The Rithm ID™ Electrophysiology Catheters have been designed to facilitate electrophysiological mapping of cardiac structures in 115 models and 17 kind of curves.

The catheter has a high-torque shaft with an array of platinum electrodes at the distal tip that can be used for recording. The high-torque shaft allows the plane of the distal curve to be manually rotated to assist in positioning the catheter tip at the desired site.

The Rithm IDM Electrophysiology Catheters have to connect with the EP by interface cables, model CI8RS04S, C25S04S, C18RS10S and C25RS10S with different trunk length, leadwire and equipment connector for the different Electrophysiology Catheters.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria, reported device performance metrics, or the details of a study demonstrating the device meets such criteria. Instead, it details a 510(k) submission for the "Rithm ID™ Electrophysiology Catheter," which focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to provide:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for a test set.
Information about an MRMC comparative effectiveness study or its effect size.
Details of a standalone algorithm performance study.
The type of ground truth used.
Sample size for the training set or how its ground truth was established.

What the document does provide is:

Non-Clinical Test Conclusions: The submission 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. These tests assessed compliance with various standards (IEC, ISO, ASTM) and included specific bench tests relating to the catheter's physical and electrical properties.
- Bench Test 1: Surface, Dimensions, and Shape Keeping of Tip Curve
- Bench Test 2: Buckling Force, Tip Fatigue, Shaft Fatigue, Torsional Strength, Tensile Strength, Connector Retention Force
- Bench Test 3: Electrode Isolation, Electrode Conductor Resistance, Insulation Resistance
- Bench Test 4: Corrosion Resistance and Radio-detectability
- Bench Test 5: Freedom from leakage
- Bench Test 6: Shape Keeping of Tip Curve, Electrode Conductor Resistance on Simulation Test
- Bench Test 7: Acquiring Clear Intracardiac Electrograms Test
- Bench Test 8: Stimulating Capability Test
Clinical Test Conclusion: "No clinical study is included in this submission." This indicates that the device's clearance was based on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, rather than through a clinical performance study.

The acceptance criteria here are implicitly linked to compliance with the listed standards and satisfactory performance in these bench tests, demonstrating similar characteristics and safety profiles to the predicate device. However, specific quantitative acceptance criteria or detailed performance metrics are not provided in this summary.

Summary

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K133028

Tab #7 510(k) Summary .......

REF #: M0122013Bd

MAR 0 4 2014

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: K133028

7.1 Date of Submission
09/15/2013

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. Tarzan Wang

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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Premarket Notification 510(k) Submission

Tab #7 510(k) Summary

REF #: M0122013Bd

7.4 Identification of Proposed Device

Trade Name: Rithm IDTM Electrophysiology Catheter Common Name: Electrophysiology Catheter

Regulatory Information: Classification Name: Catheter, Electrode Recording Classification: II; Product Code: DRF; Regulation Number: 21 CFR 870.1220; Review Panel: Cardiovascular;

Intended Use Statement:

The Rithm ID™ Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

7.5 Device Description

The Rithm ID™ Electrophysiology Catheters have been designed to facilitate electrophysiological mapping of cardiac structures in 115 models and 17 kind of curves.

7.6 Identification of Predicate Device
510(k) Number: K002976 Product Name: Diagnostic Electrophysiology Catheter Manufacturer: St. Jude Medical,DAIG Division

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:

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Premarket Notification 510(k) Submission Tab #7 510(k) Summary

IEC 60601-1:2005 Medical Electrical Equipment-Part 1 General Requirements for basic safety 产 and essential performance;
IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2 General Requirements for basic 公 safety and essential performance - collateral standard: Electromagnetic compatibility -Requirements and tests;
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 A 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;
Bench Test 1: Surface, Dimensions and Shape Keeping of Tip Curve; A
Bench Test 2: Buckling Force, Tip Fatigue, Shaft Fatigue, Torsional Strength, Tensile Strength, A Connector Retention Force;
Bench Test 3: Electrode Isolation, Electrode Conductor Resistance, Insulation Resistance; A
A Bench Test 4: Corrosion Resistance and Radio-detectability;
A Bench Test 5: Freedom from leakage;
Bench Test 6: Shape Keeping of Tip Curve, Electrode Conductor Resistance on Simulation > Test:
Bench Test 7: Acquiring Clear Intracardiac Electrograms Test;
A Bench Test 8: Stimulating Capability Test.
7.8 Clinical Test Conclusion

No clinical study is included in this submission.

7.9 Substantially Equivalent (SE) Comparison

ITEM	Proposed DeviceRithm ID™ ElectrophysiologyCatheter	Predicate DeviceDiagnostic Electrophysiology CatheterK002976	Remark
Product Code	DRF	DRF	SE
Regulation No.	21 CFR 870.1220	21 CFR 870.1220	SE
Class	Class II	Class II	SE

Table 6-1 Comparison of Technology Characteristics

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K133028

Tab #7 510(k) Summary Premarket Notification 510(k) Submission

REF #: M0122013Bd_

Intended Use	The Rithm ID™ Electrophysiology Catheter canbe used in the evaluation of a variety of cardiacarrhythmias from endocardial and intravascularsites.	Daig Electrophysiology Catheters can be usedin the evaluation of a variety of cardiacarrhythmias form endocardial and intravascularsites.	SE
Configuration	Cable Connector	Cable Connector	SE
	Tip Electrode	Tip Electrode	SE
	Shaft	High-torque shaft	SE
	Strain reinforcement shrink tubing	Strain reinforcement shrink tubing	SE
Features	Fixed Curve	Fixed Curve	SE
	High-torque shaft	High-torque shaft	SE
	Electrode Spacing	Electrode Spacing	SE
	Multiple curve and length option	Multiple curve and length option	SE
How Supplied	EO Sterilized	EO Sterilized	SE

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.

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three bars extending from the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002

March 4, 2014

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

Re: K133028

Trade/Device Name: Rithm ID Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: DRF Dated: January 26, 2014 Received: January 30, 2014

Dear Ms. 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 - Ms. 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 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/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement Tab # 6

510(k) Number: K133028 Device Name: Rithm ID™Electrophysiology Catheter

Indications for Use:

The Rithm IDM Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Image /page/6/Picture/7 description: The image shows two options, prescription use and over-the-counter use, with the prescription use box checked. The prescription use option is labeled as (Part 21 CFR 801 Subpart D), while the over-the-counter use option is labeled as (21 CFR 801 Subpart C). Below these options, there is a note that says, "PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED." The image also mentions the Concurrence of CDRH, Office of Device Evaluation (ODE).

Image /page/6/Picture/8 description: The image contains the name "Linda J. Ric". Below the name is a timestamp. The timestamp reads "2014.03:04:16:01:29+05'00'".

Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).