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 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 exclusion of the 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 available in the following lengths to accommodate difference 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the AtriClip LAA Exclusion System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria for a novel device.

The document does not contain acceptance criteria or performance data in the way typically expected for a new device's clinical or algorithmic performance. Instead, it aims to show that a modified version of an already cleared device (AtriClip LAA Exclusion System, K191413) is substantially equivalent to that predicate. This means the manufacturer did not conduct a new study to establish performance against acceptance criteria for a novel device.

Here's what can be inferred from the document regarding the information requested, with caveats:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated for this submission as it's a modification to an already cleared device. The "acceptance criteria" here are implicitly that the modified device's performance is equivalent to the predicate device and that the modifications do not introduce new safety or effectiveness concerns.
Reported Device Performance: The document states that "verification and validation testing... Demonstrated equivalency in performance" to the predicate device. However, specific performance metrics or a table comparing them are not provided in this summary. The comparison table focuses on design and material characteristics, not performance data points.

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

This is not a clinical study on a new device. The document mentions "preclinical animal studies (Kamohara 2005, 2006)" and a "human clinical study (Starck 2012)" to support the predicate device's description, confirming electrical isolation (acute and chronic for animal, acute for human). However, no new sample sizes or data provenance for a "test set" are provided for this specific 510(k) modification. The modification primarily concerns an alternate raw material supplier for titanium and minor proprietary name changes.

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

Not applicable to this 510(k) submission. This type of information would be relevant for studies establishing ground truth for diagnostic devices or software, not for demonstrating substantial equivalence of a modified implantable clip.

4. Adjudication Method:

Not applicable for this type of submission.

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

No, a MRMC comparative effectiveness study was not done for this 510(k). This is an implantable clip, not an AI or imaging diagnostic device where MRMC studies are common.

6. Standalone Performance Study (Algorithm Only):

No, this is an implantable medical device, not an algorithm.

7. Type of Ground Truth Used:

For the predicate device, the "ground truth" for electrical isolation was established through "preclinical animal studies (Kamohara 2005, 2006)" (acute and chronic electrical isolation) and a "human clinical study (Starck 2012)" (acute electrical isolation). This implies physiological measurements and clinical observations.
For this specific 510(k) submission, the "ground truth" for the modifications is demonstrating that the changes (e.g., alternate raw material supplier) do not alter the established performance and safety of the predicate device, likely through bench testing and material characterization, not patient-level "ground truth."

8. Sample Size for the Training Set:

Not applicable. This is not a machine learning model.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary of what the document focuses on instead:

The core of this 510(k) notification is a comparison of technological characteristics between the previously cleared AtriClip LAA Exclusion System (predicate) and the modified version. The comparison table (pages 4-5) highlights that almost all features (Proprietary Name, Device Classification, Regulatory Class, FDA Division, Performance Standards, Intended Use, Device Description, Software, Shelf Life, Biocompatibility, Sterilization, Sterility Assurance Level, Pyrogen, Suture Material, Preloaded Clip, Clip Opening) are "Same" between the predicate and the modified device. The only noted change regarding the clip itself is the addition of an "alternate raw material supplier of the titanium for the AOD1 clip."

The conclusion states that AtriCure "demonstrated that the modifications made to the AtriClip LAA Exclusion System are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the previously cleared AtriClip LAA Exclusion System (K191413)." This equivalency was supported by "verification and validation testing" which "Demonstrated equivalency in performance," "Device biocompatibility remains unchanged," and "Did not raise any new issues of safety." However, the details of these tests and their specific results against quantitative acceptance criteria are not provided in this public summary.

Summary

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March 3, 2021

AtriCure, Inc. Mary Galeano Senior Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040

Re: K210293

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: January 29, 2021 Received: February 2, 2021

Dear Mary Galeano:

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.

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

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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 531-542 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 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 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) K210293

Device Name

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip

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)
X 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 45040
Contact Person:	Mary Galeano, RACSr. Regulatory Affairs SpecialistP: 513-257-6279
Alternate Contact:	Jonathan McElwee, RACSr. Manager, Regulatory AffairsP: 513-795-9127
Date Prepared:	03/03/2021

ll. Device Information

Proprietary Name:	AtriClip™ LAA Exclusion System with preloaded Gillinov-Cosgrove Clip(LAA0, ACH1, ACH2, PRO1, and PRO2)AtriClip™ LAA Exclusion System with preloaded V-Clip(PROV and ACHV)
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:	The device proposed for modification in this submission is theAtriClip LAA Exclusion System cleared via K191413 on August 212019.

III. Device Description

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Intended Use/ Indications for Use

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.

IV. Comparison of Technological Characteristics with the Predicate Device (AtriClip LAA Exclusion System - K191413)

#	Feature	Previously Cleared AtriClip™ LAAExclusion System	Modified AtriClip™ LAA ExclusionSystem	EquivalenceComparison
1	Proprietary Name	AOD1: AtriClip LAA Exclusion System withPreloaded Gillinov-Cosgrove ClipAOD2: AtriClip LAA Exclusion System withPreloaded PROV Clip	AOD1: AtriClip LAA Exclusion System withPreloaded Gillinov-Cosgrove ClipAOD2: AtriClip LAA Exclusion System withPROV Clip	Same
		2	Clip ApplierProduct Code(s)
3	DeviceClassification	21 CFR 878.4300,product code: PZX	21 CFR 878.4300,product code: PZX	Same
4	Regulatory Class	Class II	Class II	Same
5	FDA Division	Cardiovascular	Cardiovascular	Same
6	PerformanceStandards	No performance standards applicable tothis product have been promulgated byFDA	No performance standards applicable tothis product have been promulgated byFDA	Same
7	Intended Use	The AtriClip LAA Exclusion System isindicated for the exclusion of the heart's leftatrial appendage, performed under directvisualization and in conjunction with othercardiac surgical procedures.Direct visualization, in this context, requiresthat the surgeon is able to see the heartdirectly, with or without assistance from acamera, endoscope, etc., or otherappropriate viewing technologies.	The AtriClip LAA Exclusion System isindicated for the exclusion of the heart's leftatrial appendage, performed under directvisualization and in conjunction with othercardiac surgical procedures.Direct visualization, in this context, requiresthat the surgeon is able to see the heartdirectly, with or without assistance from acamera, endoscope, etc., or otherappropriate viewing technologies.	Same
#	Feature	Previously Cleared AtriClip™ LAAExclusion System	Modified AtriClip™ LAA ExclusionSystem	EquivalenceComparison
8	DeviceDescription in theInstructions forUse	The AtriClip LAA Exclusion Systemcontains the Gillinov-Cosgrove LAA Clip(Clip) for exclusion of the heart's left atrialappendage (LAA). Preclinical animalstudies (Kamohara 2005, 2006)demonstrate that complete exclusion withthe Clip also results in acute and chronicelectrical isolation of the LAA. A humanclinical study (Starck 2012) hasdemonstrated acute electrical isolation.Chronic electrical isolation has not beenevaluated in human clinical studies.The Clip is pre-loaded on a disposableClip applier. The AtriClip LAA ExclusionSystem with preloaded Gillinov-CosgroveClip does not contain natural rubber latexcomponents.	The AtriClip LAA Exclusion Systemcontains the Gillinov-Cosgrove LAA Clip(Clip) for exclusion of the heart's left atrialappendage (LAA). Preclinical animalstudies (Kamohara 2005, 2006)demonstrate that complete exclusion withthe Clip also results in acute and chronicelectrical isolation of the LAA. A humanclinical study (Starck 2012) hasdemonstrated acute electrical isolation.Chronic electrical isolation has not beenevaluated in human clinical studies.The Clip is pre-loaded on a disposableClip applier. The AtriClip LAA ExclusionSystem with preloaded Gillinov-CosgroveClip does not contain natural rubber latexcomponents.	Same
9	Software	This product does not contain software.	This product does not contain software.	Same
10	Shelf Life	3 years.	3 years.	Same
11	Biocompatibility	Passed. Materials have been assessedbased on ISO 10993 and are commonlyemployed in tissue contacting devices.	Passed. Materials have been assessedbased on ISO 10993 and are commonlyemployed in tissue contacting devices.	Same
12	Sterilization	Gamma Irradiation.	Gamma Irradiation.	Same
13	SterilityAssurance Level	10-6 SAL	10-6 SAL	Same
14	Pyrogen	Non-Pyrogenic.	Non-Pyrogenic.	Same
Clip
15	Suture Material	Polyethylene Terephthalate	Polyethylene Terephthalate	Same
16	Preloaded Clip	AOD1: Preloaded Gillinov-Cosgrove ClipAOD2: Preloaded V-Clip	AOD1: Preloaded Gillinov-Cosgrove ClipAOD2: Preloaded V-Clip	Same
17	Clip Opening	AOD1: Opens 12.5mm ± 1.5mm asmeasured between the beams of theAOD1 clip.AOD2: Opens AOD2 Clip to a minimum of12mm at the distal end and 4mm at theproximal end of the clip.	AOD1: Opens 12.5mm ± 1.5mm asmeasured between the beams of theAOD1 clip.AOD2: Opens AOD2 Clip to a minimum of12mm at the distal end and 4mm at theproximal end of the clip.	Same
19	Biocompatibility	Passed. Materials have been assessedbased on ISO 10993 and are commonlyemployed in tissue contacting devices.	Passed. Materials have been assessedbased on ISO 10993 and are commonlyemployed in tissue contacting devices.	Same
20	Sterilization	Gamma Irradiation.	Gamma Irradiation.	Same

AtriCure added an alternate raw material supplier of the titanium for the AOD1 clip.

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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:
- o Demonstrated equivalency in performance
- Device biocompatibility remains unchanged o
- Did not raise any new issues of safety o

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V. Performance Data

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 do not add or remove any features of the device or change the clinical application.

The proposed changes do not include any chanqe 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.

VI. Conclusions

AtriCure has demonstrated that the modifications made to the AtriClip LAA Exclusion System are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the previously cleared AtriClip LAA Exclusion System) per K191413.

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.