(90 days)
Not Found
No
The description focuses on data recording, analysis, and presentation for manual diagnosis by a trained physician. There is no mention of AI or ML algorithms being used for automated analysis or interpretation. The analysis is described as "manual diagnosis" and the software provides "charts, graphs and reports for manual evaluation".
No
The device is described as a "sleep quality screening device" and is intended for the "collection of physiological (Actigraphy) and Electrocardiogram (ECG) recordings during sleep that will be used for screening different sleep associated disorders." Its purpose is to present data for "manual diagnosis" and "manual evaluation of sleep quality screening." The description explicitly states, "After this screening evaluation, the patient may require further testing and examination for possible treatment," indicating it does not provide treatment itself.
Yes
The device, through its "M1 sleep data recording device" and "CPC WEB Application Software," is intended for the "collection of physiological (Actigraphy) and Electrocardiogram (ECG) recordings during sleep" and their "analysis, manipulation and final presentation" to be "used for screening different sleep associated disorders." The output "provides graphs and reports for manual diagnosis," and "A trained physician would typically review and analyze the charts, graphs and reports created and presented by the CPC Web Application Software." This process of collecting and analyzing data to aid a physician in forming a diagnosis clearly positions it as a diagnostic device. While it's described as a "screening device," screening is a form of diagnosis, intended to identify potential issues that may require further diagnostic testing.
No
The device description clearly states the system includes a "single channel (EKG) hardware recording device (M1 Sleep Data Recorder)" in addition to the software components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples in vitro (outside the body). The M1 Sleep Data Recorder and CPC Web Application Software collect physiological signals (Actigraphy and ECG) directly from the patient's body in vivo (within the body).
- The intended use is for collecting and analyzing physiological recordings for sleep disorder screening. This involves measuring electrical activity of the heart and body movement, not analyzing components of blood, urine, or other biological fluids.
- The device description focuses on hardware for recording physiological signals and software for presenting and analyzing these signals. There is no mention of reagents, test strips, or any components typically associated with IVD testing.
The device is a medical device used for physiological monitoring and analysis, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sleep Data Recorder
The M1 sleep data recording device is intended for use by a physician or a trained technician for the collection of physiological (Actigraphy) and Electrocardiogram (ECG) recordings during sleep that will be used for screening different sleep associated disorders.
The intended environment is any dry space used for sleeping.
CPC WEB Application Software
The CPC application software (and associated modules) is intended for use by a physician or a trained technician for the analysis, manipulation and final presentation of physiological (Actigraphy) and Electrocardiogram (ECG) recordings during sleep.
The intended environment is any dry space suitable for the operation of a conventional computer.
The device and software do not monitor or diagnose the patient and do not issue any alarms.
Product codes (comma separated list FDA assigned to the subject device)
TBD
Device Description
Cardiopulmonary coupling (CPC) is currently a functional module included as one of many features in Embla's polysomnographic (PSG) presentation software of the predicate device. This can be invoked by the user to provide a CPC analysis from the EKG signals provided by the current multi-channel recorders in Embla's hardware product line. It has been decided to duplicate this presentation software module into its own product line with a separate web based application using a dedicated recorder. Therefore. MyCardio and Embla have developed a single channel (EKG) hardware recording device (M1 Sleep Data Recorder) and associated WEB site (CPC Web Application Software) to present the data and provide graphs and reports for manual diagnosis.
The model M1 Sleep Data Recorder is intended to be used as a sleep quality screening device. The M1 is a small palm size data recorder used with two commercially available EKG patient electrodes. One electrode snaps directly onto the recorder body. while the second electrode snaps onto a short cable in turn connected to a connector on the M1. The M1 is to be attached to the patient at home by the two electrodes and used to record multiple individual sleep periods. Following the home study, the M1 is returned to the clinic and the data is uploaded by the clinician to the CPC Web Application Software.
The CPC Application Software consists of three separate software programs working as a system. (1) CPC Console software - this software is similar to the predicate device presentation software CPC module and receives the data uploaded from the M1 recorder and performs the actual data graphing and reporting. (2) CPC Client software - this software manages the interaction between the user and the M1 device and uploads the analyzed M1 data from the CPC Console to the CPC Web software. (3) CPC Web software - this software creates the user interface screens, manages the data inputted by the user, keeps track of the studies and patient demographics, and provides charts, graphs and reports for manual evaluation of sleep quality screening.
A trained physician would typically review and analyze the charts, graphs and reports created and presented by the CPC Web Application Software. After this screening evaluation, the patient may require further testing and examination for possible treatment.
The battery operated M1 device will be capable of 72 hours (representing approximately 10 overnight studies) of recording to an internal memory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The users are the general public, trained physicians, trained sleep technicians (RPGST) or people working under the supervision of one of these professionals. The user may or may not possess knowledge of the physiological signals or test criteria.
The general intended environment is the patient home but the device is capable of functioning in any environment where patients can sleep reasonably comfortably.
The intended environment is any dry space used for sleeping.
The intended environment is any dry space suitable for the operation of a conventional computer.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety tests have been performed on the M1 Sleep Data Recorder to verify compliance with IEC 60601-1/UL60601-1 and any applicable particular standards in this family of international safety standards to ensure that there are no potential hazards on patients, operators, or the surroundings.
Electromagnetic Compatibility tests according to IEC 60601-1-2 are being performed on the M1 Sleep Data Recorder to ensure that no intolerable electromagnetic disturbances are introduced.
Immunity tests to IEC 60601-1-2 are being performed on the M1 Sleep Data Recorder to ensure that the device operates satisfactorily in an electromagnetic environment.
The internal testing, verification in various design phases, and validation of performance specifications are currently being completed and the reports will be provided in a supplement to this application.
The EKG signal recorded by the M1 Sleep Data Recorder was compared to EKG signals recorded by qualified sleep technicians using the predicate Embletta Gold recorder. The result of the comparison is that the EKG signal recorded by the M1 Sleep Data Recorder is in every respect clinically equivalent in the context of screening to the EKG signal currently recorded by the predicate device.
The presentation, analysis and reports generated by the CPC Web Application Software for the EKG signal recorded by the M1 Sleep Data Recorder were compared by qualified sleep technicians to the presentation, analysis and reports generated by the CPC module of the PSG application software for EKG signals recorded by the predicate Embletta Gold recorder. The result of the comparison is that the presentation, analysis and reports generated by the CPC Web Application Software are in every respect clinically equivalent to the presentation, analysis and reports generated by the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(K) SUMMARY
SUBMITTER INFORMATION
| A. Company Name: | MyCardio LLC. |
|---|---|
| B. Company Address: | 11001 W. 120th Ave., Suite 200 |
| Broomfield, Colorado 80021 | |
| C. Company Phone: | (303) 790-1801 |
| D. Company Facsimile: | (303) 790-1810 |
| E. Company Contact: | Robert G. Schueppert |
| Manager, Regulatory Affairs | |
| E-mail: bob.schueppert(@embla.com |
PREPARATION DATE
June 29, 2009
DEVICE IDENTIFICATION
| A. Device Trade Name: | M1 Sleep Data Recorder and CPC Application
Software |
|--------------------------|--------------------------------------------------------|
| B. Device Common Name: | M1 Sleep Data Recorder and CPC Application
Software |
| C. Classification Name: | TBD |
| D. Regulation Number: | TBD |
| E. Product Code: | TBD |
| F. Device Class: | Class II |
| G. Classification Panel: | TBD |
PREDICATE DEVICE
Trade Name: Embletta Gold, 510(k) Number: K073682
1
DEVICE DESCRIPTION
Cardiopulmonary coupling (CPC) is currently a functional module included as one of many features in Embla's polysomnographic (PSG) presentation software of the predicate device. This can be invoked by the user to provide a CPC analysis from the EKG signals provided by the current multi-channel recorders in Embla's hardware product line. It has been decided to duplicate this presentation software module into its own product line with a separate web based application using a dedicated recorder. Therefore. MyCardio and Embla have developed a single channel (EKG) hardware recording device (M1 Sleep Data Recorder) and associated WEB site (CPC Web Application Software) to present the data and provide graphs and reports for manual diagnosis.
The model M1 Sleep Data Recorder is intended to be used as a sleep quality screening device. The M1 is a small palm size data recorder used with two commercially available EKG patient electrodes. One electrode snaps directly onto the recorder body. while the second electrode snaps onto a short cable in turn connected to a connector on the M1. The M1 is to be attached to the patient at home by the two electrodes and used to record multiple individual sleep periods. Following the home study, the M1 is returned to the clinic and the data is uploaded by the clinician to the CPC Web Application Software.
The CPC Application Software consists of three separate software programs working as a system. (1) CPC Console software - this software is similar to the predicate device presentation software CPC module and receives the data uploaded from the M1 recorder and performs the actual data graphing and reporting. (2) CPC Client software - this software manages the interaction between the user and the M1 device and uploads the analyzed M1 data from the CPC Console to the CPC Web software. (3) CPC Web software - this software creates the user interface screens, manages the data inputted by the user, keeps track of the studies and patient demographics, and provides charts, graphs and reports for manual evaluation of sleep quality screening.
A trained physician would typically review and analyze the charts, graphs and reports created and presented by the CPC Web Application Software. After this screening evaluation, the patient may require further testing and examination for possible treatment.
The battery operated M1 device will be capable of 72 hours (representing approximately 10 overnight studies) of recording to an internal memory.
The general intended environment is the patient home but the device is capable of functioning in any environment where patients can sleep reasonably comfortably.
The users are the general public, trained physicians, trained sleep technicians (RPGST) or people working under the supervision of one of these professionals. The user may or may not possess knowledge of the physiological signals or test criteria.
2
The M1 Sleep Data Recorder and CPC Web Application Software do not provide any alarms and are not intended as a monitor.
INTENDED USE
Sleep Data Recorder
The M1 sleep data recording device is intended for use by a physician or a trained technician for the collection of physiological (Actigraphy) and Electrocardiogram (ECG) recordings during sleep that will be used for screening different sleep associated disorders.
The intended environment is any dry space used for sleeping.
CPC WEB Application Software
The CPC application software (and associated modules) is intended for use by a physician or a trained technician for the analysis, manipulation and final presentation of physiological (Actigraphy) and Electrocardiogram (ECG) recordings during sleep.
The intended environment is any dry space suitable for the operation of a conventional computer.
The device and software do not monitor or diagnose the patient and do not issue any alarms.
COMPARISON TO PREDICATE DEVICES
The M1 Sleep Data Recorder and CPC Web Application Software is substantially equivalent in the following technological ways to the intended use and application in the identified predicate devices;
- Indications for Use o
- O Target population
- Basic design and architecture (software) O
- o Physiological signals recorded
- Where used O
- O Standards met
The Embletta Gold predicate recording device is a small palm-size portable device that connects to one or more probes or sensors on the patient to record a variety of physiological signals, including EKG. This data is then downloaded into a separate
3
computer where the Embla PSG application software presents the signals in a format that can be read by a trained technician or physician.
TESTING AND PERFORMANCE DATA
Safety tests have been performed on the M1 Sleep Data Recorder to verify compliance with IEC 60601-1/UL60601-1 and any applicable particular standards in this family of international safety standards to ensure that there are no potential hazards on patients, operators, or the surroundings.
Electromagnetic Compatibility tests according to IEC 60601-1-2 are being performed on the M1 Sleep Data Recorder to ensure that no intolerable electromagnetic disturbances are introduced.
Immunity tests to IEC 60601-1-2 are being performed on the M1 Sleep Data Recorder to ensure that the device operates satisfactorily in an electromagnetic environment.
The internal testing, verification in various design phases, and validation of performance specifications are currently being completed and the reports will be provided in a supplement to this application.
No other specific guidance document on performance is required for this type of device.
BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING
Biocompatibility and Sterilization do not apply. The M1 Sleep Data Recorder is connected to a commercially available EKG electrode, and is not intended to contact the body.
Packaging -
- · The M1 Sleep Data Recorder, together with the cables, batteries, screwdriver (to insert the batteries), and a small supply of commercially available EKG electrodes will be packaged in a small pouch.
- · The CPC Web Application Software can be purchased by logging on to the SleepImage.com website.
Bench testing - Bench testing with the predicate devices is ongoing at this time. A full report will be provided in a supplement to this application.
4
CONCLUSION
The EKG signal recorded by the M1 Sleep Data Recorder was compared to EKG signals recorded by qualified sleep technicians using the predicate Embletta Gold recorder. The result of the comparison is that the EKG signal recorded by the M1 Sleep Data Recorder is in every respect clinically equivalent in the context of screening to the EKG signal currently recorded by the predicate device.
The presentation, analysis and reports generated by the CPC Web Application Software for the EKG signal recorded by the M1 Sleep Data Recorder were compared by qualified sleep technicians to the presentation, analysis and reports generated by the CPC module of the PSG application software for EKG signals recorded by the predicate Embletta Gold recorder. The result of the comparison is that the presentation, analysis and reports generated by the CPC Web Application Software are in every respect clinically equivalent to the presentation, analysis and reports generated by the predicate device.
It is therefore the conclusion of MyCardio LLC that the M1 Sleep Data Recorder and CPC Web Application Software are substantially equivalent to devices already on the market [cleared by the 510(k) process] and presents no new concerns about safety and effectiveness.