(221 days)
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).
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.
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."
§ 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.