FSSB Nylon Surgical Suture (Non-absorbable Polyamide) is indicated for use in general soft tissue approximation and/or ligation including use in ophthalmic and neurological procedures.

Device Description

FSSB Nylon Surgical Suture is a monofilament non-absorbable sterile surgical suture composed of the long chain aliphatic polymers Nylon 6,6. The suture is provided dyed (black). The pigment for the black dyed suture is Hematein black (Logwood: Color Code 75290). All products meet the requirements of 21 CFR 70.5(c) regarding the use of color additives in sutures.

The product is available in several lengths and USP diameters. The FSSB Surgical Suture is equipped with single or double high-grade stainless steel needles of various types of points, lengths, diameters and curves (Product List provided as Appendix A). The product meets all requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures.

AI/ML Overview

The provided 510(k) summary for FSSB Nylon Surgical Sutures does not describe a study involving a device with AI or machine learning components, nor does it detail acceptance criteria and performance against those criteria in the typical sense of a diagnostic or predictive device.

Instead, this document establishes substantial equivalence of the FSSB Nylon Surgical Suture to existing predicate devices based on material composition, intended use, and performance testing that meets established industry standards (USP, ISO) and FDA guidance for surgical sutures.

Therefore, the requested information, which is relevant for AI/ML-driven devices, cannot be extracted from this document in its entirety. However, I can interpret the provided information within the context of demonstrating substantial equivalence, which is a form of "acceptance" for a medical device.

Here's an attempt to structure the information based on the request, noting where the information is not applicable (N/A) for this type of device:

Acceptance Criteria and Study for FSSB Nylon Surgical Sutures

1. Table of Acceptance Criteria and Reported Device Performance

For a surgical suture, "acceptance criteria" are primarily defined by adherence to recognized standards and demonstrated equivalence to legally marketed predicate devices in terms of material properties and performance.

Criterion Type	Specific Criteria (Derived from USP, ISO, and FDA Guidance)	Reported Device Performance (FSSB Nylon Surgical Sutures)
Material Composition	Composed of Nylon 6 or Nylon 6,6. Pigment (if dyed) meets 21 CFR 70.5(c).	Composed of Nylon 6,6. Black dye uses Hematein black (Logwood: Color Code 75290), meeting 21 CFR 70.5(c). Meets Criterion.
Physical Properties	Meets USP 28 <861> for Diameter.	Meets U.S.P. 28 for diameter 861. Meets Criterion.
	Meets USP 28 <871> and <881> for Tensile Strength.	Performance testing conducted in accordance with USP 28 <871> and <881>. Implicitly, device meets these requirements as substantial equivalence is claimed. Meets Criterion.
	Biocompatibility in accordance with ISO 10993 standards.	Performance testing conducted in accordance with ISO 10993 standards. Implicitly, device meets these requirements. Meets Criterion.
	Pliability and handling properties consistent with industry standards and predicate devices.	Performance testing characterized pliability and handling. Minor differences from predicates do not new safety/effectiveness questions. Meets Criterion.
Intended Use	General soft tissue approximation and/or ligation, including ophthalmic and neurological procedures.	Indicated for use in general soft tissue approximation and/or ligation, including ophthalmic and neurological procedures. Equivalent to Predicates.
Design Features	Monofilament, nonabsorbable, various lengths/diameters, with/without surgical needle, dyed or undyed.	Monofilament, dyed (black), non-absorbable, available in several lengths and USP diameters, equipped with single/double high-grade stainless steel needles. Equivalent to Predicates.

2. Sample Size for Test Set and Data Provenance

This information is not explicitly detailed in the provided summary. For a surgical suture, "testing" primarily refers to bench testing of material properties, not a clinical "test set" for diagnostic performance.

Sample Size for Test Set: Not specified in terms of distinct patient data or a clinical "test set." Testing refers to physical samples of the suture material.
Data Provenance: N/A for this type of physical product testing. The testing is conducted on manufactured suture product.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is N/A for this type of device. "Ground truth" in the context of AI/ML devices typically refers to expert labels on data. For surgical sutures, "ground truth" is established by adherence to recognized material and performance standards (e.g., USP monographs, ISO) and empirical testing against these standards.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (e.g., 2+1, 3+1) are relevant for human interpretation of data/images to establish ground truth in diagnostic studies, not for the physical properties testing of a surgical suture.

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

N/A. An MRMC study is relevant for evaluating the impact of an AI tool on the diagnostic performance of human readers. This concept does not apply to a surgical suture.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

N/A. This is a physical medical device (suture), not an algorithm or software. Its performance is inherent in its physical properties and how it functions during surgical use.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

Industry and Regulatory Standards: Specific quantitative and qualitative requirements outlined in the United States Pharmacopeia (USP 28 <861>, <871>, <881>) and ISO 10993 standards for biocompatibility.
Comparison to Predicate Devices: Demonstrating that its material composition, intended use, and technological characteristics are "substantially equivalent" to previously cleared surgical sutures. "Equivalence" serves as the functional ground truth for regulatory acceptance.

8. Sample Size for the Training Set

N/A. This device does not use an AI/ML model that requires a "training set."

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

N/A. As there is no training set for an AI/ML model, this question is not applicable.

Summary

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JUL 26 2006 510(K) Summary of Data and Information III.

The following information is provided as required by 21 CFR § 807.87 for FSSB Chirurgische Nadeln GmbH's 510(k) premarket notification for FSSB Nylon Surgical Sutures and in accordance with FDA's "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" (June 3, 2003).

A. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

FSSB Nylon Surgical Sutures

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the FSSB Nylon Surgical Sutures is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices currently having 510k clearance.

Submitter's Name, Address, Telephone Number, Contact Person and Date

Prepared

FSSB Chirurgische Nadeln GmbH	Phone:	+49 7745 92 79 90
Allmendweg 2 (Postfach 1132)	Fax:	+49 7745 92 79 999
Jestetten, Germany D-79798
US Contact:
M Squared Associates, Inc.	Phone:	202-546-1262 ext. 257
Cherita James	Fax:	202-546-3848
719 A Street, NE	e-mail:	CJames@msquaredassociates.com
Washington DC 20002
Date prepared: February 22, 2006

Proprietary Name:	FSSB Nylon Surgical Sutures
Common Name:	Nonabsorbable Nylon Surgical Suture
Classification Status:	Class II per regulations §878.5020
Product Code:	GAR- Surgical, Nonabsorbable, Synthetic, Polyamide

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K060471
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Device Description

Intended Use

FSSB Nylon Surgical Suture (Non-absorbable Polyamide) is indicated for use in general soft tissue approximation and/or ligation including use in ophthalmic and neurological procedures.

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K060471

	Predicate Devices		Subject Device
Company	T.CAD	Sherwood-Davis & Geck	S & T	FSSB
Device	International -Nylon	Surgilon®,Ophtalon® andDermalon®Non-absorbableSurgical Suture	Micro surgicalsuture	FSSB NylonSurgical Suture
510(k) Number	K993998	K981582	K031531	No number yet
Characteristic
Intended use	General softtissueapproximationand/or ligationIncluding use incardiovascularophthalmic andneurologicalprocedures.	General softtissueapproximationand/or ligationIncluding use incardiovascularophthalmic andneural tissue.	General soft tissueapproximationand/or ligationIncluding use incardiovascular andophthalmic Iprocedures.	General soft tissueapproximation and/orligation including usein ophthalmic andneurologicalprocedures.
Suture Material	Nylon 6 or Nylon6,6	Nylon 6 or Nylon6,6	Nylon 6 or Nylon 6,6	Nylon 6 or Nylon 6,6
SutureCharacteristics	Not absorbed,progressivedegradation ofthe Nylon in vivomay result ingradual loss ofall of thesuture's tensilestrength overtime	Not absorbed,progressivehydrolysis of theNylon in vivomay result ingradual loss ofall of thesuture's tensilestrength overtime	Unknown	Not absorbed,progressivehydrolysis of theNylon in vivo mayresult in gradualloss of all of thesuture's tensilestrength over time
Suture Diameter	Meet U.S.P.Requirements	Unknown	Unknown	U.S.P. 28 fordiameter 861
How supplied	Monofilamentthread, coatedor uncoated,undyed or dyedwith an FDAlisted coloradditive. Sterileand offered forSingle Use Only.Available with orwithout surgicalneedle.	Braided andmonofilamentsutures availablein variouslengths anddiameters withor withoutsurgical needles.	Monofilament, dyedblack available invarious lengths anddiameters withsurgical needles.	Monofil, dyed,variety of lengthsand diameters withsurgical needle.
Packaging	Dry packaged inAluminum Foiland Polyestertear openpackaging	Tyvek/Mylarpackaging	Unknown	Double packagedHeat sealed

Technological characteristics, comparison to predicate device.

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Technological Characteristics and Substantial Equivalence

The FSSB Nylon Surgical Sutures and the identified predicate devices have the same indications for use, are made from the same materials (Nylon 6 or Nylon 6,6), and have similar design features (monofilament, dyed, nonabsorbable, various lengths, available with needle). Performance testing has demonstrated that any minor differences between the FSSB Nylon Surgical Sutures and the predicate devices do not raise new questions of device safety or effectiveness.

Discussion of performance testing.

A collection of tests has been conducted to characterize biocompatibility, diameter, tensile strength, and properties such as pliability and handling in accordance to:

ISO 10993 standards .
USP 28 <861>, <871>, <881> .
Class II Special Control Guidance, Surgical Suture; Guidance for Industry and . FDA, June 3, 2003

Conclusion

FSSB Nylon Surgical Suture has the same principles of operation and similar technological characteristics as the previously 510k cleared predicates. The minor differences do not present new issues of safety or effectiveness.

Based on extensive performance testing and a comparison to the predicate devices, we believe that the FSSB Nylon Surgical Suture is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness. Additionally, the device has identical indications to the predicate devices and the labeling of the device is consistent both with FDA's guidance as well as current medical practice.

K060471

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 2006

FSSB Chirurgische Nadeln GmbH % M Squared Associate Ms. Cherita James 719 A Street, Northeast Washington, District of Columbia 20002

Re: K060471

Trade/Device Name: FSSB Nylon Surgical Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR Dated: July 20, 2006 Received: July 24, 2006

Dear Ms. James:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Cherita James

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Harbare Buchup

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications for Use Statement ll.

510(k) Number:	To be assigned
Device Name:	FSSB Nylon Surgical Suture
	FSSB Nylon Surgical Suture (Non-absorbable Polyamide) is
	indicated for use in general soft tissue approximation and/or
Indications for Use:	ligation including use in ophthalmic and neurological procedures.

Prescription Use(Part 21 CFR 801 Subpart D)	X
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Over-the-Counter Use(Part 21 CFR 801 Subpart C)
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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)

Choubare Parekhan)
(Division sign-off)

Division of General, Restorative, and Neurological Devices

510(k): K060471

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.