(218 days)
The intended use of the HHSsystems QANS (Quantitative Autonomic Nervous System) Monitoring System:
OANS (Quantitative Autonomic Nervous System) Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate, and muscle activity) using sensors. The QANS monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data which the clinician can use it make clinical assessments of medical, dental or peak performance interventions.
The physiological information can be used as a general patient monitoring system as well as for research. QANS is not intended to produce any interpretation of the measurements obtained and does not provide any type of diagnosis.
Patients should be 5 years old or older.
The HHSsystems QANS Monitoring System is the same as that of the Thought Technology devices as the HHSsystems QANS uses the same hardware as the previously cleared ProComp Infiniti, FlexComp Infiniti, ProComp5 and ProComp2 devices with the same BioGraph Infiniti and CardioPro software.
This information is contained in 510(k)'s K903497 for the ProComp Infiniti, FlexComp Infiniti, ProComp5 and ProComp2 and in K972723 for the BioGraph Infiniti and CardioPro software.
The technology and the method of monitoring heart rate, respiration rate, and muscle activity, are essentially the same as those of the other legally marketed predicate devices.
QANS (Quantitative Autonomic Nervous System) Monitoring System is a computer-based system for measurement of Heart Rate Variability (HRV) in response to paced respiration. It is comprised of off-the-shelf Personal Computers (PCs) and special purpose hardware capable of acquiring, storing, analyzing and reporting ECG data from cardiac monitoring devices, respiration rate and muscle activity, using sensors designed to monitor these functions. Data is acquired using the Thought ProComp Infiniti, FlexComp Infiniti, ProComp5 and ProComp2 and in K972723 for the BioGraph Infiniti and CardioPro software.
The analysis algorithms identify heart rate variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability. QANS evaluates the variation of the heart rate, both in the time domain (statistical methods) and in the frequency domain (spectral analysis). Each QRS complex (Q, R and S wave deflections on a ECG) detected and the so-called normal-to-normal (NN) or Rate-to-Rate (RR) intervals between adjacent QRS complexes are resulting from sinus node depolarization. The system performs a fully automated quantitative analysis of HRV based on data collected by an FDA-compliant R Wave Trigger device. The system presents the results to the healthcare provider through a computerbased user interface. The system has patient data management capability.
The provided document is a 510(k) summary for the QANS (Quantitative Autonomic Nervous System) Monitoring System. It mainly focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria through a standalone performance study.
Based on the information provided, here's a breakdown of the requested data:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of acceptance criteria with corresponding performance metrics from a specific study of the QANS device itself. Instead, it relies on the safety and accuracy of its predicate devices and the fact that the QANS system uses the same hardware and software as those predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy and Safety of Measurements (Heart Rate, Respiration Rate, Muscle Activity, HRV) | "For safety and accuracy: 1. Thought Technology ProComp Infiniti, FlexComp Infiniti, ProComp5 and ProComp 2 Encoder systems --K903497. 2. using BioGraph Infiniti and CardioPro software -- K972723." "The HHSsystems QANS uses the same hardware as the previously cleared ProComp Infiniti, FlexComp Infiniti, ProComp5 and ProComp2 devices with the same BioGraph Infiniti and CardioPro software." "The technology and the method of monitoring heart rate, respiration rate, and muscle activity, are essentially the same as those of the other legally marketed predicate devices." |
| Functional Equivalence to Predicate Monitoring Functions | "For monitoring functions: 1. HeRO ™ HRV analysis system (510(k) K021230). 2. Intelwave Heart Rate Variability System (510(k) K062068)" "All of the parameters that are recorded by the QANS system are recorded by the Thought Technology devices." |
| Compliance with Regulations | "This system was developed in accordance with 21CFR820 Quality System Regulation and has been tested in accordance with UL 60601-1 and IEC 60601-1-2." |
| Functionality Verification and Validation | "All HHSsystems QANS functionality has been verified and validated both as part of the BioGraph and the QANS application suite." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a separate "test set" for the QANS device's performance study. Instead, it relies on the testing and validation performed on the predicate devices (Thought Technology ProComp Infiniti, FlexComp Infiniti, ProComp5 and ProComp2, and the BioGraph Infiniti and CardioPro software). Therefore, details on the sample size and data provenance for a distinct QANS test set are not available in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided as the document defers to the existing validation of the predicate devices. There is no mention of a ground truth establishment process specifically for the QANS device's performance in this summary.
4. Adjudication Method for the Test Set:
This information is not provided as there is no specific test set or adjudication process described for the QANS device's performance in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The filing focuses on substantial equivalence based on identical hardware and software with predicate devices, not on the impact of the QANS system on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
While the document states that "All HHSsystems QANS functionality has been verified and validated," it does not explicitly detail a standalone algorithm-only performance study with quantitative metrics. The emphasis is on the QANS system using the same hardware and software as the already cleared predicate devices, implying that the standalone performance is inherited from these predicates. The device itself is described as a physiological monitoring device that provides data for clinicians to make assessments, rather than a device with an AI algorithm providing interpretations or diagnoses.
7. The Type of Ground Truth Used:
The document does not describe a specific ground truth used for a performance study of the QANS device. Its substantial equivalence argument relies on the inherent accuracy and safety of the predicate devices that the QANS system directly incorporates. The predicate devices, such as the Thought Technology systems, would have undergone their own validation against established physiological measurement standards (e.g., comparison to gold-standard ECGs for heart rate, respiratory monitors for respiration rate).
8. The Sample Size for the Training Set:
This information is not applicable/provided. The QANS system uses the same software as predicate devices (BioGraph Infiniti and CardioPro software). Therefore, if any "training" (in the context of machine learning) occurred, it would have been part of the development and validation of the predicate software, not separately for QANS. The document does not indicate that the QANS device itself utilizes a machine learning algorithm that requires a "training set." It processes physiological measurements and calculates statistical data and HRV.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided for the same reasons as point 8. The device's functionality is based on established methods of physiological measurement and calculation, not on a machine learning model trained on a specific dataset with ground truth established for that training.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure, with three stylized profiles facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 16, 2015
HHSsystems, LLC c/o Jane B. Campbell 164 Hammock Avenue Pawleys Island, SC 29585
Re: K142551
Trade/Device Name: OANS (quantitative Autonomic Nervous System) Monitoring System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, BZO, KZM Dated: March 6, 2015 Received: March 9, 2015
Dear Ms. Campbell:
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 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
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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 vours.
Mude Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Revised Indications for Use Statement
510(k) Number: K142551
Device Name: QANS (Quantitative Autonomic Nervous System) Monitoring System
Indications for Use:
The intended use of the HHSsystems QANS (Quantitative Autonomic Nervous System) Monitoring System:
OANS (Quantitative Autonomic Nervous System) Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate, and muscle activity) using sensors. The QANS monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data which the clinician can use it make clinical assessments of medical, dental or peak performance interventions.
The physiological information can be used as a general patient monitoring system as well as for research. QANS is not intended to produce any interpretation of the measurements obtained and does not provide any type of diagnosis.
Patients should be 5 years old or older.
Prescription Use X Over-The Counter Use (Per 21 CFR 801 Subpart D) AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
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510(k) Summary
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.
| Date: | April 13, 2015 |
|---|---|
| Sponsor: | HHSsystems, LLC |
| 2 Executive Blvd, Suites 206 | |
| Suffern, NY 10901 | |
| Howard G. Hindin, DDS | |
| Telephone: | 845-357-1595 |
| Fax : | 845-357-2428 |
| E-mail : | hindincenter@verizon.net |
| Contact: | Jane B. Campbell |
| 164 Hammock Avenue | |
| Pawleys Island, SC 29585 | |
| Tel: (843) 314-3670 | |
| Email: jane.campbell@campbellassociates.net | |
| Trade Name: | QANS (Quantitative Autonomic Nervous System) Monitoring System |
| Common Name: | HRV Monitoring System |
| Respiration Rate Monitoring System | |
| Muscle Activity Monitoring System | |
| Classification Name: | Electrocardiograph |
| Breathing Frequency Monitor (Respiration Rate) | |
| Electromyograph | |
| Classification Number: | Electrocardiograph 21 C.F.R. 870.2340 DPS, Class II. |
| Breathing Frequency Monitor (Respiration Rate) 21 C.F.R. 868.2375, BZQ, Class II. | |
| Electromyograph 21 C.F.R. 890.1375, KZM, Class II. | |
| Product Codes: | DPS, BZQ, KZM |
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| Predicate Devices: | QANS (Quantitative Autonomic Nervous System) MonitoringSystem is substantially equivalent to the following predicatedevices: |
|---|---|
| For safety and accuracy1. Thought Technology ProComp Infiniti, FlexComp Infiniti,ProComp5 and ProComp 2 Encoder systems --K903497.2. using BioGraph Infiniti and CardioPro software -- K972723. | |
| Note: All of the parameters that are recorded by the QANSsystem are recorded by the Thought Technology devices. | |
| For monitoring functions: | |
| 1. HeRO ™ HRV analysis system (510(k) K021230).2. Intelwave Heart Rate Variability System (510(k) K062068) | |
| Device Description: | The HHSsystems QANS Monitoring System is the same as that ofthe Thought Technology devices as the HHSsystems QANS usesthe same hardware as the previously cleared ProComp Infiniti,FlexComp Infiniti, ProComp5 and ProComp2 devices with thesame BioGraph Infiniti and CardioPro software. |
| This information is contained in 510(k)'s K903497 for theProComp Infiniti, FlexComp Infiniti, ProComp5 and ProComp2and in K972723 for the BioGraph Infiniti and CardioPro software. | |
| The technology and the method of monitoring heart rate,respiration rate, and muscle activity, are essentially the sameas those of the other legally marketed predicate devices. | |
| QANS (Quantitative Autonomic Nervous System) MonitoringSystem is a computer-based system for measurement of HeartRate Variability (HRV) in response to paced respiration. It iscomprised of off-the-shelf Personal Computers (PCs) andspecial purpose hardware capable of acquiring, storing,analyzing and reporting ECG data from cardiac monitoringdevices, respiration rate and muscle activity, using sensorsdesigned to monitor these functions. Data is acquired usingthe Thought ProComp Infiniti, FlexComp Infiniti, ProComp5and ProComp2 and in K972723 for the BioGraph Infiniti andCardioPro software. |
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The analysis algorithms identify heart rate variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability. QANS evaluates the variation of the heart rate, both in the time domain (statistical methods) and in the frequency domain (spectral analysis). Each QRS complex (Q, R and S wave deflections on a ECG) detected and the so-called normal-to-normal (NN) or Rate-to-Rate (RR) intervals between adjacent QRS complexes are resulting from sinus node depolarization. The system performs a fully automated quantitative analysis of HRV based on data collected by an FDA-compliant R Wave Trigger device. The system presents the results to the healthcare provider through a computerbased user interface. The system has patient data management capability.
Intended use: QANS (Quantitative Autonomic Nervous System) Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate, muscle activity) using sensors. The QANS monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) data from EKG and provides statistical data as well as heart rate variability (HRV) data which the clinician can use it make clinical assessments of medical, dental or peak performance interventions.
The physiological information can be used as a general patient monitor as well as for research. QANS is not intended to produce any interpretation of the measurements obtained and does not provide any type of diagnosis. Patients should be 5 years old or older.
The QANS System is indicated for use by physicians and dentists in hospital, clinic or professional offices and other health care professionals.
Technological The technological characteristics of the HHSsystems QANS Monitoring System are the same as those of the Thought Technology devices as the HHSsystems QANS uses the same hardware as the previously cleared FlexComp Infiniti, ProComp Infiniti, ProComp5 and ProComp2 with the BioGraph Infiniti and CardioPro software.
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K142551
| This information is contained in 510(k)'s K903497 for theProComp Infiniti, FlexComp Infiniti, ProComp5 and ProComp2and in K972723 for the BioGraph Infiniti. | |
|---|---|
| The technology and the method of monitoring heart rate,respiration rate, and muscle activity are essentially the same asthose of the other legally marketed predicate devices | |
| Technology: | Microprocessor based system |
| Comparison ofTechnologicalthe Predicate Devices: | QANS system is identical to the Thought Technology ProCompInfiniti, FlexComp Infiniti, ProComp5 and ProComp 2 encoders towith BioGraph Infiniti and CardioPro General purpose software asthey use the same hardware and software. |
| The sensors and leads are the same and the way the informationis gathered, and stored is identical. The QANS applicationsoftware allows the user to report the information in a mannermost suited to the user's needs. | |
| There are no new tests and no new results reported. There isa quick start feature and the user can customize the screensand reports. The form of the results report is the only change. | |
| Summary: | The HHSsystems QANS Monitoring System was developed and isbased on ProComp Infiniti, FlexComp Infiniti, ProComp5 andProComp2 with the BioGraph Infiniti and CardioPro software. |
| This system was developed in accordance with 21CFR820Quality System Regulation and has been tested in accordancewith UL 60601-1 and IEC 60601-1-2. | |
| Performance data: | All HHSsystems QANS functionality has been verified andvalidated both as part of the BioGraph and the QANSapplication suite. |
§ 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).