AESCULAP MONOMAX ABSORBABLE SUTURE

K100876 · Aesculap, Inc. · NWJ · Jul 14, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100876
• Device Name: AESCULAP MONOMAX ABSORBABLE SUTURE
• Applicant: Aesculap, Inc.
• Product Code: NWJ · General, Plastic Surgery
• Decision Date: Jul 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4494
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MonoMax absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Device Story

Aesculap MonoMax is a sterile, monofilament, absorbable surgical suture composed of poly-4-hydroxybutyrate. Available in sizes 2 through 5-0, with or without attached needles, and in undyed or D&C Violet No. 2 dyed configurations. Used by surgeons for soft tissue approximation and ligation. Device functions as a mechanical support for tissue healing, eventually resorbing in the body. Performance relies on material properties and mechanical strength.

Clinical Evidence

Bench testing performed per FDA Class II Special Control Guidance for Surgical Sutures. Includes mechanical testing (USP 28), biocompatibility (ISO 10993-1), and animal studies to characterize resorption profile. No human clinical trial data provided; substantial equivalence supported by bench and animal performance data.

Technological Characteristics

Monofilament absorbable suture; material: poly-4-hydroxybutyrate. Sizes: 2, 1, 0, 2-0, 3-0, 4-0, 5-0. Available undyed or dyed with D&C Violet No. 2 (21 CFR 74.3602). Sterile. Mechanical properties tested per USP 28; biocompatibility per ISO 10993-1.

Indications for Use

Indicated for general soft tissue approximation and/or ligation. Contraindicated for cardiovascular, neurological, microsurgical, or ophthalmic procedures.

Regulatory Classification

Identification

An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).

Predicate Devices

• TephaFLEX® Absorbable Suture (K082178/K081099/K052225)

Submission Summary (Full Text)

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| B. 510(k) SUMMARY (as required by 21 CFR 807.92) | JUL 14 2010 |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| | Aesculap® MonoMax Absorable Suture<br>July 13, 2010 |
| 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® MonoMax Poly(hydroxybutyrate) Absorbable Suture |
| COMMON NAME: | Poly(hydroxybutyrate) Absorbable Suture |
| CLASSIFICATION NAME: | Absorbable poly(hydroxybutyrate) surgical suture |
| REGULATION NUMBER: | 878.4494 |
| PRODUCT CODE: | NWJ |

### SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the MonoMax Absorbable Suture is substantially equivalent to the TephaFLEX® Absorbable Suture (K082178/K081099/K052225).

### DEVICE DESCRIPTION

The Aesculap® MonoMax Absorbable Sutures are sterile, monofilament, absorbable surgical sutures constructed of poly-4-hydroxybutyrate. The MonoMax sutures will be offered in sizes 2, 1, 0, 2-0, 3-0, 4-0, and 5-0. The sutures will be available in a variety of cut lengths with or without needles attached. The sutures will be available undyed, and dyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, 74.3602.

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K100876 pg. 2 of 2

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#### INDICATIONS FOR USE

MonoMax absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

## TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

The MonoMax sutures are offered in the same range of sizes as the predicate devices. The material used for the MonoMax sutures is the same as that used to manufacture the predicate devices.

#### PERFORMANCE DATA

Testing was performed in accordance to FDA's Class II Special Control Guidance Document for Surgical Sutures, including mechanical testing in accordance to USP 28, biocompatibility testing in accordance to ISO 10993-1, and animal testing to demonstrate the resorption profile of the device. All specifications were met apart from diameter. Please reference K082178 for performance data, which were collected by Tepha, Inc. for the predicate device, that were used to support the substantial equivalence of the MonoMax suture device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is in a simple, sans-serif font.

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

Aesculap® Inc. % Ms. Kathy A. Rocosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

# JUL 1 4 2010

Re: K100876

Trade/Device Name: Aesculap® MonoMax Absorable Suture Regulation Number: 21 CFR 878.4494 Regulation Name: Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology. Regulatory Class: II

Product Code: NWJ Dated: June 15, 2010 Received: June 16, 2010

Dear Ms. Rocosky:

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

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Page 2 .- Ms. Kathy A. Rocosky

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerel yours.

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .

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MonoMax Absorbable Suture

Page 1 of 1

1008740 Pg. 1 of

#### INDICATIONS FOR USE STATEMENT A.

510(k) Number:

Device Name: Aesculap® MonoMax Absorable Suture

×

#### Indications for Use:

MonoMax absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Prescription Use __

__ and/or Over-the-Counter Use

(per 21 CFR 801.109)

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED). Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane for Mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100876