Who is the manufacturer of BONHAWA Respiratory Humidifier?

Telesair, Inc. filed the 510(k) submission for BONHAWA Respiratory Humidifier (K223863).

What is the FDA product code for BONHAWA Respiratory Humidifier?

BTT. It is classified under 21 CFR 868.5450 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for BONHAWA Respiratory Humidifier?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BONHAWA Respiratory Humidifier?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BONHAWA Respiratory Humidifier

Q: What are the predicate devices for BONHAWA Respiratory Humidifier?

Airvo 2 Humidifier series (K131895).

K223863 · Telesair, Inc. · BTT · Oct 13, 2023 · Anesthesiology

Device Facts

Record ID	K223863
Device Name	BONHAWA Respiratory Humidifier
Applicant	Telesair, Inc.
Product Code	BTT · Anesthesiology
Decision Date	Oct 13, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5450
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

Heated humidifier with integrated blower, heater plate, and heated breathing circuit; delivers warm, humidified respiratory gas via nasal cannula. Inputs: filtered ambient air and external low-pressure oxygen (LPO) source. Blower blends gases; internal sensor monitors oxygen concentration. Device controlled by professional users (e.g., Respiratory Therapists) to set flow rate, temperature, and oxygen concentration. Output: humidified, heated gas mixture. Clinical benefit: provides respiratory support for patients with respiratory distress or hypoxemia. Used in hospital settings. Output displayed on graphical user interface to inform clinicians of device function and gas delivery parameters; aids in clinical decision-making regarding patient oxygenation and respiratory support.

Clinical Evidence

Bench testing only. Performance validated against ISO 80601-2-74:2017, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 10993-1, and ISO 18562-1. Testing confirmed humidity performance (>=33mg/L at 37°C), flow rate accuracy, and alarm system functionality.

Technological Characteristics

Heated humidifier with integrated blower. Materials: single-use water chamber, adapter, heated breathing circuit, nasal cannula. Sensing: internal oxygen sensor. Energy: 110-120V AC, 150W heater plate. Connectivity: standalone. Sterilization: single-use components. Standards: ISO 80601-2-74, IEC 60601-1, ISO 10993, ISO 18562.

Indications for Use

Indicated for spontaneously breathing patients (pediatric 20kg+ to adult) in hospitals requiring high-flow warmed/humidified respiratory gases with oxygen delivery. Contraindicated for patients with unresolved tension pneumothorax or facial trauma.

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

Airvo 2 Humidifier series (K131895)

Reference Devices

Airvo 3 High Flow Humidified Oxygen Delivery (K221338)

Related Devices

K221338 — F&P Airvo 3 · Fisher & Paykel Healthcare · Jan 27, 2023
DEN170001 — Precision Flow® HVNI · Vapotherm, Inc. · Apr 10, 2018
K072845 — PRECISION FLOW · Vapotherm, Inc. · Jul 17, 2008
K121975 — AIRVO HUMIDIFIER MYAIRO HUMIDIFIER · Fisher & Paykel Healthcare, Ltd. · Jan 3, 2013
K070056 — VAPOTHERM MODEL# 2000I AND 2000H · Vapotherm, Inc. · Apr 13, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {3}------------------------------------------------ ## 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. " FORM FDA 3881 (6/20) 443-6740 EF Page 1 of 1 SC Publishing Services (301) {4}------------------------------------------------ | 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. {5}------------------------------------------------ #### 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. {6}------------------------------------------------ ## 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. The Airvo 3 is not intended to provide total ventilatory requirements and is not for use during field transport. | | | Environment of Use | BONHAWA respiratory humidifier is for hospitals. | The AIRVO 2 is for patients in hospitals and long-term care facilities. | The AIRVO 3 is for patients in hospitals and sub-acute facilities. | Similar but not for long- term facility use | | Patient Population | Pediatric patients, 20kg and above, and Adult | 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 | | Operating principle | Constant flow of warmed, humidified gas delivery via blower and humidifier | 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 sources | Low-Pressure Oxygen (LPO) low-pressure connector (from rotameter) | Low-Pressure Oxygen (LPO) low- pressure connector (from rotameter) | High-Pressure Oxygen (HPO) Inlet from wall supply 280-600 kPa (41-87 psi) and Low-Pressure Oxygen (LPO) low- pressure connector (from rotameter) | Similar | | Humidity source | Heated humidification chamber. | 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 | At 37°C >= to 33mg/L At 34°C >= to 12mg/L At 31°C >= to 12mg/L | Similar | | Flow range | Pediatric: 2 - 25 L/min Adults: 10 - 70 L/min The achievable flow range depends on the patient interface selected. | Junior mode: 2 – 25 L/min Default mode: 10 - 60 L/min | Infants: 2 - 25 L/min Children: 2 – 36 L/min Adolescents: 10 - 70 L/min Adults: 20 - 70 L/min The achievable flow range depends on the patient interface selected. | Flow rates up to 60 lpm are available for the predicate. Up to 70 lpm in the reference. | | Temperature range | 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 cannula And Unsealed tracheostomy connector And Unsealed mask adapter | Nasal cannula And Unsealed tracheostomy connector And Unsealed mask adapter | Similar for the patient without 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+AMD1:2012 IEC 60601-1-2 2014 ANSI/AAMI ES 60601-1:2005 A1:2012 EN 60601-1:2006 + A1:2013 IEC 60601-1-8:2006+AMD1:2012 ISO 80601-2-74;2017 ISO 80601-2-55:2018 | IEC 60601-1:2005+AMD1:2012 IEC 60601-1-2 2014 ANSI/AAMI ES 60601-1:2005 A1:2012 EN 60601-1:2006 + A1:2013 IEC 60601-1-8:2006+AMD1:2012 ISO 80601-2-74:2017 | IEC 60601-1:2005+AMD1:2012 IEC 60601-1-2 2014 ANSI/AAMI ES 60601-1:2005 A1:2012 IEC 60601-1-6:2010 +AMD1:2013 IEC 60601-1-8:2006+AMD1:2012 ISO 80601-2-61:2017 ISO 80601-2-74:2017 | Similar | | Testing |…