The PathBuilder™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

Device Description

PathBuilder™ Transseptal Needle is consisted of thin section, curved section, main body, pointer flange, hub and stylet. The distal end of PathBuilder™ Transseptal Needle is curved for easy positioning within the heart when used together with the catheter introducer. The outer diameter of needle stepped down within the curved section for better fitness to the dilator which fixes the maximum length of the needle into the dilator. The distal tip of the needle is beveled to facilitate the transseptal process. The proximal end of PathBuilder™ Transseptal Needle is with a pointer flange which indicates the curve orientation of the needle. And a hub is equipped for aspiration, fluid injection/infusion etc. The stylet is straight. The proximal end of the stylet is curved to lock on the hub when inserted into the needle lumen. The stylet is used to help insert the needle into the dilator.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "PathBuilder™ Transseptal Needle". This document describes the device and its equivalence to a predicate device, but it does not include any information about an AI/ML device.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study proving an AI/ML device meets acceptance criteria. The document explicitly states: "No clinical study was used to support this submission."

The closest information provided related to performance testing is for the transseptal needle device (not an AI/ML system):

Non-Clinical Performance Testing:

Biocompatibility Verification: Verified as per ISO 10993-1:2018 and FDA guidelines. Tests included Cytocompatibility, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Complement Activation, and Thrombogenicity.
Bench Validation: Included visual inspection, dimensional verification, packaging testing (visual inspection, sealing strength, dye penetration), and mechanical failure/performance (joint forces). Compatibility of the needle and dilator was validated with compatibility, puncture force, radio detectability, and luer fitting. All samples were sterilized and aged prior to testing. All tested samples passed bench testing.
Cleaning and Sterilization Validation: Performed in accordance with ISO 11135:2014, AAMI TIR 28:2009, and FDA guidance.
Shelf Life Validation: Demonstrated a shelf life of three years.

Since no AI/ML device is described, I cannot answer questions 2 through 9 regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Summary

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March 23, 2022

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

Re: K212625

Trade/Device Name: PathBuilder™ Transseptal Needle Regulation Number: 21 CFR 870.1390 Regulation Name: Trocar Regulatory Class: Class II Product Code: DRC 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.

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,

Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: 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) K212625

Device Name PathBuilder Transseptal Needle

Indications for Use (Describe)

The PathBuilder Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

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) # K212625 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

ldentification of Proposed Device

PathBuilder™ Transseptal Needle A. Trade Name:
B. Common Name: Transseptal Needle
C. Classification Name: Trocar
21 CFR 870.1390 D. Regulation Number
E. Product Code: DRC
F. Device Class: Class II
G. Review Panel Cardiovascular
H. 510(k) Number K212625

Device Description

Intended Use Statement

The PathBuilder™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

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Image /page/4/Picture/0 description: The image shows the EverPace logo. The logo consists of a stylized "E" and "O" connected together, with the "E" in blue and the "O" in red. To the right of the symbol is the word "EverPace" in blue, with a small "TM" symbol in the upper right corner.

ldentification of Predicate Device

A. Product Name: BRK™ Transseptal Needle
B. Manufacturer: St. Jude Medical
C. 510(k) Number: K122587
D. Regulation Number 21 CFR 870.1390
E. Product Code: DRC
F. Device Class: Class II

Non-Clinical Performance Testing

Non-clinical performance testing was completed for the PathBuilder™ Transseptal Needle 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 transseptal needle 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)
- b) Sensitization
- Irritation C)
- Acute Systemic Toxicity ರು)
- Hemocompatibility e)
- f) Complement Activation
- Thrombogenicity ರು)
(2) Bench Validation: Validation testing of the transseptal needle was performed to validate the design of the device. This testing included visual inspection, dimensional verification, packaging testing (visual inspection, sealing strength, dye penetration) and mechanical failure/performance (Joint forces between each parts). Additionally, the compatibly of the needle and dilator was validated with compatibility, puncture force, radio detectability, luer fitting. 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 transseptal needle could be sterilized in accordance with ISO 11135:2014 Sterilization of health care products-

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Image /page/5/Picture/0 description: The image shows the EverPace logo. The logo consists of a stylized "E" and "O" connected together, followed by the word "EverPace" in a sans-serif font. The "E" and part of the "O" are in blue, while the rest of the "O" is in red. There is a trademark symbol next to the word EverPace.

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 transseptal needle is three years.

Clinical Tests Conclusion

No clinical study was used to support this submission.

Description	Proposed Device	Predicate Device (K122587)	Remark
Product Code	DRC	DRC	SE
RegulationNo.	21 CFR 870.1390	21 CFR 870.1390	SE
Class	Class II	Class II	SE
Intended Use	The PathBuilderTM TransseptalNeedle is used to puncture theinteratrial septum during atransseptal catheterizationprocedure to gain left heartaccess.	The BRKTM Transseptal Needleis used to puncture theinteratrial septum during atransseptal catheterizationprocedure to gain left heartaccess.	SE
Indicationsfor Use	The PathBuilderTM TransseptalNeedle is used to puncture theinteratrial septum during atransseptal catheterizationprocedure to gain left heartaccess.	The BRKTM Transseptal Needleis used to puncture theinteratrial septum during atransseptal catheterizationprocedure to gain left heartaccess.	SE
	Hub	Hub	SE
Configuration	Pointer flange	Pointer flange	SE
	Needle tip	Needle tip	SE
DimensionalComparison	Effective length	Effective length	SE
	Diameter	Diameter	SE
	Effective length of stylet	Effective length of stylet	SE
	Outer diameter of stylet	Outer diameter of stylet	SE
	Curve shape	Curve shape	SE
Functionalperformance	Comply with ISO 11070: 2014	Comply with ISO 11070: 2014	SE
Biologicalcharacteristics	Comply with ISO 10993-1	Comply with ISO 10993-1	Similar
Intended	Professional healthcare	Professional healthcare	SE

Comparison to Predicate Device、

Shanghai MicroPort EP MedTech Co., Ltd.

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Image /page/6/Picture/0 description: The image shows the logo for EverPace. The logo consists of a stylized "E" and "O" in blue and red, respectively, followed by the word "EverPace" in blue. The "TM" symbol is located to the right of the word "EverPace".

healthcareenvironment		environment
Sterilizationmethod	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 Needle is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1390 Trocar.

(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.