Aesculap Optilene Nonabsorbable Suture

K180321 · Aesculap, Inc. · GAW · Mar 7, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180321
• Device Name: Aesculap Optilene Nonabsorbable Suture
• Applicant: Aesculap, Inc.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Mar 7, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Optilene is a sterile, nonabsorbable monofilament surgical suture composed of 95% polypropylene and 5% polyethylene. It is available with or without 300-series stainless steel needles and may be used with PTFE pledgets. The device is used by surgeons in clinical settings for soft tissue approximation and ligation. The suture provides mechanical support to hold tissue edges together during healing. This submission extends the existing product line (K133890) to include USP sizes 1 and 2 and increases the maximum length to 240 cm.

Clinical Evidence

Bench testing only. Testing verified conformance to USP 40 monographs for nonabsorbable sutures, specifically USP <861> (Diameter), USP <881> (Tensile Strength), and USP <871> (Needle Attachment). Materials were evaluated per ISO 10993-1.

Technological Characteristics

Monofilament suture composed of 95% polypropylene and 5% polyethylene. Dyed with [Phthalacyaninato(2-)] copper (21 CFR 74.3045). Sizes USP 10-0 to 2. Lengths 8 cm to 240 cm. Needles: 300 series stainless steel. Pledgets: 100% PTFE. Sterilization: Ethylene Oxide (EO). Packaging: HDPE support, Tyvek peel pouch, polyester-polyethylene terephthalate film.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in cardiovascular, ophthalmic, microsurgery, and neural tissue applications.

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

• Optilene Nonabsorbable Surgical Suture (K133890)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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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Special 510(k) Premarket Notification

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

Aesculap Monosyn Synthetic Absorbable Surgical Suture February 5, 2018

| 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>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

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.

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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.

## 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.<br>Optilene Nonabsorbable Surgical<br>Suture | Aesculap, Inc.<br>Optilene Nonabsorbable Surgical<br>Suture |
|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| K# | Predicate device (K133890) | Proposed device |
| Indications | Indicated for use in all types of general<br>soft tissue approximation and/or ligation,<br>including use in cardiovascular,<br>ophthalmic, microsurgery and neural<br>tissue. | 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 attached<br>with or w/out oledgets attached | same<br>same |
| Thread length | -8 cm to 150 cm<br>-ligature reels oflon•er len""h | -8 cm to 240 cm<br>-li!!ature reels of lon.2'.er len£Jth |
| Physical:<br>- Diameter<br>- Length<br>- Needle Attachment<br>- 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 card<br>fold card lid in a tyvek peel pouch and<br>oolvester-oolvethylene tereohatalate film. | Same |
| Sterilization | Ethylene Oxide (EO) | Same |

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Special 510(k) Premarket Notification

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#### 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.