(162 days)
Not Found
No
The description focuses on basic ECG recording and display, with no mention of AI/ML algorithms for analysis or interpretation.
No.
The device is intended for recording and displaying ECG data for diagnostic purposes, not for therapeutic intervention. It helps monitor heart rhythm concerns and symptoms for healthcare professionals to review, but it does not treat or alleviate any condition.
Yes
Explanation: The device is described as a "Portable ECG monitor" that records and displays "ECG data" and provides an "indication to the user on the LCD which contains the heart rate and the rhythm of the heart." It is used for "self-testing before diagnosis" to confirm symptoms "as reliable evidence" for healthcare professionals. These functions of recording physiological data and providing an "indication" related to heart rhythm directly align with the purpose of diagnostics.
No
The device description explicitly details hardware components such as metal electrodes, an LCD display, and the ability to use lead wires and disposable electrodes, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided text, the ACG-8511 portable ECG Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- ACG-8511 Function: The ACG-8511 measures electrical impulses directly from the body surface (skin) to record ECG data. It does not analyze samples taken from the body.
- Intended Use: The intended use is for recording and displaying ECG data for adult patients concerned about their heart rhythm, with the data being shown to healthcare professionals. This is a direct physiological measurement, not an in vitro test.
Therefore, the ACG-8511 falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes
DPS
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.
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.
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
Adult patients
Intended User / Care Setting
User-activated / Self-testing before diagnosis. Data for healthcare professionals during office visits.
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)
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.
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
§ 870.2340 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).
0
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 =AZ, Y= blank or AZ) .
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
P44
1
Kilo328.
P2/4
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.
2
$3/4
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 |
3
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.
ર- 4
4
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.
5
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 (800) 638-2041 or (301) 796-7100 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
6
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