(134 days)
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.
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.
This document describes the 510(k) premarket notification for the DreamStation 2 System, a noncontinuous ventilator (CPAP system) for treating Obstructive Sleep Apnea. It does not contain information about a study proving the device meets acceptance criteria from clinical trials involving human subjects, nor does it provide a table of acceptance criteria and reported device performance from such a study.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing, software testing, biocompatibility testing, general safety and electrical compatibility testing, and human factors/usability testing.
Therefore, I cannot fulfill the request for information regarding clinical acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, or training set specifics, as this information is not present in the provided text.
The document explicitly states: "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."
The only "acceptance criteria" presented are related to technical specifications (e.g., pressure accuracy) and compliance with various international standards, which is then demonstrated through the completion of non-clinical testing.
Here's a breakdown of what is available in the document regarding performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparison of technical characteristics between the DreamStation 2 System and its predicate devices in Table 5-1 (pages 5-6) and Table 5-2 (page 8). While it doesn't explicitly state "acceptance criteria" for clinical outcomes, it does list performance specifications for pressure accuracy and notes whether the subject device's performance is "Same" or "Similar" to the predicates.
| Feature/Function | Predicate 1 (K131982) Performance | Predicate 2 (K130077) Performance | Subject Device DreamStation 2 CPAP/Auto CPAP Performance | Acceptance Criteria (Implied by Substantial Equivalence to Predicates) |
|---|---|---|---|---|
| Pressure Accuracy (Static) | ||||
| 15mm/22mm Tubing | $\pm$ 0.5 cm H2O | N/A | $\pm$ 0.5 cm H2O | Match Predicate 1: $\pm$ 0.5 cm H2O |
| 12mm Tubing | N/A | $\pm$ 1.0 cm H2O | $\pm$ 1.0 cm H2O | Match Predicate 2: $\pm$ 1.0 cm H2O |
| Pressure Accuracy (Dynamic) | ||||
| 15mm/22mm Tubing | $\pm$ 1.0 cm H2O (of established static pressure values) | N/A | $\pm$ 1.0 cm H2O | Match Predicate 1: $\pm$ 1.0 cm H2O |
| 12mm Tubing | N/A | Device: $\pm$ 2.0 cm H2O, Device w/ Humidifier (15mm/22mm Tubing): $\pm$ 2.0 cm H2O / $\pm$ 2.5 cm H2O | $\pm$ 2.0 cm H2O | Match Predicate 2: $\pm$ 2.0 cm H2O |
Note: The "Acceptance Criteria" column is inferred from the document's claim of "Same" or "Similar" performance to the predicates, which is the basis for substantial equivalence. The document does not specify exact acceptance criteria values for new features, but rather demonstrates that the new device meets or exceeds the performance of existing legally marketed predicate devices for similar functionality.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The document explicitly states that clinical tests were not required. The testing performed was non-clinical. Therefore, no "test set" of patient data or data provenance information is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical "test set" was used, there was no need for experts to establish ground truth in a clinical context. Product requirement and specification experts within the company would have been involved in defining the non-clinical testing parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This refers to clinical data adjudication, which was not performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. No MRMC study involving human readers or AI assistance was performed or described. This device is a CPAP system, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This refers to AI algorithm performance. The DreamStation 2 System is a hardware device for delivering airway pressure, not primarily an AI algorithm. Its software is for controlling the device and managing patient data, not for making diagnostic or treatment recommendations independently in an "algorithm only" sense beyond its intended function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable (for clinical ground truth). For the non-clinical and software testing, the "ground truth" would be the device's technical specifications, design requirements, and adherence to recognized international standards (e.g., ISO, IEC).
8. The sample size for the training set:
- Not Applicable. No clinical training set was used or described.
9. How the ground truth for the training set was established:
- Not Applicable. No clinical training set was used or described.
Summary of the Study that Proves the Device Meets the (Non-Clinical) Acceptance Criteria:
The DreamStation 2 System demonstrated that it meets acceptance criteria through a series of non-clinical performance tests which include:
- Performance Testing: To address device requirements, risk mitigations, show substantial equivalence, and assure safety and efficacy. (Details not provided in terms of specific tests, but performance characteristics like pressure accuracy are compared to predicates).
- Software Testing: Developed according to IEC 62304:2015 ("Medical Device Software - Software Life Cycle Processes"). Software verification and validation were performed based on product requirements, following FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was deemed to have a "Moderate" level of concern.
- Biocompatibility Testing: Conducted in accordance with FDA Guidance and international standards ISO 10993-1:2018 and ISO 18562-1:2017, proving the device to be biocompatible.
- General Safety, Electrical Safety, and Electromagnetic Compatibility (EMC) Testing: The system complies with 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, and ISO 80601-2-74: 2017.
- Human Factors/Usability Testing: Aligned with IEC 62366-1: 2015 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." A human factors validation study indicated safe and effective operation by intended users with acceptable residual risk.
The conclusion drawn from these non-clinical tests is that the DreamStation 2 System is substantially equivalent to its predicate devices, and that modifications do not raise new questions of safety and effectiveness. Clinical tests were not deemed necessary.
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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
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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
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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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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 LaneMurrysville, PA 15668 |
|---|---|
| Official Correspondent | Andy ZeltwangerDirector, Regulatory AffairsP: 724-579-6095E: 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 868.5905BZD |
| Primary Predicate Device: | REMSTAR AUTO A-FLEX HT (K131982) |
Secondary Predicate Device: REMSTAR SE (K130077)
Submission Reason: New Device
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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.
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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 2CPAP/Auto CPAP | Subject Device:DreamStation 2AdvancedCPAP/Auto CPAP | Similarities and/orDifferences |
|---|---|---|---|---|---|
| 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 80601-2-70has since replacedISO 17510-1 and ISO80601-2-74 has sincereplaced ISO 8185. | Note: ISO 80601-2-70has since replacedISO 17510-1 and ISO80601-2-74 has sincereplaced ISO 8185. | |||
| TherapyAlgorithm andFlex WaveformComparison | SubstantiallyEquivalent Results | Not Available | SubstantiallyEquivalent Results | SubstantiallyEquivalent Results | Same. |
| Energy Delivered | Continuous PositiveAirway Pressure(CPAP) | Continuous PositiveAirway Pressure(CPAP) | Continuous PositiveAirway Pressure(CPAP) | Continuous PositiveAirway Pressure(CPAP) | Same. |
| Feature/Function | Device Predicate 1:REMstar Auto A-Flex HT (K131982) | Device Predicate 2:REMstar SE(K130077) | Subject Device:DreamStation 2CPAP/Auto CPAP | Subject Device:DreamStation 2AdvancedCPAP/Auto CPAP | Similarities and/orDifferences |
| Energy Source | External SwitchingPower SupplyAC Power (Input):100 – 240 VACDC Power (Output):12 VDC | External SwitchingPower SupplyAC Power (Input):100 – 240 VACDC Power (Output):12 VDC | External SwitchingPower SupplyAC Power (Input):100 – 240 VACDC Power (Output):12 VDCBattery PackVoltage Range(Input): 11.0-14.4VDCVoltage Range(Output): 11.0-15.0VDC | External SwitchingPower SupplyAC Power (Input):100 – 240 VACDC Power (Output):12 VDCBattery PackVoltage Range(Input): 11.0-14.4VDCVoltage Range(Output): 11.0-15.0VDC | Similar. Subjectdevice includesadditional powersource via a batterypack. |
| Modes ofOperation | • CPAP• Auto CPAPo SplitNight withAutoCPAPo Auto-Trialo CPAP-Check | • CPAP | • CPAP• Auto CPAP | • CPAP• Auto CPAPo Auto-Trialo CPAP-Check | Similar. Variesdepending 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 2CPAP/Auto CPAP | Subject Device:DreamStation 2AdvancedCPAP/Auto CPAP | Similarities and/orDifferences |
| PressureAccuracy (Static) | $\pm$ 0.5 cm H2O | $\pm$ 1.0 cm H2O | For 15mm and 22mmtubing:$\pm$ 0.5 cm H2OFor 12mm tubing:$\pm$ 1.0 cm H2O for12mm tubing. | For 15mm and 22mmtubing:$\pm$ 0.5 cm H2OFor 12mm tubing:$\pm$ 1.0 cm H2O for12mm tubing. | Same.15mm is same asPrimary Predicate(K131982).12mm is same asSecondary Predicate(K130077). |
| PressureAccuracy(Dynamic) | $\pm$ 1.0 cm H2O of thepressure valuesestablished duringverification of theStatic Pressureaccuracy | Device:$\pm$ 2.0 cm H2ODevice w/ Humidifier(22mm Tubing):$\pm$ 2.0 cm H2ODevice w/ Humidifier(15mm Tubing):+ 2.5 cm H2O | For 15mm and 22mmtubing:$\pm$ 1.0 cm H2OFor 12mm tubing:$\pm$ 2.0 cm H2O | For 15mm and 22mmtubing:$\pm$ 1.0 cm H2OFor 12mm tubing:$\pm$ 2.0 cm H2O | Same.15mm is the same asPrimary Predicate(K131982).12mm the sameSecondary Predicate(K130077). |
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Section 5: 510(k) Summary
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Section 5: 510(k) Summary
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Section 5: 510(k) Summary
| Feature/Function | Tube Predicate:REMstar Auto A-Flex HT(K131982) | Subject Device:15mm Heated Tube and 12mmHeated Tube | Similarities and/orDifferences |
|---|---|---|---|
| Intended Use | The heated tube is used, alongwith the heated humidifier, tocontrol the providedhumidification. This isaccomplished by controlling thetemperature of the air in order toensure that it does not cool downprior to reaching the mask. | The heated tube is used, alongwith the heated humidifier, tocontrol the providedhumidification. This isaccomplished by controlling thetemperature of the air in order toensure that it does not cool downprior to reaching the mask. | Same. |
| Target PatientPopulation | Patients weighing more than 66lb (30 kg) | Patients weighing more than 66lb (30 kg) | Same. |
| Energy Used orDelivered | Due to the wire resistance, heat isdissipated through the wall of thetube construction into the airflow in the lumen of the tubing.As a result, the air passingthrough the tubing is warmed toor above the dew point (of the airexisting the humidifier) reducingor eliminating watercondensation and/or pooling ofwater in the breathing circuit.The raising of the gastemperature does not exceed | Due to the wire resistance, heat isdissipated through the wall of thetube construction into the airflow in the lumen of the tubing.As a result, the air passingthrough the tubing is warmed toor above the dew point (of the airexisting the humidifier) reducingor eliminating watercondensation and/or pooling ofwater in the breathing circuit.The raising of the gastemperature does not exceed | Same. |
| Feature/Function | Tube Predicate:REMstar Auto A-Flex HT(K131982) | Subject Device:15mm Heated Tube and 12mmHeated Tube | Similarities and/orDifferences |
| 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 12mmTubing (Heated andNon-Heated) |
Table 5-2. High-Level Comparison of Subject Heated Tube (15mm and 12mm) to Predicate Device
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Section 5: 510(k) Summary
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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
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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.
§ 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).