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 Exclusion System contains a clip for exclusion of the heart's left atrial appendage (LAA). Preclinical animal studies (Kamohara 2005, 2006) demonstrate that complete exclusion with the Clip also results in acute and chronic electrical isolation of the LAA. A human clinical study (Starck 2012) has demonstrated acute electrical isolation. Chronic electrical isolation has not been evaluated in human clinical studies. The Clip is pre-loaded on a disposable Clip applier. The AtriClip Exclusion System does not contain natural rubber latex components.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the AtriClip LAA Exclusion System. It focuses on demonstrating substantial equivalence to a predicate device (K181474), primarily based on labeling changes (indications for use and device description in the instructions for use) rather than a new design or device performance study.

Therefore, many of the requested criteria related to a study proving device performance against acceptance criteria (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are explicitly stated as not applicable or not performed because the submission is not for a new device design or a change in its intended use or function.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not detail specific quantitative acceptance criteria or performance metrics for the AtriClip LAA Exclusion System itself, as it's a 510(k) for a modified labeling of an existing, already cleared device. The "performance data" section explicitly states: "The proposed changes do not include any change to design or performance specifications of the AtriClip LAA Exclusion System. Additionally, the proposed changes did not modify the intended use, therefore the previously submitted bench and animal data remain valid for the AtriClip LAA Exclusion System."

Instead, the "acceptance criteria" here are implicitly about demonstrating that the labeling changes do not negate the device's substantial equivalence to its predicate. The "performance" is therefore the assertion that the device continues to meet the established performance parameters of its predicate.

Feature	Predicate (K181474) AtriClip™ LAA Exclusion System (Original Labeling)	Subject AtriClip™ LAA Exclusion System (Modified Labeling)	Equivalence Comparison (Acceptance)
Proprietary Name	AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip/V-Clip	AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip/V-Clip	n/a (same)
Model Numbers	LAA, ACH, PRO, ACHV, PROV series	LAA, ACH, PRO, ACHV, PROV series	n/a (same)
Indications for Use	Occlusion of LAA, under direct visualization, in conjunction with other cardiac surgical procedures.	Exclusion of LAA, under direct visualization, in conjunction with other cardiac surgical procedures.	Similar. AtriClip devices have the same intended use. (The term "occlusion" was changed to "exclusion," but the core meaning and clinical application are deemed equivalent.)
Device Description in IFU	Describes the Clip for occlusion of LAA; pre-loaded on applier; no natural rubber latex.	Describes Clip for exclusion of LAA; adds reference to preclinical animal studies (Kamohara 2005, 2006) demonstrating acute and chronic electrical isolation, and human clinical study (Starck 2012) showing acute electrical isolation (with statement that chronic electrical isolation not evaluated in human studies); pre-loaded on applier; no natural rubber latex.	Different, but AtriClip devices have the same intended use. (The added descriptive text is considered an update to the IFU, not a change in fundamental device function or safety/effectiveness for the stated intended use.)
Preloaded Clip	Gillinov-Cosgrove Clip / V-Clip	Gillinov-Cosgrove Clip / V-Clip	Same
Shelf Life	3 years	3 years	Same
Biocompatibility	Passed. ISO 10993 assessed.	Passed. ISO 10993 assessed.	Same
Sterilization	Gamma Irradiation.	Gamma Irradiation.	Same
Sterility Assurance Level	10^-6 SAL	10^-6 SAL	Same

Study Proving Device Meets Acceptance Criteria:

The "study" referenced in this submission is the 510(k) premarket notification process itself, which argues for substantial equivalence based on the updated labeling. The core argument is that the device's fundamental design, operating principles, and function have not changed. Therefore, previously submitted preclinical and clinical data from the predicate device (K181474) and referenced literature (Kamohara 2005, 2006; Starck 2012) are considered sufficient to support the device with its updated labeling.

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

Test Set: No new "test set" in the context of device performance testing was used for this 510(k) submission, as it relates to labeling changes only.
Data Provenance for Referenced Studies (Kamohara, Starck): The document does not specify the country of origin or whether these were retrospective or prospective studies. Kamohara (2005, 2006) are referred to as "preclinical animal studies," and Starck (2012) as a "human clinical study."

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This was not a study requiring expert ground truth for performance evaluation of a new or modified device. The "ground truth" here is regulatory compliance and a determination of substantial equivalence by the FDA.

4. Adjudication Method for the Test Set

Not applicable. No new test set for device performance was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size

Not applicable. No MRMC study was performed or required for this labeling update.

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

Not applicable. This device is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission's approval is the established regulatory framework for 510(k) clearances, specifically demonstrating substantial equivalence to a predicate device. This is based on comparisons of design, materials, manufacturing, indications for use, and a demonstration that any changes (in this case, primarily labeling) do not raise new questions of safety or effectiveness. The supporting data for the claims made in the updated labeling (e.g., electrical isolation) come from previously published preclinical and clinical studies (Kamohara 2005/2006, Starck 2012).

8. The Sample Size for the Training Set

Not applicable. This submission is not for an AI/ML algorithm or a device requiring a training set in that context.

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

Not applicable.

Summary

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August 21, 2019

AtriCure, Inc Jim Taufen Sr. Manager, Regulatory Affairs 7555 Innovation Way Mason, Ohio 45040

Re: K191413

Trade/Device Name: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip. AttiClip LAA Exclusion System with preloaded V-Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: PZX Dated: May 24, 2019 Received: May 28, 2019

Dear Mr. Taufen:

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. 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 located 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.

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542 of the Act); 21 CFR 1000-1050.

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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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).

Sincerely.

Rachel Neubrander, Ph.D. Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191413

Device Name AtriClip LAA Exclusion System

Indications for Use (Describe)

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.

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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Image /page/3/Picture/0 description: The image shows the AtriCure logo. The word "Atri" is in blue, while "Cure" is in orange. There is a blue dot in the middle of the "C" in "Cure". There is a registered trademark symbol next to the "e" in "Cure".

510(k) Summary

l. Applicant Information

Manufacturer: AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 P: (952) 314-1507 F: (513) 755-4108 Contact Person: Jim M. Taufen Senior Manager, Regulatory Affairs Date Prepared: August 20, 2019 II. Device Information AtriClip® LAA Exclusion System Name of Device: Common Name: Implantable Clip and Clip Applier Implantable Clip and Clip Applier (21 CFR 878.4300) Classification Name: 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 K181474 on June 28, 2018. The following reference devices were also used in this submission: K093679 AtriClip LAA Exclusion System K153500 AtriClip LAA Exclusion System ● ● ● K122276 AtriClip LAA Exclusion System K163261 AtriClip LAA Exclusion System ● K131107 AtriClip LAA Exclusion System K172742 AtriClip LAA Exclusion System ● ● K142120 K173031 AtriClip LAA Exclusion System ●
●

●

AtriClip LAA Exclusion System
K150996 AtriClip LAA Exclusion System
K160454 AtriClip LAA Exclusion System
K180010 AtriClip LAA Exclusion System
K181474 AtriClip LAA Exclusion System

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Device Description lll.

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

AtriCure updated the LAA Exclusion System indications and device description in the instructions for use labeling. A comparison of the technological characteristics with the predicate device are provided in Table 1 below.

Feature	Predicate (K181474)AtriClip™ LAA ExclusionSystem	Subject AtriClip™ LAAExclusion System	EquivalenceComparison
ProprietaryName	AtriClip LAA Exclusion Systemwith Preloaded Gillinov-Cosgrove Clip	AtriClip LAA Exclusion Systemwith Preloaded Gillinov-CosgroveClip	n/a
	AtriClip® LAA ExclusionSystem with preloaded V-Clip	AtriClip® LAA Exclusion Systemwith preloaded V-Clip	n/a
ModelNumbers	LAA035 LAA040 LAA045LAA050 ACH135 ACH140ACH145 ACH150 ACH235ACH240 ACH245 ACH250PRO135 PRO140 PRO145PRO150 PRO235 PRO240PRO245 PRO250ACHV35 ACH40 ACHV45ACHV50 PROV35 PROV40PROV45 PROV50	LAA035 LAA040 LAA045 LAA050ACH135 ACH140 ACH145ACH150 ACH235 ACH240ACH245 ACH250 PRO135PRO140 PRO145 PRO150PRO235 PRO240 PRO245PRO250ACHV35 ACH40 ACHV45ACHV50 PROV35 PROV40PROV45 PROV50	n/a
Indications forUse	The AtriClip LAA ExclusionSystem is indicated for theocclusion of the heart's leftatrial appendage, performed	The AtriClip LAA Exclusion Systemis indicated for the exclusion of theheart's left atrial appendage,performed under direct	Similar. AtriClipdevices have
Feature	Predicate (K181474)AtriClip™ LAA ExclusionSystem	Subject AtriClip™ LAAExclusion System	EquivalenceComparison
	under direct visualization and inconjunction with other cardiacsurgical procedures.	visualization and in conjunctionwith other cardiac surgicalprocedures.	the sameintended use
	Direct visualization, in thiscontext, requires that thesurgeon is able to see the heartdirectly, with or withoutassistance from a camera,endoscope, etc., or otherappropriate viewingtechnologies.	Direct visualization, in this context,requires that the surgeon is able tosee the heart directly, with orwithout assistance from a camera,endoscope, etc., or otherappropriate viewing technologies.
DeviceDescription inthe Instructionsfor Use	The AtriClip LAA ExclusionSystem contains the Gillinov-Cosgrove LAA Clip (Clip) forocclusion of the heart's leftatrial appendage (LAA). TheClip is pre-loaded on adisposable Clip applier. TheAtriClip LAA Exclusion Systemwith preloaded Gillinov-Cosgrove Clip does not containnatural rubber latex component.	The AtriClip LAA Exclusion Systemcontains {Clip Type} LAA Clip(Clip) for exclusion of the heart'sleft atrial appendage (LAA).Preclinical animal studies(Kamohara 2005, 2006)demonstrate that completeexclusion with the Clip also resultsin acute and chronic electricalisolation of the LAA.A human clinical study (Starck2012) has demonstrated acuteelectrical isolation. Chronicelectrical isolation has not beenevaluated in human clinicalstudies.The Clip is pre-loaded on adisposable Clip applier. TheAtriClip LAA Exclusion Systemwith preloaded {Clip Type} Clipdoes not contain natural rubberlatex component. AOD1: "Gillinov-Cosgrove" AOD2: "V"	Different.AtriClip deviceshave the sameintended use
Preloaded Clip	AOD1: Preloaded Gillinov-Cosgrove Clip	AOD1: Preloaded Gillinov-Cosgrove Clip	Same
	AOD2: Preloaded V-Clip	AOD2: Preloaded V-Clip
Shelf Life	3 years	3 years	Same
Biocompatibility	Passed. Materials have beenassessed based on ISO 10993and are commonly employed intissue contacting devices	Passed. Materials have beenassessed based on ISO 10993and are commonly employed intissue contacting devices	Same
Sterilization	Gamma Irradiation.	Gamma Irradiation.	Same

Table 1: Comparison of Technological Characteristics

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Image /page/5/Picture/0 description: The image shows the AtriCure logo. The word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot in the middle of the "C" in "Cure". There is a registered trademark symbol next to the word "Cure".

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Image /page/6/Picture/0 description: The image shows the AtriCure logo. The word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot in the middle of the "C" in "Cure". There is a registered trademark symbol next to the "e" in "Cure".

Feature	Predicate (K181474)AtriClip™ LAA ExclusionSystem	Subject AtriClip™ LAAExclusion System	EquivalenceComparison
SterilityAssuranceLevel	10-6 SAL	10-6 SAL	Same

The proposed changes in the indications for use statement and instruction for use were supported by published animal and clinical data. The proposed changes do not include any change to intended use, contraindications, or precautions. Additional warnings have been added to the labeling:

Warning:

The safety and effectiveness of this device in atrial rhythm control management, either alone or in ● combination with ablative treatment, has not been established.
. AtriClip placement that allows blood flow into the LAA may not result in complete exclusion and/or electrical isolation.

The proposed changes have no impact on design, operating principles, performance specifications, packaging, sterilization or expiring dating.

VI. Performance Data

The proposed changes do not include any change to design or performance specifications of the AtriClip LAA Exclusion System. Additionally, the proposed changes did not modify the intended use, therefore the previously submitted bench and animal data remain valid for the AtriClip LAA Exclusion System.

VII. Conclusions

A review of the risk analysis concluded there is no overall change to the risk profile of the proposed AtriClip LAA Exclusion System versus the previously cleared AtriClip LAA Exclusion System as the modifications to the proposed AtriClip LAA Exclusion System IFU do not add or remove any features of the device or change the clinical application. AtriCure has demonstrated that the AtriClip LAA Exclusion System IFU, as labeled per the proposed Indication for Use and IFU description section, is substantially equivalent to the predicate LAA Exclusion System (K181474) 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.