(41 days)
The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, stress, or Holter) from any compatible device, displaying such data to the clinician for analysis and review.
The product does not modify the original ECG waveform and does not provide an automated ECG analysis.
HealthView ECG Manager (version 1.0), herein after referred to as ECG Manager, is a Programmable Diagnostic Computer system. It is a "software only" medical device, to be installed on a server and workstation(s) that meet the minimum hardware requirements noted in the documentation. The hardware itself is not considered a medical device and is not part of this 510(k) submission. The device provides a trained user with the ability to find, retrieve, view and integrate ECGs into a single patient record, to assist in the diagnosis and treatment planning of patients. The device does not contact the patient and does not control any life sustaining devices.
The provided document is a 510(k) summary for the HealthView ECG Manager. As such, it is designed to demonstrate substantial equivalence to predicate devices rather than fully detail a clinical study with acceptance criteria and performance data in the way a Pre-Market Approval (PMA) submission might.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance for a formal clinical study. Instead, it describes performance substantiation through a series of verification and validation activities.
| Acceptance Criteria (Inferred from Performance Test Data) | Reported Device Performance |
|---|---|
| Accuracy of measurement tools: Ability to provide accurate measurements comparable to cleared devices. | Verified accuracy of measurement tools using other cleared devices. |
| Speed of performance in simulated network environment: Efficient operation under specified network conditions. | Verified the speed of performance in a simulated network environment. |
| Retrieval speed at validation site: Timely retrieval of data in a real-world clinical setting. | Validated the retrieval speed at a validation site. |
| Tools accuracy at validation site: Accuracy of tools when used in a real-world clinical setting. | Validated tools accuracy at a validation site. |
| All identified requirements met: All functional and non-functional requirements are satisfied. | Every identified requirement has been tested and confirmed to be performing as expected (see Section 16, and provided screenshots of test files). |
| Risk management effectiveness: Potential hazards identified and mitigated according to ISO14971 (2007). | Risk management ensured by use of the ISO14971 (2007) standard; potential hazards individually confirmed to be controlled via verification and validation testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" sample size in the context of a clinical study or a specific number of ECGs or patient records used for performance testing. The performance substantiation relies on internal verification and validation activities, including "simulated network environment" and "validation site" testing, but no details on the number of cases or data provenance are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
No information is provided regarding the number of experts or their qualifications used to establish ground truth for a test set. The document states that "Data created or modified on this device are evaluated by medical professionals," implying human oversight in clinical use, but this is not tied to a specific test set or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is described, as the document does not detail the creation of a ground truth for a specific test set using multiple experts.
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
A multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisting AI or vice-versa was not conducted or reported. The device is explicitly stated to "not provide an automated ECG analysis" and is a "software only" system for managing ECGs, not an AI-driven diagnostic tool. It is intended for use by "trained and qualified professionals who have ample opportunity for competent human intervention in interpreting the waveforms and information presented to them."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device "does not provide an automated ECG analysis" and is designed to assist trained professionals in managing and reviewing ECGs. It is not an algorithm performing a diagnostic task independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the establishment of a specific "ground truth" using expert consensus, pathology, or outcome data for performance evaluation in a clinical study context. The performance verification focuses on system functionalities like measurement tool accuracy and data retrieval speed, presumably against known standards or expected outputs.
8. The sample size for the training set
This information is not applicable as the HealthView ECG Manager is a software system for managing ECG data, not an AI/ML device that requires training data for a diagnostic algorithm.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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K123466
5. HealthView ECG Manager 510(k) Summary
DEC 2 0 2012
The following safety and effectiveness summary has been prepared pursuant to 21 CFR 807.87 and 21 CFR 807.92 (for 510(k) summaries).
Submitter Information
LUMEDX
| 110 110th Ave Ne (Suite 475) | |
|---|---|
| Bellevue, WA 98004 | |
| Phone: | 425 818 2326 |
| Fax: | 425 450 0962 |
| Contact Person: | Chris Pearce |
| Date prepared: | Nov 5th 2012 |
ባ
Device name and Classification
Trade name:
HealthView ECG Manager (version 1.0)
ECG Management System Common name: Classification Name: Programmable Diagnostic Computer 21 CFR Part 870.1425 Classification number: Device Class: Class II DQK (Cardiology Panel) Product Code:
Substantial Equivalence
The HealthView ECG Manager (version 1.0) device, addressed in this premarket notification, is substantially equivalent to both of the following commercially available devices:
| 510(k) # | Trade Name | Manufacturer |
|---|---|---|
| K052883 | Cardio Server | Epiphany |
| K083639 | MUSE | GE Healthcare |
Device description
HealthView ECG Manager (version 1.0), herein after referred to as ECG Manager, is a Programmable Diagnostic Computer system. It is a "software only" medical device, to be
Lumedx HealthView ECG Manager
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installed on a server and workstation(s) that meet the minimum hardware requirements noted in the documentation. The hardware itself is not considered a medical device and is not part of this 510(k) submission. The device provides a trained user with the ability to find, retrieve, view and integrate ECGs into a single patient record, to assist in the diagnosis and treatment planning of patients. The device does not contact the patient and does not control any life sustaining devices.
Intended Use
The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, stress, or Holter) from any compatible device, displaying such data to the clinician for analysis and review.
The product does not modify the original ECG waveform and does not provide an automated ECG analysis.
Technological characteristics of the device
ECG Manager is a software-only device that can be used on multiple hardware platforms (provided that the minimum hardware requirements are met) that allows acquiring, archiving, viewing, and editing. This device is used by trained and qualified professionals who have ample opportunity for competent human intervention in interpreting the waveforms and information presented to them. These technological characteristics are the same as those in the predicate devices, in terms of hardware needs, operating system requirements, overall functional characteristics, storage methodology, and waveform generation. This device does not physically come in contact with a patient, nor does it control any life-sustaining devices.
Performance Test Data
Every identified requirement has been tested and confirmed to be performing as expected (see Section 16, and provided screen shots of test files). Additionally, performance of the device has been substantiated in multiple ways: i) verifying accuracy of measurement tools using other cleared devices, ii) verifying the speed of performance in a simulated network environment, iii) validating the retrieval speed at a validation site, and iv) validating tools accuracy at a validation site.
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General Safety and Effectiveness Concerns
Risk management is ensured by use of the ISO14971 (2007) standard, which has been used to identify and mitigate potential hazards. These potential hazards are also individually confirmed to be controlled via verification and validation testing, and any necessary cautions and warnings are included in user documentation.
Data created or modified on this device are evaluated by medical professionals, thus allowing for intervention in the event of a malfunction.
Lumedx therefore believes this device to be as safe and effective as the predicate devices referenced above; it does not introduce new technology or new indications for use.
Conclusions - Substantial Equivalence
This submission includes the results of a hazard analysis, and shows that the potential hazards have been controlled. The Level of Concern of the device has been demonstrated to be "Moderate". All verification and validation testing has successfully concluded. The 510(k) premarket notification for the HealthView ECG Manager (version 1.0) contains adequate information to show substantial equivalence to the listed predicate devices.
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Image /page/3/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized, curved lines that converge at the bottom, resembling a stylized human form or a flame. The text is arranged around the circle's perimeter, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the top and "USA" at the top right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DEC 2 0 2012
LUMEDX. c/o Mr. Chris Pearce Director, Regulatory Affairs 110, 110th Ave NE Bellevue, WA 98004
Re: K123466
Trade/Device Name: HealthView ECG Manager Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II (two) Product Code: DQK Dated: November 8, 2012 Received: November 9, 2012
Dear Mr. Pearce:
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. 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.
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Page 2 – Mr. Chris Pearce
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 yours,
Owen P. Faris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, stress, or Holter) from any compatible device, displaying such data to the clinician for analysis and review.
The product does not modify the original ECG waveform and does not provide an automated ECG analysis.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K123466
Lumedx HealthView ECG Manager
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§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).