The PathBuilder™ Transseptal Guiding Introducer is introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Device Description

PathBuilder™ Transseptal Guiding Introducer is comprised of a sheath, a dilator and a guidewire. At the distal end of the sheath, a marker band is embedded to mark the position of the sheath during the procedure. Near the marker band, there are three vent holes to reduce cavitation during aspiration and device withdrawal. At the proximal end of the sheath, a sideport with three-way stopcock is located for aspiration, fluid infusion, blood sampling and pressure monitoring. Sheath is fitted with a valve to provide hemostasis during catheter introduction and/or exchange over a guidewire. The dilator, which is mainly used to expand the opening during the inter-atrial septal puncture, is a straight tube with a specially curved portion. The distal end of the dilator is designed to a tip and there is a hub at the proximal end where the needle goes through. The internal lumen of dilator is tapered at the distal tip to fix the location of the needle. Both the sheath and dilator are with a specially curved portion to accommodate positioning against the atrial septum. When the dilator is inserted into the sheath, the sheath tip fit that of dilator well, which help the set to enter the sheath. Guidewire is a thin wire leading the introducer set to the desired position.

AI/ML Overview

The provided text is a 510(k) summary for the PathBuilder™ Transseptal Guiding Introducer and does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

This document describes a conventional medical device (catheter introducer) and its comparison to a predicate device for substantial equivalence. The "Non-Clinical Performance Testing" section details various bench tests and validations performed on the physical device, not an AI/ML algorithm.

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document explicitly states: "No clinical study was used to support this submission."

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 & 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.

March 23, 2022

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

Re: K212626

Trade/Device Name: PathBuilder™ Transseptal Guiding Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 15, 2022 Received: February 22, 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) K212626

Device Name

PathBuilder Transseptal Guiding Introducer

Indications for Use (Describe)

The PathBuilder Transseptal Guiding Introducer is introducing various cardiovascular catheters into 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 two interlocking shapes, one blue and one red, followed by the word "EverPace" in blue. The shapes are abstract and modern, and the word "EverPace" is written in a clean, sans-serif font. There is a trademark symbol to the right of the word "EverPace".

510(k) # K212626 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: February 15, 2022

Identification of Proposed Device

PathBuilder™ Transseptal Guiding Introducer A. Trade Name: B. Common Name: Catheter Introducer C. Classification Name: Introducer, Catheter D. Regulation Number 21 CFR 870.1340 E. Product Code: DYB F. Device Class: Class II G. Review Panel Cardiovascular H. 510(k) Number K212626

Device Description

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

Intended Use Statement

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

Identification of Predicate Device

Fast-Cath™ Transseptal Catheter Introducer A. Product Name:
B. Manufacturer: St. Jude Medical
K964518
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™ Transseptal Guiding Introducer to support its substantial equivalence to the predicate device. The test results demonstrated that the proposed device complies with the following standards and quidance:

(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 guidance 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 ರು)
- Hemocompatibility e)
- Complement Activation f)
- Thrombogenicity ರು)
(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 guidewire). Additionally, the compatibly of the of the introducer, guidewire and dilator was validated with compatibility,

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

EverPace

bending load, 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 3-way 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(K964518)	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 PathBuilderTMTransseptal GuidingIntroducer is indicatedfor introducing variouscardiovascular cathetersinto the left side of theheart through theinteratrial septum.	The Fast-CathTMTransseptal CatheterIntroducer is indicatedfor introducing variouscardiovascular cathetersinto the left side of theheart through theinteratrial septum.	SE
Indications for Use	The PathBuilderTMTransseptal GuidingIntroducer is indicatedfor introducing variouscardiovascular cathetersinto the left side of theheart through theinteratrial septum.	The Fast-CathTMTransseptal CatheterIntroducer is indicatedfor introducing variouscardiovascular cathetersinto the left side of theheart through theinteratrial septum.	SE

Comparison to Predicate Device

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

Image /page/6/Picture/0 description: The image shows the EverPace logo. The logo consists of a stylized "E" and "O" in blue and red, respectively, followed by the word "EverPace" in blue. The letters are bold and sans-serif, and there is a trademark symbol in the upper right corner of the word "EverPace".

Configuration		sheath	sheath	SE
		Dilator	Dilator	SE
		Guidewire	Guidewire	SE
DimensionalComparison	Sheath	Effective length	Effective length	SE
		Diameter	Diameter	SE
		Inner diameter ofsheath tip	Inner diameter ofsheath tip	SE
		Inner diameter of mainbody	Inner diameter of mainbody	SE
		The length of necking atsheath tip	The length of necking atsheath tip	SE
		Curve shape	Curve shape	SE
	Dilator	Effective length	Effective length	SE
		Diameter	Diameter	SE
		Inner diameter ofdilator tip	Inner diameter ofdilator tip	SE
		Inner diameter of mainbody	Inner diameter of mainbody	SE
	Guidewire	Curve shape	Curve shape	SE
	Guidewire	Effective length	Effective length	SE
		Diameter	Diameter	SE
Functional performance		Comply with ISO 11070:2014	Comply with ISO 11070:2014	SE
Biological characteristics		Comply with ISO10993-1	Comply with ISO10993-1	SE
Intended healthcareenvironment		Professional healthcareenvironment	Professional healthcareenvironment	SE
Sterilization method		EO Sterilized	EO Sterilized	SE
Single use		Yes	Yes	SE
Shelf life		3 years	3 years	SE

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™ Transseptal Guiding 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).