(221 days)
No
The summary describes a respiratory support device that delivers warmed and humidified gas. It mentions hardware, software, sensors, and controls for flow and oxygen percentage, but there is no mention of AI or ML capabilities for data analysis, prediction, or adaptive control based on patient data. The performance studies focus on standard device performance metrics.
Yes
The device is intended to augment breathing and deliver warmed and humidified respiratory gas to treat respiratory distress and hypoxemia.
No
The device is described as providing high velocity nasal insufflation to augment breathing for patients suffering from respiratory distress and/or hypoxemia; its intended use is therapeutic, not diagnostic.
No
The device description explicitly states that the HVT 2.0 System is comprised of "hardware containing software" and "single use disposables," clearly indicating it is not a software-only device.
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 delivering warmed and humidified respiratory gas to augment breathing in 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 gas, including a blower, blender, and humidification components. 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 biomarkers, or providing diagnostic information based on in vitro testing.
The device is a respiratory support system used directly on the patient to assist with breathing.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
QAV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal pathway to the nasopharyngeal space
Indicated Patient Age Range
adult and pediatric patients (5 kg and up)
Intended User / Care Setting
hospital setting
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)
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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
2
Indications for Use
510(k) Number (if known) K221318
Device Name HVT 2.0
Indications for Use (Describe)
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).
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 Drive | |
| Exeter, NH 03833 USA | |
| Official Contact: | Michael J. Webb |
| Tel: 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 II |
| Product Code: QAV | |
| Predicate Device: | DEN170001 Vapotherm Precision Flow HVNI |
| Reference Device: | K203357 Vapotherm HVT 2.0 |
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.
4
Indications for Use:
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).
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 HVNI | |
| DEN170001 | HVT 2.0 | |
| Indications for | ||
| Use | Precision Flow® HVNI is intended for | |
| use to add warm moisture to breathing | ||
| gases from an external source for | ||
| administration to a neonate/infant, | ||
| pediatric and adult patients in the | ||
| hospital and subacute institutions | ||
| settings. It adds heat and moisture to a | ||
| blended medical air/ oxygen mixture | ||
| and assures the integrity of the precise | ||
| air/oxygen mixture via an integral | ||
| oxygen analyzer. The flow rates may | ||
| be from 1 to 40 liters per minute via | ||
| nasal cannula. | ||
| Precision Flow® HVNI provides high | ||
| velocity nasal insufflation (HVNI) | ||
| with simultaneous oxygen delivery to | ||
| augment breathing of spontaneously | ||
| breathing patients suffering from | ||
| respiratory distress and/or hypoxemia | ||
| in the hospital setting. Precision | ||
| Flow® HVNI is not intended to | ||
| provide total ventilatory requirements | ||
| of the patient and not for use during | ||
| field transport. | SIMILAR | |
| QAV Indications: | ||
| 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). | ||
| Patient | ||
| Population | Pediatric, adult | DIFFERENT |
| Pediatric (>5kg), adult | ||
| Environment of | ||
| Use for QAV | Hospital setting | SAME |
| Hospital setting | ||
| Duration of | ||
| Use | Disposable can be used for up to 30 | |
| days single patient use. | SAME | |
| Disposable can be used for up to 30 days | ||
| single patient use. | ||
| Prescriptive | Rx Only | SAME |
| Rx Only | ||
| Patient | ||
| Interface for | ||
| QAV | Small bore nasal cannula | SAME |
| Small bore nasal cannula | ||
| Flow Range | 1 to 40 L/Min (SLPM), converted as: | |
| 1.1 to 45 L/Min (BTPS) | DIFFERENT | |
| 5-45 L/Min (BTPS) | ||
| Patient | ||
| contacting | ||
| materials | Externally communicating, tissue, | |
| permanent duration | SAME | |
| Externally communicating, tissue, | ||
| permanent duration | ||
| Temperature | ||
| Range | 33°C to 39°C | SAME |
| 33°C to 39°C | ||
| Temperature | ||
| Alarm | Alarms if 2°C above set point. | SAME |
| Alarms if 2°C above set point. | ||
| Temperature | ±2°C | SAME |
| ±2°C | ||
| Characteristic | Predicate: | |
| Precision Flow HVNI | ||
| DEN170001 | Subject Device: | |
| HVT 2.0 | ||
| FiO2 Range | 0.21 to 1.00 | SAME |
| 0.21 to 1.00 | ||
| Oxygen | ||
| Accuracy | ±2% Wall/tank | SAME |
| ±2% Wall/tank | ||
| Operating | ||
| Principle | Air flow via a compressor and | |
| humidification via semi-permeable | ||
| polymer technology which allows for | ||
| delivery of entrained, humidified | ||
| gases at constant flow to the patient | DIFFERENT | |
| Air flow 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 | Extensive audible and visual alarms to | |
| ensure essential performance of the | ||
| device is maintained. | SAME | |
| Extensive audible and visual alarms to | ||
| ensure essential performance of the device | ||
| is maintained. | ||
| User interface | ||
| settings | User sets flow rate, temperature, and | |
| oxygen fraction F;O2 | SAME | |
| User sets flow rate, temperature, and | ||
| oxygen fraction F;O2 | ||
| Control | Software control | SAME |
| Software control | ||
| Modes of | ||
| operation | Sleep, Standby and Run Modes | SAME |
| Sleep, Standby and Run Modes | ||
| Gas/Air input | Standard DISS non-interchangeable | |
| fitting for oxygen, room air via wall | ||
| source or compressor | DIFFERENT | |
| Standard DISS non-interchangeable fitting | ||
| for oxygen, room air via blower | ||
| Humidification | Via semi-permeable small-bore tubing | SAME |
| Via semi-permeable small-bore tubing | ||
| Power | ||
| Requirements | 100-240 VAC, 50-60Hz | |
| Back-up power: 4.8V nickel-metal | ||
| hydride battery pack |
Back-up power with Vapotherm
Transfer Unit (VTU): Medipower™
unit, one hour limited use | DIFFERENT
110 to 240VAC, 50 to 60Hz
Back-up power (Safety Battery): Li-Ion
Battery 14.4V, 2900mAh, 99.Wh.
Back-up power with Transfer Battery:
Li-Ion Battery Pack consisting of 2X
(14.4V, 2900mAh, 99.4Wh), one hour
limited use |
6
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.
7
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.