EpiAccess System

K170831 · Epiep, Inc. · DYB · May 9, 2017 · Cardiovascular

Device Facts

• Record ID: K170831
• Device Name: EpiAccess System
• Applicant: Epiep, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: May 9, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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 Story

System facilitates epicardial access during electrophysiology procedures; utilizes sterile, single-use Tuohy needle with integrated distal pressure transducer; connects to reusable Control Unit (Gen2). Input: pressure signals from needle tip; output: real-time pressure/frequency information displayed on Cath Lab monitor. Used in clinical setting by physicians; needle placed under fluoroscopic guidance. System provides pressure data to assist physician in determining needle tip location based on anatomical pressure differences; does not provide clinical decision guidance or alerts. Modification from predicate involves reduced Control Unit size, removal of dedicated touch screen, and integration with existing lab display monitors. Benefits include improved convenience for epicardial access.

Clinical Evidence

Bench testing only. Verification and validation testing performed to demonstrate compliance with design requirements and equivalence to predicate. Testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 62366), and software validation (BS EN ISO 62304). No clinical data presented.

Technological Characteristics

System comprises single-use Tuohy needle with integrated pressure transducer and reusable Control Unit (Gen2). Connectivity: video output to external Cath Lab display monitor. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 62366 (usability), BS EN ISO 62304 (software). Software: embedded, validated, rule-based algorithm for pressure/frequency processing. Sterilization: single-use needle component.

Indications for Use

Indicated for adult patients undergoing electrophysiology procedures requiring access to the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• EpiAccess System (K142245)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 201 Subpart D)</span> | <span style="text-decoration: underline;">Over-The-Counter Use (21 CFR 201.66)</span> |
| <span style="text-decoration: underline;">☑</span> | <span style="text-decoration: underline;">☐</span> |

| 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: [phone] 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 and<br>Regulation: | 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

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.

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## Technological Characteristics

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.

#### 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: General<br>Requirements for Basic Safety and Essential<br>Performance |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI/AAMI/IEC 60601-1-2 Edition 4.0 | Medical Electrical Equipment – Part 1-2: General<br>Requirements for Basic Safety and Essential<br>Performance - Collateral Standard: Electromagnetic<br>Disturbances - Requirements and Tests |
| IEC 60601-1-6 Edition 3.1 | Medical Electrical Equipment - Part 1-6: General<br>Requirements for Basic Safety and Essential<br>Performance - 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 Cycle<br>Processes |
|-----------------------------|--------------------------------------------------------------------------------------------------|
| FDA Guidance (Jan 11, 2002) | General Principles of Software Validation; Final<br>Guidance for Industry and FDA Staff |
| FDA Guidance (May 11, 2005) | Guidance for the Content of Premarket<br>Submission for Software Contained in Medical<br>Devices |
| 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.