Optilene Nonabsorbable Polypropylene Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.

Device Description

Optilene is a nonabsorbable monofilament surgical suture which is supplied sterile. Optilene is composed of 95% polypropylene and 5% polyethylene. The Optilene suture is offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Optilene suture previously ranged in diameters from USP size 10-0 through 0 in lengths ranging from 8 cm to 150 cm. The Optilene suture is offered with or without needles attached. The Optilene sutures are also offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are available separately packaged six per pouch.

The purpose of this submission is to seek clearance for a line extension to the Optilene Nonabsorbable Surgical Suture (K133890). This submission proposes two additional USP sizes, size 1 and 2 and to extend the length range to 240 cm.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically a surgical suture. Such documents focus on demonstrating "substantial equivalence" to a predicate device rather than presenting a standalone study with acceptance criteria in the traditional sense of a clinical trial for an AI-powered diagnostic or therapeutic device.

Therefore, the information requested in your prompt (acceptance criteria, details of a study with sample sizes, expert ground truth, MRMC, standalone performance, training set details) is not applicable to this type of regulatory submission.

This document describes a line extension for an existing nonabsorbable surgical suture (Aesculap Optilene Nonabsorbable Suture). The purpose of the submission is to introduce additional USP sizes (size 1 and 2) and to extend the length range (up to 240 cm) for an already cleared device.

Instead of a clinical study demonstrating AI performance, the manufacturer performed non-clinical laboratory performance testing to show that the new sizes and lengths of the suture meet the established standards for nonabsorbable surgical sutures.

Here's how the information aligns with your request, despite the different context:

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

The "acceptance criteria" here are the requirements set forth by the USP (United States Pharmacopeia) Monograph for Nonabsorbable Surgical Sutures and the FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.

Acceptance Criteria (Standards Met)	Reported Device Performance (Compliance)
USP 40 Monograph for Nonabsorbable Surgical Sutures (as applicable)	Complied
USP40 <861> Sutures - Diameter	Complied
USP 40 <881> Tensile Strength	Complied
USP 40 <871> Sutures - Needle Attachment	Complied
ISO 10993-1 (Materials evaluation)	Complied

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the document. For non-clinical performance testing of physical devices, specific sample sizes for various tests (e.g., tensile strength, diameter measurements) would be defined in testing protocols, but these details are typically not included in the summary provided in the 510(k).
Data Provenance: Not explicitly stated, but derived from non-clinical laboratory testing performed by the manufacturer (Aesculap, Inc.) to verify compliance with U.S. and international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This pertains to a physical medical device (suture), not an AI device requiring expert-established ground truth for diagnostic or prognostic purposes. The "ground truth" is defined by the objective physical and chemical standards of the USP monograph.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This refers to adjudication of expert opinions for ground truth in AI studies.

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 a non-AI surgical suture.

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

Not applicable. This is a non-AI physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on objective, quantifiable physical and material specifications defined by established standards:
- United States Pharmacopeia (USP) Monograph for Nonabsorbable Surgical Sutures.
- ISO 10993-1 for biocompatibility of materials.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

In summary, this 510(k) premarket notification is for a conventional medical device line extension. The "study" mentioned refers to non-clinical laboratory testing demonstrating compliance with established physical standards for surgical sutures. The concepts of AI acceptance criteria, expert ground truth, training sets, and MRMC studies are not relevant to this specific device and its regulatory submission path.

Summary

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March 7, 2018

Aesculap, Inc. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K180321

Trade/Device Name: Aesculap Optilene Nonabsorbable Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: February 5, 2018 Received: February 5, 2018

Dear Ms. Racosky:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K180321

Device Name

Aesculap Optilene Nonabsorbable Surgical Suture

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Special 510(k) Premarket Notification

Page 1 of 3

B. 510(k) SUMMARY (as required by 21 CFR 807.92)

Aesculap Monosyn Synthetic Absorbable Surgical Suture February 5, 2018

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racoskv@acscula p.com
TRADE NAME:	Aesculap Optilene Nonabsorbable Suture
COMMON NAME:	Nonabsorbable polypropylene/polyethylene surgical suture
CLASSIFICATION:	Class II
CLASSIFICATION NAME:	Nonabsorbable polypropylene surgical suture
REGULATION NUMBER:	878.5010
PRODUCT CODE:	GAW

PREDICATE DEVICE

Optilene Nonabsorbable Surgical Suture (K133890) ●

DEVICE DESCRIPTION

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Page 2 of 3

INDICATIONS FOR USE

Optilene Nonabsorbable Polypropylene/Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.

SUBSTANTIAL EOUIV ALENCE and COMPARISON OF TECHNOLICAL

CHARACTERISTICS

The Optilene Nonabsorbable Surgical Suture line extension is as safe an effective as the previously cleared Optilene Nonabsorbable Surgical Suture. The proposed additional USP sizes, size 1 and 2, and suture lengths up to 240 cm to the Optilene Nonabsorbable Surgical Suture (K133890) product line have the same material, design, intended use and technological characteristics as the predicate device. The only difference between the proposed and predicate device is the suture diameter and length. The device characteristics comparing the Optilene Nonabsorbable Surgical Suture to the predicate device are summarized below.

	Aesculap Inc.Optilene Nonabsorbable SurgicalSuture	Aesculap, Inc.Optilene Nonabsorbable SurgicalSuture
K#	Predicate device (K133890)	Proposed device
Indications	Indicated for use in all types of generalsoft tissue approximation and/or ligation,including use in cardiovascular,ophthalmic, microsurgery and neuraltissue.	Same
Material	95% oolypropylene and 5% Polyethylene	Same
Colorant	Phthalacyaninato(2-)l conner	Same
Dyed	Yes	Same
Structure	Monofilament	Same
Size	USP 10-0 through 0	USP 1 & 2
	with or w/out needles attachedwith or w/out oledgets attached	samesame
Thread length	-8 cm to 150 cm-ligature reels oflon•er len""h	-8 cm to 240 cm-li!!ature reels of lon.2'.er len£Jth
Physical:- Diameter- Length- Needle Attachment- Tensile Strength	All characteristics meet USP	Same
Needle material	300 series stainless steel	Same
Pled!!ets	oolvtetrafluoroethylene	Same
Packaging	Oval HDPE support with an oval cardfold card lid in a tyvek peel pouch andoolvester-oolvethylene tereohatalate film.	Same
Sterilization	Ethylene Oxide (EO)	Same

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Special 510(k) Premarket Notification

Page 3 of 3

PERFORMANCE DATA

Performance tests: Non-clinical laboratory performance testing was conducted to verify that the Optilene Nonabsorbable Surgical Suture, USP sizes I and 2 conforms to the USP monograph for nonabsorbable sutures (as applicable). This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003. Materials used were evaluated per ISO 10993-1.

The test results demonstrate that proposed device complies with the following standards:

USP 40 Monograph for Nonabsorbable Surgical Sutures USP40<861>Sutures-Diameter USP 40 <881> Tensile Strength USP 40 <871> Sutures -Needle Attachment

CONCLUSION:

The information provided in this submission demonstrates that the Optilene Nonabsorbable Surgical Suture line extension is substantially equivalent to the marketed predicate device.

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene 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 undyed or dyed with an FDA approved color additive; and 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.