The ExpanSure Transseptal Dilation System is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

Device Description

The ExpanSure Transseptal Dilation System represents a modification to the legally marketed TorFlex Transseptal Guiding Sheath (K102948). The subject device comprises a dilator (ExpanSure Dilator) and J-tip quidewire, which are single-use and supplied sterile to the user.

The ExpanSure Dilator consists of an inner and outer polyethylene layer containing radio-pacifier for visibility under fluoroscopy during procedures. The inner and outer shaft layers are separated by a braid material for torqueability. The outer surface of the dilator is coated with a silicone lubricant. The ExpanSure Dilator is compatible with .032″ and .035″ transseptal devices/quidewires and 12.5 Fr introducer sheaths. The J-tip quidewire supplied with the ExpanSure Dilator is .032".

AI/ML Overview

This document describes the FDA's 510(k) clearance for the ExpanSure™ Transseptal Dilation System. The acceptance criteria and the study proving the device meets these criteria are primarily based on performance testing to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing efficacy with human data.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with quantitative acceptance criteria and reported numerical performance values for direct comparison. Instead, it states that "All test requirements were met as specified by applicable standards and the test protocols." The acceptance criteria are implicit in the standards and internal requirements listed.

Acceptance Criteria (Implied by Standards/Tests)	Reported Device Performance
Mechanical Integrity:
Air Leakage (ISO 11070:2014)	Met specifications
Liquid Leakage (ISO 11070:2014)	Met specifications
Torque Transmission + Strength of Union Torque (ISO 11070:2014, Baylis requirements)	Met specifications
Three Point Bend (Baylis requirements)	Met specifications
Strength of Union Tip Deflection (Baylis requirements)	Met specifications
Strength of Union Tip to Shaft (Baylis requirements)	Met specifications
Strength of Union Shaft to Hub (Baylis requirements)	Met specifications
Biocompatibility:
Biocompatibility (ISO 10993-1:2009/Cor.1:2010, FDA guidance)	Met specifications
Sterilization:
Sterility Assurance Level (SAL) of 10-6 (ISO 11135-1:2014)	Met specifications (achieved via Ethylene Oxide)
Residual Limits (ISO 10993-7:2008/Cor.1:2009)	Met specifications
Packaging Integrity:
Seal Strength and Sterile Barrier Integrity (ANSI/AAMI/ISO 11607:2006 Parts 1 & 2) over proposed shelf life	Met specifications (demonstrated through ship testing)
General Physical Properties:
Visual Analysis (ISO 11070:2014, Baylis requirements)	Met specifications
Dimensional Measurements (ISO 11070:2014, Baylis requirements)	Met specifications
Curve Retention (Baylis requirements)	Met specifications
Coating Integrity and Friction Testing (Baylis requirements)	Met specifications
Luer Testing (Baylis requirements)	Met specifications
Corrosion Resistance (Baylis requirements)	Met specifications
Pyrogenicity:
Pyrogen Limit Specifications (FDA and USP)	Met specifications (LAL testing, Kinetic Chromogenic method)

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

The document relates to pre-market regulatory clearance based on engineering and bench testing, not clinical data or a test set of patient cases. Therefore, concepts like "sample size for a test set," "country of origin of the data," or "retrospective/prospective" studies are not applicable in the context of this 510(k) submission. The "sample" would refer to the number of devices tested in each mechanical, biocompatibility, sterilization, and physical test. This information (specific lot numbers, number of units per test) is generally detailed in the actual test reports submitted to the FDA, but not summarized in this public 510(k) summary.

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)

Not applicable. This is a medical device 510(k) clearance based on substantial equivalence to a predicate device, demonstrated through engineering and bench testing, not an AI/imaging device requiring expert ground truth for interpretation.

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

Not applicable, as there is no "test set" in the context of human interpretation or clinical cases.

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 is not relevant for this type of device (vessel dilator). The clearance is based on demonstrating the device's physical and biological properties meet safety and performance standards equivalent to a legally marketed predicate.

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

Not applicable. This is a medical device, not an algorithm. Performance tests evaluate the device itself.

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

The "ground truth" for this device's performance is established by validated engineering and biological standards (e.g., ISO standards, Baylis self-enforced requirements, FDA guidance) that define acceptable performance parameters for vessel dilators. Compliance with these standards serves as the "ground truth" for demonstrating safety and performance.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model. There is no "training set" of data in this context.

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

Not applicable, as there is no training set.

Summary

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March 21, 2019

Baylis Medical Company Inc. May Tsai Team Leader, Regulatory Affairs 2775 Matheson Blvd. East Mississauga, Ontario Canada L4W 5S4

Re: K182064

Trade/Device Name: ExpanSure™ Transseptal Dilation System Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: February 25, 2019 Received: February 26, 2019

Dear Ms. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Rachel E. Neubrander -S

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) K182064

Device Name ExpanSure Transseptal Dilation System

Indications for Use (Describe)

The ExpanSure Transseptal Dilation System is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

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

Submitter Information

A. Company Name: Baylis Medical Company Inc.
B. Company Address: 2775 Matheson Blvd. East Mississauga, Ontario L4W 4P7 Canada
C. Company Phone: (905) 602-4875
D. Company Facsimile: (905) 602-5671
E. Contact Person: May Tsai Manager, Regulatory Affairs
F. Summary Prepared on: 18-Mar-2019

Device Identification

A. Device Trade Name: ExpanSure™ Transseptal Dilation System
B. Device Common Name: Vessel Dilator For Percutaneous Catheterization
C. Classification Name: CFR 870.1310 Vessel Dilator For Percutaneous Catheterization
D. Product Code: DRE
E. Device Class: Class II

Identification of Legally Marketed Device

Table 8.1: Predicate Device
PredicateDevice	Manufacturer	510(k)	Indications for Use
TorFlex™TransseptalGuidingSheath	Baylis MedicalCompany Inc.	K102948	The TorFlex Transseptal GuidingSheath is used for the percutaneousintroduction of various types ofcardiovascular catheters to all heartchambers, including the left atriumvia transseptal perforation / puncture.

Table 8.1 : Predicate Device

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Indications for Use

The ExpanSure Transseptal Dilation System is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

Device Description

Comparison to Predicate Devices

The subject ExpanSure Transseptal Dilation System and predicate TorFlex Transseptal Guiding Sheath (K102948) have the same intended use.

The proposed and predicate devices share fundamental scientific technology, including principles of operation and mechanism of action (Table 8.2). Differences in design and technological characteristics between the proposed and predicate devices do not raise different questions of safety and effectiveness. The results of verification and validation testing provide reasonable assurance of substantial equivalence of the ExpanSure Transseptal Dilation System with the predicate device.

Characteristic	Subject Device Compared to PredicateTorFlex Transseptal Guiding Sheath(K102948)
Intended Use	Identical
Indications for Use	Similar
Fundamental scientific technology	Identical
Operating principles	Identical
Mechanism of action	Identical
Technological aspects	Similar

Table 8.2: Comparison of Subject and Predicate Device

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Performance Testing

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

Mechanical Testing

Mechanical verification testing was conducted for the subject ExpanSure Dilator to ensure compliance with the requirements of ISO 11070:2014 and Baylis self-enforced requirements. The following tests were performed:

1. Air Leakage
1. Liguid Leakage
1. Torque Transmission + Strength of Union Torque
1. Three Point Bend
1. Strength of Union Tip Deflection
1. Strength of Union Tip to Shaft
1. Strength of Union Shaft to Hub

Biocompatibility Verification

Biocompatibility testing was performed in accordance with current requirements of ISO 10993-1:2009/Cor.1:2010 and the 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" (June 16, 2016).

Sterilization Verification

Sterilization verification was completed for the subject device to current requirements of ISO 11135-1:2014. 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.

Packaging Verification

Ship testing was performed to ensure the integrity of the device packaging through the rigors of shipping and handling. The seal strength and sterile barrier integrity is validated per ANSI/AAMI/ISO 11607:2006 (Parts 1 and 2) over the proposed shelf life of the device.

General Physical Testing

General physical verification testing was conducted for the ExpanSure Dilator to ensure compliance with ISO 11070:2014 and Baylis selfenforced requirements. The following tests were performed:

1. Visual Analysis
1. Dimensional Measurements
1. Curve Retention

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1. Coating Integrity and Friction Testing
1. Luer Testing
1. Corrosion Resistance

Pyrogen Testing

The ExpanSure Transseptal Dilation System is supplied non-pyrogenic. LAL testing using the Kinetic Chromogenic method was conducted to ensure the device meets current FDA and USP pyrogen limit specifications.

Conclusions

The subject ExpanSure Transseptal Dilation System and predicate TorFlex Transseptal Guiding Sheath (K102948) have the same intended use. The subject and predicate devices also share the same fundamental scientific technology, including principles of operation and mechanism of action. Differences in design and technological characteristics do not raise any different questions of safety and effectiveness. The results of verification and validation activities support the substantial equivalence of the subject ExpanSure Transseptal Dilation System to the predicate device.

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).