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 will be offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Optilene suture will be offered in diameters ranging from USP size 10-0 through 0 and with be available in a variety of cut lengths with or without needles attached. The Optilene sutures will also be offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are also available separately packaged six per pouch.

AI/ML Overview

This 510(k) Premarket Notification is for the Aesculap Optilene Nonabsorbable Surgical Suture. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from FDA's Class II Special Control Guidance Document for Surgical Sutures)	Reported Device Performance (Optilene Nonabsorbable Surgical Suture)
Diameter meets USP 35 specifications	All specifications were met.
Tensile Strength meets USP 35 specifications	All specifications were met.
Needle Attachment meets USP 35 specifications	All specifications were met.
Biocompatibility: Cytotoxicity	Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices.
Biocompatibility: Sensitization	Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices.
Biocompatibility: Intracutaneous Irritation	Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices.
Biocompatibility: Hemolysis	Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices.
Biocompatibility: Genotoxicity - Mouse Lymphoma	Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices.
Biocompatibility: Genotoxicity - Mouse Peripheral Blood Micronucleus	Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices.
Biocompatibility: Bacterial Reverse Mutation	Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices.
Biocompatibility: Muscle Implantation (12-week)	Testing demonstrated the device is as safe, as effective, and performs as well as predicate devices.
Chemical Characterization (of polypropylene/polyethylene raw material)	Results demonstrated substantial equivalence to predicate devices.
Accelerated Aging	Data generated to support the submission (specific results not detailed, but implies meeting shelf-life requirements).
Sterilization (Ethylene Oxide)	Device is sterilized by ethylene oxide (implies efficacy meeting standards).
Material composition (Polypropylene/Polyethylene)	95% polypropylene and 5% polyethylene, shown to be substantially equivalent.
Colorant (Phthalacyaninato(2-)] copper)	FDA approved colorant, shown to be substantially equivalent.
Structure (Monofilament)	Monofilament, shown to be substantially equivalent.
Size range (USP 10-0 through 0)	Within the range of predicate devices, shown to be substantially equivalent.
Packaging	Oval HDPE support with an oval card fold card lid in a tyvek peel pouch and polyester-polyethylenerephatalate film, shown to be substantially equivalent.

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

The document does not explicitly state specific sample sizes for each mechanical or biocompatibility test. It broadly states that "Tests were conducted for diameter, tensile strength, and needle attachment" and that "Biocompatibility testing... includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Hemolysis, Genotoxicity - Mouse Lymphoma, Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation and Muscle Implantation (12-week)."

The data provenance is not explicitly stated in terms of country of origin. Given that it's a 510(k) submission to the FDA, the testing would generally be expected to comply with US regulatory standards, but the physical location of labs or studies isn't provided. The studies are prospective in nature, as they are specifically conducted to support this premarket notification.

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

This information is not applicable in this context. The "ground truth" for suture performance is established by recognized standards, specifically USP 35 (United States Pharmacopeia) for mechanical properties and ISO 10993-1 for biocompatibility. These standards define the acceptable range or nature of results for the device to be considered safe and effective. Expert consensus is not used to establish these fundamental criteria; rather, the tests are performed in accordance with these pre-defined, validated methodologies.

4. Adjudication Method for the Test Set:

Not applicable. The performance is measured against objective, quantitative standards (USP 35) or standardized test outcomes (ISO 10993-1). There is no "adjudication" in the sense of reconciling differing expert opinions, but rather a direct comparison of test results to predetermined acceptance limits.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study investigates human reader performance, typically with medical imaging or diagnostic devices. This device is a surgical suture, and its performance is evaluated through laboratory and preclinical (biocompatibility) testing, not by human readers interpreting data.

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

Not applicable. This is not an algorithmic or AI-based device. Its performance is inherent to the physical and chemical properties of the suture itself, measured through standalone laboratory and biocompatibility tests.

7. The Type of Ground Truth Used:

The ground truth used is primarily based on:

Established Standards: USP 35 for mechanical properties (diameter, tensile strength, needle attachment).
International Standards for Biocompatibility: ISO 10993-1 for biological safety.
Chemical Equivalence: Comparison of chemical characterization results of the raw materials to those of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable, as there is no training set for this type of device submission.

Summary

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510(k) Premarket Notification

Optilene Nonabsorbable Surgical Suture

JUL 15 2014

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

Aesculap Optilene Nonabsorbable Surgical Suture July 3. 2014

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

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Optilene Nonabsorbable Polypropylene/Polyethylene Surgical Suture is substantially equivalent to:

. Premilene Nonabsorbable Polypropylene Surgical Suture, Aesculap Inc. (K980703)
· Prolene Polypropylene Nonabsorbable Surgical Suture, Ethicon Inc. (N16374)
· USS Polypropylene Suture, United States Surgical (K050947/K010909/K954808)

The Optilene Nonabsorbable Polypropylene/Polyethylene Surgical Suture pledget is substantially equivalent to:

· PremiCron Nonabsorable PET Surgical Suture, Aesculap Inc. (K012201)

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 will be offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, $74.3045. The Optilene suture will be offered in diameters ranging from USP size 10-0 through 0 and with be available in a variety of cut lengths with or without needles attached. The Optilene sutures will also be offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are also available separately packaged six per pouch.

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INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}

As established in this submission, the Aesculap Optilene suture is a synthetic nonabsorbable monofilament surgical suture offered dyed in the same range of diameters and cut lengths that are substantially equivalent to other predicate devices cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics to its predicate devices through comparison in design, intended use, material composition, function and range of sizes.

Please see attached Substantial Equivalence table comparing the Optilene Nonabsorbable Polypropylene/Polyethylene Suture to the predicate devices.

PERFORMANCE DATA

As recommended by the FDA's Class II Special Control Guidance Document for Surgical Sutures, including mechanical testing in accordance to USP 35 and biocompatibility testing in accordance to ISO 10993-1 has been performed to demonstrate that the Optilene Nonabsorbable Suture is substantially equivalent to other predicate devices.

Tests were conducted for diameter, tensile strength, and needle attachment. All specifications were met. Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Hemolysis, Genotoxicity - Mouse Lymphoma, Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation and Muscle Implantation (12-week).

Testing demonstrated that the device is as safe, as effective, and performs as well as the predicate devices.

Additional chemical characterization testing and a biological risk assessment were conducted in order to evaluate the chemical equivalency of the polypropylene/polyethylene raw material. The results of this testing demonstrate that the Optilene Nonabsorbable Suture is substantially equivalent to the predicate devices.

The Optilene Nonabsorbable Suture is blister packed and sterilized by ethylene oxide. Accelerated aging data for the Optilene Nonabsorbable Suture has been generated to support this submission.

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10(k) Premarket Notification

Optilene Nonabsorbable Surgical Suture

Page 3 of 4

K#	Indications	Material	Dyed, Un-dyedColorant	Structure	Size	Physical:- Diameter- Length- NeedleAttachment- Tensile StrengthNeedles	Pledgets	Packaging	Sterilization
	Aesculap, Inc.Optilene NonabsorbableSuture
Pending	Indicated for use in all types ofgeneral soft tissueapproximation and/or ligation,including use in cardiovascular,ophthalmic, microsurgery andneural tissue.	95% polypropylene and 5%Polyethylene	Dyed, Un-dyedDyed[Phthalacyaninato(2-)] copper	Monofilament	10-0 through 0 (variouslengths)	with or w/out needles attachedwith or w/out pledgets attached		Oval HDPE support with anoval card fold card lid in atyvek peel pouch and polyester-polyethylenerephatalate film.	Ethylene Oxide (EO)
K980703	Aesculap, Inc.Premilene NonabsorbableSutureIndicated for use in all types ofgeneral soft tissueapproximation and ligation,including use in cardiovascular,ophthalmic, microsurgery andneural tissue.	Polypropylene	Un-dyed and Dyed[Phthalacyaninato(2-)] copper	Monofilament	11-0 through 2 (variouslengths)	with or w/out needles attached	N/A	Oval HDPE support with anoval card fold card lid in atyvek peel pouch and polyester-polyethylenerephatalate film.	Ethylene Oxide (EO)
K050947/K010909/K954808	USS PolypropyleneNonabsorbable SutureIndicated for use in general softtissue approximation and/orligation, including use incardiovascular, ophthalmic,and neurological surgery.	Polypropylene andPolyethylene	Un-dyed and DyedCopper phthalocyanine, CI74160	Monofilament	10-0 through 2 (variouslengths)	with or w/out needles attachedwith or w/out pledgets attached	polytetrafluoroethylene	Foil packaging in a secondouter peel-pack with paper andplastic film	Ethylene Oxide (EO)
N16374	Prolene PolypropyleneNonabsorbableIndicated for use in general softtissue approximation and/orligation, including use incardiovascular, ophthalmic,and neurological surgery.	Polypropylene	Un-dyed and DyedCopper phthalocyanine, Cl74160	Monofilament	10-0 through 1 (variouslengths)	with or w/out needles attachedwith or w/out pledgets attached	polytetrafluoroethylene	Oval HDPE support with anoval card fold card lid in atyvek peel pouch and polyester-polyethylenerephatalate film.	Ethylene Oxide (EO)
						All characteristics meet USPRequirements.
						All characteristics meet USPRequirements
						All characteristics meet USPRequirements, except fordiameter.
						All characteristics meet USPRequirements
						300-series stainless steel
						300 or 455 series stainless steel
						300-series stainless steel andtungsten-rhenium

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510(k) Premarket Notificatio

・

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K#
	Aesculap, Inc.Optilene Nonabsorbable Suture	Aesculap, Inc.PremiCron Nonabsorbable Suture
Indications	PendingIndicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.	K980703Indicated for use in all types of general soft tissue approximation and ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.
Material	95% polypropylene and 5% Polyethylene	poly(ethylene terephthalate)
Dyed, Un-dyed	Dyed	Un-dyed and Dyed
Colorant	[Phthalacyaninato(2-)] copper	D&C Green no. 6
Structure	Monofilament	Multifilament
Size	10-0 through 0 (various lengths)with or w/out needles attachedwith or w/out pledgets attached	8-0 through 5 (various lengths)with or w/out needles attachedwith or w/out pledgets attached
Physical:- Diameter- Length- Needle Attachment- Tensile Strength	All characteristics meet USP Requirements.	All characteristics meet USP Requirements
Needles	300-series stainless steel	300 or 400 series stainless steel
	polytetrafluoroethylene	polytetrafluoroethylene
Pledgets
Packaging	Oval HDPE support with an oval card fold card lid in a tyvek peel pouch and polyester-polyethylenerephatalate film.	Oval HDPE support with an oval card fold card lid in a tyvek peel pouch and polyester-polyethylenerephatalate film.
Sterilization	Ethylene Oxide (EO)	Ethylene Oxide (EO)

1000

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 15, 2014

Aesculap® Incorporated Ms. Kathy A. Racovsky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K133890

Trade/Device Name: Aesculap Optilene Nonabsorbable Surgical Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW Dated: June 11, 2014 Received: June 12, 2014

Dear Mr. Racovsky:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kathy A. Racovsky

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fdagov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133890

Device Name

Aesculup Optilene Nonahsorbable Surgical Suture

Indications for Use (Describe)

Optilene Nonabsorbable Polypropylene 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.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Peter L. Hudson -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the rime to review instructions, search exisling data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.