(386 days)
HERO is intended to acquire, store, analyze, and report on ECG data collected from infants. HERO is intended to be used under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment.
HERO is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HERO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate.
HERO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
The specialized HRV measurements produced by HERO have not been approved by the FDA for any specific clinical diagnosis.
HERO acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.
HERO is comprised of several off-the-shelf Personal Computers (PC's) capable of acquiring, storing, analyzing, and reporting ECG data from the cardiac monitoring real-time network. Data is acquired, stored, analyzed, and displayed on a Bedside Monitoring Station (BMS) located near each patient. Demographic data is entered on a Central Monitoring Station (CMS). Results of the analyses are reported by both the CMS and the BMS. The analysis algorithms identify Heart Rate Variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability.
The provided text describes the "HERO HRV Analysis System" (K021230), but it does not contain acceptance criteria or a study proving that the device meets specific performance metrics.
The document is a 510(k) summary for a medical device cleared in 2003, which primarily focuses on establishing "substantial equivalence" to a predicate device rather than detailing performance acceptance criteria and a study to meet them.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document does not specify any quantitative acceptance criteria for the device's performance (e.g., accuracy, sensitivity, specificity for detecting HRV patterns). It describes the device's function (acquiring, storing, analyzing, and reporting ECG data for HRV patterns) but not how its performance against a ground truth was measured or what level of performance was deemed acceptable.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. No information on a test set sample size or its provenance is 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)
- Missing. As there's no mention of a test set where ground truth was established, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. No adjudication method is described.
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. An MRMC comparative effectiveness study was not done. The device's intended use explicitly states: "HERO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis." This indicates it's a measurement tool, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied, but details missing. The device is described as an "HRV Analysis System" that identifies "HRV patterns that reflect transient decelerations and/or reduced baseline variability." This suggests a standalone algorithmic analysis. However, there are no performance metrics (e.g., how accurately it identifies these patterns) for a standalone performance provided in the document. The "Test Summary" only mentions software validation procedures and hardware certification.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing. No ground truth type is mentioned.
8. The sample size for the training set
- Missing. There is no information about a training set since the document describes a 510(k) for substantial equivalence to a predicate device, not the development and validation of a novel algorithm with training data.
9. How the ground truth for the training set was established
- Missing. Not applicable, as no training set is mentioned.
Summary of the study and its purpose:
The document describes the 510(k) premarket notification for the HERO HRV Analysis System (K021230).
- Purpose of the study (as presented in the 510(k) context): To demonstrate "substantial equivalence" of the HERO device to a legally marketed predicate device (K991786 GE Marquette MARS Unity Workstation with Heart Rate Variability (HRV) Option).
- Methodology (as described for this 510(k)): The summary states:
- "HERO software was tested under software validation procedures developed in accordance with the General Principles of Software Validation; Final Guidance for Industry and FDA Staff and the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices published by the FDA."
- "HERO hardware is UL 2601-1 (standard for Medical Electrical Equipment) tested and certified, and meets appropriate requirements for the intended environment."
- Conclusion: "HERO has a similar intended use as the predicate device. HERO raises no new questions of safety or efficacy when compared with the predicate device. Therefore, HERO is judged substantially equivalent to the MARS Unity Workstation with Heart Rate Variability (HRV) Option."
In essence, this document is a regulatory submission demonstrating equivalence, not a clinical performance study with defined acceptance criteria and performance data against a ground truth. The "testing" mentioned pertains to software validation and hardware safety/compliance, not a clinical trial to evaluate the accuracy or efficacy of the HRV analysis itself against a defined ground truth.
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Medical Decision Networks
Traditional 510(k) Application
Vz
K021230
510(k) Summary 3
| Date: | 5/7/2003 |
|---|---|
| Submitter: | Medical Predictive Science Corporation2246 Ivy Rd, Suite 17Charlottesville, VA 22903 |
| Contact: | William E KingProject Manager(800) 394 1625(434) 951 2980 (Direct)(434) 951 0226 (FAX)wking@rals.com |
| Trade Name:Common Name: | HEROHRV Analysis System |
| Classification Name:Classification Number: | Electrocardiograph21CFR 870.2340 74DPS, Class II |
| Predicate Device: | K991786 GE MarquetteMARS Unity Workstation with Heart Rate Variability(HRV) Option |
| Device Description: | HERO is comprised of several off-the-shelf PersonalComputers (PC's) capable of acquiring, storing,analyzing, and reporting ECG data from the cardiacmonitoring real-time network. Data is acquired, stored,analyzed, and displayed on a Bedside MonitoringStation (BMS) located near each patient. Demographicdata is entered on a Central Monitoring Station (CMS).Results of the analyses are reported by both the CMSand the BMS. The analysis algorithms identify HeartRate Variability (HRV) patterns that reflect transientdecelerations and/or reduced baseline variability. |
| Intended Use: | HERO is intended to acquire, store, analyze, and reporton ECG data collected from infants. HERO is intendedto be used under the direct supervision of a licensedhealth care practitioner in a hospital neonatal orpediatric ICU environment. |
| HERO is intended to be used for the analysis of thevariability in RR intervals (heart rate) and to reportmeasurements of the variability of heart rate data(HRV). The HRV measurements reported by HEROare specialized in nature, and intended to identifyperiods of transient decelerations and/or reduced.baseline variability in the heart rate. | |
| HERO is intended to provide only specialized HRVmeasurements and is not intended to produce anyinterpretation of those measurements or any kind ofdiagnosis . | |
| The specialized HRV measurements produced byHERO have not been approved by the FDA for anyspecific clinical diagnosis. | |
| HERO acquires data from a user-supplied ECGmonitor, and requires a user-supplied local areanetwork. | |
| Technology: | Microprocessor based system. |
| Test Summary: | HERO software was tested under software validationprocedures developed in accordance with the GeneralPrinciples of Software Validation; Final Guidance forIndustry and FDA Staff and the Guidance for theContent of Premarket Submissions for SoftwareContained in Medical Devices published by the FDA.HERO hardware is UL 2601-1 (standard for MedicalElectrical Equipment) tested and certified, and meetsappropriate requirements for the intended environment. |
| Conclusion: | HERO has a similar intended use as the predicatedevice. HERO raises no new questions of safety orefficacy when compared with the predicate device.Therefore, HERO is judged substantially equivalent tothe MARS Unity Workstation with Heart RateVariability (HRV) Option. |
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines representing its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Predictive Science Corporation c/o Mr. William E. King Project Manager 2300 Commonwealth Drive
Re: K021230
Charlottesville, VA 22901
Trade Name: HERO Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: February 7, 2003 Received: February 10, 2003
Dear Mr. King:
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.
MAY - 9 2003
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.
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
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Page 2 - Mr. William E. King
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
K. Ogle T
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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Indications for Use Statement 2
| 510(k) Number (if known): | K021230 |
|---|---|
| Device Name: | HERO |
Indications for Use:
HERO is intended to acquire, store, analyze, and report on ECG data collected from infants. HERO is intended to be used under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment.
HERO is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HERO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate.
HERO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
The specialized HRV measurements produced by HERO have not been approved by the FDA for any specific clinical diagnosis.
HERO acquires data from a user-supplied ECG monitor, and requires a usersupplied local area network.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use | (Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K021730
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§ 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).