Who is the manufacturer of BPAP System?

BMC Medical Co., Ltd. filed the 510(k) submission for BPAP System (K213169).

What is the FDA product code for BPAP System?

MNS. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for BPAP System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BPAP System?

Juno VPAP ST-A (K153061); Luna®G3 BPAP 25A (K201620).

Who can help prepare an FDA 510(k) submission like BPAP System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BPAP System

K213169 · BMC Medical Co., Ltd. · MNS · Dec 5, 2022 · Anesthesiology

Device Facts

Record ID	K213169
Device Name	BPAP System
Applicant	BMC Medical Co., Ltd.
Product Code	MNS · Anesthesiology
Decision Date	Dec 5, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide noninvasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment.

Device Story

BPAP System delivers positive airway pressure to splint airways and prevent collapse; treats OSA and respiratory insufficiency. Inputs: patient breathing signals; device transforms inputs via therapy modes (CPAP, S, T, S/T, Auto CPAP, Auto S) and pressure ranges (4-30 cm H2O). Outputs: pressurized air, humidified via integrated humidifier; audio/visual alarms for abnormal conditions. Used in home or hospital; operated by patient or clinician. Includes cellular module, SD card for data transfer, and iCode/iCodeConnect software for compliance/therapy management. Healthcare providers use output data to monitor therapy settings and patient compliance. Benefits: noninvasive respiratory support, improved airway patency, and remote therapy monitoring.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified against AAMI/ANSI/ES60601-1, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-70, ISO 80601-2-74, and ISO 80601-2-79. Biocompatibility verified per ISO 10993-5, ISO 10993-10, ISO 18562-2, ISO 18562-3, and ISO 18562-4.

Technological Characteristics

Bi-level PAP flow generator with integrated humidifier. Pressure range 4-30 cm H2O. Modes: CPAP, S, T, S/T, Auto CPAP, Auto S. Connectivity: Cellular module, SD card. Electrical safety: IEC 60601-1 series. Biocompatibility: ISO 10993/18562 series. Non-sterile, reusable.

Indications for Use

Indicated for adult patients (>66lbs/30kg) with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency requiring noninvasive ventilation.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

Juno VPAP ST-A (K153061)
Luna®G3 BPAP 25A (K201620)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 5, 2022 BMC Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China Re: K213169 Trade/Device Name: BPAP System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: MNS Dated: December 5, 2022 Received: November 4, 2022 Dear Diana Hong: 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 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, # Ethan ㄴ. Nyberg -S for James Lee, Ph.D. Division 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213169 Device Name BPAP System ### Indications for Use (Describe) The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide noninvasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment. Type of Use (Select one or both, as applicable) | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <line stroke="black" stroke-width="2" x1="2" x2="14" y1="2" y2="14"></line> <line stroke="black" stroke-width="2" x1="14" x2="2" y1="2" y2="14"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [PRAStaff@fda.hhs.gov](mailto:PRAStaff@fda.hhs.gov) *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: _K213169 - 1. Date of Preparation: 12/05/2022 - 2. Sponsor Identification ### BMC Medical Co., Ltd. Room 901, Building 1, No.28 Pingguoyuan Road, Shijingshan, Beijing 100041, CHINA Establishment Registration Number: 3008566132 Contact Person: Fang Zheng Position: Director of Regulatory Affairs & Quality Assurance Tel: +86-10-5166 3880 Fax: +86-10-5166 3880-810 Email: zhengfang@bmc-medical.com - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person) ### Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net {4}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: BPAP System Common Name: Continuous ventilator Regulatory Information Classification Name: Continuous Ventilator Classification: II Product Code: MNS Regulation Number: 21 CFR 868.5895 Review Panel: Anesthesiology Indication for Use Statement: The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment. ### Device Description The proposed device is a non-invasive, continuous positive airway pressure ventilator, incorporating a heated respiratory humidifier. The device is intended to treat obstructive sleep apnea or respiratory insufficiency by delivering a flow of positive airway pressure at a level prescribed by a physician to splint open the airway and prevent airway collapse. The proposed device is available in different models designed with different therapy modes and pressure ranges. The therapy modes are available in six types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T), Timed (T), Auto CPAP and Auto S. The pressure range for the proposed devices is available in two types, which are 4-25cm H2O and 4-30 cm H2O. The designated pressure range and therapy mode for each proposed model was provided in following table | Model | Work Mode | Pressure Range | |----------|---------------------|----------------| | G3 B25VT | CPAP, S, T, S/T | 4-25 cm H2O | | G3 B30SV | CPAP, S/T | | | G3 B30VT | CPAP, S, T, S/T | 4-30 cm H2O | | G3 LAB | CPAP, Auto CPAP, S, | | {5}------------------------------------------------ | Auto S, T, S/T | | |----------------|--| |----------------|--| Alarm module is incorporated in the device. The device will generate audio and visual alarm for any abnormal conditions. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use. The proposed device can be reused by single patient and multi-patients - ર. Identification of Predicate Device 510(k) Number: K153061 Product Name: Juno VPAP ST-A - Identification of Secondary Predicate Device 6. 510(k) Number: K201620 Product Name: Luna®G3 BPAP 25A - 7. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: - > AAMI/ANSI/ES60601-1: 2005/(R)2012 And A1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; - > IEC 60601-1-8:2006+A1: 2012 Medical Electrical Equipment-Part 1-8: General requirements for basic safety and essential performance-Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems - > 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 - > IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests - > ISO 80601-2-70: 2015 Medical electrical equipment - Part 2-70: Particular reguirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment - A ISO 80601-2-74: 2017 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment - > ISO 80601-2-79: 2018 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment - 8. Clinical Test Conclusion {6}------------------------------------------------ No clinical study is included in this submission. {7}------------------------------------------------ ### 9. Substantially Equivalent (SE) Comparison | Table 1 General Comparison | | | | | |----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Item | Proposed Device | Predicate Device | Secondary Predicate Device | Remark | | | | K153061 | K201620 | | | Product Code | MNS | MNS | BZD | Same | | Regulation Number | 21 CFR 868.5895 | 21 CFR 868.5895 | 21 CFR 868.5905 | Same | | Indication for Use | The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment. | The Juno VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnoea (OSA). The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg). The Juno VPAP ST-A is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment. | The luna® G3 BPAP 25A is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult obstructive Sleep Apnea (OSA). The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/institutional environment on adult patients. It is to be used on patients >66lbs/30kg for whom CPAP therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy. | Analysis 1 | | Environment of Use | Hospital/Home | Hospital/Home | Hospital/Home | Same | | Supplemental oxygen | Yes | Yes | Yes | Same | | Sterile | Non-sterile | Non-sterile | Non-sterile | Same | | | | | | | | Single Use | Reuse | Reuse | Reuse | Same | | Prescription status | Prescription | Prescription | Prescription | Same | | Alarm | Yes | Yes | No | Same | | Humidifier | | | | | | Integrated | Yes | Yes | Yes | Same | | Humidity Output | $\ge 15$ mg/L, as required by ISO80601-2-74 | $\ge 10$ mg/L | $\ge 15$ mg/L, as required by ISO80601-2-74 | Analysis 2 | | Humidifier Setting | 1-5 (95 to 154.4°F/35 to 68°C) | 1-8 | 1-5 (95 to 154.4°F/35 to 68°C) | Analysis 2 | | Delay | Yes | Yes | Yes | Same | | Physical specification | | | | | | Dimensions | 265 x 145x114 mm (with integrated humidifier) | 153 mm x 172 mm x 86 mm | 265 x 145x114 mm (with integrated humidifier) | Analysis 3 | | Weight | 1.7kg (with integrated humidifier) | 1.04kg | 1.7kg (with integrated humidifier) | Analysis 3 | | AC Power | 100-240V, 50/60Hz, | 100-240V, 50-60Hz | 100-240V, 50/60Hz | Same | | Accessory | | | | | | Air filter | Yes | Yes | Yes | Same | | Non-heated tubing | Yes | Yes | Yes | Same | | Heated tubing | Yes | Yes | Yes | Same | Table 1 General Comparison {8}------------------------------------------------ Analysis 1-Indication for Use The indication for use for the proposed device is not exactly same as the predicate device. Firstly, the intent weight for the proposed device does not include the population whose weight larger than 301bs. The adult patiended for the adult patients whose weight is larger than 66ths and this population was also covered by predicate device, it can be concluded that the intended population can be covered in the population range of predicate device. In addition, the intended for single patient and multi-patients re-use, while the predicate device is intended for single patient re-use. However, whent reuse or multi-patient reuse, the device shall be cleaned and disinfected prior to subsequent use, and the cleaning and disinfection method for the been validated per FDA recognized standard, the test result is {9}------------------------------------------------ acceptable. # Analysis 2- Humidity Output and humidifier setting The humidity output and humidifier setting for the proposed device, however, it is same as the secondary predicate device. # Analysis 3-Dimension and Weight The dimension and weight for the proposed device. The difference in weight and dimension will not affect the intended use and this difference will not raise any safety and in addition to the predicate device, a secondary predicate device was cited, it can be noted that the weight and dimension for the proposed device is same as the secondary predicate device. | Item | Proposed Device | Predicate Device K153061 | Secondary Predicate Device K201620 | Remark | |-----------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------|------------| | Modes Available | CPAP; S; T S/T; Auto CPAP Auto S | CPAP S T S/T PAC iVAPS | Auto CPAP Auto S S CPAP | Analysis 4 | | Pressure Range | CPAP: 4~20cmH2O Auto CPAP: 4~20cmH2O S: 4~25cmH2O for G3B25VT, 4~30cmH2O for G3 B30SV, G3 B30VT, G3 LAB; T: 4~25cmH2O for G3B25VT, | CPAP: 4-20cmH2O S, S/T, T: 3-30cmH2O | For CPAP and Auto CPAP mode: 4.0~20.0 cmH2O For Auto S and S mode: 4.0~25.0 cmH2O | Analysis 5 | | | Table 2 Performance and Safety Comparison | | | | | |--|-------------------------------------------|--|--|--|--| |--|-------------------------------------------|--|--|--|--| {10}------------------------------------------------ | | 4~30cmH2O for G3 B30SV, G3 B30VT,G3 LAB; S/T:4~25cmH2O for G3B25VT, 4~30cmH2O for G3 B30SV, G3 B30VT, G3 LAB; Auto S: 4~30cmH2O | | | | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Pressure regulation | ±0.5 cmH2O | ±0.5 cmH2O | ±0.5 cmH2O | Same | | Automatic adjusting CPAP algorithm | Yes | No | Yes | Analysis 6 | | Ramp | 0-60 | User selected as “off” to 45minutes in 5 minutes increments Max ramp time set at clinician’s driscretion | 0-60 | Analysis 7 | | Expiratory Pressure Relief | Reslex® function Level 1-3 | Yes | Reslex® function Level 1-3 | Analysis 8 | | Cellular module | Yes | No | Yes | Analysis 9 | | iCode® | iCode, iCode QR, iCode QR + A feature that is intended to give access to compliance and therapy management information. The iCode consists of six separate codes displayed in the Patient Menu, each code is a sequence of numbers. The “iCode QR” and “iCode QR+” display | No | iCode, iCode QR, iCode QR + A feature that is intended to give access to compliance and therapy management information. The iCode consists of six separate codes displayed in the Patient Menu, each code is a sequence of numbers. The “iCode QR” and “iCode QR+” display two-dimensional codes | Analysis 10 | | | two-dimensional codes. | | | | | iCodeConnect® Software | Yes | No | Yes | Analysis 11 | | Transmit data | therapy data, therapy settings, upgrade device software | therapy data, therapy settings, upgrade device software | therapy data, therapy settings, upgrade device software | Same | | Data transfer medium | SD card, Cellular module | SD card, Wireless | SD card, Cellular module | Analysis 12 | | Smart A | Yes | No | Yes | Same | | Smart B | Yes | No | Yes | Same | | Smart C | Yes | No | Yes | Same | | Respiratory event detection function | Yes | Yes | Yes | Same | | Biocompatibility | | | | | | Cytotoxicity | Comply with ISO 10993-5 | Comply with ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-12 standards | Comply with ISO 10993-5 | Same | | Skin Irritation | Comply with ISO 10993-10 | | Comply with ISO 10993-10 | | | Sensitization | Comply with ISO 10993-10 | | Comply with ISO 10993-10 | | | Particulate matter | Comply with ISO 18562-2 | Comply with ISO 18562-2 |…

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