PERIPATCH ENDO-SLEEVE

K063556 · Pm Devices, Inc. · FTM · Mar 20, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063556
• Device Name: PERIPATCH ENDO-SLEEVE
• Applicant: Pm Devices, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Mar 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PeriPatch Aegis is intended for reinforcing staples and suture lines during a number of resection techniques - surgical repair of tissue deficiencies such as: - Lung resections . - Biopses . - Lobectomies - Gastric banding - Abdominal and thoracic wall repair

Device Story

PeriPatch Aegis is a surgical mesh device designed to reinforce staple lines during endoscopic stapling procedures. The device assembly comprises a strip of buttress material, a cartridge for mating with an endoscopic stapler, and a loader to assist in placement. Used in clinical settings (OR) by surgeons during resection techniques and tissue repair. The buttress material provides mechanical reinforcement to staple lines, potentially reducing tissue trauma or leakage at the site of resection. No complex electronics or software involved.

Clinical Evidence

Bench testing only. Tissue functional testing was conducted in accordance with the Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh to demonstrate suitable material properties.

Technological Characteristics

Surgical mesh device consisting of a buttress material strip, endoscopic stapler cartridge, and loader. Mechanical reinforcement device; no energy source or software. Materials and design characteristics are similar to predicate devices.

Indications for Use

Indicated for patients undergoing resection techniques or surgical repair of tissue deficiencies, including lung resections, biopsies, lobectomies, gastric banding, and abdominal/thoracic wall repair, requiring staple or suture line reinforcement.

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

• PeriPatch Sleeve (K033985)
• Peri-Strips Staple Line Reinforcement - Sleeve Configuration (K992537)

Submission Summary (Full Text)

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## 510(k) Summary of Safety & Effectiveness

Submitter:

PM Devices Inc. 13700 Mayfield Place, Unit 2135 Richmond, British Columbia V6V 2E4 Canada Phone: [phone] Fax: [phone]

Contact Person: Tim Verspagen

Device Name: PeriPatch Aegis

Common Name: Surgical Mesh

Classification Name: Surgical Mesh (Product Code: FTM)

Predicate Devices:

2) Peri-Strips Staple Line Reinforcement - Sleeve Configuration (K992537)

Device Description:

Intended Use:

Technological Comparison &

Performance Data:

The PeriPatch Aegis is intended be used as a surgical patch reinforce surgical staples during material to stapling procedures. The PeriPatch Aegis device assembly consists of a strip of buttress material, a cartridge which mates the device to the endoscopic stapler, and finally a loader which assists the user to place the device on to the stapler.

The PeriPatch Endo-Sleeve is intended for reinforcing staples and suture lines during a number of resection techniques surgical repair of tissue deficiencies such as:

- Lung resections .
1) PeriPatch Sleeve (K033985)

- Biopses .
- Lobectomies .
- Gastric banding .
- Abdominal and thoracic wall repair

Tissue functional testing was carried out in accordance with the Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh. The test results demonstrate suitable material properties for the indications of the device.

The PeriPatch Aegis is substantially equivalent to the predicate devices as it has similar indications for use, similar materials and similar technological characteristics.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PM Devices, Inc. % Mr. Tim Verspagen Regulatory Affairs Director 13700 Mayfield Place, Unit 2135 Richmond, British Columbia V6V 2E4 Canada

Re: K063556

Trade/Device Name: PeriPatch Aegis Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: February 23, 2007 Received: February 26, 2007

MAR 2 0 2007

Dear Mr. Verspagen:

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

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Page 2 -- Mr. Tim Verspagen

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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/industry/support/index.html.

Sincerely yours

Mark N. Mallery

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

Enclosure

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## Statement of Indications for Use

510(k) Number (if known): K063556

Device Name: PeriPatch Aegis

Indications for Use:

The PeriPatch Aegis is intended for reinforcing staples and suture lines during a number of resection techniques - surgical repair of tissue deficiencies such as:

- Lung resections .
- Biopses .
- Lobectomies
- Gastric banding
- Abdominal and thoracic wall repair

Over-The-Counter Use _ X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General, Restorative,<br>and Neurological Devices | |
| 510(k) Number | 1063556 |