The ViaOne Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to deliver diagnostic and therapeutic interventions for ventricular tachycardia.

Device Description

ViaOne Epicardial Access System is a sterile, single-use access tool consisting of a concealed needle within a leading channel to facilitate guidewire access into the pericardium through a subxiphoid incision. The device consists of a radiopaque distal tip designed to retract a portion of the pericardial tissue into the device, and away from the heart muscle, where it is punctured by the concealed needle and a guidewire is introduced into the pericardial space.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the ViaOne Epicardial Access System. However, it does not contain the detailed acceptance criteria and the specific study results in a format that would allow for a complete table of acceptance criteria and reported device performance.

The text generally states that the device "met the predetermined acceptance criteria" and "All tests were successfully completed and passed, and the device met the defined acceptance criteria." but does not quantify these criteria or results.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document lists performance tests but does not state the specific acceptance criteria (e.g., "tensile strength > X N") nor the quantitative results from those tests (e.g., "tensile strength Y N").

2. Sample size used for the test set and the data provenance

Biocompatibility: Not specified.
Sterilization, Packaging and Shelf Life Testing: Not specified.
Performance Testing: Not specified for individual tests.
Animal Study: Not specified (e.g., number and type of animals).
Clinical Information: "multi-central clinical trial which included VT subjects." The exact number of subjects is not specified. Data provenance (country of origin, retrospective/prospective) explicitly is not specified, though "multi-central" implies a prospective clinical trial.

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

This information is not provided for any of the studies mentioned.

4. Adjudication method for the test set

This information is not provided for any of the studies mentioned.

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

An MRMC study is not applicable to this device. The ViaOne Epicardial Access System is an access tool, not an AI-powered diagnostic device.

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

A standalone performance study of an algorithm is not applicable to this device as it is a physical medical device, not an AI algorithm.

7. The type of ground truth used

Biocompatibility: Established by ISO 10993-1 standards.
Sterilization, Packaging and Shelf Life Testing: Established by ISO 11135-1 standards and internal performance criteria.
Performance Testing: Established by internal design specifications and ISO 11070:2014 standards.
Animal Study: Ground truth was based on observation of device performance, malfunction, and Histopathology evaluation and pathological examination.
Clinical Information: Ground truth for adverse events would be clinical observation and diagnosis by medical professionals. Ground truth for pericardial space access success would be confirmed during the procedure.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as this is a physical medical device.

Summary of available and missing information:

Information Category	Status in Document
1. Table of Acceptance Criteria and Reported Device Performance	Missing (Qualitative statements only)
2. Sample size for test set	Missing (Not specified for any study type)
2. Data Provenance (country, retrospective/prospective)	"multi-central clinical trial" implies prospective; country not specified for clinical or animal studies
3. Number of experts & qualifications for ground truth	Missing
4. Adjudication method	Missing
5. MRMC comparative effectiveness study? Effect size?	Not Applicable (Not an AI device)
6. Standalone (algorithm only) performance?	Not Applicable (Not an AI device)
7. Type of Ground Truth Used	ISO standards, pathological examination (animal), clinical observation (human trials)
8. Sample size for training set	Not Applicable (Not an AI device)
9. How ground truth for training set was established	Not Applicable (Not an AI device)

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION" in blue.

March 20, 2025

CardioVia Ltd. Orly Maor Company Regulatory Consultant Wadi El Haj, 13, P.O. Box 1252 Nazareth, 17111 Israel

Re: K243928

Trade/Device Name: ViaOne Epicardial Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: December 16, 2024 Received: December 20, 2024

Dear Orly Maor:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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 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) K243928

Device Name ViaOne Epicardial Access System

Indications for Use (Describe)

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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510(k) Summary

Traditional Premarket Notification Submission - 510(k) ViaOne Epicardial Access System 510(k) Number K243928

Date Prepared: March 20, 2025

L SUBMITTER

CardioVia Ltd. Wadi El Haj, 13, P.O. Box 1252 1711 Nazareth, Israel M: +(972) 524807162 T: +(972) 46098609 W: www.cardiovia.com

Contact Person

Orly Maor 25 Sirkin Street Kfar Saba 44421 Israel Tel: +972-9-7453607 oram.ma@gmail.com

II. DEVICE

Name of Device: ViaOne Epicardial Access System Common or Usual Name: ViaOne Classification Name: Introducer, Catheter Regulatory Class: Class II, per 21 CFR 870.1340 Product Code: DYB. Classification Panel: Cardiovascular

III. PREDICATE DEVICE

CardioVia Ltd. believes that the ViaOne Epicardial Access System, which is the subject of this premarket notification, is substantially equivalent to the following predicate device:

AtriCure, Inc. EPi-Ease™ Epicardial Access System (EAS) cleared under K233959 (product . code DYB Regulation No. 21 CFR 870.1340).

DEVICE DESCRIPTION IV.

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INDICATIONS FOR USE v.

TECHNOLOGICAL CHARACTERISTICS WITH THE VI. COMPARISON OF PREDICATE DEVICE

ViaOne Epicardial Access System has the same intended use as the predicate device. Its indications for use are identical to that of the predicate device. The ViaOne Epicardial Access System has similar technological characteristics to the predicate device as demonstrated in the table below.

Feature	Proposed:ViaOne EpicardialAccess System	Predicate:EPi-Ease™Epicardial AccessSystem (EAS)	SE Justification
510(k) Number	K243928	K233959
Manufacturer	CardioVia Ltd.	AtriCure, Inc.
Product Code	DYB	DYB	Same
CFR	21 CFR 870.1340	21 CFR 870.1340	Same
Intended Use	The ViaOneEpicardial AccessSystem is intended toaccess the epicardialsurface of the heart viaa subxiphoid approachto deliver diagnosticand therapeuticinterventions forventriculartachycardia.	The EPi-Ease™Epicardial AccessSystem is intendedto access theepicardial surfaceof the heart viasubxiphoidapproach.	SameWithin the predicatescope (The indicationwas confirmed underFDA's BreakthroughDevice Designation)
Access	Sub-xiphoid	Sub-xiphoid	Same
Needle size andDevice profile	17.5 Ga. Needle(similar to Tuohy - 17Ga.)11 Fr. device profile	22 Ga. Tuohyneedle18 Fr. device profile	SimilarViaOne device profileis 2/3 of the predicateand the smaller needlediameter has no impacton safety as it isconcealed and intendedto puncture thepericardium within thetube
Visualization	Fluoroscopy required.Endoscopicvisualization-Notrequired	Fluoroscopy Required.Endoscopicvisualization-Optional	Same
Feature	Proposed:ViaOne EpicardialAccess System	Predicate:EPi-Ease™Epicardial AccessSystem (EAS)	SE Justification
Tissue retraction	Engagementelement enableretraction	Vacuum enableretraction	DifferentAlthough capturing ofthe tissue is performeddifferently it brings thesame result of insertingthe pericardium into asealed compartment
Radiopaque marker	Yes-distal tip	Yes-distal tip	Same
OperatingPrinciples	Advancementthrough adiposetissue to reachpericardial sac,needle puncturespericardial sac,guidewire advancesthrough needle intopericardial sac,introducer advancesover guidewire andpre- dilatespericardial sac,sheath advancesover guidewire intopericardial sac toaccess epicardialsurface of the heart.Needleadvancement limitsto mitigate risksassociated with thepredicate.	Advancementthrough adiposetissue to reachpericardial sac,needle puncturespericardial sac,guidewire advancesthrough needle intopericardial sac,introducer advancesover guidewire andpre- dilatespericardial sac,sheath advancesover guidewire intopericardial sac toaccess epicardialsurface of the heart.Needleadvancement limitsto mitigate risksassociated with thepredicate.	Same
Reuse	Single Use.	Single Use.	Same
Environments ofUse	OR with imagingequipment,includingfluoroscopy understerile technique.	OR with imagingequipment,includingfluoroscopy understerile technique.	Same
Sterilization	Sterile for singleuse (EtO).	Sterile for singleuse (EtO).	Same

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VII. PERFORMANCE DATA

The following performance data were conducted. The ViaOne Epicardial Access System met the predetermined acceptance criteria ensuring substantial equivalence to the predicate. No new safety or effectiveness issues were raised during testing:

. Biocompatibility

Biocompatibility evaluation in compliance with ISO 10993-1 was performed. The following tests were conducted:

Cytotoxicity Study - ViaOne
Cytotoxicity Study fluid path ●
ISO Intracutaneous /irritation Study ●
Sensitization Test ●
. Acute Systemic Toxicity Study
. Pyrogen Study - Material Mediated Study

All tests were successfully completed and passed, and the device met the defined acceptance criteria and was found to be biocompatible.

● Sterilization, Packaging and Shelf Life Testing

Sterilization validation was performed to demonstrate compliance with ISO 11135-1. In addition, transportation simulation and environmental tests prior to real-time shelf life that included packaging testing and performance to support the one year labeled shelf life.

All tests were successfully completed and passed. and the device met the defined acceptance criteria.

● Performance Testing

Performance testing included the following:

Simulated Use O
o Dimensions
Visual inspection surface analysis O
Spring force O
Tensile Strength O
Radiopacity o
o Corrosion
Engagement element functionality о
· Verification testing, following ISO 11070:2014 standards including:
- Outer tube surface analysis
- Outer tube rim analysis
- Laser-cut flower shaft & outer tube rim inspection

All tests were successfully completed and passed, and the device met the defined acceptance criteria.

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● Animal Study

Animal Study evaluated the ViaOne Epicardial Access System safety and performance. The devices performed as intended without malfunction. The Histopathology evaluation and pathological examination indicated that there were or clinically significant events following use of the ViaOne Epicardial Access System.

● Clinical Information

CardioVia provided information on clinical experience from its multi-central clinical trial which included VT subjects. The primary endpoint of the clinical study focused on the occurrence and resolution of adverse events associated with the ViaOne device. The secondary endpoint of the clinical study evaluated the success rate of pericardial space access. The observed adverse events were consistent with those expected in similar epicardial procedures and were resolved without additional intervention. The collected clinical data demonstrated a safety profile consistent with established standards and demonstrates that the ViaOne Epicardial Access System supports its intended use in the indicated population.

VIII. CONCLUSIONS

CardioVia has demonstrated that the ViaOne Epicardial Access System 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 EPi-Ease Epicardial Access 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).