(324 days)
Auto CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only, either in the hospital or at home.
Auto CPAP System is for prescription use only. It is a travel CPAP device intended for single-patient use.
LightTrip App is a mobile application for patients to remotely operate BMC Mini serial devices, and transmit, store and display usage and treatment information. It can also receive parameters and device firmware upgrade data from the cloud, and then transmit these data to the device. The LightTrip app also allows healthcare professionals to remotely configure compatible OSA therapy devices. LightTrip App is for prescription use only.
Auto CPAP System is a microprocessor controlled, blower-based system that generates continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. The system provides fixed or auto-adjust pressure from 4 to 20 cmH2O above the ambient atmospheric pressure to a patient's oral/nasal airway.
The Auto CPAP System is designed and developed on the basis of the predicate device Luna CPAP and Auto CPAP System (K153387). The parameters and algorithms of the two devices, such as the treatment mode (CPAP and AutoCPAP), the pressure range (4 to 20 cm H2O), and the Respiratory Event Detection, are consistent. Compared with the predicate device, the subject device does not include a humidifier and an LCD screen. The parameters of subject device are displayed and set via the LightTrip App.
The provided document is a 510(k) summary for the BMC Medical Co., Ltd. Auto CPAP System. Unlike typical AI/ML device submissions, this document focuses on the substantial equivalence of a CPAP device to existing predicate devices, primarily through bench testing for various physical and electrical performance metrics. It does not describe a study involving an AI algorithm that diagnoses or assists in the diagnosis of a medical condition in the way that would typically involve acceptance criteria related to diagnostic performance.
Therefore, many of the requested elements for describing AI/ML device performance, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this specific submission.
The "Performance Data" section primarily details bench testing and standards compliance, which are the acceptance criteria for a device like a CPAP system.
Here's an interpretation of the provided document in the context of your request, noting where information is not applicable:
1. A table of acceptance criteria and the reported device performance
For a CPAP device, the acceptance criteria are generally defined by performance standards that ensure the device delivers therapy accurately and safely. The document states that "bench testing were conducted according to ISO 80601-2-70:2015" and lists specific tests. The implication is that the device met the requirements of these standards.
| Acceptance Criteria (Bench Tests) | Reported Device Performance (Implied by "were conducted according to ISO 80601-2-70:2015") |
|---|---|
| Maximum flow rate testing per ISO 80601-2-70:2015 | Met ISO 80601-2-70:2015 requirements |
| Static pressure testing per ISO 80601-2-70:2015 | Met ISO 80601-2-70:2015 requirements |
| Dynamic pressure testing per ISO 80601-2-70:2015 | Met ISO 80601-2-70:2015 requirements |
| Sound pressure level testing per ISO 80601-2-70:2015 | Met ISO 80601-2-70:2015 requirements (< 30 dB, when the device is working at the pressure of 10 hPa, identical to predicate) |
| Display accuracy testing per ISO 80601-2-70:2015 | Met ISO 80601-2-70:2015 requirements (±(0.5 hPa+4%) for pressure display accuracy, identical to predicate) |
| Biocompatibility Assessment per ISO 10993 series and FDA guidance | Met relevant standards |
| Electrical Safety per AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-70 | Met relevant standards |
| Software Verification and Validation per FDA Guidance | Met relevant FDA guidance |
| Mechanical Testing (Shock, Vibration, etc.) | Tests showed no new safety or effectiveness questions |
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 "test set" here refers to the device itself being subjected to bench tests, not a dataset for an AI algorithm. Therefore, there is no sample size of patients or images, nor data provenance in the context of an AI study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for CPAP device performance is established by recognized engineering and medical device standards (e.g., ISO 80601-2-70). It does not involve expert interpretation of clinical data in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of clinical data, which is not part of this device's performance evaluation.
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. This device is an Auto CPAP System, a therapy device, not an AI diagnostic tool intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This application is for an Auto CPAP System, which is a therapeutic device that delivers continuous positive airway pressure. While it contains algorithms for automatic pressure adjustment and respiratory event detection, these algorithms are integral to the device's function and are not presented as a standalone diagnostic tool. The performance of these internal algorithms is validated through the general device bench testing (e.g., "Dynamic pressure testing," "Algorithm" section, which states it utilizes the "same algorithm as the primary predicate device").
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is adherence to established international and national medical device standards (e.g., ISO 80601-2-70, IEC 60601 series) for safety and essential performance, as well as demonstrating equivalence to the predicate device's established performance characteristics (e.g., pressure delivery accuracy, sound levels).
8. The sample size for the training set
Not applicable. This device is not an AI/ML diagnostic system that reports on training data. The algorithms within the CPAP device (e.g., for auto-adjusting pressure, respiratory event detection) are stated to be the "same algorithm as the primary predicate device," implying they were previously developed and validated, not newly trained for this submission.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a new training set for AI/ML development in this submission. The algorithms are inherited from a predicate device.
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Image /page/0/Picture/0 description: The image shows 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 square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 9, 2022
BMC Medical Co., Ltd. Amy Wang RA Room 901, Building 1, No. 28 Pingguoyuan Road Beijing, Shijingshan 100041 China
Re: K211155
Trade/Device Name: Auto CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: February 7, 2022 Received: February 7, 2022
Dear Amy Wang:
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
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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); 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 (QS) 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 medical devices and radiation-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,
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K21155
Device Name Auto CPAP System
Indications for Use (Describe)
Auto CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only, either in the hospital or at home.
Auto CPAP System is for prescription use only. It is a travel CPAP device intended for single-patient use.
LightTrip App is a mobile application for patients to remotely operate BMC Mini serial devices, and transmit, store and display usage and treatment information. It can also receive parameters and device firmware upgrade data from the cloud, and then transmit these data to the device. The LightTrip app also allows healthcare professionals to remotely configure compatible OSA therapy devices. LightTrip App is for prescription use only.
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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510(k) Summary
| Device Trade Name | Auto CPAP System |
|---|---|
| Model | M1 Mini |
| Common/Usual Name | Auto CPAP System |
| Date Prepared | March 8, 2022 |
| Sponsor Identification | BMC Medical Co., Ltd.Room 901, Building 1, No.28 Pingguoyuan Road,Shijingshan, Beijing 100041, CHINA |
| Submission Correspondent | Amy WangBMC Medical Co., Ltd.Room 901, Building 1, No.28 Pingguoyuan Road,Shijingshan, Beijing 100041, CHINA |
| Phone | 86-18701556244 |
| Fax | 86-22-82939881 |
| wangliping@bmc-medical.com | |
| Establishment Registration # | 3008566132 |
| Classification | BMC Medical Co., Ltd.Room 901, Building 1, No.28 Pingguoyuan Road,Shijingshan, Beijing 100041, CHINA |
| Classification | Class II Device (21 CFR 868.5905) |
| Classification Name | Noncontinuous ventilator |
| Classification Panel | Medical Device |
| Products Code | BZD |
| Medical Specialties | Anesthesiology |
| Predicate Device(s) | Luna CPAP and Auto CPAP System (K153387) |
| Menai System (K160836) |
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| Reason for Submission: | New Device |
|---|---|
| Indications for Use | Auto CPAP System is a CPAP (ContinuousPositive Airway Pressure) device designed for the treatmentof adult Obstructive Sleep Apnea (OSA) only, either in thehospital or at home.Auto CPAP System is for prescription use only. It is a travelCPAP device intended for single-patient use.LightTrip App is a mobile application for patients toremotely operate BMC Mini serial devices, and transmit,store and display usage and treatment information. It can alsoreceive parameters and device firmware upgrade data fromthe cloud, and then transmit these data to the device. TheLightTrip app also allows healthcare professionals toremotely configure compatible OSA therapy devices.LightTrip App is for prescription use only. |
| Device Description | Auto CPAP System is a microprocessor controlled,blower-based system that generates continuous positiveairway pressure (CPAP) to support treatment of obstructivesleep apnea. The system provides fixed or auto-adjustpressure from 4 to 20 cmH2O above the ambient atmosphericpressure to a patient's oral/nasal airway.The Auto CPAP System is designed and developed on thebasis of the predicate device Luna CPAP and Auto CPAPSystem (K153387). The parameters and algorithms of thetwo devices, such as the treatment mode (CPAP andAutoCPAP), the pressure range (4 to 20 cm H2O), and theRespiratory Event Detection, are consistent. Compared withthe predicate device, the subject device does not include ahumidifier and an LCD screen. The parameters of subjectdevice are displayed and set via the LightTrip App. |
Substantial Equivalence:
The subject and predicate devices have the following similarities:
- Same Indications for Use ●
- Similar operating principle ●
- Similar technologies
Auto CPAP System retains similar functionality and performance features of the primary predicate device Luna CPAP and Auto CPAP System (K153387). It utilizes the same algorithm as the primary predicate device Luna CPAP and Auto CPAP System (K153387) for respiratory event detection and therapy for sleep disordered breathing events. The subject device and the primary
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predicate device share the similar intended use, similar operating principal, and are manufactured and packaged with similar processes.
Compared with the primary predicate device, the subject device makes the following main modifications:
- By removing the humidifier, the subject device is provided in a portable smaller footprint than the predicate for user convenience, especially for using on an aircraft or in travel. Choosing a mask with a humidifier component can improve the moisture level in the breathing air and offer relief from possible dryness.
- The subject device includes a Bluetooth module, which enables the device to be connected with the LightTrip App on the smartphone.
- LightTrip App is a mobile application of Auto CPAP System. The patient and the health care professional can set parameters of the device via this application. Patients can set the comfort settings, turn the device on and off using the LightTrip App. However, only health care professional is able to remotely change the prescription settings. The device can upload the running data to LightTrip App where they can be displayed, stored and uploaded to the cloud platform. LightTrip App can also obtain the remote parameter setting of the cloud platform and realize the on-line firmware upgrade of the device.
The substantial equivalence comparison is provided below.
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| Subject Device | Primary Predicate Device | Reference Device | ||
|---|---|---|---|---|
| Auto CPAP System(K211155) | Luna® CPAP and AutoCPAP System(K153387) | Menai System(K160836) | Comparison | |
| Classification | ||||
| DeviceClassification | Class II Device | Class II Device | Class II Device | Identical to primarypredicate |
| Product Code | BZD | BZD | BZD, MNR | Identical to primarypredicate |
| ClassificationPanel | Anesthesiology | Anesthesiology | Anesthesiology | Identical to primarypredicate |
| RegulationNumber | 21 CFR 868.5905 | 21 CFR 868.5905 | 21 CFR 868.590521 CFR 868.2375 | Identical to primarypredicate |
| RegulationName | Noncontinuous ventilator | Noncontinuous ventilator | Noncontinuous ventilator | Identical to primarypredicate |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Identical to primarypredicate |
| Intended Use and Indications for Use | ||||
| Subject Device | Primary Predicate Device | Reference Device | ||
| Auto CPAP System(K211155) | Luna® CPAP and AutoCPAP System(K153387) | Menai System(K160836) | Comparison | |
| Intended Use ofthe Device | Auto CPAP System is aCPAP(ContinuousPositive Airway Pressure)device designed for thetreatmentofadultObstructive Sleep Apnea(OSA) only, either in thehospital or at home.Auto CPAP System is forprescription use only. It is atravelCPAPdeviceintended for single-patientuse. | The Luna CPAP and AutoCPAP System are intended todeliver positive pressure for thetreatment of Obstructive SleepApnea. The optional integratedheated humidifier is indicatedforthehumidification and warming ofair from the flow generator.These devices are intended forsinglepatientusebyprescription in the home orhospital / institutionalenvironment on adult patients. | The Menai self-adjustingsystem is indicated for thetreatment of ObstructiveSleep Apnea (OSA) inpatients (female patients withmild to moderate OSA whenusing AfH treatment mode)weighing more than 66 lb (30kg). It is intended for homeand hospital use. | Similar to primarypredicate. |
| Intended Use ofthe SoftwareApplication | LightTrip App is a mobileapplication for patients toremotely operate BMCMini serial devices, andtransmit, store and displayusage and treatmentinformation. It can alsoreceive parameters anddevice firmware upgradedata from the cloud, andthen transmit these data tothe device. The LightTripapp also allows healthcareprofessionals to remotelyconfigure compatible OSAtherapy devices.LightTrip App is forprescription use only. | N/A | Monte Carlo is a mobileapplication for patients toremotely operate a prescribedcompatible ResMed machineand transfer, analyze anddisplay usage and therapeuticinformation. Monte Carlo alsoallows healthcareprofessionals to remotelyconfigure compatible OSAtherapy devices. | Similar to thesecondary predicate. |
| Subject Device | Primary Predicate Device | Secondary Predicate Device | ||
| Auto CPAP System(K211155) | Luna® CPAP and AutoCPAP System(K153387) | Menai System(K160836) | Comparison | |
| Pressure Delivery | ||||
| TherapyDelivered | CPAP,AutoCPAP | CPAP,AutoCPAP | CPAP,AutoSet,AutoSet for Her (AfH) | Identical to primarypredicate |
| Pressure Range | 4 to 20 cm H2O (in 0.5 cmH2O increments), ≤30 cmH2O under single faultconditions | 4 to 20 cm H2O (in 0.5 cmH2O increments), ≤ 30 cmH2O under single faultconditions | • 4-20 cm H2O (CPAP Mode)• 4-20 cm H2O (AutoSetMode)• 4-20 cm H2O (AutoSet AfHMode)• EPR +3 cm H2O (all modes) | Identical to primarypredicate |
| PressureDisplayAccuracy (hPa) | ±(0.5 hPa+4%) | ±(0.5 hPa+4%) | ±0.5 hPa | Identical to primarypredicate |
| Algorithm | ||||
| AutomaticadjustingCPAPalgorithm | Yes | Yes | Yes | Identical to primarypredicate |
| Ramp | Yes, the ramp time rangesfrom 0 to 60 minutes | Yes, the ramp time rangesfrom 0 to 60 minutes | Yes, user selected as "Off" to45 minutes in 5 minuteincrements | Identical to primarypredicate |
| ExpiratoryPressure Relief | Yes,Reslex® functionLevel 1-3 | Yes,Reslex® functionLevel 1-3 | Yes,EPR function | Identical to primarypredicate |
| RespiratoryEventDetection | OSA detectionHypopnea detectionSnore detection | OSA detectionHypopnea detectionSnore detection | OSA detectionHypopnea detectionSnore detection | Identical to primarypredicate |
| Physical Characteristics | ||||
| Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison | |
| Auto CPAP System(K211155) | Luna® CPAP and AutoCPAP System(K153387) | Menai System(K160836) | ||
| IEC 60601Classification | Class II, Type BF | Class II, Type BF | Class II, Type BF | Identical to primarypredicate |
| Degree ofProtectionAgainst WaterIngress | IP22 | IP22 | IP22 | Identical to primarypredicate |
| Sound PressureLevel | < 30 dB, when the device isworking at the pressure of 10hPa. | < 30 dB, when the device isworking at the pressure of 10hPa. | Air tubing connected toAirMini F20 connector withmask: 19 dBA with uncertaintyof 3 dBA;Air tubing connected toAirMini N20 or P10 connectorswith mask: 15 dBAwith uncertainty of 3 dBA | Identical to primarypredicate |
| Air Filter | Yes | Yes | Yes | Identical to primarypredicate |
| Non-heatedTubing | Yes | Yes | Yes | Identical to primarypredicate |
| Humidifier | No | Yes | No | Identicaltosecondary predicatedevice. Choosing theappropriatemaskwithhumidificationcomponentcanimprove the moisturelevel in the breathingair and offer relieffrompossibledryness |
| Subject Device | Primary Predicate Device | Secondary Predicate Device | ||
| Auto CPAP System(K211155) | Luna® CPAP and AutoCPAP System(K153387) | Menai System(K160836) | Comparison | |
| Data Reporting | ||||
| WirelessFunction | Bluetooth | N/A | Bluetooth | Identical tosecondary predicatedevice |
| ParametersTransferred bythe Mobile App | Usage and treatment data | N/A | Usage and therapeutic data | Identical tosecondary predicatedevice |
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Performance Data:
The following performance data were used in support of the substantial equivalence determination.
Bench Testing:
To demonstrate that the performance of the substantially equivalent to the predicate device, the following bench testing were conducted according to ISO 80601-2-70:2015:
- Maximum flow rate testing
- Static pressure testing .
- Dynamic pressure testing ●
- Sound pressure level testing .
- Display accuracy testing .
Biocompatibility Assessment:
Evaluation and testing of biocompatibility were conducted in accordance with the following standards and guidance documents:
- · ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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• FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016
• ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- · ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process
- ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 2: Tests for emissions of particulate matter
• ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic compounds (VOCs)
• ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate
Electrical Safety and Electromagnetic Compatibility:
Electrical safety and EMC testing were conducted on the subject device Auto CPAP System. The following standards for electrical safety and EMC:
• AAMI/ANSI ES 60601-1:2005/(R) 2012 And A1:2012. Medical Electrical Equipment - Part 1: General Requirements for Basic Safety And Essential Performance
· IEC 60601-1-2:2014 Medical electrical equipments for basic safety and essential performance -
-
Collateral standard: Electromagnetic disturbances Requirements and tests
• 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
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- ISO 80601-2-70:2015 Medical electrical equipments for basic safety and essential performance of sleep apnoea breathing therapy equipment
Software Verification and Validation:
Software verification and validation testing were conducted and documentation was 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"
- · "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
- · "Guidance-Radio Frequency Wireless Technology in Medical Devices"
Mechanical Testing:
Mechanical Shock Test, Sine Vibration, etc. were conducted on the tests show that there is no new safety or effectiveness question.
Conclusion
Auto CPAP System has similar intended use as the predicate device. The technological characteristics between the subject device and predicate device do not raise new/different questions of safety or effectiveness. Thus, the is substantially equivalent to the predicate device.
§ 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).