(87 days)
The Audicor 200 System, when used with AUDICOR Sensors on the chest wall, is intended for use 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. In addition, the Audicor 200 System can be used with an add-on laptop computer that allows data to be presented in the format of real-time and trended display of advanced parameters derived from simultaneous ECG data and heart sounds data.
The 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, and is for use on adults (>= 18 years).
The Audicor 200 is a stand-alone device that can be used to capture 10-second evaluations of ECG and heart sounds in patients suspected of heart failure or acute coronary syndrome. In addition the system can be connected to a compatible laptop computer and used to display and analyze patient data over time in a trended format. The trending system can be used in monitoring patient changes during therapeutic treatment or during CRT studies.
The provided text is a 510(k) summary for the "SDI Modification to AUDICOR 200 System." A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance metrics for a novel algorithm.
Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets them is largely not present within the provided document. The submission references compliance with performance standards for medical electrical equipment (AAMI EC-11, EN 60601-1, etc.), which are general safety and performance standards for electrocardiographs, not specific performance metrics for the SDI algorithm or its interpretive statements.
However, I can extract and infer some related information:
Description of the Device and its New Features
The "SDI Modification to AUDICOR 200 System" adds a new parameter, the Systolic Dysfunction Index (SDI), and associated interpretive statements. These statements are:
- "Prolonged EMAT, consider LV systolic dysfunction"
- "Consider LV systolic dysfunction [reason block]"
- "Consider severe LV systolic dysfunction with diastolic dysfunction [reason block]"
- "Consider elevated LV filling pressure"
- "S3 detected -consider acute heart failure in presence of dyspnea"
These statements are only for patients over 40 years of age.
The document primarily focuses on demonstrating substantial equivalence to an existing predicate device (AUDICOR® 200 system K043074, with Audicor Advanced Parameters K051450). It states that the new device and the predicate are "technologically equivalent" in their ability to acquire and display ECG and heart sound data, and analyze "Advanced Parameters."
Addressing Your Specific Questions based on the Provided Text:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics for the SDI modification. The document indicates compliance with general medical device standards (AAMI EC-11, EN 60601-1, IEC 60601-2-25) related to electrocardiograph safety and performance, which are not specific to the diagnostic accuracy of the new SDI parameter or interpretive statements.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, AUC) for the SDI or its interpretive statements are provided. The only "performance" discussed is compliance with the aforementioned general safety and device standards.
Table (Based on Inference - No Specific AI Performance Metrics Found):
| Acceptance Criterion (Inferred from 510(k) focus) | Reported Device Performance |
|---|---|
| Compliance with AAMI EC-11 (Diagnostic Electrocardiographic Devices) | The Audicor 200 System has been tested and shown to comply. |
| Compliance with EN 60601-1 (Medical Electrical Equipment: General Requirements for Safety) | The Audicor 200 System has been tested and shown to comply. |
| Compliance with EN 60601-1-2 (EMC Requirements) | The Audicor 200 System has been tested and shown to comply. |
| Compliance with IEC 60601-2-25 (Particular requirement for safety of electrocardiographs) | The Audicor 200 System has been tested and shown to comply. |
| Substantial Equivalence to Predicate Device (AUDICOR® 200 system K043074, with K051450 Advanced Parameters) | Device determined to be substantially equivalent based on technological characteristics and intended use. |
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document. 510(k) summaries for modifications of existing devices often rely on the predicate device's data or general engineering tests rather than new clinical trials with specified test sets for performance of new algorithms.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided. As no specific clinical test set for the SDI algorithm's performance is detailed, the method of establishing ground truth is not described.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided.
-
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:
- No MRMC comparative effectiveness study is mentioned. The device's interpretive statements are "for consideration by physicians" and "are only significant when used in conjunction with physician over read," indicating the device is intended as an aid, but no study on physician improvement with this aid is presented.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone performance study for the SDI or its interpretive statements is not described. The document explicitly states the interpretations "are only significant when used in conjunction with physician over read."
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This information is not provided.
-
The sample size for the training set:
- This information is not provided. The document describes a "modification" to an existing system, implying the underlying algorithms were likely developed and validated prior to this specific submission, or that the new SDI parameter was developed based on existing clinical understanding rather than a large-scale machine learning training effort documented here.
-
How the ground truth for the training set was established:
- This information is not provided.
In conclusion, this 510(k) summary focuses on demonstrating the safety and technological equivalence of a device modification (adding an SDI parameter and interpretive statements) to a previously cleared predicate device, rather than providing detailed clinical performance data for a new AI algorithm. It adheres to general device standards but does not offer specific acceptance criteria or study results for the diagnostic accuracy of the new features.
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Summary of Safety and Effectiveness
As required by 21 CFR, part 807.92
.....
:
111
| Submitted By: | Inovise Medical, Inc.10565 SW Nimbus Ave, Suite 100Portland, OR 97233-4311Phone 503-431-3837Fax 503-431-3801 | APR 13 20 | ||
|---|---|---|---|---|
| Contact: | Steve HeslerDirector, Quality and Regulatory | |||
| Date Prepared: | January 15, 2007 | |||
| ProprietaryName: | SDI Modification to AUDICOR 200 System | |||
| Common/ UsualName: | Electrocardiograph/Acoustic Cardiograph | |||
| Classification: | 870.2340, DPS class II, Electrocardiograph | |||
| 870.1875, DQD, class II, Electronic Stethoscope | ||||
| PerformanceStandards: | AAMI EC 11 | |||
| Intended Use: | The Audicor 200 System, when used with AUDICOR Sensors on the chest wall, isintended for use in acquiring, analyzing and reporting ECG and heart sound dataand to provide interpretation of the data in an integrated report for consideration byphysicians. In addition the Audicor 200 System can be used with an add-on laptopcomputer that allows data to be presented in the format of real-time and trendeddisplay of cardiac indices derived from simultaneous ECG data and heart soundsdata. | |||
| The interpretations of ECG and heart sound data offered by the device are onlysignificant when used in conjunction with physician over read as well asconsideration of other relevant patient data. | ||||
| The device is intended for use only under the direct supervision of a physician, andis for use on adults (> 18 years). | ||||
| DeviceDescription: | The Audicor 200 is a stand-alone device that can be used to capture 10-secondevaluations of ECG and heart sounds in patients suspected of heart failure oracute coronary syndrome. In addition the system can be connected to acompatible laptop computer and used to display and analyze patient data overtime in a trended format. The trending system can be used in monitoring patientchanges during therapeutic treatment or during CRT studies. | |||
| Test Summary &Conclusion: | The Audicor 200 System has been tested to the applicable requirements of thefollowing standards, and shown to comply. | |||
| • AAMI EC-11 Standard for Diagnostic Electrocardiographic Devices• EN 60601-1 (UL 60601-1) Standard for Medical Electrical Equipment: GeneralRequirements for Safety | ||||
| • EN 60601-1-2 Standard for Medical Electrical Equipment Part 1-2: GeneralRequirements for Safety - Collateral Standard: Electromagnetic Compatibility –Requirements and Tests | ||||
| • IEC 60601-2-25 Medical Electrical Equipment Part 2-25: Particular requirementfor the safety of electrocardiographs |
APR 1 3 2007
:
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- AAMI EC 11 Diagnostic Electrocardiographic Devices .
Substantial Equivalence: The Inovise Audicor 200 System with added interpretive statements is substantially equivalent to the AUDICOR® 200 system (K043074, cleared as Liberty) with the incorporation of Audicor Advanced Parameters (K051450, cleared as Extended Measurements)
Technological Characteristics:
The SDI modification to the Audicor 200 System and the AUDICOR 200 predicate device are technologically equivalent in that both acquire ECG and heart sounds data from adult patients then present the data in the AUDICOR report format which can include graphic display of MI and LVH conditions along with detection and display of S3 and S4 heart sounds. Both systems can analyze and display "Advanced Parameters" derived from ECG and heart sounds information to include:
- . Left Ventricular Systolic Time (LVST)
- Left Ventricular Diastolic Time (LVDT) ●
- Pre-atrial Diastolic Filling Time (PADT)
- Accelerated Atrial Filling Time (AAFT) ●
- QS1 (EMAT) .
- QS2 .
- . R-R Interval
- S3 Strength .
- S4 Strength .
- S1/S2 Intensity Ratio �
The SDI modification to the Audicor 200 System includes addition of a new parameter, the Systolic Dysfunction Index (SDI). The system will also display added interpretive statements when analysis of patient data warrants. The added statements, appropriate only for patients over 40 years of age, are:
- Prolonged EMAT, cconsider LV systolic dysfunction .
- Consider LV systolic dysfunction [reason block] .
- Consider severe LV systolic dysfunction with diastolic dysfunction freason . block]
- � Consider elevated LV filling pressure
- S3 detected -consider acute heart failure in presence of dyspnea
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2007
Inovise Medical, Inc. c/o Mr. Steve C. Hesler Director, Quality and Regulatory 10565 SW Nimbus Avenue, Suite 100 Portland, Oregon 97223-4311
Re: K070136
Trade Name: SDI Modification to AUDICOR® 200 System Regulation Number: 21 CFR 870.2340 and 870.1875 Regulation Name: Electrocardiograph and Stethoscope Regulatory Class: Class II Product Code: DPS and DQD Dated: January 15, 2007 Received: January 16, 2007
Dear Mr. Hessler:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bzemmema 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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Indications for Use
510(k) Number (if known):
SDI Modification to AUDICOR ® 200 System Device Name:
Indications For Use:
The Audicor 200 System, when used with AUDICOR Sensors on the chest wall, is intended for use 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. In addition, the Audicor 200 System can be used with an add-on laptop computer that allows data to be presented in the format of real-time and trended display of advanced parameters derived from simultaneous ECG data and heart sounds data.
The 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, and is for use on adults (≥ 18 years).
Prescription Use (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)
B. Summa
ardiovi
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§ 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).