The Easyrode is intended for use in ECG Monitoring. The Easyrode can be used in all ECG applications where standard ECG monitoring electrodes are used. This electrode can be used for short term and long term (2 Days) monitoring.

Device Description

Easyrode is a self-adhesive, non-sterile, single use disposable electorode which includes a silver/silver chloride sensing element and conductive gel. These electrodes include a pressure sentive adhesive non-woven tape which hold the conductive elements of the electrodes in place on the patient's skin for short or long term ECG procedures.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with statistical results proving the device meets said criteria for the "Easyrode Disposal ECG Electrodes, Model Easyrode." The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with performance metrics.

However, based on the information provided, here's what can be extracted and inferred regarding the "acceptance criteria" and "study":

The "acceptance criteria" in this context are primarily informal, focusing on demonstrating that the Easyrode performs "as well as" the predicate device in fundamental ECG monitoring functionalities and meets general safety and effectiveness standards for such devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Safe and effective for ECG monitoring.	The conclusion states: "The results of these measurements demonstrated that the Easyrode is as safe, as effective, and performs as well as the predicate device." This is a qualitative statement of equivalence. No specific quantitative performance metrics (e.g., impedance, signal-to-noise ratio, artifact levels) are provided in the summary. The comparison focuses on similar intended use and general technological characteristics.
Suitable for short-term and long-term (up to 2 days) monitoring.	Easyrode: Intended for use in ECG Monitoring, for short-term and long-term (2 Days) monitoring. This matches the intended use of the predicate devices. Predicate device (3M Red Dot 2560): Used for short time and long time (2 day). The document explicitly states "Easyrode is used for 2day and below," confirming alignment with the predicate's duration of use.
Functional equivalence to predicate device in ECG applications.	The device description and intended use state: "The Easyrode can be used in all ECG applications where standard ECG monitoring electrodes are used." Under "Technological Characteristics," it indicates both Easyrode and the predicate are "Used for short time and long time (up to 2day)." The primary difference noted is the material (Non-woven tape for Easyrode vs. Foam tape for predicate), with the claim that "Non-woven is allow air pass through easily than foam. That means non-woven is more adhesive to patient skin." This implies performance is at least equivalent, potentially better in adhesion for the Easyrode, without compromising ECG signal quality or patient safety. The approval letter confirms "substantially equivalent."
Meets general requirements for disposable ECG electrodes.	This is implicitly met through the 510(k) clearance process, which reviews if the device adheres to general controls, including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Study Information (Based on Available Text):

The document does not describe a clinical trial or a specific standalone study with statistical results to prove performance against pre-defined acceptance criteria in the way one might expect for a novel device. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "study" mentioned abstractly ("The results of these measurements demonstrated...") refers to comparative testing and analysis against the predicate device to support this equivalence. No details of these "measurements" are provided.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document states "The results of these measurements," implying some form of testing was done, but no specifics on the number of electrodes tested, number of subjects, or duration of testing are provided.
Data Provenance: Not specified. The manufacturer is based in Japan (SUZUKEN CO, LTD.). The context implies tests were likely conducted by the manufacturer or on their behalf, but the location and whether it was retrospective or prospective data are not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided. Given the nature of a 510(k) for an ECG electrode, ground truth likely pertains to technical performance measurements (e.g., impedance, adhesion, signal quality) rather than expert clinical interpretation of ECGs produced by the electrodes. If human evaluation was part of the "measurements," no details are included.

4. Adjudication Method for the Test Set

Not applicable/Not specified. There is no mention of a human adjudication process for establishing ground truth, as the 'measurements' likely pertain to technical specifications rather than diagnostic output requiring clinical consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically associated with diagnostic imaging or interpretation where multiple readers evaluate medical cases. This type of study is not relevant or described for a disposable ECG electrode, which is a physical component, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable/No. This device is a passive, disposable ECG electrode. It does not involve an algorithm or AI. Performance is inherently "standalone" in the sense that it's the electrode's physical properties being measured, but not an algorithm's.

7. The Type of Ground Truth Used

Inferred Technical Performance Data/Comparison to Predicate: The "ground truth" (or basis for comparison) was the performance characteristics of the legally marketed predicate device (3M Red Dot 2560 Monitoring Electrode). "Measurements" were conducted to demonstrate that the Easyrode performs "as safe, as effective, and performs as well as" the predicate. This would typically involve measuring electrical characteristics (e.g., impedance, DC offset, AC impedance, defibrillation recovery), adhesion properties, and biocompatibility, all compared against established standards or the predicate's known performance. No specific details on which data types were collected are in the summary.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device (an electrode), not an AI algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set for a physical device, this question is not relevant.

Summary

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K092389

5. 510(k) Summary

1. Company Identification

SUZUKEN CO, LTD. 8 Higashikataha-machi, Higashi Nagoya, Aichi, JAPAN 46191 Tel: +81-52-950-6327 Fax: +81-52-950-7440

OCT 1.3 2009

2. Official Correspondent

Motokazu Takeuchi (Mr.) Senior Manager

3. Date of Submission

August 4, 2009

4. Device Trade name Disposal ECG electrodes, Model Easyrode

5. Common/Usual Name

Electrocardiograph Electrode

6. Classification Number

Electrocardiograph Electrode classified in Class II per 21 CFR 870.2360, DRX

7. Predicate Device

Manufacturer	: 3M Health Care
Device Name	: 3M Red Dot 2560 Monitoring Electrode with Foam Tape andStickey Gel
510(k) No.	: K970796

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8. Description of the Device

Easyrode is a self-adhesive, non-sterile, single use disposable electorode which includes a silver/silver chloride sensing element and conductive gel.

These electrodes include a pressure sentive adhesive non-woven tape which hold the conductive elements of the electrodes in place on the patient's skin for short or long term ECG procedures.

9. Intended Use

10. Technological Characteristics

Intended for Use

Easyrode: Used for short time and long time (up to 2day) Predicate device: Used for short time and long time (2day)

Easyrode is used for 2day and below.

Material:

Easyrode: Non-woven tape Predicate device: Foam tape

Non-woven is allow air pass through easily than foam. That means non-woven is more adhesive to patient skin

Comparison table of the principal characteristics of 2 devices is shown in the 9. Substantial Equivalence Discussions.

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11. Conclusion

The results of these measurements demonstrated that the Easyrode is as safe, as effective, and performs as well as the predicate device.

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

AUG 26 2011

Suzuken Co., Ltd c/o Mr. Koji Kubo Cosmos Corporation 3F, 2-17-6 Akebono-cho Tachikawa-shi, Tokyo 190-0012 JAPAN

Re: K092389

Trade/Device Name: Disposal ECG Electrodes, Model Easyrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: II (two) Product Code: DRX Dated: July 31, 2009 Received: August 5, 2009

Dear Mr. Kubo:

This letter corrects our substantially equivalent letter of October 13, 2009.

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.

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

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Page 2 - Mr. Koji Kubo

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.
Director

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K092389 510(K) Number (if known) Device Name: Disposal ECG electrodes, Model Easyrode

Indications For Use :

Prescription Use × (Per 21 CFR 801.109 Subpart D)

AND / OR Over-The Counter Use

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W. M.

(Division Sign-Off)
Division of Cardiovascular Devices

) Number RR 1200

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Regulation Number and Section

§ 870.2360 Electrocardiograph electrode.

(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). 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. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.