(154 days)
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.
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.
The provided text describes a 510(k) summary for the Sleepstyle™ 200 Auto Series HC254, an auto CPAP humidifier. The document focuses on establishing substantial equivalence to a predicate device and details non-clinical and clinical testing, but it does not contain detailed acceptance criteria or a study proving the device specifically meets quantified acceptance criteria related to its software algorithms (breath detection, event detection, SensAwake™).
The "Clinical Tests" section mentions efficacy was shown by "reduction of the obstructive indices to below 15/hour, improvement in oxygen saturation <90%, and reduction of arousal index from baseline," but these are presented as outcomes observed in a clinical study rather than pre-defined acceptance criteria for the device performance in detecting events. The text indicates a clinical study report is in Appendix F, which is not provided.
Therefore, much of the requested information regarding acceptance criteria for the device's algorithmic performance and a study proving it meets those criteria cannot be fully extracted from the provided text. However, I can still provide information based on what is available and indicate where details are missing.
Here's an attempt to answer your request based on the provided text, highlighting what's present and what's absent:
Acceptance Criteria and Device Performance for Sleepstyle™ 200 Auto Series HC254
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as implied or stated; explicit criteria for algorithms not given) | Reported Device Performance/Outcome |
|---|---|---|
| Clinical Efficacy (Overall Treatment Outcome) | Reduction of obstructive indices to below 15/hour | Observed reduction of obstructive indices to below 15/hour (implies successful treatment) |
| Improvement in oxygen saturation > 90% (this is usually a target, not a threshold <90%) | Observed improvement in oxygen saturation to >90% (implies successful treatment) | |
| Reduction of arousal index from baseline | Observed reduction of arousal index from baseline (implies successful treatment) | |
| Device Safety | Lack of adverse events | Demonstrated safety by a lack of adverse events |
| Functional Verification & Performance | Compliance with IEC 60601-1 (Electrical Safety) | Complies with IEC 60601-1 |
| Compliance with IEC 60601-1-2 (EMC) | Complies with IEC 60601-1-2 | |
| Compliance with 17510-1 (Sleep Apnea Therapy Devices) | Complies with 17510-1 | |
| Mechanical, Electrical, Thermal Safety | Not explicitly stated (e.g., temperature limits, pressure accuracy) | Non-clinical testing carried out covering mechanical, electrical and thermal safety; reports included in Appendix E. |
| Environmental Conditions | Not explicitly stated (e.g., operating temperature, humidity) | Non-clinical testing carried out covering environmental conditions; reports included in Appendix E. |
| Electromagnetic Compatibility (EMC) | Not explicitly stated (e.g., emissions limits, immunity levels) | Non-clinical testing carried out covering electromagnetic compatibility; reports included in Appendix E. Complies with IEC 60601-1-2. |
| Software Algorithm Performance | Explicit, quantified acceptance criteria for breath detection, apnea/hypopnea, and flow-limitation detection algorithms are not provided in this document. | The device "detects apneas, and flow-limitation," using "time-domain based algorithms" and "frequency domain" analysis. SensAwake™ detects "anxious" awake state. |
Missing Information:
- Explicit, quantitative acceptance criteria for the accuracy, sensitivity, or specificity of the breath detection, apnea/hypopnea detection, flow-limitation detection, or SensAwake™ algorithms are not provided in this summary. The provided text only states that these algorithms exist and what they aim to detect.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "clinical testing" and a "clinical study report is included in appendix F," but it does not specify the sample size of patients or cases used in this clinical study (which would serve as the test set for overall device efficacy).
- Data Provenance: The document does not specify the country of origin of the data. The study is described as "Clinical Tests" and refers to "patients," implying a prospective clinical study, but it does not explicitly state this.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the given text. While a clinical study report is mentioned (Appendix F), the details about how the obstructive indices, oxygen saturation, and arousal index were determined or adjudicated, or the qualifications of those experts, are not included.
4. Adjudication Method for the Test Set
- This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is mentioned. The study described focuses on the device's clinical efficacy and safety, not on comparing human readers' performance with and without AI assistance. Therefore, no effect size for human reader improvement with AI assistance is provided.
6. Standalone (Algorithm Only) Performance Study
- The document describes the presence of various algorithms (breath detection, apnea/hypopnea detection, flow-limitation detection, SensAwake™). It states that non-clinical tests included "functional verification and performance." However, it does not explicitly describe a standalone study specifically evaluating the performance metrics (e.g., sensitivity, specificity, accuracy) of these algorithms in isolation from the overall device's clinical impact on patients. The clinical study focuses on patient outcomes.
7. Type of Ground Truth Used
- For the clinical efficacy outcomes, the ground truth appears to be derived from clinical measurements and assessments from a prospective clinical study. The "obstructive indices," "oxygen saturation," and "arousal index" relate to physiological measurements typically used in sleep studies. It's implied that these formed the basis for evaluating treatment efficacy. The document does not specify if these were confirmed by a consensus of experts, pathology, or direct outcomes data beyond the physiological measurements.
8. Sample Size for the Training Set
- The document does not provide any information about a training set size. The algorithms are described as being present in the device, but details on how they were developed or trained (if machine learning based) are absent. This 510(k) summary focuses on the end-device performance and substantial equivalence.
9. How the Ground Truth for the Training Set was Established
- Since information on a training set is not provided, how its ground truth was established is also not available in the given text.
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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 |
| Classificationname | Non continuous ventilator IPPB, Class II(21 CFR § 868.5905, product code BZD) |
| Predicatedevices | K040941 Fisher & Paykel Healthcare HC234 CPAP Humidifier |
| EstablishmentRegistration | 9611451 |
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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.
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Differences between the Sleepstyle™ 200 Auto Series HC254 and the predicate devices include:
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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.
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New PerformanceMaximizer™ efficacy reporting software accessory.
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SmartStick removal storage media device for data analysis.
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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 <90%, and reduction of arousal index from baseline. A clinical study report is included in appendix F.
5.6 Conclusion
Testing carried out on the Sleepstyle ™ 200 Auto Series HC254 indicates that it meets design. and performance functional requirements. The proposed device meets the requirements of sleep apnea breathing therapy device standards for safety and performance.
This information indicates that the Sleepstyle™ 200 Auto Series HC254 is substantially equivalent to the predicate device in terms of safety, effectiveness and performance.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle-like symbol with flowing ribbons, representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2008
Mr. James Thompson Regulatory Affairs Manager Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki P.O. Box 14 348, Panmure Auckland NEW ZEALAND
Re: K081029
Trade/Device Name: Sleepstyle™ 200 Auto Series HC254 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 5, 2008 Received: September 5, 2008
Dear Mr. Thompson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Thompson
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Himmellindens for
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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SECTION 4 - Indications for Use Statement
510(k) Number:
Device Name: Sleepstyle™ 200 Auto Series HC254
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.
Prescription Use (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
N. Waly fn M. Husband
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Kb 8102 7 510(k) Number:
§ 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).