(154 days)
Not Found
No
The device description details algorithms for breath and event detection (apnea, hypopnea, flow-limitation) and a specific algorithm (SensAwake™) for detecting an "anxious" awake state. These are described as time-domain and frequency-domain based algorithms with defined thresholds, which are characteristic of traditional signal processing and rule-based systems, not AI/ML. There is no mention of learning, training data, or adaptive models typically associated with AI/ML.
Yes
The device is described as treating "Obstructive Sleep Apnea (OSA)" and its efficacy is shown by "reduction of the obstructive indices," directly indicating its therapeutic purpose.
No
The device is described as a non-invasive auto-adjusting Continuous Positive Airway Pressure (CPAP) flow generator for the treatment of Obstructive Sleep Apnea (OSA). While it detects apneas, flow-limitation, and certain breathing patterns, these detections are primarily for the purpose of adjusting the therapy delivered by the device, not for providing a diagnosis in itself. It is a therapeutic device that incorporates monitoring capabilities.
No
The device description clearly outlines hardware components such as a motorised fan assembly, a heated passover humidifier, a humidification chamber, and a heaterplate. While software controls some functions, it is integral to a physical device.
Based on the provided information, the Sleepstyle™ 200 Auto Series HC254 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a CPAP flow generator with a humidifier. Its function is to deliver positive airway pressure to treat OSA, not to perform tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on laboratory tests.
The device's algorithms are used to detect breathing patterns and events for the purpose of adjusting the therapeutic pressure, not for providing a diagnosis based on in vitro analysis. The reporting software provides information on therapy effectiveness, which is related to treatment monitoring, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Sleepstyle ™ 200 Auto Series HC254 is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory.
Product codes
BZD
Device Description
The Sleepstyle™ 200 Auto Series HC254 is a non-invasive auto-adjusting Continuous Positive Airway Pressure (CPAP) flow generator, incorporating a heated respiratory humidifier.
The HC254 is comprised of two functional units. One is a motorised fan assembly that provides positive air pressure. The fan speed is directly related to air pressure, and is controlled by software. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second functional unit of the HC254 is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heaterplate at the front of the unit. The chamber connects directly to the blower assembly via a port at the back of the chamber. Ambient temperature is monitored in order to reduce breathing tube condensation in cooler operating conditions.
The Sleepstyle ™ 200 Auto Series HC254 detects apneas, and flow-limitation. To this end the HC254 contains a breath detection algorithm and event detection algorithms. The apnea and hypopnea detection algorithms are time-domain based algorithms that compare the patients breathing and/or flow to thresholds dependent on the patient's peak inspiratory flow. The flow-limitation detection algorithm analyzes the patients breathing in the frequency domain and determines the presence or absence of flow-limitation.
The HC254 also contains an algorithm, called SensAwake™, that is capable of detecting breathing patterns that are indicative of the "anxious" awake state. If SensAwake™ detects this "anxious" awake state then the pressure is reduced to help facilitate the patients return to sleep.
An available treatment efficacy reporting software accessory is PerformanceMaximizer™, The package offers detailed reporting on therapy effectiveness, including compliance, AHI. leak and pressure. The supplied SmartStick™ fitted at the rear of the device transfers this information via USB technology.
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
adult patients
Intended User / Care Setting
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing of the Sleepstyle™ 200 Auto Series HC254 demonstrated the safety of the device by a lack of adverse events, while efficacy of treatment was shown by a reduction of the obstructive indices to below 15/hour, improvement in oxygen saturation
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
SECTION 5 - 510K Summary
SEP 1 2 2008
Fisher & Paykel HEALTHCARE
Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com
| Contact person | James Thompson |
|---|---|
| Date prepared | 4 April 2008 |
| Trade name | Sleepstyle™ 200 Auto Series HC254 |
| Common name | Auto CPAP Humidifier |
| Classification | |
| name | Non continuous ventilator IPPB, Class II |
| (21 CFR § 868.5905, product code BZD) | |
| Predicate | |
| devices | K040941 Fisher & Paykel Healthcare HC234 CPAP Humidifier |
| Establishment | |
| Registration | 9611451 |
1
5.1 Description
The Sleepstyle™ 200 Auto Series HC254 is a non-invasive auto-adjusting Continuous Positive Airway Pressure (CPAP) flow generator, incorporating a heated respiratory humidifier.
The HC254 is comprised of two functional units. One is a motorised fan assembly that provides positive air pressure. The fan speed is directly related to air pressure, and is controlled by software. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second functional unit of the HC254 is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heaterplate at the front of the unit. The chamber connects directly to the blower assembly via a port at the back of the chamber. Ambient temperature is monitored in order to reduce breathing tube condensation in cooler operating conditions.
The Sleepstyle ™ 200 Auto Series HC254 detects apneas, and flow-limitation. To this end the HC254 contains a breath detection algorithm and event detection algorithms. The apnea and hypopnea detection algorithms are time-domain based algorithms that compare the patients breathing and/or flow to thresholds dependent on the patient's peak inspiratory flow. The flow-limitation detection algorithm analyzes the patients breathing in the frequency domain and determines the presence or absence of flow-limitation.
The HC254 also contains an algorithm, called SensAwake™, that is capable of detecting breathing patterns that are indicative of the "anxious" awake state. If SensAwake™ detects this "anxious" awake state then the pressure is reduced to help facilitate the patients return to sleep.
An available treatment efficacy reporting software accessory is PerformanceMaximizer™, The package offers detailed reporting on therapy effectiveness, including compliance, AHI. leak and pressure. The supplied SmartStick™ fitted at the rear of the device transfers this information via USB technology.
5.2 Intended Use
The Sleepstyle ™ 200 Auto Series HC254 is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory.
5.3 Technological Characteristics Comparison
The Sleepstyle™ 200 Auto Series HC254 is substantially equivalent to the Fisher & Paykel Healthcare HC234 in terms of intended use, operating principle, fundamental technological characteristics and manufacturing process.
2
Differences between the Sleepstyle™ 200 Auto Series HC254 and the predicate devices include:
-
Introduction of software algorithms for detecting and responding to apneas, and flow-limitation.
-
New SensAwake™ algorithm for detecting breathing patterns indicative of the "anxious" awake state.
-
New PerformanceMaximizer™ efficacy reporting software accessory.
-
SmartStick removal storage media device for data analysis.
-
Pressure adjustment for leak compensation.
Non-Clinical Tests 5.4
Non-clinical testing of the Sleepstyle™ 200 Auto Series HC254 has been carried out covering mechanical, electrical and thermal safety, environmental conditions. electromagnetic compatibility, functional verification and performance. Copies of these test reports are included in Appendix E and are outlined in section 18 of this submission.
The Sleepstyle™ 200 Auto Series HC254 complies with the requirements of IEC 60601-1 Electrical Safety, IEC 60601-1-2 EMC and 17510-1 Sleep Apnea Therapy Devices. Copies of these test reports are included in Appendix D.
Clinical Tests ર .5
Clinical testing of the Sleepstyle™ 200 Auto Series HC254 demonstrated the safety of the device by a lack of adverse events, while efficacy of treatment was shown by a reduction of the obstructive indices to below 15/hour, improvement in oxygen saturation