Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related concepts like neural networks, training data, or specific algorithms associated with AI/ML. The device description focuses on basic heating and humidification functions.

Therapeutic

Yes

The device is designed to add moisture and warm breathing gases for administration to patients, which is a therapeutic function to improve respiratory comfort and alleviate issues associated with dry or cold oxygen.

Diagnostic

No.
The O₂asis Personal Oxygen Humidifier is designed to add moisture and warm breathing gases for administration to patients; it does not collect information to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "self-contained, palm-sized, mobile device" that "provides heat and humidified gas," indicating it is a physical hardware device with heating and humidification components, not solely software. The mention of "Software Verification and Validation" in the performance studies refers to the software within the hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
Device Function: The O2asis Personal Oxygen Humidifier's intended use and device description clearly state its function is to add moisture and potentially warm breathing gases for administration to patients. It works with an external gas source and delivers the gas via a nasal cannula.
Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its purpose is to modify the gas being delivered to the patient, not to test something from the patient.

Therefore, the O2asis Personal Oxygen Humidifier falls under the category of a respiratory support device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

BTT

Device Description

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.

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

infant, pediatric and adult patients

Intended User / Care Setting

home, hospital, and clinical settings.

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

Bench testing was performed involving the following standards: ISO 80601-2-74:2017 (Particular requirements for basic safety and essential performance of respiratory humidifying equipment), AAMI 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, Cross-contamination transfer, Effects of Age and Durability, Software Verification and Validation.
Results: The device met the applicable performance requirements for the applicable standards.

Biocompatibility testing was performed and included: 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.
Results: 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.

Key Metrics

Not Found

Predicate Device(s)

K042245

Reference Device(s)

K041693

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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)

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FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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Date Prepared:	04-Nov-2020
Sponsor:
Perma Pure LLC
1001 New Hampshire Ave
Lakewood, NJ 08701
Sponsor Contact:	Sidra Hankins, RA/QA
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-
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.
Principle of Operation:	The O₂asis Personal Oxygen Humidifier is a respiratory
humidifier that provides a heat source, temperature
control to heat and humidify dry respiratory gases. It
uses semi-permeable membrane technology to deliver
water vapor to dry gas.
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.
Patient Population:	Infant, pediatric and adult patients.
Environments of use:	Home, hospital, and clinical environments.

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Substantial Equivalence Comparison

| Attribute | Proposed
O2asis Personal Oxygen
Humidifier | Predicate
Vapotherm 2000i | Discussion |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K193411 | K042245 | N/A |
| Classification | BTT - Humidifier, Respiratory Gas
(Direct Patient Interface)
CFR 868.5450 | BTT - Humidifier,
Respiratory Gas (Direct
Patient Interface)
CFR 868.5450 | No |
| 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. | The Vapotherm™ 2000h
and 2000i are designed to
add moisture to and to
warm breathing gases for
administration to patients,
including neonates/infant,
pediatrics, and adults. The
flow rates may be from I to
40 liters per minute via
nasal cannula. | Similar Subject device is
within the range of
predicate, Vapotherm
which has a range of flow
rates based upon the
disposable cartridge 1 to 8
lpm and up to 40 Lpm. It
is intended for high flow
while the subject device is
not. |
| Principle of Operation | Humidity transfer via membrane
transfer with tubing submerged in
distilled water where water
molecules then are picked up by the
stream of dry gases.
Heat is supplied by a heater plate,
but the device can also provide
humidity in a non-heated mode | Humidity transfer through
membrane fibers that are
surrounded by warm water.
Heat is supplied by
circulating heated water
around the gas delivery
tube. | No. This difference does
not raise new concerns as
the use of membrane
technology is similar to the
predicate Vapotherm
Model 2000i, K042245. |
| Patient Population | Infants, Pediatrics, Adults | Neonates / Infants,
Pediatrics
Adults | Similar. The proposed
device has narrower
population. |
| Environments of use | Home, hospital, and clinical setting | Home, Hospital, Sub-acute
Institutions | Similar |
| Connection to other
devices | Oxygen concentrator or other gas
source | Wall gas source | Similar |
| Patient interface | Standard nasal cannula | Specific nasal cannula for
high flow device | Similar, subject device
delivers subset of flow
range delivered by the
Vapotherm |
| Prescriptive | Yes | Yes | Similar |
| Water source | Distilled water | Sterile | Similar. Testing has
demonstrated that the
proposed device does not
transfer any contaminates. |
| | 510(k) Summary | | |
| Attribute | O2asis Personal Oxygen
Humidifier | Predicate
Vapotherm 2000i | Discussion |
| Water reservoir | Water Well Chamber
Can be refilled
Up to 30 days use | No internal reservoir, water
is supplied via a hang-up
bag | Similar. Each use water to
generate humidity.
Vapotherm and the subject
device both have a
reservoir which supplies
water to be transferred
across the membrane. |
| Connections | Inlet from gas source
Outlet to patient
Port for refilling water well | Inlet from gas source
Outlet to patient
Water is autofilled from a
bag | Similar |
| Heating source | Heater plate and heated patient
tubing | Heater of surrounding water
for the heated patient tubing | Similar. Both heat the
humidified gas with an
externally heated outer
tube |
| Basic components | Heater
Water Well Chamber
Heated tube
Nasal Cannula
Pump to fill water well chamber
from bottles | Heater
Reservoir bag for water
Heated tube
Nasal Cannula
Filled from water bag | Similar |
| Performance testing | ISO 80601-2-74 (Respiratory
Humidifying Equipment) | ISO 8185 (Respiratory
Humidifying Equipment) | Similar. ISO 8185 was
replaced by ISO 80601-2-
74 |
| Flow rate range | 0.5 to 6 Lpm based upon clinician
judgement | 1 to 40 Lpm
Pediatric Cartridge - 1 to 8
Lpm | Similar. The subject device
is intended for low flow
oxygen therapy while the
predicate is a high flow
system but can deliver the
lower flow rates. |
| Heated Patient
Delivery Tube
Temperature | Up to 41°C at exit of nasal cannula
Passive temperature - ambient
room temperature | Up to 41°C

95% RH | Similar. The propose
device can deliver
humidity as a passive
device whereas the
predicate cannot. |
| Adjustable heat and
Humidity Levels | 3 pres-set temperature levels
Low - 34°C, Medium - 36°C
High - 39°C | Adjustable temperature and
flow settings | Similar
Vapotherm is adjustable |
| Humidification Output | Up to 49 mg H2O/1
Depends upon flow rate, ambient
temperature and heat setting | 40-50 mg H2O/1
Depends upon flow rate and
heat setting | Similar
Humidification output
varies with flow and
temperature settings. |
| ?Biocompatibility | Gas Pathway
Externally Communicating
Tissue, Permanent Duration (>30
days)
Cannula
Surface Contact
Mucosa, Permanent Duration (>30
days) | Gas Pathway
Externally Communicating
Tissue, Permanent Duration
(>30 days)
Cannula
Surface Contact
Mucosa, Permanent
Duration (>30 days) | Similar |
| Connectors | Standard oxygen tube fitting
Luer fitting for water refill port | Proprietary cartridge and
fittings to proprietary
cannula | Similar |

Table 1 – Comparison – Subject vs. Predicate

5

K193411
Page 3 of 6

6

Table 2 – Reference vs. proposed

| Attribute | Proposed
O₂asis Personal Oxygen
Humidifier | Reference
American Bantex | Discussion |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K193411 | K041963 | N/A |
| Classification | BTT - Humidifier,
Respiratory Gas (Direct
Patient Interface)
CFR 868.5450 | BTT - Humidifier,
Respiratory Gas (Direct
Patient Interface)
CFR 868.5450 | No |
| Indications for Use | The O₂asis 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 American Bantex
Humidifier is intended for use
with oxygen concentrators or
gas sources in a patient's
home, physician's office or
hospital / institutional
environment. The humidifier
increases the moisture content
of the airstream gases for
administration directly to the
patient | No, The predicate
does not mention
flow rate and does
not provide warmth |
| Principle of Operation | Humidity transfer via Nafion
tubing submerged in distilled
water where water molecules
then are picked up by the
stream of dry gases.

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.