KENZ CARDY302 MAX by SUZUKEN CO., LTD.

The Cardy302Max Compact Digital Holter Recorder System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric or adult patients. The device stored this data along with patient demographic information onto a removable SD memory card.

The Cardy302Max Compact Digital Holter Recorder System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility.

The Cardy302Max Compact Digital Holter Recorder System does not perform any analysis of the ECG data.

The Cardy302Max Compact Digital Holter Recorder System is not intended for use on patients weighing less than 10 kg.

Device Description

The Cardy302Max Compact Digital Holter System is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for up to 48 hours. The device stores the acquired ECG data on its removable memory card.

The Cardy Controller02 downloads patient demographic information into the Cardy302Max Compact Digital Holter Recorder and allows the user to check the signal quality of the ECG data at hookup time. At the end of recording, the ECG data can be transferred to the controller by removing the SD memory card from the recorder and installing it into the Cardy Controller02.

AI/ML Overview

The provided document describes the acceptance criteria and study for the Kenz® Cardy302Max Digital Holter System.

This device is a digital ambulatory Holter recorder that acquires ECG signals but does not perform any analysis of the ECG data. Therefore, the acceptance criteria and studies focus on the hardware's safety, performance, and compliance with relevant standards, rather than the diagnostic accuracy of an AI algorithm.

Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety	Complies with IEC 60601-1 (General requirements for safety).
Electromagnetic Compatibility	Complies with IEC 60601-1-2.
Particular Requirements for Safety (including Essential Performance)	Complies with IEC 60601-2-47 (Ambulatory electrocardiographic systems for medical electrical equipment).
Water Ingress Protection	Successfully conducted independent water ingress testing in accordance with IEC 60529:2001 for IPX5, X8H.
Software Functionality	Software verification and validation testing demonstrated that all modes and functions operated as designed and in accordance with the indications for use.

2. Sample size used for the test set and the data provenance

Not applicable for an AI algorithm test set. The testing described focuses on hardware and software functional verification against engineering standards. The document does not specify a "test set" in the context of clinical data for AI performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The device does not perform analysis, so clinical ground truth (e.g., diagnosis by experts) is not relevant for its mechanical and electrical performance verification.

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

Not applicable, as there's no clinical "test set" requiring adjudication.

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

No. This device is not an AI analysis system. It is a data acquisition device, and therefore, an MRMC study comparing human readers with AI assistance is not relevant or described.

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

No. This device is a hardware system for recording ECG data. It does not contain an "algorithm" for independent diagnostic performance without human-in-the-loop intervention. The software verification confirmed the device's operational functionality, not diagnostic accuracy.

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

The "ground truth" for this device's performance is based on regulatory and engineering standards compliance. This includes:

Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-47 for safety and essential performance.
Compliance with IEC 60529:2001 for water ingress protection.
Software verification and validation outputs demonstrating that the software operates "as designed" and "in accordance with the indications for use."

8. The sample size for the training set

Not applicable. This device is a data acquisition hardware system and does not employ machine learning or AI algorithms requiring a training set.

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

Not applicable, as there is no training set for an AI algorithm.

Summary

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K101024
pg 1 of 2

5. 510(k) SUMMARY

Submitter:	Suzuken Co., Ltd.8 Higashikataha-machi Higashi-kuNagoya, Aichi, Japan 461-0015	JAN - 6 2011
Contact Person:	Mr. Shuji FunahashiSenior Manager, Kenz Product Development R&D SectionTEL: +81-52-701-4402FAX: +81-52-703-0914s.funahashi@suzuken.co.jp
Date Prepared:	December 7, 2010
Trade Name:	Kenz® Cardy302Max Digital Holter System
Common Name:	Digital Ambulatory Holter Recorder
ClassificationName:	Electrocardiograph, Ambulatory (without analysis)Medical Magnetic Tape Recorder
Predicate Device:	SEER Light Extend (K050731)
Device Description:	The Cardy302Max Compact Digital Holter System is designed to acquireambulatory 2 or 3 channels of ECG signal from the chest surface of pediatricor adult patients for up to 48 hours. The device stores the acquired ECG dataon its removable memory card.The Cardy Controller02 downloads patient demographic information into theCardy302Max Compact Digital Holter Recorder and allows the user to checkthe signal quality of the ECG data at hookup time. At the end of recording,the ECG data can be transferred to the controller by removing the SDmemory card from the recorder and installing it into the Cardy Controller02.
Statement ofIntended Use:	The Cardy302Max Compact Digital Holter Recorder System is intended toacquire ambulatory 2 or 3 channel ECG signals from the chest surface ofpediatric or adult patients. The device stores this data along with patientdemographic information onto a removable SD memory card.The Cardy302Max Compact Digital Holter Recorder System is intended tobe used by trained operators under the direct supervision of a licensedhealthcare practitioner in a hospital or medical professional's facility.The Cardy302Max Compact Digital Holter Recorder System does notperform any analysis of the ECG data.The Cardy302Max Compact Digital Holter Recorder System is not intendedfor use on patients weighing less than 10 kg.

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K101024
pg 2 of 2

Summary of Technological Characteristics: The proposed Compact Digital Holter Recorder System employs the same functional scientific technology as the predicate device SEER Light Extend Compact Digital Holter System (K050731).

Summary of Test Data:

Testing reports demonstrate successful outcomes to compliance testing to the voluntary standards listed below. These successful outcomes indicate that the Cardy302Max meets the (1) general requirements for safety, (2) electromagnetic compatibility, and (3) particular requirements for safety, including essential performance, for ambulatory electrocardiographic systems for medical electrical equipment.

(1) IEC 60601-1 (2) IEC 60601-1-2 (3) IEC 60601-2-47

The following quality assurance measures were applied to the development of this device.

1. Risk Analysis
1. Requirement Reviews
1. Design Reviews
1. Testing on Unit Level (Module Verification)
1. Integration Testing (System Verification)
1. Final Acceptance testing (Validation)
1. Performance Testing
1. Safety Testing
1. Environmental Testing

Independent water ingress testing was successfully conducted in accordance with IEC 60529: 2001 for IPX5, X8H for the Cardy302Max device.

Software verification and validation testing was conducted, which demonstrated that all modes and functions of the Cardy302Max device operated as designed and in accordance with the indications for use.

Conclusion:

The documented design output, device labeling, and test results demonstrate that the Cardy302Max Compact Digital Holter System is equivalent to the predicate device regarding safety, effectiveness, and performance.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002

Suzuken Co. Ltd. c/o Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Suite 280 Richardson, TX 75080

JAN - 6 2011

Re: K101024

Trade/Device Name: Cardy302Max Digital Holter System Regulation Number: 21 CFR 870.2800 Regulation Name: Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ Dated: December 7, 2010 Received: December 8, 2010

Dear Ms. Rutherford:

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. Diane Rutherford

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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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,

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 Statement

JAN - 6 2011

510(k) Number: K101024

Page: 1 of 1

Device Name: Cardy302Max Compact Digital Holter Recorder System

Indications for Use:

The Cardy302Max Compact Digital Holter Recorder System does not perform any analysis of the ECG data.

The Cardy302Max Compact Digital Holter Recorder System is not intended for use on patients weighing less than 10 kg.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/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 IF NEEDED)

Concurrence of CDHR, Office of Device Evaluation (ODE)

W.M.D.

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K101024

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).