(104 days)
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.
The Vicor PD2i Analyzer is a software algorithm for recording heart rate variability (HRV) using the Point Correlation Dimension Algorithm (PD2i).
Here's an analysis of the provided text regarding the Vicor PD2i Analyzer, focusing on acceptance criteria and the study details:
Missing Information:
It's important to note that the provided text is a 510(k) summary and letter from the FDA. While it discusses the device's intended use and substantial equivalence to a predicate, it does not contain the details of specific acceptance criteria or a study outlining the device's performance against those criteria. Such information would typically be detailed in a separate technical report or validation study submitted as part of the 510(k) application, but not usually fully reproduced in the summary letter itself.
Therefore, the following answers are based on the absence of this information in the provided document and general understanding of 510(k) submissions for similar devices where performance data is crucial.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Not specified in the provided document. | Not specified in the provided document. | The 510(k) summary and FDA letter focus on intended use and substantial equivalence to a predicate, but do not detail specific performance metrics or thresholds for the Vicor PD2i Analyzer. For an electrocardiograph and HRV measurement device, typical criteria would involve accuracy, precision, and agreement with the predicate device for various HRV parameters. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified in the provided document.
- Qualifications of Experts: Not specified in the provided document.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Not specified in the provided document.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study details are provided. This type of study comparing human readers with and without AI assistance is more common for diagnostic imaging AI devices, rather than a device primarily for heart rate variability measurement/analysis as described here.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? The Description of Device states, "The Vicor PD2i Analyzer is a software algorithm for recording heart rate variability (HRV) using the Point Correlation Dimension Algorithm (PD2i)." The Intended Use also describes it as displaying and analyzing ECG information and measuring HRV. This strongly implies that the device is the algorithm, and any performance study would inherently be a standalone evaluation of this algorithm's ability to measure HRV from ECG data. However, the specific details or results of such a standalone study are not provided in the document.
7. Type of Ground Truth Used (for the Test Set, if applicable)
- Type of Ground Truth: Not specified in the provided document. For an HRV measurement device, ground truth would likely be established through a reference standard for ECG acquisition and calculation of HRV parameters, possibly validated against expert manual analysis or established physiological measurement techniques.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not specified in the provided document.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not specified in the provided document.
Summary of Device and Regulatory Context (from the provided text):
The Vicor PD2i Analyzer is a software algorithm (using the Point Correlation Dimension Algorithm - PD2i) intended to display and analyze electrocardiographic information and measure heart rate variability (HRV). It is classified as an Electrocardiograph (21 CFR 870.2340, Product Code DPS) and is a Class II device. The FDA found it substantially equivalent to the predicate device, "The Portable ANSiscope ECG Monitoring System (K071168)," meaning it has the same intended use.
Key takeaway: The provided 510(k) summary and FDA letter confirm the device's regulatory clearance and its intended use, but they do not delve into the detailed performance study data, acceptance criteria, or methodological specifics that would typically be found in accompanying technical documentation.
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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
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| 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 SystemK071168 |
| Description of Device | The Vicor PD2i Analyzer is a software algorithm forrecording heart rate variability (HRV) using the PointCorrelation Dimension Algorithm (PD2i). |
| Intended Use | The Vicor PD2i Analyzer is intended to display andanalyze electrocardiographic information and to measureheart rate variability (HRV). These and othermeasurements are not intended for any specific clinicaldiagnosis. The clinical significance of HRV and otherparameters must be determined by the physician. |
| Comparison to Predicate Device | The Vicor PD2i Analyzer has the same intended use asthe legally marketed predicate device. The Vicor PD2iAnalyzer is intended for use in heart rate variability(HRV) measurements. |
1000 - 1000
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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.
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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
§ 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).