AESCULAP OPTILENE NONABSORBABLE SUTURE

K133890 · Aesculap, Inc. · GAW · Jul 15, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133890
• Device Name: AESCULAP OPTILENE NONABSORBABLE SUTURE
• Applicant: Aesculap, Inc.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Jul 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Optilene is a sterile, nonabsorbable monofilament surgical suture composed of 95% polypropylene and 5% polyethylene. Available in USP sizes 10-0 through 0, with or without attached needles and optional PTFE pledgets. Used by surgeons in clinical settings for soft tissue approximation and ligation. Device provides mechanical wound closure; performance verified via tensile strength, diameter, and needle attachment testing per USP standards. Biocompatibility confirmed via ISO 10993-1 testing. Sterilized via ethylene oxide.

Clinical Evidence

No clinical data. Bench testing only. Mechanical testing (diameter, tensile strength, needle attachment) performed per USP 35. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, intracutaneous irritation, hemolysis, genotoxicity (Mouse Lymphoma, Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation), and 12-week muscle implantation. Chemical characterization and biological risk assessment supported material equivalency.

Technological Characteristics

Synthetic nonabsorbable monofilament suture; 95% polypropylene/5% polyethylene. Dyed with [Phthalacyaninato(2-)] copper (21 CFR 74.3045). Sizes 10-0 to 0. Optional PTFE pledgets. Sterilized via ethylene oxide. Mechanical specs meet USP 35. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in patients requiring cardiovascular, ophthalmic, microsurgical, or neural procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Premilene Nonabsorbable Polypropylene Surgical Suture (K980703)
• Prolene Polypropylene Nonabsorbable Surgical Suture (N16374)
• USS Polypropylene Suture (K050947/K010909/K954808)

Reference Devices

• PremiCron Nonabsorbable PET Surgical Suture (K012201)

Submission Summary (Full Text)

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510(k) Premarket Notification

Optilene Nonabsorbable Surgical Suture

# JUL 15 2014

Page 1 of 4

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

Aesculap Optilene Nonabsorbable Surgical Suture July 3. 2014

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky<br>610-984-9291 (phone)<br>610-791-6882 (fax)<br>[e-mail] |
| 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

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.

### 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-dyed<br>Colorant | Structure | Size | Physical:<br>- Diameter<br>- Length<br>- Needle<br>Attachment<br>- Tensile Strength<br>Needles | Pledgets | Packaging | Sterilization |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------|--------------|-------------------------------------|------------------------------------------------------------------------------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------|
| | Aesculap, Inc.<br>Optilene Nonabsorbable<br>Suture | | | | | | | | |
| Pending | Indicated for use in all types of<br>general soft tissue<br>approximation and/or ligation,<br>including use in cardiovascular,<br>ophthalmic, microsurgery and<br>neural tissue. | 95% polypropylene and 5%<br>Polyethylene | Dyed, Un-dyed<br>Dyed<br>[Phthalacyaninato(2-)] copper | Monofilament | 10-0 through 0 (various<br>lengths) | with or w/out needles attached<br>with or w/out pledgets attached | | Oval HDPE support with an<br>oval card fold card lid in a<br>tyvek peel pouch and polyester-<br>polyethylenerephatalate film. | Ethylene Oxide (EO) |
| K980703 | Aesculap, Inc.<br>Premilene Nonabsorbable<br>Suture<br>Indicated for use in all types of<br>general soft tissue<br>approximation and ligation,<br>including use in cardiovascular,<br>ophthalmic, microsurgery and<br>neural tissue. | Polypropylene | Un-dyed and Dyed<br>[Phthalacyaninato(2-)] copper | Monofilament | 11-0 through 2 (various<br>lengths) | with or w/out needles attached | N/A | Oval HDPE support with an<br>oval card fold card lid in a<br>tyvek peel pouch and polyester-<br>polyethylenerephatalate film. | Ethylene Oxide (EO) |
| K050947/K010909/K954808 | USS Polypropylene<br>Nonabsorbable Suture<br>Indicated for use in general soft<br>tissue approximation and/or<br>ligation, including use in<br>cardiovascular, ophthalmic,<br>and neurological surgery. | Polypropylene and<br>Polyethylene | Un-dyed and Dyed<br>Copper phthalocyanine, CI<br>74160 | Monofilament | 10-0 through 2 (various<br>lengths) | with or w/out needles attached<br>with or w/out pledgets attached | polytetrafluoroethylene | Foil packaging in a second<br>outer peel-pack with paper and<br>plastic film | Ethylene Oxide (EO) |
| N16374 | Prolene Polypropylene<br>Nonabsorbable<br>Indicated for use in general soft<br>tissue approximation and/or<br>ligation, including use in<br>cardiovascular, ophthalmic,<br>and neurological surgery. | Polypropylene | Un-dyed and Dyed<br>Copper phthalocyanine, Cl<br>74160 | Monofilament | 10-0 through 1 (various<br>lengths) | with or w/out needles attached<br>with or w/out pledgets attached | polytetrafluoroethylene | Oval HDPE support with an<br>oval card fold card lid in a<br>tyvek peel pouch and polyester-<br>polyethylenerephatalate film. | Ethylene Oxide (EO) |
| | | | | | | All characteristics meet USP<br>Requirements. | | | |
| | | | | | | All characteristics meet USP<br>Requirements | | | |
| | | | | | | All characteristics meet USP<br>Requirements, except for<br>diameter. | | | |
| | | | | | | All characteristics meet USP<br>Requirements | | | |
| | | | | | | 300-series stainless steel | | | |
| | | | | | | 300 or 455 series stainless steel | | | |
| | | | | | | 300-series stainless steel and<br>tungsten-rhenium | | | |

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510(k) Premarket Notificatio

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| K# | | |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Aesculap, Inc.<br>Optilene Nonabsorbable Suture | Aesculap, Inc.<br>PremiCron Nonabsorbable Suture |
| Indications | Pending<br>Indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue. | K980703<br>Indicated 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)<br>with or w/out needles attached<br>with or w/out pledgets attached | 8-0 through 5 (various lengths)<br>with or w/out needles attached<br>with or w/out pledgets attached |
| Physical:<br>- Diameter<br>- Length<br>- Needle Attachment<br>- 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 [phone] or [phone] 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 [phone] or [phone] 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

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