(79 days)
No
The description focuses on the device's ability to record and display ECG data for review by healthcare professionals. There is no mention of automated analysis, interpretation, or any technology that would suggest AI/ML is being used. The device is described as a simple recording and display tool.
No.
The device is described as an ECG monitor which records and displays data for healthcare professionals, and explicitly states it is "not intended for use as a diagnostic tool." It does not provide any treatment or therapy.
No
The "Device Description" section explicitly states: "This device is not intended for use as a diagnostic tool."
No
The device description explicitly states it is a "dry single lead electrode, handheld, portable, selftesting electrocardiograph (ECG) device" and describes physical components like finger electrodes and a chest electrode, indicating it is a hardware device with integrated software.
Based on the provided information, the Omron HCG-801 portable ECG Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Omron HCG-801 Function: The Omron HCG-801 records and displays electrical signals from the heart (ECG data) directly from the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for adult patients to record their ECG data for display to healthcare professionals. It is explicitly stated that the device is "not intended for use as a diagnostic tool." While the data can be used by healthcare professionals for diagnosis, the device itself is not performing the diagnostic test on a specimen.
Therefore, the Omron HCG-801 falls under the category of a medical device that records physiological signals, but it is not an IVD.
N/A
Intended Use / Indications for Use
The Omron HCG-801 portable ECG Monitor is intended for recording and displaying ECG data by adult patients who are concerned about their heart rhythm. This Omron HCG-801 portable ECG Monitor allows the consumer to record their ECG data into the device memory for display by healthcare professionals during office visits.
Specifically, Omron HCG-801 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 Omron HCG-801 portable ECG Monitor is activated by the user whenever symptoms (palpitations, skipped beats, pounding heart) are experienced. The recorded data serves as reliable evidence and are later shown to physicians or other health care professionals for confirmation of these symptoms. When a user feels that a cardiac event is occurring. the utilization of HCG-801 has the unique feature of recording this real time data that is normally difficult to capture.
HCG-801 portable ECG Monitor is a dry single lead electrode, handheld, portable, selftesting electrocardiograph (ECG) device that records cardiac event data and displays the data in a clear and precise waveform.
HCG-801 portable ECG Monitor has been developed considering ergonomic product designs to provide a clear display and an accurate measurement of waveforms as well as actual usage flow. The device is very simple to use. After turning the device on, the user holds it in their hand insuring that the index finger is placed so that it fits closely over the two finger electrodes. The chest electrode is placed on bare skin about 5 cm (2 inches) below left nipple. The START button is then pressed. Measurement takes about 30 seconds to complete then the unit beeps. No gel usage is necessary and no lead wires are connected.
The recorded data can also be downloaded to Personal Computer via SD memory card that has the capability of storing 300 measurements. This device is not intended for use as a diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. This device is not recommended for users with implanted pacemakers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest
Indicated Patient Age Range
Adult
Intended User / Care Setting
Prescription use for self testing anywhere and anytime. The consumer records their ECG data into the device memory for display by 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)
Bench testing was performed to demonstrate safety and effectiveness and equivalency to the predicate device.
Study type: Bench Testing
Standards Met:
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety; Amendment 1, 1991-11, Amendment 2, 1995-03. Version 1995
- EMC tests according to IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility-Requirements and Tests. Version 2001.
- AAMI EC 38 Ambulatory Electrocardiographs (which includes testing with a known database, e.g., MIT, AHA)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Koto766
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 6 21-Feb-06
JUN - 9 2006 Omron Healthcare, Inc. 1200 Lakeside Dr. Tel -- 847-247-5713 Fax - 847-680-6269 Bannockburn, IL 60015 Donna Djinovich - Regulatory Affairs Manager Official Contact: HCG-801 Portable ECG Monitor Proprietary or Trade Name: Common/Usual Name: Portable, ECG Monitor Classification Name: Class II Device: Omron HCG-801 Portable ECG Monitor Predicate Devices: CG 5000 ECG Mini Monitor Transmitter K992696 Device Description:
The Omron HCG-801 portable ECG Monitor is activated by the user whenever symptoms (palpitations, skipped beats, pounding heart) are experienced. The recorded data serves as reliable evidence and are later shown to physicians or other health care professionals for confirmation of these symptoms. When a user feels that a cardiac event is occurring. the utilization of HCG-801 has the unique feature of recording this real time data that is normally difficult to capture.
HCG-801 portable ECG Monitor is a dry single lead electrode, handheld, portable, selftesting electrocardiograph (ECG) device that records cardiac event data and displays the data in a clear and precise waveform.
HCG-801 portable ECG Monitor has been developed considering ergonomic product designs to provide a clear display and an accurate measurement of waveforms as well as actual usage flow. The device is very simple to use. After turning the device on, the user holds it in their hand insuring that the index finger is placed so that it fits closely over the two finger electrodes. The chest electrode is placed on bare skin about 5 cm (2 inches) below left nipple. The START button is then pressed. Measurement takes about 30 seconds to complete then the unit beeps. No gel usage is necessary and no lead wires are connected.
The recorded data can also be downloaded to Personal Computer via SD memory card that has the capability of storing 300 measurements. This device is not intended for use as a diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. This device is not recommended for users with implanted pacemakers.
BATOPER THE
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 6 21-Feb-06
Indications for Use: 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
The Omron HCG-801 portable ECG Monitor is intended for recording and displaying ECG data by adult patients who are concerned about their heart rhythm. This Omron HCG-801 portable ECG Monitor allows the consumer to record their ECG data into the device memory for display by healthcare professionals during office visits.
Specifically, Omron HCG-801 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
2
Non-Confidential Summary of Safety and Effectiveness
Page 3 of 6 21-Feb-06
Prescription Environment of Use --
Device Attributes: 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 1
| Features | HCG-801 | |
|---|---|---|
| Indications for use | Self testing of patients intended for recording and displaying real- | |
| time ECG data by adult consumers who are concerned about their | ||
| heart rhythm. | ||
| Environment of Use | Prescription use for self testing anywhere and anytime. | |
| Patient Population | Adult | |
| Type of | ||
| waveform | Real Time ECG Waveform Display | |
| Hear Rate Range | 2 to 200 beats/min. | |
| Software driven | Yes | |
| Materials in | ||
| patient contact | Material is identical to a previously approved Omron HBF-400 | |
| Model K043060. | ||
| Standard met | IEC 60601-1, IEC 60601-1-2, AAMI EC 38 | |
| Measurement | ||
| Rate | 30 Seconds | |
| Components | SD Card, 2 AAA Batteries, storage pouch, instruction manual, | |
| quick reference card, warranty card, registration card | ||
| Operating | ||
| conditions | +10 to +40 °C | |
| 30 to 85%RH (relative humidity) | ||
| Storage | ||
| conditions | -20 to +60 °C | |
| 10% to 90% RH | ||
| Dimensions (mm) | 121 mm (W) × 67 mm (H) × 24 mm (D) | |
| Weight (kg) | ||
| without battery | 130 Grams |
.
.........
. .
Eugestate
3
Non-Confidential Summary of Safety and Effectiveness Page 4 of 6 21-Feb-06
Differences Between Other Legally Marketed Predicate Devices - See Section Collection
The Omron HCG-801 portable ECG Monitor is viewed as substantially equivalent to predicate device: CG 5000 ECG MiniMonitor Transmitter. ( K992696)
The portable CG-5000 MiniMonitor Transmitter features real-time display of waveform And ECG recording, output to electrocardiograph and trans-telephonic communication capabilities.
BASIC COMPARISONS BETWEEN HCG 801 and CG-5000 ECG MiniMonitor. CG-5000
| | HCG 801 | CG-3000
ECG MiniMonitor |
|-------------------------------------------|-------------------------------------|--------------------------------------|
| SUBSTANTIAL
EQUIVALENCE
COMPARISONS | | K992696 |
| Intended Use | Same | Same |
| Prescription/ Over the Counter | Prescription | Prescription |
| Display of waveform | Displays real-time ECG
wave-form | Displays real-time ECG wave-form |
| Type of Transmission | Non Transmission | Transmission and
non-Transmission |
| Lead placement on body | Chest
Placement | Chest
Placement |
| Multiple Event Recording | Yes | Yes |
| Base-line stabilization | Yes | Yes |
| Battery Life Indicator | Yes | Yes |
| Optional Cables | No | Yes |
| Pacemaker Detection | No | Yes |
4
Non-Confidential Summary of Safety and Effectiveness Page 5 of 6 21-Feb-06
In summary, the Omron HCG-801 portable ECG Monitor is substantially equivalent to Card Guard Model CG-5000 ECG MiniMonitor in the following ways:
OMRON HCG-801 is schematically similar to Card Guard Model CG-5000 ECG MiniMonitor.
Both devices are portable, personal, single lead electrode non-transmission type ECG monitors. Card Guard Model CG-5000 MiniMonitor does provide the telephone transmission option which is not an option the Omron HCG-801 ECG offers. Both devices are prescription devices intended for self-testing by patients under doctors' supervision. In both devices, user is required to place device on his/her chest and hold it steadily for at least 30 seconds.
In both devices the user is not required to apply external electrodes to the body although the Card Guard Model CG-5000 ECG MiniMonitor provides electrodes as an option.
Both devices have the capability to record real time heart rhythm waveform and heart beat and store data that can be displayed and downloaded.
The Omron HCG-801 portable ECG Monitor constitutes a safe, accurate, and reliable means for recording of ECG data. When this device is used as intended it is as safe and effective as the predicate device. As shown, Omron HCG-801 device has generally the same technological characteristics and intended use as CG 5000 ECG MiniMonitor but more advantageous and practical in terms of ease of use and reliability.
Validation testing contained in the submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety and effectiveness. When the device is used as it is intended it poses no adverse health effects or safety risks to users.
Performance Testing:
We performed the following bench testing to demonstrate safety and effectiveness and equivalency to the predicate device:
IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety; Amendment 1, 1991-11, Amendment 2, 1995-03. Version 1995
EMC tests according to IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility-Requirements and Tests. Version 2001.
AAMI EC 38 Ambulatory Electrocardiographs (which includes testing with a known database, e.g., MIT, AHA)
Page 5 .
5
Non-Confidential Summary of Safety and Effectiveness Page 6 of 6 21-Feb-06
Conclusion:
Based upon the performance testing and comparison to legally marketed predicate device (for indications for use, technology, and performance) we have demonstrated that the Omron HCG-801 Portable ECG Monitor is substantially equivalent in safety and effectiveness to the predicate device.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.
Page 56
6
Image /page/6/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2006
Omron Healthcare, Inc. c/o Ms. Silvia Ankova Project Engineer Underwriters Laboratories, Inc. 333 Pfingsten Rd Northbrook, IL 60062
Re: K060766
Trade Name: HCG-801 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: May 22, 2006 Received: May 25, 2006
Dear Ms. Ankova:
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.
7
Page 2 - Ms. Silvia Ankova
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bfimmimorfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Omron
Page 1 of 1
510(k) Number:
KObo 1 bb (To be assigned)
Device Name:
Omron HCG-801 Portable ECG Monitor
Indications for Use: The Omron HCG-801 portable ECG Monitor is intended for recording and displaying ECG data by adult patients who are concerned about their heart This Omron HCG-801 portable ECG Monitor allows the consumer to record rhythm. their ECG data into the device memory for display by healthcare professionals during office visits.
Specifically, Omron HCG-801 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
Prescription Use XX (Part 21 CFR 801 Subpart D) 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)
Blummon
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K060766