(288 days)
No
The description focuses on automated analysis of ECG data using a general purpose computing platform and does not mention AI, ML, or related terms. The performance study compares the system's ECG analysis to a predicate device and alternate ECG sources, not validating an AI/ML model.
No
The device is described as medical software that analyzes and displays ECG data to aid in the evaluation of sleep disorders, informing clinical management. It does not actively treat or provide therapy.
Yes
The device analyzes, displays, and summarizes ECG data to aid in the evaluation of sleep disorders and inform clinical management, which are functions of a diagnostic device.
Yes
The device is explicitly described as "medical software" and a "standalone, sleep health evaluation application" that operates on a "general purpose computing platform." It analyzes data from external sources (ECG, accelerometer, oximeter) but the device itself is the software performing the analysis and reporting. The update from the predicate device specifically highlights its independence from dedicated hardware.
Based on the provided text, the SleepImage System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to obtain information for diagnostic or monitoring purposes.
- SleepImage System's Function: The SleepImage System analyzes ECG data collected from the patient's body. It processes physiological signals (electrical activity of the heart) and optionally accelerometer and oximeter data. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to aid in the evaluation of sleep disorders by analyzing physiological data, not by analyzing biological samples.
Therefore, the SleepImage System falls under the category of a medical device that analyzes physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SleepImage System is medical software that establishes sleep quality. The SleepImage system analyzes, displays and summarizes ECG data, typically collected during sleep that is intended for use by or on the order of a Health Care Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The SleepImage System consists of an operator-independent process that automatically analyzes Electrocardiography data using a general purpose computing platform. When provided in addition to the ECG data, the SleepImage System can optionally display accelerometer and oximeter data.
The results of the processed data are graphical and numerical presentations and reports of sleep latency, sleep duration, sleep quality and sleep pathology for the use by or on the order of physicians, trained technicians, or other healthcare professionals.
The data output establishes sleep quality and allows the healthcare professional to evaluate sleep disorders, where it may inform or drive clinical management taking into consideration other factors that normally are considered for clinical management of sleep disorders.
The clinician can create unique patient reports for the patient being evaluated, and configure parameters in the software.
The SleepImage System is a standalone, sleep health evaluation application that provides automated analysis of cardiovascular and respiratory waveforms. Like the predicate device, it processes information recorded during sleep. The SleepImage System is considered to be medical software.
The SleepImage System is being updated from the predicate device, the M1 Sleep Data Recorder and CPC Application Software to operate independent of the dedicated M1 Sleep Data Recorder cleared under K092003.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Care Professional (physicians, trained technicians, or other healthcare professionals)
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)
A study was conducted to compare electrocardiography (ECG) analysis and results of the SleepImage System based on simultaneous recordings with alternate ECG collection sources (ECG signal extracted from a typical hospital PSG study and ECG sensors for home use) and the predicate M1 Sleep Data Recorder. The result of this comparison is that the output from the ECG signals from the alternate recordings are in every respect statistically equivalent to the output from ECG signals recorded by the predicate M1 Sleep Data Recorder 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.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 13, 2017
Mycardio, LLC Dba Sleepimage. Mr. Robert Schueppert Manager, Regulatory Affairs 370 Interlocken Blvd. Suite 650 Broomfield, Colorado 80021
Re: K163696
Trade/Device Name: SleepImage System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: September 11, 2017 Received: September 12, 2017
Dear Mr. Schueppert:
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.
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
1
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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tara A. Ryan -S
for Tina Kiang, Ph.D. 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
510(k) Number (if known) K163696
Device Name SleepImage System
Indications for Use (Describe)
The SleepImage System is medical software that establishes sleep quality. The SleepImage system analyzes, displays and summarizes ECG data, typically collected during sleep that is intended for use by or on the order of a Health Care Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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370 Interlocken Blvd. Suite 650 Broomfield, CO 80021 USA Tel: 888.975.7464
Date: September 11, 2016
510(K) SUMMARY
SUBMITTER INFORMATION
| A. Company Name: | MyCardio LLC dba SleepImage |
|---|---|
| B. Company Address: | 370 Interlocken Blvd. Suite 650 |
| Broomfield, CO 80021, USA | |
| C. Company Phone: | 720-708-4209 |
| D. Company Email: | regulatory@sleepimage.com |
| E. Company Contact: | Robert Schueppert, Manager of Regulatory and Quality |
PREPARATION DATE September 11, 2017
DEVICE IDENTIFICATION
| A. Device Trade Name: | SleepImage System |
|---|---|
| ------------------------ | ------------------- |
- B. Device Common Name: SleepImage
- C. Classification Name: Breathing frequency monitor
- D. Regulation Number: 21 CFR 868.2375
- E. Product Code: MNR
- F. Device Classification: Class II
- G. Classification Panel: Unknown
PREDICATE DEVICE
- A. Trade Name: CPC Application Software from M1 Sleep Data Recorder and CPC Application Software (K092003)
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Regulation Number: 21 CFR 868.2375 Product Code: MNR
REFERENCE DEVICE
A. Trade Name: Sleep Quality (K070855) Regulation Number: 21 CFR 868.2375 Product Code: MNR
Rationale: This device has been cleared to analyze ECG data for the purposes of sleep quality measurements and sleep disorder detection without referencing a particular, or a list of particular ECG signal sources or recording devices. The description states the following: "Sleep Quality system takes text format ECG recording into ASCII data format. Most commercially available Holter Monitors devices have this capability. ECG recording data is first collected by a standard Holter device during subject's sleep, is converted into ASCII data format, and is then analyzed by the Sleep Quality system."
INDICATIONS FOR USE
The Sleeplmage System is medical software that establishes sleep quality. The SleepImage system analyzes, displays and summarizes ECG data, typically collected during sleep that is intended for use by or on the order of a Health Care Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management.
DEVICE DESCRIPTION
The SleepImage System consists of an operator-independent process that automatically analyzes Electrocardiography data using a general purpose computing platform. When provided in addition to the ECG data, the SleepImage System can optionally display accelerometer and oximeter data.
The results of the processed data are graphical and numerical presentations and reports of sleep latency, sleep duration, sleep quality and sleep pathology for the use by or on the order of physicians, trained technicians, or other healthcare professionals.
The data output establishes sleep quality and allows the healthcare professional to evaluate sleep disorders, where it may inform or drive clinical management taking into consideration other factors that normally are considered for clinical management of sleep disorders.
1 Electrocardiography (ECG or EKG) is defined as the process of recording the electrical activity of the heart over a period of time.
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The clinician can create unique patient reports for the patient being evaluated, and configure parameters in the software.
The SleepImage System is a standalone, sleep health evaluation application that provides automated analysis of cardiovascular and respiratory waveforms. Like the predicate device, it processes information recorded during sleep. The SleepImage System is considered to be medical software.
The SleepImage System is being updated from the predicate device, the M1 Sleep Data Recorder and CPC Application Software to operate independent of the dedicated M1 Sleep Data Recorder cleared under K092003.
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INTENDED USE
The SleepImage System is medical software that establishes sleep quality, intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders based on Electrocardiogram (ECG) recordings, typically collected during sleep.
The results of these analyses are graphical and numerical presentations and reports of sleep latency, sleep duration, sleep quality and sleep pathology. These presentations and reports are intended to inform or drive clinical management.
The SleepImage System is intended for use on a general-purpose computing platform, it does not monitor or diagnose the patient and does not issue any alarms.
COMPARISON TO PREDICATE DEVICES
The SleepImage System is substantially equivalent in the following technological ways to the intended use and application to the identified predicate device;
- Indications for Use O
- Basic design O
- Materials used O
- O Where used
- Standards met O
TESTING AND PERFORMANCE DATA
Product Safety Testing - not applicable (software). Electromagnetic Compatibility and Immunity Testing - not applicable (software). No other specific guidance document on performance is required for this type of device.
BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING
Biocompatibility - not applicable (software). Sterilization - not applicable (software). Packaging - not applicable (software). Bench testing -
- . The SleepImage System software is identical in specifications and performance to the original cleared CPC Application Software (predicate - K092003). Repeat bench testing conducted on the SleepImage System was not considered necessary.
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- . A study was conducted to compare electrocardiography (ECG) analysis and results of the SleepImage System based on simultaneous recordings with alternate ECG collection sources (ECG signal extracted from a typical hospital PSG study and ECG sensors for home use) and the predicate M1 Sleep Data Recorder. The result of this comparison is that the output from the ECG signals from the alternate recordings are in every respect statistically equivalent to the output from ECG signals recorded by the predicate M1 Sleep Data Recorder predicate device.
CONCLUSION
It is the the conclusion of MyCardio LLC that the SleepImage System is substantially equivalent to the predicate device [cleared by the 510(k) process] and presents no new concerns about safety and effectiveness.