VICOR PD2I ANALYZER

K101867 · Vicor Technologies, Inc. · DPS · Apr 14, 2011 · Cardiovascular

Device Facts

• Record ID: K101867
• Device Name: VICOR PD2I ANALYZER
• Applicant: Vicor Technologies, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Apr 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Vicor PD2i Analyzer is intended to display and analyze electrocardiographic information and to measure heart rate variability (HRV) at rest and in response to controlled exercise and paced respiration in patients undergoing cardiovascular disease testing. The results are to be interpreted by a qualified healthcare practitioner. These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.

Device Story

The Vicor PD2i Analyzer is a software-based system for heart rate variability (HRV) analysis. It accepts electrocardiographic (ECG) input data, which is transmitted to a central server for processing. The device utilizes the Point Correlation Dimension Algorithm (PD2i) to calculate HRV metrics. Additionally, the system displays blood pressure data from an approved noninvasive blood pressure measuring device and calculates the Ewing ratio. The output is presented to a healthcare practitioner to assist in cardiovascular disease testing. The device does not provide a specific clinical diagnosis; clinical significance is determined by the physician. The system is intended for use in a clinical setting.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and software validation.

Technological Characteristics

Software-based analyzer utilizing the Point Correlation Dimension Algorithm (PD2i) for HRV measurement. Features include central server-based data processing, integration with noninvasive blood pressure monitors, and Ewing ratio calculation. Complies with voluntary standards; software development followed a structured lifecycle including IQ/OQ/PQ validation.

Indications for Use

Indicated for patients undergoing cardiovascular disease testing to measure heart rate variability (HRV) at rest and during controlled exercise or paced respiration. Results are for interpretation by qualified healthcare practitioners; not intended for specific clinical 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

• Vicor PD2i Analyzer (K082709)

Submission Summary (Full Text)

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# 510(k) Summary

APR 1 4 2011

:

# 1.1 Applicant and Contact Information

| Date | 30 March 2011 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Vicor Technologies, Inc.<br>2300 NW Corporate Boulevard,<br>Suite 123<br>Boca Raton, FL 33431 |
| Contact Person | Primary<br>Dr. Glen Park<br>Sr Director, Clinical and Regulatory Affairs<br>Target Health Inc.<br>261 Madison Avenue, 24th Floor<br>New York, NY 10016<br><br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| | Secondary<br>David H. Fater<br>Vicor Technologies, Inc.<br>2300 NW Corporate Boulevard, Suite 123<br>Boca Raton, FL 33431<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |

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#### 1.2 Basic Device Identification

. .

| Device Name | Vicor PD2i Analyzer | | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------|
| Device Proprietary Name | Vicor PD2i Analyzer | | |
| Common/Usual Name | Programmable Diagnostic Computer | | |
| Classification Names / Numbers and Code | 21 CFR<br>870.2340 | Classification Name<br>Electrocardiograph | Code<br>DPS |
| Regulatory Class | II | | |
| Prescription Status | Prescription Device | | |
| Device /<br>Classification Panel | Cardiovascular | | |
| Predicate Device | Vicor PD2i Analyzer | K082709 | |
| Performance Standards | The Vicor PD2i Analyzer complies with voluntary standards. The following quality assurance measures were applied to the development of the system:<br>Level of Concern and Hazard Analysis User Requirements Software Requirement Specification Software Design Specification Detailed Software Design Specification Software Development IQ/OQ/PQ IQ/OQ/PQ RESULTS Software Release | | |
| Technology | The Vicor PD2i Analyzer employs the same functional technology as the predicate device. This 510(k) notification presents changes to the user interface of the PD2i Analyzer software without change in the PD2i algorithm.<br><br>Data in this submission demonstrate that these technological characteristics do not raise new questions of safety and performance. | | |
| Description of Device | The Vicor PD2i Analyzer is a software algorithm for measuring heart rate variability (HRV) using the Point Correlation Dimension Algorithm (PD2i). | | |
| Intended Use | The Vicor PD2i Analyzer is intended to display and analyze electrocardiographic information and to measure heart rate variability (HRV) at rest and in response to controlled exercise and paced respiration in patients undergoing cardiovascular disease testing. The results are to be interpreted by a qualified healthcare | | |
| | practitioner. These and other measurements are not intended for<br>any specific clinical diagnosis. The clinical significance of HRV and<br>other parameters must be determined by the physician. | | |
| Comparison to<br>Predicate Device | Similarities | Differences | |
| | The software algorithm for<br>calculating the HRV is<br>unchanged. | ECG data is transmitted to a<br>central server for calculating and<br>reporting the HRV values. | |
| | | The device displays blood<br>pressure data from an approved<br>noninvasive blood pressure<br>measuring device. | |
| | | The device displays the Ewing<br>ratio in addition to the PD2i<br>score. | |
| Conclusion | The modifications in the Vicor PD2i Analyzer as stated above do<br>not change the intended use. The information submitted in this<br>application regarding the changes in technology does not raise new<br>questions of safety and effectiveness and demonstrates that the<br>device is as safe and effective as the legally marketed device. | | |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing the agency's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Vicor Technologies, Inc. c/o Glen D. Park PharmD Sr. Director, Clinical and Regulatory Affairs Target Health, Inc. 261 Madison Avenue, 24th Floor New York, NY 10016

APR 1 4 2011

Re: K101867 Vicor PD2i Analyzer Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: March 29, 2011 Received: March 31, 2011

Dear Dr. Park:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 - Glen D. Park, PharmD

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Bram D. Znekerman, 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

510(k) Number: K101867

Device Name: Vicor PD2i Analyzer

Indications for Use:

The Vicor PD2i Analyzer is intended to display and analyze electrocardiographic information and to measure heart rate variability (HRV) at rest and in response to controlled exercise and paced respiration in patients undergoing cardiovascular disease testing. The results are to be interpreted by a qualified healthcare practitioner. These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign /Off) r Devices Division of Cardiovascula 510(k) Number