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.

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.

AI/ML Overview

Acceptance Criteria and Device Performance Study for HeRO Version 2.0

This submission describes the HeRO Version 2.0 HRV Analysis System, which is a substantial equivalence determination for an updated version of a previously approved device (HeRO, K021230). The focus of this 510(k) is on demonstrating the updated device maintains the same intended use, technology, and safety/efficacy profile as its predicate, rather than establishing new clinical performance metrics. Therefore, explicit "acceptance criteria" for novel clinical performance and a specific "study" proving these criteria are met are not presented in the traditional sense of a de novo device. Instead, the submission focuses on demonstrating equivalency to the predicate.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) (Special 510(k) for an updated device), the "acceptance criteria" are primarily centered around maintaining the performance, safety, and intended use of the predicate device. The "reported device performance" is then the assertion that HeRO Version 2.0 achieves this equivalence.

Aspect	Acceptance Criteria (Implied for Special 510(k))	Reported Device Performance
Intended Use	Identical to the predicate device	"HeRO Version 2.0 has an identical intended use as the predicate (unmodified) device." The device is intended to acquire, store, analyze, and report on ECG data from infants in a hospital neonatal or pediatric ICU, specifically for analyzing variability in RR intervals (heart rate) to identify periods of transient decelerations and/or reduced baseline variability. It does not produce interpretations or diagnoses.
Safety and Efficacy	Raises no new questions of safety or efficacy compared to the predicate device.	"HeRO Version 2.0 raises no new questions of safety or efficacy when compared with the predicate device." Tested in accordance with UL 60601-1 and IEC 60601-1-2 (electrical safety and electromagnetic compatibility). Manufactured in accordance with 21CFR820 Quality System Regulations.
Technology	Maintains similar underlying technology and functionality for HRV analysis.	Microprocessor based system. "The analysis algorithms identify Heart Rate Variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability." It is comprised of off-the-shelf PCs, special-purpose hardware, a Data Acquisition Device (DAD), a server (Central Monitoring Station), and viewing stations (Remote Monitoring Stations).
Functional Equivalence	Performs the same specialized HRV measurements as the predicate.	"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."
Regulatory Compliance	Complies with general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).	Stated compliance with 21CFR820 Quality System Regulations. The FDA's letter confirms that the device is subject to these general controls.
Predicate Equivalence	Substantially equivalent to the predicate device (HeRO, K021230).	Concluded to be substantially equivalent to HeRO (K021230).

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not detail any specific test set, its sample size, or data provenance used for a clinical performance study demonstrating the device's accuracy or effectiveness with patient data. This is typical for a Special 510(k) where the device is an update to an existing one, and the focus is on engineering changes and maintained performance, rather than new clinical claims. The "Test Summary" section refers to third-party testing for electrical safety and electromagnetic compatibility (UL 60601-1 and IEC 60601-1-2), not clinical performance with a patient data test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

As no clinical performance study with a test set of patient data is described, there is no information provided on experts or ground truth establishment for such a dataset.

4. Adjudication Method

Since no clinical performance study involving expert review of a test set is described, there is no adjudication method mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The HeRO device is described as an "HRV Analysis System" that provides "specialized HRV measurements" and is not intended to "produce any interpretation of those measurements or any kind of diagnosis." This indicates it's an analytical tool, not a diagnostic aid requiring human interpretation in a comparative effectiveness study as typically understood for AI-assisted diagnostics.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone performance study in terms of diagnostic accuracy or clinical utility using patient data. The device's function is to "acquire, store, analyze, and report on ECG data" by identifying "HRV patterns." The performance being demonstrated here is primarily related to its technical ability to compute these HRV measurements and its safety, not its standalone diagnostic accuracy for a specific condition.

7. Type of Ground Truth Used

As no clinical performance study on patient data is detailed, no specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned for establishing the accuracy of the device's HRV measurements in a clinical context.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is consistent with the nature of the submission not detailing a new algorithm development or extensive clinical validation study. The algorithm likely evolved from previous versions or established HRV analysis techniques, rather than being a de novo algorithm from a large training dataset for this specific submission.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, there is no information provided on how its ground truth might have been established.

Summary

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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:

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K081473 pg 2 of 2

Special 510(k) Application

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 reducedbaseline 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 ECG monitor,and requires a user-supplied local area network.
Technology:	Microprocessor based system.
Test Summary:	HeRO Version 2.0 was developed and is manufacturedin accordance with 21CFR820 Quality SystemRegulations. The HeRO system has been third-partytested in accordance with UL 60601-1 and IEC 60601-1-2.
Conclusion:	HeRO Version 2.0 has an identical intended use as thepredicate (unmodified) device. HeRO Version 2.0raises no new questions of safety or efficacy whencompared with the predicate device. Therefore, HeROVersion 2.0 is judged substantially equivalent to HeRO.

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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

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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

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Indications for Use Statement 2

510(k) Number (if known):	K08 1473
Device Name:	HeRO

Indications for Use:

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 -

Regulation Number and Section

§ 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).