(134 days)
Not Found
No
The description mentions a microprocessor-controlled blower and automatic adjustments based on detected breathing events, but it does not explicitly mention or imply the use of AI or ML algorithms for these functions. The "Not Found" entries for mentions of AI/ML and descriptions of training/test sets further support this conclusion.
Yes.
The device delivers positive airway pressure for the treatment of Obstructive Sleep Apnea, which directly addresses a medical condition.
No
The device is described as a CPAP system for treating Obstructive Sleep Apnea, which is a therapeutic function, not a diagnostic one. While it can detect breathing events for automatic pressure adjustment, its primary purpose is treatment delivery.
No
The device description explicitly mentions a "microprocessor-controlled blower" and discusses hardware components like integrated Bluetooth and cellular technology, indicating it is a physical device with embedded software, not a software-only medical device. The performance studies also mention biocompatibility and electrical safety testing, which are relevant to hardware.
Based on the provided information, the DreamStation 2 CPAP/DreamStation 2 Auto CPAP system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device "delivers positive airway for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients". This describes a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details how the device provides positive airway pressure and adjusts it based on breathing events. This is a treatment mechanism, not a method for analyzing biological samples to diagnose a condition.
- Lack of IVD Indicators: The document 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 those samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
Therefore, the DreamStation 2 system is a therapeutic medical device used for treating a condition, not a diagnostic device used for identifying or characterizing a condition through in vitro analysis.
N/A
Intended Use / Indications for Use
The DreamStation 2 CPAP/DreamStation 2 Auto CPAP system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional environment.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The DreamStation 2 System uses a microprocessor-controlled blower to treat patients with Obstructive Sleep Apnea (OSA). There are 2 models: DreamStation 2 and DreamStation 2 Advanced. Both aforementioned models will be available in two therapy modes: CPAP only and Auto CPAP. With CPAP therapy, the device provides a continuous positive airway pressure throughout the entire therapy session. With Auto CPAP therapy, the device provides a positive airway pressure that automatically adjusts to the patient's needs as various breathing events are detected, such as apneas and hypopneas.
In addition to the therapy modes, the DreamStation 2 System provides several optional features to aid with patient comfort. These patient comfort features include: Ramp Plus, adjustable pressure relief (FLEX), EZ-Start, Opti-Start, and humidification (adaptive and adaptive with heated tube). Note: some of the features are only available in the DreamStation 2 Advanced model.
The DreamStation 2 device also features integrated Bluetooth and cellular technology for the transfer of patient management data between the therapy device and Respironics proprietary compliance software, Care Orchestrator.
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
patients weighing over 30 kg (66 lbs)
Intended User / Care Setting
home or hospital/institutional environment
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)
Non-Clinical Tests:
Performance Testing: Appropriate testing was completed on the DreamStation 2 System to address: all device requirements, any mitigations required per the risk assessment, to show substantial equivalence to the predicate(s), and lastly to provide reasonable assurance of safety and efficacy.
Software Testing: The DreamStation 2 software was developed following IEC 62304:2015, "Medical Device Software - Software Life Cycle Processess". Software verification and validation testing was performed on the DreamStation 2 System based on the product requirements. Testing was conducted and documentation has been provided, as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued May 2005. This software is considered to have a "Moderate" level of concern. The testing included system level testing to verify all required functionality of the DreamStation 2 System.
Biocompatibility Testing: The biocompatibility evaluation, for the DreamStation 2 System, was conducted in accordance with FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process",ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", and ISO 18562-1 "Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – Part 1: Evaluation and Testing within a Risk Management Process", as recognized by FDA. The DreamStation 2 System has proven to be biocompatible when tested in its final, finished, form to both ISO 10993-1:2018 and ISO 18562-1:2017.
General Safety, Electrical Safety and Electromagnetic Compatibility (EMC): General Safety, Electrical Safety, and Electromagnetic Compatibility testing was conducted on the DreamStation 2 System. The system complies with the following standards: AAMI/ANSI/ES 60601-1:2005/A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-1-11:2015, ISO 80601-2-61: 2011, ISO 80601-2-70: 2015, ISO 80601-2-74: 2017.
Human Factors/Usability: The DreamStation 2 System has been found to be safe and effective for the intended users, uses, and use environments. The Human Factors/Usability Engineering process, followed for the development of this device, aligns with IEC 62366-1: 2015. "Medical Devices - Part 1: Application of Usability Engineering to Medical Devices", and the latest applicable FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices", issued February 2016. Results of following this process, in particular the results of the human factors validation study, indicate that intended users can operate the device safely and effectively, and that residual risk associated with use of the device is acceptable.
Clinical Tests: Clinical tests were not required to demonstrate the safety and effectiveness of the DreamStation 2 System. Safety and efficacy of the DreamStation 2 System has been established via nonclinical tests.
Key results: Based upon the intended use, design, materials, function, side by side analysis with its predicates, and verification and validation testing, it is concluded that the DreamStation 2 System is substantially equivalent to the aforementioned predicate devices. The modifications between the DreamStation 2 System and its predicate devices do not raise any new questions regarding the safety and effectiveness.
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.
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.
Not Found
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 10, 2020
Respironics, Inc. Andy Zeltwanger Director, Regulatory Affairs 1740 Golden Mile Highway Monroeville, Pennsylvania 15146
Re: K200480
Trade/Device Name: DreamStation 2 System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: June 12, 2020 Received: June 12, 2020
Dear Andy Zeltwanger:
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,
for Michael Ryan 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200480
Device Name DreamStation 2 System
Indications for Use (Describe)
The DreamStation 2 CPAP/DreamStation 2 Auto CPAP system delivers positive airway for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional environment.
| 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
Section 5: 510(k) Summary
Pursuant to the requirements of 21 CFR Section 807.92(c), this 510(k) summary is being provided as part of the DreamStation 2 System 510(k) Premarket Notification.
Submitter
| 510(k) Owner | Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 |
|---------------------------------------|------------------------------------------------------------------------------------------------------|
| Official Correspondent | Andy Zeltwanger
Director, Regulatory Affairs
P: 724-579-6095
E: andy.zeltwanger@philips.com |
| Date of Preparation | 26 February 2020 |
| Device | |
| Proprietary/Trade Name: | DreamStation 2 System |
| Common/Usual Name: | CPAP System |
| Device Classification: | II |
| Classification Name/
Product Code: | Ventilator, Non-Continuous (Respirator), 21 CFR 868.5905
BZD |
| Primary Predicate Device: | REMSTAR AUTO A-FLEX HT (K131982) |
Secondary Predicate Device: REMSTAR SE (K130077)
Submission Reason: New Device
4
Device Description
The DreamStation 2 System uses a microprocessor-controlled blower to treat patients with Obstructive Sleep Apnea (OSA). There are 2 models:
- DreamStation 2
- . DreamStation 2 Advanced
Both aforementioned models will be available in two therapy modes: CPAP only and Auto CPAP. With CPAP therapy, the device provides a continuous positive airway pressure throughout the entire therapy session. With Auto CPAP therapy, the device provides a positive airway pressure that automatically adjusts to the patient's needs as various breathing events are detected, such as apneas and hypopneas.
In addition to the therapy modes, the DreamStation 2 System provides several optional features to aid with patient comfort. These patient comfort features include: Ramp Plus, adjustable pressure relief (FLEX), EZ-Start, Opti-Start, and humidification (adaptive and adaptive with heated tube). Note: some of the features are only available in the DreamStation 2 Advanced model.
The DreamStation 2 device also features integrated Bluetooth and cellular technology for the transfer of patient management data between the therapy device and Respironics proprietary compliance software, Care Orchestrator.
Indications for Use
The DreamStation 2 CPAP/DreamStation 2 Auto CPAP system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional environment.
5
Comparison of Technological Characteristics with the Predicate Device(s)
| Table 5-1. High-Level Comparison of DreamStation 2 Device to Primary and Secondary Predicates | ||
|---|---|---|
| Feature/Function | Device Predicate 1:
REMstar Auto A-
Flex HT (K131982) | Device Predicate 2:
REMstar SE
(K130077) | Subject Device:
DreamStation 2
CPAP/Auto CPAP | Subject Device:
DreamStation 2
Advanced
CPAP/Auto CPAP | Similarities and/or
Differences |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the treatment of | For the treatment of | For the treatment of | For the treatment of | Same. |
| | Obstructive Sleep | Obstructive Sleep | Obstructive Sleep | Obstructive Sleep | |
| | Apnea (OSA) | Apnea (OSA) | Apnea (OSA) | Apnea (OSA) | |
| Patient | Spontaneously | Spontaneously | Spontaneously | Spontaneously | Same. |
| Population (age, | breathing patients | breathing patients | breathing patients | breathing patients | |
| gender, etc.) | >30 kg (66 lbs) | >30 kg (66 lbs) | >30 kg (66 lbs) | >30 kg (66 lbs) | |
| Principle of | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Same. |
| Operation | controlled motor | controlled motor | controlled motor | controlled motor | |
| | blower design | blower design | blower design | blower design | |
| Product Specific | ISO 17510-1 | ISO 17510-1 | ISO 80601-2-70 | ISO 80601-2-70 | Same. |
| Performance | ISO 8185 | ISO 8185 | ISO 80601-2-74 | ISO 80601-2-74 | |
| Standards | | | Note: ISO 80601-2-70
has since replaced
ISO 17510-1 and ISO
80601-2-74 has since
replaced ISO 8185. | Note: ISO 80601-2-70
has since replaced
ISO 17510-1 and ISO
80601-2-74 has since
replaced ISO 8185. | |
| Therapy
Algorithm and
Flex Waveform
Comparison | Substantially
Equivalent Results | Not Available | Substantially
Equivalent Results | Substantially
Equivalent Results | Same. |
| Energy Delivered | Continuous Positive
Airway Pressure
(CPAP) | Continuous Positive
Airway Pressure
(CPAP) | Continuous Positive
Airway Pressure
(CPAP) | Continuous Positive
Airway Pressure
(CPAP) | Same. |
| Feature/Function | Device Predicate 1:
REMstar Auto A-
Flex HT (K131982) | Device Predicate 2:
REMstar SE
(K130077) | Subject Device:
DreamStation 2
CPAP/Auto CPAP | Subject Device:
DreamStation 2
Advanced
CPAP/Auto CPAP | Similarities and/or
Differences |
| Energy Source | External Switching
Power Supply
AC Power (Input):
100 – 240 VAC
DC Power (Output):
12 VDC | External Switching
Power Supply
AC Power (Input):
100 – 240 VAC
DC Power (Output):
12 VDC | External Switching
Power Supply
AC Power (Input):
100 – 240 VAC
DC Power (Output):
12 VDC
Battery Pack
Voltage Range
(Input): 11.0-14.4
VDC
Voltage Range
(Output): 11.0-15.0
VDC | External Switching
Power Supply
AC Power (Input):
100 – 240 VAC
DC Power (Output):
12 VDC
Battery Pack
Voltage Range
(Input): 11.0-14.4
VDC
Voltage Range
(Output): 11.0-15.0
VDC | Similar. Subject
device includes
additional power
source via a battery
pack. |
| Modes of
Operation | • CPAP
• Auto CPAP
o Split
Night with
Auto
CPAP
o Auto-Trial
o CPAP-
Check | • CPAP | • CPAP
• Auto CPAP | • CPAP
• Auto CPAP
o Auto-Trial
o CPAP-
Check | Similar. Varies
depending on model. |
| Pressure | 4 to 20 cm H2O | 4 to 20 cm H2O | 4 to 20 cm H2O | 4 to 20 cm H2O | Same. |
| Feature/Function | Device Predicate 1:
REMstar Auto A-
Flex HT (K131982) | Device Predicate 2:
REMstar SE
(K130077) | Subject Device:
DreamStation 2
CPAP/Auto CPAP | Subject Device:
DreamStation 2
Advanced
CPAP/Auto CPAP | Similarities and/or
Differences |
| Pressure
Accuracy (Static) | $\pm$ 0.5 cm H2O | $\pm$ 1.0 cm H2O | For 15mm and 22mm
tubing:
$\pm$ 0.5 cm H2O
For 12mm tubing:
$\pm$ 1.0 cm H2O for
12mm tubing. | For 15mm and 22mm
tubing:
$\pm$ 0.5 cm H2O
For 12mm tubing:
$\pm$ 1.0 cm H2O for
12mm tubing. | Same.
15mm is same as
Primary Predicate
(K131982).
12mm is same as
Secondary Predicate
(K130077). |
| Pressure
Accuracy
(Dynamic) | $\pm$ 1.0 cm H2O of the
pressure values
established during
verification of the
Static Pressure
accuracy | Device:
$\pm$ 2.0 cm H2O
Device w/ Humidifier
(22mm Tubing):
$\pm$ 2.0 cm H2O
Device w/ Humidifier
(15mm Tubing):
- 2.5 cm H2O | For 15mm and 22mm
tubing:
$\pm$ 1.0 cm H2O
For 12mm tubing:
$\pm$ 2.0 cm H2O | For 15mm and 22mm
tubing:
$\pm$ 1.0 cm H2O
For 12mm tubing:
$\pm$ 2.0 cm H2O | Same.
15mm is the same as
Primary Predicate
(K131982).
12mm the same
Secondary Predicate
(K130077). |
6
Section 5: 510(k) Summary
7
Section 5: 510(k) Summary
8
Section 5: 510(k) Summary
| Feature/Function | Tube Predicate:
REMstar Auto A-Flex HT
(K131982) | Subject Device:
15mm Heated Tube and 12mm
Heated Tube | Similarities and/or
Differences |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Intended Use | The heated tube is used, along
with the heated humidifier, to
control the provided
humidification. This is
accomplished by controlling the
temperature of the air in order to
ensure that it does not cool down
prior to reaching the mask. | The heated tube is used, along
with the heated humidifier, to
control the provided
humidification. This is
accomplished by controlling the
temperature of the air in order to
ensure that it does not cool down
prior to reaching the mask. | Same. |
| Target Patient
Population | Patients weighing more than 66
lb (30 kg) | Patients weighing more than 66
lb (30 kg) | Same. |
| Energy Used or
Delivered | Due to the wire resistance, heat is
dissipated through the wall of the
tube construction into the air
flow in the lumen of the tubing.
As a result, the air passing
through the tubing is warmed to
or above the dew point (of the air
existing the humidifier) reducing
or eliminating water
condensation and/or pooling of
water in the breathing circuit.
The raising of the gas
temperature does not exceed | Due to the wire resistance, heat is
dissipated through the wall of the
tube construction into the air
flow in the lumen of the tubing.
As a result, the air passing
through the tubing is warmed to
or above the dew point (of the air
existing the humidifier) reducing
or eliminating water
condensation and/or pooling of
water in the breathing circuit.
The raising of the gas
temperature does not exceed | Same. |
| Feature/Function | Tube Predicate:
REMstar Auto A-Flex HT
(K131982) | Subject Device:
15mm Heated Tube and 12mm
Heated Tube | Similarities and/or
Differences |
| | 41°C. | 41°C. | |
| Mode of Action | Applied voltage through heating wires | Applied voltage through heating wires | Same. |
| Power Source | Power supplied by attached therapy device | Power supplied by attached therapy device | Same. |
| Tube Diameter (inner) | 15 mm | 15mm and 12mm | Similar.
Modification:
Addition of 12mm
Tubing (Heated and
Non-Heated) |
Table 5-2. High-Level Comparison of Subject Heated Tube (15mm and 12mm) to Predicate Device
9
Section 5: 510(k) Summary
10
Performance Testing Data
Non-Clinical Tests
Performance Testing
Appropriate testing was completed on the DreamStation 2 System to address: all device requirements, any mitigations required per the risk assessment, to show substantial equivalence to the predicate(s), and lastly to provide reasonable assurance of safety and efficacy.
Software Testing
The DreamStation 2 software was developed following IEC 62304:2015, "Medical Device Software - Software Life Cycle Processess". Software verification and validation testing was performed on the DreamStation 2 System based on the product requirements. Testing was conducted and documentation has been provided, as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued May 2005.
This software is considered to have a "Moderate" level of concern, since prior to mitigation of hazards, a failure of the device could potentially result in minor injury to patient or user of the device. Additionally, a malfunction of, or a latent design flaw in the device, could lead to a delay of appropriate medical care that could potentially lead to a minor injury.
The testing included system level testing to verify all required functionality of the DreamStation 2 System.
Biocompatibility Testing
The biocompatibility evaluation, for the DreamStation 2 System, was conducted in accordance with FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process",ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", and ISO 18562-1 "Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – Part 1: Evaluation and Testing within a Risk Management Process", as recognized by FDA. The DreamStation 2 System has proven to be biocompatible when tested in its final, finished, form to both ISO 10993-1:2018 and ISO 18562-1:2017.
General Safety, Electrical Safety and Electromagnetic Compatibility (EMC)
General Safety, Electrical Safety, and Electromagnetic Compatibility testing was conducted on the DreamStation 2 System. The system complies with the following standards:
- AAMI/ANSI/ES 60601-1:2005/A1:2012
- IEC 60601-1-2:2014
- IEC 60601-1-6:2013
- IEC 60601-1-11:2015
- · ISO 80601-2-61: 2011
- ISO 80601-2-70: 2015
- ISO 80601-2-74: 2017
11
Human Factors/Usability
The DreamStation 2 System has been found to be safe and effective for the intended users, uses, and use environments. The Human Factors/Usability Engineering process, followed for the development of this device, aligns with IEC 62366-1: 2015. "Medical Devices - Part 1: Application of Usability Engineering to Medical Devices", and the latest applicable FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices", issued February 2016.
Results of following this process, in particular the results of the human factors validation study, indicate that intended users can operate the device safely and effectively, and that residual risk associated with use of the device is acceptable.
Clinical Tests
Clinical tests were not required to demonstrate the safety and effectiveness of the DreamStation 2 System. Safety and efficacy of the DreamStation 2 System has been established via nonclinical tests.
Substantial Equivalence Conclusion
Based upon the intended use, design, materials, function, side by side analysis with its predicates, and verification and validation testing, it is concluded that the DreamStation 2 System is substantially equivalent to the aforementioned predicate devices. The modifications between the DreamStation 2 System and its predicate devices do not raise any new questions regarding the safety and effectiveness.
This "510k Notification" demonstrates that the DreamStation 2 System is substantially equivalent to its predicate devices, which are currently marketed under the Federal Food, Drug, and Cosmetic Act.