MTA PROTECTIVE SHEET

K090778 · Xylos Corporation · FTM · Apr 28, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090778
• Device Name: MTA PROTECTIVE SHEET
• Applicant: Xylos Corporation
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Apr 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MTA Protective Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and endoscopic procedures. MTA Protective Sheet is intended for one-time use.

Device Story

MTA Protective Sheet is a non-resorbable surgical mesh composed of microbial-derived cellulose; used for management and protection of tendon injuries where no substantial loss of tendon tissue has occurred. Device minimizes tissue attachment upon direct contact. Implanted during open or endoscopic surgical procedures by physicians. Provides physical barrier to protect tendon; intended for one-time use.

Clinical Evidence

Bench testing only. Performance testing included material property and suture pull-out testing to demonstrate biomechanical equivalence to the predicate device.

Technological Characteristics

Material: microbial-derived cellulose. Form factor: surgical mesh sheet. Sterilization: sterile double-pouched packaging. Biocompatibility: identical to Securian Tissue Reinforcement Matrix (K083823).

Indications for Use

Indicated for management and protection of tendon injuries without substantial loss of tendon tissue in patients undergoing open or endoscopic procedures.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• XYLOS® Surgical Mesh (K081882)
• MAST Biosurgery Ortho-Wrap™ Bioresorbable Sheet (K072190)

Reference Devices

• Securian Tissue Reinforcement Matrix (K083823)

Submission Summary (Full Text)

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K090778

510(k) Premarket Notification

# XYLOS Corporation

# Section 5: 510(k) Summary

APR 2 8 2009

The safety and effectiveness of MTA Protective Sheet is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.

| Sponsor: | Xylos Corporation<br>838 Town Center Drive<br>Langhorne, PA 19047 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Joyce Elkins<br>838 Town Center Drive<br>Langhorne, PA 19047<br>Phone: [phone] ext. 642<br>Facsimile: 215-741-4804<br>[e-mail] |
| Date of Submission: | March 20, 2009 |
| Proprietary Name: | MTA™ Protective Sheet |
| Common Name: | Surgical Mesh |
| Regulatory Class: | Class II |
| Product Codes: | FTM |
| Predicate Device(s): | XYLOS® Surgical Mesh, K081882<br>MAST Biosurgery Ortho-Wrap™ Bioresorbable Sheet,<br>K072190<br>(Ortho-Wrap™ is a Trademark of MAST Biosurgery, Inc.) |

### Device Description:

MTA Protective Sheet is composed of microbial-derived cellulose. The non-resorbable surgical mesh is used for the management and protection of tendon injuries. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The implantable device is presented in a sterile double-pouched package for appropriate removal in preparation for surgery.

CONFIDENTIAL

Page 13 of 36

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## Indications for Use:

The MTA Protective Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and endoscopic procedures. MTA Protective Sheet is intended for one-time use.

# Technological Characteristics and Substantial Equivalence:

The MTA Protective Sheet is biocompatible since it is biologically and chemically identical to Securian Tissue Reinforcement Matrix previously cleared in K083823 and very similarly manufactured. In addition, the MTA Protective Sheet has similar indications for use to Securian Tissue Reinforcement Matrix as released in K083823.

### Discussion of Performance Testing:

MTA Protective Sheet was subjected to various performance tests typical for its product code such as material property and suture pull out testing. Testing demonstrated its biomechanical equivalence to the predicate device, MAST Biosurgery Ortho-Wrap Bioresorbable Sheet. The MTA Protective Sheet met the test requirements, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.

## Conclusion:

MTA Protective Sheet is substantially equivalent to the previously cleared devices since it is:

- 1. Biologically and chemically identical and therefore has equivalent biocompatibility to the Securian Tissue Reinforcement as previously released in K083823.
- Biomechanically equivalent as demonstrated via the above bench performance testing to 2. MAST Biosurgery Ortho-Wrap Bioresorbable Sheet.

### CONFIDENTIAL

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2009

Xylos Corporation % Ms. Joyce Elkins Director Regulatory Affairs and Quality Assurance 838 Town Center Drive Langhorne, Pennsylvania 19047

Re: K090778

Trade/Device Name: MTA Protective Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: March 20, 2009 Received: March 23, 2009

Dear Ms. Elkins:

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 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 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 - Ms. Joyce Elkins

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours

for

Der

Mark N. Melkerso 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): KO90778

Device Name: MTA Protective Sheet

Indications For Use:

The MTA Protective Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and endoscopic procedures. MTA Protective Sheet is intended for one-time use.

Prescription Use × (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)

Daniel Krone for MXM

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

**510(k) Number** KD90778