(248 days)
Juno VPAP ST-A (K153061)
No
The document describes a standard Bi-level PAP device with microprocessor control and various therapy modes. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
Yes
The device is intended for the treatment of Obstructive Sleep Apnea (OSA), which is a medical condition, making it a therapeutic device.
No
The device description indicates it is a treatment device (Bi-level PAP device for Obstructive Sleep Apnea), not a diagnostic one.
No
The device description explicitly states it is a "microprocessor controlled, blower-based system" and mentions hardware design, indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Luna® G3 BPAP System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a device for treating Obstructive Sleep Apnea (OSA) by providing positive airway pressure. This is a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on the mechanical and software aspects of generating and controlling air pressure. It doesn't mention any analysis of biological samples (blood, urine, tissue, etc.), which is the core function of an IVD.
- Lack of IVD-related information: The document does not mention any of the typical elements associated with IVD devices, such as:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or prognosis based on biological sample analysis.
Therefore, the Luna® G3 BPAP System is a medical device used for therapy, not for in vitro diagnosis.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult
Intended User / Care Setting
single-patient use by prescription in the home or hospital/institutional environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
Biocompatibility Evaluation:
- 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
- Additional testing conducted post accelerated aging: ISO18562-2:2017 and ISO 18562-3:2017
Electromagnetic Compatibility:
- 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:
- 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
- Performance comparison testing (subject, predicate, and reference devices): Maximum flow rate, Static pressure, Dynamic pressure, Sound pressure level, Rise time, Display accuracy, Pressure conversion.
Software Verification and Validation:
- 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"
Other Non-clinical Performance Testing (leveraged from predicate submission):
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Luna G3 BPAP 25A (K201620)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Juno VPAP ST-A (K153061)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
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) |
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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 Estafanous |
| 3B 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-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 Description | 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). The pressure ranges and modes | |
| are listed as follows: |
| Product Name | Model | Pressure Range | Work Modes |
|---|---|---|---|
| Luna® G3 BPAP | |||
| 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.
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 | ||||
| Device | ||||
| Classification | Class II Device | Class II Device | Class II Device | Identical to predicate |
| Product Code | BZD | BZD | MNS | Identical to predicate |
| Classification | ||||
| Panel | Anesthesiology | Anesthesiology | Anesthesiology | Identical to predicate |
| Regulation | ||||
| 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 | ||||
| (K212263) | Luna® G3 BPAP 25A | |||
| (K201620) | Juno VPAP ST-A | |||
| (K153061) | Comparison | |||
| Indications | ||||
| For 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. | 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. | The Juno VPAP ST-A is | |||
| indicated to provide | ||||
| noninvasive ventilation for | ||||
| patients weighing more than | ||||
| 30lbs (13 kg) with | ||||
| respiratory insufficiency or | ||||
| obstructive sleep apnoea | ||||
| (OSA). | ||||
| The iVAPS mode is | ||||
| indicated for patients | ||||
| weighing more than 66lbs | ||||
| (30 kg). The Juno VPAP ST- | ||||
| A is intended for home and | ||||
| hospital use. | ||||
| The humidifier is intended | ||||
| for single patient use in the | ||||
| home environment and re- | ||||
| use in a | ||||
| hospital/institutional | ||||
| environment. | Identical to predicate | |||
| Pressure Delivery | ||||
| Therapy | ||||
| Delivered | CPAP, | |||
| S, | ||||
| T, | ||||
| S/T | CPAP, | |||
| AutoCPAP, | ||||
| S, | ||||
| Auto S | CPAP, | |||
| S, | ||||
| T, | ||||
| S/T, | ||||
| PAC, | ||||
| iVAPS | CPAP and S modes are | |||
| identical to predicate. T | ||||
| and S/T modes are | ||||
| identical to reference | ||||
| device. | ||||
| 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 cmH2O | |||
| S, T, S/T mode: | ||||
| 4-25 cmH2O for LG3800- | ||||
| 25VT, | ||||
| 4-30 cmH2O for LG3800- | ||||
| 30VT | CPAP mode: 4-20cmH2O | |||
| S mode: 4-25cmH2O | CPAP mode: 4-20 cmH2O | |||
| S, T, S/T mode: 3-30 cmH2O | For LG3800-25VT, the | |||
| pressure range is | ||||
| identical to the predicate. | ||||
| For LG3800-30VT, the | ||||
| pressure range of CPAP | ||||
| mode is identical to the | ||||
| predicate, while that of S | ||||
| T, S/T mode is similar to | ||||
| the reference device. | ||||
| Pressure Display | ||||
| Accuracy (hPa) | ±(0.8cmH2O+4%) | ±(0.8cmH2O+4%) | ±(0.5 cmH2O+4%) | Identical to predicate |
| Humidifier | ||||
| Integrated | Yes | Yes | Yes | Identical to predicate |
| Humidifier | ||||
| Settings | 1-5 (95 to 154.4°F/35 to | |||
| 68°C) | 1-5 (95 to 154.4°F/35 to | |||
| 68°C) | 1-8 | Identical to predicate | ||
| Physical Characteristics | ||||
| Dimensions | 265 × 145×114 mm | |||
| (with integrated humidifier) | 265 × 145×114 mm | |||
| (with integrated | ||||
| humidifier) | 255 mm x 150 mm x 116 mm | |||
| (with integrated | ||||
| humidifier) | Identical to predicate | |||
| Weight | 1.7kg (with integrated | |||
| humidifier) | 1.7kg (with integrated | |||
| humidifier) | 1.336kg (with integrated | |||
| humidifier) | Identical to predicate | |||
| AC Power | ||||
| Consumption | 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 60601 | ||||
| Classification | Class II, Type BF | Class II, Type BF | Class II, Type BF | Identical to predicate |
| Degree of | ||||
| Protection | ||||
| Against Water | ||||
| Ingress | IP22 | IP22 | IP22 | Identical to predicate |
| Sound Pressure | ||||
| Level | 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.