(282 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard medical device components like blowers, blenders, and sensors.
Yes.
The device delivers warmed and humidified high-flow respiratory gases for treatment purposes which directly impacts the patient's physiological function.
No
The device is described as a system to deliver warmed and humidified high-flow respiratory gases. Its function is therapeutic (delivery of gas for breathing support), not diagnostic (identifying or characterizing a condition).
No
The device description explicitly states that the HVT 2.0 system consists of a "HVT 2.0 main device," a "Disposable Patient Circuit (DPC)," and a "patient interface (nasal cannula)." It further details that the "HVT 2.0 main device contains all the electrical and electronic components," including a blower, blender, and sensors. This clearly indicates the presence of significant hardware components beyond just software.
Based on the provided information, the HVT 2.0 system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for delivering warmed and humidified respiratory gases to 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 gases, including a blower, blender, and flow sensors. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device interacts directly with the patient's respiratory system.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HVT 2.0 system does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients and pediatric patients (5 kg and up)
Intended User / Care Setting
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 device is intended to be used in hospital, sub-acute facility, and home-use settings.
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)
Non-clinical performance testing included:
Biocompatibility / 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.
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.
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.
Not Found
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
§ 868.5450 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).
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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.
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)
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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 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.
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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:
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.
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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 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) |
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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.
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.