The Steerable Intracardiac Catheter Introducer Kit is intended to introduce various catheters into the heart, including the left side of the heart through the interatrial septum.

Device Description

The proposed device includes Steerable Intracardiac Catheter Introducer Kit as well as its accessory, Transseptal Needle. The Steerable Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart, including both right and left side. When left side of heart is accessed, Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.

The Steerable Intracardiac Catheter Introducer Kit includes three components, which are (1) steerable sheath introducer, (2) dilator and (3) guidewire. The steerable sheath introduced into a body vessel, along with the dilator, over the guidewire, it is available in variable specification and curve configuration: Dilator is assembled with the sheath introduced into a body vessel over the guidewire. It is used to provide support to sheath and ensure smooth advancement; the guidewire is percutaneous placed into the body vessel to function as a guide for the introduction into the chambers of the heart.

The handle of Steerable Intracardiac Catheter Introducer is equipped with the rotation collar, turn the collar in clockwise, the tip can be stered from 0 to 180 degree(s), while turn the collar in counterclockwise, the tip can be steered from 0 to 90 degree(s) on the other side.

The transseptal needle includes two components, which are (1) stylet. The needle is used to puncture the interatrial septum during a transseptal catheterization procedure; the stylet is used to keep the needle lumen intact during handling and facilitate the needle advancement within the dilator.

The kit and the transseptal needle are provided sterilized. They are subject to Ethylene Oxide sterilization prior to release. The Sterility Assurance Level (SAL) is 10-6.

The shelf life of the proposed device is three (3) years.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle". It seeks to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria through a clinical study with an AI component. Therefore, much of the requested information regarding AI study details cannot be extracted from this document.

However, I can provide information based on the non-clinical tests performed to demonstrate substantial equivalence.

1. Acceptance Criteria and Reported Device Performance

The document states that non-clinical tests were conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device. The acceptance criteria for these non-clinical tests are implicitly defined by compliance with the listed international and ASTM standards. The "reported device performance" is the conclusion that the device complied with these standards.

Acceptance Criteria Category	Specific Standard / Requirement	Reported Device Performance
Sterility	ISO 11070-2014: Sterile single-use intravascular catheter introducer	Proposed device complies with ISO 11070-2014
	Ethylene Oxide sterilization residuals	Proposed device complies with ISO 10993-7:2008
Biocompatibility	In Vitro cytotoxicity	Proposed device complies with ISO 10993-5:2009
	Systemic toxicity	Proposed device complies with ISO 10993-11:2006
	Irritation and skin sensitization	Proposed device complies with ISO 10993-10:2010
	Interactions with blood (hemolytic properties)	Proposed device complies with ISO 10993-4:2002 and ASTM F 756-08
	General Biocompatibility	Proposed device complies with ISO 10993-1
Packaging & Shelf Life	Seal Strength of Flexible Barrier Materials	Proposed device complies with ASTM F88/F88M-09
	Internal Pressurization Failure Resistance	Proposed device complies with ASTM F1140-07 (Reapproved 2012)
Performance (general)	ISO 11070-1998 (related to catheter introducer performance)	Proposed device complies with ISO 11070-1998
Shelf Life	(Implicitly tested to justify 3-year claim)	3 years (Identical to predicate)

2. Sample Size and Data Provenance

This document describes non-clinical bench testing and biocompatibility testing, not a clinical study involving patient data. Therefore, the concepts of "test set" sample size and "data provenance" (country of origin, retrospective/prospective) are not applicable in this context. The samples used would be units of the manufactured device for the specific tests.

3. Number of Experts and their Qualifications for Ground Truth

Not applicable. This is a submission for a physical medical device, not an AI/software device that requires expert-established ground truth for image or data interpretation. The "ground truth" for the non-clinical tests is derived from the objective measurements and defined parameters within the standardized test methods.

4. Adjudication Method

Not applicable. This is a submission for a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies involving human readers/interpreters to resolve discrepancies in assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical study is included in this submission." Also, the device is a physical medical instrument (catheter introducer), not an AI system. Therefore, a study comparing human readers with and without AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical medical instrument and does not involve an algorithm with standalone performance.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria and measurable parameters established within the referenced international and ASTM standards (e.g., specific sterility assurance levels, cytotoxicity assays, seal strength measurements, etc.).

8. Sample Size for the Training Set

Not applicable. This document does not describe the development or evaluation of an AI algorithm; there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no AI algorithm or training set discussed in this document.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 4, 2015

Synaptic Medical Ltd c/o Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120

Re: K151936

Trade/Device Name: Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: October 23, 2015 Received: November 3, 2015

Dear Diana Hong:

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -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)

Device Name

Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle

Indications for Use (Describe)

The Steerable Intracardiac Catheter Introducer Kit is intended to introduce various 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)

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Exhibit # 3 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K151936

1. Date of Preparation: 10/20/2015
1. Sponsor

Synaptic Medical Ltd

Building C, 100 Kechuang 6th Street Beijing Economic-Technological Development Area, Beijing, 101111, China

Establishment Registration Number: Not yet registered

Contact Person: Mr. Yang, Tiecheng Position: Senior Quality Director Tel: +86-10-51297209-813 Fax: +86-10-51297209-802 Email: tiecheng.yang(@synapticmed.com.cn

3. Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle Common Name: Catheter Introducer

Regulatory Information: Classification Name: Introducer, Catheter Classification: II; Product Code: DYB; Regulation Number: 21 CFR 870.1340; Review Panel: Cardiovascular;

Intended Use Statement:

The Steerable Intracardiac Catheter Introducer Kit is introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Device Description

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The kit and the transseptal needle are provided sterilized. They are subject to Ethylene Oxide sterilization prior to release. The Sterility Assurance Level (SAL) is 10-6.

The shelf life of the proposed device is three (3) years.

Identification of Predicate Device ર.
510(k) Number: K081645 Product Name: Agilis™ NxT Steerable Introducer Manufacturer: St. Jude Medical
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 11070-2014 Sterile single-use intravascular catheter introducer;
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity;
ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
A ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood;
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals:
ASTM F 756-08, Standard practice for assessment of hemolytic properties of material;
ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials;
A ASTM F1140-07 (Reapproved 2012), Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
Clinical Test Conclusion 7.

No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate DevicesK081645
Product Code	DYB	DYB
Regulation Number	21 CFR 870.1340	21 CFR 870.1340
Intended Use	The Steerable Intracardiac Catheter Introducer Kit is intended to introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.	The Agilis™ NxT Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Sterile	EO Sterilized	EO Sterilized
Single Use	Yes	Yes
Shelf Life	3 years	3 years
Biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1
Performance	Comply with ISO 11070-1998	Comply with ISO 11070-1998
Feature	Steerable sheath introducer tipCurl at sheath introducer tipRadiopaqueCurve at needle Transseptal Needle tipJ Shape Guidewire	Steerable sheath introducer tipCurl at sheath introducer tipRadiopaqueCurve at needle Transseptal Needle tipJ Shape Guidewire

Table 6-1 Comparison of Technology Characteristics

9. 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.

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).