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

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

Device Description

The LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection quide. 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 then deployed and is left as a permanent implant. 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 Appliers are disposable device with a handle, shaft, suture anchors, articulation controls, and deployment loop which contains the Clip. This Special 510(k) contains an alternate to the PET suture supply sourcing used within the AtriClip implant and Clip Appliers of the LAA Exclusion system.

AI/ML Overview

This is a 510(k) premarket notification for the AtriClip LAA Exclusion System, a medical device designed for occluding the heart's left atrial appendage during cardiac surgical procedures. This submission is for modifications to an already cleared device (K180010).

The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics. The submission asserts that the modifications made do not change the intended use, operating principles, or function of the device, and therefore, the prior approval and equivalence still hold.

However, based on the information provided, we can infer and construct some of the requested details:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are not presented as numerical targets for performance metrics like sensitivity or specificity. Instead, they are based on demonstrating that the modified device is as safe and effective as the predicate device and that the changes do not raise new questions of safety or effectiveness.

Acceptance Criteria (Inferred from Substantial Equivalence Determination)	Reported Device Performance
Intended Use: Same as predicate device.	"The devices have the same intended use."
Operating Principle: No changes from predicate device.	"No changes were made in operating principle."
Specifications of Performance: No changes from predicate device.	"No changes were made in... specifications of performance."
Contraindications, Warnings, and Precautions: Remain the same as predicate device.	"The contraindications, warnings, and precautions remain the same."
Equivalency in Performance (Bench Testing): Demonstrated for design and performance elements.	"Demonstrated equivalency in performance." Specifically, conducted: Tensile Testing (Strength, Knotted Strength), Suture Elongation, Friction Comparison Testing.
Biocompatibility: Remains unchanged and meets ISO 10993-1.	"Device biocompatibility remains unchanged." Tested for: Material Mediated Pyrogen, Genotoxicity, Cytotoxicity, Implantation, Sensitization, Irritation, Systemic Toxicity.
Safety Issues: No new issues raised.	"Did not raise any new issues of safety."

Study Information (Based on Substantial Equivalence Submission)

Since this is a 510(k) for modifications to an already cleared device, the "study" proving acceptance is primarily a demonstration of equivalence through bench testing and biocompatibility assessment of the modified components, rather than a clinical trial with patient outcomes.

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

Sample Size (Test Set): Not explicitly stated as "sample size" in the context of a clinical test set. The "test set" here refers to the materials and components of the modified device that underwent bench testing and biocompatibility evaluation. The quantity of items tested for Tensile, Elongation, Friction, and Biocompatibility (e.g., number of clips, appliers, or material samples) is not specified.
Data Provenance: Not explicitly stated. Given that these are bench tests and biocompatibility tests, the data would originate from the manufacturer's internal testing facilities or contract labs. The country of origin is not mentioned. The data is prospective in the sense that the tests were conducted specifically for this submission on the modified materials.

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

This question is not directly applicable to a 510(k) based on bench testing and biocompatibility. There is no concept of "ground truth" derived from expert consensus on images or clinical cases in this submission. The "ground truth" in this context is the objective measurement from the specified engineering and biological tests demonstrating that the modified material performs equivalently and is biocompatible. The experts would be the engineers and toxicologists who designed, performed, and interpreted these tests, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous data or expert disagreement requiring an adjudication method for the physical and chemical properties tested. The results are objective measurements from the tests performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a physical implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating equivalence is based on:

Engineering Specifications: Testing the physical properties (tensile strength, elongation, friction) of the modified components against established engineering specifications and comparing them to the predicate device's performance.
Biological Standards: Testing biocompatibility according to recognized international standards (ISO 10993-1) using established biological assays (Material Mediated Pyrogen, Genotoxicity, Cytotoxicity, Implantation, Sensitization, Irritation, Systemic Toxicity).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of AI or machine learning for this physical device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

June 28, 2018

AtriCure, Inc. Jonathan McElwee Regulatory Affairs Manager 7555 Innovation Way Mason, Ohio 45040

Re: K181474

Trade/Device Name: AtriClip LAA Exclusion System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: PZX Dated: June 1, 2018 Received: June 4, 2018

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. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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K181474

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Rachel E. Neubrander -S

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) K181474

Device Name AtriClip LAA Exclusion System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

l. Applicant Information

Manufacturer:	AtriCure, Inc.7555 Innovation WayMason, OH 45040P: 513-755-4100F: 513-755-4108
Contact Person:	Jonathan McElweeManager of Regulatory Affairs
Date Prepared:	05/31/2018

II. Device Information

Name of Device: AtriClip® LAA Exclusion System

Implantable Clip and Clip Applier Common Name:
Classification Name: Implantable Clip and Clip Applier (21 CFR 878.4300) Class II Product Code: PZX Classification Panel: General and Plastic Surgery
Predicate Device: The device proposed for modification in this submission is the AtriClip LAA Exclusion System cleared via K180010 on January 31, 2018.
●

●

The following reference devices were also used in this submission:

K093679 AtriClip LAA Exclusion System
K122276 AtriClip LAA Exclusion System ●
AtriClip LAA Exclusion System ● K131107
K142120 AtriClip LAA Exclusion System
K150996 AtriClip LAA Exclusion System
K153500 AtriClip LAA Exclusion System
K160454 AtriClip LAA Exclusion System
K163261 AtriClip LAA Exclusion System ●
- K172742 AtriClip LAA Exclusion System
K173031 AtriClip LAA Exclusion System ●

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III. Device Description

IV. Indications For Use

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

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other viewing technologies.

V. 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 contraindications, warnings, and precautions remain the same
- The results of the verification and validation testing:
  - Demonstrated equivalency in performance O
    - Device biocompatibility remains unchanged O
    - Did not raise any new issues of safety o

VI. Performance Data

●

The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared AtriClip LAA Exclusion System

Non-clinical Bench Testing

. Tensile Testing (Strength, Knotted Strength)
Suture Elongation ●
Friction Comparison Testing ●

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Image /page/5/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.

Biocompatibility Testing

The biocompatibility evaluation for the AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip AOD1, and PROV Clip, AOD2 was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The battery of testing included the following tests:

. Material Mediated Pyrogen
Genotoxicity
Cytotoxicity
Implantation
. Sensitization
Irritation ●
Systemic Toxicity ●

VII. Conclusions

AtriCure has demonstrated that the modifications made to the AtriClip LAA Exclusion System is equivalent to the previously cleared AtriClip LAA Exclusion System as there is no change to intended use, operating principals, or function of the device.

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.