AESCULAP NOVOSYN ABSORBABLE SUTURE

K122734 · Aesculap, Inc. · GAM · Dec 18, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K122734
• Device Name: AESCULAP NOVOSYN ABSORBABLE SUTURE
• Applicant: Aesculap, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Dec 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Novosyn sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

Device Story

Novosyn is a synthetic absorbable braided surgical suture; composed of 90% glycolide and 10% L-lactide (PGLA) copolymer; coated with 35/65 poly(glycolide-co-L-lactide) and calcium stearate. Supplied sterile in USP sizes 8-0 through 2; available undyed or dyed with D&C Violet No. 2. Used by clinicians for soft tissue approximation and ligation. Device provides mechanical support during healing before being absorbed by the body. Performance verified via mechanical testing (USP 34) and biocompatibility testing (ISO 10993-1).

Clinical Evidence

Bench testing only. Includes mechanical testing per USP 34 (diameter, tensile strength, needle attachment) and biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute systemic toxicity, hemolysis, genotoxicity, and 12-week muscle implantation). In-vitro and in-vivo resorption testing performed.

Technological Characteristics

Synthetic absorbable braided suture; material: 90/10 glycolide/L-lactide copolymer (PGLA); coating: 35/65 poly(glycolide-co-L-lactide) and calcium stearate; sizes: USP 8-0 to 2; sterile; non-electronic; mechanical device.

Indications for Use

Indicated for general soft tissue approximation and ligation, including ophthalmic procedures. Contraindicated for cardiovascular and neurological tissues.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, 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

• Safil Synthetic Absorbable Surgical Suture, Aesculap Inc. (K980704)
• Coated Vicryl (Polyglactin 910) Suture, Ethicon Inc. (K022269)

Submission Summary (Full Text)

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K122734

## DEC 1 8 2012

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

### Aesculap® Novosyn Absorbable Suture December 5, 2012

| 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® Novosyn Absorbable Suture |
| COMMON NAME: | Synthetic Polyglycolic Absorbable Suture |
| CLASSIFICATION NAME: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| REGULATION NUMBER: | 878.4493 |
| PRODUCT CODE: | GAM |

#### SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Novosyn Absorbable Suture is substantially equivalent to:

- Safil Synthetic Absorbable Surgical Suture, Aesculap Inc. (K980704) t
- Coated Vicryl (Polyglactin 910) Suture, Ethicon Inc. (K022269) .

## DEVICE DESCRIPTION

Novosyn is a synthetic absorbable braided surgical suture which is supplied sterile. Novosyn is composed of a copolymer made from 90% gylcolide and 10% L-lactide (PGLA). The Novosyn suture is coated with 35/65 poly(glycolide-co-L-lactide) and calcium stearate. The Novosyn suture will be offered undyed or dyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, §74.3206. The Novosyn suture will be offered in diameters ranging from USP size 8-0 through 2 and will be available in a variety of cut lengths with or without needles attached.

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K122734

#### INDICATIONS FOR USE

Novosyn sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

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

As established in this submission, the Aesculap Novosyn suture is a synthetic absorbable braided surgical suture offered undyed or 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.

### PERFORMANCE DATA

As recommended by the FDA's Class II Special Control Guidance Document for Surgical Sutures, including mechanical testing in accordance to USP 34. biocompatibility testing in accordance to ISO 10993-1, and in-vitro as well as in-vivo resorption testing has been performed to demonstrate that the Novosyn Absorable Suture is substantial equivalent to other predicate devices.

Tests were conducted for diameter, tensile strength, and needle attachment. All specifications were met apart from diameter. Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, Genotoxicity - Chromosomal Aberration and 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.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 18, 2012

Aesculap, Inc. % Ms. Kathy A. Racosky 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K122734

Trade/Device Name: Aesculap® Novosyn Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: December 05, 2012 Received: December 06, 2012

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kathy A. Racosky

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.fdagov/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT A.

510(k) Number: K122734

#### Device Name: Aesculap® Novosyn Absorbable Suture

#### Indications for Use:

Novosyn sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

X Prescription 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)

## David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K122734