DISPOSAL ECG ELECTRODES, MODEL EASYRODE

K092389 · Suzuken Co., Ltd. · DRX · Oct 13, 2009 · Cardiovascular

Device Facts

• Record ID: K092389
• Device Name: DISPOSAL ECG ELECTRODES, MODEL EASYRODE
• Applicant: Suzuken Co., Ltd.
• Product Code: DRX · Cardiovascular
• Decision Date: Oct 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Indications for Use

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 Story

Easyrode is a self-adhesive, non-sterile, single-use disposable ECG electrode. It consists of a silver/silver chloride sensing element, conductive gel, and a pressure-sensitive adhesive non-woven tape backing. The device is applied to the patient's skin by a clinician to facilitate the acquisition of electrical signals for ECG monitoring. The non-woven tape allows for air permeability, improving adhesion compared to foam-based alternatives. The device is intended for both short-term and long-term (up to 2 days) monitoring applications.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technological characteristics.

Technological Characteristics

Disposable ECG electrode; silver/silver chloride sensing element; conductive gel; non-woven adhesive tape backing; non-sterile; single-use; intended for up to 2 days of monitoring.

Indications for Use

Indicated for patients requiring short-term or long-term (up to 2 days) ECG monitoring in any application where standard ECG monitoring electrodes are used.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 3M Red Dot 2560 Monitoring Electrode with Foam Tape and Stickey Gel (K970796)

Submission Summary (Full Text)

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K092389

## 5. 510(k) Summary

## 1. Company Identification

SUZUKEN CO, LTD. 8 Higashikataha-machi, Higashi Nagoya, Aichi, JAPAN 46191 Tel: [phone] Fax: [phone]

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 and<br>Stickey 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

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.

## 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 [phone] or [phone] 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 :

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.

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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