The HVT 2.0 system provides high velocity nasal insufflation (HVNI) with simultaneous warmed and humidified respiratory gas delivery to augment breathing of spontaneously breathing adult and pediatric patients (5 kg and up) suffering from respiratory distress and/or hypoxemia in the hospital setting, via a small bore nasal cannula. HVT 2.0 is not intended to provide total ventilatory requirements of the patient and not for use during field transport. The flow rates may be from 5 to 45 liters per minute (BTPS).

Device Description

The HVT 2.0 System is comprised of hardware containing software, and single use disposables that are designed to deliver the same High Velocity Nasal Insufflation (HVNI) as the Vapotherm Precision Flow HVNI.

The HVT 2.0 system consists of the HVT 2.0 hardware containing software, 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 5 to 45 L/min (BTPS) to spontaneously breathing patients, without the need of wall air or any pressurized air source. The addition of an external oxygen source (wall or tank for QAV indication) enables FiO2 delivery from 21% to 100%. The device incorporates a blender and flow sensors that allow the oxygen percentage and total gas flow to be set independently.

The HVT 2.0 main hardware device contains all the electrical and electronic components including the electronic blender and flow controllers, and sensors to monitor the disposable patient circuit. The main hardware device has no water pathways and the gas pathway only contains dry gas at room temperature, and therefore does not require internal cleaning or disinfection.

AI/ML Overview

The available text does not describe an acceptance criteria and a study proving the device meets said criteria in the format requested. The document is a 510(k) summary for the HVT 2.0 device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria for AI or automated system performance.

Here's why the requested information cannot be extracted and what is provided instead:

1. A table of acceptance criteria and the reported device performance: This is not present. The document includes a comparison table between the predicate and subject device (HVT 2.0) for various characteristics like Indications for Use, Patient Population, Flow Range, etc. While it lists "Temperature Accuracy" as "±2°C" and "Oxygen Accuracy" as "±2%", these are device specifications and not explicitly presented as "acceptance criteria" for a study in the context of an AI/algorithm performance. It then states "SAME" for the subject device, implying it meets these for equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document discusses "bench / performance testing" and "comparative performance testing" but does not detail sample sizes for these tests in a way that would be relevant to a "test set" for an algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This document does not describe the use of experts to establish a "ground truth" for a test set, as it does not involve the evaluation of an algorithm's diagnostic or predictive performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the same reasons as point 3.
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. This summary does not describe any MRMC studies or AI assistance for human readers. The device (HVT 2.0) is a high-flow humidified oxygen delivery device, a physical medical device, not an AI or software-as-a-medical-device (SaMD) that typically undergoes such evaluations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is not an algorithm. Its software is mentioned for verification and validation but not as a standalone performance entity.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable, as there is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is provided:

The document describes the HVT 2.0, a High Flow Humidified Oxygen Delivery Device, and its comparison to a predicate device (Precision Flow HVNI). The main point is to demonstrate "substantial equivalence" of the HVT 2.0 to the predicate device, not to prove algorithm performance against specific criteria.

The "studies" mentioned are non-clinical performance and bench testing, including:

Biocompatibility testing (leveraged from prior testing, compliant with ISO 10993-1)
Electrical safety and electromagnetic compatibility (compliant with IEC 60601-1 and IEC 60601-1-2)
Alarms testing (compliant with IEC 60601-1-8)
RFID testing (compliant with AIM 7351731)
Software verification, validation, and hazard analysis (compliant with FDA guidance for software and ISO 14971:2019)
Bench/Performance Testing, including:
- Precision Flow and HVT 2.0 Comparison Testing (to demonstrate same HVNI technological characteristics and performance)
- Oxygen accuracy/Blender Performance
- Temperature accuracy/Thermal Stability
- Flow rate accuracy
- Humidification output (ISO 80601-2-74)
- Patient contacting surface temperature/Thermal Safety
- Volume of liquid exiting the humidification chamber outlet
- Continuous use (Use Lifespan)
- Operating environment
- Nurse call compatibility
- Usability/Human Factors
- Cleaning Validation (for hardware)

The conclusion is that "Any differences in technological characteristics of the devices do not raise different questions of safety and effectiveness based on the performance testing, further supported by the prior clearance of the Reference Device HVT 2.0, cleared under K203357. The devices are substantially equivalent."

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

December 13, 2022

Vapotherm Inc. Michael Webb VP of Regulatory Affairs 100 Domain Drive Exeter, New Hampshire 03833

Re: K221318

Trade/Device Name: HVT 2.0 Regulation Number: 21 CFR 868.5454 Regulation Name: High Flow Humidified Oxygen Delivery Device Regulatory Class: Class II Product Code: QAV Dated: November 10, 2022 Received: November 14, 2022

Dear Michael Webb:

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.

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

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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 (OS) 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 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,

Ethan L. Nyberg -S

for James Lee, Ph.D. Division Director DHT1C: Division of 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) K221318

Device Name HVT 2.0

Indications for Use (Describe)

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)

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510(k) SUMMARY

Date:	12-Dec-2022
Company:	Vapotherm, Inc.100 Domain DriveExeter, NH 03833 USA
Official Contact:	Michael J. WebbTel: 866-410-9986
Proprietary or Trade Name:	HVT 2.0
Common/Usual Name:	High Flow Humidified Oxygen Delivery Device
Classification:	21 CFR 868.5454, Class IIProduct Code: QAV
Predicate Device:	DEN170001 Vapotherm Precision Flow HVNI
Reference Device:	K203357 Vapotherm HVT 2.0

Device Description:

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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 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. ●
Not for use with an Oxygen Concentrator .

Substantial Equivalence:

The technological characteristics that define HVNI and achieve the flush of expired CO2 from the accessible extrathoracic anatomic dead space are equivalent for HVT 2.0 and the predicate Precision Flow HVNI DEN170001. Therefore HVT 2.0 possesses the same clinical utility as Precision Flow HVNI (Product Code QAV). Bench testing has further demonstrated substantial equivalence of the devices.

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	Predicate:	Subject Device:
Characteristic	Precision Flow HVNIDEN170001	HVT 2.0
Indications forUse	Precision Flow® HVNI is intended foruse to add warm moisture to breathinggases from an external source foradministration to a neonate/infant,pediatric and adult patients in thehospital and subacute institutionssettings. It adds heat and moisture to ablended medical air/ oxygen mixtureand assures the integrity of the preciseair/oxygen mixture via an integraloxygen analyzer. The flow rates maybe from 1 to 40 liters per minute vianasal cannula.Precision Flow® HVNI provides highvelocity nasal insufflation (HVNI)with simultaneous oxygen delivery toaugment breathing of spontaneouslybreathing patients suffering fromrespiratory distress and/or hypoxemiain the hospital setting. PrecisionFlow® HVNI is not intended toprovide total ventilatory requirementsof the patient and not for use duringfield transport.	SIMILARQAV Indications:The HVT 2.0 system provides highvelocity nasal insufflation (HVNI) withsimultaneous warmed and humidifiedrespiratory gas delivery to augmentbreathing of spontaneously breathing adultand pediatric patients (5 kg and up)suffering from respiratory distress and/orhypoxemia in the hospital setting, via asmall bore nasal cannula. HVT 2.0 is notintended to provide total ventilatoryrequirements of the patient and not for useduring field transport. The flow rates maybe from 5 to 45 liters per minute (BTPS).
PatientPopulation	Pediatric, adult	DIFFERENTPediatric (>5kg), adult
Environment ofUse for QAV	Hospital setting	SAMEHospital setting
Duration ofUse	Disposable can be used for up to 30days single patient use.	SAMEDisposable can be used for up to 30 dayssingle patient use.
Prescriptive	Rx Only	SAMERx Only
PatientInterface forQAV	Small bore nasal cannula	SAMESmall bore nasal cannula
Flow Range	1 to 40 L/Min (SLPM), converted as:1.1 to 45 L/Min (BTPS)	DIFFERENT5-45 L/Min (BTPS)
Patientcontactingmaterials	Externally communicating, tissue,permanent duration	SAMEExternally communicating, tissue,permanent duration
TemperatureRange	33°C to 39°C	SAME33°C to 39°C
TemperatureAlarm	Alarms if 2°C above set point.	SAMEAlarms if 2°C above set point.
Temperature	±2°C	SAME±2°C
Characteristic	Predicate:Precision Flow HVNIDEN170001	Subject Device:HVT 2.0
FiO2 Range	0.21 to 1.00	SAME0.21 to 1.00
OxygenAccuracy	±2% Wall/tank	SAME±2% Wall/tank
OperatingPrinciple	Air flow via a compressor andhumidification via semi-permeablepolymer technology which allows fordelivery of entrained, humidifiedgases at constant flow to the patient	DIFFERENTAir flow via a blower andhumidification via semi-permeablepolymer technology which allows fordelivery of entrained, humidified gases atconstant flow to the patient
Alarms	Extensive audible and visual alarms toensure essential performance of thedevice is maintained.	SAMEExtensive audible and visual alarms toensure essential performance of the deviceis maintained.
User interfacesettings	User sets flow rate, temperature, andoxygen fraction F;O2	SAMEUser sets flow rate, temperature, andoxygen fraction F;O2
Control	Software control	SAMESoftware control
Modes ofoperation	Sleep, Standby and Run Modes	SAMESleep, Standby and Run Modes
Gas/Air input	Standard DISS non-interchangeablefitting for oxygen, room air via wallsource or compressor	DIFFERENTStandard DISS non-interchangeable fittingfor oxygen, room air via blower
Humidification	Via semi-permeable small-bore tubing	SAMEVia semi-permeable small-bore tubing
PowerRequirements	100-240 VAC, 50-60HzBack-up power: 4.8V nickel-metalhydride battery packBack-up power with VapothermTransfer Unit (VTU): Medipower™unit, one hour limited use	DIFFERENT110 to 240VAC, 50 to 60HzBack-up power (Safety Battery): Li-IonBattery 14.4V, 2900mAh, 99.Wh.Back-up power with Transfer Battery:Li-Ion Battery Pack consisting of 2X(14.4V, 2900mAh, 99.4Wh), one hourlimited use

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From the comparison above, the subject device and predicate device have the same intended use, are both prescription use, and have the same operating principle, gas input and method of humidification. Any differences do not raise different questions of safety or effectiveness.

Non-clinical performance testing Biocompatibility / Materials:

Biocompatibility testing is leveraged from the prior testing performed as part of K203357, whereby the 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 System demonstrates an appropriate biocompatibility profile for the device.

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Electrical Safetv, Alarms, RFID:

Electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1:2012 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. Alarms testing was performed compliant with IEC 60601-1-8:2006, ed 2.1. RFID testing was successfully completed in accordance with AIM 7351731.

Software Verification, Validation Testing, and Hazard Analysis

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 is considered as a "moderate" level of concern. Hazard Analysis/Risk Management activities for the device comply with ISO 14971:2019 Medical Devices – Application of risk management to medical devices.

Bench / Performance Testing -

Comparative performance testing was performed to demonstrate substantial equivalence and to meet the Special Controls requirements of 21 CFR 868.5454 High flow humidified oxygen delivery device, and included:

. Precision Flow and HVT 2.0 Comparison Testing to demonstrate the same High Velocity Nasal Insufflation (HVNI) technological characteristics and performance
Oxygen accuracy/Blender Performance ●
Temperature accuracy/Thermal Stability ●
Flow rate accuracy
. Humidification output ISO 80601-2-74
Patient contacting surface temperature/Thermal Safety
Volume of liquid exiting the humidification chamber outlet
Continuous use (Use Lifespan)
Operating environment
. Nurse call compatibility
Usability/Human Factors ●
Cleaning Validation (for hardware) .

Substantial Equivalence Conclusion

HVT 2.0 is substantially equivalent to the predicate device based on the intended use and comparison of the technological characteristics and performance testing.

Any differences in technological characteristics of the devices do not raise different questions of safety and effectiveness based on the performance testing, further supported by the prior clearance of the Reference Device HVT 2.0, cleared under K203357. The devices are substantially equivalent.

Regulation Number and Section

§ 868.5454 High flow humidified oxygen delivery device.

(a)
Identification. A high flow humidified oxygen delivery device is a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:
(i) Alarm testing must be performed;
(ii) Continuous use thermal stability testing must be performed;
(iii) Humidity output testing must be performed; and
(iv) Blender performance testing must evaluate fraction of inspired oxygen (
Fi O2 ) blending accuracy.(3) Performance data must validate cleaning instructions for any reusable components of the device.
(4) Electrical safety, thermal safety, mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include:
(i) A description of available
Fi O2 ranges for different flowrates and inlet gas pressures;(ii) Instructions for applicable flowrates for all intended populations;
(iii) A warning that patients on high flow oxygen are acute and require appropriate monitoring, to include pulse oximetry;
(iv) A warning regarding the risk of condensation at low set temperatures and certain flows; and
(v) A description of all alarms and their functions.