(339 days)
The O2asis Personal Oxygen Humidifier is indicated to add moisture and may warm breathing gases for administration to infant, pediatric and adult patients in the home, hospital, and clinical settings. It is used with an external gas source of up to 6 Lpm via nasal cannula.
The O₂asis Personal Oxygen Humidifier is a self-contained, palm-sized, mobile device, making it possible for an individual to move the system to a new location without assistance. The O₂asis Personal OxygenHumidifier provides heat and humidified gas when used with a home oxygen concentrator or cylinder supply with flow rates up to 6 lpm. The subject device humidifies and heats the gas (oxygen) and delivers the warmed gas via a nasal cannula. When unplugged, the subject device provides passive humidification but no heat.
The Perma Pure LLC O2asis Personal Oxygen Humidifier, intended to add moisture and potentially warm breathing gases for patients, underwent various non-clinical testing to demonstrate its performance and substantial equivalence to predicate devices. The information provided heavily focuses on the comparison with predicate and reference devices and a summary of the types of tests conducted rather than a detailed study report with specific acceptance criteria and performance results in a table format.
Based on the provided information, the following can be extracted, acknowledging that detailed performance metrics and acceptance criteria values are largely absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Test | Acceptance Criteria (if specified) | Reported Device Performance (if specified) |
|---|---|---|---|
| Performance | Humidification Output | 40-50 mg H2O/L (predicate) | Up to 49 mg H2O/L (similar to predicate) |
| Heated Patient Delivery Tube O2 Temperature | Up to 41°C at exit of nasal cannula | Up to 41°C at exit of nasal cannula | |
| Adjustable heat and Humidity Levels | Adjustable temperature and flow settings (predicate) | 3 pre-set temperature levels (Low - 34°C, Medium - 36°C, High - 39°C) | |
| Flow rate range | 1 to 40 Lpm (predicate) | 0.5 to 6 Lpm (low flow subset of predicate) | |
| Safety & Essential Performance | ISO 80601-2-74:2017 (Respiratory Humidifying Equipment) | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" |
| AAMI ANSI ES 60601-1: 2005 +A1: 2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" | |
| Electromagnetic Compatibility | IEC 60601-1-2: 2014 (Collateral standard: Electromagnetic disturbances Requirements O and Tests) | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" |
| IEC 60601-1-11: 2015 (Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare Environment) | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" | |
| AIM Standard 7351731 Rev. 2.00 2017-02-23 (Medical Electrical Equipment and System O Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers) | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" | |
| Device Functionality | Humidifier Active and Passive Performance | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" |
| Cleaning & Durability | Cleaning compatibility | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" |
| Cross-contamination transfer | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" | |
| Effects of Age and Durability | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" | |
| Software | Software Verification and Validation | Not explicitly detailed but implied compliance | "The device meet the applicable performance for the applicable standards" |
| Biocompatibility | ISO 10993-5:2009 (Cytotoxicity) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." |
| ISO 10993-10:2010 (Sensitization and Irritation) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." | |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." | |
| ISO 10993-18:2020 (Chemical Characterization) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." | |
| ISO 18562-2:2017 (Particulate Matter) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." | |
| ISO 18562-3:2017 (VOC Compounds) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." | |
| ISO 18562-4:2017 (Leachables in Condensate) | Not explicitly detailed but implied compliance | "The materials were found to meet the applicable endpoints of the specific tests." | |
| Human Factors/Usability | FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices:2016 | Implied compliance with guidance | "A Human Factors / usability study was performed with the user population" |
Note on "Acceptance Criteria" and "Reported Device Performance": The document primarily lists the types of tests performed and broad statements of compliance ("The device meet the applicable performance for the applicable standards" or "The materials were found to meet the applicable endpoints"). Specific quantitative acceptance criteria and detailed performance results are generally not provided in this summary. The table uses predicate device performance as a proxy for implied acceptance criteria where available (e.g., humidification output).
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document describes non-clinical bench testing, biocompatibility testing, and a human factors study, but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature for any data collection). The tests appear to be conducted on the device itself (bench testing) or its components (biocompatibility).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The testing described is primarily non-clinical (bench, biocompatibility, software V&V, human factors). There is no mention of an expert panel establishing ground truth for a test set in the context of clinical imagery review or similar applications. The "Human Factors / Usability" study mentions a "user population," implying participation from intended users, but details on their qualifications or how "ground truth" was established are absent for this type of test.
4. Adjudication Method for the Test Set
This information is not provided. As the tests are non-clinical and do not involve diagnostic interpretation or multi-reader review, an adjudication method as typically understood in those contexts is not applicable or detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The device is a physical humidifier; its evaluation does not involve diagnostic image interpretation or AI assistance to human readers in a way that an MRMC study would be relevant.
6. If a Standalone (Algorithm Only) Performance Study Was Done
This is not applicable as the O2asis Personal Oxygen Humidifier is a physical medical device, not an algorithm or AI software. Therefore, no standalone algorithm-only performance study was conducted.
7. The Type of Ground Truth Used
For the non-clinical tests described, the "ground truth" is based on adherence to:
- Engineering and Performance Standards: The device's physical performance (e.g., humidification output, temperature, flow rates) is measured against the specifications of relevant ISO and IEC standards.
- Biocompatibility Standards: The materials are tested against endpoints defined in ISO 10993 and ISO 18562 series.
- FDA Guidance Documents: For human factors/usability, the study adheres to FDA guidance, implying that successful completion against the guidance's recommendations constitutes the ground truth for usability.
- Design Specifications: Implicitly, the device's design and functionality are tested against its own pre-defined specifications.
There is no mention of "expert consensus," "pathology," or "outcomes data" as ground truth in the context of this device's evaluation, as these are typically relevant for diagnostic or treatment efficacy studies.
8. The Sample Size for the Training Set
This is not applicable. The O2asis Personal Oxygen Humidifier is a hardware device; it does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.
Perma Pure LLC % Paul Dryden President - consultant to Perma Pure Perma Pure LLC c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K193411
Trade/Device Name: O2asis Personal Oxygen Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: October 9, 2020 Received: October 13, 2020
Dear Paul Dryden:
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,
Brandon Blakely, PhD Assistant Director (Acting) 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
K193411
Device Name
O2asis Personal Oxygen Humidifier
Indications for Use (Describe)
The O2asis Personal Oxygen Humidifier is indicated to add moisture and may warm breathing gases for administration to infant, pediatric and adult patients in the home, hospital, and clinical settings. It is used with an external gas source of up to 6 Lpm via nasal cannula.
Type of Use (Select one or both, as applicable)
XX 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 respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
{3}------------------------------------------------
| Date Prepared: | 04-Nov-2020 |
|---|---|
| Sponsor:Perma Pure LLC1001 New Hampshire AveLakewood, NJ 08701 | |
| Sponsor Contact: | Sidra Hankins, RA/QAT - 732-244-0010 |
| Proprietary or Trade Name: | O₂asis Personal Oxygen Humidifier |
| Common/Usual Name: | Humidifier, Respiratory Gas (Direct Patient Interface) |
| Classification Name: | Respiratory gas humidifier |
| Classification: | Class II |
| Product Code: | BTT |
| Regulation Number: | 21CFR 868.5450 |
| Predicate Device: | K042245 - Vapotherm TM 2000h and 2000i |
| Reference Device: | K041693 – American Bantex |
| Device Description: | The O₂asis Personal Oxygen Humidifier is a self-contained, palm-sized, mobile device, making it possiblefor an individual to move the system to a new locationwithout assistance. The O₂asis PersonalOxygenHumidifier provides heat and humidified gaswhen used with a home oxygen concentrator or cylindersupply with flow rates up to 6 lpm. The subject devicehumidifies and heats the gas (oxygen) and delivers thewarmed gas via a nasal cannula. When unplugged, thesubject device provides passive humidification but noheat. |
| Principle of Operation: | The O₂asis Personal Oxygen Humidifier is a respiratoryhumidifier that provides a heat source, temperaturecontrol to heat and humidify dry respiratory gases. Ituses semi-permeable membrane technology to deliverwater vapor to dry gas. |
| Indications for Use: | The O₂asis personal Oxygen Humidifier is indicated toadd moisture and may warm breathing gases foradministration to infant, pediatric and adult patients inthe home, hospital, and clinical settings. It is used withan external gas source of up to 6 Lpm via nasal cannula. |
| Patient Population: | Infant, pediatric and adult patients. |
| Environments of use: | Home, hospital, and clinical environments. |
{4}------------------------------------------------
Substantial Equivalence Comparison
| Attribute | ProposedO2asis Personal OxygenHumidifier | PredicateVapotherm 2000i | Discussion |
|---|---|---|---|
| K# | K193411 | K042245 | N/A |
| Classification | BTT - Humidifier, Respiratory Gas(Direct Patient Interface)CFR 868.5450 | BTT - Humidifier,Respiratory Gas (DirectPatient Interface)CFR 868.5450 | No |
| Indications for Use | The O2asis Personal OxygenHumidifier is indicated to addmoisture and may warm breathinggases for administration to infant,pediatric and adult patients in thehome, hospital, and clinicalsettings. It is used with an externalgas source of up to 6 Lpm via nasalcannula. | The Vapotherm™ 2000hand 2000i are designed toadd moisture to and towarm breathing gases foradministration to patients,including neonates/infant,pediatrics, and adults. Theflow rates may be from I to40 liters per minute vianasal cannula. | Similar Subject device iswithin the range ofpredicate, Vapothermwhich has a range of flowrates based upon thedisposable cartridge 1 to 8lpm and up to 40 Lpm. Itis intended for high flowwhile the subject device isnot. |
| Principle of Operation | Humidity transfer via membranetransfer with tubing submerged indistilled water where watermolecules then are picked up by thestream of dry gases.Heat is supplied by a heater plate,but the device can also providehumidity in a non-heated mode | Humidity transfer throughmembrane fibers that aresurrounded by warm water.Heat is supplied bycirculating heated wateraround the gas deliverytube. | No. This difference doesnot raise new concerns asthe use of membranetechnology is similar to thepredicate VapothermModel 2000i, K042245. |
| Patient Population | Infants, Pediatrics, Adults | Neonates / Infants,PediatricsAdults | Similar. The proposeddevice has narrowerpopulation. |
| Environments of use | Home, hospital, and clinical setting | Home, Hospital, Sub-acuteInstitutions | Similar |
| Connection to otherdevices | Oxygen concentrator or other gassource | Wall gas source | Similar |
| Patient interface | Standard nasal cannula | Specific nasal cannula forhigh flow device | Similar, subject devicedelivers subset of flowrange delivered by theVapotherm |
| Prescriptive | Yes | Yes | Similar |
| Water source | Distilled water | Sterile | Similar. Testing hasdemonstrated that theproposed device does nottransfer any contaminates. |
| 510(k) Summary | |||
| Attribute | O2asis Personal OxygenHumidifier | PredicateVapotherm 2000i | Discussion |
| Water reservoir | Water Well ChamberCan be refilledUp to 30 days use | No internal reservoir, wateris supplied via a hang-upbag | Similar. Each use water togenerate humidity.Vapotherm and the subjectdevice both have areservoir which supplieswater to be transferredacross the membrane. |
| Connections | Inlet from gas sourceOutlet to patientPort for refilling water well | Inlet from gas sourceOutlet to patientWater is autofilled from abag | Similar |
| Heating source | Heater plate and heated patienttubing | Heater of surrounding waterfor the heated patient tubing | Similar. Both heat thehumidified gas with anexternally heated outertube |
| Basic components | HeaterWater Well ChamberHeated tubeNasal CannulaPump to fill water well chamberfrom bottles | HeaterReservoir bag for waterHeated tubeNasal CannulaFilled from water bag | Similar |
| Performance testing | ISO 80601-2-74 (RespiratoryHumidifying Equipment) | ISO 8185 (RespiratoryHumidifying Equipment) | Similar. ISO 8185 wasreplaced by ISO 80601-2-74 |
| Flow rate range | 0.5 to 6 Lpm based upon clinicianjudgement | 1 to 40 LpmPediatric Cartridge - 1 to 8Lpm | Similar. The subject deviceis intended for low flowoxygen therapy while thepredicate is a high flowsystem but can deliver thelower flow rates. |
| Heated PatientDelivery TubeTemperature | Up to 41°C at exit of nasal cannulaPassive temperature - ambientroom temperature | Up to 41°C>95% RH | Similar. The proposedevice can deliverhumidity as a passivedevice whereas thepredicate cannot. |
| Adjustable heat andHumidity Levels | 3 pres-set temperature levelsLow - 34°C, Medium - 36°CHigh - 39°C | Adjustable temperature andflow settings | SimilarVapotherm is adjustable |
| Humidification Output | Up to 49 mg H2O/1Depends upon flow rate, ambienttemperature and heat setting | 40-50 mg H2O/1Depends upon flow rate andheat setting | SimilarHumidification outputvaries with flow andtemperature settings. |
| ?Biocompatibility | Gas PathwayExternally CommunicatingTissue, Permanent Duration (>30days)CannulaSurface ContactMucosa, Permanent Duration (>30days) | Gas PathwayExternally CommunicatingTissue, Permanent Duration(>30 days)CannulaSurface ContactMucosa, PermanentDuration (>30 days) | Similar |
| Connectors | Standard oxygen tube fittingLuer fitting for water refill port | Proprietary cartridge andfittings to proprietarycannula | Similar |
Table 1 – Comparison – Subject vs. Predicate
{5}------------------------------------------------
K193411
Page 3 of 6
{6}------------------------------------------------
Table 2 – Reference vs. proposed
| Attribute | ProposedO₂asis Personal OxygenHumidifier | ReferenceAmerican Bantex | Discussion |
|---|---|---|---|
| K# | K193411 | K041963 | N/A |
| Classification | BTT - Humidifier,Respiratory Gas (DirectPatient Interface)CFR 868.5450 | BTT - Humidifier,Respiratory Gas (DirectPatient Interface)CFR 868.5450 | No |
| Indications for Use | The O₂asis Humidifier isindicated to add moisture andmay warm breathing gases foradministration to infant,pediatric and adult patients inthe home, hospital, andclinical settings. It is usedwith an external gas source ofup to 6 Lpm via nasal cannula. | The American BantexHumidifier is intended for usewith oxygen concentrators orgas sources in a patient'shome, physician's office orhospital / institutionalenvironment. The humidifierincreases the moisture contentof the airstream gases foradministration directly to thepatient | No, The predicatedoes not mentionflow rate and doesnot provide warmth |
| Principle of Operation | Humidity transfer via Nafiontubing submerged in distilledwater where water moleculesthen are picked up by thestream of dry gases.Heat is supplied by a heaterplate, but the device can alsoprovide humidity in a non-heated mode | Dry gases are bubbled througha container of distilled waterand in the process pick upmoisture to humidify the gasesbeing delivered to the patient | No. This differencedoes not raise newconcerns as the useof membranetechnology is similarto the predicateVapotherm Model2000i, K042245. |
| Patient Population | Infants, Pediatrics, Adults | Not specified by intended foruse with any patient onoxygen or a concentrator | NoThis predicate did notspecify population |
| Environments of use | Home, hospital, and clinicalsetting | Patients home, physician'soffice or hospital /institutional | No. |
| Connection to otherdevices | Oxygen concentrator or othergas source | Oxygen concentrator or othergas source | No. |
| Patient interface | Standard nasal cannula | Standard nasal cannula | No. |
| Water source | Distilled water | Distilled water | No. |
| Water reservoir | Water Well ChamberCan be refilledUp to 30 days use | Disposable BottleNo specified limitation asbottle is refillable | No |
| Connections | Inlet from gas sourceOutlet to patientPort for refilling water well | Inlet from gas sourceOutlet to patientAbility to refill by removinglid | No. |
| 510(k) Summary | |||
| Attribute | ProposedO2asis personal OxygenHumidifier | ReferenceAmerican Bantex | Discussion |
| Basic components | HeaterWater Well ChamberHeated tubeNasal CannulaPump to fill water wellchamber from bottles | Reservoir for waterNasal CannulaFilled from bottles | NoNo heating |
| BiocompatibilityTesting | ISO 10993-1ISO 18562 | Not available | Similar |
| Performance testing | ISO 80601-2-74 (RespiratoryHumidifying Equipment) | No data provided | Similar |
| Recommended flowrates | 0.5 to 6 Lpm based uponclinician judgement | Not specified but oxygenconcentrators have an upperflow rate limit of 6 Lpm | Similar |
| Heated PatientDelivery Tube O2Temperature | Up to 41ºC at exit of nasalcannulaPassive temperature - ambientroom temperature | No heat providedPassive temperature - ambientroom temperature | Similar. Referencedoes not provideactive heat. |
| Adjustable heat andHumidity Levels | 3 Levels of Heat andHumidity | No adjustments other thanflow rate into the device. | No. Reference doesnot provide activeheat. |
{7}------------------------------------------------
Non-Clinical Testing Summary -
Bench testing -
We performed tests related to the following standards:
- o ISO 80601-2-74:2017: Particular requirements for basic safety and essential performance of respirAAMI ANSI ES 60601-1: 2005 +Al: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2014 Collateral standard: Electromagnetic disturbances Requirements O and Tests
- IEC 60601-1-11: 2015 Collateral Standard: Requirements for medical electrical O equipment and medical electrical systems used in the home healthcare Environment
- AIM Standard 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and System O Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers Humidifier Active and Passive Performance
- Cleaning compatibility O
- Cross-contamination transfer O
- Effects of Age and Durability O
- Software Verification and Validation O
Discussion - The device meet the applicable performance for the applicable standards
{8}------------------------------------------------
Biocompatibility -
We performed and the results were : ISO 10993-5:2009 - Cytotoxicity ISO 10993-10:2010 - Sensitization and Irritation ISO 10993-11:2017 - Acute Systemic Toxicity ISO 10993-18:2020 - Chemical Characterization ISO 18562-2:2017 - Particulate Matter ISO 18562-3:2017 – VOC Compounds ISO 18562-4:2017 – Leachables in Condensate
The materials were found to meet the applicable endpoints of the specific tests.
Human Factors / Usability
A Human Factors / usability study was performed with the user population following FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices:2016.
Discussion of Differences -
There are no significant differences between the proposed device and the predicate and reference devices.
Conclusion
The performance testing has demonstrated that the subject devise met the applicable standard performance requirements.
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).