(104 days)
Not Found
No
The summary describes a software algorithm for calculating HRV using a specific, non-AI/ML algorithm (Point Correlation Dimension Algorithm). There are no mentions of AI, ML, or related concepts.
No
The device is described as an analyzer for displaying and analyzing electrocardiographic information and measuring HRV, but it explicitly states that these measurements are "not intended for any specific clinical diagnosis." It also notes that the clinical significance must be determined by a physician, indicating it does not provide therapeutic intervention itself.
No
The "Intended Use / Indications for Use" states that the measurements are "not intended for any specific clinical diagnosis." While it displays and analyzes ECG information, it explicitly disclaims diagnostic intent.
Yes
The device description explicitly states it is a "software algorithm" and there is no mention of any associated hardware components 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:
- Intended Use: The intended use explicitly states that the measurements are "not intended for any specific clinical diagnosis." IVDs are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Vicor PD2i Analyzer analyzes electrocardiographic information and measures HRV, which are physiological signals from the body, not in vitro specimens.
- Device Description: The device is described as a "software algorithm for recording heart rate variability." This further reinforces that it's analyzing physiological data, not in vitro samples.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as analyzing biological specimens, using reagents, or being used in a laboratory setting.
Therefore, the Vicor PD2i Analyzer falls under the category of a medical device that analyzes physiological signals, 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). 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 (comma separated list FDA assigned to the subject device)
DPS
Device Description
The Vicor PD2i Analyzer is a software algorithm for recording 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
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary 5.
Date: 15 September 2008
Applicant:
Vicor Technologies, Inc. 2300 NW corporate Boulevard, Suite 123 Boca Raton, FL 33431
Tel: (561) 995-7313 Fax: (800) 244-5197
Contact:
Dr. Jules T. Mitchel Target Health Inc. 261 Madison Avenue, 24" Floor New York, NY 10016
Tel: (212) 681-2100 Fax: (212) 682-2105 julesmitchel@targethealth.com
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 |
| K071168 | |
| Description of Device | The Vicor PD2i Analyzer is a software algorithm for |
| recording 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). 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 | The Vicor PD2i Analyzer has the same intended use as |
| the legally marketed predicate device. The Vicor PD2i | |
| Analyzer is intended for use in heart rate variability | |
| (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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
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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