensitivity, specificity, or reader improvement. The device is a conventional surgical suture, and its "performance" is largely defined by its adherence to established USP standards and its similarity to already approved sutures.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a conventional surgical suture demonstrating substantial equivalence, the "acceptance criteria" are intrinsically tied to meeting the requirements of existing U.S. Pharmacopeia (U.S.P.) standards and exhibiting physical properties comparable to predicate devices. The "reported device performance" is its successful demonstration of meeting these standards and equivalency.

Acceptance Criterion (Implicit)	Reported Device Performance
Conformance to U.S. Pharmacopeia (U.S.P.) XXIII Official Monograph for Nonabsorbable Surgical Sutures (Class I), including specific sections:	The subject device conforms in all respects to the requirements of the Official Monograph for Nonabsorbable Surgical Suture in U.S.P. XXIII, including <861> Sutures -- Diameter, <871> Sutures -- Needle Attachment, and <81> Tensile Strength.
Substantial equivalence in physical properties to predicate devices (Perma-Hand®, Davis & Geck Silk Suture, SOFSILK®).	Physical properties of the subject device are substantially equivalent to those of the predicate devices, including fiber diameter, knot pull tensile strength, knot security, capillarity, and needle attachment strength.
Substantial equivalence in manufacturing process.	The subject device is manufactured in the same manner as the predicate devices, from degummed and bleached yarns of natural silk, braided in standard operations.
Substantial equivalence in packaging and sterilization.	The subject device is packaged and sterilized in the same or equivalent manner as the predicate devices.
Substantial equivalence in labeling claims.	The subject device has the same labeling claims as the predicate devices.
Acceptable biosafety profile.	In vitro and in vivo biosafety studies were conducted. (Implied acceptability given the substantial equivalence conclusion). The suture fiber has "essentially the same physical and chemical properties, and hence, biosafety profile and in vivo performance characteristics, as do the predicate devices."
Retention of tensile strength over time.	12 and 24 month implant studies in animals were conducted to demonstrate retention of tensile strength. (Implied acceptability given the substantial equivalence conclusion).
Material composition: Nonabsorbable, sterile, flexible, braided multifilament thread, organic protein fibroin, derived from Bombyx mori silkworm.	Confirmed: Composed of "organic protein called fibroin... derived from the domesticated silkworm species Bombyx mori." Identical material as predicate devices.
Dye: Undyed or dyed with FDA listed Logwood extract per 21 CFR §73.1410.	Confirmed: Offered undyed, and dyed with FDA listed colorant Logwood extract at ≤1.0% by suture weight in accordance with 21 CFR §73.1410. Identical to predicate devices.
Coating: Uncoated or with biocompatible coating to enhance characteristics.	Confirmed: Offered uncoated, or with a coating to enhance certain characteristics. "Treated with a biocompatible coating to enhance its handling properties" (identical to predicate devices).
Available with and without standard needles attached.	Confirmed: Available with and without standard needles attached. Identical to predicate devices.
Intended Use: General soft tissue approximation and/or ligation, including cardiovascular, ophthalmic and neurological procedures.	This is the stated intended use, found to be substantially equivalent to predicate devices. The FDA clearance letter re-affirms this intended use.

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

Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of number of sutures or animal subjects used for the non-clinical tests. The testing performed was to demonstrate conformance to USP standards and substantial equivalence by comparing physical properties. The USP outlines testing methodologies, which inherently involve a statistically relevant number of samples for each parameter (e.g., diameter, tensile strength).
Data Provenance: The studies were internal non-clinical tests ("Non-Clinical testing conducted on the subject device"). The mention of "in vivo biosafety studies, and 12 and 24 month implant studies in animals" indicates prospective animal studies were conducted. The country of origin of the data is implicitly the United States, as the submission is to the FDA for a US market.

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

Number of Experts: Not applicable/not mentioned. This device is a physical product (suture) with well-defined physical and material properties measured quantitatively. "Ground truth" is established by adherence to established engineering, material science, and biological testing standards (e.g., USP monographs) rather than expert consensus on subjective interpretations.
Qualifications of Experts: Not applicable/not mentioned. The assessment relies on laboratory measurements and analytical testing, not human expert interpretation for "ground truth" in the way it would for, for instance, a diagnostic imaging AI.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no mention of an adjudication process, as the tests are for physical properties against defined standards, not subjective assessments requiring multiple experts for consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No.
Effect Size of Human Readers: Not applicable. An MRMC study is relevant for diagnostic or interpretive devices (e.g., AI in radiology) where human-in-the-loop performance is assessed. This is a nonabsorbable surgical suture, a physical product, not an AI or interpretive device.

6. Standalone Performance Study

Standalone Study Done: Yes, in essence. The non-clinical tests (e.g., physical testing for USP conformance, biosafety studies, implant studies) represent the "standalone" performance of the device itself (the suture material, its strength, biocompatibility) when tested against established benchmarks and compared to predicate devices. This is "algorithm only without human-in-the loop performance" in the context of the device's function as a physical object, not an AI algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used is primarily defined by standardized test methods and quantitative measurements outlined in the U.S. Pharmacopeia (U.S.P.) XXIII, combined with comparative data from predicate devices.
- USP Monograph Requirements: For parameters like diameter, needle attachment, and tensile strength (e.g., <861>, <871>, <81>).
- In Vitro and In Vivo Biosafety Data: Scientific data from biological studies.
- Animal Implant Study Data: Data on tensile strength retention from animal studies.
- Comparative Data: Performance metrics demonstrated by the legally marketed predicate devices.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. "Training set" is a concept specific to machine learning and AI development. This product is a physical medical device, not an AI system. The manufacturing process itself (from which "training" for humans might occur) is described as standard in the fiber industry, based on historical knowledge and established techniques, rather than iterative learning from a distinct "training set."

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the AI sense. The "ground truth" for suture manufacturing and quality control is established through decades of industrial practice, material science, and regulatory standards (like the USP). The manufacturing process itself is well-understood and governed by established quality assurance protocols to ensure consistency and meet specifications; it does not involve establishing "ground truth" in an AI/ML context.

Summary

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K990089

3/15/99

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

Steve Reitzler, RAC Regulatory Consultant to AESCULAP® 13221 Maricotte Place San Diego, California 92130 Telephone: (619) 977-1465 Telefacsimile: (619) 794-7601

Regulatory Agent for: AESCULAP® 1000 Gateway Boulevard South San Francisco, California 94080-7030 Telephone: (650) 876-7000 Contact: Victoria Mackinnon, Director of Regulatory Affairs & Quality Assurance Date Prepared: January 7, 1999

B. Device Name

Trade or Proprietary Name:	Silkam® Nonabsorbable Silk Surgical Suture
Common or Usual Name:	Nonabsorbable Silk Surgical Suture
Classification Name:	Natural Nonabsorbable Silk Surgical Suture

C. Predicate Devices

Perma-Hand® Nonabsorbable Silk Surgical Suture (Ethicon, Inc.) ●
Nonabsorbable Silk Surgical Suture (Davis & Geck)
SOFSILK® Nonabsorbable Silk Surgical Suture (U. S. Surgical Corp.) .

The subject device is substantially equivalent to predicate devices listed above.

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D. Device Description

The subject device is a nonabsorbable, sterile, flexible, braided multifilament thread composed of an organic protein called fibroin. It is derived from the domesticated silkworm species Bombyx mori, of the family Bombicidae, and is indicated for general soft tissue approximation and/or ligation. It meets all applicable requirements of the U. S. Pharmacopeia Official Monograph for Nonabsorbable Surgical Sutures (Class I). It will be offered undyed, and dyed with the FDA listed colorant Logwood extract in accordance with Title 21 CFR, $73.1410. It will be offered uncoated, or with a coating to enhance certain characteristics. It will be available with and without standard needles attached.

E. Intended Use

Silkam® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

F. Comparison to Predicate Devices

The subject Silkam® Nonabsorbable Silk Surgical Suture is composed of the same material as are the predicate devices, that being the organic protein fibroin in the form of degummed silk derived from domesticated B. mori. Further, as are the predicate devices, the subject device is offered undyed, and dyed with Logwood extract, or hematein, at a concentration of $1.0% by suture weight in accordance with Title 21 CFR, §73.1410. In addition, as are the predicate devices, the suture is offered both uncoated, or treated with a biocompatible coating to enhance its handling properties.

The subject device has the same design as do the predicate devices, being a sterile, flexible, braided multifilament thread which 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 which 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 Nonabsorbable Surgical Suture in U.S.P. XXIII, including <861> Sutures -- Diameter, <871> Sutures -- Needle Attachment, and &81> Tensile Strength.

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Physical properties of the subject device are substantially equivalent to those of the predicate devices, including fiber diameter, knot pull tensile strength, knot security, capillarity, and needle attachment strength.

The subject device is manufactured in the same manner as the predicate devices, being produced from degummed and bleached yarns of natural silk harvested through sericulture of B. mori, and braided in operations considered standard in the fiber industry to form the finished suture fiber. As such, the suture fiber from which the subject device is made has essentially the same physical and chemical properties, and hence, biosafety profile and in vivo performance characteristics, as do the predicate devices.

The subject device is packaged and sterilized in the same or equivalent manner, and has the same labeling claims, as do the predicate devices.

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 and to prove conformance to the requirements of U.S.P., in vitro and in vivo biosafety studies, and 12 and 24 month implant studies in animals to demonstrate retention of tensile strength.

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/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Mr. Steve Reitzler Regulatory Consultant to AESCULAP® 13221 Maricotte Place San Diego, California 92130

Re: K990089

Trade Name: Silkam @ Nonabsorbable Silk Surgical Suture Regulatory Class: II Product Code: GAP Dated: January 7, 1999 Received: January 11, 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 Tuesday, October 26, 1993 (Vol. 58, No. 205, Pages 57557 and 57558). 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 Silkam® Nonabsorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
1. This device may not be manufactured from any material other than multifilamentous fibers composed of fibroin, an organic protein that is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. 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 Silkam® Nonabsorbable 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.

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Page 2 - Mr. Steve Reitzler, RAC

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) 594-4595. 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,

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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V. Draft Labeling

A. Indications for Use

510(k) Number (if known): K990089

Device Name: Silkam® Nonabsorbable Silk Surgical Suture

Indications for Use:

Silkam® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Concurrence of CDRH, Office of Device Evaluation (ODE)


	General Restorative Devices
	K90089

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
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· pane (哪个

1 :

Regulation Number and Section

§ 878.5030 Natural nonabsorbable silk surgical suture.

(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.