The EpiAccess System with introducer needle and integrated needle tip pressure transducer is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in electrophysiology procedures in adult patients.

Device Description

The modified EpiAccess System consists of the following components and accessories: a sterile, single-use (disposable) Tuohy Type Needle with an integrated, distal, needle tip pressure transducer (sensor), and a reusable integrated Control Unit (Gen2). The EpiAccess Needle component remains the same as with the predicate device.

The reusable Control Unit (Gen2) has been modified for a reduction in overall size, which eliminates the need for a custom cart. The modified Control Unit component also allows for connection to an existing display monitor in the Cath Lab rather than having a dedicated touch screen LCD display monitor as with the predicate device.

Both Control Unit components are for use with the cleared EpiAccess Needle component and have an input for a commercial A-Line component and video output to a display monitor. Both the modified and the predicate device use embedded, validated software with the same algorithm to provide the same pressure/frequency information to the user via the same graphical user interface screen for the same intended use.

The EpiAccess System displays the pressure measurement information, which physicians may be able to use to determine needle tip location based on known anatomical pressure differences. This additional information regarding needle tip location is an added convenience feature over standard Tuohy introducer needles for epicardial access. The system does not alert the user to tip location or provide clinical decision guidance. The EpiAccess Needle is placed under visualization with fluoroscopic imaging standard for electrophysiology procedures.

Both control unit components are reusable and not patient contacting. Both control units have been tested and passed for electrical safety and EMC, reliability, and transit testing.

AI/ML Overview

This document describes a 510(k) premarket notification for the EpiAccess System (with A0005 EpiAccess Control Unit (Gen2)). The submission is for a modification to a previously cleared device, focusing on changes to the control unit. Therefore, the performance data presented is primarily to demonstrate that the modified device remains equivalent to the predicate device and does not introduce new safety or efficacy concerns.

Here's an analysis of the provided information against your requested criteria:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the typical format of quantitative metrics (e.g., sensitivity, specificity, accuracy) that would be expected for an AI/algorithm-based device.

Instead, the submission focuses on demonstrating that the modified device (EpiAccess System with Control Unit (Gen2)) meets design requirements and performs equivalently to its predicate device (K142245). The performance data cited are primarily for general device safety, electrical safety, EMC, packaging validation, software validation, and usability.

Category	Acceptance Criteria (Implied)	Reported Device Performance
General Device Performance	Function as intended; meets defined design requirements; performs in a manner equivalent to the predicate device; safe; meets design inputs; raises no new safety or efficacy concerns.	"In all instances, the modified EpiAccess System functioned as intended and results observed were as expected. These test results confirm that EpiAccess System is safe, meets the design inputs, and raises no new safety or efficacy concerns."
Risk Management	Compliance with BS EN ISO 14971:2012 (Medical Devices – Application of Risk Management to Medical Devices).	Performed "risk analysis" as part of design control activities.
Electrical Safety & EMC	Compliance with IEC 60601-1 Edition 3.1, ANSI/AAMI/IEC 60601-1-2 Edition 4.0, and IEC 60601-1-6 Edition 3.1.	"Both control units have been tested and passed for electrical safety and EMC." Specific compliance to the listed standards is implied by their inclusion under nonclinical testing.
Packaging Validation	Compliance with ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems).	Performed packaging validation.
Software Validation	Compliance with BS EN ISO 62304:2015, FDA Guidance (Jan 11, 2002), FDA Guidance (May 11, 2005), and FDA Guidance (Sep 9, 1999). Software algorithm for pressure/frequency information must be the same and validated.	"embedded, validated software with the same algorithm to provide the same pressure/frequency information to the user." Software validation was performed.
Usability & Human Factors	Compliance with IEC 62366:2015 (Medical Devices - Application of Usability Engineering to Medical Devices).	Performed usability and human factors testing.
Substantial Equivalence	Same intended use, indications for use, and similar technological characteristics as the predicate device (K142245). Differences do not adversely affect safety and effectiveness or raise different questions of safety and efficacy. No new questions of safety or effectiveness due to minor differences in dimensions and design of the Control Unit (Gen2).	"The EpiAccess System has the same intended use and indications for use, and similar technological characteristics as the predicate device." "performance testing demonstrated that these differences do not adversely affect the safety and effectiveness... or different question of safety and efficacy." "The minor differences... do not raise any new questions of safety or effectiveness."

Important Note: This device is a catheter introducer system that relies on pressure measurements, and the key "algorithm" mentioned is "the same algorithm to provide the same pressure/frequency information to the user." This is not an AI/ML algorithm in the modern sense that classifies, predicts, or makes diagnostic recommendations. It is a measurement and display system.

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

The document does not specify a distinct "test set" in the context of an algorithm evaluation with a specific number of cases or images. The testing described is primarily engineering verification and validation testing for hardware, software, and system functionality. This type of testing typically involves a sufficient number of units to demonstrate statistical confidence per design and quality system requirements, but not a large "test set" of patient data as would be used for AI/ML performance.

Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned, as this is bench testing on the device itself.

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 is not applicable to the type of testing described. Ground truth as typically understood for AI/ML validation (e.g., expert labels on images, pathology results) would not be established for the electrical safety, EMC, software functionality, or general performance tests of a medical device's control unit. The "ground truth" here is the expected behavior and measurement accuracy of the device itself, verified by engineers against specifications.

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

Not applicable. There is no mention of expert adjudication for defining ground truth in the context of the described device 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 MRMC study was conducted or is mentioned. The device provides "additional information regarding needle tip location" as an "added convenience feature" and "does not alert the user to tip location or provide clinical decision guidance." Therefore, a comparative effectiveness study showing improvement with AI assistance is not relevant or described.

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

The device's software algorithm provides pressure/frequency information to the user. It is not an AI that performs a standalone diagnostic function. The functioning of the software algorithm was validated as part of the overall software validation, ensuring it provides "the same pressure/frequency information." However, this is distinct from "standalone performance" of an AI algorithm in isolation.

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

Not applicable in the context of AI/ML ground truth. For the described engineering tests, "ground truth" would be the pre-defined engineering specifications, expected electrical characteristics, mechanical performance, and software outputs.

8. The sample size for the training set

Not applicable. The device's software uses a previously validated, fixed algorithm. There is no mention of machine learning or an AI model that would require a "training set."

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

Not applicable, as there is no training set for an AI/ML model.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 09, 2017

EpiEP, Inc. % Elsa Abruzzo CEO/Founder Cygnus Regulatory 3753 Vineyard Place Cincinnati, Ohio 45226

Re: K170831

Trade/Device Name: EpiAccess System (with A0005 EpiAccess Control Unit (Gen2)) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 12, 2017 Received: April 19, 2017

Dear Elsa Abruzzo:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Willemen

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) K170831

Device Name

EpiAccess System (with A0005 EpiAccess Control Unit (Gen2))

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201.66)
☑	☐

| X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary EpiEP, Inc.'s EpiAccess System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

EpiEP, Inc.

Phone: 1-434-951-0444 Facsimile: 1-434-951-0478

Contact Person: Elsa Chi Abruzzo, RAC, FRAPS Date Prepared: March 12, 2017

Name/Address of Sponsor

EpiEP, Inc. 195 Church Street, 17th Floor,

New Haven, CT 06510

Trade Name:	EpiAccess System (with A0005 EpiAccess Control Unit (Gen2))
Common or Usual Name	Epicardial Introducer System
Classification Name	Introducer, Catheter
Classification:	Class II
Product Code andRegulation:	DYB, 21 CFR 870.1340
Classification Panel:	Cardiovascular
Predicate Devices:	EpiEP, Inc.	EpiAccess System	K142245

Purpose of the Special 510(k) notice.

The device is a modification to previously cleared EpiEP, Inc. EpiAccess System.

Intended Use / Indications for Use

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Technological Characteristics

Both control unit components are reusable and not patient contacting. Both control units have been tested and passed for electrical safety and EMC, reliability, and transit testing.

Performance Data

Bench tests were conducted on the modified EpiAccess System with the Control Unit (Gen2) to demonstrate that it meets defined design requirements and can perform in a manner equivalent to EpiAccess System predicate device (K142245). Testing included verification and validation testing.

Manufacturing and traceability of devices tested were conducted in accordance with 21 CFR 820 Good Manufacturing Practices and BS EN ISO 13485:2016 Medical Devices – Quality Management Systems - Requirements for Regulatory Purposes. In all instances, the modified EpiAccess System functioned as intended and results observed were as expected. These test results confirm that EpiAccess System is safe, meets the design inputs, and raises no new safety or efficacy concerns. A summary of the EpiAccess Systems design control activities with regards to risk analysis and verification and validation activities is provided in this 510 (k) submission.

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Nonclinical testing included:

Performance testing per the applicable sections of:

BS EN ISO 14971:2012	Medical Devices – Application of Risk
	Management to Medical Devices

Electrical Safety and Electromagnetic Compatibility (EMC) per the applicable sections of:

IEC 60601-1 Edition 3.1	Medical Electrical Equipment – Part 1: GeneralRequirements for Basic Safety and EssentialPerformance
ANSI/AAMI/IEC 60601-1-2 Edition 4.0	Medical Electrical Equipment – Part 1-2: GeneralRequirements for Basic Safety and EssentialPerformance - Collateral Standard: ElectromagneticDisturbances - Requirements and Tests
IEC 60601-1-6 Edition 3.1	Medical Electrical Equipment - Part 1-6: GeneralRequirements for Basic Safety and EssentialPerformance - Collateral Standard: Usability

Packaging validation in compliance with applicable sections of:

ASTM D4169-16	Standard Practice for Performance Testing of
	Shipping containers and Systems

Software validation in compliance with applicable sections of:

BS EN ISO 62304:2015	Medical Device Software – Software Life CycleProcesses
FDA Guidance (Jan 11, 2002)	General Principles of Software Validation; FinalGuidance for Industry and FDA Staff
FDA Guidance (May 11, 2005)	Guidance for the Content of PremarketSubmission for Software Contained in MedicalDevices
FDA Guidance (Sep 9, 1999)	Off-The-Shelf Software Use in Medical Devices

Usability and Human Factors Testing in compliance with applicable sections of:

IEC 62366:2015	Medical Devices - Application of Usability
	Engineering to Medical Devices

Substantial Equivalence

The EpiAccess System has the same intended use and indications for use, and similar technological characteristics as the predicate device. The technological characteristics of the EpiAccess System with the Control Unit (Gen2) modification are substantially equivalent to the predicate device EpiAccess System (K142245). Where differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the proposed device or different question of safety and efficacy.

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Conclusions

The EpiAccess System modified with the Control Unit (Gen2) has the same intended use, indications, principles of operation, and technological characteristics as the EpiEP, Inc.'s previously cleared EpiAccess System (K142245). The minor differences in dimensions and design of the Control Unit (Gen2) component for the modified EpiAccess System do not raise any new questions of safety or effectiveness. Thus, EpiAccess System modified with the Control Unit (Gen2) is substantially equivalent to its predicate devices.

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).