(297 days)
The eWave monitor is an ambulatory ECG monitor intended to provide continuous extended duration cardiac monitoring. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, fatigue, or anxiety.
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This document is an FDA 510(k) clearance letter for the eWave Monitor. While it describes the intended use and regulatory classification, it does not contain the detailed information required to fill out the table and answer all the questions about acceptance criteria and the study that proves the device meets them.
The information typically found in a 510(k) summary or a more detailed submission document, which is not provided here, would be needed to answer your specific questions.
Therefore, I cannot extract the requested information from the provided text.
However, based on the type of device (ambulatory ECG monitor), I can provide examples of what might be expected for such a device in a regulatory submission:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|---|
| Arrhythmia Detection Accuracy | ||
| - Sensitivity for AFib | ≥ 90% | 92.5% |
| - Specificity for AFib | ≥ 80% | 85.1% |
| - Sensitivity for Tachycardia | ≥ 90% | 91.0% |
| - Specificity for Tachycardia | ≥ 80% | 83.2% |
| - Sensitivity for Bradycardia | ≥ 90% | 90.5% |
| - Specificity for Bradycardia | ≥ 80% | 82.9% |
| Signal Quality | Percentage of analyzable data > 95% | 97.2% analyzable data |
| Wear Time | Mean wear time > 10 days | 12.3 days (average continuous wear) |
| False positive rate for critical arrhythmias | < 0.1 per 24 hours | 0.05 per 24 hours |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size (Example): 500 patients / 10,000 hours of ECG data
- Data Provenance (Example): Retrospective, multi-center study from hospitals in the United States and Europe.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts (Example): 3
- Qualifications (Example): Board-certified cardiologists or clinical electrophysiologists with 5+ years of experience in ECG interpretation and arrhythmia diagnosis.
4. Adjudication method for the test set
- Adjudication Method (Example): 2+1 (Two experts independently reviewed each ECG trace, and any discrepancies were resolved by a third senior expert).
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
- This document does not indicate if an MRMC study was done, nor would it contain such detailed results. An ambulatory ECG monitor primarily focuses on automated detection and recording, not necessarily on improving human reader performance directly like an AI-assisted diagnostic imaging tool might. If an MRMC study were performed, it would likely focus on human over-read accuracy with and without the device's automated analysis.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes (Likely): For an ECG monitor with automated arrhythmia detection, a standalone algorithm performance study is crucial. The acceptance criteria in point 1 (Sensitivity, Specificity) are typically derived from such a standalone study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth (Example): Expert consensus by a panel of cardiologists/electrophysiologists upon review of the full ECG recordings. In some cases, correlation with patient symptoms recorded in a diary might also be part of the ground truth establishment.
8. The sample size for the training set
- Training Set Sample Size (Example): 5,000 patients / 100,000 hours of ECG data (significantly larger than the test set).
9. How the ground truth for the training set was established
- Ground Truth for Training Set (Example): Similar to the test set, expert consensus or annotations by qualified ECG technicians under cardiologist supervision. This data would often be sourced from large, previously collected clinical datasets.
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October 20, 2022
WearLinq, Inc. Konrad Morzkowski CEO 1819 Polk St #148 San Francisco, California 94109
Re: K214073
Trade/Device Name: eWave Monitor Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH Dated: August 9, 2022 Received: August 11, 2022
Dear Konrad Morzkowski:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K214073
Device Name eWave Monitor
Indications for Use (Describe)
The eWave monitor is an ambulatory ECG monitor intended to provide continuous extended duration cardiac monitoring. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, fatigue, or anxiety.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).