(69 days)
Not Found
No
The 510(k) summary describes a standard ECG electrode and does not mention any AI or ML components or functionalities.
No
The device is described as an ECG monitoring electrode, which is used for diagnostic purposes (monitoring heart activity), not for treating a condition.
Yes
Explanation: The device is intended for ECG monitoring, which is a diagnostic procedure used to detect cardiac abnormalities.
No
The device description explicitly states it is a "self-adhesive, non-sterile, single use disposable electrode" which includes physical components like a sensing element, conductive gel, and adhesive tape. This indicates it is a hardware device, not software-only.
Based on the provided text, the Easyrode device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "ECG Monitoring," which involves measuring electrical activity of the heart on the patient's body.
- Device Description: The description details a self-adhesive electrode applied to the patient's skin.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (in vitro), such as blood, urine, or tissue.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Easyrode is a device used for direct physiological measurement on the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of these measurements demonstrated that the Easyrode is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 and |
| Stickey Gel | |
| 510(k) No. | : K970796 |
81 of 3
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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.
2
11. Conclusion
:
The results of these measurements demonstrated that the Easyrode is as safe, as effective, and performs as well as the predicate device.
r
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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 :
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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