(248 days)
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.
The Luna® G3 BPAP system is a microprocessor controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. Its hardware design is identical to the previously cleared Luna® G3 BPAP 25A (K201620). The subject device includes two models, with different pressure ranges. They both have four therapy modes, which are CPAP, Spontaneous (S), Timed (T) and Spontaneous/Timed (S/T).
This 510(k) summary (K212263) describes a device modification to an existing Bi-level PAP system (Luna G3 BPAP System). The core of the submission revolves around demonstrating substantive equivalence to a predicate device (Luna G3 BPAP 25A, K201620) and referencing a device (Juno VPAP ST-A, K153061) for new functionalities.
It is crucial to understand that this document describes a device intended for treatment of Obstructive Sleep Apnea (OSA), providing positive airway pressure. It is not an AI/ML powered diagnostic device that would typically involve a multi-reader multi-case (MRMC) study or complex ground truth establishment from expert consensus or pathology, as might be seen for an imaging AI.
Therefore, many of the typical "acceptance criteria" and "study types" for AI/ML-powered devices, such as those related to standalone performance (e.g., sensitivity, specificity, AUC), MRMC studies, and expert ground truth establishment for a diagnostic output, are not applicable to this type of medical device submission.
Instead, the acceptance criteria and supporting studies are focused on engineering and performance characteristics of the medical device itself, ensuring it functions safely and effectively as intended and is equivalent to previously cleared devices.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a single aggregated table of "acceptance criteria" versus "reported performance" for a diagnostic output as would be seen for AI/ML diagnostic tools. Instead, it details specific performance tests and standards met, comparing the subject device's characteristics to its predicate and reference devices. The "acceptance criteria" are implied by adherence to recognized standards and demonstrated equivalence to the cleared predicate.
Here's an interpretation of relevant performance characteristics that serve as de facto acceptance criteria and their reported performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Adherence to ISO 10993 and ISO 18562 standards for breathing gas pathways. | Leveraged testing from predicate (K201620) for no material/manufacturing/hardware changes. Additional accelerated aging tests performed for particulate matter and VOC emissions (ISO 18562-2, -3). |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | EMC Testing conducted and in accordance with IEC 60601-1-2:2014. |
| Device Performance (Therapy Modes): Functionality of CPAP, S, T, and S/T modes. | CPAP and S modes identical to predicate. T and S/T modes identical to reference device. Functional performance testing conducted. |
| Device Performance (Static/Dynamic Pressure): (Implicit measurement accuracy and stability) | Testing conducted for Static pressure and Dynamic pressure. (Specific numerical results not provided in summary, but indicated as passed). |
| Device Performance (Maximum Flow Rate): (Implicit measurement accuracy) | Testing conducted for Maximum flow rate. (Specific numerical results not provided in summary, but indicated as passed). |
| Device Performance (Rise Time): (Implicit measurement accuracy) | Testing conducted for Rise time. (Specific numerical results not provided in summary, but indicated as passed). |
| Pressure Display Accuracy: Within specified limits. | Subject Device: ±(0.8cmH2O+4%). (Identical to predicate). |
| Pressure Range: Correct implementation for models. | LG3800-25VT: CPAP 4-20 cmH2O; S, T, S/T 4-25 cmH2O. LG3800-30VT: CPAP 4-20 cmH2O; S, T, S/T 4-30 cmH2O. |
| Sound Pressure Level: Below specified maximum. | < 26 dB at 10 cmH2O. (Identical to predicate and better than reference device's < 27 dB). |
| Software Verification & Validation: Adherence to FDA guidance. | Conducted and documentation 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". |
| Electrical and Mechanical Safety: (Implicit compliance with relevant standards). | Leveraged testing from predicate for no changes in manufacturing process or hardware. |
| Cybersecurity: (Implicit compliance with relevant standards/guidance). | Leveraged testing from predicate for no changes in manufacturing process or hardware. |
2. Sample Size Used for the Test Set and the Data Provenance
This is an engineering and performance validation study for a medical device, not a clinical study involving patient data for diagnostic accuracy.
- Sample Size: Not applicable in the traditional sense of patient data. The "test set" consists of the physical device units subjected to various engineering and performance tests (e.g., electrical safety, fluid dynamics, sound, software functionality). The document does not specify the number of physical units tested, but it would typically involve a small number of production or pre-production units.
- Data Provenance: Not applicable in the sense of country of origin of patient data. The tests are performed in a laboratory setting by the manufacturer, or by accredited third-party labs on behalf of the manufacturer, to verify product specifications and compliance with standards. The manufacturing location is indicated as Beijing, China (BMC Medical CO., LTD.).
- Retrospective or Prospective: Not applicable. These are engineering validation tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The "ground truth" for this type of device is defined by engineering specifications, validated performance against benchmarks (predicate and reference devices), and adherence to international recognized standards (e.g., ISO, IEC). There are no human "experts" establishing a clinical "ground truth" diagnosis for the device's output in the way a radiologist would for an imaging AI. The "experts" involved would be the engineers, quality assurance personnel, and regulatory affairs specialists who design, test, and approve the device.
4. Adjudication Method for the Test Set
Not applicable. There is no subjective interpretation or "adjudication" of results in the way there would be for a clinical diagnostic study with human readers. Test results are objective measurements against defined performance criteria and standards.
5. 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
Not applicable. This is not an AI/ML-powered diagnostic device, nor is it designed to assist human readers in interpretation. It is a breathing therapy device. Therefore, an MRMC study is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device does not have a "standalone" algorithmic component in the sense of a diagnostic AI assessing, for example, medical images. Its "algorithm" refers to the control software that manages the positive airway pressure delivery. The "standalone performance" refers to the device's ability to accurately deliver and control pressure, humidification, and other functions as per its specifications, which is what the various performance tests (e.g., static pressure, dynamic pressure, maximum flow rate, rise time, display accuracy) described under "Non-Clinical Performance Testing" are designed to evaluate. The results of these tests demonstrate the device's standalone performance in a lab setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance validation is based on:
- Engineering Specifications: The device's design parameters and target performance levels.
- International Standards: Adherence to recognized medical device standards (e.g., ISO 80601-2-70, ISO 80601-2-74, IEC 60601-1-2) which define acceptable ranges for various functional properties.
- Predicate Device Performance: The established, cleared performance characteristics of the Luna G3 BPAP 25A (K201620) and the relevant functionalities of the Juno VPAP ST-A (K153061). The current submission leverages the "substantial equivalence" argument, meaning the performance of the new device is compared to and validated as being equivalent to the legally marketed predicate.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML model that is "trained" on a "training set" of data. The device's internal control software/algorithm is based on fixed programming, not machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as point 8. The "ground truth" for the device's design and programming comes from established physiological principles of breathing support and engineering principles for mechanical ventilation devices.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
{1}------------------------------------------------
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 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 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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
"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."
{3}------------------------------------------------
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.203 Avenue A NW, Suite 300,Winter Haven, FL 33881 |
| 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 Pingguoyuan Road,Shijingshan, Beijing 100041, CHINA | |
| Classification | Class II Device (21 CFR 868.5905) |
| Classification Name | Noncontinuous ventilator |
| Classification Panel | Medical Device |
| Products Code | BZD |
| Medical Specialties | Anesthesiology |
| Predicate Device | Luna G3 BPAP 25A (K201620) |
| Reference Device | Juno VPAP ST-A (K153061) |
{4}------------------------------------------------
| Reason for Submission: | Device Modification |
|---|---|
| Intended Use | The Luna® G3 BPAP System is a Bi-level PAP (Bi-levelPositive Airway Pressure) device designed for the treatmentof adult Obstructive Sleep Apnea (OSA). The integratedhumidifier is indicated for the humidification and warmingof air from the flow generator device. These devices areintended for single-patient use by prescription in the home orhospital/institutional environment on adult patients. It is to beused on patients > 66 lbs / 30 kg for whom CPAP therapy hasbeen prescribed. |
| Device Description | The Luna® G3 BPAP system is a microprocessor controlled,blower-based system that generates positive airway pressureto support treatment of obstructive sleep apnea. Its hardwaredesign is identical to the previously cleared Luna® G3 BPAP25A (K201620). The subject device includes two models,with different pressure ranges. They both have four therapymodes, which are CPAP, Spontaneous (S), Timed (T) andSpontaneous/Timed (S/T). The pressure ranges and modesare listed as follows: |
| Product Name | Model | Pressure Range | Work Modes |
|---|---|---|---|
| Luna® G3 BPAPsystem | 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.
{5}------------------------------------------------
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.
{6}------------------------------------------------
| Subject Device | Predicate Device | Reference Device | ||
|---|---|---|---|---|
| Luna® G3 BPAP System(K212263) | Luna® G3 BPAP 25A(K201620) | Juno VPAP ST-A(K153061) | Comparison | |
| Classification | ||||
| DeviceClassification | Class II Device | Class II Device | Class II Device | Identical to predicate |
| Product Code | BZD | BZD | MNS | Identical to predicate |
| ClassificationPanel | Anesthesiology | Anesthesiology | Anesthesiology | Identical to predicate |
| RegulationNumber | 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(K212263) | Luna® G3 BPAP 25A(K201620) | Juno VPAP ST-A(K153061) | Comparison | |
| IndicationsFor Use | The Luna® G3 BPAPSystem 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 are intendedfor single-patient use byprescription in the home orhospital/institutionalenvironment on adultpatients. It is to be used onpatients > 66 lbs / 30 kg forwhom CPAP therapy hasbeen prescribed. | The Luna® G3 BPAP 25Ais a Bi-level PAP (Bi-levelPositive Airway Pressure)device designed for thetreatment of adultObstructive Sleep Apnea(OSA). The integratedhumidifier is indicated forthe humidification andwarming of air from theflow generator device.These devices are intendedfor single-patient use byprescription in the home orhospital/institutionalenvironment on adultpatients. It is to be used onpatients >66lbs/30kg forwhom CPAP therapy hasbeen prescribed. Thesystem can deliver bi-leveltherapy or auto bi-leveltherapy. | The Juno VPAP ST-A isindicated to providenoninvasive ventilation forpatients weighing more than30lbs (13 kg) withrespiratory insufficiency orobstructive sleep apnoea(OSA).The iVAPS mode isindicated for patientsweighing more than 66lbs(30 kg). The Juno VPAP ST-A is intended for home andhospital use.The humidifier is intendedfor single patient use in thehome environment and re-use in ahospital/institutionalenvironment. | Identical to predicate |
| Pressure Delivery | ||||
| TherapyDelivered | CPAP,S,T,S/T | CPAP,AutoCPAP,S,Auto S | CPAP,S,T,S/T,PAC,iVAPS | CPAP and S modes areidentical to predicate. Tand S/T modes areidentical to referencedevice. |
| Subject Device | Predicate Device | Reference Device | ||
| Luna® G3 BPAP System(K212263) | Luna® G3 BPAP 25A(K201620) | Juno VPAP ST-A(K153061) | Comparison | |
| Pressure Range | CPAP mode: 4-20 cmH2OS, T, S/T mode:4-25 cmH2O for LG3800-25VT,4-30 cmH2O for LG3800-30VT | CPAP mode: 4-20cmH2OS mode: 4-25cmH2O | CPAP mode: 4-20 cmH2OS, T, S/T mode: 3-30 cmH2O | For LG3800-25VT, thepressure range isidentical to the predicate.For LG3800-30VT, thepressure range of CPAPmode is identical to thepredicate, while that of ST, S/T mode is similar tothe reference device. |
| Pressure DisplayAccuracy (hPa) | ±(0.8cmH2O+4%) | ±(0.8cmH2O+4%) | ±(0.5 cmH2O+4%) | Identical to predicate |
| Humidifier | ||||
| Integrated | Yes | Yes | Yes | Identical to predicate |
| HumidifierSettings | 1-5 (95 to 154.4°F/35 to68°C) | 1-5 (95 to 154.4°F/35 to68°C) | 1-8 | Identical to predicate |
| Physical Characteristics | ||||
| Dimensions | 265 × 145×114 mm(with integrated humidifier) | 265 × 145×114 mm(with integratedhumidifier) | 255 mm x 150 mm x 116 mm(with integratedhumidifier) | Identical to predicate |
| Weight | 1.7kg (with integratedhumidifier) | 1.7kg (with integratedhumidifier) | 1.336kg (with integratedhumidifier) | Identical to predicate |
| AC PowerConsumption | 100-240V, 50/60Hz, 2.0A | 100-240V, 50/60Hz, 2.0A | 100-240 V AC, 50-60 Hz,1.0-1.5A | Identical to predicate |
| Subject Device | Predicate Device | Reference Device | ||
| Luna® G3 BPAP System(K212263) | Luna® G3 BPAP 25A(K201620) | Juno VPAP ST-A(K153061) | Comparison | |
| IEC 60601Classification | Class II, Type BF | Class II, Type BF | Class II, Type BF | Identical to predicate |
| Degree ofProtectionAgainst WaterIngress | IP22 | IP22 | IP22 | Identical to predicate |
| Sound PressureLevel | < 26 dB, when the device isworking at the pressure of 10cmH20. | < 26 dB, when the device isworking at the pressure of10 cmH2O. | < 27 dB, when the device isworking at the pressure of 10cmH2O. | Identical to predicate |
| Air Filter | Available | Available | Available | Identical to predicate |
| Non-heatedTubing | AvailableModel: L1 | AvailableModel: L1 | Available | Identical to predicate |
| Heated Tubing | AvailableModel: LH1 | AvailableModel: LH1 | Available | Identical to predicate |
| Cellular Module | Available4G Module | Available4G Module | Available | Identical to predicate |
| Operating Conditions | ||||
| AtmosphericPressure | 760 to 1060 cmH2O | 760 to 1060 cmH2O | 738 to 1013 cmH2O | Identical to predicate |
| OperatingAltitude | 0 to 8,000 ft | 0 to 8,000 ft | 0 to 8,500 ft | Identical to predicate |
| OperatingTemperature | 5°C to 35°C (41°F to 95°F) | 5°C to 35°C (41°F to 95°F) | 5°C to 35°C (41°F to 95°F) | Identical to predicate |
| OperatingHumidity | 15% to 93% non-condensing | 15% to 93% non-condensing | 10 to 95% relative humidity,non-condensing | Identical to predicate |
| Shipping and Storage Conditions | ||||
| Shipping /StorageTemperature | -25°C to 70°C | -25°C to 70°C | -20°C to +60°C | Identical to predicate |
| Shipping /StorageHumidity | 15% to 93% non-condensing | 15% to 93% non-condensing | 5% to 95% relativehumidity, non-condensing | Identical to predicate |
| Data Reporting | ||||
| iCode® | Available | Available | NA | Identical to predicate |
| iCodeConnect®Software | Available | Available | NA | Identical to predicate |
| Reprocessing | ||||
| Single-patient Use | Yes | Yes | Single patient use in thehome environment and re-use in ahospital/institutionalenvironment | Identical to predicate |
| Sterilization/Reuse | Not provided sterile.Reusable with cleaninginstructions | Not provided sterile.Reusable with cleaninginstructions | When the device is used formultiple patients, thecleanable parts should becleaned and disinfectedbetween each patient use. Ifthe cleanable parts are being | Identical to predicate |
| to the cleaning instructionsin the User Guide. | ||||
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
Non-Clinical Performance Testing:
The following performance data were used in support of the substantial equivalence determination.
> Biocompatibility Evaluation:
The subject device is categorized as permanent contact duration (>30 days) including dry and humidified gas pathways. As the subject device has no changes in material, manufacturing process, and hardware from the predicate (K201620, same manufacturer/sponsor), the following Biocompatibility testing from the predicate submission were leveraged to support substantial equivalence:
-
· ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
• FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016 -
· ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
-
· ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
•ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process
- ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 2: Tests for emissions of particulate matter
- ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 3: Tests for emissions of volatile organic compounds (VOCs)
• ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
Additionally, to verify the biocompatibility of the subject device during the vole, the following testing was conducted post accelerated aging. The accelerated aging test was use of the subject device under worst case conditions over the whole life cycle.
- ISO18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 2: Tests for emissions of . particulate matter
- ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 3: Tests for emissions of . volatile organic compounds (VOCs)
{13}------------------------------------------------
>> Electromagnetic Compatibility:
EMC Testing was conducted on the subject device in accordance with the following standard:
· IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - requirements and tests
>> Performance Testing:
Testing was conducted on the subject device in accordance with the following standards for performance evaluation:
• ISO 80601-2-70:2015 Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnea breathing therapy equipment.
• ISO 80601-2-74:2017 Medical electrical equipments for basic safety and essential performance of respiratory humidifying equipment
The following performance comparison testing was conducted on the subject device as well as the predicate and reference devices, to support the substantial equivalence:
- Maximum flow rate .
- Static pressure .
- Dynamic pressure .
- Sound pressure level .
- Rise time .
- Display accuracy .
- Pressure conversion .
>> Software Verification and Validation:
Software verification and validation 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"
{14}------------------------------------------------
> Other Non-clinical Performance Testing
The subject device has no changes in manufacturing process, and hardware from the predicate (K201620, same manufacturer/sponsor). Therefore, the following testing from the predicate submission were leveraged to support substantial equivalence.
- Reprocessing .
- Electrical safety .
- Mechanical safety .
- Cybersecurity .
Conclusion
The subject device and the predicate device have intended use. They are identical in terms of structure, material and basic algorithm. Risk analysis, EMC testing, and performance comparison testing demonstrated that the 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).