ACCUMESH DEPLOYMENT SYSTEM

K130782 · Covidien, LLC · ORQ · Apr 5, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130782
• Device Name: ACCUMESH DEPLOYMENT SYSTEM
• Applicant: Covidien, LLC
• Product Code: ORQ · General, Plastic Surgery
• Decision Date: Apr 5, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair).

Device Story

Manual laparoscopic surgical instrument designed to facilitate hernia mesh delivery and placement during ventral hernia repair. Device consists of an operation handle and a deployment section connected by a tube; includes a furling sleeve to assist surgeons in tightly and rapidly furling mesh over the positioning system. Operated by surgeons in a laparoscopic clinical setting. The device functions as a mechanical delivery aid for soft tissue prosthetics. This specific submission introduces an orange ink colorant to the central distal shaft of the deployment frame; no changes to device function or core technological characteristics.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Manual laparoscopic instrument; consists of operation handle, deployment section, and furling sleeve. Modification involves addition of orange ink colorant to the central distal shaft of the deployment frame. No changes to materials or mechanical function.

Indications for Use

Indicated to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair).

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

• Accumesh Positioning System (PatchAssist) (K101218)
• Accumesh Positioning System PatchAssist Large (K103269)
• AccuMesh Positioning System (K123066)

Submission Summary (Full Text)

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## K 130782

AccuMesh Positioning System

### 4.0 510(K) SUMMARY

Covidien

APR 5 2013

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.

#### Submitter Information

| Name: | Covidien |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 15 Crosby Drive<br>Bedford, MA 01730 |
| Establishment Registration: | 9615742 |
| Name of contact person: | Jose Marquez<br>Regulatory Affairs Manager<br>Covidien<br>15 Crosby drive<br>Bedford, MA 01730 USA<br>Phone: [phone] |
| Date prepared: | March 20, 2013 |
| Trade or proprietary name: | AccuMesh™ Positioning System |
| Common or usual name: | Mesh Deployer |
| Classification name: | Mesh, Surgical, Deployer |
| Classification panel: | General and Plastic Surgery (79) |
| Regulation: | 21 CFR 878.3300 |
| Product Code: | ORQ |
| Legally marketed devices to which equivalence is claimed: | <ul><li>Accumesh Positioning System (510k cleared as the PatchAssist device - K101218</li><li>Accumesh Positioning System PatchAssist Large (510k cleared as the PatchAssist device - K103269</li><li>AccuMesh Positioning System - K123066</li></ul> |

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Covidien

#### AccuMesh Positioning System

#### Reason for 510(k) submission:

To obtain market clearance on the Accumesh Positioning System with a component color addition of an orange ink.

#### Device description:

Positioning System is a manual The AccuMesh laparoscopic surgical instrument intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. It is comprised of two main sections: operation handle and deployment section which are Included in the packaging connected via a tube. configuration is a furling sleeve intended to assist the surgeons to furl the mesh tightly and rapidly over the AccuMesh positioning system.

#### Intended use of the device:

Intended to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair).

Indications for use:

Indicated to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair).

#### Summary comparing the technological characteristics of the subject and predicate devices:

The proposed colorant addition is on the central distal shaft found on the deployment frame. The central distal shaft on the deployment frame or the frame, itself, has not changed and is previously cleared in the AccuMesh (PatchAssist) device (K101218, K103269, and K123066) 510(k)s. Accumesh is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair). There are no changes to the technological characteristics as a result of the proposed colorant addition.

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Image /page/2/Picture/0 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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: April 5, 2013

Covidien % Mr. Jose Marquez Regulatory Affairs Manager 15 Crosby Drive Bedford, Massachusetts 01730

Re: K130782

Trade/Device Name: AccuMesh™ Positioning System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: ORQ Dated: March 20, 2013 Received: March 21, 2013

Dear Mr. Marquez:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Jose Marquez

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Covidien

#### AccuMesh Positioning System

#### 3.0 INDICATION FOR USE STATEMENT

510(k) Number (if known): K130782

Device Name: AccuMesh™ Positioning System

Indications for Use: The AccuMesh Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

Prescription Use X (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)

## David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130782