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 AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection guide. 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 PRO·V Clip Applier is a disposable device with a handle, shaft, suture anchors, articulation controls, and deployment end-effector containing the Clip.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device and therefore does not contain all the typical information one would expect from a full study report. The acceptance criteria and "study" described herein are primarily focused on demonstrating substantial equivalence to a previously cleared device, rather than proving efficacy or safety in a clinical setting in the way a clinical trial would.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary from this document)
Reliability Testing	Met predetermined acceptance criteria.
Mechanical Testing	Met predetermined acceptance criteria.
Confirmatory Biologic Testing	Met predetermined acceptance criteria.
Fundamental Design	Substantially equivalent to the previously cleared PRO-V device.
Technology	Substantially equivalent to the previously cleared PRO-V device.
Function	Substantially equivalent to the previously cleared PRO-V device.
Device Materials	Substantially equivalent to the previously cleared PRO-V device (still titanium and polyester).
Packaging	Substantially equivalent to the previously cleared PRO-V device (no changes).
Sterilization	Substantially equivalent to the previously cleared PRO-V device (no changes).
Operating Principle	Substantially equivalent to the previously cleared PRO-V device (no changes).
Intended Use/Indication for Use	Substantially equivalent to the previously cleared PRO-V device (same).

Explanation of the "Study":
The "study" referenced in this document is a series of non-clinical bench tests designed to demonstrate that minor modifications to the AtriClip® LAA Exclusion System with Preloaded PRO-V™ Clip (K173031) did not affect its safety, effectiveness, or fundamental characteristics compared to its predicate device (K153500). The purpose was to prove substantial equivalence, not necessarily to establish new performance metrics against a clinical standard.

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

Sample Size for Test Set: Not specified in the provided text. The document refers to "bench testing," which typically involves a number of units tested to statistical confidence levels, but the exact number is not detailed here.
Data Provenance: Not explicitly stated as "country of origin," but "bench testing" implies laboratory-based testing conducted by the manufacturer (AtriCure, Inc.) or a contracted lab. This is retrospective in the sense that it evaluates a manufactured product, but it's not based on patient data provenance.

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

Not applicable / Not provided. For this type of 510(k) submission, the "ground truth" for bench testing is typically adherence to engineering specifications, material properties, and functional performance as outlined in test protocols, rather than expert clinical consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are used for clinical trial endpoints or expert review of medical images/cases. For bench testing, the "adjudication" is typically a pass/fail against predetermined engineering and performance specifications.

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

No. An MRMC study is a type of clinical comparative study, often used for diagnostic imaging devices to assess how human readers' performance improves with or without artificial intelligence (AI) assistance. This document describes a 510(k) for an implantable clip system and non-clinical bench testing, not an AI-assisted diagnostic device, and therefore no MRMC study was conducted or is relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a physical, implantable medical device (an implantable clip and applicator), not a software algorithm or an AI product with standalone performance. Its function is to physically occlude the left atrial appendage, and its application inherently involves a human surgeon.

7. Type of Ground Truth Used

Engineering Specifications and Performance Standards: For bench testing, the ground truth is established by design specifications, material standards, and functional performance requirements that the device must meet. This is verified through specific tests (reliability, mechanical, biologic compatibility). It is not expert consensus, pathology, or outcomes data, as those relate to clinical performance in patients.

8. Sample Size for the Training Set

Not applicable / Not provided. The concept of a "training set" is relevant for machine learning algorithms. This device is a physical implantable device, and thus does not have a training set in the context of AI or data-driven model development. The design and manufacturing process involve various validated methods, but not a "training set" like an AI model would.

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

Not applicable / Not provided. As there is no training set for this type of device, the method for establishing its ground truth is not relevant. Ground truth for the device itself (its design, materials, and functional performance) is established through established engineering principles, regulatory standards, and internal design controls.

Summary

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October 25, 2017

AtriCure, Inc. Melissa Smallwood Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040

Re: K173031

Trade/Device Name: AtriClip® LAA Exclusion System with Preloaded PRO-VTM Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: September 27, 2017 Received: September 28, 2017

Dear Ms. Smallwood:

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 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,

Nicole G. Ibrahim -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) K173031

Device Name

AtriClip LAA Exclusion System with Gillinov-Cosgrove PRO·V Clip

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)
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X 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, Ohio 45040P: 513-644-4736F: 513-895-9013
Contact Person:	Melissa SmallwoodRegulatory Affairs Specialist
Alternate Contact:	Jonathan McElwee, RACManager, Regulatory Affairs
Date Prepared:	09/27/2017

ll. Device Information

Proprietary Name:	AtriClip® LAA Exclusion System with Preloaded PRO·V™ Clip
Common Name:	Implantable Clip and Clip Applier
Classification:	Implantable Clip and Clip ApplierRegulatory Class: Class II; per 21 CFR 878.4300Product Code: FZPClassification Panel: General and Plastic Surgery
Predicate Device:	AtriClip LAA Exclusion System with Preloaded PRO·V Clip(K153500, FZP, May 19, 2017)

lll. Device Description

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IV. Intended Use/ Indications for Use

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.

V. Comparison of Technological Characteristics (PRO-V cleared via K153500)

Minor dimensional modifications were made to internal components of the end effector of the Clip Applier, and a minor internal component was replaced with an equivalent component in the handle of the Clip Applier. A minor dimensional modification was also made to the PRO-V Clip Implant.

. The devices have the same intended use and;
. No changes were made in operating principle, or specifications of performance.
. No changes were made to the labeling.
No changes were required in packaging sterilization or expiration dating.
The PRO·V Clip continues to be made of titanium and polyester. .

VI. Performance Data

The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared PRO-V device. The PRO-V device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared PRO-V device. No new safety or performance issues were raising during testina.

Non-clinical Bench Testing:

. Reliability Testing
Mechanical Testing ●
. Confirmatory Biologic Testing

VII. Conclusions

AtriCure has demonstrated that the modifications made for the PRO V device are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principal, and intended use/ indication for use as the previously cleared device: AtriClip LAA Exclusion System with Preloaded PRO·V Clip

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.