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 Description

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.

AI/ML Overview

The provided text describes the HVT 2.0 respiratory gas humidifier and its review by the FDA for substantial equivalence to a predicate device. However, the document primarily focuses on regulatory approval, device description, and non-clinical performance testing. It does not contain information about acceptance criteria and a study proving the device meets those criteria, particularly within the context of artificial intelligence (AI) or machine learning (ML) performance.

Therefore, I cannot provide the requested table and details because the input text does not contain that information. The document focuses on the HVT 2.0 being "substantially equivalent" to a predicate device based on non-clinical performance testing, not on meeting specific, reported performance metrics with acceptance criteria, especially not in the context of an AI/ML study.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance related to a diagnostic or analytical function. The testing described is for physical characteristics and safety of the humidifier.
Sample size for a test set, data provenance, ground truth establishment, or expert involvement. These are typically relevant for AI/ML performance studies.
Adjudication method.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study information.
Information about standalone (algorithm-only) performance.
Type of ground truth used (pathology, outcomes data, etc.) relevant to AI/ML or comparative diagnostic performance.
Sample size for a training set or how ground truth for a training set was established.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K203357

Device Name HVT 2.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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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 DriveExeter, NH 03833
Official Contact:	Dennis Francoeur – Regulatory MangerTel – 603-658-0491
Proprietary or Trade Name:	HVT 2.0
Common/Usual Name:	Respiratory gas humidifier
Classification Name:	21 CFR 868.5450, Class IIProduct Code: BTT
Predicate Device:	K191010 - Palladium High Flow Therapy System

Device Description:

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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:

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.

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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 TherapySystem (K191010)	HVT 2.0
Indications forUse	The Palladium High Flow TherapySystem is intended to deliverwarmed and humidified high-flowrespiratory gases to spontaneouslybreathing adult and pediatric andpatients weighing at least 3.5 kgwithin hospital, sub-acute andhomecare settings.	SIMILAR - K191010The HVT 2.0 system is intended todeliver warmed and humidifiedhigh-flow respiratory gases tospontaneously breathing adultpatients and pediatric patients (5kg and up). The device is intendedto be used in hospital, sub-acutefacility, and home-use settings.
PatientPopulation	Pediatric, adult	SAME - K191010Pediatric, adult
Environment ofUse	Hospital, sub-acute and homecaresettings	SAME - K191010Hospital, sub-acute and homecaresettings
Duration of Use	Disposable can be used for up to 30days single patient use.	SAME - K191010Disposable can be used for up to30 days single patient use.
Prescriptive	Rx Only	SAME - K191010Rx Only
PatientInterfaces	Nasal cannula	SIMILAR - K191010Nasal cannula, 22mm TubingAdapter
Flow Range	5 to 40 L/Min (SLPM)	SIMILAR - K1910103-45 L/Min (BTPS)
Patientcontactingmaterials	Externally communicating, tissue,prolonged duration	SAME - K191010Externally communicating, tissue,prolonged duration
TemperatureRange	33C to 38C	SIMILAR - K19101033C to 39C
Heater	Flat heater element within thecapital unit that contacts disposablepatient circuit - Flexible KaptonCircuit heater element (Conductionheating)	SIMILAR - K191010Flat heater element that is withinthe disposable patient circuit andpowered by an energy source inthe capital unit. (Inductionheating)
TemperatureAlarm	Software controlled; Alarms at 41 °C	SAME - K191010 Softwarecontrolled; Alarms at 41 °C
TemperatureAccuracy	± 2 °C	SAME - K191010± 2 °C
Oxygen Range	21 to 95 % O₂	SIMILAR - K19101021 to 100% O₂Limited 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 ortank source)$\pm$ 4% (when connected to anoxygen concentrator source)
OperatingPrinciple	Gas delivery via a blower andhumidification via semi-permeablepolymer technologywhich allows for delivery ofentrained, humidified gases atconstant flow to the patient	SAME - K191010Gas delivery via a blower andhumidification via semi-permeablepolymer technologywhich allows for delivery ofentrained, humidified gases atconstant flow to the patient
Alarms	Audible and visual for temperature,low oxygen fraction, blocked tube,water out, disposable water pathnot present, loss of power and lossof flow	SAME - K191010Audible and visual fortemperature, low oxygen fraction,blocked tube, water out,disposable water path notpresent, loss of power and loss offlow
User interface	User set point adjustment via menusystem on display for flow rate,temperature, and oxygen fraction	SAME - K191010User set point adjustment viamenu system on display for flowrate, temperature, and oxygenfraction
Control	Software control	SAME - K191010Software control
Modes ofoperation	Sleep, Standby and Run ModesSleep: Display is in sleep mode, nogas flowStand-by: Input parameters can beadjusted, no gas flowRun: Warming to set pointtemperature, gas flowUnit operating at set point, gas flow	SAME - K191010Sleep, Standby and Run ModesSleep: Display is in sleep mode, nogas flowStand-by: Input parameters can beadjusted, no gas flowRun: Warming to set pointtemperature, gas flowUnit operating at set point, gasflow
Gas input	Standard DISS non-interchangeablefitting for medical oxygen, room airvia blower	SAME - K103316Standard DISS non-interchangeable fitting for oxygen,room air via blower
Characteristic	Predicate:Palladium High Flow TherapySystem (K191010)	Subject Device:HVT 2.0
Humidification	Via semi-permeable small-boretubing	SAME - K191010Via semi-permeable small-boretubing
PowerRequirements	100-240 VAC, 50-60 Hz	SIMILAR - K191010AC Power:110-240 VAC, 50-60 HzExternal DC Power:12-24 VDC, 200 VA
Battery	Lithium Ion 2600mAh, 7.26V, 19Whbackup battery	SIMILAR - K191010Safety Battery - Lithium ion 14.4V,6900mAh, 99.4 Wh.Transfer Battery - Lithium-ionbattery (VTBP-2.0, 14.4Vdc; 2x6900mAh; 2 x99.4 Wh)

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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.

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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.

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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.

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).