(290 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, 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.
The AUDICOR System employs the AUDICOR AM (Home) ambulatory recording device to capture 10-second snapshots or up to 48 continuous hours of physiologic data. ECG, heart sound, sleep-disordered breathing, snoring sounds, and activity level are interpreted from the physiologic signals captured. The AUDICOR System includes software to analyze recorded data, then display and present 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.
Here's a breakdown of the acceptance criteria and study details for the AUDICOR System - CPAM with SDB (Accelerometer Based), based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The 510(k) summary states that the study demonstrates the "substantial equivalence of the subject device's algorithm performance to that of the predicate device" regarding SDB detection. This implies that the acceptance criterion was likely to show a statistically equivalent or non-inferior performance compared to the previously cleared predicate device (K120462).
The exact performance metrics (e.g., sensitivity, specificity, accuracy) and specific thresholds for acceptance are not explicitly listed as quantitative acceptance criteria in the provided text. Instead, the focus is on a comparative statistical analysis.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| SDB detection performance is substantially equivalent to the predicate device (K120462). | "Substantial equivalence of the subject device's algorithm performance to that of the predicate device was demonstrated through this statistical comparison." The subject device's accelerometer-based SDB algorithm was found to be statistically equivalent in performance to the predicate device's ECG-based SDB algorithm. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 77 recordings
- Data Provenance: Prospective clinical testing conducted at Taipei Veterans General Hospital in Taipei, Taiwan.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth. It mentions "Physician-overread results from concurrent polysomnography recordings" as the clinical gold standard. This implies that medical professionals (likely sleep physicians or trained polysomnography technologists) were involved in interpreting the PSG data to determine SDB positive and negative cohorts.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. It only mentions "Physician-overread results from concurrent polysomnography recordings" for establishing the clinical gold standard. It does not detail if multiple physicians reviewed, if there was a consensus process, or if a single reading was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on comparing the algorithm's performance (subject device vs. predicate device) against a clinical gold standard (physician-overread PSG), not on how human readers improve with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The study compared the "AUDICOR SDB detection performance of the predicate device (K120462) to that of the subject device" using their respective algorithms applied to concurrent data. This directly assesses the algorithm's performance without human intervention in the SDB detection process itself.
7. Type of Ground Truth Used
The type of ground truth used was expert consensus / physician-overread polysomnography (PSG) results. Specifically, "Physician-overread results from concurrent polysomnography recordings on the test subjects was the clinical gold-standard used for establishing PSG-AHI positive and PSG-AHI negative cohorts."
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. It only mentions the "test set of 77 recordings." The study appears to be an evaluation of an already developed algorithm, not the training process itself.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established, as it focuses on the evaluation (test) phase of the device's modification.
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K131883: 510(k) Notification: Modification to AUDICOR System - CPAM with SDB (Accelerometer Based)
510k Summary
As required by 21 CFR, part 807.92
| Submitted By: | Inovise Medical, Inc.8770 SW Nimbus Ave, Suite DPortland, OR 97008-7196Phone 503-431-3821 |
|---|---|
| Fax 503-431-3801 | |
| Contact: | Earl Anderson |
| Director, Quality and Regulatory | |
| Date Prepared: | June 14, 2013 (Revised April 11, 2014 - Test Summary and Conclusions) |
| ProprietaryName: | Modification to AUDICOR CPAM (Cardiopulmonary Ambulatory Monitor) |
| Common/ UsualName: | Ambulatory Monitor / Acoustic Cardiograph |
| Classification: | Primary: 868.2375, MNR, Ventilatory Effort Recorder |
| Secondary: 870.2800, MLO, class II, Electrocardiograph, Ambulatory (with analysis program | |
| PerformanceStandards: | AAMI EC38 and AAMI EC57 |
| Intended Use: | The AUDICOR System when used with AUDICOR Sensors on the chest wall andproperly attached Holter unit, is intended for use on adults 18 years of age andolder in acquiring, analyzing and reporting ECG, heart sound, Sleep DisorderedBreathing (SDB) and snoring detection and to provide interpretation of the data inan integrated report for consideration by physicians. The SDB analysis andreporting is intended for use on adult patients only as a screening device forobstructive or mixed apnea to determine the need for evaluation bypolysomnography based on the patient's score. Patients screened for SDB shouldhave periods of sleep of at least 4 hours duration during which the ECG ispredominantly sinus rhythm in nature. The AUDICOR recording may be obtainedat any location specified by a physician including home, hospital or clinic. Thedevice is intended for use only under the direct supervision of a physician. |
| Device: | The AUDICOR System employs the AUDICOR AM (Home) ambulatory recording |
Description:
device to capture 10-second snapshots or up to 48 continuous hours of physiologic data. ECG, heart sound, sleep-disordered breathing, snoring sounds, and activity level are interpreted from the physiologic signals captured. The AUDICOR System includes software to analyze recorded data, then display and present 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 .
APR 1 1 2014
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- 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.
The AUDICOR System has been tested to the applicable requirements of the Test Summary: 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
Prospective clinical testing was performed to evaluate the performance of the technology modification for SDB detection. A study was designed and undertaken that compares AUDICOR SDB detection performance of the predicate device (K120462) to that of the subject device. The prospective study was undertaken at Taipei Veterans General Hospital in Taipei, Taiwan. The study resulted in development of a testset of 77 recordings which were used for the performance comparison. Physician-overread results from concurrent polysomnography recordings on the test subjects was the clinical gold-standard used for establishing PSG-AHI positive and PSG-AHI negative cohorts. The ECG-based SDB algorithm of the predicate device was applied to the concurrent ECG data recorded from the subjects. The accelerometer-based SDB algorithm of the subject device was applied to concurrent accelerometer data recorded from the subjects. Using these algorithm results, statistical analyses were undertaken to compare the SDB accuracy of the predicate device to that of the subject device. Substantial equivalence of the subject device's algorithm performance to that of the predicate device was demonstrated through this statistical comparison. (see Attachment 6, "Clinical Study Report", "K131883 - Response to reviewer's request for additional information, dated 09/12/2013"). This statistical equivalency in performance is central to the claim of substantial equivalency with the predicate device.
The reporting of SDB detection of the subject device is substantially equivalent to Substantial AUDICOR CPAM with SDB detection (K120462). Any differences between the Equivalence: subiect device and the predicate do not raise new questoins of safety and effectiveness.
The subject device and the predicate device are technologically equivalent in that Technological the devices: Characteristics:
-
- Are small, wearable, battery-powered devices
- Acquire ECG data from patients using limited ECG leads 2)
- Acquire a sound signal for detection of snoring 3)
-
- 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 subject device is different from the predicates in the following ways:
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- The predicate device uses ECG waveform signals for SDB detection. Through a technology change, the subject device accomplishes SDB detection using waveform signals obtained from an extant tri-axial accelerometer housed within the Hemo ambulatory recording device. This accelerometer was previously described within K120462 where it as used for activity level assessment only.
- The combination of non-clinical tests outlined above and described in the Conclusion: Declaration of Conformity together with clinical performance testing, also outlined above, demonstrates the subject device is as safe and as effective and performs substantially equivalent to the predicate device noted.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11. 2014
Inovise Medical. Incorporated Mr. Earl Anderson Director, Quality and Regulatory 8770 SW Nimbus Avenue, Suite D Portland, OR 97008
Re: K131883
Trade/Device Name: AUDICOR® CPAM with SDB Regulation Number: 21 CFR 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: II Product Code: MNR. MLO Dated: March 5. 2014 Received: March 6, 2014
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. Iabeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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.
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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/7 description: The image contains a logo or seal with some text. The text includes "Tejashri Purohit-Sheth, M.D.," "Clinical Deputy Director," and "DAGRID." There is also the word "FOR" at the bottom right of the image. The image appears to be a signature or approval stamp.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Device Name: AUDICOR® CPAM with SDB
Indications For Use:
The AUDICOR System when used with AUDICOR Sensors on the chest wall and properly attached Hotter 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.
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)
Anya C. Harry Page 1 of 1
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2014.04.11 12:58:52 -04'00'
§ 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).