(324 days)
No
The summary describes a standard CPAP device with a mobile app for control and data display. There is no mention of AI or ML algorithms for pressure adjustment, event detection, or any other function. The "AutoCPAP" mode likely refers to a traditional algorithm for pressure adjustment based on detected events, not an AI/ML approach.
Yes
The device is designed for the treatment of adult Obstructive Sleep Apnea (OSA) by generating continuous positive airway pressure, which directly addresses a medical condition.
No
This device is a CPAP system designed for the treatment of Obstructive Sleep Apnea, not for its diagnosis. While it mentions "Respiratory Event Detection" (consistent with its predicate), its primary function is to deliver positive airway pressure for therapy.
No
The device description clearly states it is a "microprocessor controlled, blower-based system that generates continuous positive airway pressure (CPAP)". This indicates the presence of hardware components beyond just software. While the LightTrip App is software, the Auto CPAP System itself is a hardware device with integrated software.
Based on the provided information, the Auto CPAP System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of adult Obstructive Sleep Apnea (OSA) by providing continuous positive airway pressure to the patient's airway. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a blower-based system that generates pressure. It does not analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the detection of specific analytes or markers.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Auto CPAP System's function is to deliver air pressure for therapeutic treatment.
N/A
Intended Use / Indications for Use
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.
Product codes
BZD
Device Description
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.
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
adult
Intended User / Care Setting
Home or hospital for patients. Healthcare professionals can remotely configure devices.
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)
Bench Testing:
- 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
- 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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Luna CPAP and Auto CPAP System (K153387), Menai System (K160836)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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
1
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
2
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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3
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 Wang |
| BMC 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) |
4
| Reason for Submission: | New Device |
|---|---|
| Indications for Use | 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. |
| Device Description | 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. |
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
5
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.
6
| Subject Device | Primary Predicate Device | Reference Device | ||
|---|---|---|---|---|
| Auto CPAP System | ||||
| (K211155) | Luna® CPAP and Auto | |||
| CPAP System | ||||
| (K153387) | Menai System | |||
| (K160836) | Comparison | |||
| Classification | ||||
| Device | ||||
| Classification | Class II Device | Class II Device | Class II Device | Identical to primary |
| predicate | ||||
| Product Code | BZD | BZD | BZD, MNR | Identical to primary |
| predicate | ||||
| Classification | ||||
| Panel | Anesthesiology | Anesthesiology | Anesthesiology | Identical to primary |
| predicate | ||||
| Regulation | ||||
| Number | 21 CFR 868.5905 | 21 CFR 868.5905 | 21 CFR 868.5905 | |
| 21 CFR 868.2375 | Identical to primary | |||
| predicate | ||||
| Regulation | ||||
| Name | Noncontinuous ventilator | Noncontinuous ventilator | Noncontinuous ventilator | Identical to primary |
| predicate | ||||
| Sterile | Non-sterile | Non-sterile | Non-sterile | Identical to primary |
| predicate | ||||
| Intended Use and Indications for Use | ||||
| Subject Device | Primary Predicate Device | Reference Device | ||
| Auto CPAP System | ||||
| (K211155) | Luna® CPAP and Auto | |||
| CPAP System | ||||
| (K153387) | Menai System | |||
| (K160836) | Comparison | |||
| Intended Use of | ||||
| the Device | 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. | The Luna CPAP and Auto | |||
| CPAP System are intended to | ||||
| deliver positive pressure for the | ||||
| treatment of Obstructive Sleep | ||||
| Apnea. The optional integrated | ||||
| heated humidifier is indicated | ||||
| for | ||||
| the | ||||
| humidification and warming of | ||||
| air from the flow generator. | ||||
| These devices are intended for | ||||
| single | ||||
| patient | ||||
| use | ||||
| by | ||||
| prescription in the home or | ||||
| hospital / institutional | ||||
| environment on adult patients. | The Menai self-adjusting | |||
| system is indicated for the | ||||
| treatment of Obstructive | ||||
| Sleep Apnea (OSA) in | ||||
| patients (female patients with | ||||
| mild to moderate OSA when | ||||
| using AfH treatment mode) | ||||
| weighing more than 66 lb (30 | ||||
| kg). It is intended for home | ||||
| and hospital use. | Similar to primary | |||
| predicate. | ||||
| Intended Use of | ||||
| the Software | ||||
| Application | 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. | N/A | Monte Carlo is a mobile | ||
| application for patients to | ||||
| remotely operate a prescribed | ||||
| compatible ResMed machine | ||||
| and transfer, analyze and | ||||
| display usage and therapeutic | ||||
| information. Monte Carlo also | ||||
| allows healthcare | ||||
| professionals to remotely | ||||
| configure compatible OSA | ||||
| therapy devices. | Similar to the | |||
| secondary predicate. | ||||
| Subject Device | Primary Predicate Device | Secondary Predicate Device | ||
| Auto CPAP System | ||||
| (K211155) | Luna® CPAP and Auto | |||
| CPAP System | ||||
| (K153387) | Menai System | |||
| (K160836) | Comparison | |||
| Pressure Delivery | ||||
| Therapy | ||||
| Delivered | CPAP, | |||
| AutoCPAP | CPAP, | |||
| AutoCPAP | CPAP, | |||
| AutoSet, | ||||
| AutoSet for Her (AfH) | Identical to primary | |||
| predicate | ||||
| Pressure Range | 4 to 20 cm H2O (in 0.5 cm | |||
| H2O increments), ≤30 cm | ||||
| H2O under single fault | ||||
| conditions | 4 to 20 cm H2O (in 0.5 cm | |||
| H2O increments), ≤ 30 cm | ||||
| H2O under single fault | ||||
| conditions | • 4-20 cm H2O (CPAP Mode) | |||
| • 4-20 cm H2O (AutoSet | ||||
| Mode) | ||||
| • 4-20 cm H2O (AutoSet AfH | ||||
| Mode) | ||||
| • EPR +3 cm H2O (all modes) | Identical to primary | |||
| predicate | ||||
| Pressure | ||||
| Display | ||||
| Accuracy (hPa) | ±(0.5 hPa+4%) | ±(0.5 hPa+4%) | ±0.5 hPa | Identical to primary |
| predicate | ||||
| Algorithm | ||||
| Automatic | ||||
| adjusting | ||||
| CPAP | ||||
| algorithm | Yes | Yes | Yes | Identical to primary |
| predicate | ||||
| Ramp | Yes, the ramp time ranges | |||
| from 0 to 60 minutes | Yes, the ramp time ranges | |||
| from 0 to 60 minutes | Yes, user selected as "Off" to | |||
| 45 minutes in 5 minute | ||||
| increments | Identical to primary | |||
| predicate | ||||
| Expiratory | ||||
| Pressure Relief | Yes, | |||
| Reslex® function | ||||
| Level 1-3 | Yes, | |||
| Reslex® function | ||||
| Level 1-3 | Yes, | |||
| EPR function | Identical to primary | |||
| predicate | ||||
| Respiratory | ||||
| Event | ||||
| Detection | OSA detection | |||
| Hypopnea detection | ||||
| Snore detection | OSA detection | |||
| Hypopnea detection | ||||
| Snore detection | OSA detection | |||
| Hypopnea detection | ||||
| Snore detection | Identical to primary | |||
| predicate | ||||
| Physical Characteristics | ||||
| Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison | |
| Auto CPAP System | ||||
| (K211155) | Luna® CPAP and Auto | |||
| CPAP System | ||||
| (K153387) | Menai System | |||
| (K160836) | ||||
| IEC 60601 | ||||
| Classification | Class II, Type BF | Class II, Type BF | Class II, Type BF | Identical to primary |
| predicate | ||||
| Degree of | ||||
| Protection | ||||
| Against Water | ||||
| Ingress | IP22 | IP22 | IP22 | Identical to primary |
| predicate | ||||
| Sound Pressure | ||||
| Level |