(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.
§ 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).