ATRICLIP GILLINOV-COSGROVE LAA CLIP

K131107 · AtriCure, Inc. · FZP · May 14, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131107
• Device Name: ATRICLIP GILLINOV-COSGROVE LAA CLIP
• Applicant: AtriCure, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: May 14, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AtriClip Gillinov-Cosgrove LAA Clip is indicated for the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Device Story

AtriClip Gillinov-Cosgrove LAA Clip is a sterile, single-use, self-closing implantable device designed for secure occlusion of the left atrial appendage (LAA). The clip is deployed using a reusable clip applier during open cardiac surgery. It applies uniform pressure across the LAA to ensure consistent, reproducible occlusion. The device is available in 35 mm, 40 mm, 45 mm, and 50 mm lengths to accommodate varying LAA sizes. The modification in this submission involves individual packaging of the clip for loading onto the reusable applier. The device is intended for use by cardiac surgeons in an operating room setting.

Clinical Evidence

No clinical data. Bench testing was conducted to confirm that the new packaging adequately protects the device during shipment. Biocompatibility testing was previously conducted in accordance with ISO 10993-1.

Technological Characteristics

Implantable clip; self-closing mechanism; available in 35, 40, 45, and 50 mm lengths. Materials are unchanged from the predicate and comply with ISO 10993-1 for biocompatibility. Sterile, single-use implant; reusable applier. No software or electronic components.

Indications for Use

Indicated for occlusion of the left atrial appendage in patients undergoing open cardiac surgical procedures, performed under direct visualization.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip (K093679)
• AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip (K122276)

Submission Summary (Full Text)

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< 13 110 7

### 510(k) Summary

General Information

MAY 1 4 2013

| Classification | Class 2 |
|---------------------|-------------------------------------------------------|
| Trade name | AtriClip™ Gillinov-Cosgrove™ LAA Clip |
| Common name | Implantable Clip |
| Classification Name | Clip, Implantable (21 CFR 878.4300, Product Code FZP) |
| Manufacturer | AtriCure, Inc. |
| | 6217 Centre Park Dr. |
| | West Chester, OH 45069 |
| | P: 513-755-4100 |
| | F: 513-755-4108 |
| Contact | Rebecca Walters, RAC |
| | Regulatory Affairs Manager |

Date of Submission April 17, 2013

#### Intended Use

The AtriClip Gillinov-Cosgrove LAA Clip is indicated for the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

#### Cleared Device

The device proposed for modification in this submission is the AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip cleared via 510(k) K093679 on June 10, 2010 and K122276 on August 29, 2012.

#### Device Description

The AtriClip Gillinov Cosgrove LAA Clip is a single use, sterile, self-closing, implantable Clip to be deployed with a Reusable Clip Applier. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. This Special 510(k) does not include any changes to the Clip.

This Special 510(k) includes modifications to package the Clip individually to be loaded on a Reusable Clip Applier.

#### Materials

There are no changes to materials of the Clip. All materials in the Clip are suitable for their Testing was conducted in accordance with ISO 10993-1 to ensure appropriate intended use. biocompatibility of all materials.

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#### Testing

The Clip was tested to confirm new packaging of the Clip adequately protects the device during shipment. Complete Design Control testing for the Clip was previously included in the original 510(k) K093679.

#### Summary of Equivalence

The AtriClip Gillinov-Cosgrove LAA Clip is equivalent to the previously cleared AtriClip LAA Exclusion System as there is no change to indications for use/intended use, the implant Gillinov-Cosgrove Clip, or the basic design of the Clip and Clip Applier configuration. The modifications do not affect the ability of the Clip to be successfully deployment on the LAA,

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting and promoting the health and well-being of Americans. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 14, 2013

AtriCure, Inc. Rebecca Walters Regulatory Affairs Manager 6217 Centre Park Drive West Chester, OH 45069

Re: K131107

Trade/Device Name: AtriClip™ Gillinov-Cosgrove™ LAA Clip Regulation Number: 21 CFR 870.4300 Regulation Name: Clip, Implantable Regulatory Class: Class II Product Code: FZP Dated: April 17, 2013 Received: April 19, 2013

Dear Ms. Walters:

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 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 - Ms. Rebecca Walters

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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

## Matthew Gallillebrenner

D

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) _K131107

Device Name: AtriClip Gillinov-Cosgrove LAA Clip

Indications for Use:

The AtriClip Gillinov-Cosgrove Clip is indicated for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Prescription Use ਮ (Part 21 CRF 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Matthew G. Hillebrenner