ECG PEN by MERIDIAN DYNAMICS BIOMEDICAL, INC

The Vion.ECG Pen (Model no.: 800E) is intended for recording ECG data and displaying general information by adult patients who are concerned their heart rhythm and waveform. This Vion.ECG Pen allows the patients to record transient cardiac events voluntarily for providing to the healthcare professionals as references during office visits.

In addition, the patient can also record their ECG data and transmit the recorded data to personal computer.

The Vion.ECG Pen is not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemakers are not recommended to use this device. This device is not intended to substitute a conventional diagnostic tool.

Device Description

The MD's Vion.800E ECG Pen is a small, portable and easy-to-use electrocardiograph unit that can record and store electrocardiogram (ECG) measurements of your heart rhythm. Each ECG reading records 30 seconds measurement and these ECG readings can help your doctor monitor your condition.

The unit included build-in memory that can store up to 99 measurements, including the ECG data along with date and time of measurement. With USB interface, it allows you or your doctor to view detail information of measurement.

Furthermore, Vion® ECG Pen (Model no.: 800E) has similar general design with the Omron HCG-801 portable ECG Monitor (K060766 ) marketed by Omron Healthcare, Inc.. & MD100 Handheld ECG Monitor (K080933) marketed by Beijing Choice Electronic Technology Co., Ltd.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Vion® ECG Pen (Model no.: 800E), based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" in a numerical format (e.g., specific accuracy thresholds for a diagnostic task). Instead, the clinical study's goal was to demonstrate performance "as good as" a predicate device for various ECG parameters.

Parameter/Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (Vion® ECG Pen vs. PHILIPS, PageWriter Trim II Cardiograph)
Heart rate	Performance "as good as" 12-lead ECG	Performance "as good as" 12-lead ECG
QRS interval	Performance "as good as" 12-lead ECG	Performance "as good as" 12-lead ECG
QT interval	Performance "as good as" 12-lead ECG	Performance "as good as" 12-lead ECG
PR interval	Performance "as good as" 12-lead ECG	Performance "as good as" 12-lead ECG
R-wave	Performance "as good as" 12-lead ECG	Performance "as good as" 12-lead ECG
S-wave	Performance "as good as" 12-lead ECG	Performance "as good as" 12-lead ECG
T-wave	Performance "as good as" 12-lead ECG	Performance "as good as" 12-lead ECG
Recording ECG data	Performance "as good as" 12-lead ECG	Performance "as good as" 12-lead ECG
Displaying general information	Performance "as good as" 12-lead ECG	Performance "as good as" 12-lead ECG

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

Sample Size: 206 patients
Data Provenance: The document does not explicitly state the country of origin. It also doesn't specify if the study was retrospective or prospective, but clinical investigations are typically prospective.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth. The study design appears to use the 12-lead standard ECG (PHILIPS, PageWriter Trim II Cardiograph) as the reference for comparison, rather than an expert panel adjudicating the Vion® ECG Pen results independently.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The study compared the Vion® ECG Pen's performance against a standard 12-lead ECG for various parameters directly.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study directly compared device performance against a predicate standard ECG, not human readers with and without AI assistance.

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

Yes, the clinical investigation was a standalone device performance study. It compared the "Vion.800E" device directly against a "12-lead standard ECG" in terms of recording and displaying ECG data and various parameters. There's no mention of human interpretation or human-in-the-loop performance being part of this comparison.

7. The Type of Ground Truth Used

The ground truth or reference standard used in this study was a 12-lead standard ECG (PHILIPS, PageWriter Trim II Cardiograph).

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This suggests the study was purely a validation/comparison study, or the device does not employ machine learning that requires a separate training set.

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

As no training set is mentioned, there is no information on how ground truth for a training set was established.

Summary

{0}------------------------------------------------

KI 03077

510(K) SUMMARY

JUL 1 3 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92.

1.0 Submitter's Name: Meridian Dynamics Biomedical, Inc. (MD Biomedical, Inc.) 3E No 100.Sec 3. Mingsheng E. Rd., Taipei, Taiwan, 105 Address:

Address:	3F,NO 100,Sec 3, Mingsheng E. Rd., Taipei, Taiwan, 105
Tel:	+886-2-27183000 Ext.103
Fax:	+886-2-27180123
Contact:	Carl Yu/Vice President
E-Mail:	carl@mdbiomedical.com

2.0 Device Name Vion® ECG Pen(Model no .: 800E) Trade Name: Handheld ECG monitor Common Name: Electrocardiograph Classification name:
3.0 Classification: Class II DPS Product Code: 21CFR870.2340 Regulation No.:
The predicate device is the Omron HCG-801 portable ECG 4.0 Predicate Device: Monitor (K060766) marketed by Omron Healthcare, Inc. & MD100 Handheld ECG Monitor (K080933) marketed by Beijing Choice Electronic Technology Co., Ltd..
The Vion.ECG Pen (Model no.: 800E) is intended for 5.0 Intended Use: recording ECG data and displaying general information by adult patients who are concerned their heart rhythm and waveform. This Vion,ECG Pen allows the patients to record transient cardiac events voluntarily for providing to the healthcare professionals as references during office visits.

In addition, the patient can also record their ECG data and transmit the recorded data to personal computer.

The Vion.ECG Pen is not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemakers are not recommended to use this

Product: Vion. 800E ECG Pen by MD Biomedical, Inc. Section 4 - 510(k) Summary REV. 【C】 Page 1 of 3

{1}------------------------------------------------

device. This device is not intended to substitute a conventional diagnostic tool.

6.0 Device Description: The MD's Vion.800E ECG Pen is a small, portable and easy-to-use electrocardiograph unit that can record and store electrocardiogram (ECG) measurements of your heart rhythm. Each ECG reading records 30 seconds measurement and these ECG readings can help your doctor monitor your condition.

The unit included build-in memory that can store up to 99 measurements, including the ECG data along with date and time of measurement. With USB interface, it allows you or your doctor to view detail information of measurement.

Furthermore, Vion® ECG Pen (Model no.: 800E) has similar general design with the Omron HCG-801 portable ECG Monitor (K060766 ) marketed by Omron Healthcare, Inc.. & MD100 Handheld ECG Monitor (K080933) marketed by Beijing Choice Electronic Technology Co., Ltd.

In terms of operating specification, Safety & EMC 7.0 Non-Clinical Performance Tests requirements, the device conforms to applicable standards include Summary: All Safety test: according to IEC 60601-2-25 & IEC

All Burst, test:	60601-1,
EMC test:	according to IEC 60601-1-2
Performance test:	according to IEC 60601-2-47

A Clinical Investigation study was performed in such a way 8.0 Clinical test that compared the performance , including Heart rate. QRS Summary: interval, OT interval, PR interval, R-wave, S-wave, T-wave --------etc., between single channel patient-activated ECG device "Vion.800E" VS. 12-lead standard ECG "PHILIPS, PageWriter Trim II Cardiograph. 206 patients are involved in this study.

According to the clinical investigation results and discussion, the performance of Vion.ECG Pen (Model: Vion.800E) is as

Product: Vion. 800E ECG Pen by MD Biomedical, Inc. Section 4 - 510(k) Summary REV. (C) Page 2 of 3

{2}------------------------------------------------

good as the 12-lead ECG (PHILIPS, PageWriter Trim II Cardiograph) in recording ECG data and displaying general information.

The patient-activated ECG system used in this study is a leadless recorder, which records 30 seconds ECG signal. The time it costs for use is much shorter than other conventional ECG recorders, and requires no external wires and electrodes. Therefore, the patient-activated ECG recorder, Vion.800E, is ideal to be used to document the behavior of rhythm and signal waveform during symptoms in order to replace a more expensive and invasive diagnostic procedures.

Conclusions:

Vion® ECG Pen (Model no.: 800E) has the same intended use, principles of operation, and similar technological characteristics as predicate devices. Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Vion® ECG Pen (Model no.: 800E) is substantially equivalent to the predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Meridian Dynamics Biomedical, Inc. C/O Jennifer Reich Harvest Consulting Corp. 2904 N. Boldt Drive Flagstaff, AZ 86001

JUL 1 3 2011

Re: K103077

Trade/Device Name: ECG Pen Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: June 14, 2011 Received: June 24, 2011

Dear Ms. Reich:

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.

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

{4}------------------------------------------------

Page 2 – Ms. Jennifer Reich

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/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/ReportalProblem/default.html 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,

Bryan D. Zuckerman, M.D.

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): ___K103077

Device Name: Vion.® 800E ECG Pen MD Biomedical, Inc.

Indications for Use:

The Vion.ECG Pen (Model no.: 800E) is intended for recording ECG data and displaying general information by adult patients who are concerned their hearter hythm and waveform. This Vion.ECG Pen allows the patients to record transient cardiac events voluntarily for providing to the healthcare professionals as references during office visits.

In addition, the patient can also record their ECG data and transmit the recorded data to personal computer.

Prescription Use(Part 21 CFR 801 Subpart D)	V	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)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number	K103077
---------------	---------

Page 1 of 1

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
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.(b)
Classification. Class II (performance standards).