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.

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 ●

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AUDICOR CA300/CC100 Analyzer with SDB, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the device's performance in a table format. Instead, it describes capabilities and then broadly concludes that non-clinical and clinical testing demonstrate the device's functionality and performance are comparable (for non-clinical) and statistically equivalent (for clinical, regarding a specific new feature) to the predicate device.

However, based on the narrative, the implicit acceptance criterion for the clinical study was statistical equivalence between the subject device's new aggregation method and the predicate device's aggregation method.

Acceptance Criterion (Implicit)	Reported Device Performance
Clinical performance of the new heart sound measurement aggregation method (periodic sampling) is statistically equivalent to the predicate device's existing aggregation method (contiguous sampling).	Statistical analyses performed on retrospective data from 252 subjects demonstrated that both the subject device's (periodic sampling) and predicate device's (contiguous sampling) aggregation methods for heart sound measurements are statistically equivalent.
Functionality and performance of the AUDICOR CA300/CC100 Analyzer software are comparable to the currently marketed predicate device (for non-clinical aspects like risk analysis, design requirements, software verification, validation).	Verification and validation tests (including risk analysis, design requirements/traceability, unit/system level software verification, system-level validation, and compliance with ANSI/AAMI EC57) concluded that the functionality and performance are comparable to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 252 subjects
Data Provenance: Retrospective analysis of AUDICOR AM data. The country of origin is not specified, but the submission is to the U.S. FDA, implying the data might be from the US or a region with similar clinical practices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set in the clinical study. It mentions the study subjects included a cohort "clinically diagnosed with heart failure" and a cohort "determined to be negative for heart failure." This suggests that the clinical diagnoses used as ground truth were established by medical professionals in a clinical setting, but the specifics of who and how many made these diagnoses for the purpose of this study's ground truth are not detailed.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth for the test set. It mentions cohorts "clinically diagnosed" or "determined to be negative" for heart failure, implying standard clinical diagnostic processes were followed, rather than a specific adjudication protocol by a panel for the study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The clinical testing focused on the statistical equivalence of the device's aggregation method compared to the predicate's aggregation method for heart sound measurements, not on human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the clinical testing described is primarily a standalone (algorithm only) performance study. It evaluated the device's "new capability of aggregating periodically sampled heart sound measurements" by comparing its statistical output to that of the predicate device. This assessment does not appear to involve human readers interpreting the output in a loop, but rather directly comparing the analytical results of the algorithms.

7. Type of Ground Truth Used

The ground truth for the clinical study was based on clinical diagnosis (subjects "clinically diagnosed with heart failure" and "determined to be negative for heart failure"). This is a form of patient outcome/diagnosis data.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or its sample size. The clinical study described refers to a "total study population of 252 subjects" used for retrospective analysis, which appears to be the evaluation (test) set for the clinical performance claim. It is possible that the algorithm was trained on other data not described in this summary or that it was an update to an existing algorithm.

9. How the Ground Truth for the Training Set Was Established

Since a training set is not explicitly mentioned or described, the method for establishing its ground truth is also not provided in this document.

Summary

{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 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:

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/CC100Analyzer is a software-onlysystem intended to be used toanalyze recordings fromAUDICOR-compatible recordingdevices. AUDICORCA300/CC100 is capable ofanalyzing, editing, storing andreporting ECG, heart sound,sleep-disordered breathing(SDB), snoring detection, bodyposition and activity level. Aninterpretation of the analysisresults is produced in anintegrated report forconsideration by physicians.The AUDICOR CA300/CC100Analyzer software is intendedfor use on adults 18 years ofage and older.The SDB analysis and reportingis intended for use on adultpatients as a screening devicefor obstructive or mixed apneato determine the need forevaluation by polysomnographybased on the patient's score.Patients screened for SDBshould have periods of sleep ofat least 4 hours duration.AUDICOR CA300/CC100 isintended to be used by trainedoperators under the directsupervision of a physician in ahospital or clinic environment.	The AUDICOR System whenused with AUDICOR Sensors onthe chest wall and properlyattached Holter unit, is intendedfor use on adults 18 years ofage and older in acquiring,analyzing and reporting ECG,heart sound, Sleep DisorderedBreathing (SDB) and snoringdetection and to provideinterpretation of the data in anintegrated report forconsideration by physicians.The SDB analysis and reportingis intended for use on adultpatients only as a screeningdevice for obstructive or mixedapnea to determine the need forevaluation by polysomnographybased on the patient's score.Patients screened for SDBshould have periods of sleep ofat least 4 hours duration duringwhich the ECG is predominantlysinus rhythm in nature. TheAUDICOR recording may beobtained at any locationspecified by a physicianincluding home, hospital orclinic. The device is intendedfor use only under the directsupervision of a physician.
Device Classification	MNR, Ventilatory EffortRecorder, MLO, class II,Electrocardiograph, Ambulatory(with analysis program)	MNR, Ventilatory EffortRecorder, MLO, class II,Electrocardiograph, Ambulatory(with analysis program)
General Functionalities:
Data utilized from AUDICOR-compatible recording devices	Yes	Yes
Data display on PC forinterpretation	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 andclassification	Yes	Yes
ECG morphology groupingand editing	Yes	Yes
Atrial Fibrillation	Yes	Yes
Heartsound Analysis
Heart sound analysis of single10 second recordings	Yes	Yes
Minimum analysis interval	10 second snapshot	10 second snapshot
Typical analysis interval	At least 4 hours, aggregatedcontiguous or periodic 10second interval results	At least 4 hours, aggregatedcontiguous 10 second intervalresults
Heart sound analysisaggregation of continuous10s intervals, totaling up to 48hours	Yes	Yes
Heart sound analysisaggregation of periodicsampling 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 trendsof ECG and heart soundparameters	Yes
10 second reports	Yes, with heart soundscalogram	Yes
Cardiac report	Yes, with cardiac cyclogram andreference ranges for heartsound parameters	Yes
Sleep report	Yes, with SDB events andsnoring index also presentedwith respect to body position	Yes, with SDB events andsnoring index
Miscellaneous
Report patient triggeredevents	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.

Regulation Number and Section

§ 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).