Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard respiratory humidifier technology.

Therapeutic

Yes
The device is described as a respiratory humidifier that provides warmed and humidified respiratory gases and oxygen to spontaneously breathing patients, which is a therapeutic function for respiratory support.

Diagnostic

No

The device is described as a respiratory humidifier that adds heat and moisture to gases for patients, and delivers warm and humidified respiratory gas. Its function is therapeutic (humidification, gas delivery) rather than diagnostic (detecting, monitoring, or diagnosing a disease or condition).

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as a blower, heater plate, heated breathing circuit, and internal oxygen sensor. The performance studies also reference standards related to physical medical equipment (e.g., electrical safety, biocompatibility of breathing pathways).

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is for providing warmed and humidified respiratory gases to spontaneously breathing patients. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
Device Description: The description details a system for delivering gases to a patient via a nasal cannula, including a blower, heater, and oxygen sensor. This aligns with a respiratory support device, not a device for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to support respiration by providing conditioned gases directly to the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

BTT

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.

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

20 kg and up, child to adults

Intended User / Care Setting

Professional users known as Respiratory Therapists, in hospitals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K131895

Reference Device(s)

K221338

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 and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

2

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 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.

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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Date Prepared:	12-Oct-2023
Sponsor:	Telesair Inc
204 Technology Drive, Suite F
Irvine, CA 92618
Official Contact:	Paul Dryden
ProMedic, 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:

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.

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 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.

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 Device
Telesair
Bonhawa Respiratory Humidifier
(K223863) | Predicate Device
Fisher & Paykel
Airvo 2 Humidifier Series
(K131895) | Reference
Fisher & Paykel
Airvo 3 High Flow
(K221338) | Differences |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Name | Humidifier, Respiratory Gas, (Direct
Patient Interface) | Humidifier, Respiratory Gas, (Direct
Patient Interface) | High Flow Humidified Oxygen
Delivery Device | Similar to the predicate |
| Regulation | 21 CFR 868.5450 | 21 CFR 868.5450 | 21 CFR 868.5454 | Similar |
| Indications for
Use | 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. | The AIRVO 2 is for the treatment of
spontaneously breathing patients who
would benefit from receiving high
flow warmed and humidified
respiratory gases.
This includes patients who have had
upper airways bypassed. | The Airvo 3 is intended to provide high
flow warmed and humidified
respiratory gases for administration to
spontaneously breathing infant, child,
adolescent and adult patients in
hospitals and sub-acute facilities. It
adds heat and moisture to the flow of
air, or blended air/medical oxygen
mixture, and assures the user of the
air/oxygen mixture using an
integrated oxygen analyzer and visual
display. The flow may be from 2 to 70
L/min depending on the patient
interface.
The Airvo 3 provides high flow gases
with simultaneous oxygen delivery to
spontaneously breathing patients with
or without bypassed upper airways in
hospitals and sub-acute facilities.
The Airvo 3 provides high flow gases
with simultaneous oxygen delivery
through nasal cannula interfaces to
augment the breathing of spontaneously
breathing patients suffering from | Both the predicate,
reference and the
subject device have the
same overall intended use.
of delivering high flow
breathing gases
(air/oxygen mixtures) with
humidification for
patients
Subject is substantially
equivalent to both
predicate and reference |
| Attributes | Subject Device
Telesair
Bonhawa Respiratory Humidifier
(K223863) | Predicate Device
Fisher & Paykel
Airvo 2 Humidifier Series
(K131895) | Reference
Fisher & Paykel
Airvo 3 High Flow
(K221338) | Differences |
| | | | respiratory distress and/or hypoxemia
in the hospital setting.