(228 days)
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 >66lbs/30kg for whom CPAP therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.
The Luna® G3 BPAP 25A is a microprocessor controlled, blower-based system that generates bi-level positive airway pressure (IPAP/EPAP) to support treatment of obstructive sleep apnea. The system provides fixed or auto-adjust pressure from 4 to 25 cmH2O above the ambient atmospheric pressure to a patient's oral/nasal airway.
This document, primarily a 510(k) Pre-market Notification to the FDA, describes a medical device called the Luna® G3 BPAP 25A, a Bi-level Positive Airway Pressure (BPAP) device for treating Obstructive Sleep Apnea (OSA). The document outlines its intended use, technological characteristics, and compares it to predicate devices to prove substantial equivalence.
Acceptance Criteria and Device Performance:
The acceptance criteria for the Luna® G3 BPAP 25A are not explicitly stated as quantitative performance metrics (e.g., accuracy, sensitivity, specificity) but are derived from comparing its technological characteristics and performance against legally marketed predicate and reference devices, as well as adherence to recognized regulatory standards. The "reported device performance" refers to the demonstrated compliance with these standards and the equivalence of its characteristics to established devices.
Here's a table summarizing the implicit acceptance criteria (based on predicate device characteristics and regulatory standards) and the reported performance of the subject device:
| Acceptance Criteria (Derived / Implicit) | Reported Device Performance (Luna® G3 BPAP 25A) |
|---|---|
| Clinical Performance: | |
| Treatment of adult Obstructive Sleep Apnea (OSA) | Indicated for the treatment of adult OSA. |
| Ability to deliver Bi-level therapy or Auto Bi-level therapy | Delivers S, Auto S, CPAP, AutoCPAP therapies. |
| Pressure Range (CPAP/AutoCPAP: 4-20 cmH2O; Auto S/S: 4-25 cmH2O) | Meets this range (CPAP/AutoCPAP: 4.0–20.0 cmH2O; Auto S/S: 4.0-25.0 cmH2O). |
| Pressure Regulation (± 0.5 cmH2O) | Meets this (± 0.5 cmH2O). |
| Expiratory Pressure Relief (e.g., Reslex® function Level 1-3) | Has Reslex® function Level 1-3. |
| Humidity Output (e.g., ≥10 mg/L as per ISO8185 or ≥15 mg/L as per ISO80601-2-74) | ≥15 mg/L, as required by ISO80601-2-74 (more rigorous than predicate's ≥10 mg/L). |
| Humidifier Settings (range of temperatures) | 1-5 (95 to 154.4°F/35 to 68°C), similar to predicate (104 to 149°F/40 to 65°C). |
| Safety and Performance Standards: | |
| Biocompatibility (ISO 10993 series, ISO 18562 series) | Complies with ISO 10993-1, -5, -10; ISO 18562-1, -2, -3, -4. Test results confirm biocompatibility. |
| Electrical Safety (AAMI ANSI ES 60601-1, IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-74) | Complies with AAMI ANSI ES 60601-1:2005/(R)2012, IEC 60601-1-11:2015, ISO 80601-2-70:2015, ISO 80601-2-74:2017. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Complies with IEC 60601-1-2:2014. Wireless coexistence of cellular module tested. |
| Usability (IEC 60601-1-6) | Complies with IEC 60601-1-6:2013. |
| Software Verification and Validation (FDA Guidance) | Software V&V conducted; documentation provided per FDA guidance. |
| Cybersecurity (FDA Guidance) | Cybersecurity of cellular module software tested and assessed. |
| Mechanical Robustness (Shock, Vibration, Drop, Damp Heat, Dielectric, Leakage tests) | Mechanical tests performed; results indicate no new safety/effectiveness questions. |
| Sound Pressure Level (<30 dB at 10 cmH2O pressure) | < 26 dB at 10 cmH2O (better than predicate's <30 dB). |
| Degree of Protection Against Water Ingress (e.g., IPX1) | IP22 (more rigorous than predicate's IPX1). |
| Operating Conditions (Atmospheric Pressure, Altitude, Temperature, Humidity range) | Ranges are similar to predicate; determined not to impact safety or effectiveness. |
| Shipping and Storage Conditions (Temperature, Humidity range) | Ranges are similar to predicate; determined not to impact safety or effectiveness. |
| Algorithm for respiratory event detection and therapy | Utilizes the same blower and algorithm as the primary predicate (RESmart® BPAP 25A) for respiratory event detection and therapy. AutoCPAP algorithm identical to reference device (Luna® CPAP and Auto CPAP System). |
| Data Reporting (iCode, iCode QR, iCode QR+, iCodeConnect compatibility) | Includes iCode, iCode QR, iCode QR+, and is compatible with iCodeConnect® Software. Similar to predicate/reference devices; differences do not impact safety or effectiveness. |
Study Details:
The document describes a submission for a 510(k) premarket notification, which relies on demonstrating substantial equivalence to existing legally marketed devices rather than conducting new clinical trials to prove efficacy from scratch. Therefore, the "study" is a collection of non-clinical tests and comparisons to predicate devices.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document does not describe a clinical "test set" in the context of patient data. The evaluation is based on non-clinical performance data and comparison of device specifications.
- For biocompatibility, electrical safety, EMC, software, and mechanical testing, specific sample sizes for components or devices under test are not provided. These are typically standard engineering and regulatory tests performed on a defined number of device units or materials.
- The provenance of data for these non-clinical tests would be the manufacturer's testing facilities or certified third-party labs where the tests were performed. This is not explicitly stated but is implied by the submission from 3B Medical, Inc. (USA) and the manufacturer BMC Medical CO., LTD. (CHINA).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- No "ground truth" established by external experts in medical diagnosis (like radiologists) is relevant for this type of 510(k) submission, as it focuses on engineering and performance equivalence, not a new clinical diagnostic claim.
- The "experts" involved would be the engineers, toxicologists, and regulatory specialists who conducted and reviewed the non-clinical tests (biocompatibility, electrical safety, software validation, etc.) and assessed the substantial equivalence. Their specific qualifications are not detailed in this summary but are implicit in the adherence to international standards and FDA guidance.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- There is no "adjudication method" in the sense of expert review of case data for this submission. The determination of substantial equivalence is made by the FDA based on the provided non-clinical data and comparisons.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is a therapeutic device (BPAP machine), not an AI-assisted diagnostic or interpretative tool that would involve human "readers."
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device has algorithms for controlling pressure delivery and detecting respiratory events. The document states that the blower and algorithm are the same as the primary predicate device for respiratory event detection and therapy. The AutoCPAP algorithm is identical to a reference device.
- The performance of these algorithms is implicitly validated through the device's conformance to safety standards and its functional equivalence to predicate devices, which are already marketed and established as safe and effective. No specific "standalone" performance study of the algorithm in isolation (e.g., measuring its diagnostic accuracy against a gold standard in a clinical population) is described, as the 510(k) pathway focuses on equivalence.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- There is no "ground truth" of clinical outcomes or expert consensus in this submission. The "ground truth" in this context refers to the established safety and performance characteristics of the predicate devices and the requirements of the relevant international and FDA standards (e.g., for biocompatibility, electrical safety, software V&V). The device demonstrates its performance by meeting these standards and showing that its specifications are equivalent or superior to the predicate devices without raising new safety or effectiveness concerns.
-
The sample size for the training set:
- Not applicable. This device is not an AI/ML device that requires a "training set" in the sense of learning from clinical data. The algorithms are based on established principles of respiratory therapy.
-
How the ground truth for the training set was established:
- Not applicable, as no training set is described.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Device Trade Name | Luna® G3 BPAP 25A |
|---|---|
| Model | LG3700 |
| Common/Usual Name | BPAP System |
| Date Prepared | January 29, 2021 |
| Sponsor Identification | 3B Medical, Inc.203 Avenue A NW, Suite 300, |
| Submission Correspondent | Yasser Estafanous3B Medical, Inc.203 Avenue A NW, Suite 300,Winter Haven, FL 33881 |
| Phone | 863-226-6285 |
| Fax | 863-226-6284 |
| yestafanous@3bproducts.com | |
| Establishment Registration # | 3008566132 |
| BMC Medical CO., LTD.Room 901, Building 1, No.28 PingguoyuanRoad, 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(K153387) |
| Reason for Submission: | New Device |
| Intended Use | The Luna® G3 BPAP 25A is a Bi-level PAP (Bi-level Positive Airway Pressure) device designedfor the treatment of adult Obstructive Sleep Apnea(OSA). The integrated humidifier is indicated forthe humidification and warming of air from theflow generator device. These devices are intendedfor single-patient use by prescription in the homeor hospital/institutional environment on adultpatients. It is to be used on patients >66lbs/30kgfor whom CPAP therapy has been prescribed. Thesystem can deliver bi-level therapy or auto bi-leveltherapy. |
| Device Description | The Luna® G3 BPAP 25A is a microprocessorcontrolled, blower-based system that generates bi-level positive airway pressure (IPAP/EPAP) tosupport treatment of obstructive sleep apnea. Thesystem 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(K201620) | RESmart® BPAP 25A(K133769) | DreamStation Auto BiPAP (K131982) | Luna® CPAP and AutoCPAP System(K153387) | Comparison | ||
| Classification | ||||||
| DeviceClassification | Class II Device | Class II Device | Class II Device | Class II Device | Identical to primarypredicate | |
| Product Code | BZD | BZD | BZD | BZD | Identical to primarypredicate | |
| ClassificationPanel | Anesthesiology | Anesthesiology | Anesthesiology | Anesthesiology | Identical to primarypredicate | |
| RegulationNumber | 21 CFR 868.5905 | 21 CFR 868.5905 | 21 CFR 868.5905 | 21 CFR 868.5905 | Identical to primarypredicate | |
| RegulationName | Noncontinuous ventilator | Noncontinuous ventilator | Noncontinuous ventilator | Noncontinuous ventilator | Identical to primarypredicate | |
| Intended Use and Indications for Use | ||||||
| Subject Device | Primary PredicateDevice | Predicate Device | Reference Device | |||
| Luna® G3 BPAP 25A(K201620) | RESmart® BPAP 25A(K133769) | DreamStation Auto BiPAP (K131982) | Luna® CPAP and AutoCPAP System(K153387) | Comparison | ||
| IndicationsFor Use | The Luna® G3 BPAP25A is a Bi-level PAP(Bi-level Positive AirwayPressure) device designedfor the treatment of adultObstructive Sleep Apnea(OSA). The integratedhumidifier is indicated forthe humidification andwarming of air from theflow generator device.These devices areintended for single-patient use byprescription in the homeor hospital/institutionalenvironment on adultpatients. It is to be usedon patients >66lbs/30kgfor whom CPAP therapyhas been prescribed. Thesystem can deliver bi-level therapy or auto bi-level therapy. | The RESmart® BPAP25A is a Bi-level PAP(Bi-level PositiveAirway Pressure) devicedesigned for thetreatment of adultObstructive Sleep Apnea(OSA). The optionalintegrated humidifier isindicated for thehumidification andwarming of air from theflow generator device.These devices areintended for singlepatient use byprescription in the homeor hospital/institutionalenvironment on adultpatients. It is to be usedon patients >66lbs/30kgfor whom CPAP therapyhas been prescribed. Thesystem can deliver bi-level therapy or auto bi-level therapy. | The DreamStation AutoBiPAP device deliverspositive airway pressuretherapy for the treatmentof Obstructive SleepApnea (OSA) inspontaneously breathingpatients weighing over30kg (66 lbs). It is for usein the home orhospital/institutionalenvironment. | The Luna® CPAP andAuto CPAP Systems areintended to deliverpositive pressure for thetreatment of ObstructiveSleep Apnea (OSA). Theoptional integrated heatedhumidifier is indicatedfor the humidificationand warming of air fromthe flow generator. Thesedevices are intended forsingle patient use byprescription in the homeor hospital/institutionalenvironment on adultpatients. | Identical to primarypredicate | |
| Subject Device | Primary PredicateDevice | Predicate Device | Reference Device | |||
| Luna® G3 BPAP 25A(K201620) | RESmart® BPAP 25A(K133769) | DreamStation Auto BiPAP (K131982) | Luna® CPAP and AutoCPAP System(K153387) | Comparison | ||
| TherapyDelivered | S,Auto S,CPAP,AutoCPAP | S,Auto S,CPAP | S,Auto S,CPAP | CPAP,AutoCPAP | Similar to primarypredicate. Adding theAutoCPAP mode of thereference device doesnot affect safety oreffectiveness. | |
| Pressure Range | For CPAP andAutoCPAP mode: 4.0–20.0 cmH2OFor Auto S and S mode:4.0-25.0 cmH2O | For CPAP mode: 4.0–20.0 cmH2OFor Auto S and S mode:4.0-25.0 cmH2O | For CPAP mode: 4.0–20.0 cmH2OFor Auto Bi-level mode:4.0-25.0 cmH2O | 4.0–20.0 cmH2O | Similar to primarypredicate. Pressurerange of the AutoCPAPmode is added, whichdoes not affect safety oreffectiveness. | |
| PressureRegulation | $\pm$ 0.5 cmH2O | $\pm$ 0.5 cmH2O | $\pm$ 0.5 cmH2O | $\pm$ 0.5 cmH2O | Identical to primarypredicate | |
| PressureDisplayAccuracy (hPa) | $\pm$ (0.8cmH2O+4%) | $\pm$ 0.5 cmH2O | $\pm$ (0.3cmH2O+3.7%) | $\pm$ (0.5 cmH2O+4%) | Similar to primarypredicate. Change doesnot impact safety oreffectiveness. | |
| Algorithm | ||||||
| AutomaticadjustingCPAPalgorithm | Yes | No | No | Yes | Identical to referencedevice | |
| Ramp(minutes) | 0-60 | 0-60 | 0-60 | 0-60 | Identical to primarypredicate | |
| ExpiratoryPressure Relief | Reslex® functionLevel 1-3 | Reslex® functionLevel 1-3 | Flex® functionLevel 1-3 | Reslex® functionLevel 1-3 | Identical to primarypredicate | |
| Humidifier | ||||||
| Subject Device | Primary PredicateDevice | Predicate Device | Reference Device | |||
| Luna® G3 BPAP 25A(K201620) | RESmart® BPAP 25A(K133769) | DreamStation Auto BiPAP (K131982) | Luna® CPAP and AutoCPAP System(K153387) | Comparison | ||
| Integrated | Yes | No | No | No | Both subject andprimary predicatedevices have a methodto attach ahumidification system.Change does not impactsafety or effectiveness. | |
| HumidityOutput | ≥15 mg/L, as required byISO80601-2-74 | ≥10 mg/L, as requiredby ISO8185 | ≥10 mg/L, as required byISO8185 | ≥10 mg/L, as required byISO8185 | Similar to primarypredicate. Change doesnot impact safety oreffectiveness. | |
| HumidifierSettings | 1-5 (95 to 154.4°F/35 to68°C) | 1-5 (104 to 149°F/40 to65°C) | 1 to 5 (95 to 149°F/35 to65°C) | 1-5 (95 to 167°F/35 to75°C) | Similar to primarypredicate. Change doesnot impact safety oreffectiveness. | |
| Delay | Yes | Yes | No | Yes | Identical to primarypredicate | |
| Physical Characteristics | ||||||
| Dimensions | 265 × 145 × 114 mm(with integratedhumidifier) | 220 x 194 x 112 mm,313 x 194 x 112 mm(with humidifier) | 157 × 193 × 84 mm,297 × 193 × 84 mm (withhumidifier) | 170 x 180 x 118 mm,290 × 180 × 134 mm (withhumidifier) | Dimensions are smallerthan primary predicate.No impact on safetyand effectiveness. | |
| Weight | 1.7kg (with integratedhumidifier) | 2.2 kg,3 kg (with humidifier) | 1.33kg,1.98kg (with humidifier) | 1.5kg,2.5kg (with humidifier) | Weight is less thanprimary predicate. Noimpact on safety andeffectiveness. | |
| AC PowerConsumption | 100-240V, 50/60Hz, 2.0A | 100-240V AC, 50/60Hz,1.0A max | 100-240V AC, 50/60 Hz,2.0-1.0 A | 100-240 V AC, 50/60 Hz,2.0 A max | Similar to primarypredicate | |
| Subject Device | Primary PredicateDevice | Predicate Device | Reference Device | Comparison | ||
| Luna® G3 BPAP 25A(K201620) | RESmart® BPAP 25A(K133769) | DreamStation Auto BiPAP (K131982) | Luna® CPAP and AutoCPAP System(K153387) | |||
| IEC 60601Classification | Class II, Type BF | Class II, Type BF | Class II, Type BF | Class II, Type BF | Identical to primarypredicate | |
| Degree ofProtectionAgainst WaterIngress | IP22 | IPX1-Drip-Proof,Vertical | IP22 | IP22 | IP22 is a more rigoroustest than IPX1. Changedoes not impact safetyor effectiveness. | |
| Sound PressureLevel | < 26 dB, when the deviceis working at the pressureof 10 cmH2O. | <30 dB, when thedevice is working at thepressure of 10 cmH2O. | Device: 26.1 dB(A) withand uncertainty of 2dB(A).Device with humidifier:27.3 dB(A) with anduncertainty of 2 dB(A). | < 30 dB, when the deviceis working at the pressureof 10 cmH2O. | The subject device hasa lower sound pressurelevel than the primarypredicate, so it isquieter when in use. | |
| Air Filter | Yes | Yes | Yes | Yes | Identical to primarypredicate | |
| Non-heatedTubing | Available | Available | Available | Available | Identical to primarypredicate | |
| Heated Tubing | Available | Unavailable | Available | Unavailable | Identical to predicate.Testing confirms thebiocompatibility of thematerials. No impact onsafety or effectiveness. | |
| Operating Conditions | ||||||
| AtmosphericPressure | 760 to 1060 cmH2O | 860 to 1060 cmH2O | 770 to 1010 cmH2O | 760 to 1060 cmH2O | Similar to primarypredicate. No impact onsafety or effectiveness. | |
| Subject Device | Primary PredicateDevice | Predicate Device | Reference Device | |||
| Luna® G3 BPAP 25A(K201620) | RESmart® BPAP 25A(K133769) | DreamStation Auto BiPAP (K131982) | Luna® CPAP and AutoCPAP System(K153387) | Comparison | ||
| OperatingAltitude | 0 to 8.000 ft | 0 to 8,000 ft | 0 to 8,000 ft | 0 to 8,000 ft | Identical to primarypredicate | |
| OperatingTemperature | 5°C to 35°C(41°F to 95°F) | 5 °C to 30° C(41°F to 86 °F) | 5°C to 35° C(41°F to 95 °F ) | 5°C to 35°C(41°F to 95°F) | Similar to primarypredicate. No impact onsafety or effectiveness. | |
| OperatingHumidity | 15% to 93% Non-condensing | ≤ 80% Non-condensing | 15% to 95% Non-condensing | 15% to 93% Non-condensing | Similar to primarypredicate. No impact onsafety or effectiveness. | |
| Shipping and Storage Conditions | ||||||
| Shipping/StorageTemperature | -25°C to 70°C(-13°F to 158°F) | -20°C to 55° C(-4°F to 131°F) | -20°C to 60°C(-4°F to 140°F) | -25°C to 70°C(-13°F to 158°F) | Similar to primarypredicate. No impact onsafety or effectiveness. | |
| Shipping/StorageHumidity | 15% to 93% Non-condensing | ≤ 93% Non-condensing | 15% to 95% Non-condensing | Up to 93% Non-condensing | Similar to primarypredicate. No impact onsafety or effectiveness. | |
| Data Reporting | ||||||
| CellularModule | Available | Unavailable | Available | Available | Identical to predicate.Testing confirm thewireless coexistenceand cybersecurity of thesubject device. Noimpact on safety oreffectiveness. | |
| Subject Device | Primary Predicate Device | Predicate Device | Reference Device | Comparison | ||
| Luna® G3 BPAP 25A(K201620) | RESmart® BPAP 25A(K133769) | DreamStation Auto BiPAP (K131982) | Luna® CPAP and AutoCPAP System(K153387) | |||
| iCode® | iCode,iCode QR,iCode QR +A feature that is intendedto give access tocompliance and therapymanagement information.The iCode consists of sixseparate codes displayedin the Patient Menu, eachcode is a sequence ofnumbers. The "iCodeQR" and "iCodeQR+" display two-dimensional codes. | iCodeA feature that givesaccess to complianceand therapy managementinformation usingencrypted codes. TheiCode consists of sixseparate codes (1 day,7day, 30 day, 60 day,90 day, 180day)displayed in the patientmenu and retrieved bypressing the humidifierbutton when the deviceis not being used. | NA | iCode I,iCode IIiCode provides access tothe patient's compliancedata during a recent timeperiod. The iCode I modedisplays data insequences of characters,and the iCode II modedisplays data in two-dimensional codes | Similar to primarypredicate.The "iCode QR" and"iCode QR+" displaytwo-dimensional codes,which is a different wayof display from the"iCode". No impact onsafety or effectiveness. | |
| iCodeConnect®Software | Available. | Unavailable | NA | Available. | Similar to referencedevice.Both of them have amethod to transmit thepatient data to theiCodeConnect software.The difference is thehardware of themodule. The subjectdevice uses a 4G kit,while the reference usesa Wifi kit. EMC andcybersecurity have beentested and assessed, andthere is no impact onsafety or effectiveness. | |
| Subject Device | Primary PredicateDevice | Predicate Device | Reference Device | |||
| Luna® G3 BPAP 25A(K201620) | RESmart® BPAP 25A(K133769) | DreamStation Auto BiPAP (K131982) | Luna® CPAP and AutoCPAP System(K153387) | Comparison | ||
| Reuse/Cleaning/Sterility | ||||||
| Single-patientUse | Yes | Yes | Yes | Yes | Identical to primarypredicate | |
| Sterilization/Reuse | Not provided sterile.Reusable with cleaninginstructions | Not provided sterile.Reusable with cleaninginstructions | Not provided sterile.Reusable with cleaninginstructions | Not provided sterile.Reusable with cleaninginstructions | Identical to primarypredicate |
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Non-Clinical Performance Data
The following performance data were used in support of the substantial equivalence determination.
Biocompatibility Assessment:
The Luna® G3 BPAP 25A device is categorized as permanent contact duration (>30 days) with dry and humidified gas pathways. Evaluation and testing 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
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• 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: Texts for leachables in condensate
Electrical Safety and Electromagnetic Compatibility:
Testing was conducted on the subject device Luna® G3 BPAP 25A. The system complies with 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 compatibility - requirements and tests
· IEC 60601-1-6:2013. Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Usability
• IEC 60601-1-11:2015. Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance
- Collateral Standard: Requirements For Medical 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
• ISO 80601-2-74:2017. Medical electrical equipments for basic safety and essential performance of respiratory humidifying 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"
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Luna® G3 BPAP 25A
Mechanical Testing:
Mechanical shock test, Sine vibration test, Drop test, Damp heat test, Dielectric voltage withstand test, Leakage current test.
Results of tests and assessments did not raise new safety or effectiveness questions.
Conclusion
The subject and predicate devices are used for the treatment of obstructive sleep apnea (OSA). They are substantially equivalent in terms of technology and intended use. Risk assessments, biocompatibility evaluation, electromagnetic compatibility and electrical safety, as well as mechanical that any differences do not raise new questions of safety or effectiveness. The subject device Luna® G3 BPAP 25A is, therefore, substantially equivalent to the predicate device.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).