The Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.

Device Description

The Epicardial Access System by Baylis Medical Company Inc. is a single use device that is supplied sterile to the user. The System is comprised of the following devices:

Epicardial Access Needle
Epicardial Steerable Guiding Sheath containing:
- Steerable Sheath,
- Dilator and
- J-Tip Guidewire
Epicardial Introducer and Stylet

The device is designed to provide access to the epicardial surface of the heart via a subxiphoid approach. It is used in percutaneous access procedures primarily by Electrophysiologists and Interventional Cardiologists trained in the subxiphoid approach. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy under sterile technique.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study proving device performance, specifically focusing on the Epicardial Access System.

It's important to note that the provided FDA 510(k) summary primarily focuses on benchtop and mechanical testing for substantial equivalence rather than a clinical study evaluating the device's accuracy or effectiveness in a diagnostic or AI-assisted context. Therefore, many of the requested elements (like MRMC studies, specific performance metrics for an AI algorithm, or detailed ground truth establishment for a diagnostic output) are not applicable or not explicitly stated in this type of submission. This document describes a medical device, a catheter introducer, not an AI/ML-driven diagnostic device.

Acceptance Criteria and Device Performance (Based on available information)

Since this is a submission for a Catheter Introducer (Epicardial Access System), the acceptance criteria are related to its physical and functional performance, ensuring it can safely and effectively provide access as intended. It is not an AI/ML diagnostic device, so criteria like sensitivity, specificity, or reader improvement with AI assistance are not relevant here.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests / Requirements	Reported Device Performance
Mechanical Performance	- Air and Liquid Leakage (Needle, Sheath, Dilator, Introducer)	"All test requirements were met as specified by applicable standard and the test protocols."
	- Resistance to Separation (Needle)	(Implicitly met, as above)
	- Stress Cracking (Needle)	(Implicitly met, as above)
	- Strength of Union (Various components: Hub to Hypotube, Stylet Cap, Tip to Sheath Body, etc.)	(Implicitly met, as above)
	- Torque Transmission (Sheath, Dilator)	(Implicitly met, as above)
	- Flow Rate (Introducer)	(Implicitly met, as above)
	- Tip Integrity (Introducer)	(Implicitly met, as above)
	- Three-Point Bend (Introducer)	(Implicitly met, as above)
	- Torque Withstand Test (Introducer)	(Implicitly met, as above)
	- Tensile Test (Various components)	(Implicitly met, as above)
General Physical Performance	- Corrosion Resistance (Needle, Introducer)	(Implicitly met, as above)
	- Surface Defects (Sheath, Dilator)	(Implicitly met, as above)
	- Range of Motion and Geometry (Sheath)	(Implicitly met, as above)
	- Curve Retention and Integrity (Sheath)	(Implicitly met, as above)
	- Friction (Sheath)	(Implicitly met, as above)
	- Handle Lubricity (Sheath)	(Implicitly met, as above)
	- Tip Stiffness (Sheath)	(Implicitly met, as above)
	- Compatibility	(Implicitly met, as above)
	- Flexural Modulus (Dilator)	(Implicitly met, as above)
	- Clinical Valve (Sheath)	(Implicitly met, as above)
Biocompatibility	- ISO 10993-1:2009/Cor.1:2010 compliance	"The biological safety... was verified in accordance with the requirements."
Sterilization	- ISO 11134-1:2014 & SAL of 10-6 via Ethylene Oxide	"Sterilization verification was completed... to the requirements."
	- Residual limits per ISO 10993-7:2008/Cor.1:2009	(Implicitly met, as above)
Pyrogenicity	- Meet current FDA and USP pyrogen limit specifications (LAL testing)	"The Epicardial Access System is supplied non-pyrogenic."
Packaging Validation	- Integrity through shipping/handling (ANSI/AAMI/ISO 11607:2006)	"Ship testing was performed... to ensure the integrity... through the rigors of shipping and handling."
	- Sterile barrier integrity over shelf life	"The sterile barrier integrity was validated."
Bench-top Validation (Usability/Clinical Workflow)	- Ease of use, errors made in simulated clinical workflow by "users familiar with catheter-based procedures."	"The validation testing demonstrated the devices contained in the Epicardial Access System meet the intended use to support substantial equivalence."

Study Details (as per the document):

Sample Size Used for the Test Set and Data Provenance:
- For Mechanical and General Physical Testing: The document states "All test requirements were met as specified by applicable standard and the test protocols." It doesn't specify an exact sample size for each individual test (e.g., number of needles tested for leakage). These typically involve a statistically determined sample size per test characteristic as per the relevant ISO standards (e.g., ISO 11070:2014).
- For Bench-top Validation (Usability): "A minimum of 15 users drawn from populations familiar with catheter-based procedures."
- Data Provenance: The and testing was conducted by Baylis Medical Company Inc., based in Mississauga, Ontario, Canada. The nature of these tests (mechanical, physical, chemical, and simulated usability) means that "country of origin of the data" in the sense of patient data is not applicable. These are in-vitro/ex-vivo tests. All studies described are prospective tests performed on the device prototypes/production samples.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable in the context of this device and study. The "ground truth" for mechanical testing is defined by engineering specifications and objective measurements (e.g., a specific force to failure, a specific leakage rate). For biocompatibility, it's defined by the biological response in standardized tests. For usability, it's based on observed user performance against pre-defined success criteria.
- For the bench-top validation, the "experts" were "users drawn from populations familiar with catheter-based procedures" (e.g., Electrophysiologists and Interventional Cardiologists, as mentioned in the device description). Their "errors made" and "ease of use" observations would contribute to validating the device's usability in a simulated environment, rather than establishing a diagnostic "ground truth."
Adjudication Method for the Test Set:
- None applicable in the sense of physician adjudication of image interpretations. For mechanical and physical tests, results are objectively measured against predefined pass/fail criteria. For the bench-top validation, observations were "recorded and evaluated to conclude if customer requirement were met." This implies internal evaluation against a benchmark rather than multi-expert adjudication for a diagnostic task.
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 done, and it is not applicable for this type of device. The Epicardial Access System is a physical medical device (catheter introducer), not an AI-driven diagnostic tool or an imaging software. Its performance is related to its ability to provide access to the heart, not to improve human reading accuracy of images.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm for standalone performance.
The Type of Ground Truth Used:
- For Mechanical and Physical Tests: Engineering specifications, ISO standards, and predefined pass/fail criteria (e.g., "Strength of Union," "Air and Liquid Leakage" within specified limits).
- For Biocompatibility: Standardized in-vitro and in-vivo biological tests (e.g., hemolysis, cytotoxicity, irritation) with results compared against established safety benchmarks (ISO 10993).
- For Sterilization: Confirmation of Sterility Assurance Level (SAL 10^-6) through validated methods.
- For Pyrogenicity: LAL testing against FDA and USP limits.
- For Packaging: Integrity under simulated shipping conditions per ANSI/AAMI/ISO 11607.
- For Bench-top Validation: User performance against pre-defined tasks and operational criteria in a simulated environment. The "ground truth" is whether users can successfully perform the intended actions and if critical errors occur.
The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set. The device design and manufacturing process are based on engineering principles and material science, not machine learning.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI/ML algorithm.

Summary Conclusion:

The document describes the regulatory submission for a physical medical device, an Epicardial Access System, used for catheter introduction. The acceptance criteria and performance evaluation are primarily focused on the device's mechanical, physical, material, and usability characteristics to demonstrate substantial equivalence to a predicate device. It does not involve AI or diagnostic imaging, and therefore, many of the typical questions for AI medical devices (like MRMC, training sets, or expert ground truth for diagnostic accuracy) are not relevant to this submission. The "study" here is a series of comprehensive engineering and simulated-use verification and validation activities.

Summary

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August 2, 2019

Baylis Medical Company Inc. May Tsai Manager, Regulatory Affairs 2580 Matheson Blvd. East Mississauga, L4W 4J1 Ontario, Canada

Re: K191546

Trade/Device Name: Epicardial Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 11, 2019 Received: June 12, 2019

Dear May Tsai:

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,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191546

Device Name Epicardial Access System

Indications for Use (Describe)

The Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.

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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510(K) SUMMARY

Submitter Information

A. Company Name:	Baylis Medical Company Inc.
B. Company Address:	2580 Matheson Blvd. EastMississauga, Ontario, L4W 4J1Canada
C. Company Phone:	+1 (905) 602-4875
D. Company Facsimile:	+1 (905) 602-5671
E. Contact Person:	May TsaiManager, Regulatory Affairs
F. Summary Prepared on:	11-JUN-2019

Device Identification

A. Device Trade Name:	Epicardial Access System
B. Device Common Name:	Catheter Introducer
C. Classification Name:	Catheter Introducer (21 CFR 870.1340)
D. Product Code:	DYB
E. Review Panel:	Cardiovascular
F. Device Class:	Class II

Identification of Legally Marketed Device

A. Predicate Device:	St Jude Medical Agilis™ PF Introducer System
B. Manufacturer:	St Jude Medical

ﻥ 510(k) K11943
The Agilis™ PF Introducer System is intended to D. Indications for Use access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.

Indications for Use

The Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.

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Device Description

The Epicardial Access System by Baylis Medical Company Inc. is a sinqle use device that is supplied sterile to the user. The System is comprised of the following devices:

. Epicardial Access Needle
Epicardial Steerable Guiding Sheath containing: .
- Steerable Sheath, o
- Dilator and o
- J-Tip Guidewire o
. Epicardial Introducer and Stylet

The Epicardial Access System's intended use is achieved through the following steps:

The needle advances through adipose tissue to reach the pericardial sac;
. The needle punctures the pericardial sac;
. The quidewire advances through the needle's inner lumen into the pericardial space;
. The introducer advances over the quidewire and pre-dilate the pericardial sac; and
. The Steerable Guiding Sheath (and Dilator) advances over the quidewire into the pericardial space to access the epicardial surface of the heart to facilitate electrophysiology studies.

Comparison to Predicate Device

The Epicardial Access System and predicate device share the same intended use/indications for use and fundamental scientific technology, including principles of operation and mechanism of action. Differences in design between the predicate and subject devices do not raise any different questions. The results of verification and validation testing provide reasonable assurance for the Epicardial Access System.

Characteristic	Comparison Results
Intended Use	Identical
Indications for Use	Identical
Fundamental Scientific Technology	Identical
Operating Principles	Identical
Mechanism of Action	Identical
Materials	Similar
Technological Aspects	Similar
Packaging and Sterilization	Similar

Table 11.1: Comparison of Subject and Predicate Device

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Performance Testing Summary

Performance Testing has been completed to demonstrate substantial equivalence of the subject device and predicate device. All test requirements were met as specified by applicable standard and the test protocols. The device was subjected to the following verification and validation activities.

Mechanical Testing

Mechanical verification testing was conducted for the devices contained in the Epicardial Access System to ensure compliance with the requirements of ISO 11070:2014 and Baylis Medical Company Inc. self-enforced requirements. The following mechanical tests were performed:

. Epicardial Access Needle:
- Air and Liquid Leakage o
- o Resistance to Separation
- Stress Cracking o
- Strength of Union Hub to Hypotube O
- Strength of Union Stylet Cap to Stylet O
Epicardial Steerable Guiding Sheath: ●
- Sheath Torque Transmission + Hub to Shaft Strength of Union O
- Sheath Air and Liquid Leakage Hemostasis Valve O
- Sheath Air and Liquid Leakage O
- Sheath Strength of Union Tip to Sheath Body O
- Sheath Strength of Union Hub to Sheath Body O
- Sheath Strength of Union Hub to Hub Cap O
- Sheath Strength of Union Hub to Tubing O
- Sheath Strength of Union Stopcock to Tubing O
- Sheath Strength of Union Crimp to Pull Wire O
- Sheath Strength of Union Inner Knob to Outer Knob Snap Fit O
- Sheath Strength of Union End Cap to Handle Snap Fit O
- Sheath Tip Transition O
- Snap Fit O
- Valve Insertion O
- Dilator Torque Transmission Hub to Tubing Joint O
- Dilator Air and Liguid Leakage O
- Dilator Strength of Union Tip to Tubing O
- Dilator Strength of Union Butt Weld Joint O
- Dilator Strength of Union Hub to Tubing o
Epicardial Introducer and Stylet: ●
- Air and Liquid Leakage Hemostasis Valve o
- Air and Liquid Leakage O
- O Flow Rate
- Tip Integrity O
- Three-Point Bend O
- Torque Withstand Test O
- Tensile Test Stylet Hub to Rod O

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Tensile Test Sideport Tubing to Hub o
Tensile Test Stylet Threads to Proximal Threads O
O Tensile Test – Distal Hub to Shaft
Tensile Test Distal Hub to Proximal Hub O
Tensile Test Stopcock to Sideport Tubing O

General Physical Testing

General physical verification testing was conducted for the devices contained in the Epicardial Access System to ensure compliance with ISO 11070:2014 and Baylis Medical Company Inc. self-enforced requirements. The following general physical tests were performed:

Epicardial Access Needle: ●
- Corrosion Resistance O
Epicardial Steerable Guiding Sheath:
- Sheath Surface Defects o
- Sheath Range of Motion and Geometry O
- Sheath Curve Retention and Integrity O
- O Sheath Friction
- Sheath Handle Lubricity o
- Sheath Tip Stiffness O
- Compatibility O
- Dilator Surface Defects O
- O Dilator Flexural Modulus
- Sheath Clinical Valve O
Epicardial Introducer and Stylet: ●
- Corrosion Resistance O

Biocompatibility Verification

The biological safety of the devices comprising the subject Epicardial Access System was verified in accordance with the requirements of ISO 10993-1:2009/Cor.1:2010 and the June 16, 2016 FDA quidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".

Sterilization Validation

Sterilization verification was completed for the devices comprising the subject Epicardial Access System to the requirements of ISO 11134-1:2014. Sterilization is performed with Ethylene Oxide to a Sterility Assurance Level (SAL) of 10-6. Residual limits are in accordance with ISO 10993-7:2008/Cor.1:2009.

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Pvrogen Testina

The Epicardial Access System is supplied non-pyrogenic. LAL testing using the Kinetic Chromogenic method was conducted to ensure the devices meet current FDA and USP pyrogen limit specifications.

Packaging Validation

Ship testing was performed on each packaging system in the Epicardial Access System to ensure the integrity of the device packaging through the rigors of shipping and handling. The sterile barrier integrity was validated per ANSI/AAMI/ISO 11607:2006 (Parts 1 and 2) over the shelf life of the device.

Bench-top Validation

Customer requirements that could not be verified through compliance to appropriate standards were validated through a benchtop validation study. A minimum of 15 users drawn from populations familiar with catheter-based procedures were presented with a sequence of actions to perform with a benchtop model representative of a clinical workflow involving the device. Observations regarding ease of use and errors made were recorded and evaluated to conclude if customer requirement were met. The validation testing demonstrated the devices contained in the Epicardial Access System meet the intended use to support substantial equivalence.

Conclusion

The intended use and fundamental scientific technology, including principles of operation and mechanism of action, of the subject Epicardial Access System are identical to those of the predicate St. Jude Medical Agilis™ PF Introducer System (K111943). Differences in design and technological characteristics do not raise any different questions. The results of verification and validation activities provide reasonable assurance for the use of the Epicardial Access System and support the substantial equivalence of the subject and 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).