(324 days)
Not Found
No
The summary describes automated analysis based on published guidelines and peer-reviewed publications, but does not mention AI or ML.
No
Explanation: The device is intended to aid in the evaluation and diagnosis of sleep disorders by analyzing sleep data and providing information for healthcare professionals; it does not directly provide therapy.
Yes
The device is described as aiding healthcare professionals in the diagnosis and management of sleep disorders and sleep-disordered breathing, including generating a SleepImage Apnea Hypopnea Index (sAHI) to aid in diagnosis.
Yes
The device is explicitly described as "Software as a Medical Device (SaMD)" and states it is an "application that is indicated for use on a general-purpose computing platform." While it processes data from external sensors (ECG, PLETH, oximeter, accelerometer), the device itself is the software that performs the analysis and reporting.
Based on the provided text, the SleepImage System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- SleepImage analyzes physiological signals: The SleepImage System analyzes physiological data like Electrocardiogram (ECG) and Plethysmogram (PLETH) data, which are collected from the body externally, not from a biological sample.
- The intended use is for evaluating sleep disorders: The primary purpose described is to aid in the evaluation of sleep disorders by analyzing physiological signals related to sleep.
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 Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for children, adolescents and adults.
The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing.
The SleepImage System output is not interpreted or clinical action taken without consultation of a qualified healthcare professional.
Product codes
MNR
Device Description
The SleepImage System is a Class II Software as a Medical Device (SaMD), intended to aid in the evaluation of sleep disorders, where it may inform or drive clinical management.
The Sleeplmage System automatically analyzes and displays Electrocardiogram (ECG) and Plethysmogram (PLETH) data. When provided in addition to the ECG or PLETH data, the SleepImage System can optionally analyze and 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 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 for children, adolescents and adults. When oximeter data is available, the Sleeplmage System will generate the Sleeplmage Apnea Hypopnea Index (sAHI) to aid healthcare professionals in diagnosis and management of sleep disordered breathing.
The SleepImage System reports results of the automated data analysis, including expected values for sleep quality, sleep duration and sleep pathology based on published peer-reviewed publications, and guidelines for sleep duration (National Sleep Foundation) and sleep apnea (American Academy of Sleep Medicine).
The clinician can view raw data for interpretation, adjust study duration, write clinical notes in the report and make recommendations to patients for further testing, recommend a referral to another clinician and/or recommendations for therapy.
The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional. Due to the intra-night variability of sleep, it is recommended that patients track their sleep over time.
The SleepImage System is a sleep health evaluation application that is indicated for use on a general-purpose computing platform. Like the predicate device, it processes data typically recorded during sleep, using a cloud-based web application.
The SleepImage System is being updated from the predicate device; the SleepImage System cleared under K163696.
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
children, adolescents and adults.
Intended User / Care Setting
Healthcare Professional / Not Found
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
In accordance with FDA Guideline for clinical evaluation of Software as a Medical Device (SaMD), reference data from over 2,000 sleep studies obtained from prospective clinical trials in children and adults that were conducted for the same intended use as the subject device were analyzed.
Each sleep recording obtained and utilized for this clinical evaluation contained ECG, PLETH and SpO2 signals, collected simultaneously. Study results from children (n=1334) are all based on PSG studies and study results from adults (n=761) are reported separately from PSG (n=189) and HSAT (n=572) in the labeling.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Evaluation, Software Verification and Validation Testing
Sample Size: Over 2,000
Key Results:
Tests for modification #1 were performed to compare agreement of the automated output from CPC analysis using the predicate device to compare PLETH vs ECG as the input signals for the test. The tests were performed based on pre-determined agreement in outcomes. All parameters tested exceeded the thresholds set for the tests. Reference is made to published results from the American Academy of Sleep Medicine (AASM) Interscorer Reliability Program: Sleep Scoring, published in the Journal of Clinical Sleep Medicine reporting the average agreement for sleep stage scoring among expert scorers in accredited sleep centers using PSG, which is on average 82.6%.
Tests for modification #2 were performed (1) to compare agreement from SleepImage Apnea Hypopnea Index (sAHI) vs. manual human scoring of Apnea Hypopnea Index (AHI) using American Academy of Sleep Medicine (AASM) scoring criteria for mild, moderate and severe sleep apnea in pediatric and adult patients and (2) to evaluate sAHI using guidelines issued by the AASM to compare sensitivity and Positive Likelihood Ratio (LR+) against pre-determined thresholds for use in Out Of Center (OOC) sleep diagnostic devices. All parameters tested exceeded the thresholds set for the tests.
Clinical evaluation has confirmed that the output of Cardiopulmonary Coupling (CPC) analysis PLETH signal input of the subject device when compared to the ECG signal input of the predicate device are comparable for clinical decisions.
Clinical evaluation has confirmed that the SleepImage System auto-scoring algorithms calculating the Sleeplmage Apnea Hypopnea Index (sAHI) generate comparable output to human manual scoring of an Apnea Hypopnea Index (AHI) from Polysomnography (PSG) studies, using American Academy of Sleep Medicine (AASM) scoring guidelines for children and adult patients.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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August 14, 2019
MyCardio, LLC dba SleepImage. Robert Schueppert Manager, Regulatory Affairs 3513 Brighton Blvd, Suite 530 Denver, Colorado 80216
Re: K182618
Trade/Device Name: SleepImage System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: Class II Product Code: MNR Dated: August 5, 2019 Received: August 6, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number K182618
Device Name SleepImage System
Indications for Use
The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for children, adolescents and adults.
The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing.
The SleepImage System output is not interpreted or clinical action taken without consultation of a qualified healthcare professional.
| Type of Use | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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3
510(K) SUMMARY
l. SUBMITTER INFORMATION
| Contact | Robert Schueppert
Manager of Regulatory and Quality
regulatory@sleepimage.com |
|---------------------|-------------------------------------------------------------------------------------|
| | MyCardio, LLC dba SleepImage
3513 Brighton Blvd, Suite 530
Denver, CO 80216 |
| | Phone: 720-708-4200 |
| Date of Preparation | August 13, 2019 |
II. DEVICE IDENTIFICATION
| Device Trade Name: | SleepImage System |
|---|---|
| Device Common Name: | SleepImage |
| Classification Name: | Breathing frequency monitor |
| Regulation Number: | 21 CFR 868.2375 |
| Product Code: | MNR |
| Device Classification: | Class II |
| Classification Panel: | Anesthesiology |
lll. PREDICATE DEVICE
SleepImage System (K163696) Device Trade Name:
IV. DEVICE DESCRIPTION
The SleepImage System is a Class II Software as a Medical Device (SaMD), intended to aid in the evaluation of sleep disorders, where it may inform or drive clinical management.
4
The Sleeplmage System automatically analyzes and displays Electrocardiogram (ECG) and Plethysmogram (PLETH) data. When provided in addition to the ECG or PLETH data, the SleepImage System can optionally analyze and 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 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 for children, adolescents and adults. When oximeter data is available, the Sleeplmage System will generate the Sleeplmage Apnea Hypopnea Index (sAHI) to aid healthcare professionals in diagnosis and management of sleep disordered breathing.
The SleepImage System reports results of the automated data analysis, including expected values for sleep quality, sleep duration and sleep pathology based on published peer-reviewed publications, and guidelines for sleep duration (National Sleep Foundation) and sleep apnea (American Academy of Sleep Medicine).
The clinician can view raw data for interpretation, adjust study duration, write clinical notes in the report and make recommendations to patients for further testing, recommend a referral to another clinician and/or recommendations for therapy.
The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional. Due to the intra-night variability of sleep, it is recommended that patients track their sleep over time.
The SleepImage System is a sleep health evaluation application that is indicated for use on a general-purpose computing platform. Like the predicate device, it processes data typically recorded during sleep, using a cloud-based web application.
The SleepImage System is being updated from the predicate device; the SleepImage System cleared under K163696.
V. INDICATIONS FOR USE
The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The Sleeplmage System analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for children, adolescents and adults.
5
The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing.
The Sleeplmage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.
VI. COMPARISON TO PREDICATE DEVICE
Like the predicate device (K163696), the SleepImage System subject device (K182618) is Software as a Medical Device (SaMD) designed and intended to establish sleep quality and evaluate sleep disorders. The subject and predicate devices are based on the following same technological elements:
- Both are Software as a Medical Device (SaMD). ●
- Both are cloud-based web applications, using general-purpose computing platforms.
- Both have the same basic software design, control mechanism and operating principle.
- Both use the same technology to couple Heart Rate Variability and Respiration.
- Both are intended to Inform or Drive Clinical Management of sleep disorders.
The following similarities / differences exist between the subject and predicate devices:
Modification #1: Plethysmography (PLETH) is added as valid input signal for Cardiopulmonary Coupling (CPC) analysis. This modification required a change in the software to add PLETH as an alternative to electrocardiogram (ECG) as valid input signal.
CPC processing remains unchanged and is the same for both input signals using peak-topeak intervals of heart (pulse) rate variability coupled with respiration.
Report output and user instructions are expanded to accommodate this change.
Modification #2: Calculation of a SleepImage Apnea Hypopnea Index (sAHI) is added to aid healthcare professionals in diagnosis of sleep disordered breathing. This modification required a change in the software to automatically calculate the sAHI output, using SpO2 data input already cleared in the predicate device.
sAHI calculations are performed and presented using American Academy of Sleep Medicine (AASM) guidelines and thresholds to categorize sleep apnea as mild; moderate and severe, both in adults and children. The sAHI output is based on calculating desaturations from SpO2 data and based on sleep time.
Report output and user instructions are expanded to accommodate this change.
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VII. SUBSTANTIAL EQUIVALENCE
Substantial equivalence is established through a phased clinical evaluation process and performance testing, referencing American Academy of Sleep Medicine (AASM) published guidelines and recommendations.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided based on Guidance Documents for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Software as a Medical Device (SaMD): Clinical Evaluation".
Clinical Evaluation
In accordance with FDA Guideline for clinical evaluation of Software as a Medical Device (SaMD), reference data from over 2,000 sleep studies obtained from prospective clinical trials in children and adults that were conducted for the same intended use as the subject device were analyzed.
Each sleep recording obtained and utilized for this clinical evaluation contained ECG, PLETH and SpO2 signals, collected simultaneously. Study results from children (n=1334) are all based on PSG studies and study results from adults (n=761) are reported separately from PSG (n=189) and HSAT (n=572) in the labeling.
Tests for modification #1 were performed to compare agreement of the automated output from CPC analysis using the predicate device to compare PLETH vs ECG as the input signals for the test. The tests were performed based on pre-determined agreement in outcomes. All parameters tested exceeded the thresholds set for the tests. Reference is made to published results from the American Academy of Sleep Medicine (AASM) Interscorer Reliability Program: Sleep Scoring, published in the Journal of Clinical Sleep Medicine reporting the average agreement for sleep stage scoring among expert scorers in accredited sleep centers using PSG, which is on average 82.6%. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3525994/
Tests for modification #2 were performed (1) to compare agreement from SleepImage Apnea Hypopnea Index (sAHI) vs. manual human scoring of Apnea Hypopnea Index (AHI) using American Academy of Sleep Medicine (AASM) scoring criteria for mild, moderate and severe sleep apnea in pediatric and adult patients and (2) to evaluate sAHI using guidelines issued by the AASM to compare sensitivity and Positive Likelihood Ratio (LR+) against pre-determined thresholds for use in Out Of Center (OOC) sleep diagnostic devices. Guidelines were published in the Journal of Clinical Sleep Medicine. https://www.ncbi.nlm.nih.gov/pubmed/22003351
7
All parameters tested exceeded the thresholds set for the tests.
ECG signal processing and CPC analysis in the subject device is unchanged, the output of CPC analysis from ECG signal therefore remains identical to the predicate device.
Labeling and Instructions for Use have been updated with information on performance results and references to academic guidelines from the American Academy of Pediatrics stating that clinicians should familiarize themselves with the sensitivity and specificity of the test against a full polysomnography test to determine if it is conclusive to be reliable for clinical diagnosis.
Validation and verification was performed to verify that the software modifications did not have any adverse impact on the functionality of the SleepImage System. Software verification and validation included software code reviews as well as labeling and user manual review.
The verification and validation testing demonstrate that both new feature requirements have been satisfied and safety and effectiveness has not been inadvertently affected by modifications to the system.
| Product Information | Subject Device | Predicate Device | |
|---|---|---|---|
| Device | Medical Software (SaMD) | Medical Software (SaMD) | |
| 510(k) # | K182618 | K163696 | |
| Trade / Product Name | SleepImage System | SleepImage System | |
| Regulation No. | 21 CFR 868.2375 | 21 CFR 868.2375 | |
| Product Code | MNR | MNR | |
| Classification | II | II | |
| Panel | Anesthesiology | Anesthesiology | |
| Manufacturer | MyCardio LLC | MyCardio LLC | |
| Environment of Use | N/A (Software) | N/A (Software) | |
| Indications for Use | The SleepImage System is | ||
| Software as a Medical Device | |||
| (SaMD) that establishes sleep | |||
| quality. The SleepImage | |||
| System analyzes, displays and | |||
| summarizes Electrocardiogram | |||
| (ECG) or Plethysmogram | |||
| (PLETH) data, typically collected | |||
| during sleep, that is intended | |||
| for use by or on the order of a | |||
| Healthcare Professional to aid | |||
| in the evaluation of sleep | |||
| disorders, where it may inform | 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 | |||
| Healthcare Professional to aid | |||
| in the evaluation of sleep | |||
| disorders, where it may inform | |||
| or drive clinical management. | |||
| Intended Use | for children, adolescents and adults. The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing. The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional. | 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 is not a monitor and does not issue any alarms. | |
| The SleepImage System is Software as a Medical Device (SaMD) 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) or Plethysmogram (PLETH) 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 for children, adolescents and adults. The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing. The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional. The SleepImage System is intended for use on a general-purpose computing | |||
| Principle of Operation | platform, it is not a monitor | ||
| and does not issue any alarms. | |||
| The SleepImage System is a | |||
| cloud-based web application | |||
| Software as a Medical Device | |||
| (SaMD). | The SleepImage System is a | ||
| cloud-based web application | |||
| Software as a Medical Device | |||
| (SaMD). | |||
| Computer Requirements | General-purpose computing | ||
| platform with internet | |||
| connection | General-purpose computing | ||
| platform with internet | |||
| connection | |||
| Software | Cloud-based software | ||
| application that analyzes and | |||
| displays ECG, PLETH and | |||
| oximeter data | Cloud-based software | ||
| application that analyzes and | |||
| displays ECG and oximeter data | |||
| Data Transfer | Data is transferred between | ||
| user's general-purpose | |||
| computing platform and cloud- | |||
| based server, utilizing secure | |||
| authentication protocols over | |||
| the Internet | Data is transferred between | ||
| user's general-purpose | |||
| computing platform and cloud- | |||
| based server, utilizing secure | |||
| authentication protocols over | |||
| the Internet | |||
| Computer Security | Use of secure authentication | ||
| protocols | Use of secure authentication | ||
| protocols | |||
| Target Population | Children, Adolescents and | ||
| Adults | Unspecified |
VIII. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE
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IX. CONCLUSION
Clinical evaluation has confirmed that the output of Cardiopulmonary Coupling (CPC) analysis PLETH signal input of the subject device when compared to the ECG signal input of the predicate device are comparable for clinical decisions.
Clinical evaluation has confirmed that the SleepImage System auto-scoring algorithms calculating the Sleeplmage Apnea Hypopnea Index (sAHI) generate comparable output to human manual scoring of an Apnea Hypopnea Index (AHI) from Polysomnography (PSG) studies, using American Academy of Sleep Medicine (AASM) scoring guidelines for children and adult patients.
The conclusions of these performance tests support the same intended use of the subject device as the predicate device and do not raise any new concerns about safety and effectiveness. It is concluded that the Sleeplmage System subject device, using either ECG or PLETH for Cardiopulmonary Coupling is substantially equivalent to the predicate device. It is further concluded that despite differences in how the SleepImage Apnea Hypopnea Index (SAHI) is automatically calculated compared to how the Apnea Hypopnea Index (AHI) is manually scored from PSG studies, that the sAHI has demonstrated agreement levels compared to manually scored AHI from PSG studies to be used to aid clinical diagnosis of sleep apnea in children and adults.