(386 days)
Not Found
No
The description focuses on standard signal processing and analysis of ECG data to calculate Heart Rate Variability (HRV) measurements. There is no mention of AI, ML, or related concepts like training sets, test sets, or complex algorithms typically associated with AI/ML. The analysis algorithms are described as identifying specific HRV patterns, which is consistent with traditional signal processing techniques.
No
The device is intended to acquire, store, analyze, and report on ECG data, specifically focusing on Heart Rate Variability (HRV) measurements. It specifically states that it is not intended to produce any interpretation or diagnosis, nor has it been approved for any specific clinical diagnosis. This indicates it is a diagnostic or monitoring device, not a therapeutic one.
No
Explanation: The "Intended Use / Indications for Use" section 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 clearly indicates it is not a diagnostic device.
No
The device description explicitly states that HERO is comprised of "several off-the-shelf Personal Computers (PC's)" and mentions "HERO hardware is UL 2601-1... tested and certified," indicating the presence of hardware components beyond just software.
Based on the provided information, HERO is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs analyze specimens from the human body. The definition of an IVD involves examining specimens such as blood, urine, tissue, etc., outside of the body to provide information about a patient's health.
- HERO analyzes ECG data. HERO acquires and analyzes electrical signals from the heart (ECG data) collected from infants. This is a physiological measurement taken directly from the patient, not a specimen collected and analyzed in vitro.
- The intended use focuses on physiological monitoring and analysis. The intended use clearly states that HERO is for acquiring, storing, analyzing, and reporting on ECG data and heart rate variability (HRV). This is consistent with a physiological monitoring device.
Therefore, while HERO is a medical device used in a clinical setting, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 user-supplied local area network.
Product codes
DPS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ECG data
Anatomical Site
Not Found
Indicated Patient Age Range
infants
Intended User / Care Setting
licensed health care practitioner in a hospital neonatal or pediatric ICU environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K991786 GE Marquette
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Medical Decision Networks
Traditional 510(k) Application
Vz
K021230
510(k) Summary 3
| Date: | 5/7/2003 |
|---|---|
| Submitter: | Medical Predictive Science Corporation |
| 2246 Ivy Rd, Suite 17 | |
| Charlottesville, VA 22903 | |
| Contact: | William E King |
| Project Manager | |
| (800) 394 1625 | |
| (434) 951 2980 (Direct) | |
| (434) 951 0226 (FAX) | |
| wking@rals.com | |
| Trade Name: | |
| Common Name: | HERO |
| HRV Analysis System | |
| Classification Name: | |
| Classification Number: | Electrocardiograph |
| 21CFR 870.2340 74DPS, Class II | |
| Predicate Device: | K991786 GE Marquette |
| MARS Unity Workstation with Heart Rate Variability | |
| (HRV) Option | |
| Device Description: | 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. | |
| Intended 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 user-supplied local area | |
| network. | |
| Technology: | Microprocessor based system. |
| Test Summary: | 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. |
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KO21230
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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
3
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
4
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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