(266 days)
Not Found
Yes
The device description explicitly states that the audio recording is "analyzed by locked machine learnt software algorithms".
No
The device is solely for pre-screening and risk assessment, not for treating or ameliorating a disease or condition. It helps determine if further diagnosis and evaluation are needed.
Yes
The device is intended to "pre-screen patients for obstructive sleep apnea (OSA) syndrome" and provide a "risk assessment of the presence of OSA", which are diagnostic functions. It provides a binary outcome ('Minimal to Mild Risk of OSA' or 'Moderate to Severe Risk of OSA') based on analysis of patient data.
Yes
The device is described as a "software application" that uses the "device's inbuilt microphone" of a compatible smartphone. It explicitly states it is "software only" and relies on existing hardware (the smartphone and its microphone) for data acquisition. The analysis and output are also performed by the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Sleep CheckRx's function: Sleep CheckRx analyzes audio recordings of breathing and snore sounds captured by a smartphone's microphone. It does not analyze biological samples taken from the patient's body.
- Intended Use: The intended use is to record respiratory patterns during sleep for pre-screening for OSA, not to perform a diagnostic test on a biological sample.
Therefore, Sleep CheckRx falls outside the scope of an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
SleepCheckRx is indicated to record a patient's respiratory pattern during sleep for the purpose of pre-screening patients for obstructive sleep apnea (OSA) syndrome.
The device is designed for use in home-screening of adults (≥ 22 years of age) with suspected possible sleep breathing disorders. Results can be used to assist the healthcare professional in determining the need for further diagnosis and evaluation.
The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.
Product codes
MNR
Device Description
SleepCheckRx is a software application used by healthcare providers to pre-screen adults at home for the risk of Obstructive Sleep Apnea (OSA). The application is accessed via a compatible smartphone and uses the device's inbuilt microphone to record breathing and snore sounds while the user is asleep, over a minimum duration of 6 hours.
This audio recording, in conjunction with basic information about the user, is analyzed by locked machine learnt software algorithms to provide a risk assessment of the presence of OSA. Prior to use, the patient installs SleepCheckRx on a compatible smartphone and activates the application by entering a code issued to their Healthcare Professional (HCP) through a secure cloud server portal.
The patient enters basic information including date of birth, biological sex, height, weight, and neck circumference. The patient is also required to answer a STOP-Bang questionnaire. The phone is placed on a nightstand as directed, and when the user is ready to go to sleep, they initiate the software that begins a recording.
SleepCheckRx then captures breathing and snore sounds continuously throughout the night until the user stops the recording once they have awoken in the morning (a minimum of 6 hours of recording is required).
In the event of a successful recording, SleepCheckRx provides the user with a binary outcome of either 'Minimal to Mild Risk of OSA' (AHI
§ 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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July 5, 2022
ResApp Health Neroli Anderson VP Clinical, Quality And Regulatory Level 12, 100 Creek Street Brisbane, Queensland 4000 Australia
Re: K213360
Trade/Device Name: SleepCheckRx Regulation Number: 21 CFR 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: Class II Product Code: MNR Dated: June 9, 2022 Received: June 10, 2022
Dear Neroli 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. 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
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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 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 (QS) 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 medical devices and radiation-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,
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of 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
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Indications for Use
510(k) Number (if known) K213360
Device Name SleepCheckRx
Indications for Use (Describe)
Sleep CheckRx is indicated to record a patient's respiratory pattern during sleep for the purpose of pre-screening patients for obstructive sleep apnea (OSA) syndrome.
The device is designed for use in home-screening of adults (≥ 22 years of age) with suspected possible sleep breathing disorders. Results can be used to assist the healthcare professional in determining the need for further diagnosis and evaluation.
The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K213360 510(k) Summary (As required by section 807.92(c))
SLEEPCHECKRx
| I. GENERAL INFORMATION | |
|---|---|
| Submitter: | ResApp Health |
| Level 12, 100 Creek Street | |
| Brisbane QLD 4000 | |
| Australia | |
| Contact Person: | Neroli Anderson |
| VP Clinical, Quality and Regulatory | |
| Level 12, 100 Creek Street | |
| Brisbane QLD 4000 | |
| Australia | |
| Phone: +61 416 220 239 | |
| Email: neroli@resapphealth.com.au | |
| Date Prepared: | July 02, 2022 |
| II. DEVICE DETAILS | |
| Trade Name: | SleepCheckRx |
| Common or Usual Name: | Breathing Frequency Monitor |
| Classification Name: | Device: Ventilatory Effort Recorder |
| Regulation: | 21 CFR 868.2375 |
| Regulatory Class: | II |
| Product Code: | MNR |
| Review Panel: | Anesthesiology |
| III. PREDICATE DEVICE | |
| Predicate Device(s): | DROWZLE (K173974) |
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IV. DEVICE DESCRIPTION
SleepCheckRx is a software application used by healthcare providers to pre-screen adults at home for the risk of Obstructive Sleep Apnea (OSA). The application is accessed via a compatible smartphone and uses the device's inbuilt microphone to record breathing and snore sounds while the user is asleep, over a minimum duration of 6 hours.
This audio recording, in conjunction with basic information about the user, is analyzed by locked machine learnt software algorithms to provide a risk assessment of the presence of OSA. Prior to use, the patient installs SleepCheckRx on a compatible smartphone and activates the application by entering a code issued to their Healthcare Professional (HCP) through a secure cloud server portal.
The patient enters basic information including date of birth, biological sex, height, weight, and neck circumference. The patient is also required to answer a STOP-Bang questionnaire. The phone is placed on a nightstand as directed, and when the user is ready to go to sleep, they initiate the software that begins a recording.
SleepCheckRx then captures breathing and snore sounds continuously throughout the night until the user stops the recording once they have awoken in the morning (a minimum of 6 hours of recording is required).
In the event of a successful recording, SleepCheckRx provides the user with a binary outcome of either 'Minimal to Mild Risk of OSA' (AHI10
seconds. | Breathing pauses of
duration ≥ 6s but 15).
CONCLUSIONS X.
Based on the information provided in this submission, the SleepCheckRx is substantially equivalent to the predicate DROWZLE device.