The BONHAWA Respiratory Humidifier is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing patients 20 kg and up, child to adults in hospitals. It adds heat and moisture to the flow of gases. The flow may be from 2 to 70 L/min depending on the patient interface.

The BONHAWA Respiratory Humidifier provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients without bypassed upper airways in hospitals.

Device Description

The BONHAWA Respiratory Humidifier is a heated humidifier with integrated blower, heater plate and heated breathing circuit that delivers warm and humidified respiratory gas to a patient via nasal cannula. A blower inside the device blends the externally provided oxygen with entrained filtered air and controls the gas flow rate delivered to the patient per the professional user established setting. An internal oxygen sensor monitors and reports the delivered oxygen concentration. The patient interface, heated breathing circuit chamber and chamber adapter are single use.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the BONHAWA Respiratory Humidifier. It focuses on demonstrating substantial equivalence to a predicate device (Airvo 2 Humidifier series) and a reference device (Airvo 3 High Flow Humidified Oxygen Delivery Device) based on technical characteristics and performance testing against recognized consensus standards.

However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device. The device described is a physical medical device (a respiratory humidifier), not an AI/ML-driven diagnostic or therapeutic software. Therefore, the specific questions related to AI/ML device performance metrics (e.g., sample size for test sets, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable and are not addressed in this filing.

The "Performance Testing" section (Page 11) states that substantial equivalence is based on:

Product validation and risk mitigation verification testing.
Meeting pertinent recognized consensus standards:
- ISO 80601-2-74:2017 (Respiratory humidifying equipment)
- IEC 60601-1:2005+AMD1:2012 (General requirements for basic safety and essential performance)
- IEC 60601-1-2:2014 +A1:2020 (Electromagnetic disturbances)
- IEC 60601-1-8 (Alarm systems)
- ISO 10993-1 (Biocompatibility)
- ISO 18562-1 (Biocompatibility of breathing gas pathways).

The table "Comparison of Technological Characteristics" (Pages 6, 7, 8, 9) effectively serves as the "acceptance criteria" through a direct comparison to the predicate and reference devices, demonstrating that the subject device's specifications are either identical or offer non-inferior performance without raising new safety or effectiveness concerns.

Given the nature of the device, the following points address the relevant aspects of your request based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate and reference devices, and adherence to relevant consensus standards. The "reported device performance" is presented through direct specifications and the claim of meeting the standards.

Attribute	Acceptance Criteria (Predicate/Reference Standard)	Reported Device Performance (BONHAWA Respiratory Humidifier)	Notes/Differences
Classification Name	Humidifier, Respiratory Gas (Direct Patient Interface) (Predicate)	Humidifier, Respiratory Gas (Direct Patient Interface)	Similar to the predicate.
Regulation Number	21 CFR 868.5450 (Predicate)	21 CFR 868.5450	Similar.
Indications for Use	High flow warmed and humidified respiratory gases for spontaneously breathing patients. (Predicate similar, Reference broader to include infants and sub-acute facilities, and bypassed upper airways).	High flow warmed and humidified respiratory gases for administration to spontaneously breathing patients 20 kg and up, child to adults in hospitals. Without bypassed upper airways.	The subject device includes a more specific lower weight limit (20kg and up) and explicitly excludes use with bypassed upper airways, aligning more closely with the predicate's narrower scope for non-bypassed upper airways. The overall intended use of delivering high flow breathing gases with humidification remains similar.
Environment of Use	Hospitals (Predicate: Hospitals and long-term care facilities; Reference: Hospitals and sub-acute facilities)	Hospitals	Similar but not for long-term facility use as the predicate.
Patient Population	Pediatric to Adult (Predicate) / Infant to Adults (Reference)	Pediatric patients, 20kg and above, and Adult	Similar. More specific starting weight.
Breathing Type	Spontaneously breathing	Spontaneously breathing	Similar.
Flow Rate	Predicate: up to 60 L/min; Reference: up to 70 L/min	Pediatric: 2 - 25 L/min, Adults: 10 - 70 L/min	Subject device's adult flow rate (70 lpm) matches the reference device and is higher than the predicate (60 lpm), which is considered acceptable for achieving intended FiO2 by matching patient inspiratory demand.
Operating Principle	Constant flow of warmed, humidified gas delivery via blower and humidifier	Constant flow of warmed, humidified gas delivery via blower and humidifier	Similar.
Oxygen Input Source	Low-Pressure Oxygen (LPO) low-pressure connector (from rotameter)	Low-Pressure Oxygen (LPO) low-pressure connector (from rotameter)	Similar. The reference device also has a High-Pressure Oxygen (HPO) inlet.
Humidity Source	Heated humidification chamber	Heated humidification chamber	Similar.
Humidity Performance	At 37°C >= to 33mg/L, At 34°C >= to 12mg/L, At 31°C >= to 12mg/L	At 37°C >= to 33mg/L, At 34°C >= to 12mg/L, At 31°C >= to 12mg/L	Similar.
Temperature Range	31 - 37 °C	31 - 37 °C (Adult: 37°C, 34°C, 31°C; Pediatric: 34°C)	Similar.
Ambient Operating Temp	18 – 28 °C	18 – 28 °C	Similar.
Alarms	Visual and audible alarm system; Mute button	Visual and audible alarm system; Mute button	Similar.
Patient Interfaces	Nasal cannula, Unsealed tracheostomy connector, Unsealed mask adapter (Predicate/Reference)	Nasal cannula	Similar for the patient without bypassed airway (which is the stated indication). The subject device does not include tracheostomy or mask adapter interfaces.
Heated Breathing Tube	Single-lumen, spiral heater wires	Single-lumen, spiral heater wires	Similar.
Duration of Use	14 Days single patient use	14 Days single patient use	Similar.
Oxygen Concentration	Input Oxygen < 60 lpm (Predicate); Input Oxygen < 70 lpm (Reference)	Input Oxygen < 80 lpm; O2 concentration mixing of 21 to 100%	Substantially equivalent, allowing for a greater O2 flow input, which facilitates attainment of intended FiO2 by matching patient inspiratory demand.
Non-Clinical Testing	Compliance with IEC 60601-1, IEC 60601-1-2, ANCSI/AAMI ES 60601-1, EN 60601-1, IEC 60601-1-8, ISO 80601-2-74 (Predicate/Reference)	Compliance with listed standards (IEC 60601-1, IEC 60601-1-2, ANSI/AAMI ES 60601-1, EN 60601-1, IEC 60601-1-8, ISO 80601-2-74, ISO 80601-2-55 (additional))	Similar, demonstrating adherence to recognized safety and performance standards. The subject device specifically lists ISO 80601-2-55:2018 (Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors) in its non-clinical testing section, which is not explicitly listed for the predicate/reference in the table but aligns with its function.
Biocompatibility	Compliance with ISO 10993-5, ISO 10993-10 (Predicate/Reference also include ISO 10993-11, ISO 10993-18 and ISO 18562-1)	Compliance with ISO 10993-5:2009, ISO 10993-10:2010, ISO 18562-1	Similar patient contact and duration of use, demonstrating materials safety.
System Components	Device, power cord, water chamber, water chamber adapter, heated breathing circuit, cannula (Similar for predicate/reference)	Device, power cord, water chamber, water chamber adapter, heated breathing circuit, cannula	Same. Substantially equivalent.
Device Weight	4.8 lb (predicate) / 9.8 lb (reference)	5.7 lb (unit)	Falls within the range of the predicate and reference, considered substantially equivalent as it does not raise new safety or effectiveness concerns.
Dimensions (H x W x D)	11.6" x 6.7" x 6.9" (predicate) / 11.6" x 8.1" x 7.5" (reference)	12.5" x 8.7" x 7.2"	Considered substantially equivalent.
Technological Characteristics	Intake from User chosen flowmeter is mixed by a blower and gas is delivered to the patient after mixing by passing over a heated water chamber to add humidity. Gas is delivered via a heated breathing circuit and cannula interface. (Predicate/Reference)	Intake from User chosen flowmeter is mixed by a blower and gas is delivered to the patient after mixing by passing over a heated water chamber to add humidity. Gas is delivered via a heated breathing circuit and cannula interface.	Similar. There are no fundamental scientific principle differences. The differences (e.g., higher flow rate, graphical user interface) do not alter the safety or effectiveness or raise new concerns.
Graphical User Interface	Not explicitly mentioned in predicate/reference comparison table, but implied by functional description.	Graphical user interface - to better inform users of the device function and attainment of intended use.	This is a key characteristic differing from the predicate, intended to improve user information and use. The document states this difference does not alter safety or effectiveness.
User Supplied Accessories	Oxygen source, oxygen flowmeter, oxygen tubing	Oxygen source, oxygen flowmeter, oxygen tubing	Identical.
Power Input	110-115 V, 50-60 Hz, 2.2-2.4 A max (Predicate/Reference)	110-120 V, 50-60 Hz, 1.2 A (1.4 A max)	Substantially equivalent. The subject device has a lower maximum current (1.4A vs 2.4A).
Heater Plate Max Power	160 W (Predicate); Not stated (Reference)	150 W	Lower wattage reduces heat and power compared to the predicate, but is still considered substantially equivalent as it does not raise new safety/effectiveness concerns regarding the humidification performance (which is met).
Battery	None (Predicate) / Lithium Ion (Reference)	None	Similar to the predicate.
Operating Conditions	Ambient temperature 18-28°C, Humidity 10-95%, Altitude 0-2000m (Predicate)	Ambient temperature 18-28°C, Humidity 10-95%, Altitude 0-2000m (6,000 ft)	Similar to the predicate.

2. Sample sized used for the test set and the data provenance:

This information is not provided as it's a physical device and not an AI/ML model evaluated on a data set. The performance testing relies on engineering verification and validation against specified standards. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as this is not an AI/ML device requiring expert annotation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable, as this is not an AI/ML-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. There is no AI/ML algorithm involved to be evaluated in standalone mode.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of AI/ML. The "ground truth" for this device's performance is objective measurement against specified engineering standards (e.g., flow rate, temperature, humidity output) and safety benchmarks, as well as biocompatibility testing.

8. The sample size for the training set:

Not applicable, as there is no AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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October 13, 2023

Telesair, Inc. % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr. NE Saint Petersburg, Florida 33704

Re: K223863

Trade/Device Name: BONHAWA Respiratory Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: September 18, 2023 Received: September 19, 2023

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Ting Song-S

for Ethan Nyberg Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and

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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)

K223863

Device Name

Bonhawa Respiratory Humidifier

Indications for Use (Describe)

The BONHAWA Respiratory Humidifier provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients without bypassed upper airways in hospitals.

Type of Use (Select one or both, as applicable)

| XX Prescription Use (Part 21 CFR 801 Subpart D)

7 Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (6/20) 443-6740 EF

Page 1 of 1

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Date Prepared:	12-Oct-2023
Sponsor:	Telesair Inc204 Technology Drive, Suite FIrvine, CA 92618
Official Contact:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:	Bonhawa Respiratory Humidifier
Common/Usual Name:	Respiratory Gas Humidifier
Classification Name:	Respiratory Gas Humidifier
Regulation Number:	21 CFR 868.5450
Predicate Device:	Airvo 2 Humidifier series (K131895)
Classification Name:	Respiratory Gas Humidifier
Regulation Number:	21 CFR 868.5450
Reference Device:	Airvo 3 High Flow Humidified Oxygen Delivery (K221338)
Classification Name:	High Flow Humidified Oxygen Delivery Device
Regulation Number:	21 CFR 868.5454

Device Description:

Principle of Operation:

The Bonhawa Respiratory Humidifier entrains filtered ambient air and mixes it with the user selected Oxygen source to achieve a intended oxygen concentration and flow. The respiratory gas is transported over a heated water bath to attain humidity and is delivered to the patient through heated breathing circuits and nasal interface. O2 concentration, respiratory gas flow, and temperature are controlled and monitored to achieve the intended use of the device. The device is primarily operated by professional users known as Respiratory Therapists.

Indications for Use:

The BONHAWA Respiratory Humidifier provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients without bypassed upper airways in hospitals.

Patient Population:

Humidifier is for patients, 20kg and above, in hospitals.

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Contraindications:

The Bonhawa Respiratory Humidifier is contraindicated for use with unresolved tension pneumothorax and facial trauma.

Substantial Equivalence:

The following information presents summary technological features in the determination of substantial equivalence comparison of the proposed Bonhawa Respiratory Humidifier to the identified predicate and reference devices.

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510(k) Summary Page 3 of 8

Attributes	Subject DeviceTelesairBonhawa Respiratory Humidifier(K223863)	Predicate DeviceFisher & PaykelAirvo 2 Humidifier Series(K131895)	ReferenceFisher & PaykelAirvo 3 High Flow(K221338)	Differences
ClassificationName	Humidifier, Respiratory Gas, (DirectPatient Interface)	Humidifier, Respiratory Gas, (DirectPatient Interface)	High Flow Humidified OxygenDelivery Device	Similar to the predicate
Regulation	21 CFR 868.5450	21 CFR 868.5450	21 CFR 868.5454	Similar
Indications forUse	The BONHAWA Respiratory Humidifieris intended to provide high flow warmedand humidified respiratory gases foradministration to spontaneously breathingpatients 20 kg and up, child to adults inhospitals. It adds heat and moisture to theflow of gases. The flow may be from 2 to70 L/min depending on the patientinterface.The BONHAWA Respiratory Humidifierprovides high flow gases withsimultaneous oxygen delivery tospontaneously breathing patients withoutbypassed upper airways in hospitals.	The AIRVO 2 is for the treatment ofspontaneously breathing patients whowould benefit from receiving highflow warmed and humidifiedrespiratory gases.This includes patients who have hadupper airways bypassed.	The Airvo 3 is intended to provide highflow warmed and humidifiedrespiratory gases for administration tospontaneously breathing infant, child,adolescent and adult patients inhospitals and sub-acute facilities. Itadds heat and moisture to the flow ofair, or blended air/medical oxygenmixture, and assures the user of theair/oxygen mixture using anintegrated oxygen analyzer and visualdisplay. The flow may be from 2 to 70L/min depending on the patientinterface.The Airvo 3 provides high flow gaseswith simultaneous oxygen delivery tospontaneously breathing patients withor without bypassed upper airways inhospitals and sub-acute facilities.The Airvo 3 provides high flow gaseswith simultaneous oxygen deliverythrough nasal cannula interfaces toaugment the breathing of spontaneouslybreathing patients suffering from	Both the predicate,reference and thesubject device have thesame overall intended use.of delivering high flowbreathing gases(air/oxygen mixtures) withhumidification forpatientsSubject is substantiallyequivalent to bothpredicate and reference
Attributes	Subject DeviceTelesairBonhawa Respiratory Humidifier(K223863)	Predicate DeviceFisher & PaykelAirvo 2 Humidifier Series(K131895)	ReferenceFisher & PaykelAirvo 3 High Flow(K221338)	Differences
			respiratory distress and/or hypoxemiain the hospital setting.The Airvo 3 is not intended to providetotal ventilatory requirements and is notfor use during field transport.
Environment ofUse	BONHAWA respiratory humidifier is forhospitals.	The AIRVO 2 is for patients inhospitals and long-term carefacilities.	The AIRVO 3 is for patients inhospitals and sub-acute facilities.	Similar but not for long-term facility use
PatientPopulation	Pediatric patients, 20kg and above, andAdult	Pediatric to Adult	Infant to adults	Similar
Patients	Spontaneously breathing	Spontaneously breathing	Spontaneously breathing	Similar
Performance	Flow rate up to 70 lpm	Flow rate up to 60 lpm	Flow rate up to 70 lpm	Similar
Operatingprinciple	Constant flow of warmed, humidified gasdelivery via blower and humidifier	Constant flow of warmed, humidifiedgas delivery via blower and humidifier	Constant flow of warmed, humidifiedgas delivery via blower and humidifier	Similar
Oxygen inputsources	Low-Pressure Oxygen (LPO) low-pressureconnector (from rotameter)	Low-Pressure Oxygen (LPO) low-pressure connector (from rotameter)	High-Pressure Oxygen (HPO) Inletfrom wall supply 280-600 kPa (41-87psi) andLow-Pressure Oxygen (LPO) low-pressure connector (from rotameter)	Similar
Humidity source	Heated humidification chamber.	Heated humidification chamber.	Heated humidification chamber.	Similar
HumidityPerformance	At 37°C >= to 33mg/LAt 34°C >= to 12mg/LAt 31°C >= to 12mg/L	At 37°C >= to 33mg/LAt 34°C >= to 12mg/LAt 31°C >= to 12mg/L	At 37°C >= to 33mg/LAt 34°C >= to 12mg/LAt 31°C >= to 12mg/L	Similar
Flow range	Pediatric: 2 - 25 L/minAdults: 10 - 70 L/minThe achievable flow range depends on thepatient interface selected.	Junior mode: 2 – 25 L/minDefault mode: 10 - 60 L/min	Infants: 2 - 25 L/minChildren: 2 – 36 L/minAdolescents: 10 - 70 L/minAdults: 20 - 70 L/minThe achievable flow range depends onthe patient interface selected.	Flow rates up to 60 lpmare available for thepredicate. Up to 70 lpmin the reference.
Temperaturerange	31 - 37 °C	31 - 37 °C	31 - 37 °C	Similar
Attributes	Subject Device	Predicate Device	Reference	Differences
	Telesair	Fisher & Paykel	Fisher & Paykel
	Bonhawa Respiratory Humidifier	Airvo 2 Humidifier Series	Airvo 3 High Flow
	(K223863)	(K131895)	(K221338)
Ambient	18 – 28 °C	18 – 28 °C	18 – 28 °C	Similar
operating
temperature
range
Alarms	Visual and audible alarm system.Mute button.	Visual and audible alarm system.Mute button.	Visual and audible alarm system.Mute button.	Similar
Patient interfaces	Nasal cannula	Nasal cannulaAndUnsealed tracheostomy connectorAndUnsealed mask adapter	Nasal cannulaAndUnsealed tracheostomy connectorAndUnsealed mask adapter	Similar for the patientwithout bypassed airway.
Heated Breathing	Heated breathing tube: single-lumen,spiral heater wires	Heated breathing tube: single-lumen,spiral heater wires	Heated breathing tube: single-lumen,spiral heater wires	Similar
tube
Duration of Use -	14 Days single patient use	14 Days single patient use	14 Days single patient use	Similar
Heated
Breathing Tube
Non Clinical	IEC 60601-1:2005+AMD1:2012IEC 60601-1-2 2014ANSI/AAMI ES 60601-1:2005 A1:2012EN 60601-1:2006 + A1:2013IEC 60601-1-8:2006+AMD1:2012ISO 80601-2-74;2017ISO 80601-2-55:2018	IEC 60601-1:2005+AMD1:2012IEC 60601-1-2 2014ANSI/AAMI ES 60601-1:2005A1:2012EN 60601-1:2006 + A1:2013IEC 60601-1-8:2006+AMD1:2012ISO 80601-2-74:2017	IEC 60601-1:2005+AMD1:2012IEC 60601-1-2 2014ANSI/AAMI ES 60601-1:2005A1:2012IEC 60601-1-6:2010 +AMD1:2013IEC 60601-1-8:2006+AMD1:2012ISO 80601-2-61:2017ISO 80601-2-74:2017	Similar
Testing
Biocompatibility	ISO 10993-5:2009ISO 10993-10:2010ISO 18562-1	ISO 10993-5:2009ISO 10993-10:2010	ISO 10993-5:2009ISO 10993-10:2010ISO 10993-11:2017ISO 10993-18:2020ISO 18562-1	Similar patient contact andduration of use
	Subject	Predicate	Reference	RemarksSubstantial equivalence
SystemComponents	Device, power cord, water chamber,water chamber adapter, heated breathingcircuit, cannula	Device, power cord, water chamber, waterchamber adapter, heated breathing circuit,cannula	Device, power cord, waterchamber, water chamber adapter,heated breathing circuit, cannula	Same - Substantiallyequivalent
Device Weight	5.7 lb (unit)	4.8 lb (unit)	9.8 lb (unit)	Substantially equivalent
DimensionH x W x D	12.5" x 8.7" x 7.2"	11.6" x 6.7" x 6.9"	11.6" x 8.1" x 7.5"	Substantially equivalent
TechnologicalCharacteristics	Intake from User chosen flowmeter ismixed by a blower and gas is deliveredto the patient after mixing by passingover a heated water chamber to addhumidity the respiratory gas. Gas isdelivered to the patient via a heatedbreathing circuit and cannula interface.	Intake from User chosen flowmeter ismixed by a blower and gas is delivered tothe patient after mixing by passing over aheated water chamber to add humidity therespiratory gas. Gas is delivered to thepatient via a heated breathing circuit andcannula interface.	Intake from User chosen flowmeteror high pressure oxygen source ismixed by a blower and gas isdelivered to the patient after mixingby passing over a heated waterchamber to add humidity therespiratory gas. Gas is delivered tothe patient via a heated breathingcircuit and cannula interface.	SimilarDifferences do not raisequestions of safety oreffectiveness
TemperatureDew pointsettings	Adult: 37°C, 34°C, 31°CPediatric 34°C	Adult: 37°C, 34°C, 31°CPediatric 34°C	31°C to 37°CNot specified by population	Similar
OxygenConcentration	Input Oxygen < 80 lpmO2 concentration mixing of 21 to 100%	Input Oxygen < 60 lpmO2 concentration mixing of 21 to 100%	Input Oxygen < 70 lpmO2 concentration mixing of 21 to100%	Substantially equivalent wherethe subject allows a greater O2flow input which allowsattainment of intended FiO2by matching patientinspiratory demand.
AccessoriesSponsor	Single Use	Single Use	Single Use	Similar Single Use approach
	Water Chamber, Chamber adapter,Heated breathing circuit, nasal cannula,and masks	Water Chamber, Chamber adapter, Heatedbreathing circuit, nasal cannula, and masks	Water Chamber, Chamber adapter,Heated breathing circuit, nasalcannula, and masks	Similar, differences do notraise new concerns of safety or
	Subject	Predicate	Reference	RemarksSubstantial equivalence
				effectiveness compared to thepredicate.
AccessoriesUser supplied	Oxygen sourceOxygen flowmeterOxygen tubing	Oxygen sourceOxygen flowmeterOxygen tubing	Oxygen sourceOxygen flowmeterOxygen tubing	Identical
Power Input	110-120 V50-60 Hz1.2 A (1.4 A max)	110-115 V50-60 Hz2.2 A (2.4 A max)	110-115 V50-60 Hz2.2 A (2.4 A max)	Substantially equivalent
Heater platemaximumpower	150 W	160 W	Not stated	Lower wattage reduces heatand power .
Battery	none	none	Lithium Ion	Similar to predicate
OperatingConditions	Ambient temperature 18-28°CHumidity 10-95%Altitude 0-2000 m (6,000 ft)	Ambient temperature 18-28°CHumidity 10-95%Altitude 0-2000 m (6,000 ft)	Ambient temperature 18-28°CHumidity 10-95%Altitude 0-3000 m (9,000 ft)	Similar to predicate

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510(k) Summary Page 4 of 8

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510(k) Summary Page 5 of 8

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510(k) Summary Page 6 of 8 Table – Comparison of Technological Characteristics

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510(k) Summary

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510(k) Summary Page 8 of 8

Performance Testing:

Substantial equivalence to the predicate is based upon performance testing which consists of meeting the product validation and risk mitigation verification testing, which coincide with the pertinents for the product category of BTT including:

. ISO 80601-2-74:2017 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment.
. IEC 60601-1:2005+AMD1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 +A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
. IEC 60601-1-8 Medical electrical equipment General requirements for basic safety and essential performance-Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
. ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
. ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare application -Part 1: Evaluation and testing within a risk management process

Discussion of the Comparison and Differences

The fundamental scientific principle for use is the same for both the predicate and subject device. The proposed devices have the similar technological characteristics and these characteristics are summarized above. As further evidence of substantial equivalence the proposed device meets the pertinent essential requirements of the FDA recognized consensus standards. Compliance to the pertinent technological characteristics found within the recognized consensus standards for the proposed device.

Key characteristics differing from the predicate are:

More specific limit to 20 kg weight to facilitate proper use of nasal interface size. .
. Higher set flowrate of 70 liters per minute - to assure attainment of intended use
. Graphical user interface - to better inform users of the device function and attainment of intended use.

These differences in technological characteristics do not alter the safety or effectiveness of the device relative to the predicate nor raise concerns of safety and effectiveness.

Conclusion

The Bonhawa Respiratory Humidifier is substantially equivalent based upon comparative testing when compared to the predicate Airvo 2 cleared under K131895 and the higher flow rate is similar to the reference Airvo 3. K221338, which goes up to 70 lpm. Differences in the subject device do not raise different questions of safety or effectiveness in the subject device.

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).