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, microsurgery and neurological procedures.

Device Description

Dafilon is a nonabsorbable monofilament surgical suture which is supplied sterile. Dafilon is composed of the long-chain aliphatic polymers polyamide 6 and/or 6,6. The Dafilon suture is offered undyed and dyed with FDA approved colorants Logwood extract in accordance with Title 21 CRF, §73.1410 or [Phthalocyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Dafilon suture will be offered in diameters ranging from USP size 11-0 through 5 and will be available in a variety of cut lengths with out needles attached.

AI/ML Overview

This document is a 510(k) premarket notification for a surgical suture, not a device that involves performance criteria typically associated with AI/ML algorithms or interpretative medical devices. Therefore, many of the requested sections regarding acceptance criteria and study design are not applicable in the context of this document. This submission primarily focuses on demonstrating substantial equivalence to existing predicate devices based on material composition, indications for use, and mechanical/biocompatibility testing, rather than an AI model's diagnostic or predictive performance.

However, based on the provided text, I can extract the relevant "acceptance criteria" and "performance data" for this suture device where applicable.

Here's an interpretation of the document in the context of your request, focusing on the available information:

Device: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture

Since this is a surgical suture, the "acceptance criteria" are related to its physical properties, sterility, and biocompatibility, rather than diagnostic accuracy or sensitivity/specificity of a predictive model.

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

Acceptance Criterion (Suture Device)	Reported Device Performance
Physical Characteristics:
Diameter	Meets USP Requirements.
Length	Meets USP Requirements.
Needle Attachment	Meets USP Requirements.
Tensile Strength	Meets USP Requirements.
Biocompatibility:
Cytotoxicity	Testing conducted. Results demonstrate safety and effectiveness.
Sensitization	Testing conducted. Results demonstrate safety and effectiveness.
Intracutaneous Irritation	Testing conducted. Results demonstrate safety and effectiveness.
Systemic and Muscle Implantation (4-week)	Testing conducted. Results demonstrate safety and effectiveness.
Material Equivalency:
Chemical Characterization (Polyamide raw material)	Results demonstrate substantial equivalence to predicate devices.
Sterilization & Shelf Life:
Sterilization (Gamma Irradiation or EO)	Validated.
Shelf Life (Accelerated Aging)	Data generated to support submission.

2. Sample size used for the test set and the data provenance

The document specifies "tests were conducted for diameter, tensile strength, and needle attachment" and "biocompatibility testing." However, it does not specify the sample sizes for these tests. The provenance is internal testing by Aesculap, Inc. against USP (United States Pharmacopeia) requirements and ISO (International Organization for Standardization) standards. The tests are likely prospective, conducted on manufactured samples of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to a nonabsorbable surgical suture device. The "ground truth" for suture performance is established by standardized physical and biological tests (USP, ISO standards), not by human expert interpretation or consensus in the way it would be for an AI diagnostic device.

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

Not applicable for a surgical suture. Adjudication methods are relevant for subjective interpretations of data, typically in diagnostic studies. Here, the "truth" is determined by objective measurements against established standards.

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 device is a surgical suture, not an AI-assisted diagnostic tool. No human reader involvement or AI assistance is relevant to its performance evaluation for this 510(k) submission.

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

Not applicable. This device is a physical medical device (suture), not an algorithm.

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

The "ground truth" is based on established industry standards and regulatory requirements:

USP Requirements: For physical characteristics such as diameter, length, needle attachment, and tensile strength.
ISO 10993-1: For biocompatibility testing (Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic and Muscle Implantation).
21 CFR §73.1410 and §74.3045: For colorant approval.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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

February 17, 2016

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

Re: K151165

Trade/Device Name: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable Polyamide Surgical Suture Regulatory Class: Class II Product Code: GAR Dated: January 8, 2016 Received: January 11, 2016

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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" (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.

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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Indications for Use

510(k) Number (if known) K151165

Device Name

Dafilon Nonabsorbable Polyamide Surgical Sutures

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)

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)

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K151165- Page 1 of 3

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

Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture February 12, 2016

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
510(k):	K151165
TRADE NAME:	Dafilon Nonabsorbable Polyamide Surgical Suture
COMMON NAME:	Nonabsorbable Polyamide Surgical Suture
CLASSIFICATION:	Class II
CLASSIFICATION NAME:	Suture, Nonabsorbable, Synthetic, Polyamide
REGULATION NUMBER:	878.5020
PRODUCT CODE:	GAR

PURPOSE FOR PREMARKET NOTIFICATION

The Dafilon Nonabsorbable Polyamide Surgical Suture described in this submission introduces Phthalocyaninato (2)-Copper as a colorant, two packaging types and extends the available suture length range from 3 cm to 250 cm to the existing product line Dafilon Nonabsorbable Polyamide Surgical Suture K990090.

PREDICATE DEVICE

Primary Predicate: Dafilon Nonabsorbable Polyamide Surgical Suture (K990090)
Aesculap Optilene Nonabsorbable Suture (K133890)

DEVICE DESCRIPTION

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§74.3045. The Dafilon suture will be offered in diameters ranging from USP size 11-0 through 5 and will be available in a variety of cut lengths with out needles attached.

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

As established in this submission, the Aesculap Dafilon suture is a synthetic nonabsorbable monofilament surgical suture offered undyed and 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. The device characteristics comparing the Dafilon Nonabsorbable Polyamide Surgical Suture to the predicate devices are summarized below.

	Aesculap, Inc.Dafilon Nonabsorbable	Aesculap, Inc.Dafilon Nonabsorbable	Aesculap, Inc.Optilene Nonabsorbable
	Polyamide Suture	Polyamide Suture	Suture
K#	K151165	K990090	K133890
Indications	Indicated for use in all	Indicated for use in all	Indicated for use in all
	types of general soft tissue	types of general soft tissue	types of general soft tissue
	approximation and/or	approximation and/or	approximation and/or
	ligation, including use in	ligation, including use in	ligation, including use in
	cardiovascular, ophthalmic,	cardiovascular, ophthalmic	cardiovascular, ophthalmic,
	microsurgery and	and neurological	microsurgery and neural
	neurological procedures.	procedures.	tissue.
Material	Polyamide 6 and/or	Polyamide 6 and/or	95% polypropylene and 5%
	polyamide 6,6	polyamide 6,6	Polyethylene
Dyed, Un-dyed	Un-dyed and Dyed	Un-dyed and Dyed	Dyed
Colorant	[Phthalocyaninato(2-)]	FD&C Blue no. 2 or	[Phthalocyaninato(2-)]
	copper or logwood extract	logwood extract	copper
Structure	Monofilament	Monofilament	Monofilament
Size	11-0 through 5 (various	11-0 through 6 (various	10-0 through 0 (various
	lengths)	lengths)	lengths)
	with or w/out needles	with or w/out needles	with or w/out needles
	attached	attached	attached
Thread length	-3 cm to 250 cm	-5 cm to 150 cm	-8cm to 150cm
	-ligature reels of longer	-ligature reels of longer	-ligature reels of longer
	length	length	length
Physical:
- Diameter	All characteristics meet	All characteristics meet	All characteristics meet
- Length	USP Requirements.	USP Requirements	USP Requirements.
- Needle Attachment
- Tensile Strength

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	K151165- Page 3 of 3
	Aesculap, Inc.Dafilon NonabsorbablePolyamide Suture	Aesculap, Inc.Dafilon NonabsorbablePolyamide Suture	Aesculap, Inc.Optilene NonabsorbableSuture
K#	K151165	K990090	K133890
Needles	300 or 400 series stainlesssteel	300 or 400 series stainlesssteel	300-series stainless steel
Packaging	Coated cardboard supportin double peel pouch. Innerpouch composed of PET,aluminum foil and LDPElayers. Medical gradepaper and PET/LDPElaminate outer pouch.orCoated cardboard supportin peel pouch. Medicalgrade paper and PET/LDPElaminate outer pouch.orPE suture support in aPETG tray sealed with atyvek lid. Medical gradepaper and PET/LDPElaminate outer pouch.	Oval coated cardboardsupport in double peelpouch. Inner pouchcomposed of PET,aluminum foil and LDPElayers. Medical gradepaper and PET/LDPElaminate outer pouch.	Oval HDPE support with anoval card fold card lid in atyvek peel pouch andpolyester-polyethylenerephatalatefilm.
Sterilization	Gamma Irradiation orEthylene Oxide (EO)	Gamma Irradiation	Ethylene Oxide (EO)

PERFORMANCE DATA

As recommended by the FDA's Class II Special Control Guidance Document for Surgical Sutures, including mechanical testing in accordance to USP 37 and biocompatibility testing in accordance to ISO 10993-1 has been performed to demonstrate that the Dafilon Nonabsorbable Suture is substantially equivalent to other predicate devices.

Tests were conducted for diameter, tensile strength, and needle attachment. All specifications were met. The Dafilon suture is considered an implant device, tissue/bone contact device of permanent duration (>30 days). In accordance with ISO 10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing," Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic and Muscle Implantation (4-week).

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

Additional chemical characterization testing was conducted in order to evaluate the chemical equivalency of the polyamide raw material. The results of this testing demonstrates that the Dafilon Nonabsorbable Suture is substantially equivalent to the predicate devices.

The Dafilon Nonabsorbable Polyamide Suture is blister packed and sterilized by either gamma Irradiation or Ethylene Oxide. Accelerated aging data for the Dafilon Nonabsorbable Suture has been generated to support this submission.

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.