(310 days)
No
The summary describes a standard CPAP device with auto-adjusting capabilities and data connectivity, but there is no mention of AI or ML being used in the device's operation or data analysis.
Yes
The device is described as a flow generator intended to treat Obstructive Sleep Apnea (OSA) by delivering positive airway pressure to prevent airway collapse, which is a therapeutic function.
No.
The device is described as a flow generator that delivers positive airway pressure to treat Obstructive Sleep Apnoea, which is a therapeutic function, not a diagnostic one. While it collects therapy data, this data is for monitoring treatment progress, not for diagnosing the condition itself.
No
The device description clearly outlines hardware components such as a flow generator, humidifier, breathing tubes, water chamber, USB stick, integrated Bluetooth, and an integrated modem. While it includes software for data transfer and reporting, it is fundamentally a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the treatment of Obstructive Sleep Apnoea (OSA) by delivering positive airway pressure. It is a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on the mechanical function of delivering pressurized air and humidification to the patient's airway. It does not describe any components or processes that analyze biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Function: While the device collects therapy data, this data is used for monitoring therapy progress and potentially for self-assessment or by healthcare providers for managing treatment. It is not used to diagnose OSA itself. The diagnosis of OSA is typically made through other methods, such as a polysomnography (sleep study).
In vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. This device does not perform such examinations.
N/A
Intended Use / Indications for Use
The device is for use on adult patients for the treatment of Obstructive Sleep Apnoea (OSA). The device is for use in the home or sleep laboratory.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The F&P SleepStyle™ is a non-invasive, auto adjusting Continuous Positive Airway Pressure (CPAP) flow generator, incorporating a heated respiratory humidifier. The device is intended to treat Obstructive Sleep Apnea (OSA) by delivering a flow of positive airway pressure at a level prescribed by a physician to splint open the airway and prevent airway collapse.
The F&P SleepStyle™ system is comprised of the following devices/accessories:
- F&P SleepStyle™ models SPSAAN and SPSCAN: .
- . Breathing tubes:
- ThermoSmart™ heated breathing tube; o
- Standard breathing tube, i.e. non-heated, and elbow connector; O
- Water chamber and water chamber seal; .
- USB stick (F&P InfoUSB) .
The F&P SleepStyle™ system is available in two modes, fixed and auto-adjusting CPAP.
Similar to the predicate device, the SleepStyle™ works by pressurizing room air which is then transported to a patient interface. The delivery of positive air pressure to the patient holds the soft tissue in the throat open, preventing airway collapse and thus disruptions to the patient's breathing and sleep.
Humidified CPAP devices include a water chamber which holds water that is heating element in the CPAP device, thus adding water vapor to the gas prior to delivery to the patient. This is integrated into the device. The humidifier reduces nasal dryness and improves patient comfort.
An optional heated breathing tube (ThermoSmart) reduces condensation and improves humidity delivery to the patient.
The proposed device has integrated Bluetooth which allows therapy data to be sent to general wellness applications which can be used by patients for self-assessment and monitoring of therapy progress.
The proposed device also has an integrated modem which automatically uploads therapy data to the software reporting tool InfoSmart (K161686) managed by the healthcare provider. Alternatively data from the device can be stored onto a USB stick and uploaded to the software reporting tool InfoSmart (K161686).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Home or sleep laboratory
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 validation study, 50 patients, Fisher & Paykel Sleep Laboratory in New Zealand, following GCP guidelines.
To validate the device, for the treatment of OSA using APAP and CPAP modes with and without pressure relief technologies (expiratory relief and SensAwake).
Results obtained from non-clinical and clinical testing demonstrate that, SleepStyle™ is substantially equivalent to the predicate device F&P ICON (K094040).
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.
F&P ICON (K094040)
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.
InfoSmart (K161686), InfoGSM (K110316)
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
§ 868.5905 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below that.
August 8, 2018
Fisher & Paykel Healthcare Ltd Jayanti Karandikar Regulatory Affairs Specialist 15 Maurice Paykel Place East Tamaki, Auckland 2013 NZ
Re: K173193
Trade/Device Name: F&P SleepStyle TM Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: July 5, 2018 Received: July 9, 2018
Dear Jayanti Karandikar:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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. Le
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
2
Indications for Use
510(k) Number (if known)
Device Name
F&P SleepStyle™
Indications for Use (Describe)
The device is for use on adult patients for the treatment of Obstructive Sleep Apnoea (OSA). The device is for use in the home or sleep laboratory.
| 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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3
F&P SleepStyle- Traditional 510(k)
Image /page/3/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a larger, bold font on the top line. Below that, there is a horizontal line, and then the word "HEALTHCARE" is in a smaller, bold font.
510(k) Summary
| Contact person/submitter | Jayanti Karandikar |
|---|---|
| Date prepared | 04 Aug 2018 |
| Contact details | Address: 15 Maurice Paykel Place |
| East Tamaki | |
| Auckland 2013, New Zealand | |
| Telephone: +64 9 574 0100 | |
| Fax: +64 9 574 0158 | |
| Trade name | F&P SleepStyle™ |
| Classification name | Non Continuous Ventilator (IPPB) |
| Class II (21 CFR §868.5905) | |
| Product code BZD (Anaesthesiology) | |
| Predicate device | F&P ICON (K094040) |
Intended Use and Indications for Use
The device 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.
Device Description
The F&P SleepStyle™ is a non-invasive, auto adjusting Continuous Positive Airway Pressure (CPAP) flow generator, incorporating a heated respiratory humidifier. The device is intended to treat Obstructive Sleep Apnea (OSA) by delivering a flow of positive airway pressure at a level prescribed by a physician to splint open the airway and prevent airway collapse.
The F&P SleepStyle™ system is comprised of the following devices/accessories:
- F&P SleepStyle™ models SPSAAN and SPSCAN: .
- . Breathing tubes:
- ThermoSmart™ heated breathing tube; o
- Standard breathing tube, i.e. non-heated, and elbow connector; O
- Water chamber and water chamber seal; .
- USB stick (F&P InfoUSB) .
The F&P SleepStyle™ system is available in two modes, fixed and auto-adjusting CPAP.
Similar to the predicate device, the SleepStyle™ works by pressurizing room air which is then transported to a patient interface. The delivery of positive air pressure to the patient holds the soft tissue in the throat open, preventing airway collapse and thus disruptions to the patient's breathing and sleep.
4
Image /page/4/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, sans-serif font, with the "&" symbol connecting the two words. Below the company name is the word "HEALTHCARE" in a smaller, bold, sans-serif font. A horizontal line separates the company name from the word "HEALTHCARE".
Humidified CPAP devices include a water chamber which holds water that is heating element in the CPAP device, thus adding water vapor to the gas prior to delivery to the patient. This is integrated into the device. The humidifier reduces nasal dryness and improves patient comfort.
An optional heated breathing tube (ThermoSmart) reduces condensation and improves humidity delivery to the patient.
The proposed device has integrated Bluetooth which allows therapy data to be sent to general wellness applications which can be used by patients for self-assessment and monitoring of therapy progress.
The proposed device also has an integrated modem which automatically uploads therapy data to the software reporting tool InfoSmart (K161686) managed by the healthcare provider. Alternatively data from the device can be stored onto an USB stick and uploaded to the software reporting tool InfoSmart (K161686).
The following table outlines the features of the F&P SleepStyle™ models.
| Performance features | SleepStyle Auto CPAP
(SPSAAN) | SleepStyle CPAP
(SPSCAN) |
|-------------------------------|----------------------------------|-----------------------------|
| Fully integrated humidifier | ● | ● |
| Auto-adjusting pressure | ● | ● |
| ThermoSmart technology | ● | ● |
| SensAwake | ● | ● |
| Expiratory relief | ● | ● |
| Ramp | ● | ● |
| Auto-altitude adjustment | ● | ● |
| Leak compensation | ● | ● |
| Efficacy reporting | ● | ● |
| Compliance reporting | ● | ● |
| F&P InfoUSB | ● | ● |
| Bluetooth wireless technology | ● | ● |
5
F&P SleepStyle— Traditional 510(k)
Image /page/5/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a bold, dark blue font on the top line. Below that is a horizontal line, and below that is the word "HEALTHCARE" in a smaller, bold, dark blue font.
| Cellular modem | • | • |
|---|---|---|
| ---------------- | --- | --- |
Technological Characteristics Comparison
| Design /
technological
characteristic
for
comparison | Subject device
(F&P SleepStyleTM
CPAP) | Predicate device
(F&P ICON
SERIES CPAP,
K094040) | Comments | |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Intended Use and Indications for Use | Intended Use/
Indications
for use | The device 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 F&P ICON
Series CPAP 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. | Identical |
| Classification | Device
classification | II (868.5905) | II (868.5905) | Identical |
| | Product code | BZD | BZD | Identical |
| | Classification
panel | Anesthesiology | Anesthesiology | Identical |
| Pressure delivery | | | | |
| | Fixed CPAP | Yes | Yes | Identical feature offered |
| | Automatic
adjusting
pressure | Yes (Auto CPAP
model) | Yes (Auto CPAP
model) | Identical feature offered |
| Algorithm | | | | |
| | Automatic
adjusting
СРАР
algorithm | Yes | Yes | Modified algorithm - Refer
to §5.3.1 a) |
| | AHI
measurement
algorithm | Yes | Yes | Modified algorithm - Refer
to §5.3.1 b) |
| Design /
technological
characteristic
for
comparison | Subject device
(F&P SleepStyle™
CPAP) | Predicate device
(F&P ICON
SERIES CPAP,
K094040) | Comments | |
| Performance specifications | | | | |
| Pressure
range | 4 – 20 cmH2O | 4 – 20 cmH2O | Identical | |
| Humidity
output | ≥ 10 mg/L, as
required by ISO
8185 | ≥ 10 mg/L, as
required by ISO
8185 | Identical | |
| Features | | | | |
| Altitude
adjustment | 0 to 3000m (0 to
9000ft) | 0 to 3000m (0 to
9000ft) | Identical | |
| Leak
compensation | Yes | Yes | Identical feature offered | |
| Comfort features | | | | |
| Pressure
ramp | Up to 20 minutes | Up to 20 minutes | Identical feature offered | |
| Humidification | Yes | Yes | Similar feature with option of
7 comfort settings for both,
subject and predicate
device. | |
| SensAwake™ | Yes | Yes | Similar feature offered –
Refer to §5.3.1 c) | |
| Expiratory
Relief | Yes | No | New comfort feature – Refer
to §5.3.1 c) | |
| User interface | | | | |
| User controls | Buttons | Dial | Updated user interface –
Refer to §5.3.1 d) | |
| Menu | Text | Symbols | | |
| Reuse / sterilization / shelf life | | | | |
| Reuse | Multi-patient, multi-
use | Multi-patient, multi-
use | Similar.
The SleepStyle heated
breathing tube is not
intended for multi-patient
use | |
| Design /
technological
characteristic
for
comparison | Subject device
(F&P SleepStyle™
CPAP) | Predicate device
(F&P ICON
SERIES CPAP,
K094040) | Comments | |
| Sterility | Components
(including
accessories) are not
provided sterile or
intended to be
sterilized | Components
(including
accessories) are
not provided sterile
or intended to be
sterilized | Identical | |
| Cleaning | Single patient,
multi-use:
cleaning Multi-patient,
multi-use:
disinfection of
components in
the humidified air
path | Single patient,
multi-use:
cleaning Multi-patient,
multi-use:
disinfection of
components in
the humidified
air path | Similar types of cleaning
identified for single-patient,
multi-use and multi-patient,
multi-use - Refer to §5.3.1
e) | |
| Shelf Life | 2 years | Not defined | Shelf life defined for
SleepStyle accessories:
heated breathing tube,
standard breathing tube,
water chamber, inlet filter | |
| Data reporting | | | | |
| Data reporting
tool | InfoSmart
(K161686) | InfoSmart
(K094040) | Identical - Refer to §5.3.1 f) | |
| USB data stick | Yes | Yes | Similar function of data
storage and data transfer -
Refer to §5.3.1 g) | |
| Cellular
modem | Yes (built-in) | Yes (external -
InfoGSM,
K110316) | Similar function of data
transfer - Refer to §5.3.1 h) | |
| Bluetooth® | Yes | No | New feature - Refer to
§5.3.1 i) | |
| Accessories | | | | |
| Heated
breathing
tube | Available | Available | Identical accessory offered | |
| Non-heated
breathing
tube | Available | Available | Identical accessory offered | |
| Design /
technological
characteristic
for
comparison | Subject device
(F&P SleepStyle™
CPAP) | Predicate device
(F&P ICON
SERIES CPAP,
K094040) | Comments | |
| Water
chamber | Yes | Yes | Identical accessory type
offered; detachable lid seal
added - Refer to §5.3.1 j) | |
| Operating conditions | | | | |
| Temperature | 12 to 35° C
54 to 95° F | 5 to 35° C
41 to 95° F | Similar | |
| Humidity | 15 to 90% RH | 5 to 95%RH | | |
| Altitude | 0 to 3000m
0 to 9,000 ft | 0 to 3000m
0 to 9,000 ft | Identical | |
| Storage and Transport conditions | | | | |
| Temperature | -10 °C to 60 °C
14 to 140 °F | -10 °C to 60 °C
14 to 140 °F | Identical | |
| Humidity | 15 to 90% RH | Not specified | Humidity has been specified
for the SleepStyle device
storage conditions. | |
| Electrical ratings | | | | |
| Supply
voltage | 100-115 V | 100-115 V | Identical | |
| Current input | 1.2 A (2.5 A max.) | 1.27 A (1.43 A
max.) | Similar | |
| Supply
Frequency | 50-60 Hz | 50-60 Hz | Identical | |
6
F&P SleepStyle— Traditional 510(k)
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7
F&P SleepStyle— Traditional 510(k)
Image /page/7/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a bold, dark blue font on the top line. Below that is a horizontal line, and below that is the word "HEALTHCARE" in a bold, dark blue font.
8
F&P SleepStyle= Traditional 510(k)
Image /page/8/Picture/1 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a large, bold, blue font. Below that, the word "HEALTHCARE" is in a smaller, bold, blue font. There is a blue line separating the two lines of text.
Key Differences
The key differences between the subject device and predicate device, are that F&P SleepStyle™:
- a) Has a revised auto adjusting CPAP algorithm. The algorithm from the predicate device has been modified.
- b) Has a revised AHI measurement algorithm. Changes were made to the algorithm used in the predicate device.
- c) Has a revised SensAwake algorithm and new comfort feature expiratory relief. Changes were made to the SensAwake algorithm used in the predicate device. Expiratory relief reduces pressure delivered to the patient each time the patient exhales.
9
F&P SleepStyle= Traditional 510(k)
Image /page/9/Picture/1 description: The image contains the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are in a bold, dark blue font on the top line. Below that is a horizontal line, and below that is the word "HEALTHCARE" in a bold, dark blue font.
- d) Uses a modified user interface The SleepStyle™ device uses dedicated buttons for key features i.e. therapy on/off and a graphical display to display text.
- e) Has similar reprocessing instructions to the predicate device, with additional disinfection options. Performance and verification testing was conducted as per the recommendations of FDA quidance "Reprocessing Medical Devices in Health Care Settings: Validations Methods and Labelling." Similar to the predicate device, chemical disinfection for SleepStyle™ parts (excluding the heated breathing tube) can be performed using Cidex OPA.
The main differences are described below:
- The heated breathing tube used with the SleepStyle™ is for single-patient use only and . therefore is not intended for high level disinfection.
- Thermal disinfection of some SleepStyle™ parts can be carried out at 2 different . temperatures: 75°C for 30 min and 90°C for 1 min. Thermal disinfection of the predicate device was validated at 70°C for 30 min.
- f) Is compatible with InfoSmart, a software reporting tool. The client version of InfoSmart was cleared with the predicate device through 510K K094040. InfoSmart was recently cleared through K161686 to be able to work with compatible flow generators and incorporated the client and web versions. InfoSmart simply displays data as recorded by the compatible CPAP device. Introducing a new compatible device does not change the basic functionality of InfoSmart.
- g) Includes an USB stick which is used to store sleep data that is captured by the device during therapy. The data is transferred from the memory of the CPAP device when the USB stick is inserted into the device's USB port. The USB stick can then be sent to the healthcare provider to view/report on the data, and/or adjust therapy settings. Alternatively, the application in the stick can enable data to be uploaded via the internet to a remote server which can be accessed by the healthcare provider via a web based software called InfoSmart Web (K161686). The stick, in the predicate device, functions in a similar fashion to the stick above but does not have the software application to support web based data transfer.
- h) Includes an integrated modem as opposed to an external modem InfoGSM (K110316) which is compatible with the predicate F&P ICON (K094040). The purpose of the integrated modem within the proposed device is to enable data transfer via cellular network to a software reporting tool InfoSmart (K161686).
The external modem used with the predicate device performs a similar function.
- i) Includes integrated Bluetooth which enables data transfer by pairing the device with the mobile phone or tablet. This allows the user to view their data on the SleepStyle™ mobile application or the SleepStyle™ website.
- j) Includes a water chamber that has a detachable seal to allow easier cleaning, and filling of the water chamber. The predicate device has the chamber seal permanently attached to the chamber.
10
F&P SleepStyle= Traditional 510(k)
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Non-Clinical Performance Data
Non-clinical performance testing of the SleepStyle™ device was carried out covering mechanical. electrical and thermal safety, environmental conditions, electromagnetic compatibility and functional verification.
The SleepStyle™ device has been tested according to the following standards:
- ANSI/AAMI ES60601-1:2005 (R) 2012, A1:2012, C1:2009 (R) 2012 and A2:2010 (R) . 2012. Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance (FDA recognition number: 19-4)
- IEC 60601-1-2:2014. Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. (FDA recognition number:19-8)
- . IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- . IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- ISO 8185:2008 Respiratory tract humidifiers for medical use – Particular requirements for respiratory humidification systems. (FDA recognition number:1-86)
- . 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing within a Risk Management Process. (FDA recognition number: 2-220)
- . ISO 10993-3:2014. Biological Evaluation of Medical Devices -- Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity. (FDA recognition number: 2-228)
- . 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity. (FDA recognition number: 2-245)
- . ISO 10993-10:2010. Biological Evaluation of Medical Devices -- Part 10: Tests for Sensitization and Irritation. (FDA recognition number: 2-174)
- ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for systemic . toxicity (FDA recognition number:2-176)
- ISO 80601-2-70:2015 Medical Electrical Equipment - Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnea Breathing Therapy Equipment. (FDA recognition number: 1-115)
- . ISO 5356-1 Anaesthetic and Respiratory Equipment - Conical Connectors: Part 1: Cones and Sockets. (FDA recognition number: 1-62)
- . ISO 5367:2014 Anaesthetic and respiratory equipment - Breathing sets and connector
Functional Bench Testing:
The following functional testing was conducted on the SleepStyle device:
11
F&P SleepStyle- Traditional 510(k)
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- Static and Dynamic Pressure Accuracy ●
- . Flowrate at Maximum Pressure
- Max Pressure Single Fault
- Noise Verification
- . Water Chamber Spillage Test
- Transport, Storage, Drop testing ●
- . Altitude adjustment
- Pull test .
Biocompatibility:
The F&P SleepStyle™ is classified as an externally communicating device, tissue contact, permanent duration (>30 days). The humidified gas pathway components of the F&P SleepStyle™ device system were tested together as a full system. The testing of cytotoxicity, sensitization, intracutaneous reactivity, and acute systemic toxicity were conducted based on applicable ISO 10993 test standards. In addition, the chemical characterization study plus a toxicological risk assessment for the identified chemical extractables were conducted.
The testing of particulate matters and volatile organic compounds (VOCs) for both the humidified and dry gas path, and testing of carbon monoxide, carbon dioxide and ozone for the dry gas pathway were also performed.
Software:
The device software level of concern is moderate and software testing was done as per IEC 62304:2006 (Medical device software - Software life-cycle processes) and ISO 14971:2007 (Medical devices - Application of risk management to medical devices).
Clinical Performance Data
The clinical validation study, involving 50 patients, was conducted at the Fisher & Paykel Sleep Laboratory in New Zealand following GCP guidelines.
Clinical studies were carried out:
- . To validate the device, for the treatment of OSA using APAP and CPAP modes with and without pressure relief technologies (expiratory relief and SensAwake).
Conclusion
Results obtained from non-clinical and clinical testing demonstrate that, SleepStyle™ is substantially equivalent to the predicate device F&P ICON (K094040).