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 Description

The Vicor PD2i Analyzer is a software algorithm for measuring heart rate variability (HRV) using the Point Correlation Dimension Algorithm (PD2i).

AI/ML Overview

Here's an analysis of the provided text regarding the Vicor PD2i Analyzer:

Important Note: The provided document (K101867) is a 510(k) summary for a modification to an existing device (Vicor PD2i Analyzer, predicate K082709). The primary claim of this 510(k) is that the changes (user interface, transmission method, display of additional parameters) do not alter the underlying PD2i algorithm and thus do not raise new questions of safety or effectiveness. Therefore, this document does not contain a new study to prove the device meets acceptance criteria for its core functionality. Instead, it relies on the previous clearance (K082709) for the algorithm's performance and focuses on demonstrating that the changes are substantially equivalent.

Because the document states: "This 510(k) notification presents changes to the user interface of the PD2i Analyzer software without change in the PD2i algorithm," and "The software algorithm for calculating the HRV is unchanged," there is no performance data or acceptance criteria provided in this specific 510(k) document relating to the accuracy or clinical performance of the PD2i algorithm itself. The information requested below regarding acceptance criteria and a study to prove its performance would likely be found in the original 510(k) for the predicate device (K082709) or subsequent clinical studies if they were performed.

However, based on the information available in this K101867 document, here's what can be inferred or stated about the device and its regulatory pathway:

Acceptance Criteria and Device Performance Study (Based on K101867)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance	Comments / Source
Core Algorithm Performance: (e.g., accuracy of HRV calculation, clinical efficacy)	Not provided in this 510(k) document.	This 510(k) is for modifications that do not change the PD2i algorithm. Performance data for the algorithm itself would be found in the predicate 510(k) (K082709) or prior validation studies for that device. The current submission implicitly relies on the predicate's established performance.
New Features Functionality: (e.g., successful transmission of ECG data to server, accurate display of blood pressure, accurate display of Ewing ratio)	Implied to be met via substantial equivalence. No specific performance metrics or acceptance criteria for these new features are explicitly stated in this document.	The submission states, "Data in this submission demonstrate that these technological characteristics do not raise new questions of safety and performance." This implies the new features function as intended without negatively impacting the device or introducing new risks.
Software Design Control Compliance: (Level of Concern and Hazard Analysis, User Requirements, Software Requirement/Design Specifications, IQ/OQ/PQ, Software Release)	Complies with voluntary standards.	The document lists these as "quality assurance measures...applied to the development of the system." This is a process-based acceptance criterion rather than a performance-based one.

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

No specific test set or sample size is mentioned in this 510(k) document for directly proving the PD2i algorithm's performance. The submission primarily focuses on the unchanged nature of the algorithm and the equivalence of new features.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable for this 510(k) document. No new test set requiring expert ground truth establishment for the PD2i algorithm's core function is described.

4. Adjudication Method for the Test Set:

Not applicable for this 510(k) document. No new test set requiring adjudication is described.

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

No MRMC study is mentioned in this 510(k) document. This submission is for modifications to a previously cleared device, not a new clinical effectiveness study.

6. Standalone (Algorithm Only) Performance Study:

No standalone performance study is directly described in this K101867 document. This 510(k) relies on the previous clearance of the PD2i algorithm as part of the predicate device (K082709). The initial standalone performance of the algorithm would have been part of that submission.

7. Type of Ground Truth Used:

Not described in this K101867 document. The nature of the ground truth used to validate the original PD2i algorithm (in K082709) is not detailed here.

8. Sample Size for the Training Set:

Not applicable / not provided in this K101867 document. This submission does not describe the training of the PD2i algorithm, as the algorithm itself is stated to be unchanged from the predicate device.

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

Not applicable / not provided in this K101867 document. As above, the document does not describe the training or ground truth establishment for the PD2i algorithm.

Summary of this 510(k) Document (K101867):

This 510(k) is a "Special 510(k)" or similar modification submission. It seeks clearance for changes to the Vicor PD2i Analyzer that primarily involve the user interface, data transmission methods, and the display of additional physiological parameters (blood pressure, Ewing ratio). The crucial point for this submission is that the core algorithm (PD2i) for calculating Heart Rate Variability (HRV) remains unchanged from its predicate device (K082709). Therefore, the document asserts substantial equivalence by demonstrating that these modifications do not introduce new questions of safety or effectiveness, rather than by presenting new performance data for the algorithm itself. To find the detailed performance validation of the PD2i algorithm, one would need to consult the original 510(k) submission for the predicate device, K082709.

Summary

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K101867 p 1/3

510(k) Summary

APR 1 4 2011

1.1 Applicant and Contact Information

Date	30 March 2011
Applicant	Vicor Technologies, Inc.2300 NW Corporate Boulevard,Suite 123Boca Raton, FL 33431
Contact Person	PrimaryDr. Glen ParkSr Director, Clinical and Regulatory AffairsTarget Health Inc.261 Madison Avenue, 24th FloorNew York, NY 10016Tel: (212) 681-2032Fax: (212) 682-2105Gpark@targethealth.com
	SecondaryDavid H. FaterVicor Technologies, Inc.2300 NW Corporate Boulevard, Suite 123Boca Raton, FL 33431Tel: (561) 995-7313Fax: (800) 244-5197dfater@vicortech.com

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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 CFR870.2340	Classification NameElectrocardiograph	CodeDPS
Regulatory Class	II
Prescription Status	Prescription Device
Device /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: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.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 forany specific clinical diagnosis. The clinical significance of HRV andother parameters must be determined by the physician.
Comparison toPredicate Device	Similarities	Differences
	The software algorithm forcalculating the HRV isunchanged.	ECG data is transmitted to acentral server for calculating andreporting the HRV values.
		The device displays bloodpressure data from an approvednoninvasive blood pressuremeasuring device.
		The device displays the Ewingratio in addition to the PD2iscore.
Conclusion	The modifications in the Vicor PD2i Analyzer as stated above donot change the intended use. The information submitted in thisapplication regarding the changes in technology does not raise newquestions of safety and effectiveness and demonstrates that thedevice 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 (800) 638-2041 or (301) 796-7100 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:

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)

signature

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

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).