(295 days)
Not Found
No
The document does not mention AI, DNN, or ML, and the description of the analysis methods and performance studies does not suggest the use of these technologies.
No.
The device is a software-only system for analyzing and reporting physiological signals for diagnostic purposes, not for providing therapy or treatment.
Yes
The device analyzes physiological signals and provides an interpretation of the analysis results for consideration by physicians, specifically mentioning its use as a "screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography." This indicates its role in identifying potential medical conditions.
Yes
The device description explicitly states "AUDICOR CA300/CC100 Analyzer is a software-only system". While it analyzes data from "AUDICOR-compatible recording devices", the device itself is described as solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine biological specimens like blood, urine, tissue, etc., outside of the body to provide information about a patient's health.
- This device analyzes physiological signals: The AUDICOR CA300/CC100 Analyzer analyzes signals acquired from the body (ECG, heart sound, snoring, body position, activity level) through compatible recording devices. It's processing data from the body itself, not analyzing a biological sample taken from the body.
The device is a software system for analyzing physiological data to aid in the diagnosis and screening of conditions like sleep-disordered breathing and heart-related issues. This falls under the category of medical devices that process physiological signals, not IVDs.
N/A
Intended Use / Indications for Use
AUDICOR CA300/CC100 Analyzer with SDB is a software-only system intended to be used to analyze recordings from AUDICOR-compatible recording devices.
AUDICOR CA300/CC100 Analyzer with SDB is capable of analyzing, editing, storing and reporting ECG, heart sound, sleep-disordered breathing (SDB), snoring detection, body position and activity level. An interpretation of the analysis results is produced in an integrated report for consideration by physicians.
The AUDICOR CA300/CC100 Analyzer with SDB software is intended for use on adults 18 years of age and older. The SDB analysis and reporting is intended for use on adult patients as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's screened for SDB should have periods of sleep of at least 4 hours duration.
AUDICOR CA300/CC100 Analyzer with SDB is intended to be used by trained operators under the direct supervision of a physician in a hospital or clinic environment.
Product codes
MNR, MLO
Device Description
AUDICOR CA300/CC100 Analyzer is a software-only system for the analysis of physiologic signals acquired through AUDICOR-compatible recording devices. Analysis results from ECG, heart sound, sleep-disordered breathing, snoring sounds, body position and activity levels are automatically interpreted. The AUDICOR CA300/CC100 software system allows for the review, edit, and storage of the analysis results. Reporting of analysis results is provided, together with patient data and notable events for review by the clinician.
The AUDICOR Analyzer software analyzes and reports the following parameters:
- Heart rate including bradycardia and tachycardia events .
- Atrial fibrillation ●
- ECG beat classification and morphology grouping with user-editing ●
- Heart rate variability ●
- Snoring detection ●
- Sleep disordered breathing events
- Sleep disordered breathing score
- Activity level ●
- Body Position
- Heart sound and combined ECG/heart sound measurements
- Heart rate distributions of heart sound parameters ●
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
adults 18 years of age and older
Intended User / Care Setting
trained operators under the direct supervision of a physician in a hospital or clinic environment.
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
The testing approach involved retrospective analysis of AUDICOR AM data obtained from a total study population of 252 subjects. The study subjects included a cohort clinically diagnosed with heart failure and a cohort of subjects determined to be negative for heart failure.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: The objective of the testing was to support the substantial equivalence claim for the new capability of aggregating periodically sampled heart sound measurements. The testing approach involved retrospective analysis of AUDICOR AM data obtained from a total study population of 252 subjects. The study subjects included a cohort clinically diagnosed with heart failure and a cohort of subjects determined to be negative for heart failure. Statistical analyses were performed that demonstrated both subject and predicate aggregation methods are statistically equivalent. These results support the substantial equivalence claim for the new measurement aggregation method of the subject device.
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
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
Inovise Medical, Inc. Earl Anderson Director, Quality and Regulatory 8770 SW Nimbus Avenue, Suite D Beaverton, Oregon 97008
Re: K151433
Trade/Device Name: AUDICOR CA300/CC100 Analyzer with SDB Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR, MLO Dated: February 9, 2016 Received: February 16, 2016
Dear Mr. Anderson:
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 devicerelated 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.
1
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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151433
Device Name AUDICOR CA300 / CC100 Analyzer with SDB
Indications for Use (Describe)
AUDICOR CA300/CC100 Analyzer with SDB is a software-only system intended to be used to analyze recordings from AUDICOR-compatible recording devices.
AUDICOR CA300/CC100 Analyzer with SDB is capable of analyzing, editing, storing and reporting ECG, heart sound, sleep-disordered breathing (SDB), snoring detection, body position and activity level. An interpretation of the analysis results is produced in an integrated report for consideration by physicians.
The AUDICOR CA300/CC100 Analyzer with SDB software is intended for use on adults 18 years of age and older. The SDB analysis and reporting is intended for use on adult patients as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's screened for SDB should have periods of sleep of at least 4 hours duration.
AUDICOR CA300/CC100 Analyzer with SDB is intended to be used by trained operators under the direct supervision of a physician in a hospital or clinic environment.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summarv
As required by 21 CFR, part 807.92 Submitted By: Inovise Medical, Inc. 8770 SW Nimbus Ave, Suite D Portland, OR 97008-7196 Phone 503-431-3821 Fax 503-431-3801 Contact: Earl Anderson Director, Quality and Requlatory Date Prepared: February 9, 2016 Date Revised: March 18, 2016 Proprietary Name: AUDICOR CA300 / CC100 Analyzer with SDB Common/ Usual ECG, Heart Sounds and SDB Analyzer Name: Classification: Primary: 868.2375, MNR (Regulation Description: Breathing frequency monitor) (Device Classification Name: Ventilatory effort recorder) Subsequent: 870.2800, MLO, (Regulation Description: Medical magnetic tape recorder) (Device Classification Name: Electrocardiograph, ambulatory, with analysis algorithm)
Device Description:
AUDICOR CA300/CC100 Analyzer is a software-only system for the analysis of physiologic signals acquired through AUDICOR-compatible recording devices. Analysis results from ECG, heart sound, sleep-disordered breathing, snoring sounds, body position and activity levels are automatically interpreted. The AUDICOR CA300/CC100 software system allows for the review, edit, and storage of the analysis results. Reporting of analysis results is provided, together with patient data and notable events for review by the clinician.
The AUDICOR Analyzer software analyzes and reports the following parameters:
- Heart rate including bradycardia and tachycardia events .
- Atrial fibrillation ●
- ECG beat classification and morphology grouping with user-editing ●
- Heart rate variability ●
- Snoring detection ●
- Sleep disordered breathing events
- Sleep disordered breathing score
- Activity level ●
- Body Position
- Heart sound and combined ECG/heart sound measurements
- Heart rate distributions of heart sound parameters ●
Intended Use:
AUDICOR CA300/CC100 Analyzer is a software-only system intended to be used to analyze recordings from AUDICOR-compatible recording devices.
AUDICOR CA300/CC100 is capable of analyzing, editing, storing and reporting ECG, heart sound, sleepdisordered breathing (SDB), snoring detection, body position and activity level. An interpretation of the analysis results is produced in an integrated report for consideration by physicians.
4
The AUDICOR CA300/CC100 Analyzer software is intended for use on adults 18 years of age and older.
The SDB analysis and reporting is intended for use on adult patients as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score. Patients screened for SDB should have periods of sleep of at least 4 hours duration.
AUDICOR CA300/CC100 is intended to be used by trained operators under the direct supervision of a physician in a hospital or clinic environment.
| Characteristic | Subject Device | Predicate (K131883) |
|---|---|---|
| Intended Use | AUDICOR CA300/CC100 | |
| Analyzer is a software-only | ||
| system intended to be used to | ||
| analyze recordings from | ||
| AUDICOR-compatible recording | ||
| devices. AUDICOR | ||
| CA300/CC100 is capable of | ||
| analyzing, editing, storing and | ||
| reporting ECG, heart sound, | ||
| sleep-disordered breathing | ||
| (SDB), snoring detection, body | ||
| position and activity level. An | ||
| interpretation of the analysis | ||
| results is produced in an | ||
| integrated report for | ||
| consideration by physicians. | ||
| The AUDICOR CA300/CC100 | ||
| Analyzer software is intended | ||
| for use on adults 18 years of | ||
| age and older. | ||
| The SDB analysis and reporting | ||
| is intended for use on adult | ||
| patients as a screening device | ||
| for obstructive or mixed apnea | ||
| to determine the need for | ||
| evaluation by polysomnography | ||
| based on the patient's score. | ||
| Patients screened for SDB | ||
| should have periods of sleep of | ||
| at least 4 hours duration. | ||
| AUDICOR CA300/CC100 is | ||
| intended to be used by trained | ||
| operators under the direct | ||
| supervision of a physician in a | ||
| hospital or clinic environment. | The AUDICOR System when | |
| used with AUDICOR Sensors on | ||
| the chest wall and properly | ||
| attached Holter unit, is intended | ||
| for use on adults 18 years of | ||
| age and older in acquiring, | ||
| analyzing and reporting ECG, | ||
| heart sound, Sleep Disordered | ||
| Breathing (SDB) and snoring | ||
| detection and to provide | ||
| interpretation of the data in an | ||
| integrated report for | ||
| consideration by physicians. | ||
| The SDB analysis and reporting | ||
| is intended for use on adult | ||
| patients only as a screening | ||
| device for obstructive or mixed | ||
| apnea to determine the need for | ||
| evaluation by polysomnography | ||
| based on the patient's score. | ||
| Patients screened for SDB | ||
| should have periods of sleep of | ||
| at least 4 hours duration during | ||
| which the ECG is predominantly | ||
| sinus rhythm in nature. The | ||
| AUDICOR recording may be | ||
| obtained at any location | ||
| specified by a physician | ||
| including home, hospital or | ||
| clinic. The device is intended | ||
| for use only under the direct | ||
| supervision of a physician. | ||
| Device Classification | MNR, Ventilatory Effort | |
| Recorder, MLO, class II, | ||
| Electrocardiograph, Ambulatory | ||
| (with analysis program) | MNR, Ventilatory Effort | |
| Recorder, MLO, class II, | ||
| Electrocardiograph, Ambulatory | ||
| (with analysis program) | ||
| General Functionalities: | ||
| Data utilized from AUDICOR- | ||
| compatible recording devices | Yes | Yes |
| Data display on PC for | ||
| interpretation | Yes | Yes |
| Data analysis (computer, | ||
| computer-assisted or manual) | Computer-assisted | Computer-assisted |
| Comprehensive report | Optional | Optional |
| generation | ||
| ECG Analysis | ||
| Channels | 3 | 3 |
| Minimum analysis interval | 10 second snapshot | 10 second snapshot |
| Typical analysis interval | 24 - 48 hours | 24 - 48 hours |
| Heart rate | Yes | Yes |
| Heart rate variability | Yes | Yes |
| ECG arrhythmia detection and | ||
| classification | Yes | Yes |
| ECG morphology grouping | ||
| and editing | Yes | Yes |
| Atrial Fibrillation | Yes | Yes |
| Heartsound Analysis | ||
| Heart sound analysis of single | ||
| 10 second recordings | Yes | Yes |
| Minimum analysis interval | 10 second snapshot | 10 second snapshot |
| Typical analysis interval | At least 4 hours, aggregated | |
| contiguous or periodic 10 | ||
| second interval results | At least 4 hours, aggregated | |
| contiguous 10 second interval | ||
| results | ||
| Heart sound analysis | ||
| aggregation of continuous | ||
| 10s intervals, totaling up to 48 | ||
| hours | Yes | Yes |
| Heart sound analysis | ||
| aggregation of periodic | ||
| sampling of 10s intervals, | ||
| totaling up to 48 hours | Yes | No |
| Comprehensive set of heart | Yes | Yes |
| sound parameters | ||
| SDB Analysis | ||
| Minimum analysis interval | 4 hours | 4 hours |
| SDBSS (Score) | Yes | Yes |
| Snoring detection | Yes | Yes |
| Other Analyses | ||
| Activity level | Yes | Yes |
| Body position | Yes | Yes |
| Report Components | ||
| Graphs, trends, statements | Yes, with hourly and daily trends | |
| of ECG and heart sound | ||
| parameters | Yes | |
| 10 second reports | Yes, with heart sound | |
| scalogram | Yes | |
| Cardiac report | Yes, with cardiac cyclogram and | |
| reference ranges for heart | ||
| sound parameters | Yes | |
| Sleep report | Yes, with SDB events and | |
| snoring index also presented | ||
| with respect to body position | Yes, with SDB events and | |
| snoring index | ||
| Miscellaneous | ||
| Report patient triggered | ||
| events | Yes | Yes |
| Signal quality verification | Yes | Yes |
Technological Characteristics:
5
6
Non-clinical Testing
The following quality assurance measures were conducted for the AUDICOR CA300/CC100 Analyzer software:
- Risk Analvsis ●
- . Design requirements and traceability
- Unit and system level software verification ●
- System level validation ●
In addition, the AUDICOR System has been tested for compliance with ANSI/AAMI EC57: Test and Reporting Performance Results of Cardiac Rhythm and ST-segment Measurement Algorithms. The results of the verification and validation tests concluded that the functionality and performance of the AUDICOR CA300/CC100 Analyzer software are comparable to the currently marketed predicate device.
Clinical Testing
The objective of the testing was to support the substantial equivalence claim for the new capability of aggregating periodically sampled heart sound measurements.
The testing approach involved retrospective analysis of AUDICOR AM data obtained from a total study population of 252 subjects. The study subjects included a cohort clinically diagnosed with heart failure and a cohort of subjects determined to be negative for heart failure.
Statistical analyses were performed that demonstrated both subject and predicate aggregation methods are statistically equivalent. These results support the substantial equivalence claim for the new measurement aggregation method of the subject device.
Substantial Equivalence
The subject device is substantially equivalent to AUDICOR CPAM with SDB (K131883).
The non-clinical and clinical testing results demonstrates the subject device is as safe and effective as the predicate device noted.