XYLOS POROUS SURGICAL MESH

K090880 · Xylos Corporation · FTM · May 27, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090880
• Device Name: XYLOS POROUS SURGICAL MESH
• Applicant: Xylos Corporation
• Product Code: FTM · General, Plastic Surgery
• Decision Date: May 27, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Xylos® Porous Surgical Mesh is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. Xylos® Porous Surgical Mesh is intended for one-time use.

Device Story

Xylos® Porous Surgical Mesh is a sterile, non-resorbable implant composed of solvent-dehydrated, microbial-derived cellulose. The device is used by surgeons to reinforce soft tissue during various reconstructive procedures, including hernia repair and pelvic floor reconstruction. The device is manufactured via a cleaning and dehydration process, followed by an additional perforation step to increase porosity. Sterilization is achieved via gamma irradiation. The mesh is provided in sterile double-pouched packaging for single-use implantation. It functions as a structural scaffold for soft tissue reinforcement.

Clinical Evidence

Bench testing only. Verification and validation tests confirmed the device met all acceptance criteria.

Technological Characteristics

Non-resorbable microbial-derived cellulose mesh. Sterile, single-use. Modified via perforation process to increase porosity. Sterilized by gamma irradiation.

Indications for Use

Indicated for soft tissue reinforcement in patients requiring repair of abdominal/thoracic wall defects, muscle flap reinforcement, prolapse repair, pelvic floor reconstruction, hernia repair, or suture-line reinforcement. Intended for one-time use.

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)

Submission Summary (Full Text)

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Xylos® Porous Surgical Mesh

2090880 2 Special 510(k) Premarket Application

# Section 6: 510(k) Summary

MAY 27 2009

#### 510(k) Summary

- Applicant: Xylos Corporation Joyce Elkins 838 Town Center Drive Langhorne, PA 19047 Xylos Corporation US Contact: Joyce Elkins 838 Town Center Drive Langhorne, PA 19047 Phone: [phone] ext. 642 Facsimile: 215-741-4804 [e-mail] Manufacturing/ Xylos Corporation Distribution Address: 838 Town Center Drive Langhorne, PA 19047
# Establishment Registration Number: N/A

| Date submitted: | March 30, 2009<br>(Section 6: 510(k) Summary was revised and re-<br>submitted on May 18, 2009) |
|------------------------|------------------------------------------------------------------------------------------------|
| Proprietary Name: | Xylos® Porous Surgical Mesh |
| Common Name: | Surgical Mesh |
| Classification Status: | Class II |
| Product Codes: | FTM |
| Predicate Device: | Xylos Surgical Mesh (K081882) |

#### Device Description:

Xylos® Porous Surgical Mesh is a sterile, non-resorbable product composed of

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solvent-dehydrated, microbial-derived cellulose. The implantable unit is presented in sterile double-pouched packages for appropriate removal in preparation for surgery.

Processing: The microbial derived cellulose undergoes a strict quality controlled procedure that involves thorough cleaning and dehydration. The process leaves no harmful residue. Assurance of sterility is maintained with the validated dose range of gamma irradiation having no adverse effect on the biomechanical property of the device.

### Indications for Use:

Xylos® Porous Surgical Mesh is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. Xylos® Porous Surgical Mesh is intended for one-time use.

#### Summary of Technological Characteristics:

The process modification to the Xylos Surgical Mesh since its previous clearance in K081882 is an additional processing step increasing porosity of the finished product. In addition, the name was changed to Xylos® Porous Surgical Mesh in this submission to distinguish it from Xylos Surgical Mesh. These modifications do not affect the safety or performance of the device and do not change the intended use of the Xylos Surgical Mesh.

### Summary of Nonclinical Testing:

The verification and validation tests that were performed confirmed that the Xylos® Porous Surgical Mesh met the acceptance criteria. Therefore the device should perform as intended.

# Substantial Equivalence Discussion:

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Xylos® Porous Surgical Mesh

As shown in the verification and validation testing, the additional perforation processing step of the Xylos® Porous Surgical Mesh does not change the intended use nor affect the safety and effectiveness as compared to the Xylos Surgical Mesh previously cleared in K081882.

# Conclusion:

The modified Xylos® Porous Surgical Mesh has the following similarities to the Xylos Surgical Mesh previously cleared in K081882:

- . has the same indicated use,
- . has the same operating principle,
- incorporates the same basic device design and physical properties, .
- is manufactured identically except for an additional perforation process prior . to packaging, and
- incorporates the same materials. .

Therefore the modification to the Xylos® Porous Surgical Mesh can be found substantially equivalent to the Xylos Surgical Mesh cleared in K081882.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

MAY 27 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Xylos Corporation % Ms. Joyce Elkins Director RA/QA 838 Town Center Drive Langhorne, Pennsylvania 19047

Re: K090880

Trade/Device Name: Xylos® Porous Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: May 11, 2009 Received: May 13, 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.

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

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Page 2 - Ms. Joyce Elkins

[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 Dulo Vm D.Frios.

Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Xylos® Porous Surgical Mesh

Special 510(k) Premarket Application

# Section 5: Indications for Use Statement Indications for Use

510(k) Number (if known): KOGOSSO

Device Name:

:

Xylos® Porous Surgical Mesh

Indications for Use: This device is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dainl Krone by MXM

(Division Sign-Off Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number. Km09880

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Xylos Corporation March 30, 2009