The AtriClip LAA Exclusion System is indicated for the exclusion 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 PRO-Mini LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip (AtriClip Mini) 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 exclusion of the left atrial appendage (LAA). The Clip is then deployed and is left as a permanent implant, and excludes the LAA, resulting in electrical isolation of the 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 PRO-Mini device is a disposable device with a handle, leftright and up/down articulation knobs, articulation lock, deployment tab, shaft, suture anchors, and end effector containing the AtriClip Mini.

AI/ML Overview

This document outlines the FDA's clearance for the AtriClip PRO-Mini LAA Exclusion System (PROM) based on its substantial equivalence to previously cleared predicate devices. The information provided primarily focuses on the device's technical characteristics and the non-clinical bench testing performed to demonstrate this equivalence. It does not describe a study involving algorithms, AI, human readers, or clinical performance metrics that would typically have acceptance criteria like sensitivity, specificity, or AUC when evaluating diagnostic or prognostic devices.

Therefore, many of the requested sections (2-6, 8-9) are not applicable or cannot be extracted from this document as they pertain to clinical or AI/algorithm-based studies, which are not described here.

Here's the information that can be extracted or inferred from the provided text, focusing on the device's substantial equivalence through bench testing:

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

Based on the provided text, the acceptance criteria are generalized as demonstrating "equivalence in performance" and not raising "any new issues of safety." The reported performance is that the device "met the predetermined acceptance criteria." Specific quantitative acceptance criteria are not detailed in this document, nor are specific quantitative performance results.

Acceptance Criteria (General)	Reported Device Performance
Demonstrated equivalency in performance	Met predetermined acceptance criteria
Did not raise any new issues of safety	No new safety or performance issues were raised during testing
Fundamental design is substantially equivalent	Demonstrated substantial equivalence
Technology is substantially equivalent	Demonstrated substantial equivalence
Function is substantially equivalent	Demonstrated substantial equivalence
Device materials are substantially equivalent	Demonstrated substantial equivalence
Packaging is substantially equivalent	Demonstrated substantial equivalence
Sterilization is substantially equivalent	Demonstrated substantial equivalence
Operating principle is substantially equivalent	Demonstrated substantial equivalence
Intended use / indication for use is equivalent	Demonstrated substantial equivalence

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

This information is not provided in the document. The document refers to "bench testing," which implies laboratory-based tests rather than patient data.

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)

This information is not provided as the study is non-clinical bench testing, not a study requiring expert clinical interpretation for ground truth establishment.

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

This information is not provided as the study is non-clinical bench testing, and adjudication methods are typically used for expert clinical review of cases.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not described in this document. This document pertains to the clearance of a physical medical device (implantable clip system) based on non-clinical bench testing, not an AI or imaging device involving human readers.

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

Not Applicable. This document describes a physical medical device, not an algorithm or AI system.

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

For the non-clinical bench testing, "ground truth" would likely be established by engineering specifications, material standards, and validated testing methodologies to measure mechanical properties, reliability, and tissue interaction. The document doesn't explicitly state the methodology for establishing this "ground truth" for each bench test, but it is implied by the nature of such testing.

8. The sample size for the training set

Not Applicable. This document describes the clearance of a physical medical device based on non-clinical bench testing, not an AI or algorithm-based device that would require a training set.

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

Not Applicable. As no training set is described or implied, the establishment of its ground truth is not relevant.

Summary

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January 15, 2025

AtriCure, Inc. Diane Sung Senior Regulatory Affairs Specialist 7555 Innovation Wav Mason, Ohio 45040

Re: K243860

Trade/Device Name: AtriClip PRO-Mini LAA Exclusion System (PROM) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: PZX Dated: December 16, 2024 Received: December 16, 2024

Dear Diane Sung:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely, Kalkidan Molla -S

Kalkidan A. Molla, MS Acting Assistant Director DHT2B: Division of Circulatory Support, Structural, and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K243860

Device Name AtriClip PRO-Mini LAA Exclusion System (PROM)

Indications for Use (Describe)

The AtriClip LAA Exclusion System is indicated for the exclusion of the heat'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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Applicant Information

Manufacturer:	AtriCure, Inc.7555 Innovation WayMason Ohio 45040
Contact Person:	Diane SungSenior Regulatory Affairs SpecialistP: 513-600-1804
Alternate Contact:	Jim TaufenDirector, Regulatory AffairsP: 952-314-1507
Date Prepared:	December 16, 2024
Device Information
Proprietary Name:	AtriClip PRO-Mini LAA Exclusion System (PROM)
Common Name:	Implantable Clip and Clip Applier
Classification:	Implantable Clip and Clip ApplierRegulatory Class: Class II; per 21 CFR 878.4300Product Code: PZXClassification Panel: Cardiovascular
Predicate Device:	AtriClip FLEX-Mini LAA Exclusion System (ACHM) (K234125, July 29, 2024)
Reference Device:	AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip(PRO2) (K160454, March 18, 2016, and K172742, October 11, 2017)

Device Description

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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.

Comparison of Technological Characteristics

The devices include the same intended use and indications for use, and; ●
. No changes were made in operating principle, and;
The results of the verification and validation testing: .
- o Demonstrated equivalency in performance
- O Did not raise any new issues of safety

#	Feature	AtriClip FLEX-MiniLAA ExclusionSystem with AtriClipMini(ACHM)(Predicate)K234125	AtriClip LAAExclusion Systemwith PreloadedGillinov-CosgroveLAA Clip (PRO2)(Reference)K160454, K172742	PRO-Mini(PROM)(Proposed)	EquivalenceComparison
1	ProprietaryName	AtriClip FLEX-Mini LAAExclusion System	AtriClip LAA ExclusionSystem with PreloadedGillinov-Cosgrove Clip	AtriClip PRO-Mini LAAExclusion System	N/A
2	ProductCode(s)	ACHM35 ACHM40ACHM45 ACHM50	PRO235 PRO240PRO245 PRO250	PROM35 PROM40PROM45 PROM50	N/A
3	Indications forUse	The AtriClip LAAExclusion System isindicated for theexclusion of the heart'sleft atrial appendage,performed under directvisualization and inconjunction with othercardiac surgicalprocedures.Direct visualization, inthis context, requiresthat the surgeon is ableto see the heart directly,	The AtriClip LAAExclusion System isindicated for theexclusion of the heart'sleft atrial appendage,performed under directvisualization and inconjunction with othercardiac surgicalprocedures.Direct visualization, inthis context, requiresthat the surgeon is ableto see the heart directly,	The AtriClip LAAExclusion System isindicated for theexclusion of the heart'sleft atrial appendage,performed under directvisualization and inconjunction with othercardiac surgicalprocedures.Direct visualization, inthis context, requiresthat the surgeon is ableto see the heart directly,	Same as predicateand referencedevices.
		with or withoutassistance from acamera, endoscope,etc., or otherappropriate viewingtechnologies.	with or withoutassistance from acamera, endoscope,etc., or otherappropriate viewingtechnologies.	with or withoutassistance from acamera, endoscope,etc., or otherappropriate viewingtechnologies.
4	Packaging	Sterile, Single use,disposable device	Sterile, Single use,disposable device	Sterile, Single use,disposable device	Same as predicateand referencedevices.
5	Biocompatibility	Materials have beenassessed based on ISO10993 and arecommonly employed intissue contactingdevices.	Materials have beenassessed based on ISO10993-1 and arecommonly employed intissue contactingdevices.	Materials have beenassessed based on ISO10993-1 and arecommonly employed intissue contactingdevices.	Same as predicateand referencedevices.
6	Sterilization	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation	Same as predicateand referencedevices.
7	SterilityAssuranceLevel	$10^{-6}$ SAL	$10^{-6}$ SAL	$10^{-6}$ SAL	Same as predicateand referencedevices.
Clip
8	Preloaded Clip	AtriClip Mini (AOD3)	N/A	AtriClip Mini (AOD3)	Same as predicatedevice.
9	OperatingMechanism	Uniform pressure alonglength of the Clip	N/A	Uniform pressure alonglength of the Clip	Same as predicatedevice.
10	ContactSurface	Knit Braided Polyester	N/A	Knit Braided Polyester	Same as predicatedevice.
Clip Applier
11	DeploymentEnd Effector	N/A	Stainless steel jaws thatopen and close, as wellas provide the pathwayfor stainless steelcables to route andattach to the Clip.	Stainless steel jaws thatopen and close, as wellas provide the pathwayfor stainless steelcables to route andattach to the Clip.	Same asreference device.
12	Shaft	N/A	Stainless Steel	Stainless Steel	Same asreference device.
13	Handle	N/A	Polycarbonate	Polycarbonate	Same asreference device.

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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 devices (ACHM, PRO2). The AtriClip PRO-Mini LAA Exclusion System (PROM) met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared AtriClip LAA Exclusion System devices (ACHM, PRO2). No new safety or performance issues were raised during testing.

Non-clinical Bench Testing:

Mechanical Testing
. Reliability Testing
Tissue Testing ●
Dose Audit Testing .

Conclusions

AtriCure has demonstrated that the AtriClip PRO-Mini LAA Exclusion System (PROM) is substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the previously cleared AtriClip FLEX-Mini LAA Exclusion System (ACHM) per K234125 and AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip (PRO2) per K160454 and K172742.

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.