(31 days)
Not Found
No
The description focuses on standard signal processing and analysis of heart rate variability (HRV) using defined algorithms, without mentioning AI or ML techniques. The analysis is described as identifying "patterns" and providing "measurements," which aligns with traditional signal processing rather than adaptive or learning-based methods.
No.
The device is intended for analysis and reporting of ECG data, specifically Heart Rate Variability (HRV), and explicitly states it is "not intended to produce any interpretation of those measurements or any kind of diagnosis," nor does it claim to provide any therapy.
Yes
The device is described as analyzing and reporting on ECG data to identify periods of transient decelerations and/or reduced baseline variability in heart rate, which are measurements used in diagnosing various cardiac conditions. Although it explicitly states it is not intended to produce any interpretation or diagnosis, the act of identifying and reporting specialized HRV measurements falls under the scope of diagnostic aid by providing data critical for a diagnosis.
No
The device description explicitly states that HeRO Version 2.0 is comprised of "off-the-shelf Personal Computers (PC's) and special-purpose hardware capable of acquiring, storing, analyzing, and reporting ECG data" and mentions a "special-purpose Data Acquisition Device (DAD)". This indicates the presence of hardware components beyond just software.
Based on the provided information, the HeRO device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The HeRO device acquires ECG data from a user-supplied ECG monitor, which is a non-invasive measurement of electrical activity of the heart. It does not analyze blood, urine, tissue, or other biological samples.
- The intended use focuses on analyzing ECG data and heart rate variability. This is a physiological measurement, not an analysis of a biological sample.
- The device description details hardware for acquiring, storing, analyzing, and reporting ECG data. This aligns with a physiological monitoring and analysis device, not an IVD.
Therefore, the HeRO device falls under the category of a medical device that analyzes physiological signals, rather than 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 (comma separated list FDA assigned to the subject device)
DPS
Device Description
HeRO Version 2.0 is comprised of off-the-shelf Personal Computers (PC's) and special-purpose hardware capable of acquiring, storing, analyzing, and reporting ECG data from the cardiac monitoring devices. Data is acquired on a special-purpose Data Acquisition Device (DAD). It is stored and analyzed on a server, also called the Central Monitoring Station (CMS), located in a data closet or other suitable location. Results of the analyses are reported on a viewing station, or Remote Monitoring Station (RMS). 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
Not Found
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 Version 2.0 was developed and is manufactured in accordance with 21CFR820 Quality System Regulations. The HeRO system has been third-party tested in accordance with UL 60601-1 and IEC 60601-1-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K081473 ps10f2
Special 510(k) Application
510(k) Summary 3
| JUN | 27 2008 |
|---|---|
| ----- | --------- |
Medical Predictive Science Corporation
Date:
5/23/08
Submitter:
Contact:
William E King CEO (800) 394 1625 (434) 220 0714 (Direct) (240) 220 6098 (FAX) wking@mpsc.biz
21CFR 870.2340 74DPS, Class II
2246 Ivy Rd, Suite 17 Charlottesville, VA 22903
Trade Name: Common Name:
Classification Name: Classification Number:
Predicate Device:
K021230 (HeRO)
HeRO Version 2.0 HRV Analysis System
Electrocardiograph
Device Description:
HeRO Version 2.0 is comprised of off-the-shelf Personal Computers (PC's) and special-purpose hardware capable of acquiring, storing, analyzing, and reporting ECG data from the cardiac monitoring devices. Data is acquired on a special-purpose Data Acquisition Device (DAD). It is stored and analyzed on a server, also called the Central Monitoring Station (CMS), located in a data closet or other suitable location. Results of the analyses are reported on a viewing station, or Remote Monitoring Station (RMS). The analysis algorithms identify Heart Rate Variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability.
1
K081473 pg 2 of 2
Special 510(k) Application
| 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 Version 2.0 was developed and is manufactured
in accordance with 21CFR820 Quality System
Regulations. The HeRO system has been third-party
tested in accordance with UL 60601-1 and IEC 60601-
1-2. |
| Conclusion: | HeRO Version 2.0 has an identical intended use as the
predicate (unmodified) device. HeRO Version 2.0
raises no new questions of safety or efficacy when
compared with the predicate device. Therefore, HeRO
Version 2.0 is judged substantially equivalent to HeRO. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
Medical Predictive Science Corporation c/o Mr. William E. King CEO 2246 Ivy Rd. Suite 17 Charlottesville, VA 22903
Rc: K081473
Trade/Device Name: HeRO Version 2.0 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: May 23, 2008 Received: May 27, 2008
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.
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 (21
3
Page 2 - Mr. William E. King
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
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): | K08 1473 |
|---|---|
| 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 ﺎ (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
(Division Sigh-Off) Division of Cardiovascular Devices
K08 413 510(k) Number - 2.1 -