(286 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a "software algorithm for measuring heart rate variability (HRV) using the Point Correlation Dimension Algorithm (PD2i)," which is a specific, non-AI/ML algorithm.
No.
The device is intended to display and analyze electrocardiographic information and measure HRV. It is not intended for any specific clinical diagnosis, nor does it provide therapy.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "These and other measurements are not intended for any specific clinical diagnosis." This indicates that the device provides information but does not make a diagnosis.
Yes
The device description explicitly states it is a "software algorithm" and there is no mention of any associated hardware component being part of the device itself.
Based on the provided information, the Vicor PD2i Analyzer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Vicor PD2i Analyzer Function: The description states the device "is intended to display and analyze electrocardiographic information and to measure heart rate variability (HRV)". This involves analyzing electrical signals from the heart, not samples taken from the body.
- Input: The input is electrocardiographic information, which is a physiological measurement, not a biological sample.
Therefore, the Vicor PD2i Analyzer falls under the category of a medical device that analyzes physiological data, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DPS
Device Description
The Vicor PD2i Analyzer is a software algorithm for measuring heart rate variability (HRV) using the Point Correlation Dimension Algorithm (PD2i).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified healthcare practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 123 | |
| Boca Raton, FL 33431 | |
| Contact Person | Primary |
| Dr. Glen Park | |
| Sr Director, Clinical and Regulatory Affairs | |
| Target Health Inc. | |
| 261 Madison Avenue, 24th Floor | |
| New York, NY 10016 |
Tel: (212) 681-2032
Fax: (212) 682-2105
Gpark@targethealth.com |
| | Secondary
David H. Fater
Vicor Technologies, Inc.
2300 NW Corporate Boulevard, Suite 123
Boca Raton, FL 33431
Tel: (561) 995-7313
Fax: (800) 244-5197
dfater@vicortech.com |
1
p2/3
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 | ||
| 870.2340 | Classification Name | ||
| Electrocardiograph | Code | ||
| DPS | |||
| 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 for
any specific clinical diagnosis. The clinical significance of HRV and
other parameters must be determined by the physician. | | |
| Comparison to
Predicate Device | Similarities | Differences | |
| | The software algorithm for
calculating the HRV is
unchanged. | ECG data is transmitted to a
central server for calculating and
reporting the HRV values. | |
| | | The device displays blood
pressure data from an approved
noninvasive blood pressure
measuring device. | |
| | | The device displays the Ewing
ratio in addition to the PD2i
score. | |
| Conclusion | The modifications in the Vicor PD2i Analyzer as stated above do
not change the intended use. The information submitted in this
application regarding the changes in technology does not raise new
questions of safety and effectiveness and demonstrates that the
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
4
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
5
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)
signature
(Division Sign /Off) r Devices Division of Cardiovascula 510(k) Number