EPi-Ease is composed of a radiopaque blunt distal tip, a distal suction port designed to draw pericardial tissue into the device, a hollow 22-gauge Tuohy needle that enables puncture of the pericardium internal to the device, and a lumen to allow for insertion of an endoscope to provide direct visualization during blunt dissection, needle puncture, and guidewire delivery. The distal suction port connects to the device handle and terminates in a standard luer connection. The needle connects to the handle and terminates in a needle actuator, which enables extension, and rotation of the encased needle a limited distance within the distal tip and provides a port for insertion of a commercially available guidewire. After puncture, the device allows passage of a standard, commercially available .014" guidewire. An additional flushing port is available using the 3-way stopcock.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the EPi-Ease™ Epicardial Access System (EAS), by the FDA. However, it does not contain information about a study involving an AI/Machine Learning algorithm or human readers. The document focuses on the mechanical and design verification and validation of a physical medical device (an epicardial access system) in comparison to a predicate device, as required for a 510(k) submission.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and reported device performance related to an AI/ML study.
Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for an AI/ML test set.
MRMC comparative effectiveness study, effect size, or standalone AI performance.
Ground truth type, training set sample size, or how ground truth for the training set was established in the context of an AI/ML study.

The document lists "Performance Data" which refers to bench testing conducted on the physical device to ensure mechanical integrity, biocompatibility, shelf-life, etc., demonstrating substantial equivalence to a predicate device. This is a common requirement for physical medical devices and is distinct from studies required for AI/ML-driven devices.

Here's an interpretation of the "acceptance criteria" and "study" mentioned in the document for the physical device:

Acceptance Criteria and Study for the EPi-Ease™ Epicardial Access System (EAS)

The document states: "The EPi-Ease device met the predetermined acceptance criteria ensuring substantial equivalence to the predicate." The "study" here refers to the a series of bench tests, not an AI/ML performance study.

1. Table of Acceptance Criteria and Reported Device Performance (for the physical device):

Test Description	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Testing	Device operates as intended, maintains structural integrity, compatible with accessories (endoscope, guidewire).	PASS
Biocompatibility Testing (per ISO 10993-1)	Device materials are safe for human contact.	PASS
Shelf-Life Testing (ASTM F1980-16)	Device maintains functionality and sterile barrier over its stated shelf life.	PASS
Transit Testing (per ISTA 3A)	Device withstands shipping and handling without damage.	PASS
Sterilization (per ISO 11137)	Device achieves and maintains sterility.	PASS
Synthetic Model (CADet) testing	Device functions as intended in a simulated anatomical environment.	PASS

2. Sample sized used for the test set and the data provenance:

This information (specific sample sizes for each bench test) is not provided in the document.
Data provenance: The testing was performed as part of the device's regulatory submission, likely at the manufacturer's facility or approved test labs. This is not "data provenance" in the sense of patient data for an AI/ML model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the document describes bench testing of a physical device, not an AI/ML model requiring expert consensus for ground truth. The "ground truth" for these tests are objective measurements and established standards (e.g., ISO, ASTM).

4. Adjudication method for the test set:

This is not applicable for the bench testing described. Test results are determined by meeting pre-specified engineering and performance specifications.

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, an MRMC study was not done. This device is a physical medical instrument, not an AI-assisted diagnostic tool.

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

No, this is not applicable. The device is a physical instrument, not an algorithm.

7. The type of ground truth used:

The ground truth for the bench tests are engineering specifications, material standards (e.g., ISO, ASTM), and functional performance criteria established for medical devices of this type, ensuring safety and effectiveness.

8. The sample size for the training set:

This is not applicable. The document describes a physical device, not an AI/ML model that undergoes training.

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

This is not applicable. There is no "training set" in the context of this device's development as described.

In summary, the provided document is a 510(k) clearance letter for a physical medical device, not an AI/Machine Learning product. Therefore, the specific questions related to AI/ML model testing and validation cannot be answered from the given text.

Summary

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February 13, 2024

AtriCure, Inc. Jenifer Ulrikson Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040

Re: K233959

Trade/Device Name: EPi-EaseTM Epicardial Access Device (EAS) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: December 14, 2023 Received: December 15, 2023

Dear Jenifer Ulrikson:

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.

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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" (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 QS 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.

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).

Sincerely,

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices

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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) K233959

Device Name

EPi-Ease™ Epicardial Access System (EAS)

Indications for Use (Describe)

The EPI-Ease™ Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K233959

510(k) Summary

Applicant Information

Manufacturer:

AtriCure, Inc. 7555 Innovation Way Mason Ohio 45040

Contact Person:

Jeni Ulrikson Senior Regulatory Affairs Specialist Cell: 763-691-3904

Device Information
Proprietary Name:	EPi-Ease™ Epicardial Access System (EAS)
Common Name:	EPi-Ease
Classification:	Introducer, CatheterRegulatory Class: Class II; per 21 CFR 870.1340Product Code: DYBClassification Panel: Cardiovascular
Predicate Device:	Agilis PF Introducer System(K111943, September 29, 2011)

Device Description

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Intended Use / Indications for Use

The EPi-Ease™ Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach.

Comparison of Technological Characteristics

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

	Feature	Predicate:Agilis Epicardial Access System	Proposed:AtriCure EPi-Ease System
1	Access	Sub-xiphoid	Sub-xiphoid
2	Needle size andDevice Profile	17 ga. Tuohy Needle18 Fr. Device Profile	22 ga. Tuohy Needle13 Fr. Device Profile
3	Visualization	Fluoroscopy requiredNo endoscopic visualization	Fluoroscopy requiredEndoscopic visualization
4	Indication for Use	The Epicardial Access System isintended to access the epicardialsurface of the heart via a subxiphoidapproach to facilitateelectrophysiology studies	The EPi-Ease™ Epicardial AccessSystem is intended to access theepicardial surface of the heart viasubxiphoid approach
5	Vacuum	N/A	Vacuum-enabled retraction
6	Radiopaque marker	Yes—distal tip	Yes—distal tip
7	Operating Principles	Advancement through adipose tissue toreach pericardial sac, needle puncturespericardial sac, guidewire advancesthrough needle into pericardial sac,introducer advances over guidewire andpre- dilates pericardial sac, sheathadvances over guidewire into pericardialsac to access epicardial surface of theheart.	Equivalent. EPi-Ease adds directvisualization, vacuum, and needleadvancement limits to mitigate risksassociated with the predicate

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Performance Data

The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate substantial equivalence to the previously cleared Agilis Introducer. The EPi-Ease device met the predetermined acceptance criteria ensuring substantial equivalence to the predicate. No new safety or effectiveness issues were raised during testing.

Non-clinical Bench Testing:

Test Description	Results
Mechanical Testing: Endoscopetesting, guidewire compatibility,structural integrity	PASS
Biocompatibility Testing per ISO10993-1	PASS
Shelf-Life Testing ASTM F1980-16	PASS
Transit Testing per ISTA 3A	PASS
Sterilization per ISO 11137	PASS
Synthetic Model (CADet) testing	PASS

Conclusion

AtriCure has demonstrated that the EPi-Ease Epicardial Access Device is substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principal, and intended use/ indication for use to the predicate device, the Agilis PF Introducer System.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).