The PathBuilder™ Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Device Description

PathBuilder™ Steerable Introducer is composed of a steerable sheath, a dilator and a guidewire. It is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The steerable sheath is introduced into a body vessel, along with the dilator, over the guidewire, it is available in a variety of lengths, sizes and curve configurations; Dilator is assembled with the sheath and introduced into a body vessel over the guidewire. It is used to provide support to the sheath and ensure smooth advancement; the guidewire is percutaneously placed into the body vessel to function as a guide for the introduction into the chambers of the heart.

The distal end of steerable sheath is embedded with a marker band and vent holes. The steerable sheath is finished at the proximal end with a hemostasis valve and sideport with a three-way stopcock. By turning the rotating collar on handle, the steerable sheath can be bidirectionally bended to facilitate the steerable sheath to reach complex heart structures more conveniently. The distal end of dilator has a tip, while its proximal end is connected with luer fitting. The inner diameter of dilator distal end is smaller than the main body for the purpose of locking the position of a puncture needle. The distal end of dilator has a fixed curve to adapt to the heart structure.

The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise ≥180° and counter-clockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

AI/ML Overview

The PathBuilder™ Steerable Introducer is a medical device designed for introducing various cardiovascular catheters into the heart, including into the left side of the heart through the interatrial septum. The device did not undergo clinical studies to prove these claims but a series of non-clinical, benchtop tests and analyses to establish substantial equivalence to a predicate device (Agilis™ NxT Steerable Introducer (K081645)).

Here's the breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria:

Table of acceptance criteria and the reported device performance:

Criteria	Acceptance Requirement	Device Performance
Biocompatibility	Compliance with ISO 10993-1:2018 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) and FDA's modified ISO guidelines.	The biological safety of the introducer was verified per the requirements of ISO 10993-1:2018. Tests included: Cytocompatibility, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Complement Activation, and Thrombogenicity. The results demonstrated compliance.
Bench Validation	Successful validation of the device design through various mechanical and performance tests.	Validation testing included: visual inspection, dimensional verification, packaging testing (visual inspection, sealing strength, dye penetration), transit testing, and mechanical failure/performance tests (Peak tensile force of joints, flexion testing and fracture testing of guidewire). Compatibility of the introducer, guidewire, and dilator was validated with compatibility, bending load, controlling curve force, insertion withdrawal force, pushing force, simulated use fatigue testing (repeated physiologically relevant turns and observed for damage), radio detectability, freedom from leakage, dilator hub and 3-way stopcock Luer testing. All samples were sterilized and aged prior to testing. All tested samples passed bench testing.
Cleaning & Sterilization	Compliance with ISO 11135:2014 (Sterilization of health care products – Ethylene Oxide: Requirements for development, validation and routine control of a sterilization process for medical device), AAMI TIR 28:2009, and FDA guidance.	Validation testing was performed to demonstrate that the introducer could be sterilized in accordance with ISO 11135:2014, AAMI TIR 28:2009, and FDA guidance. The device met the sterilization requirements.
Shelf Life Validation	Demonstration of a 3-year shelf life.	Validation testing was performed and confirmed a shelf life of three years.
Functional Performance	Compliance with ISO 11070:2014.	The device was shown to comply with ISO 11070:2014.
Biological Characteristics	Compliance with ISO 10993-1.	The device was shown to comply with ISO 10993-1.
Dimensional Comparison	Substantial equivalence in dimensions (total length, outer diameter, inner diameter, curve shape) for steerable sheath, dilator, and guidewire compared to the predicate device.	Dimensional analysis showed that the proposed device's total length, outer diameter, inner diameter, and curve shape for the steerable sheath, dilator, and guidewire are substantially equivalent to the predicate device.
Intended Healthcare Env.	Professional healthcare environment.	The device is intended for use in a professional healthcare environment, consistent with the predicate.
Sterilization Method	EO Sterilized.	The device is EO sterilized, consistent with the predicate.
Single Use	Yes.	The device is single use, consistent with the predicate.

Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes for each non-clinical test (biocompatibility, bench validation, cleaning and sterilization, shelf life). It states that "All samples were sterilized and aged prior to testing. All tested samples passed bench testing." As these are bench tests and not clinical studies, the data provenance is from laboratory testing performed by the manufacturer, Shanghai MicroPort EP MedTech Co., Ltd., presumably in China as that is their location.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This was a non-clinical evaluation comparing device properties to established standards and a predicate device. There was no expert-derived "ground truth" for the test set in the way it would be for a diagnostic AI device. The ground truth was based on the performance standards themselves and the characteristics of the predicate device.
Adjudication method for the test set:
Not applicable. There was no adjudication method described as it was not a study involving human interpretation of results. The tests measured physical and material properties against predefined specifications and standards.
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. This device is a steerable introducer (a physical medical device), not an Artificial Intelligence (AI) device, and thus an MRMC comparative effectiveness study was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device, not an algorithm or AI system.
The type of ground truth used:
The "ground truth" in this context refers to established national and international standards (e.g., ISO 10993-1, ISO 11135, ISO 11070, AAMI TIR 28) and the characteristics of the legally marketed predicate device (Agilis™ NxT Steerable Introducer K081645). The device's performance was compared against these benchmarks to demonstrate substantial equivalence.
The sample size for the training set:
Not applicable. As this is not an AI/machine learning device, there is no training set.
How the ground truth for the training set was established:
Not applicable. There is no training set for a physical medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

February 8, 2022

Shanghai MicroPort EP MedTech Co., Ltd. Tian Xia RA Engineer Building 23&28, Lane 588, Tianxiong Rd. Shanghai, Shanghai 201318 China

Re: K211530

Trade/Device Name: PathBuilder Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 29, 2021 Received: January 10, 2022

Dear Tian Xia:

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.

{1}------------------------------------------------

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 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.

Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K211530

Device Name PathBuilder Steerable Introducer

Indications for Use (Describe)

The PathBuilder Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for EverPace. The logo consists of a stylized "E" made up of a blue horizontal bar and a red circle. To the right of the "E" is the word "EverPace" in blue font. A small "TM" symbol is located in the upper right corner of the word "EverPace".

510(k) # K211530 510(k) Summary

Submitter Information

Shanqhai MicroPort EP MedTech Co., Ltd. A. Company Name:
B. Company Address: Building 23&28, Lane 588, Tianxiong Rd., 201318 Shanghai, PEOPLE'S REPUBLIC OF

CHINA

C. Company Phone: +86 21 38954600*3613
D. Company Facsimile: +86 21 20903925
E. Email: txia@everpace.com
F. Contact Person: Xia, Tian
G. Summary Prepared on: October 20, 2021

Identification of Proposed Device

PathBuilder™ Steerable Introducer A. Trade Name:
B. Common Name: Catheter Introducer
Introducer, Catheter C. Classification Name:
D. Regulation Number 21 CFR 870.1340
E. Product Code: DYB
F. Device Class: Class II
G. Review Panel Cardiovascular
H. 510(k) Number K211530

Device Description

{4}------------------------------------------------

dilator has a fixed curve to adapt to the heart structure.

Intended Use Statement

The PathBuilder™ Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Identification of Predicate Device

Agilis™ NxT Steerable Introducer A. Product Name:
B. Manufacturer: St. Jude Medical C. 510(k) Number: K081645 D. Regulation Number 21 CFR 870.1340 E. Product Code: DYB F. Device Class: Class II

Non-Clinical Performance Testing

Non-clinical performance testing was completed for the PathBuilder™ Steerable Introducer to support its substantial equivalence to the predicate device. The test results demonstrated that the proposed device complies with the following standards and guidance:

(1) Biocompatibility Verification: The biological safety of the introducer was verified as per the requirements of ISO 10993-1:2018 Biological evaluation of medical devices- Part 1:Evaluation and testing within a risk management process and FDA's modified ISO guidelines in accordance with 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".
- Cytocompatiblity a)
- Sensitization b)
- Irritation C)
- Acute Systemic Toxicity d)
- Hemocompatibility e)

{5}------------------------------------------------

Complement Activation f)
Thrombogenicity q)
(2) Bench Validation: Validation testing of the introducer was performed to validate the design of the device . This testing included visual inspection, dimensional verification, packaging testing (visual inspection, sealing strength, dye penetration), transit testing and mechanical failure/performance (Peak tensile force of joints, flexion testing and fracture testing of quidewire). Additionally, the compatibly of the of the introducer, guidewire and dilator was validated with compatibility, bending load, controlling curve force, insertion withdrawal force, pushing force, simulated use fatigue testing (put the device through repeated physiologically relevant turns and observed for damage), radio detectability, freedom from leakage, dilator hub and 3way stopcock Luer testing. All samples were sterilized and aged prior to testing. All tested samples passed bench testing.
(3) Cleaning and Sterilization Validation: Validation testing was performed to demonstrate that the introducer could be sterilized in accordance with ISO 11135:2014 Sterilization of health care products-Ethylene Oxide: Requirements for development, validation and routine control of a sterilization process for medical device, AAMI TIR 28:2009 Product Adoption and Process Equivalency for Ethylene Oxide sterilization and the FDA guidance document.
(4) Shelf Life Validation: Validation testing was performed to demonstrate the shelf life of the introducer is three years.

Clinical Tests Conclusion

No clinical study was used to support this submission.

Description	Proposed Device	Predicate Device(K081645)	Remark
Product Code	DYB	DYB	SE
Regulation No.	21 CFR 870.1340	21 CFR 870.1340	SE
Class	Class II	Class II	SE
Intended Use	The PathBuilderTMSteerable Introducer isindicated for introducingvarious cardiovascularcatheters into the heart,including the left side of	The AgilisTM NxTSteerable Introducer isindicated for introducingvarious cardiovascularcatheters into the heart,including the left side of	SE
	the heart through the	the heart through the
	interatrial septum.	interatrial septum.
	The PathBuilder™Steerable Introducer is	The Agilis™ NxTSteerable Introducer is
Indications for Use	indicated for introducingvarious cardiovascularcatheters into the heart,including the left side ofthe heart through theinteratrial septum.	indicated for introducingvarious cardiovascularcatheters into the heart,including the left side ofthe heart through theinteratrial septum.	SE
	Configuration	Steerable sheath	Steerable sheath	SE
		Dilator	Dilator	SE
		Guidewire	Guidewire	SE
Functionalperformance	Comply with ISO 11070:2014	Comply with ISO 11070:2014	SE
Biologicalcharacteristics	Comply with ISO 10993-1	Comply with ISO 10993-1	SE
	Total length of steerablesheath	Total length of steerablesheath	SE
	Outer diameter ofsteerable sheath	Outer diameter ofsteerable sheath	SE
	Inner diameter ofsteerable sheath tip	Inner diameter ofsteerable sheath tip	SE
	Curve shape of steerablesheath tip	Curve shape of steerablesheath tip	SE
DimensionalComparision	Effective length of dilator	Effective length of dilator	SE
	Outer diameter of dilator	Outer diameter of dilator	SE
	Inner diameter of dilatortip	Inner diameter of dilatortip	SE
	Curve shape of dilator tip	Curve shape of dilator tip	SE
	Effective length ofguidewire	Effective length ofguidewire	SE
	Outer diameter ofguidewire	Outer diameter ofguidewire	SE
	Inner diameter of J-curvetip	Inner diameter of J-curvetip	SE
	Intendedhealthcareenvironment	Professional healthcareenvironment	Professional healthcareenvironment	SE
		Sterilizationmethod	EO Sterilized	EO Sterilized
Single use		Yes	Yes	SE
Shelf Life	3 years	3 years	SE

Comparison to Predicate Device

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for EverPace. The logo consists of two stylized circles, one in blue and one in red, followed by the word "EverPace" in blue font. A small "TM" symbol is located to the right of the word "EverPace".

Shanghai MicroPort EP MedTech Co., Ltd.

Building 23&28, Lane 588, Tianxiong Rd., 201318 Shanghai, PEOPLE'S REPUBLIC OF CHINA 4 / 5

{7}------------------------------------------------

Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

The proposed and predicate devices share the same intended use and fundamental scientific technology, including principles of operation and mechanism of action. Design and technological differences between the proposed and predicate devices do not raise any new concerns of safety and effectiveness. The results of verification and validation testing demonstrate that the PathBuilder™ Steerable Introducer is substantially equivalent to the predicate device.

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).