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 procedures performed by sternotomy (full or partial as well as thoracotomy (single or multiple).

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. This Special 510(k) does not include any changes to the Clip.

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

AI/ML Overview

The provided text pertains to a 510(k) premarket notification for a medical device called the AtriClip™ LAA Exclusion System. This document is a regulatory filing and as such, it does not describe a clinical study in the typical scientific sense with acceptance criteria for device performance in patients, human reader studies, or detailed ground truth establishment.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical bench testing and animal model deployment testing. It aims to show that modifications to the clip applier (a delivery tool) do not negatively impact the performance of the actual implantable clip.

Therefore, I cannot provide a table of acceptance criteria for typical device performance metrics (like sensitivity, specificity, accuracy) or details about human reader studies, training sets, or adjudication methods, as these types of studies were not conducted or reported in this 510(k) summary.

However, I can extract the information related to the performance data and "acceptance criteria" as described in the context of a 510(k) submission, acknowledging that these are not clinical performance criteria.

Acceptance Criteria and Device Performance (Based on 510(k) Document)

The "acceptance criteria" in this context are interpreted as the successful demonstration that the modifications to the AtriClip Applier do not compromise the fundamental function of the system, particularly the successful deployment of the Clip.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (as implied by 510(k))	Stated Performance (from Document)
Clip Applier Modification Impact	Modifications to the Clip Applier (malleable aluminum alloy shaft, ability to bend in all directions) were confirmed not to affect the ability to successfully deploy the Clip on the left atrial appendage (LAA).
Design Control & Specification Conformance	Modified Clip Applier conformed to design controls and product specifications per 21 CFR 820.30 and AtriCure's Quality System.
Mechanical Performance	Non-clinical Bench Testing on "Mechanical Testing" was performed and presumably met internal specifications.
Reliability	Non-clinical Bench Testing on "Reliability Testing" was performed and presumably met internal specifications.
Transit Performance	Non-clinical Bench Testing on "Transit Testing" was performed and presumably met internal specifications.
Equivalence to Predicate	The modified system is equivalent to the previously cleared AtriClip LAA Exclusion System, with no change to intended use, the implant Gillinov-Cosgrove Clip, or the basic design of the Clip Applier.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: The document refers to "an animal model" for deployment testing. Specific animal type, number of animals, or quantity of deployment attempts are not provided.
Data Provenance: The testing appears to be internal to AtriCure, Inc. and is regulatory in nature for a 510(k) submission. No country of origin for external data is mentioned. The testing is prospective in the sense that it was conducted for this specific regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This was a non-clinical/animal model study to assess mechanical function and deployment, not an AI model evaluating diagnostic images or clinical outcomes requiring human expert ground truth. The "ground truth" for successful deployment would be direct observation by the testing personnel.

4. Adjudication Method for the Test Set

Not applicable. As above, this was a functional test, not a subjective assessment requiring adjudication among multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study (comparing human readers with and without AI assistance) was not performed or reported in this 510(k) summary. The device is a surgical tool, not an AI diagnostic system.

6. Standalone (Algorithm Only) Performance Study

No. This type of study is not applicable as the device is a physical surgical intervention system, not a standalone algorithm.

7. Type of Ground Truth Used

For the deployment testing on an animal model, the ground truth was direct observation of successful (or unsuccessful) deployment of the Clip on the LAA by the device during surgical procedures.
For bench testing, the ground truth was the measured adherence to design specifications and controls (e.g., mechanical properties, reliability, transit functionality).

8. Sample Size for the Training Set

Not applicable. This document describes testing for a physical medical device, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no AI algorithm training set, this question is not relevant to this document.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with a bird-like element above them, possibly representing an eagle or another bird of prey.

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

August 28, 2014

AtriCure, Inc. Jonathan McElwee Regulatory Engineer 6217 Centre Park Drive West Chester, OH 45069

Re: K142120

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: August 1, 2014 Received: August 4, 2014

Dear Mr. McElwee:

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 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

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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 (800) 638-2041 or (301) 796-7100 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" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

M.A. Hillebrenner

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

K142120 510(k) Number (if known)

Device Name: AtriClip LAA Exclusion System

Indications for 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.

x Prescription Use (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)

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510(k) Summary

I. Submitter
Manufacturer:	AtriCure, Inc.6217 Centre Park Dr.West Chester, OH 45069P: 513-755-4100F: 513-755-4108
Contact Person:	Jonathan McElwee, RACRegulatory Engineer
Date Prepared:	08/01/2014
II. Device
Name of Device:	AtriClip™ LAA Exclusion System with preloaded Gillinov-Cosgrove Clip(ACH235, ACH240, ACH245, ACH250)
Common Name:	Implantable Clip and Clip Applier
Classification Name:	Implantable Clip and Clip Applier (21 CFR 878.4300)
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, and K131107 on May 14, 2013.

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

No reference devices were used in this submission.

IV. Device Description

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Image /page/4/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 "O" in "Cure". There is a registered trademark symbol next to the word "Cure".

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.

VI. Comparison Of Technological Characteristics With The Predicate Device

. The devices have the same intended use and;
The devices use the same pre-loaded Gillinov-Cosgrove Clip. ●
The basic design of the proposed device and the previously cleared devices are the same. . The devices are disposable, single-use instruments including a handle, malleable shaft, suture anchors, and deployment loop containing the Clip.
. The modifications to the proposed AtriClip Applier are designed to provide increased options for surgeons based on patient body habitus and surgeon preference. Major modifications compared to the predicate include the ability to bend the shaft in all directions.

VII. Performance Data

The modified Clip Applier was tested on an animal model to confirm the modifications do not affect the ability to successfully deploy the Clip on the left atrial appendage. Additional testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Clip Applier's conformance to design controls and specification. Testing determined that the modified Clip Applier was able to successfully deploy the Clip on the LAA and that the modified Clip Applier conformed to design controls and product specifications.

Non-clinical Bench Testing

Mechanical Testing .
. Reliability Testing
Deployment Testing on an Animal Model
Transit Testing

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, the implant Gillinov-Cosgrove Clip, or the basic design of the Clip Applier. The modifications to the Clip Applier do not affect the ability of the Clip to be successfully deployment on the LAA.

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.