Dafilon® Nonabsorbable Polyamide Surgical Sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

Device Description

The subject device is a nonabsorbable, flexible, monofilament suture thread which is supplied sterile. It is composed of the long-chain, linear aliphatic polymers nylon 6 and/or nylon 6,6. It is indicated for general soft tissue approximation and/or ligation. It will be offered undyed, or dyed with the FDA listed colorants FD&C Blue No. 2 (in accordance with Title 21 CFR, §74.1102) or Logwood extract (in accordance with Title 21 CFR, §73.1410). It will be offered uncoated, and will be available with and without standard needles attached.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Dafilon® Nonabsorbable Polyamide Surgical Suture) and not a study describing AI/machine learning model performance. Therefore, many of the requested categories related to AI model evaluation, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set size," and "ground truth establishment for the training set," are not applicable.

However, I can extract information related to acceptance criteria and the non-clinical studies conducted for this traditional medical device.

Acceptance Criteria and Device Performance (Non-AI/ML Device)

The "acceptance criteria" for this device are its conformance to established medical device standards and its substantial equivalence to predicate devices. The performance is assessed against these standards and predicates.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Composition	Composed of long-chain, linear aliphatic polymers nylon 6 and/or nylon 6,6.	The device is composed of nylon 6 and/or nylon 6,6, which is the same material as the predicate devices.
Colorants	Offered undyed or dyed with FDA listed colorants FD&C Blue No. 2 (21 CFR §74.1102) or Logwood extract (21 CFR §73.1410) at allowed concentrations.	Offered undyed or dyed with FD&C Blue No. 2 or Logwood extract, at concentrations within federal regulations.
Design Characteristics	Sterile, flexible, monofilament thread; offered in various lengths and diameters conforming to U.S. Pharmacopoeia (U.S.P.) XXIII requirements; with or without standard needles. Conforms to U.S.P. XXIII Official Monograph for Nonabsorbable Surgical Suture, specifically <861> Sutures -- Diameter, <871> Sutures -- Needle Attachment, and <881> Tensile Strength.	The device has the same design, being a sterile, flexible, monofilament thread, offered in various lengths and diameters conforming to U.S.P. XXIII and with or without standard needles. It conforms in all respects to the U.S.P. XXIII Official Monograph for Nonabsorbable Surgical Suture, including <861> Diameter, <871> Needle Attachment, and <881> Tensile Strength.
Physical Properties	Substantially equivalent to predicate devices for fiber diameter, knot pull tensile strength, straight pull tensile strength, elongation, knot security, and needle attachment strength.	Physical properties (fiber diameter, knot pull tensile strength, straight pull tensile strength, elongation, knot security, and needle attachment strength) are substantially equivalent to those of the predicate devices.
Manufacturing Process	Produced from polyamide polymers via melt-spin and drawing operations standard in the fiber and suture industries, ensuring similar physical and chemical properties.	Manufactured in the same manner as predicate devices (melt-spin and drawing), resulting in essentially the same physical and chemical properties.
Biocompatibility & In Vivo Performance	Similar biocompatibility profile and in vivo performance characteristics to predicate devices. Retention of tensile strength and safety in 1 and 2-year implant studies in animals.	Biosafety studies (in vitro and in vivo), and 1- and 2-year animal implant studies demonstrated retention of tensile strength and safety, similar to predicate devices.
Packaging & Sterilization	Packaged and sterilized in the same or equivalent manner as predicate devices.	Packaged and sterilized in the same or equivalent manner as predicate devices.
Labeling Claims	Same labeling claims as predicate devices.	Same labeling claims as predicate devices.
Intended Use	Indicated for general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.	Indicated for use in all types of general soft tissue approximation and/or ligation, including in cardiovascular, ophthalmic, and neurological procedures, matching the predicate devices.

Study to Prove Acceptance Criteria:

The study to prove the device meets acceptance criteria was a series of "Non-Clinical Tests" to demonstrate substantial equivalence to predicate devices.

Sample size used for the test set and the data provenance: Not explicitly stated. The text mentions "physical testing for all parameters identified above" and "in vitro and in vivo biosafety studies, and one (1) and two (2) year implant studies in animals." The provenance for animal studies is "in animals," but specific species or location are not detailed. These are non-clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML study involving expert ground truth for image interpretation or diagnosis. The "ground truth" here is the conformance to U.S.P. standards and comparison to predicate device characteristics.
Adjudication method for the test set: Not applicable. No human interpretation or adjudication process described.
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-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used:
- Regulatory Standards: Conformance to U.S. Pharmacopoeia (U.S.P.) XXIII standards for sutures (e.g., diameter, needle attachment, tensile strength).
- Predicate Device Characteristics: Comparison of material composition, design, physical properties, manufacturing, packaging, sterilization, and labeling to existing "predicate devices" (Ethilon®, DERMALON®, MONOSOF®).
- Biological Response: Results from in vitro and in vivo biosafety studies and long-term animal implant studies (1 and 2 years) to assess retention of tensile strength and safety.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

{0}------------------------------------------------

3/22/99

AESCULAP®

K990090

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

R. Stephen Reitzler, RAC, Vice President, Regulatory Affairs Advanced Bioresearch Associates One America Plaza 600 West Broadway, Suite 900 San Diego, California 92101 Telephone: (619) 702-0700

Regulatory Agents for: AESCULAP® 1000 Gateway Boulevard South San Francisco, California 94080-7030 Telephone: (650) 876-7000 Contact: Victoria Mackinnon, Director, Regulatory Affairs & Quality Assurance Date Prepared: January 8, 1999

B. Device Name

Trade or Proprietary Name:	Dafilon® Nonabsorbable PolyamideSurgical Suture
Common or Usual Name:	Nonabsorbable Polyamide Surgical Suture
Classification Name:	Nonabsorbable Polyamide Surgical Suture

C. Predicate Devices

Ethilon® Nonabsorbable Polyamide Surgical Suture (Ethicon, Inc.) .
DERMALON® Nonabsorbable Polyamide Surgical Suture (Davis & Geck) ●
MONOSOF® Nonabsorbable Polyamide Surgical Suture (U. S. Surgical) ●

{1}------------------------------------------------

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

D. Device Description

E. Intended Use

F. Comparison to Predicate Devices

The subject Dafilon® Nonabsorbable Polyamide Surgical Suture is composed of the same material as are the predicate devices, that being the long-chain aliphatic polymers polyamide 6 and 6,6 (or nylon 6 and 6,6). Further, the subject device is offered undyed, and dyed with the same colorant as are the predicate devices, that being FD&C Blue No. 2 or Logwood extract, at concentrations within that allowed by federal regulations as defined in 21 CFR.

The subject device has the same design as do the predicate devices, being a sterile, flexible, monofilament thread which is offered in a variety of lengths and a range of diameters conforming with the requirements of U.S. Pharmacopoeia (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,

{2}------------------------------------------------

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 predicate devices, including fiber diameter, knot pull tensile strength, straight pull tensile strength, elongation, knot security, and needle attachment strength.

The subject device is manufactured in the same manner as the predicate devices, being produced from polyamide polymers via melt-spin and drawing operations considered standard in the fiber and suture industries. As such, the suture fiber from which the subject device is made has essentially the same physical and chemical properties, and hence, the same biocompatibility 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 one (1) and two (2) year implant studies in animals to demonstrate retention of tensile strength and safety.

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.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 1999

Aesculap c/o Mr. Steve Reitzler Regulatory Consultant 13221 Maricotte Place San Diego, California 92130

Re: K990090

Trade Name: Dafilon® Nonabsorbable Polyamide Surgical Suture Regulatory Class: II Product Code: GAR 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 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:

The Dafilon® Nonabsorbable Polyamide Surgical Suture is indicated for use in 1. general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
1. This device may not be manufactured from any long chain aliphatic polymers other than nylon 6 and/or nylon 6,6. 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 Dafilon® Nonabsorbable Polyamide 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.

{4}------------------------------------------------

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 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 vour 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

{5}------------------------------------------------

Draft Labeling V.

A. Indications for Use

510(k) Number (if known): K990090

Device Name: Dafilon® Nonabsorbable Polyamide Surgical Suture

Indications for Use:

Dafilon® 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)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K990090

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

Regulation Number and Section

§ 878.5020 Nonabsorbable polyamide surgical suture.

(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.