(218 days)
No
The description focuses on standard signal processing and event detection algorithms, with no mention of AI or ML terms or concepts.
No.
The device is described as a screening and diagnostic tool for acquiring, analyzing, and reporting various physiological data, including sleep disordered breathing, but it does not provide any form of treatment or therapy.
Yes
The device is intended for "acquiring, analyzing and reporting ECG, heart sound, sleep disordered breathing and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians." It also explicitly states that the sleep disordered breathing analysis is intended "as a screening device... to determine the need for evaluation by polysomnography based on the patient's score." These functions clearly indicate that the device is used to identify or assess medical conditions, which aligns with the definition of a diagnostic device.
No
The device description explicitly states that the "Audicor CPAM with SDB" is an "ambulatory device" that "can be used to capture... data from ECG, heart sounds, sleep disordered breathing and snoring detection, and activity level". It also mentions the use of "AUDICOR Sensors on the chest wall and properly attached Holter unit". These descriptions clearly indicate the presence of hardware components for data acquisition, making it a hardware and software system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AUDICOR System acquires data directly from the patient's body (ECG, heart sounds, snoring, activity) via sensors placed on the chest wall. It analyzes and reports on physiological signals and events occurring within the body.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient.
The device is an ambulatory monitoring system that collects and analyzes physiological data in vivo (within the living body).
N/A
Intended Use / Indications for Use
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, snoring detection and activity level data and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing analysis and reporting is intended for use on adult patients only as a screening device to determine the need for evaluation by polysomnography based on the patient's score. Subjects screened for sleep disordered breathing 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.
Product codes
MLO, MNR
Device Description
The Audicor CPAM with SDB (Cardiopulmonary Holter with Sleep Disordered Breathing detection) is an ambulatory device that can be used to capture 10second snapshots or up to 48 hours of continuous data from ECG, heart sounds, sleep disordered breathing and snoring detection, and activity level, particularly in patients suspected of heart failure or acute coronary syndrome. The Audicor CPAM with SDB includes software to display, analyze and provide a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The Audicor System 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 (apnea/hypopnea) events . Sleep disordered breathing score . Activity level Heart sound and combined ECG/heart sound measurements Heart rate distributions of heart sound parameters ● The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest wall
Indicated Patient Age Range
18 years of age and older
Intended User / Care Setting
Physician / home, hospital or clinic
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)
The Audicor System has been tested to the applicable requirements of the following standards, and shown to comply.
- EN 60601-1 Standard for Medical Electrical Equipment: General Requirements . for Safety
- . EN 60601-1-2 Standard for Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
- ANSI/AAMI EC38:Ambulatory Electrocardiographs ●
- ANSI/AAMI EC57: Test and Reporting Performance Results of Cardiac . Rhythm and ST-segment Measurement Algorithms
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
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| Inovise Medical, Inc. |
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| ----------------------- |
510(k) Notification: Modification to AUDICOR System - CPAM with SDB
டு/OKSummary of Safety and Effectiveness As required by 21 CFR, part 807 92 Submitted By: Inovise Medical, Inc. 8770 SW Nimbus Ave. Suite D Portland, OR 97008-7196 Phone 503-313-0149 Fax 503-431-3801 Contact: Earl Anderson Director, Quality and Regulatory Date Prepared: February, 08 2012 Proprietary Modification to AUDICOR CPAM (Cardiopulmonary Ambulatory Monitor) Name: Common/ Usual Ambulatory Monitor / Acoustic Cardiograph Name: Classification: 870.2800, MLO, class II, Electrocardiograph, Ambulatory (with analysis program) 868.2375, MNR, Ventilatory Effort Recorder Performance AAMI EC38 and AAMI EC57 Standards: The AUDICOR System when used with AUDICOR Sensors on the chest wall and Intended Use: 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, snoring detection and activity level data and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing analysis and reporting is intended for use on adult patients only as a screening device to determine the need for evaluation by polysomnography based on the patient's score. Subjects screened for sleep disordered breathing 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. The Audicor CPAM with SDB (Cardiopulmonary Holter with Sleep Disordered Device Description: Breathing detection) is an ambulatory device that can be used to capture 10second snapshots or up to 48 hours of continuous data from ECG, heart sounds, sleep disordered breathing and snoring detection, and activity level, particularly in patients suspected of heart failure or acute coronary syndrome. The Audicor CPAM with SDB includes software to display, analyze and provide a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The Audicor System 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 (apnea/hypopnea) events .
1
- . Sleep disordered breathing score
- . Activity level
- Heart sound and combined ECG/heart sound measurements
- Heart rate distributions of heart sound parameters ●
The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.
Test Summary & Conclusion:
The Audicor System has been tested to the applicable requirements of the following standards, and shown to comply.
- EN 60601-1 Standard for Medical Electrical Equipment: General Requirements . for Safety
- . EN 60601-1-2 Standard for Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
- ANSI/AAMI EC38:Ambulatory Electrocardiographs ●
- ANSI/AAMI EC57: Test and Reporting Performance Results of Cardiac . Rhythm and ST-segment Measurement Algorithms
The added algorithms for reporting of sleep disordered breathing, snoring and Substantial Equivalence: activity are substantially equivalent to:
-
- Audicor CPAM (510(k) K110569), and
-
- Spacelabs Healthcare Pathfinder SL Holter Analyzer (510(k) K110001)
- Nox Medical Nox T3 Sleep Recorder (510(k) K082113)
The Audicor System and the predicate devices are technologically equivalent in Technological that the devices: Characteristics:
- Are small, wearable, battery-powered devices .
- Acquire ECG data from patients using limited ECG leads ●
- Analyze the ECG signal to detect periods of sleep disordered breathing .
- . Acquire a sound signal for detection of snoring
- . Analyze the signals from an accelerometer to derive activity level
- Use non-volatile memory to store patient data for download to the analysis . module of the system
The Audicor System is different from the predicates in the following ways:
- Does not acquire EEG, EMG or EOG signals, or nasal pressure .
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. The emblem is positioned to the right of the text.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Inovise Medical, Incorporated Mr. Earl Anderson Director, Quality and Regulatory 8770 SW Nimbus Avenue, Suite D Beaverton, Oregon 97008
SEP 20 2012
Re: K120462
Trade/Device Name: Audicor® CPAM with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing) Regulation Number: 21 CFR 870.2800
21 CFR 868.2375
Regulation Name: Medical Magnetic Tape Recorder, Breathing Frequency Monitor Regulatory Class: II Product Code: MLO, MNR Dated: September 6, 2012
Received: September 10, 2012
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.
3
Page 2- Mr. Anderson
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-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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Audicor System (CPAM with SDB)
Indications For Use:
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 and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing 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.
Subjects screened for sleep disordered breathing 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.
Prescription Use XXX (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)
Page 1 of 1
L. Schuler
Division Slon Off Division of Anesthesiology, General Hospital Infection Control. Dental Dev
510(k) Number: K120462