(238 days)
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 and heart sound data and to provide interpretation of the data in an integrated report for consideration by physicians. The Audicor recording may be obtained at any location specified by a physician including home, hospital or clinic.
The measurements provided and interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over-read as well as consideration of other relevant patient data.
The device is intended for use only under the direct supervision of a physician.
The Audicor System is an ambulatory device that can be used to capture up to 48 hours of continuous data or 10-second snapshots of ECG and heart sounds data. The Audicor System 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 analysis package includes heart rate variability and performs ECG beat classification, editing and reporting of arrhythmias.
The Audicor System analyzes and reports the following parameters:
Heart rate distributions of heart sound parameters
Heart rate and associated events
Atrial fibrillation
ECG beat classification and morphology grouping
Ventricular and atrial ectopic beat arrhythmias
Heart rate variability
The Inovise Medical, Inc. 510(k) Notification for the AUDICOR System describes the device's functionality and its substantial equivalence to predicate devices, focusing on regulatory compliance and intended use rather than specific acceptance criteria for performance metrics. Therefore, a table of acceptance criteria and reported device performance, information about sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance information, and ground truth definitions cannot be fully extracted from the provided text.
Based on the document, here's what can be inferred and stated:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with corresponding device performance values against those criteria. Instead, it states that the Audicor System has been tested to applicable requirements of several standards and "shown to comply." It also asserts "substantial equivalence" to predicate devices for specific functionalities. This suggests that the acceptance criteria are implicitly met by complying with these standards and demonstrating equivalence to already approved devices.
| Metric / Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| General Safety and Electromagnetic Compatibility | Compliance with EN 60601-1 (Medical Electrical Equipment: General Requirements for Safety) and EN 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests) | "Shown to comply" with these standards. |
| Ambulatory ECG Performance | Compliance with ANSI/AAMI EC38 (Ambulatory Electrocardiographs) and ANSI/AAMI EC57 (Test and Reporting Performance Results of Cardiac Rhythm and ST-segment Measurement Algorithms) | "Shown to comply" with these standards. |
| Internal Software and Algorithm Performance | Compliance to internal Inovise Medical software and algorithm performance assessment protocols | "Shown to comply" with internal protocols. |
| Product Functionality (ECG & Heart Sound Analysis) | Substantially equivalent to predicate Audicor Hemo Ambulatory Monitor (510(k) K073545) for ECG and heart sound acquisition and analysis. | "Same platform and specification as predicate." |
| Heart Rate Variability & ECG Holter Analysis | Substantially equivalent to predicate Spacelabs Pathfinder SL (510(k) K110001) for Windows-based ECG analysis, editing, and report generation systems including heart rate variability. | "Both are Windows-based ECG analysis systems..." (indicating equivalence) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The assessment appears to be based on compliance with established industry standards and internal protocols rather than a specific clinical validation study to establish performance metrics against a defined patient dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The regulatory submission focuses on engineering and regulatory compliance, and equivalence to predicate devices, rather than detailed performance studies with expert-adjudicated ground truth.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The document refers to the device's role in providing interpretations "for consideration by physicians" and emphasizes that measurements and interpretations "are only significant when used in conjunction with physician over-read." This indicates the device is an aid, but no study on the effect of this aid on human reader performance is detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the Audicor System as performing "ECG beat classification, editing and reporting of arrhythmias" and providing "interpretation of the data." While this implies standalone algorithmic functions, no specific standalone clinical performance study to quantify these algorithms' accuracy (e.g., sensitivity, specificity) is provided in the text. The emphasis is on physician oversight ("under the direct supervision of a physician" and "physician over-read").
7. The type of ground truth used
The type of ground truth used for any potential testing is not specified. Given the focus on compliance with standards like ANSI/AAMI EC38 and EC57, it's likely that the "ground truth" for the technical aspects (e.g., arrhythmia detection accuracy) would be based on expertly annotated ECG databases or simulated signals as per those standards, but this is not explicitly stated.
8. The sample size for the training set
The document does not provide any information about the sample size used for training the device's algorithms.
9. How the ground truth for the training set was established
The document does not provide any information on how the ground truth for any training set was established.
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Inovise Medical, Inc. 510(k) Notification: Modification to AUDICOR System – 2nd Response to Reviewer Questions
15 of 54
OCT 2 4 2011
Summary of Safety and Effectiveness
| As required by 21 CFR, part 807.92 | |
|---|---|
| Submitted By: | Inovise Medical, Inc.8770 SW Nimbus Ave, Suite DBeaverton, OR 97008-7196Phone 503-313-0149Fax 503-431-3801 |
| Contact: | Earl AndersonDirector, Quality and Regulatory |
| Date Prepared: | September 30, 2011 |
| Proprietary Name: | AUDICOR CPAM (Cardiopulmonary Ambulatory Monitor) |
| Common/ Usual Name: | Ambulatory Monitor / Acoustic Cardiograph |
| Classification: | 870.2800, MLO, class II, Electrocardiograph, Ambulatory (with analysis program) |
| Performance Standards: | ANSI/AAMI EC38 and ANSI/AAMI EC57 |
| Intended Use: | The Audicor® System, when used with AUDICOR Sensors on the chestwall and properly attached Holter unit, is intended for use on adults 18years of age and older in acquiring, analyzing and reporting ECG and heartsound data and to provide interpretation of the data in an integrated reportfor consideration by physicians. The Audicor recording may be obtained atany location specified by a physician including home, hospital or clinic.The measurements provided and interpretations of ECG and heart sounddata offered by the device are only significant when used in conjunctionwith physician over-read as well as consideration of other relevant patientdata.The device is intended for use only under the direct supervision of aphysician. |
| Device Description: | The Audicor System is an ambulatory device that can be used to captureup to 48 hours of continuous data or 10-second snapshots of ECG andheart sounds data. The Audicor System includes software to display,analyze and provide a summary of patient data over time in a trendedformat. Notable events are detected and displayed for review by theclinician. The analysis package includes heart rate variability and performsECG beat classification, editing and reporting of arrhythmias.The Audicor System analyzes and reports the following parameters: |
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| Heart rate distributions of heart sound parameters Heart rate and associated events Atrial fibrillation ECG beat classification and morphology grouping Ventricular and atrial ectopic beat arrhythmias Heart rate variability | |||
|---|---|---|---|
| Test Summary& Conclusion: | The Audicor System has been tested to the applicable requirements of thefollowing standards, and shown to comply. EN 60601-1 Standard for Medical Electrical Equipment: GeneralRequirements for Safety EN 60601-1-2 Standard for Medical Electrical Equipment Part 1-2:General Requirements for Safety - Collateral Standard: ElectromagneticCompatibility - Requirements and Tests ANSI/AAMI EC38:Ambulatory Electrocardiographs ANSI/AAMI EC57: Test and Reporting Performance Results of CardiacRhythm and ST-segment Measurement Algorithms Compliance to intermal Inovise Medical software and algorithmperformance assessment protocols | ||
| SubstantialEquivalence: | Product FunctionalityECG and HeartSound Recording andAnalysis | The functionality for reporting of ECG and heart sound analysis includingheart rate variability and Holter ECG features (beat classification, editingand reporting of arrhythmias) are substantially equivalent to: | PredicateAudicor Hemo Ambulatory Monitor (510(k)K073545);Spacelabs Pathfinder SL (510(k) K110001) |
| TechnologicalCharacteristics: | The Audicor System and the predicate devices (Spacelabs Pathfinder SLand Audicor [Hemo] AM) are technologically equivalent in that thedevices: Are small, wearable, battery-powered devices Acquire ECG data from patients using limited ECG leads, as wellas perform beat classification, editing, reporting of arrhythmias andheart ratevariability Use non-volatile memory to store patient data for further analysis | ||
| Substantial equivalence has been measured by review of the respectivetechnologies and their effectiveness to provide equivalent performance.The technological characteristics of the AUDICOR system compares to the | |||
| predicates as follows: | |||
| ProductFunctionality | Predicate | Comparison | |
| ECG and HeartSound Recording;Heart SoundAnalysis | Audicor HemoAmbulatoryMonitor (510(k)K073545) | Same platform andspecification for ECG andheart sound acquisition andanalysis as predicate. | |
| Heart RateVariability and ECGHolter analysis andreport generation(beat classification,edting andreporting ofarrhythmias) | Pathfinder SL,Spacelabs(510(k)K110001) | Both are Windows-basedECG analysis systems,editing and report generationsystems that include heartrate variability. |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 4 2011
Inovise Medical, Inc. c/o Mr. Earl Anderson Director Quality and Regulatory 8770 SW Nimbus Ave., Suite D Beaverton, OR 97008-7196
K110569 Re:
Trade/Device Name: Audicor System Regulatory Number: 21 CFR 870.2800 Regulatory Number. 21 CF N 07012000
Regulation Name: Ambulatory Electrocardiograph with Analysis Algorithm Regulatory Class: II (two) Product Code: 74 MLO Dated: September 30, 2011 Received: October 11, 2011
Dear Mr. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the devices We have reviewed your Section 510(x) premainer nethstantially equivalent (for the indications
referenced above and have determined the device is substantially equivaled in in for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure for legally manation profitace device Ameralments, or los commerce prior to May 28, 1976, the chacinom auto of the Federal Food, Drug, devices that have been reclassified in accordance will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a la previoions of th and Cosment Act (Act) that to not require approvince of controls provisions of the Act. The Act. The Act. The Act. The You may, include, market the device, subject to the gents for annual registration, listing of the pod general Controls provisions of the Fiel Includes and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Sec above) into endor regulations affecting your device can be If may be subject to additional controls. Extraing major regoriogations In addition, FDA may found in the Code of reactive regional registerning your device in the Federal Register.
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Page 2 - Mr. Earl 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,
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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Inovise Medical, Inc. 510(k) Notification: Modification to AUDICOR System - 200 Response to Reviewer Questions 13 of 54
Indications for Use
510(k) Number K110569
Device Name:__________________________________________________________________________________________________________________________________________________________________
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 and heart sound data and to provide interpretation of the data in an integrated report for consideration by physicians. The Audicor recording may be obtained at any location specified by a physician including home, hospital or clinic.
The measurements provided and interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.
The device is intended for use only under the direct supervision of a physician.
Prescription Use __ XXX_
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
(Division Sign-Off)
Page 1 of 1
Division of Cardiovascular Devices
510(k) Number K110569
§ 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).