O2asis Personal Oxygen Humidifier
Device Facts
| Record ID | K193411 |
|---|---|
| Device Name | O2asis Personal Oxygen Humidifier |
| Applicant | Perma Pure, LLC |
| Product Code | BTT · Anesthesiology |
| Decision Date | Nov 12, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5450 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
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.
Device Story
Self-contained, palm-sized, mobile respiratory humidifier; used with external oxygen concentrator or cylinder (up to 6 Lpm). Inputs: dry oxygen gas; distilled water. Principle: semi-permeable membrane technology (Nafion tubing) transfers water vapor to gas stream; heater plate and heated patient tubing provide active warming. Outputs: warmed, humidified oxygen delivered via nasal cannula. Operates in active (heated) or passive (non-heated) modes. Used in home, hospital, or clinical settings by patients or clinicians. Provides 3 preset temperature levels (34°C, 36°C, 39°C). Benefits: prevents mucosal drying and provides comfort during oxygen therapy.
Clinical Evidence
Bench testing only. Testing included ISO 80601-2-74 (respiratory humidifying equipment), AAMI ANSI ES 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), and AIM 7351731 (RFID immunity). Biocompatibility testing performed per ISO 10993 and ISO 18562 series (cytotoxicity, sensitization, irritation, systemic toxicity, particulates, VOCs, leachables). Human factors/usability study conducted per FDA 2016 guidance.
Technological Characteristics
Materials: Nafion membrane, heated patient tubing. Energy: Electrical (heater plate). Dimensions: Palm-sized. Connectivity: Standalone. Sterilization: Not specified. Software: Embedded firmware for temperature control (3 preset levels). Standards: ISO 80601-2-74, ISO 10993, ISO 18562, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11.
Indications for Use
Indicated for infant, pediatric, and adult patients requiring supplemental oxygen therapy via nasal cannula at flow rates up to 6 Lpm in home, hospital, or clinical settings.
Regulatory Classification
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.
Predicate Devices
- Vapotherm 2000h and 2000i (K042245)
Reference Devices
- American Bantex (K041693)
Submission Summary (Full Text)
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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
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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,
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
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# 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)
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| Date Prepared: | 04-Nov-2020 |
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor:<br>Perma Pure LLC<br>1001 New Hampshire Ave<br>Lakewood, NJ 08701 | |
| Sponsor Contact: | Sidra Hankins, RA/QA<br>T - 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-<br>contained, palm-sized, mobile device, making it possible<br>for an individual to move the system to a new location<br>without assistance. The O₂asis Personal<br>OxygenHumidifier provides heat and humidified gas<br>when used with a home oxygen concentrator or cylinder<br>supply with flow rates up to 6 lpm. The subject device<br>humidifies and heats the gas (oxygen) and delivers the<br>warmed gas via a nasal cannula. When unplugged, the<br>subject device provides passive humidification but no<br>heat. |
| Principle of Operation: | The O₂asis Personal Oxygen Humidifier is a respiratory<br>humidifier that provides a heat source, temperature<br>control to heat and humidify dry respiratory gases. It<br>uses semi-permeable membrane technology to deliver<br>water vapor to dry gas. |
| Indications for Use: | The O₂asis personal Oxygen Humidifier is indicated to<br>add moisture and may warm breathing gases for<br>administration to infant, pediatric and adult patients in<br>the home, hospital, and clinical settings. It is used with<br>an 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. |
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# Substantial Equivalence Comparison
| Attribute | Proposed<br>O2asis Personal Oxygen<br>Humidifier | Predicate<br>Vapotherm 2000i | Discussion |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K193411 | K042245 | N/A |
| Classification | BTT - Humidifier, Respiratory Gas<br>(Direct Patient Interface)<br>CFR 868.5450 | BTT - Humidifier,<br>Respiratory Gas (Direct<br>Patient Interface)<br>CFR 868.5450 | No |
| Indications for Use | The O2asis Personal Oxygen<br>Humidifier is indicated to add<br>moisture and may warm breathing<br>gases for administration to infant,<br>pediatric and adult patients in the<br>home, hospital, and clinical<br>settings. It is used with an external<br>gas source of up to 6 Lpm via nasal<br>cannula. | The Vapotherm™ 2000h<br>and 2000i are designed to<br>add moisture to and to<br>warm breathing gases for<br>administration to patients,<br>including neonates/infant,<br>pediatrics, and adults. The<br>flow rates may be from I to<br>40 liters per minute via<br>nasal cannula. | Similar Subject device is<br>within the range of<br>predicate, Vapotherm<br>which has a range of flow<br>rates based upon the<br>disposable cartridge 1 to 8<br>lpm and up to 40 Lpm. It<br>is intended for high flow<br>while the subject device is<br>not. |
| Principle of Operation | Humidity transfer via membrane<br>transfer with tubing submerged in<br>distilled water where water<br>molecules then are picked up by the<br>stream of dry gases.<br>Heat is supplied by a heater plate,<br>but the device can also provide<br>humidity in a non-heated mode | Humidity transfer through<br>membrane fibers that are<br>surrounded by warm water.<br>Heat is supplied by<br>circulating heated water<br>around the gas delivery<br>tube. | No. This difference does<br>not raise new concerns as<br>the use of membrane<br>technology is similar to the<br>predicate Vapotherm<br>Model 2000i, K042245. |
| Patient Population | Infants, Pediatrics, Adults | Neonates / Infants,<br>Pediatrics<br>Adults | Similar. The proposed<br>device has narrower<br>population. |
| Environments of use | Home, hospital, and clinical setting | Home, Hospital, Sub-acute<br>Institutions | Similar |
| Connection to other<br>devices | Oxygen concentrator or other gas<br>source | Wall gas source | Similar |
| Patient interface | Standard nasal cannula | Specific nasal cannula for<br>high flow device | Similar, subject device<br>delivers subset of flow<br>range delivered by the<br>Vapotherm |
| Prescriptive | Yes | Yes | Similar |
| Water source | Distilled water | Sterile | Similar. Testing has<br>demonstrated that the<br>proposed device does not<br>transfer any contaminates. |
| | 510(k) Summary | | |
| Attribute | O2asis Personal Oxygen<br>Humidifier | Predicate<br>Vapotherm 2000i | Discussion |
| Water reservoir | Water Well Chamber<br>Can be refilled<br>Up to 30 days use | No internal reservoir, water<br>is supplied via a hang-up<br>bag | Similar. Each use water to<br>generate humidity.<br>Vapotherm and the subject<br>device both have a<br>reservoir which supplies<br>water to be transferred<br>across the membrane. |
| Connections | Inlet from gas source<br>Outlet to patient<br>Port for refilling water well | Inlet from gas source<br>Outlet to patient<br>Water is autofilled from a<br>bag | Similar |
| Heating source | Heater plate and heated patient<br>tubing | Heater of surrounding water<br>for the heated patient tubing | Similar. Both heat the<br>humidified gas with an<br>externally heated outer<br>tube |
| Basic components | Heater<br>Water Well Chamber<br>Heated tube<br>Nasal Cannula<br>Pump to fill water well chamber<br>from bottles | Heater<br>Reservoir bag for water<br>Heated tube<br>Nasal Cannula<br>Filled from water bag | Similar |
| Performance testing | ISO 80601-2-74 (Respiratory<br>Humidifying Equipment) | ISO 8185 (Respiratory<br>Humidifying Equipment) | Similar. ISO 8185 was<br>replaced by ISO 80601-2-<br>74 |
| Flow rate range | 0.5 to 6 Lpm based upon clinician<br>judgement | 1 to 40 Lpm<br>Pediatric Cartridge - 1 to 8<br>Lpm | Similar. The subject device<br>is intended for low flow<br>oxygen therapy while the<br>predicate is a high flow<br>system but can deliver the<br>lower flow rates. |
| Heated Patient<br>Delivery Tube<br>Temperature | Up to 41°C at exit of nasal cannula<br>Passive temperature - ambient<br>room temperature | Up to 41°C<br>>95% RH | Similar. The propose<br>device can deliver<br>humidity as a passive<br>device whereas the<br>predicate cannot. |
| Adjustable heat and<br>Humidity Levels | 3 pres-set temperature levels<br>Low - 34°C, Medium - 36°C<br>High - 39°C | Adjustable temperature and<br>flow settings | Similar<br>Vapotherm is adjustable |
| Humidification Output | Up to 49 mg H2O/1<br>Depends upon flow rate, ambient<br>temperature and heat setting | 40-50 mg H2O/1<br>Depends upon flow rate and<br>heat setting | Similar<br>Humidification output<br>varies with flow and<br>temperature settings. |
| ?Biocompatibility | Gas Pathway<br>Externally Communicating<br>Tissue, Permanent Duration (>30<br>days)<br>Cannula<br>Surface Contact<br>Mucosa, Permanent Duration (>30<br>days) | Gas Pathway<br>Externally Communicating<br>Tissue, Permanent Duration<br>(>30 days)<br>Cannula<br>Surface Contact<br>Mucosa, Permanent<br>Duration (>30 days) | Similar |
| Connectors | Standard oxygen tube fitting<br>Luer fitting for water refill port | Proprietary cartridge and<br>fittings to proprietary<br>cannula | Similar |
## Table 1 – Comparison – Subject vs. Predicate
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# Table 2 – Reference vs. proposed
| Attribute | Proposed<br>O₂asis Personal Oxygen<br>Humidifier | Reference<br>American Bantex | Discussion |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K193411 | K041963 | N/A |
| Classification | BTT - Humidifier,<br>Respiratory Gas (Direct<br>Patient Interface)<br>CFR 868.5450 | BTT - Humidifier,<br>Respiratory Gas (Direct<br>Patient Interface)<br>CFR 868.5450 | No |
| Indications for Use | The O₂asis Humidifier is<br>indicated to add moisture and<br>may warm breathing gases for<br>administration to infant,<br>pediatric and adult patients in<br>the home, hospital, and<br>clinical settings. It is used<br>with an external gas source of<br>up to 6 Lpm via nasal cannula. | The American Bantex<br>Humidifier is intended for use<br>with oxygen concentrators or<br>gas sources in a patient's<br>home, physician's office or<br>hospital / institutional<br>environment. The humidifier<br>increases the moisture content<br>of the airstream gases for<br>administration directly to the<br>patient | No, The predicate<br>does not mention<br>flow rate and does<br>not provide warmth |
| Principle of Operation | Humidity transfer via Nafion<br>tubing submerged in distilled<br>water where water molecules<br>then are picked up by the<br>stream of dry gases.<br><br>Heat is supplied by a heater<br>plate, but the device can also<br>provide humidity in a non-<br>heated mode | Dry gases are bubbled through<br>a container of distilled water<br>and in the process pick up<br>moisture to humidify the gases<br>being delivered to the patient | No. This difference<br>does not raise new<br>concerns as the use<br>of membrane<br>technology is similar<br>to the predicate<br>Vapotherm Model<br>2000i, K042245. |
| Patient Population | Infants, Pediatrics, Adults | Not specified by intended for<br>use with any patient on<br>oxygen or a concentrator | No<br>This predicate did not<br>specify population |
| Environments of use | Home, hospital, and clinical<br>setting | Patients home, physician's<br>office or hospital /<br>institutional | No. |
| Connection to other<br>devices | Oxygen concentrator or other<br>gas source | Oxygen concentrator or other<br>gas source | No. |
| Patient interface | Standard nasal cannula | Standard nasal cannula | No. |
| Water source | Distilled water | Distilled water | No. |
| Water reservoir | Water Well Chamber<br>Can be refilled<br>Up to 30 days use | Disposable Bottle<br>No specified limitation as<br>bottle is refillable | No |
| Connections | Inlet from gas source<br>Outlet to patient<br>Port for refilling water well | Inlet from gas source<br>Outlet to patient<br>Ability to refill by removing<br>lid | No. |
| 510(k) Summary | | | |
| Attribute | Proposed<br>O2asis personal Oxygen<br>Humidifier | Reference<br>American Bantex | Discussion |
| Basic components | Heater<br>Water Well Chamber<br>Heated tube<br>Nasal Cannula<br>Pump to fill water well<br>chamber from bottles | Reservoir for water<br>Nasal Cannula<br>Filled from bottles | No<br>No heating |
| Biocompatibility<br>Testing | ISO 10993-1<br>ISO 18562 | Not available | Similar |
| Performance testing | ISO 80601-2-74 (Respiratory<br>Humidifying Equipment) | No data provided | Similar |
| Recommended flow<br>rates | 0.5 to 6 Lpm based upon<br>clinician judgement | Not specified but oxygen<br>concentrators have an upper<br>flow rate limit of 6 Lpm | Similar |
| Heated Patient<br>Delivery Tube O2<br>Temperature | Up to 41ºC at exit of nasal<br>cannula<br>Passive temperature - ambient<br>room temperature | No heat provided<br>Passive temperature - ambient<br>room temperature | Similar. Reference<br>does not provide<br>active heat. |
| Adjustable heat and<br>Humidity Levels | 3 Levels of Heat and<br>Humidity | No adjustments other than<br>flow rate into the device. | No. Reference does<br>not provide active<br>heat. |
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### 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
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### 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.
