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 FLEX:V device 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 AtriClip FLEX:V device is a disposable device with a handle, shaft, suture anchors, shaft rotation knob, and deployment end-effector containing the Clip.

AI/ML Overview

The provided FDA document describes the AtriClip FLEX-V device, an implantable clip for occluding the heart's left atrial appendage. The document focuses on demonstrating substantial equivalence to a predicate device (AtriClip LAA Exclusion System with Preloaded PRO-V Clip, K173031) through non-clinical bench testing.

Therefore, the requested information regarding acceptance criteria and studies demonstrating device performance, as typically found in clinical trials or AI/software evaluations, is not fully available for this device within the provided document.

Here’s a breakdown of what is and is not present based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document states that the AtriClip FLEX V device "met the predetermined acceptance criteria". However, the specific criteria themselves (e.g., specific tensile strength values, deployment force ranges, etc.) are not detailed or quantified in the provided text.
Reported Device Performance: The document generally states that "No new safety or performance issues were raising during testing" and that the device "met the predetermined acceptance criteria." However, specific numerical performance results from the bench tests are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: This information is not provided as the study described is non-clinical bench testing, not a human clinical trial.
Data Provenance: This information is not applicable as the described study is laboratory-based bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical implantable clip, and the testing described is engineering bench testing rather than a diagnostic device requiring expert interpretation of results to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This relates to human interpretation of data, which is not part of the described non-clinical bench testing.

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

No. This is a physical medical device, not an AI or diagnostic tool. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This refers to AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated in terms of "ground truth" as typically used in diagnostic product evaluations. For bench testing of a physical device, the "ground truth" would be established engineering specifications, material properties, and functional requirements against which the device's performance (e.g., mechanical strength, deployment reliability) is measured. The document implies these engineering specifications were used as the basis for evaluation by stating the device "met the predetermined acceptance criteria."

8. The sample size for the training set

Not applicable. This refers to AI/machine learning.

9. How the ground truth for the training set was established

Not applicable. This refers to AI/machine learning.

Summary of available information regarding performance:

Study Type: Non-clinical bench testing.
Purpose: To demonstrate substantial equivalence to a predicate device (AtriClip LAA Exclusion System with Preloaded PRO-V Clip, K173031) due to modifications made only to the clip applier design. The implantable clip itself is identical to the predicate.
Tests Conducted:
- Reliability Testing
- Mechanical Testing
- Drop Testing
- Biocompatibility Testing
- Transit Testing
- Shelf Life Testing
Outcome: The AtriClip FLEX 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 testing."

Essentially, the provided document is a 510(k) summary focused on demonstrating equivalence through engineering and materials testing for a physical device, not a report on clinical trial outcomes or a performance study for a diagnostic or AI product.

Summary

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January 31, 2018

AtriCure, Inc. Brittany Lowe Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040

Re: K180010

Trade/Device Name: AtriClip FLEX-V Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: December 29, 2017 Received: January 2, 2018

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

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,

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) K180010

Device Name AtriClip FLEX-V

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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l. Applicant Information

Manufacturer:	AtriCure, Inc.7555 Innovation WayMason, Ohio 45040P: 513-644-4736F: 513-895-9013
Contact Person:	Brittany LoweRegulatory Affairs Specialist
Alternate Contact:	Jonathan McElwee, RACManager, Regulatory Affairs
Date Prepared:	1/31/2018

II. Device Information

Proprietary Name:	AtriClip FLEX·V™ device
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(K173031, FZP, October 25, 2017)

lll. Device Description

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IV. Intended Use/ Indications for Use

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

V. Comparison of Technological Characteristics (PRO-V cleared via K173031)

The AtriClip system is comprised of an implantable Clip Applier used to deliver the clip to the implant site. The implantable Clip used in the subject device and predicate device are identical. Modifications were made to the Clip Applier design only, to accommodate differing body habitus and surgeon preference. These changes include:

. Addition of an aluminum shaft for malleability
. An end effector that can be manually rotated 180° in 45° increments for physician preference and patient anatomy
. A one handed trigger to deploy the clip
An over-center feature to reduce the force needed to hold the clip open .
A pistol grip style handle for physician preference ●

The intended use, operating principles, performance specification and expiration dating of the subject device are the same as the predicate device.

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 AtriClip FLEX 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 testing.

Non-clinical Bench Testing:

Reliability Testing ●
. Mechanical Testing
Drop Testing ●
. Biocompatibility Testing
Transit Testing
Shelf Life Testing .

VII. Conclusions

AtriCure has demonstrated that the modifications made to the AtriClip FLEX-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.