Luna G3 BPAP System

K212263 · 3B Medical, Inc. · BZD · Mar 25, 2022 · Anesthesiology

Device Facts

• Record ID: K212263
• Device Name: Luna G3 BPAP System
• Applicant: 3B Medical, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Luna® G3 BPAP System 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 > 66 lbs / 30 kg for whom CPAP therapy has been prescribed.

Device Story

The Luna G3 BPAP System is a microprocessor-controlled, blower-based device that generates positive airway pressure to treat obstructive sleep apnea. It includes an integrated humidifier for warming and humidifying air. The device operates in four modes: CPAP, Spontaneous (S), Timed (T), and Spontaneous/Timed (S/T). It is intended for prescription use in home or hospital settings by adult patients. The device provides therapy via non-heated or heated tubing. Data reporting is available through the iCode and iCodeConnect software systems. Healthcare providers use the device to deliver prescribed pressure therapy, which helps maintain airway patency during sleep. The system is a modification of the predicate Luna G3 BPAP 25A, adding T and S/T modes and an expanded pressure range (up to 30 cmH2O for the LG3800-30VT model).

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluation included biocompatibility (ISO 10993, ISO 18562), electromagnetic compatibility (IEC 60601-1-2), and performance testing (ISO 80601-2-70, ISO 80601-2-74) covering flow rate, static/dynamic pressure, sound levels, rise time, and display accuracy.

Technological Characteristics

Microprocessor-controlled, blower-based system. Pressure range: 4-25 cmH2O (LG3800-25VT) or 4-30 cmH2O (LG3800-30VT). Integrated humidifier. Connectivity: 4G cellular module, iCode/iCodeConnect. Power: 100-240V, 50/60Hz. Classification: Class II, Type BF, IP22. Standards: IEC 60601-1-2, ISO 80601-2-70, ISO 80601-2-74, ISO 10993, ISO 18562.

Indications for Use

Indicated for adult patients > 66 lbs / 30 kg with Obstructive Sleep Apnea (OSA) for whom CPAP therapy has been prescribed.

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

• Luna G3 BPAP 25A (K201620)

Reference Devices

• Juno VPAP ST-A (K153061)

Submission Summary (Full Text)

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March 25, 2022

3B Medical, Inc. Yasser Estafanous Chief Ouality & Regulatory Officer 203 Avenue A NW. Suite 300 Winter Haven, Florida 33881

Re: K212263

Trade/Device Name: Luna G3 BPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: August 11, 2021 Received: February 17, 2022

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 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 K212263

Device Name Luna® G3 BPAP System

#### Indications for Use (Describe)

The Luna® G3 BPAP System is a Bi-level PAP (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. It is to be used on patients > 66 lbs / 30 kg for whom CPAP therapy has been prescribed.

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

| <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary

| Device Trade Name | Luna® G3 BPAP System |
|------------------------------|--------------------------------------------------------------------------------------------------------------|
| Model | LG3800-25VT, LG3800-30VT |
| Common/Usual Name | BPAP System |
| Date Prepared | May March 23, 2022 |
| Sponsor Identification | 3B Medical, Inc.<br>203 Avenue A NW, Suite 300,<br>Winter Haven, FL 33881 |
| 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 Road,<br>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 | Luna G3 BPAP 25A (K201620) |
| Reference Device | Juno VPAP ST-A (K153061) |

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| Reason for Submission: | Device Modification |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Luna® G3 BPAP System is a Bi-level PAP (Bi-level<br>Positive Airway Pressure) device designed for the treatment<br>of adult Obstructive Sleep Apnea (OSA). The integrated<br>humidifier is indicated for the humidification and warming<br>of air from the flow generator device. These devices are<br>intended for single-patient use by prescription in the home or<br>hospital/institutional environment on adult patients. It is to be<br>used on patients > 66 lbs / 30 kg for whom CPAP therapy has<br>been prescribed. |
| Device Description | The Luna® G3 BPAP system is a microprocessor controlled,<br>blower-based system that generates positive airway pressure<br>to support treatment of obstructive sleep apnea. Its hardware<br>design is identical to the previously cleared Luna® G3 BPAP<br>25A (K201620). The subject device includes two models,<br>with different pressure ranges. They both have four therapy<br>modes, which are CPAP, Spontaneous (S), Timed (T) and<br>Spontaneous/Timed (S/T). The pressure ranges and modes<br>are listed as follows: |

| Product Name | Model | Pressure Range | Work Modes |
|-------------------------|-------------|----------------|-----------------|
| Luna® G3 BPAP<br>system | LG3800-25VT | 4-25 cmH2O | CPAP, S, T, S/T |
| | LG3800-30VT | 4-30 cmH2O | CPAP, S, T, S/T |

Comparison of Technological Characteristics with the Predicate Device:

The Luna® G3 BPAP System uses the same hardware and basic algorithm as the predicate Luna® G3 BPAP 25A (K201620). The subject device and the predicate share the same intended use, same operating principle, same materials, and are manufactured and packaged with the same processes. The basic functionality and performance characteristics of the subject device are the same as the predicate. The only differences of the subject device with the predicate are as follows:

- Apart from the CPAP and S modes that are identical to the predicate, the subject device LG3800-25VT and LG3800-30VT have two new work modes: T mode and S/T mode.
- The subject device LG3800-30VT provides a wider pressure range of 4-30 cmHzO, while LG3800-25VT provides the same pressure range of 4-25cmH2O with the predicate.

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The reference device Juno VPAP ST-A (K153061) comprises the working modes of T and S/T, and its working pressure ranges from 3-30cmH2O. The relevant functionality and performance characteristics of the subject device Luna® G3 BPAP System are the same as those of the reference device. Testing and comparison were conducted on the subject device and the reference device. They are substantially equivalent on the above features.

The substantial equivalence comparison is provided as below.

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| | Subject Device | Predicate Device | Reference Device | |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Luna® G3 BPAP System<br>(K212263) | Luna® G3 BPAP 25A<br>(K201620) | Juno VPAP ST-A<br>(K153061) | Comparison |
| Classification | | | | |
| Device<br>Classification | Class II Device | Class II Device | Class II Device | Identical to predicate |
| Product Code | BZD | BZD | MNS | Identical to predicate |
| Classification<br>Panel | Anesthesiology | Anesthesiology | Anesthesiology | Identical to predicate |
| Regulation<br>Number | 21 CFR 868.5905 | 21 CFR 868.5905 | 21 CFR 868.5895 | Identical to predicate |
| Intended Use and Indications for Use | | | | |
| | Subject Device | Predicate Device | Reference Device | |
| | Luna® G3 BPAP System<br>(K212263) | Luna® G3 BPAP 25A<br>(K201620) | Juno VPAP ST-A<br>(K153061) | Comparison |
| Indications<br>For Use | The Luna® G3 BPAP<br>System 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 intended<br>for single-patient use by<br>prescription in the home or<br>hospital/institutional<br>environment on adult<br>patients. It is to be used on<br>patients > 66 lbs / 30 kg for<br>whom CPAP therapy has<br>been prescribed. | The Luna® G3 BPAP 25A<br>is a Bi-level PAP (Bi-level<br>Positive Airway Pressure)<br>device designed for the<br>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 intended<br>for single-patient use by<br>prescription in the home or<br>hospital/institutional<br>environment on adult<br>patients. It is to be used on<br>patients >66lbs/30kg for<br>whom CPAP therapy has<br>been prescribed. The<br>system can deliver bi-level<br>therapy or auto bi-level<br>therapy. | The Juno VPAP ST-A is<br>indicated to provide<br>noninvasive ventilation for<br>patients weighing more than<br>30lbs (13 kg) with<br>respiratory insufficiency or<br>obstructive sleep apnoea<br>(OSA).<br>The iVAPS mode is<br>indicated for patients<br>weighing more than 66lbs<br>(30 kg). The Juno VPAP ST-<br>A is intended for home and<br>hospital use.<br>The humidifier is intended<br>for single patient use in the<br>home environment and re-<br>use in a<br>hospital/institutional<br>environment. | Identical to predicate |
| Pressure Delivery | | | | |
| Therapy<br>Delivered | CPAP,<br>S,<br>T,<br>S/T | CPAP,<br>AutoCPAP,<br>S,<br>Auto S | CPAP,<br>S,<br>T,<br>S/T,<br>PAC,<br>iVAPS | CPAP and S modes are<br>identical to predicate. T<br>and S/T modes are<br>identical to reference<br>device. |
| | Subject Device | Predicate Device | Reference Device | |
| | Luna® G3 BPAP System<br>(K212263) | Luna® G3 BPAP 25A<br>(K201620) | Juno VPAP ST-A<br>(K153061) | Comparison |
| Pressure Range | CPAP mode: 4-20 cmH2O<br>S, T, S/T mode:<br>4-25 cmH2O for LG3800-<br>25VT,<br>4-30 cmH2O for LG3800-<br>30VT | CPAP mode: 4-20cmH2O<br>S mode: 4-25cmH2O | CPAP mode: 4-20 cmH2O<br>S, T, S/T mode: 3-30 cmH2O | For LG3800-25VT, the<br>pressure range is<br>identical to the predicate.<br>For LG3800-30VT, the<br>pressure range of CPAP<br>mode is identical to the<br>predicate, while that of S<br>T, S/T mode is similar to<br>the reference device. |
| Pressure Display<br>Accuracy (hPa) | ±(0.8cmH2O+4%) | ±(0.8cmH2O+4%) | ±(0.5 cmH2O+4%) | Identical to predicate |
| Humidifier | | | | |
| Integrated | Yes | Yes | Yes | Identical to predicate |
| Humidifier<br>Settings | 1-5 (95 to 154.4°F/35 to<br>68°C) | 1-5 (95 to 154.4°F/35 to<br>68°C) | 1-8 | Identical to predicate |
| Physical Characteristics | | | | |
| Dimensions | 265 × 145×114 mm<br>(with integrated humidifier) | 265 × 145×114 mm<br>(with integrated<br>humidifier) | 255 mm x 150 mm x 116 mm<br>(with integrated<br>humidifier) | Identical to predicate |
| Weight | 1.7kg (with integrated<br>humidifier) | 1.7kg (with integrated<br>humidifier) | 1.336kg (with integrated<br>humidifier) | Identical to predicate |
| AC Power<br>Consumption | 100-240V, 50/60Hz, 2.0A | 100-240V, 50/60Hz, 2.0A | 100-240 V AC, 50-60 Hz,<br>1.0-1.5A | Identical to predicate |
| | Subject Device | Predicate Device | Reference Device | |
| | Luna® G3 BPAP System<br>(K212263) | Luna® G3 BPAP 25A<br>(K201620) | Juno VPAP ST-A<br>(K153061) | Comparison |
| IEC 60601<br>Classification | Class II, Type BF | Class II, Type BF | Class II, Type BF | Identical to predicate |
| Degree of<br>Protection<br>Against Water<br>Ingress | IP22 | IP22 | IP22 | Identical to predicate |
| Sound Pressure<br>Level | < 26 dB, when the device is<br>working at the pressure of 10<br>cmH20. | < 26 dB, when the device is<br>working at the pressure of<br>10 cmH2O. | < 27 dB, when the device is<br>working at the pressure of 10<br>cmH2O. | Identical to predicate |
| Air Filter | Available | Available | Available | Identical to predicate |
| Non-heated<br>Tubing | Available<br>Model: L1 | Available<br>Model: L1 | Available | Identical to predicate |
| Heated Tubing | Available<br>Model: LH1 | Available<br>Model: LH1 | Available | Identical to predicate |
| Cellular Module | Available<br>4G Module | Available<br>4G Module | Available…