HERO

K021230 · Medical Decision Networks · DPS · May 9, 2003 · Cardiovascular

Device Facts

• Record ID: K021230
• Device Name: HERO
• Applicant: Medical Decision Networks
• Product Code: DPS · Cardiovascular
• Decision Date: May 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

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.

Device Story

HERO system; acquires, stores, analyzes, and reports ECG data from infants; utilizes off-the-shelf PCs; requires user-supplied ECG monitor and local area network. Operates in neonatal/pediatric ICU; used by licensed healthcare practitioners. Algorithms identify HRV patterns (transient decelerations/reduced baseline variability). Outputs specialized HRV measurements via Bedside Monitoring Station (BMS) and Central Monitoring Station (CMS). Provides data for clinical review; does not provide diagnosis or interpretation. Benefits include monitoring heart rate variability trends.

Clinical Evidence

No clinical data. Bench testing only; software validated per FDA guidance; hardware certified to UL 2601-1.

Technological Characteristics

Microprocessor-based system; off-the-shelf PC hardware; networked connectivity; UL 2601-1 certified.

Indications for Use

Indicated for infants in hospital neonatal or pediatric ICU environments. Used for analysis of heart rate variability (HRV) to identify transient decelerations and reduced baseline variability. Not for diagnosis.

Regulatory Classification

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.

Predicate Devices

• MARS Unity Workstation with Heart Rate Variability (HRV) Option (K991786)

Submission Summary (Full Text)

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Medical Decision Networks

Traditional 510(k) Application

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## K021230

## 510(k) Summary 3

| Date: | 5/7/2003 |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Medical Predictive Science Corporation<br>2246 Ivy Rd, Suite 17<br>Charlottesville, VA 22903 |
| Contact: | William E King<br>Project Manager<br>[phone]<br>[phone] (Direct)<br>[phone] (FAX)<br>[e-mail] |
| Trade Name:<br>Common Name: | HERO<br>HRV Analysis System |
| Classification Name:<br>Classification Number: | Electrocardiograph<br>21CFR 870.2340 74DPS, Class II |
| Predicate Device: | K991786 GE Marquette<br>MARS Unity Workstation with Heart Rate Variability<br>(HRV) Option |
| Device Description: | HERO is comprised of several off-the-shelf Personal<br>Computers (PC's) capable of acquiring, storing,<br>analyzing, and reporting ECG data from the cardiac<br>monitoring real-time network. Data is acquired, stored,<br>analyzed, and displayed on a Bedside Monitoring<br>Station (BMS) located near each patient. Demographic<br>data is entered on a Central Monitoring Station (CMS).<br>Results of the analyses are reported by both the CMS<br>and the BMS. The analysis algorithms identify Heart<br>Rate Variability (HRV) patterns that reflect transient<br>decelerations and/or reduced baseline variability. |
| Intended Use: | HERO is intended to acquire, store, analyze, and report<br>on ECG data collected from infants. HERO is intended<br>to be used under the direct supervision of a licensed<br>health care practitioner in a hospital neonatal or<br>pediatric ICU environment. |
| | HERO is intended to be used for the analysis of the<br>variability in RR intervals (heart rate) and to report<br>measurements of the variability of heart rate data<br>(HRV). The HRV measurements reported by HERO<br>are specialized in nature, and intended to identify<br>periods of transient decelerations and/or reduced.<br>baseline variability in the heart rate. |
| | HERO is intended to provide only specialized HRV<br>measurements and is not intended to produce any<br>interpretation of those measurements or any kind of<br>diagnosis . |
| | The specialized HRV measurements produced by<br>HERO have not been approved by the FDA for any<br>specific clinical diagnosis. |
| | HERO acquires data from a user-supplied ECG<br>monitor, and requires a user-supplied local area<br>network. |
| Technology: | Microprocessor based system. |
| Test Summary: | HERO software was tested under software validation<br>procedures developed in accordance with the General<br>Principles of Software Validation; Final Guidance for<br>Industry and FDA Staff and the Guidance for the<br>Content of Premarket Submissions for Software<br>Contained in Medical Devices published by the FDA.<br>HERO hardware is UL 2601-1 (standard for Medical<br>Electrical Equipment) tested and certified, and meets<br>appropriate requirements for the intended environment. |
| Conclusion: | HERO has a similar intended use as the predicate<br>device. HERO raises no new questions of safety or<br>efficacy when compared with the predicate device.<br>Therefore, HERO is judged substantially equivalent to<br>the MARS Unity Workstation with Heart Rate<br>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

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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 [phone]. 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 [phone] or [phone] 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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