Who is the manufacturer of HVT 2.0?

Vapotherm, Inc. filed the 510(k) submission for HVT 2.0 (K203357).

What is the FDA product code for HVT 2.0?

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

What is the regulatory pathway for HVT 2.0?

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

What are the predicate devices for HVT 2.0?

Palladium High Flow Therapy System (K191010).

Who can help prepare an FDA 510(k) submission like HVT 2.0?

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.

HVT 2.0

K203357 · Vapotherm, Inc. · BTT · Aug 25, 2021 · Anesthesiology

Device Facts

Record ID	K203357
Device Name	HVT 2.0
Applicant	Vapotherm, Inc.
Product Code	BTT · Anesthesiology
Decision Date	Aug 25, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5450
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The HVT 2.0 system is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult patients and pediatric patients (5 kg and up). The device is intended to be used in hospital, sub-acute facility, and home-use settings.

Device Story

HVT 2.0 delivers warmed, humidified high-flow respiratory gases to spontaneously breathing patients. System includes main device, disposable patient circuit, and nasal cannula. Internal blower provides flow up to 45 L/min without wall air. Integrated blender and flow sensors allow independent setting of oxygen percentage (21-100%) and flow. Used in hospital, sub-acute, and home settings by clinicians or patients under supervision. Main device contains electronic blender, flow controllers, and remote sensors; no water pathways. Healthcare providers adjust set points via menu system. Device provides audible/visual alarms for temperature, oxygen, flow, and system status. Benefits include respiratory support via high-flow therapy.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included humidification output (ISO 80601-2-74), temperature output, aging effects, and environmental testing. Human Factors and Usability Engineering validation study confirmed device safety and effectiveness for intended users and environments. Electrical safety and EMC testing conducted per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

System uses blower-based gas delivery and semi-permeable polymer small-bore tubing for humidification. Features induction heating via flat heater element in disposable circuit. Flow range 3-45 L/min; temperature range 33-39°C. Connectivity includes AC (110-240V) and external DC (12-24V) power, plus internal safety and transfer batteries. Software-controlled with audible/visual alarms. Biocompatibility per ISO 10993-1. Electrical safety per IEC 60601-1/1-2.

Indications for Use

Indicated for spontaneously breathing adult and pediatric patients (≥5 kg) requiring warmed and humidified high-flow respiratory gases in hospital, sub-acute, or home settings. Contraindicated for patients who are not spontaneously breathing, cannot protect their airway, have nasal pathway blockages, or require MRI. Not for OSA/snoring treatment or field transport.

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

Palladium High Flow Therapy System (K191010)

Reference Devices

K103316

Related Devices

K221318 — HVT 2.0 · Vapotherm, Inc. · Dec 13, 2022
DEN170001 — Precision Flow® HVNI · Vapotherm, Inc. · Apr 10, 2018
K121975 — AIRVO HUMIDIFIER MYAIRO HUMIDIFIER · Fisher & Paykel Healthcare, Ltd. · Jan 3, 2013
K103316 — FLOWREST · Vapotherm, Inc. · Feb 8, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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. August 25, 2021 Vapotherm Inc. Dennis Francoeur Regulatory Manager 100 Domain Drive Exeter, New Hampshire 03833 Re: K203357 Trade/Device Name: Hvt 2.0 Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: July 23, 2021 Received: July 26, 2021 Dear Dennis Francoeur: 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. {1}------------------------------------------------ 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 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 (QS) 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 medical devices and radiation-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, Ph.D. Acting Assistant Director 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) K203357 Device Name HVT 2.0 Indications for Use (Describe) The HVT 2.0 system is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult patients and pediatric patients (5 kg and up). The device is intended to be used in hospital, sub-acute facility, and home-use settings. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the Vapotherm logo. The logo consists of a light blue circular icon on the left and the word "VAPOTHERM" in bold, dark blue letters on the right. There is a registered trademark symbol next to the word "VAPOTHERM". # SECTION 5: 510(k) SUMMARY | Date: | 23-August-2021 | |----------------------------|------------------------------------------------------------| | Company: | Vapotherm, Inc. 100 Domain Drive Exeter, NH 03833 | | Official Contact: | Dennis Francoeur – Regulatory Manger Tel – 603-658-0491 | | Proprietary or Trade Name: | HVT 2.0 | | Common/Usual Name: | Respiratory gas humidifier | | Classification Name: | 21 CFR 868.5450, Class II Product Code: BTT | | Predicate Device: | K191010 - Palladium High Flow Therapy System | #### Device Description: The HVT 2.0 system is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult patients and pediatric patients (5 kg and up). The device is intended to be used in hospital, sub-acute facility and home-use settings. The HVT 2.0 system is intended to be used by qualified medical professionals, such as physicians, nurses, respiratory therapists and by patients in a home-use setting under the supervision of qualified medical professionals. The HVT 2.0 system consists of the HVT 2.0 main device, a Disposable Patient Circuit (DPC), and a patient interface (nasal cannula). The HVT 2.0 system utilizes an integrated internal blower to deliver warmed and humidified breathing gas at flows up to 45 L/min to spontaneously breathing patients, without the need of wall air or any pressurized air source. The device incorporates a blender and flow sensors that allow the oxygen percentage and total gas flow to be set independently. The addition of an external oxygen source (wall, tank, or oxygen concentrator) enables FiO2 delivery from 21% to 100%, dependent on the oxygen source. The HVT 2.0 main device contains all the electrical and electronic components including the electronic blender and flow controllers, and remote sensors to monitor the disposable patient circuit. The main device has no water pathways, and the gas pathway only contains dry gas at room temperature, and consequently does not need internal cleaning or disinfection. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Vapotherm. The logo consists of a light blue circular icon on the left, followed by the word "VAPOTHERM" in large, bold, blue letters. A small registered trademark symbol is located to the right of the "M" in "VAPOTHERM". ## Indications for Use: The HVT 2.0 system is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult patients and pediatric patients (5 kg and up). The device is intended to be used in hospital, sub-acute facility and home-use settings. ## Patient Population: For pediatric and adult patients Note: Vapotherm follows the definition of pediatric patients and pediatric subpopulations discussed in Guidance for Industry and Food and Drug Administration Staff "Providing Information about Pediatric Uses of Medical Devices". #### Environment of Use: Hospital, sub-acute and homecare settings ## Contraindications: Not appropriate for patients who are not spontaneously breathing, are unable to protect their airway, or have anatomic or injury induced blockage of the nasal pathway to the nasopharyngeal space. - Not for treating OSA and snoring. ● - HVT 2.0 is not for field transport. ● - HVT 2.0 is MRI unsafe. Do not use it in an MR environment. ● #### Substantial Equivalence: The HVT 2.0 System is substantially equivalent to the predicate device, the Palladium High Flow Therapy System (510(k) K191010). The table below presents the similarities and differences between the products for substantial equivalence purposes. The differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "VAPOTHERM" in blue font. To the left of the word is a blue circular logo with three curved lines inside. To the right of the word is a small "®" symbol, indicating that the word is a registered trademark. | | Predicate: | Subject Device: | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Palladium High Flow Therapy System (K191010) | HVT 2.0 | | Indications for Use | The Palladium High Flow Therapy System is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult and pediatric and patients weighing at least 3.5 kg within hospital, sub-acute and homecare settings. | SIMILAR - K191010 The HVT 2.0 system is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult patients and pediatric patients (5 kg and up). The device is intended to be used in hospital, sub-acute facility, and home-use settings. | | Patient Population | Pediatric, adult | SAME - K191010 Pediatric, adult | | Environment of Use | Hospital, sub-acute and homecare settings | SAME - K191010 Hospital, sub-acute and homecare settings | | Duration of Use | Disposable can be used for up to 30 days single patient use. | SAME - K191010 Disposable can be used for up to 30 days single patient use. | | Prescriptive | Rx Only | SAME - K191010 Rx Only | | Patient Interfaces | Nasal cannula | SIMILAR - K191010 Nasal cannula, 22mm Tubing Adapter | | Flow Range | 5 to 40 L/Min (SLPM) | SIMILAR - K191010 3-45 L/Min (BTPS) | | Patient contacting materials | Externally communicating, tissue, prolonged duration | SAME - K191010 Externally communicating, tissue, prolonged duration | | Temperature Range | 33C to 38C | SIMILAR - K191010 33C to 39C | | Heater | Flat heater element within the capital unit that contacts disposable patient circuit - Flexible Kapton Circuit heater element (Conduction heating) | SIMILAR - K191010 Flat heater element that is within the disposable patient circuit and powered by an energy source in the capital unit. (Induction heating) | | Temperature Alarm | Software controlled; Alarms at 41 °C | SAME - K191010 Software controlled; Alarms at 41 °C | | Temperature Accuracy | ± 2 °C | SAME - K191010 ± 2 °C | | Oxygen Range | 21 to 95 % O₂ | SIMILAR - K191010 21 to 100% O₂ Limited by O₂ Concentrator | | | Predicate: | Subject Device: | | Characteristic | Palladium High Flow Therapy | HVT 2.0 | | | System (K191010) | | | Oxygen Accuracy | $\pm$ 3% | SIMILAR - K191010 $\pm$ 3% (when connected to a wall or tank source) $\pm$ 4% (when connected to an oxygen concentrator source) | | Operating Principle | Gas delivery via a blower and humidification via semi-permeable polymer technology which allows for delivery of entrained, humidified gases at constant flow to the patient | SAME - K191010 Gas delivery via a blower and humidification via semi-permeable polymer technology which allows for delivery of entrained, humidified gases at constant flow to the patient | | Alarms | Audible and visual for temperature, low oxygen fraction, blocked tube, water out, disposable water path not present, loss of power and loss of flow | SAME - K191010 Audible and visual for temperature, low oxygen fraction, blocked tube, water out, disposable water path not present, loss of power and loss of flow | | User interface | User set point adjustment via menu system on display for flow rate, temperature, and oxygen fraction | SAME - K191010 User set point adjustment via menu system on display for flow rate, temperature, and oxygen fraction | | Control | Software control | SAME - K191010 Software control | | Modes of operation | Sleep, Standby and Run Modes Sleep: Display is in sleep mode, no gas flow Stand-by: Input parameters can be adjusted, no gas flow Run: Warming to set point temperature, gas flow Unit operating at set point, gas flow | SAME - K191010 Sleep, Standby and Run Modes Sleep: Display is in sleep mode, no gas flow Stand-by: Input parameters can be adjusted, no gas flow Run: Warming to set point temperature, gas flow Unit operating at set point, gas flow | | Gas input | Standard DISS non-interchangeable fitting for medical oxygen, room air via blower | SAME - K103316 Standard DISS non- interchangeable fitting for oxygen, room air via blower | | Characteristic | Predicate: Palladium High Flow Therapy System (K191010) | Subject Device: HVT 2.0 | | Humidification | Via semi-permeable small-bore tubing | SAME - K191010 Via semi-permeable small-bore tubing | | Power Requirements | 100-240 VAC, 50-60 Hz | SIMILAR - K191010 AC Power: 110-240 VAC, 50-60 Hz External DC Power: 12-24 VDC, 200 VA | | Battery | Lithium Ion 2600mAh, 7.26V, 19Wh backup battery | SIMILAR - K191010 Safety Battery - Lithium ion 14.4V, 6900mAh, 99.4 Wh. Transfer Battery - Lithium-ion battery (VTBP-2.0, 14.4Vdc; 2 x6900mAh; 2 x99.4 Wh) | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Vapotherm. The logo consists of a light blue circle with white lines inside on the left, and the word "VAPOTHERM" in blue on the right. There is a registered trademark symbol next to the letter M. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Vapotherm. The logo consists of a light blue circular graphic on the left, followed by the word "VAPOTHERM" in large, bold, blue letters. A registered trademark symbol is located to the right of the word "VAPOTHERM". From the comparison form above, the subject device and predicate device have similar intended use, are both prescription use, and have the same operating principle, gas input and method of humidification. The subject device claims slightly different flow range, patient interface, and temperature range. These differences do not raise different questions of safety or effectiveness. #### Non-clinical performance testing: #### Biocompatibilitv / Materials: Biocompatibility testing was conducted in accordance with FDA guidance. Use of International Standard ISO 10993-1. Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ''. Testing of the patient-contacting parts of the HVT 2.0 High Flow Therapy System demonstrates an appropriate biocompatibility profile for the device. #### Electrical Safety: Electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1:2005 Ed.3+A1:2012 and IEC 60601-1-2: 2014 Ed.4 to demonstrate the basic safety, essential performance and emissions and immunity characteristics of the device. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device. #### Software Verification and Validation Testing: Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Vapotherm logo. The logo consists of a light blue circular icon with several curved lines inside, followed by the word "VAPOTHERM" in bold, dark blue letters. A small, registered trademark symbol is located to the upper right of the "M" in "VAPOTHERM". ## Human Factors Testing: A Human Factors and Usability Engineering validation study was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices". The validation study demonstrates that the device has been found to be safe and effective for the intended users, uses, and use environments. ## Bench / Performance Testing: Comparative performance testing included: - Humidification system output (ISO 80601-2-74 Medical electrical equipment Part 2-● 74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment) - Temperature output ● - Effects of aging on performance ● - Environmental Testing ● The results demonstrated that the device performance was met after conditioning and was substantially equivalent to the predicate device. #### Substantial Equivalence Conclusion The performance testing demonstrates that the subject device is substantially equivalent to the predicate device.