Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and mechanical properties of a surgical suture, with no mention of AI or ML.

Therapeutic

Yes
The device, a surgical suture, is used for soft tissue approximation and/or ligation, which are therapeutic interventions.

Diagnostic

No

Explanation: The device is a surgical suture used for tissue approximation and/or ligation, which are therapeutic procedures, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical surgical suture made of polyamide, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states "use in all types of general soft tissue approximation and/or ligation". This describes a device used within the body for surgical procedures, not a device used to test samples outside the body to diagnose conditions.
Device Description: The description details a surgical suture, a physical material used to close wounds or tie off vessels. This is consistent with a surgical device, not an IVD.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening

Therefore, the Dafilon Nonabsorbable Polyamide Surgical Suture is a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

GAR

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

General soft tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K990090, K133890

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/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" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, layered on top of each other.

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

1

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

2

Indications for Use

510(k) Number (if known) K151165

Device Name

Dafilon Nonabsorbable Polyamide Surgical Sutures

Indications for Use (Describe)

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.

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)

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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 Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky
610-984-9291 (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

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,

4

§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

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.

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

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	K151165- Page 3 of 3
	Aesculap, Inc.
Dafilon Nonabsorbable
Polyamide Suture	Aesculap, Inc.
Dafilon Nonabsorbable
Polyamide Suture	Aesculap, Inc.
Optilene Nonabsorbable
Suture
K#	K151165	K990090	K133890
Needles	300 or 400 series stainless
steel	300 or 400 series stainless
steel	300-series stainless steel
Packaging	Coated cardboard support
in double peel pouch. Inner
pouch composed of PET,
aluminum foil and LDPE
layers. Medical grade
paper and PET/LDPE
laminate outer pouch.
or
Coated cardboard support
in peel pouch. Medical
grade paper and PET/LDPE
laminate outer pouch.
or
PE suture support in a
PETG tray sealed with a
tyvek lid. Medical grade
paper and PET/LDPE
laminate outer pouch.	Oval coated cardboard
support in double peel
pouch. Inner pouch
composed of PET,
aluminum foil and LDPE
layers. Medical grade
paper and PET/LDPE
laminate outer pouch.	Oval HDPE support with an
oval card fold card lid in a
tyvek peel pouch and
polyester-
polyethylenerephatalate
film.
Sterilization	Gamma Irradiation or
Ethylene 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.