Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart. Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.

Device Description

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

The Intracardiac Catheter Introducer Kit includes three components, which are (1) sheath introducer, (2) dilator and (3) guidewire. The 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 introducer and 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 transseptal needle includes two components, which are (1) needle and (2) stylet. The needle is used to puncture the the interatrial septum during a transseptal catheterization procedure; the stylet is used to keep the needle luman intact during handling and facilitate the needle advancement within the dilator.

AI/ML Overview

This document describes a medical device, the Intracardiac Catheter Introducer Kit and Transseptal Needle, and its substantial equivalence determination by the FDA. It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML or Diagnostic device.

The acceptance criteria and study described here are for a traditional medical device (catheter introducer and needle) aiming to demonstrate equivalence to a predicate device, rather than proving a diagnostic performance metric.

Therefore, many of the requested fields are not applicable to the information provided in this document.

Here's the closest possible interpretation of the requested information based on the provided text, primarily focusing on "non-clinical tests" as the "study" substitute:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Standards/Tests Met)	Reported Device Performance
ISO 11070-1998 (Sterile single-use intravascular catheter introducer)	Complies with the standard
ISO 10993-5:2009 (Tests for In Vitro cytotoxicity)	Complies with the standard
ISO 10993-11:2006 (Tests for systemic toxicity)	Complies with the standard
ISO 10993-10:2010 (Tests for irritation and skin sensitization)	Complies with the standard
ISO 10993-4:2002 (Selection of tests for interactions with blood)	Complies with the standard
ASTM F88/F88M-09 (Seal Strength of Flexible Barrier Materials)	Complies with the standard
ASTM F1140-07 (Reapproved 2012) (Internal Pressurization Failure Resistance of Unrestrained Packages)	Complies with the standard
Simulated Use Testing	Performed
Anti-kink Testing	Performed
Torque Strength Testing	Performed
Torqueability Testing	Performed
Tip Flexibility Testing	Performed
Flow Rate Testing	Performed
Coating Integrity	Performed
Particulate Evaluation	Performed
Biocompatibility (Comply with ISO 10993-1)	Complies with ISO 10993-1 (as stated in comparison table)
Performance (Comply with ISO 11070-1998)	Complies with ISO 11070-1998 (as stated in comparison table)

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

The document does not specify the sample sizes for the individual non-clinical tests. The tests were conducted to verify design specifications and substantial equivalence, implying they were performed on samples of the manufactured device. The manufacturer is Synaptic Medical Limited, located in Beijing, PR China, which can be considered the country of origin for the device and likely where these tests were performed. These appear to be prospective tests on newly manufactured devices.

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. The tests are engineering and biological evaluations against established standards, not expert-derived ground truth on patient data.

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

Not applicable. This is for expert review of data, not for engineering or biological testing.

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:

Not applicable. This is a traditional medical device, not an AI/ML-driven diagnostic or assistance tool.

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

Not applicable. This is for an AI/ML algorithm, not a physical medical device.

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

The "ground truth" here is compliance with established international and ASTM standards (e.g., ISO 11070, ISO 10993, ASTM F88, ASTM F1140), and verification of specific performance characteristics (e.g., anti-kink, torque strength). These are objective measurements against defined criteria.

8. The sample size for the training set:

Not applicable. There is no AI/ML model for which a training set would be used.

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

Not applicable. There is no AI/ML model.

Summary

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

August 29, 2014

Synaptic Medical Limited % Diana Hong General Manager Mid-Link Consulting P.O. Box 120-119 Shanghai, 200120 CH

Re: K132943

Trade/Device Name: Intracardiac Catheter Introducer Kit and Transseptal Needle Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, NKQ, DRC Dated: July 24, 2014 Received: July 28, 2014

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. 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.

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Page 2 - Diana Hong

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 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 Small Manufacturers, International and Consumer Assistance 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,

M.A. Hillebrand

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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Tab # 6 Indications for Use Statement

510(k) Number: K132943

Device Name: Intracardiac Catheter Introducer Kit and Transseptal Needle

Indications for Use:

☑PRESCRIPTION USE	OR	□OVER-THE-COUNTER USE
(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Tab # 7 510(k) Summary

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

The assigned 510(k) Number: K132943

7.1 Date of Preparation
8/29/2014
7.2 Sponsor

Synaptic Medical Limited

Building C, 100 Kechuang 6th Street Beijing Economic-Technological Development Area Beijing, 100176, PR China

Establishment Registration Number: Not yet registered

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

7.3 Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu

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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7.4 Identification of Proposed Device

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

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

Regulatory Information: Classification Name: Trocar Classification: II; Product Code: DRC; Regulation Number: 21 CFR 870.1390; Review Panel: Cardiovascular;

Regulatory Information: Classification Name: Guidewire, Catheter, Reprocessed Classification: II; Product Code: NKQ: Regulation Number: 21 CFR 870.1330; Review Panel: Cardiovascular;

Intended Use Statement:

7.5 Device Description

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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.

7.6 Identification of Predicate Device
510(k) Number: K070417 Product Name: ACross™ Transseptal Access System Manufacturer: St. Jude Medical

7.7 Non-Clinical Test Conclusion

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 11070-1998 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;
ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood;
ASTM F88/F88M-09. Standard Test Method for Seal Strength of Flexible Barrier Materials:
ASTM F1140-07 (Reapproved 2012), Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.

In addition to the following standards, the following test items have also been performed to evaluate the proposed device:

Simulated Use Testing
Anti-kink Testing;
Torque Strength Testing;
Torqueability Testing:
Tip Flexibility Testing;
A Flow Rate Testing;
Coating Integrity;
Particulate Evaluation.

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7.8 Clinical Test Conclusion

No clinical study is included in this submission.

7.9 Substantially Equivalent (SE) Comparison

Item	Proposed Device(s)	Predicate Device(s)
Product Code	DYB	DYB
Regulation Number	21 CFR 870.1340	21 CFR 870.1340
Intended Use	Intracardiac Catheter Introducer Kitis intended for introducing variouscardiovascular catheters into heart.Transseptal Needle is intended forpuncture the interatrial septumduring a transseptal catheterizationprocedure.	The St. Jude Medical ACross™Transseptal Access System isused both to puncture theinteratrial septum during atransseptal catheterizationprocedure and to introducevarious cardiovascular cathetersinto the left side of the heart.
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
Features	Curve at sheath introducer tipRadiopaqueCurve at needle Transseptal Needle tipJ Shape Guidewire	Curve at sheath introducer tipRadiopaqueCurve at needle Transseptal Needle tipJ Shape Guidewire

Table 6-1 Comparison of Technology Characteristics

7.10 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

§ 870.1390 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.