(98 days)
Not Found
No
The summary describes a system for automated quantitative analysis of HRV, but it does not mention AI, ML, or any related terms. The analysis appears to be based on standard signal processing techniques for HRV.
No.
The device is intended for measurement and analysis of Heart Rate Variability (HRV) for diagnostic purposes, not for therapeutic intervention. It presents results to a physician, indicating a diagnostic rather than a therapeutic function.
No
The device measures Heart Rate Variability (HRV) and presents results to a physician for analysis, implying it provides information for assessment rather than directly diagnosing a condition. Its stated use is for "measurements" and "quantitative analysis," which falls short of a diagnostic claim.
No
The device description explicitly states that the system performs analysis based on data collected by an "FDA-compliant R Wave Trigger device recommended or supplied by Intelwave." This indicates the system relies on external hardware for data acquisition, making it not solely software.
Based on the provided information, the Intelwave 1.0 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Heart Rate Variability (HRV) measurements in response to paced respiration and controlled exercises." This involves analyzing physiological signals (heart rate) from a living patient, not analyzing samples (like blood, urine, tissue) in vitro (outside the body).
- Device Description: The system collects data from an "FDA-compliant R Wave Trigger device," which is a device that measures electrical activity of the heart from the patient's body. It then performs analysis on this data. This is a direct measurement from the patient, not an analysis of a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on materials derived from the human body outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Intelwave 1.0 System measures and analyzes a physiological signal directly from the patient.
N/A
Intended Use / Indications for Use
The Intelwave 1.0 System is intended for use in Heart Rate Variability (HRV) measurements in response to paced respiration and controlled exercises.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
The Intelwave 1.0 System is a computer-based system for measurement of Heart Rate Variability (HRV) in response to paced respiration and controlled exercises. The system performs a fully automated quantitative analysis of HRV based on data collected by an FDA-compliant R Wave Trigger device recommended or supplied by Intelwave. The system presents the results to the physician through a computer-based user interface. The system has patient data management capability.
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)
This product is designed to comply with ANSI/AAMI EC57: 1998/(R) 2003 "Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms". Performance testing of the Intelwave system included:
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- Comparison Performance Evaluation. Testing against the Holter Plus TM system.
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- Validation of reliability of HRV assessment by the Intelwave system.
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.
K010955, K042463, K941252, K021230
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
K062068
pg 1 of 2
OCT 2 7 2006
510(k) SUMMARY
INTELWAVE HEART RATE VARIABILITY SYSTEM
1. Submitter Information
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of Section 513(i)(3) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. 807.92.
The submitter of this premarket notification is: Alexander Riftine, Ph.D. President Intelwave, LLC 1090 King Georges Post Road Suite 1004 Edison, NJ 08837 Tel: (732) 738 - 8800 (732) 738 - 8877 Fax:
This summary was prepared on June 07, 2006.
2. Name of device.
The name of the device is the Intelwave Heart Rate Variability System. The common name is the ECG monitor Heart Rate Variability System. The classification name is Electrocardiograph. 21 C.F.R. 870.2340.
3. Predicate device.
Intelwave 1.0 system is substantially equivalent to the following predicate devices:
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- Anscore™ Health Management System (510(k) K010955).
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- Holter PlusTM Ambulatory ECG Analysis System (510(k) K042463).
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- ANX 3.0 Respiratory and cardiac spectral frequency signal (510(k) K941252).
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- HeROTM HRV analysis system (510(k) K021230).
CONFIDENTIAL
1
4. Device Description:
The Intelwave 1.0 System is a computer-based system for measurement of Heart Rate Variability (HRV) in response to paced respiration and controlled exercises.
The system performs a fully automated quantitative analysis of HRV based on data collected by an FDA-compliant R Wave Trigger device recommended or supplied by Intelwave. The system presents the results to the physician through a computer-based user interface. The system has patient data management capability.
Technological characteristics. 5.
The measurement technology and the method of Heart Rate Variability analysis are essentially the same as those of the other legally marketed predicate devices.
6. Intended use:
The Intelwave 1.0 System is intended for use in heart rate variability (HRV) measurements in response to paced respiration and controlled exercises.
7. Performance data.
This product is designed to comply with ANSI/AAMI EC57: 1998/(R) 2003 "Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms". Performance testing of the Intelwave system included:
-
- Comparison Performance Evaluation. Testing against the Holter Plus TM system.
-
- Validation of reliability of HRV assessment by the Intelwave system.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2006
IntelWave, LLC c/o Alexander Riftine, PhD 1090 King Georges Post Rd Ste 1004 Edison, NJ, 08837
Re: K062068
Intelwave Heart Rate Variability System, Version 1.0 Regulation Number: 21 CFR 870.2340 Regulation Name: Electocardiograph Regulatory Class: Class II Product Code: DPS Dated: October 4, 2006 Received: September 29, 2006
Dear Dr. Riftine:
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.
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
3
Page 2 - Dr. Alexander Riftine
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,
Bhimmon for
Bram D. Zuckerman, M.D. Director . Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Intelwave 1.0
Indications For Use:
The Intelwave 1.0 System is intended for use in Heart Rate Variability (HRV) measurements in response to paced respiration and controlled exercises.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Hummer
(Division Sign Off)
on Sign-Off) Division of Cardiovascular Devices 510(k) Number