ACG-8511 PORTABLE ECG MONITOR

K110328 · Andon Health Co, Ltd. · DPS · Jul 15, 2011 · Cardiovascular

Device Facts

• Record ID: K110328
• Device Name: ACG-8511 PORTABLE ECG MONITOR
• Applicant: Andon Health Co, Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Jul 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The ACG-8511 portable ECG Monitor is intended for recording and displaying ECG data by adult patients who are concerned about their heart rhythm. This ACG-8511 portable ECG Monitor allows the consumer to record their ECG data into the device memory for display by healthcare professionals during office visits. Specifically, ACG-8511 portable ECG Monitor is intended for adult patients who are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm: -Skipped beats -Pounding heart (palpitations) -History of arrhythmia

Device Story

User-activated portable ECG event recorder; captures 30s ECG segments via three modes: hand-to-chest (metal electrodes), two-hands (metal electrodes), or 3-wire cable with disposable electrodes. Device measures electrical impulses across heart; displays heart rate and rhythm on LCD. Used by patients at home/point-of-care to record transient symptoms (heart pain, palpitations, shortness of breath). Data stored on SD card; downloaded to PC for physician review. Output provides evidence for clinical confirmation of symptoms; not intended for medical diagnosis. Benefits include capturing transient cardiac events difficult to record with conventional devices.

Clinical Evidence

Bench testing only. Device tested for compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ANSI/AAMI EC38 (ambulatory ECG systems), and ISO 10993 (biocompatibility). No clinical trial data provided.

Technological Characteristics

Portable ECG monitor; dry single-lead sensing; 3-wire cable or integrated metal electrodes. Connectivity via SD card to PC. Standards: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC38, ISO 10993-1/10/12. Powered by internal energy source. Software-based data recording and LCD display.

Indications for Use

Indicated for adult patients concerned about heart rhythm or experiencing symptoms suggestive of abnormal heart rhythm (skipped beats, palpitations, history of arrhythmia). Not recommended for users 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

• HCG-801 portable ECG Monitor (K060766)

Submission Summary (Full Text)

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# 510(k) Summary

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

## 1.0 submitter's information

Name: Andon Health Co., Ltd. Address: No 3, Jinping Street, Ya An Road, Nankai District, Tianjin, P.R. China Phone number: 86-22-6052 6161 Fax number: 86-22-6052 6162 Contact: Liu Yi Date of Application: 12/11/2010

#### 2.0 Device information

Device name: ACG-8511 series Portable ECG Monitor Model No: ACG-8511 (X =A~Z, Y= blank or A~Z) < Deciding When to Submit a 510(k) for a Change to an Existing Device>.

#### 3.0 Classification

Production code: DPS- Electorcardiograph Regulation number: 21 CFR 870.2340 Classification: II Panel: Cardiovascular

#### 4.0 Predict device information

| Manufacturer: Omron Healthcare, Inc |
|--------------------------------------|
| Device: HCG-801 portable ECG Monitor |
| 510(k) number: K060766 |

## JUL 15 2011

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### 5.0 Intended use

ACG-8511 is a kind of user-activated ECG event recorder. It allows user to initiate an ECG recording when he or she experiences symptoms such as heart pain, palpitations and shortness of breath. These symptoms are transient and difficult to be recorded by conventional devices. The measurements recorded by an ECG monitor, when combined with a medical examination, can help your doctor monitor your heart condition. The ECG measurements recorded by the unit are NOT designed or intended for medical diagnosis.

The intended use and the indication for use of ACG-8511, as described in its labeling are the same as the predict device HCG-801.

#### 6.0 Device description

The Portable ECG monitor, ACG-8511, is able to measure the electrical impulse as it passes across and through the heart. And give an indication to the user on the LCD which contains the heart rate and the rhythm of the heart.

The user can operate the monitor according to the indication provided by the menus displayed on the LCD. Each record contains about 30s ECG data.

The ACG-8511 Portable ECG Monitor is activated by the user whenever symptoms, such as heart pain, palpitations and shortness of breath are experienced. The recorded data will then be shown to physicians or other health care professionals for confirmation of these symptoms as reliable evidence.

ACG-8511 is a portable ECG monitor used for self-testing before diagnosis and are not recommended for users with implanted pacemakers. It works with dry single lead, and has 3 testing mode:

a) Hand to chest mode, using the metal electrodes integrated on the device Place your right thumb on the right two electrodes of the device and place the chest electrode on bare skin about 5cm below your left nipple.

b) Two hands mode, using the metal electrodes integrated on the device. Place your right thumb on the right two electrodes, and the left big thenar on the left electrode.

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c) Lead wires modes, using lead wires and three disposable electrodes. Paste the disposable electrodes on your body and connect them to the device through a 3 wire cable.

The measurement data can be recorded on the SD card, then download to PC after the measure process is completed.

## 7.0 Summary comparing technological characteristics with predicate device

| Technological Characteristics | Comparison result |
|-------------------------------|-------------------|
| Design principle | Identical |
| Performance | Similar |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |

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## 8.0 Performance summary

Testing for ACG-8511 Portable ECG Monitor have been tested to meet all of the following standards:

- · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- · IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
- · ANSI/AAMI EC38, Medical electrical equipment-Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems, 2007.
- · ISO 10993-1:2002: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
- · ISO 10993-10:2002/Amd1:2006: Biological Evaluation of Medical Devices-Part 10: Tests for irritation and delayed-type hypersensitivity.
- · ISO 10993-12:2002: Biological Evaluation of Medical Devices-Part 12: Sample preparation and reference materials.

## 9.0 Comparison to the predict device and the conclusion

Our device ACG-8511 Portable ECG Monitor is substantially equivalent to the Portable ECG Monitor HCG-801 whose 510(k) number is K060766.

The ACG-8511 is very similar with the predicted devices in the intended use. the design principle, the energy source and the applicable standards.

However, appropriate test will be conducted and specified acceptance criteria will be met before ACG-8511 is marketed.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

JUL 1 5 2011

Andon Health Co., Ltd. c/o Mr. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin China 300190

Re: K110328

> Trade/Device Name: ACG-8511 Portable ECG Monitor Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: June 19, 2011 Received: June 21, 2011

#### Dear Mr. Yi:

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 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. Liu Yi

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Prem D. Zuckerman, M.D.

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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## Statement of Indications for Use

510(k) Number :

ACG-8511 Portable ECG Monitor Device name:

#### Indications for use:

The ACG-8511 portable ECG Monitor is intended for recording and displaying ECG data by adult patients who are concerned about their heart rhythm. This ACG-8511 portable ECG Monitor allows the consumer to record their ECG data into the device memory for display by healthcare professionals during office visits.

Specifically, ACG-8511 portable ECG Monitor is intended for adult patients who are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm: -Skipped beats

-Pounding heart (palpitations) -History of arrhythmia

XX AND/OR Over-The-Counter Use Prescription use Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDBH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number K110328