AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip

K150996 · AtriCure, Inc. · FZP · Jun 17, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150996
• Device Name: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
• Applicant: AtriCure, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Jun 17, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AtriClip™ LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes performed by sternotomy (full or partial as well as thoracotomy (single or multiple).

Device Story

AtriClip LAA Exclusion System consists of sterile, single-use, self-closing implantable clip preloaded on disposable applier; used during open cardiac surgery. Surgeon operates device under direct visualization to occlude left atrial appendage (LAA). Clip applies uniform pressure to ensure secure occlusion; available in 35mm, 40mm, 45mm, and 50mm lengths. Device provides mechanical exclusion of LAA to potentially reduce risk of thrombus formation. Modification involves alternate raw material source for PET knit braid polyester used in implant.

Clinical Evidence

Bench testing only. Chemical characterization and in vitro biocompatibility screening were performed to verify equivalence of PET raw materials from different suppliers.

Technological Characteristics

Implantable clip and applier system. Materials include knit braided polyester (PET). Clip applies uniform pressure via self-closing mechanism. Available in 35-50 mm lengths. Single-use, sterile. No changes to sterilization or packaging.

Indications for Use

Indicated for occlusion of the left atrial appendage in patients undergoing open cardiac surgical procedures requiring direct visualization (sternotomy or thoracotomy).

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)
• AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip (K131107)
• AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip (K142120)

Submission Summary (Full Text)

{0}------------------------------------------------

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

June 17, 2015

Atricure, Inc. Brittany Lowe Regulatory Affairs 6217 Centre Park Drive West Chester, Ohio 45069

Re: K150996

> Trade/Device Name: Atriclip LAA Exclusion System with Preloaded Gillinov-cosgrove Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: June 1, 2015 Received: June 2, 2015

Dear Ms. Lowe:

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

{1}------------------------------------------------

Page 2 - Brittany Lowe

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 of medical devicerelated 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

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

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K150996

Device Name

Atriclip Laa Exclusion System With Preloaded Gillinov-cosgrove Clip

Indications for Use (Describe)

The AtriClip™ LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes performed by sternotomy (full or partial as well as thoracotomy (single or multiple).

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the AtriCure logo. The logo is in blue and orange. The word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot in the middle of the "C".

# 510(k) Summary

#### l. Submitter

| Manufacturer: | AtriCure, Inc.<br>6217 Centre Park Dr.<br>West Chester, OH 45069<br>P: 513-755-4100<br>F: 513-755-4108 |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Contact Person: | Brittany Lowe<br>Regulatory Affairs |
| Alternate Contact: | Jonathan McElwee, RAC<br>Senior Regulatory Specialist |
| Date Prepared: | 04/14/2015 |
| II.<br>Device | |
| Name of Device: | AtriClip™ LAA Exclusion System with preloaded Gillinov-Cosgrove Clip |
| Common Name: | Implantable Clip and Clip Applier |
| Classification Name: | Implantable Clip and Clip Applier (21 CFR 878.4300 and 4800) |
| Regulatory Class: | Class II |
| Product Code: | FZP |

#### lll. Predicate 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, K122276 on August 29, 2012, K131107 on May 14, 2013, and K142120 on August 28, 2014.

The predicate devices have not been subject to a design-related recall.

No reference devices were used in this submission.

### IV. Device Description

The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use 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.

The Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the Clip. This Special 510(k) contains manufacturing modifications to the proposed

{4}------------------------------------------------

AtriClip LAA Exclusion System intended to provide AtriCure with an alternate raw material source for the Polyethylene terephthalate (PET) of the knit braid polyester used in the AtriClip implant.

### V. Indications For Use

The AtriClip LAA Exclusion System is indicated for the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).

### VI. Comparison Of Technological Characteristics With The Predicate Device

- The devices have the same intended use and; .
- No changes were made in operating principle, or specifications of performance.
- The results of the verification and validation testing:
- Demonstrated equivalency in performance ■
- . Device biocompatibility remains unchanged
- . Did not raise any new issues of safety
- No changes were made to the labeling. ●
- No changes were required in packaging sterilization or expiration dating. ●

#### VII. Performance Data

Chemical characterization and in vitro biocompatibility screening testing was conducted to demonstrate equivalence of the knit braided polyester sourced from the various suppliers of PET raw material.

#### VIII. Conclusions

The modified AtriClip LAA Exclusion System is equivalent to the previously cleared AtriClip LAA Exclusion System as there is no change to intended use or the basic design of the Clip.