MONODERM

K040477 · Surgical Specialties Corp · GAM · May 18, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040477
• Device Name: MONODERM
• Applicant: Surgical Specialties Corp
• Product Code: GAM · General, Plastic Surgery
• Decision Date: May 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 synthetic, absorbable, monofilament surgical suture composed of a glycolide and e-caprolactone copolymer. The suture is coated with a mixture of caprolactone, glycolide, and glycolic acid. Used by surgeons in clinical settings for soft tissue approximation and ligation. The device provides temporary wound support during the healing process before being absorbed by the body. It functions as a mechanical fastener to hold tissue edges together, facilitating healing. It is a sterile, single-use device.

Clinical Evidence

No clinical data. Evidence consists of bench testing to USP 27 standards for suture diameter, needle attachment, and tensile strength, and animal studies to demonstrate biocompatibility per ISO 10993 and rates of tensile strength retention and mass loss.

Technological Characteristics

Material: Copolymer of glycolide and e-caprolactone; coating: caprolactone, glycolide, and glycolic acid. Form: Monofilament, synthetic, absorbable. Standards: USP 27 (physical testing), ISO 10993 (biocompatibility).

Indications for Use

Indicated for general soft tissue approximation and/or ligation in patients requiring surgical closure; contraindicated for cardiovascular, neurological, microsurgical, 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)
• U.S. Surgical's Caprosyn (Polyglytone 6211) (K013671)

Submission Summary (Full Text)

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## MAY 1 8 2004

Image /page/0/Picture/1 description: The image shows the logo for Surgical Specialties Corporation. The logo is in black and white and features the words "Surgical" and "Specialties" stacked on top of each other in a bold, sans-serif font. The word "CORPORATION" is written in a smaller font below the other two words. The image also contains the number "k040477" and the fraction "1/2" at the top.

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

| 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: | Coated Monoderm™ (Polyglactone 72) Monofilament, Synthetic<br>Absorbable, Dyed 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 |
| | U.S. Surgical's Caprosyn (Polyglytone 6211) Glycolide, caprolactone,<br>trimethylene carbonate and lactide.<br>510 (k) K013671 |
| Device Description: | Coated Monoderm™(Polyglactone 72) suture is a monofilament<br>synthetic absorbable surgical suture prepared from a copolymer of<br>glycolide and e-caprolactone. Coated Monoderm™ suture is prepared by<br>coating Monoderm™ suture with a mixture of caprolactone, glycolide<br>and glycolic acid. |
| Performance Data: | Physical testing was performed on Monoderm™Coated, Synthetic,<br>Absorbable sutures to USP 27, including <861>Suture Diameter,<br><871>Suture Needle Attachment,<881> Tensile Strength. Animal testing<br>was performed for conformance to ISO 10993 for biocompatibility and<br>implant studies to demonstrate rates of tensile strength and mass loss. |

Monoderm™ Coated, Synthetic, Monofilament Absorbable Sutures
Surgical Specialties Corporation

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Image /page/1/Picture/0 description: The image shows the logo for Surgical Specialties Corporation. The text "Surgical" is stacked on top of the text "Specialties". Below that is the word "CORPORATION". At the top of the image are the numbers "K040477" and "2/2".

## 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, Monocryl and Caprosyn, in that they are both made from a polymer blend of synthetic absorbable materials.

Equivalency: Absorbable, Synthetic, Monofilament

Coated Monoderm sutures are made of a synthetic absorbable suture material, which will dissolve essentially in 91 days.

Caprosyn sutures are made of synthetic absorbable sutures material, which will dissolve essentially in 56 days.

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

Monoderm™ Coated Synthetic Monofilament Absorbable Sutures Surgical Specialties Corporation

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the upper half of the circle.

MAY 1 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040477

Trade/Device Name: Monoderm™ Regulation Number: 21 CFR 878.4493 Regulation Name: Absorable poly(glycolide/1_lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: February 20, 2004 Received: February 24, 2004

Dear Ms. Lazaro:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roved your we your we 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 10 conniner of the 11th 11th 2011-11-11) 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 I ou may , ate , e visions of the Act include requirements for annual registration, listing of devices, good manufacturing practicc, 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 if your de rise to such additional controls. Existing major regulations affecting your device can may be sunyeet to back at Regulations, Title 21, Parts 800 to 898. In addition, I DA 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has mtatutes and regulations administered by other Federal agencies. You must or any I vatuall 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 CI K Futt 607); ideeming (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 - Ms. Elizabeth Lazaro

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in Jour e FDA finding of substantial equivalence of your device to a legally promation holicate device results in a classification 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincercly yours,

Miriam C. Provost

Fol Celia M. Witten, Ph.D., M.D. 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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Monoderm™

Indications For Use:

Monoderm™sutures are indicated for use in general soft tissue approximation and/or Monodemi ""sulures are indication for acc in yourological tissues, microsurgery or ophthalmic surgery.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number_________________________________________________________________