VICOR PD2I ANALYZER, VERSION 2.1

K082709 · Vicor Technologies, Inc. · DPS · Dec 29, 2008 · Cardiovascular

Device Facts

• Record ID: K082709
• Device Name: VICOR PD2I ANALYZER, VERSION 2.1
• Applicant: Vicor Technologies, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Dec 29, 2008
• 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). 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 device that records and analyzes electrocardiographic (ECG) data to measure heart rate variability (HRV). It utilizes the Point Correlation Dimension Algorithm (PD2i) to process input signals. The device displays HRV measurements for review by a physician. It is intended for use in a clinical setting to provide data that may assist in clinical decision-making, though it does not provide a specific diagnosis. The physician interprets the output to determine clinical significance. The device functions as an analytical tool for ECG information.

Clinical Evidence

No clinical data provided. The submission relies on substantial equivalence to a predicate device.

Technological Characteristics

Software-based algorithm (PD2i) for ECG analysis. Operates as an electrocardiograph (21 CFR 870.2340).

Indications for Use

Indicated for display and analysis of electrocardiographic information and measurement of heart rate variability (HRV). No specific patient population, age, or gender restrictions specified. Not intended for specific clinical diagnosis; clinical significance determined by physician.

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

• The Portable ANSiscope ECG Monitoring System (K071168)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary 5.

Date: 15 September 2008

Applicant:

Vicor Technologies, Inc. 2300 NW corporate Boulevard, Suite 123 Boca Raton, FL 33431

Tel: [phone] Fax: [phone]

Contact:

Dr. Jules T. Mitchel Target Health Inc. 261 Madison Avenue, 24" Floor New York, NY 10016

Tel: [phone] Fax: [phone] [e-mail]

DEC 2 9 2008

{1}------------------------------------------------

Kors 2-7-7 -12 2 24 5 2 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25

| Device name | Vicor PD2i Analyzer |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Vicor PD2i Analyzer |
| Common Name | Electrocardiograph |
| Classification Name | Electrocardiograph (21 CFR 870.2340, Product Code DPS) |
| Predicate Device | The Portable ANSiscope ECG Monitoring System<br>K071168 |
| Description of Device | The Vicor PD2i Analyzer is a software algorithm for<br>recording heart rate variability (HRV) using the Point<br>Correlation Dimension Algorithm (PD2i). |
| Intended Use | The Vicor PD2i Analyzer is intended to display and<br>analyze electrocardiographic information and to measure<br>heart rate variability (HRV). These and other<br>measurements are not intended for any specific clinical<br>diagnosis. The clinical significance of HRV and other<br>parameters must be determined by the physician. |
| Comparison to Predicate Device | The Vicor PD2i Analyzer has the same intended use as<br>the legally marketed predicate device. The Vicor PD2i<br>Analyzer is intended for use in heart rate variability<br>(HRV) measurements. |

1000 - 1000

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 7008

Vicor Technologies, Inc. c/o Jules T. Mitchel, MBA, Ph.D. President, Target Health, Inc. 261 Madison Avenue, 24th Floor New York, NY 10016

Re: K082709

Trade/Device Name: Vicor PD2i Analyzer Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: December 11, 2008 Received: December 12, 2008

Dear Dr. Mitchel:

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.

{3}------------------------------------------------

## Page 2 - Dr. Mitchel

Please be advised that FDA's issuance of a substantial equivalcnce 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); 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. 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 [phone]. 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 Biometrics' (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

M.g. Hillebronne

Bram D. Zuckerman, M.D. Sar Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement র্ধ .

510(k) Number (if known): _ Ko 827 09

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). 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 × (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)

WM. A. Hillhouse

Division of Cardiovascular Devices

510(k) Number