Luna® G3 BPAP 25A

K201620 · 3B Medical, Inc. · BZD · Jan 29, 2021 · Anesthesiology

Device Facts

• Record ID: K201620
• Device Name: Luna® G3 BPAP 25A
• Applicant: 3B Medical, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Microprocessor-controlled, blower-based system generating bi-level positive airway pressure (IPAP/EPAP) to treat obstructive sleep apnea; delivers fixed or auto-adjusting pressure (4-25 cmH2O). Inputs include patient respiratory signals; device processes these to detect respiratory events and adjust pressure. Output is pressurized air delivered to patient's oral/nasal airway. Used in home or hospital by adult patients; healthcare providers manage therapy via integrated cellular module (4G) and iCodeConnect software. Features integrated humidifier and optional heated tubing to reduce condensation. Benefits include effective OSA treatment, data-driven therapy management, and improved patient comfort via humidification and auto-adjusting pressure modes.

Clinical Evidence

Bench testing only. Performance validated via biocompatibility (ISO 10993, ISO 18562), electrical safety/EMC (IEC 60601 series), and mechanical testing (shock, vibration, drop, leakage). Software verification and validation conducted per FDA guidance.

Technological Characteristics

Microprocessor-controlled blower system; Class II, Type BF. Pressure range 4-25 cmH2O. Integrated humidifier; optional heated tubing. Connectivity via 4G cellular module for data upload. Standards: ISO 80601-2-70, ISO 80601-2-74, IEC 60601-1, IEC 60601-1-2, ISO 10993, ISO 18562. IP22 water ingress protection.

Indications for Use

Indicated for adult patients >30kg (66lbs) with Obstructive Sleep Apnea (OSA) prescribed CPAP therapy; for use in home or hospital/institutional environments.

Regulatory Classification

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.

Predicate Devices

• RESmart® BPAP 25A (K133769)
• DreamStation Auto BiPAP (K131982)

Reference Devices

• Luna® CPAP and Auto CPAP System (K153387)
• iCodeConnect (K160127)

Submission Summary (Full Text)

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January 29, 2021

3B Medical, Inc. Yasser Estafanous Director of RA/OA 203 Avenue A NW. Suite 300 Winter Haven, Florida 33881

Re: K201620

Trade/Device Name: Luna® G3 BPAP 25A Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 17, 2020 Received: December 18, 2020

Dear Yasser Estafanous:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Rachana Visaria, Ph.D. Assistant 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) K201620

Device Name Luna® G3 BPAP 25A

#### Indications for Use (Describe)

The Luna® G3 BPAP 25A is a Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated 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. If is to be used on patients >661bs/30kg for whom CPAP therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.

Type of Use (Select one or both, as applicable)

| <div> <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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______________________________________________________________________________________________________________________________________________________________________________

# 510(k) Summary

| Device Trade Name | Luna® G3 BPAP 25A |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | LG3700 |
| Common/Usual Name | BPAP System |
| Date Prepared | January 29, 2021 |
| Sponsor Identification | 3B Medical, Inc.<br>203 Avenue A NW, Suite 300, |
| Submission Correspondent | Yasser Estafanous<br>3B Medical, Inc.<br>203 Avenue A NW, Suite 300,<br>Winter Haven, FL 33881 |
| Phone | 863-226-6285 |
| Fax | 863-226-6284 |
| Email | [e-mail] |
| Establishment Registration # | 3008566132 |
| | BMC Medical CO., LTD.<br>Room 901, Building 1, No.28 Pingguoyuan<br>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) | RESmart® BPAP 25A (K133769) |
| | DreamStation Auto BiPAP (K131982) |
| Reference Device | Luna® CPAP and Auto CPAP System<br>(K153387) |
| Reason for Submission: | New Device |
| Intended Use | The Luna® G3 BPAP 25A is a Bi-level PAP (Bi-<br>level Positive Airway Pressure) device designed<br>for the treatment of adult Obstructive Sleep Apnea<br>(OSA). The integrated humidifier is indicated for<br>the humidification and warming of air from the<br>flow generator device. These devices are intended<br>for single-patient use by prescription in the home<br>or hospital/institutional environment on adult<br>patients. It is to be used on patients >66lbs/30kg<br>for whom CPAP therapy has been prescribed. The<br>system can deliver bi-level therapy or auto bi-level<br>therapy. |
| Device Description | The Luna® G3 BPAP 25A is a microprocessor<br>controlled, blower-based system that generates bi-<br>level positive airway pressure (IPAP/EPAP) to<br>support treatment of obstructive sleep apnea. The<br>system provides fixed or auto-adjust pressure from |

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4 to 25 cmH2O above the ambient atmospheric

pressure to a patient's oral/nasal airway.

Comparison of Technological Characteristics with the Predicate Devices.

The Luna® G3 BPAP 25A utilizes the same blower and the same algorithm as the primary predicate device RESmart® BPAP 25A (K133769) for respiratory event detection and therapy for sleep disordered breathing events. The subject device and the primary predicate device share the same intended use, same operating principal, and are manufactured and packaged with similar processes. The basic functionality and performance characteristics of the subject device are the same as

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the primary predicate device. Compared with the primary predicate device, the subject device includes the following main modifications:

- The humidifier is integrated into the BPAP device, which makes the physical size of the subject device smaller and does not affect the safety or effectiveness of the subject device.
- An optional heated tubing (LH1) is intended to provide warmed and/or ● humidified breathing gases before entering the patient's airway. The purpose of the heated tubing is to maintain or raise the gas temperature to or above the dew point (of the air exiting the humidifier) reducing or eliminating water condensation and/or pooling of water in the breathing circuit. The biocompatibility of the heated tubing has been tested, and there is no risks of safety or effectiveness.
- The subject device includes an integrated cellular module, which enables the . device to upload therapy data to the software iCodeConnect (K160127) managed by the healthcare provider, and the therapy parameters of the device can be adjusted by the healthcare provider through the cellular module. The EMC and wireless coexistence of the cellular module and the cybersecurity of its software are tested and assessed, and there is no risks of safety or effectiveness.
- The subject device provides an AutoCPAP mode in addition to the three therapy modes of the primary predicate device RESmart® BPAP 25A (K133769). The AutoCPAP mode delivers CPAP therapy and provides an air pressure no less than the prescribed one based on the patient's needs. The auto adjusting CPAP algorithm of the AutoCPAP mode is identical to that of the reference device Luna® CPAP and Auto CPAP System (K153387). It did not raise new safety or effectiveness questions.

The predicate device DreamStation Auto BiPAP (K131982) comprises an optional heated tubing and an optional cellular modem. The basic functionality and performance characteristics of the two components of the subject device Luna® G3 BPAP 25A are the same as those of those of of the predicate device

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DreamStation Auto BiPAP (K131982). Testings and assessments were conducted on the subject device and they did not raise new safety or effectiveness questions.

The substantial equivalence comparison is provided below.

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| | Subject Device | Primary Predicate Device | Predicate Device | Reference Device | | |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Luna® G3 BPAP 25A<br>(K201620) | RESmart® BPAP 25A<br>(K133769) | DreamStation Auto BiP<br>AP (K131982) | Luna® CPAP and Auto<br>CPAP System<br>(K153387) | Comparison | |
| Classification | | | | | | |
| Device<br>Classification | Class II Device | Class II Device | Class II Device | Class II Device | Identical to primary<br>predicate | |
| Product Code | BZD | BZD | BZD | BZD | Identical to primary<br>predicate | |
| Classification<br>Panel | Anesthesiology | Anesthesiology | Anesthesiology | Anesthesiology | Identical to primary<br>predicate | |
| Regulation<br>Number | 21 CFR 868.5905 | 21 CFR 868.5905 | 21 CFR 868.5905 | 21 CFR 868.5905 | Identical to primary<br>predicate | |
| Regulation<br>Name | Noncontinuous ventilator | Noncontinuous ventilator | Noncontinuous ventilator | Noncontinuous ventilator | Identical to primary<br>predicate | |
| Intended Use and Indications for Use | | | | | | |
| | Subject Device | Primary Predicate<br>Device | Predicate Device | Reference Device | | |
| | Luna® G3 BPAP 25A<br>(K201620) | RESmart® BPAP 25A<br>(K133769) | DreamStation Auto BiP<br>AP (K131982) | Luna® CPAP and Auto<br>CPAP System<br>(K153387) | Comparison | |
| Indications<br>For Use | The Luna® G3 BPAP<br>25A is a Bi-level PAP<br>(Bi-level Positive Airway<br>Pressure) device designed<br>for the treatment of adult<br>Obstructive Sleep Apnea<br>(OSA). The integrated<br>humidifier is indicated for<br>the humidification and<br>warming of air from the<br>flow generator device.<br>These devices are<br>intended for single-<br>patient use by<br>prescription in the home<br>or hospital/institutional<br>environment on adult<br>patients. It is to be used<br>on patients >66lbs/30kg<br>for whom CPAP therapy<br>has been prescribed. The<br>system can deliver bi-<br>level therapy or auto bi-<br>level therapy. | The RESmart® BPAP<br>25A is a Bi-level PAP<br>(Bi-level Positive<br>Airway Pressure) device<br>designed for the<br>treatment of adult<br>Obstructive Sleep Apnea<br>(OSA). The optional<br>integrated humidifier is<br>indicated for the<br>humidification and<br>warming of air from the<br>flow generator device.<br>These devices are<br>intended for single<br>patient use by<br>prescription in the home<br>or hospital/institutional<br>environment on adult<br>patients. It is to be used<br>on patients >66lbs/30kg<br>for whom CPAP therapy<br>has been prescribed. The<br>system can deliver bi-<br>level therapy or auto bi-<br>level therapy. | The DreamStation Auto<br>BiPAP device delivers<br>positive airway pressure<br>therapy for the treatment<br>of Obstructive Sleep<br>Apnea (OSA) in<br>spontaneously breathing<br>patients weighing over<br>30kg (66 lbs). It is for use<br>in the home or<br>hospital/institutional<br>environment. | The Luna® CPAP and<br>Auto CPAP Systems are<br>intended to deliver<br>positive pressure for the<br>treatment of Obstructive<br>Sleep Apnea (OSA). The<br>optional integrated heated<br>humidifier is indicated<br>for the humidification<br>and warming of air from<br>the flow generator. These<br>devices are intended for<br>single patient use by<br>prescription in the home<br>or hospital/institutional<br>environment on adult<br>patients. | Identical to primary<br>predicate | |
| | Subject Device | Primary Predicate<br>Device | Predicate Device | Reference Device | | |
| | Luna® G3 BPAP 25A<br>(K201620) | RESmart® BPAP 25A<br>(K133769) | DreamStation Auto BiP<br>AP (K131982) | Luna® CPAP and Auto<br>CPAP System<br>(K153387) | Comparison | |
| Therapy<br>Delivered | S,<br>Auto S,<br>CPAP,<br>AutoCPAP | S,<br>Auto S,<br>CPAP | S,<br>Auto S,<br>CPAP | CPAP,<br>AutoCPAP | Similar to primary<br>predicate. Adding the<br>AutoCPAP mode of the<br>reference device does<br>not affect safety or<br>effectiveness. | |
| Pressure Range | For CPAP and<br>AutoCPAP mode: 4.0–<br>20.0 cmH2O<br>For Auto S and S mode:<br>4.0-25.0 cmH2O | For CPAP mode: 4.0–<br>20.0 cmH2O<br>For Auto S and S mode:<br>4.0-25.0 cmH2O | For CPAP mode: 4.0–<br>20.0 cmH2O<br>For Auto Bi-level mode:<br>4.0-25.0 cmH2O | 4.0–20.0 cmH2O | Similar to primary<br>predicate. Pressure<br>range of the AutoCPAP<br>mode is added, which<br>does not affect safety or<br>effectiveness. | |
| Pressure<br>Regulation | $\pm$ 0.5 cmH2O | $\pm$ 0.5 cmH2O | $\pm$ 0.5 cmH2O | $\pm$ 0.5 cmH2O | Identical to primary<br>predicate | |
| Pressure<br>Display<br>Accuracy (hPa) | $\pm$ (0.8cmH2O+4%) | $\pm$ 0.5 cmH2O | $\pm$ (0.3cmH2O+3.7%) | $\pm$ (0.5 cmH2O+4%) | Similar to primary<br>predicate. Change does<br>not impact safety or<br>effectiveness. | |
| Algorithm | | | | | | |
| Automatic<br>adjusting<br>CPAP<br>algorithm | Yes | No | No | Yes | Identical to reference<br>device | |
| Ramp<br>(minutes) | 0-60 | 0-60 | 0-60 | 0-60 | Identical to primary<br>predicate | |
| Expiratory<br>Pressure Relief | Reslex® function<br>Level 1-3 | Reslex® function<br>Level 1-3 | Flex® function<br>Level 1-3 | Reslex® function<br>Level 1-3…