MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE

K052437 · Surgical Specialties Corp · GAM · Nov 7, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052437
• Device Name: MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
• Applicant: Surgical Specialties Corp
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Nov 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Monoderm™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

Monoderm™ is a monofilament synthetic absorbable surgical suture composed of a copolymer of glycolide and e-caprolactone. Used by surgeons for soft tissue approximation and ligation. Device functions as a mechanical support for tissue healing; material undergoes absorption over time (dissolving in approximately 91 days). Performance verified through physical testing (diameter, needle attachment, tensile strength) and animal implant studies to confirm biocompatibility and absorption rates.

Clinical Evidence

Bench testing only. Physical testing performed per USP 27 standards (<861> Suture Diameter, <871> Suture Needle Attachment, <881> Tensile Strength). Animal testing performed for ISO 10993 biocompatibility and implant studies to demonstrate tensile strength retention and mass loss rates.

Technological Characteristics

Monofilament synthetic absorbable suture; copolymer of glycolide and e-caprolactone. Physical properties tested to USP 27 standards. Biocompatibility verified per ISO 10993. Class II device.

Indications for Use

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

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

• Ethicon's Monocryl (Poliglecaprone 25) (K930772)
• Surgical Specialties Corporation's Polyglytone 72 (K040477)

Submission Summary (Full Text)

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# NOV - 7 2005

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### 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY

| Submitter<br>Address: | Surgical Specialties Corporation<br>100 Dennis Drive<br>Reading, PA 19606 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:<br>Contact Person: | 610 404 1000, ext. 2231<br>Elizabeth Lazaro<br>Regulatory Affairs Specialist |
| Common /<br>Classification Name: | Surgical Suture<br>Absorbable, Synthetic |
| Name of Device: | Modified MonodermTM Monofilament,Synthetic Absorbable, Dyed<br>and/or Undyed sutures. |
| Indications for Use: | Indicated for use in general soft tissue approximation and/or ligation, but<br>not for use in cardiovascular or neurological tissues, microsurgery or<br>ophthalmic surgery. |
| Predicate Devices | Ethicon's Monocryl(Poliglecaprone 25) E caprolactone/Glycolide<br>510 (k) K930772 |
| | Surgical Specialties Corporation's (Polyglytone 72) Glycolide, and e-<br>caprolactone.<br>510 (k) K040477 |
| Device Description: | MonodermTM suture is a monofilament synthetic absorbable surgical<br>suture prepared from a copolymer of glycolide and e-caprolactone. |
| Performance Data: | Physical testing was performed on MonodermTM Synthetic, Absorbable<br>sutures to USP 27, including <861>Suture Diameter, <871>Suture<br>Needle Attachment,<881> Tensile Strength. Animal testing was<br>performed for conformance to ISO 10993 for biocompatibility and<br>implant studies to demonstrate rates of tensile strength and mass loss. |

Modified Monoderm™ Synthetic, Monofilame nt Absorbable Sutures Surgical Specialties Corporation

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052437

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

Technological Characteristics

Surgical Specialties Corporation's Monoderm™Synthetic, absorbable suture is made from a mixture of Glycolide/e-caprolactone. The material has been well characterized through absorption studies and biocompatibility studies. The product is similar to the predicate devices, Monoderm (Polyglactone 72) and Monocryl in that they are both made from a polymer blend of synthetic absorbable materials.

Equivalency:

Absorbable, Synthetic, Monofilament

Surgical Specialties Corporation's Monoderm sutures are made of a synthetic absorbable suture material, which will dissolve essentially in 91 days.

#### Ethicon`s

Monocryl sutures are made of synthetic absorbable suture material which will dissolve essentially between 91 and 119 days.

Modified Monoderm™ Synthetic Monofilament Absorbable Sutures Surgical Specialties Corporation

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three parallel lines representing health, services, and people. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2005

Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606

Re: K052437

Trade/Device Name: Monoderm™ Synthetic Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: September 2, 2005 Received: September 6, 2005

Dear Ms. Lazaro:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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### Page 2- Elizabeth Lazaro

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your maneting of your device to a legally premarket notification. THC PDF mising of cation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your acon 1000) 276-0115. Also, please note the regulation entitled, Colliact the Oritec of Compliance an (21 t retification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your respended its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Barbara Buehrig

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K052437 510(k) Number (if known):

Device Name: Monoderm™ Synthetic Absorbable Surgical Suture

Indications for Use:

Monoderm™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 X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Saubaie Mullins for Nixon

Division of General, Restorative, and Neurological Devices

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(k) Number K052437

510(k) Number