(98 days)
The Intelwave 1.0 System is intended for use in Heart Rate Variability (HRV) measurements in response to paced respiration and controlled exercises.
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.
Acceptance Criteria and Study for Intelwave Heart Rate Variability System
The provided document, K062068, for the Intelwave Heart Rate Variability System, primarily discusses substantial equivalence to predicate devices and outlines general performance testing approaches. However, it does not explicitly state numerical acceptance criteria or detail a specific study proving the device meets those criteria in the way typically expected for a detailed performance study.
Instead, the performance section mentions:
- "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'."
- Two types of performance evaluations:
- "Comparison Performance Evaluation. Testing against the Holter Plus TM system."
- "Validation of reliability of HRV assessment by the Intelwave system."
Given this, the acceptance criteria are implicitly tied to demonstrating performance comparable to the predicate device (Holter Plus TM) and compliance with the mentioned ANSI/AAMI standard. The document does not provide specific numerical benchmarks for this comparison.
Based on the provided information, I cannot fill out the table with explicit numerical acceptance criteria and reported device performance, nor can I fully answer all the detailed questions regarding study specifics, as this level of detail is not present in the 510(k) summary.
Here's an attempt to answer the questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The 510(k) summary (K062068) does not explicitly define numerical acceptance criteria or present a table of reported device performance metrics against specific benchmarks. The criteria are implicit: compliance with ANSI/AAMI EC57 and performance comparable to the predicate Holter Plus TM system.
| Metric/Performance Measure | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| HRV Assessment Reliability | Consistent and accurate HRV assessment as demonstrated through "Validation of reliability of HRV assessment by the Intelwave system." | Shown to be reliable (details not provided). |
| Comparison to Predicate Device (Holter Plus TM) | Performance comparable to the Holter Plus TM system for HRV measurements. | Deemed comparable (details of comparison not provided). |
| Compliance with ANSI/AAMI EC57:1998/(R)2003 | Designed to comply with the standard for cardiac rhythm and ST-segment measurement algorithms. | Product design achieves compliance (specific test results not provided). |
2. Sample Size and Data Provenance
The document does not specify the sample size used for the comparison or reliability validation tests, nor does it provide information on the data provenance (e.g., country of origin, retrospective/prospective).
3. Number and Qualifications of Experts for Ground Truth
The document does not mention the use of experts to establish ground truth for the test set, nor does it specify the number or qualifications of any such experts. The comparison appears to be against an existing device (Holter Plus TM system) rather than an expert panel.
4. Adjudication Method
The document does not describe any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human reader performance with or without AI assistance. The device is for automated analysis.
6. Standalone (Algorithm Only) Performance Study
Yes, the performance evaluations described ("Comparison Performance Evaluation" and "Validation of reliability of HRV assessment by the Intelwave system") appear to be standalone performance tests of the algorithm, as the system performs "fully automated quantitative analysis of HRV."
7. Type of Ground Truth Used
The type of ground truth used implicitly would be the output/measurements from the predicate Holter Plus TM system for the "Comparison Performance Evaluation" and potentially an internal reference standard or established methodology for the "Validation of reliability of HRV assessment." However, the specific nature of this ground truth (e.g., expert consensus, pathology, outcomes data) is not detailed.
8. Sample Size for the Training Set
The document does not provide information on a training set or its sample size.
9. How Ground Truth for the Training Set Was Established
The document does not provide information on how a training set ground truth was established, as no training set is mentioned.
{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:
-
- Anscore™ Health Management System (510(k) K010955).
-
- Holter PlusTM Ambulatory ECG Analysis System (510(k) K042463).
-
- ANX 3.0 Respiratory and cardiac spectral frequency signal (510(k) K941252).
-
- 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
§ 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).