(79 days)
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
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.
The Omron HCG-801 Portable ECG Monitor received FDA clearance based on its substantial equivalence to the predicate device, the CG 5000 ECG MiniMonitor Transmitter (K992696). The performance testing described primarily focuses on demonstrating this equivalence rather than setting specific objective acceptance criteria for diagnostic performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria for device performance in terms of diagnostic accuracy (e.g., sensitivity, specificity for detecting arrhythmias). Instead, acceptance criteria implicitly refer to meeting established electrical safety and electromagnetic compatibility standards, and demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria Category | Criterion (Implicit from comparison/standards) | Reported Device Performance (HCG-801) |
|---|---|---|
| Safety Standards | Compliance with IEC 60601-1 (General Requirements for Safety), Amendment 1 & 2. | Compliant: "We performed the following bench testing to demonstrate safety and effectiveness... IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety; Amendment 1, 1991-11, Amendment 2, 1995-03. Version 1995" |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (Collateral Standard: Electromagnetic Compatibility-Requirements and Tests). | Compliant: "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." |
| Electrocardiograph Standards | Compliance with AAMI EC 38 (Ambulatory Electrocardiographs), including testing with known databases (e.g., MIT, AHA). | Compliant: "AAMI EC 38 Ambulatory Electrocardiographs (which includes testing with a known database, e.g., MIT, AHA)" |
| Functional Equivalence (with predicate) | Ability to display real-time ECG waveform. | Equivalent: "Displays real-time ECG wave-form" (same as predicate). |
| Functional Equivalence (with predicate) | Ability to record multiple events. | Equivalent: "Yes" (same as predicate). |
| Functional Equivalence (with predicate) | Baseline stabilization. | Equivalent: "Yes" (same as predicate). |
| Functional Equivalence (with predicate) | Battery life indicator. | Equivalent: "Yes" (same as predicate). |
| Safety and Effectiveness Equivalence | No new questions of safety and effectiveness compared to predicate. | Demonstrated: "Validation testing contained in the submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety and effectiveness." |
| Overall Substantial Equivalence (General) | Safe and effective as the predicate device when used as intended. | Demonstrated: "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." |
2. Sample size used for the test set and the data provenance
The document describes "bench testing" and compliance with standards. For AAMI EC 38, it mentions "testing with a known database, e.g., MIT, AHA." However, it does not specify the exact sample size of ECG recordings or patients used from these databases for the HCG-801's performance evaluation. The data provenance would be "known databases like MIT and AHA," which typically contain retrospective ECG recordings from a variety of sources. No country of origin is explicitly stated beyond the database names.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number or qualifications of experts used to establish ground truth. When referring to "known databases like MIT, AHA," these databases usually have their annotations (ground truth) established by a consensus of cardiologists or other qualified experts, but the specifics for this submission are not given.
4. Adjudication method for the test set
The document does not describe any specific adjudication method for the test set. For "known databases," the ground truth is often inherent in the dataset, having been established prior to its common use for testing devices.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study is mentioned. The device is a "portable ECG Monitor" intended for recording and displaying ECG data for healthcare professionals to review, not primarily for automated interpretation or AI assistance to human readers. Therefore, there's no discussion of human reader improvement with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is described as "recording and displaying ECG data" and not intended for use as a "diagnostic tool" nor for "recording and transmission of user's ECG signal simultaneously." It allows the consumer to record their ECG data for display by healthcare professionals. This indicates that there is no standalone algorithm for diagnostic interpretation in the sense of AI without a human-in-the-loop, beyond the display of the raw ECG waveform. The AAMI EC 38 standard often involves rhythm analysis, but the document doesn't detail the HCG-801's specific automatic analysis capabilities or their standalone performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the testing required by AAMI EC 38 and involving "known databases (e.g., MIT, AHA)," the ground truth for these databases typically consists of expert-annotated ECG rhythms and events. Specifics for this submission are not provided.
8. The sample size for the training set
The document does not discuss a training set or machine learning aspects. The device primarily records and displays ECG waveforms. While it might incorporate some internal signal processing or rhythm detection (especially implied by AAMI EC 38 compliance), the submission does not detail any "training set" in the context of a machine learning algorithm.
9. How the ground truth for the training set was established
As no training set is discussed in the provided text, information on how its ground truth was established is not available.
{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 theirheart rhythm. | |
| Environment of Use | Prescription use for self testing anywhere and anytime. | |
| Patient Population | Adult | |
| Type ofwaveform | Real Time ECG Waveform Display | |
| Hear Rate Range | 2 to 200 beats/min. | |
| Software driven | Yes | |
| Materials inpatient contact | Material is identical to a previously approved Omron HBF-400Model K043060. | |
| Standard met | IEC 60601-1, IEC 60601-1-2, AAMI EC 38 | |
| MeasurementRate | 30 Seconds | |
| Components | SD Card, 2 AAA Batteries, storage pouch, instruction manual,quick reference card, warranty card, registration card | |
| Operatingconditions | +10 to +40 °C | |
| 30 to 85%RH (relative humidity) | ||
| Storageconditions | -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-3000ECG MiniMonitor | |
|---|---|---|
| SUBSTANTIALEQUIVALENCECOMPARISONS | K992696 | |
| Intended Use | Same | Same |
| Prescription/ Over the Counter | Prescription | Prescription |
| Display of waveform | Displays real-time ECGwave-form | Displays real-time ECG wave-form |
| Type of Transmission | Non Transmission | Transmission andnon-Transmission |
| Lead placement on body | ChestPlacement | ChestPlacement |
| 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
§ 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).