PALM ECG RECORDER, MODEL EP-201/202

K061123 · Parama-Tech Company., Ltd. · DPS · Jun 29, 2007 · Cardiovascular

Device Facts

• Record ID: K061123
• Device Name: PALM ECG RECORDER, MODEL EP-201/202
• Applicant: Parama-Tech Company., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

This is a screening device intended to capture, display and store transient symptoms that suggest abnormal cardiac condition or to document cardiac conditions. In addition, further interpretation of ECG data recorded by Palm ECG Recorder can be sent to the prescribing physician. The Palm ECG Recorder™ Model EP-201C/202C is not a diagnostic or analytic device. It is used for screening purpose only. This is a prescription device for use only under the direction of a physician.

Device Story

Handheld, non-invasive, wireless ECG monitor; captures ECG waveforms, R-R intervals, and average heart rate. User-operated in home or clinical settings; device records data for later transmission to a personal computer. Physician reviews synchronized time-scale data to screen for transient cardiac symptoms or monitor conditions. Not for real-time diagnostic use; intended as a screening tool to facilitate physician-led cardiac assessment.

Clinical Evidence

Clinical testing performed to support safety and effectiveness. Results included electrical safety, EMI/EMC, and temperature measurement accuracy. Specific clinical study metrics (sensitivity/specificity) not detailed in summary.

Technological Characteristics

Handheld, battery-powered, non-invasive ECG monitor. Uses electrodes to detect body voltages. Factory-calibrated. Wireless data transmission to PC. Conforms to Quality Systems (21 CFR 820).

Indications for Use

Indicated for self-testing and home health care use to record, store, and transfer ECG waveforms, R-R graphs, and average heart rate data for physician interpretation. Not for use as a diagnostic tool, not a substitute for hospital ECG devices, not for simultaneous recording/transmission, and not recommended for patients with implanted pacemakers.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• Read My Heart (K042814)
• OMRON portable ECG Monitor, HCG-801 (K060766)

Submission Summary (Full Text)

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## 510(k) Summarv

# Parama-Tech Co., Ltd. Palm ECG Recorder "", Model EP-201C/202C
1 Ocotober 2006

| 1 October 2006 | |
|------------------------------------|-------------------------------------------------------------------------------------------------------|
| Sponsor | Consultant |
| Parama-Tech Co., Ltd. | Mr. Richard Keen |
| 2-19-8 Sharyo Higashi-ku | Compliance Consultants |
| Fukuoka-shi, Japan | 1151 Hope Street |
| Voice 011 81 92-623-0813 | Stamford, CT 06907-1659 |
| Fax [phone] | 203 329 2700 F 203 329 2345 |
| s.koga@Parama-Tech Co.,<br>Ltd.com | [e-mail] |
| Proprietary Name: | Palm ECG Recordertm, Model EP-201C/202C |
| Regulation Number | 21 CFR part 870.2340 |
| Product Code | DPS |
| Classification Name: | electrocardiograph |
| Device Classification | Class II |
| Common Name | ECG monitor |
| Predicate Device | 1) Read My Heart K 042814, handheld ECG device<br>2) OMRON portable ECG Monitor, HCG-801<br>(K060766) |

#### Device Description

The Palm ECG Recorder™, Model EP-201C/202C, is made by Parama-Tech Co., Ltd. This wireless ECG Monitor is portable, non-invasive and handheld. This is a Class II device that measures and displays EGC waveforms, R-R graph, an average heart rate along with comments. Once this device is prescribed by a physician, the Palm ECG Recorder "", can be used anytime, anywhere by anyone. This devices allows acquisition and transmission of ECG data from the user to a personal computer.

This device is suitable to detect transient symptoms that may suggest abnormal cardiac conditions to monitor cardiac conditions on a daily basis. This device is ideally suited for health care.

#### Intended Use

This is a screening device intended to capture, display and store transient symptoms that suggest abnormal cardiac condition or to document cardiac conditions. In addition, further interpretation of ECG data recorded by Palm ECG Recorder can be sent to the prescribing physician. The Palm ECG Recorder™ Model EP-201C/202C is not a diagnostic or analytic device. It is used for screening purpose only. This is a prescription device for use only under the direction of a physician.

#### Technological Characteristics and Substantial Equivalence

This device uses electrodes to detect voltages emitted by the body. The calibration is established by the factory and yields accurate and calibrated signals that can maintain calibration over its useful life. The Palm ECG Recorder "", Model EP-201C/202C, Palm ECG Recorder has benefited from design, development, testing and production procedures that conform to Quality Systems.

Parama-Tech Co., Ltd. Japan

Page રવેર

Palm ECG Recorder"]

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Parama-Tech Co., Ltd. has determined that the Palm ECG Recorder "", Model EP-201C/202C is substantially equivalent to

- . the Read my Heart, Daily Care BioMedical, K042814 which is a Lead I, electrocardiograph monitor and
- the OMRON portable ECG Monitor, HCG-801 (K060766). .

### Performance Testing

Information submitted in this premarket notification for the Palm ECG Recorder "", Model EP-201C/202C includes results of testing for electrical safety, EMI/EMC, temperature measurement accuracy and results of clinical testing.

Parama-Tech Co., Ltd. Japan

Page રવેલ

Palm ECG Recorder™

Model EP-201C/202C

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is oriented diagonally, facing upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2007

Parama-Tech Co., Ltd. c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907-1659

Re: K061123

Palm ECG Recorder ™, Model EP-201C/202C Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: June 07, 2007 Received: June 07, 2007

Dear Mr. Keen:

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 such 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 - Mr. Richard Keen

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); 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. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Dma R. Lachner

A 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

510(K) Number (If known):

Device Name: Palm ECG Recorder™ Model EP-201C/202C

#### Indications for Use:

The Palm ECG Recorder™ Model EP-201C/202C is intended for self-testing and home health care use. The Palm ECG Recorder™ Model EP-201C/202C records, stores and transfier ECG waveforms, R-R graph and average heart rate data and presents these cardiological events in a synchronized time scale for interpretation by a physician trained in such an analysis. This is a prescription device for use only under the direction of a physician. A software user infare allows viewing. This screening tool is not intended for use as a diagnostic tool ar as a subtitute for a hospital diagnostic ECG device. This device is not intended for simulaneously recording and transmission of a user's ECG signal. This device is not recommended for use with in planted pacemakers.

Prescription Use XXX (Part 21 CFR 801 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 Durin a (Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number Ko (a 117 3