(462 days)
Not Found
K072845d
No
The summary describes a device that delivers heated and humidified breathing gas based on set parameters and senses cartridge type. There is no mention of AI/ML in the device description, intended use, or performance studies. The studies focus on clinical outcomes comparing the device to other respiratory support methods, not on the performance of any AI/ML algorithm.
Yes
The device is described as augmenting breathing for spontaneously breathing patients suffering from respiratory distress and/or hypoxemia, indicating a therapeutic purpose to alleviate medical conditions.
No
The device is described as providing high velocity nasal insufflation with simultaneous oxygen delivery to augment breathing and add warm moisture to breathing gases. It is a therapy delivery device, not one that identifies or diagnoses a condition.
No
The device description clearly outlines hardware components such as the main unit, integrated blender, disposable patient circuit (including tubing, vapor transfer cartridge, and nasal cannula), and a backup battery. This indicates it is a physical medical device with software control, not a software-only device.
Based on the provided information, the Precision Flow® HVNI device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for adding warm moisture to breathing gases and providing high velocity nasal insufflation to augment breathing. 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 heated and humidified gas, including components like a blender, water path, vapor transfer cartridge, and nasal cannula. These are all related to gas delivery and humidification, not to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device does not perform any tests to diagnose a disease or condition.
- Performance Studies: The performance studies focus on clinical outcomes related to respiratory support (intubation rates, extubation failure, need for mechanical ventilation), not on the accuracy or performance of a diagnostic test.
In summary, the Precision Flow® HVNI is a medical device used for respiratory support, not for performing in vitro diagnostic tests.
N/A
Intended Use / 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.
Product codes
OAV
Device Description
The Precision Flow® HVNI system delivers high flow rates of heated and humidified blended breathing gas through high flow nasal cannulas. The Precision Flow® HVNI system can connect to air and oxygen source. The Precision Flow® HVNI may be operated with limited performance at gas inlet pressures as low as 4 psi (28 kPa). For the full specified range of gas flows and oxygen percentages, both gas inlet pressures must be at minimum 40 psi (276 kPa).The main unit contains an integrated blender that delivers the targeted gas mixture to the disposable patient circuit (DPC). The Disposable Patient Circuit contains:
- Water path: tubing from sterile water supply to vapor transfer cartridge
- . Vapor transfer (humidification) cartridge: 2 types; low flow (1-8 lpm) and high flow (5-40 lpm)
- Delivery Tube: triple lumen tubing
- . Nasal Cannula
The device automatically senses cartridge type. The available set temperature range is 33 °C to 39 °C. The device also contains a backup battery to provide power only for 15 minutes.
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
neonate/infant, pediatric and adult patients
Intended User / Care Setting
hospital and subacute institutions 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)
Neonates:
- Study 1: McQueen et al. Safety and Long Term Outcomes with High Flow Nasal Cannula Therapy in Neonatology: A Large Retrospective Cohort Study. J Pulm Respir Med. 2014; 4(6).
- Study type: Retrospective Cohort Study
- Sample size: VON database included 176,599 very low birth weight baby admissions (for comparison with HFT group from five centers).
- Key results: Compared pulmonary outcomes in very low birth weight babies (1000g) with RDS (38 in HFT, 38 in NIPPV).
- Key results: Compared HFT to NIPPV for RDS in preterm infants. Primary outcome was failure requiring endotracheal intubation or 'rescue' crossover. Failure rates for intubation were comparable (HFT 34.2% vs NIPPV 28.9%). No clinically meaningful differences in secondary clinical outcomes (air leak, nasal trauma, BPD, IVH, NEC, sepsis). Demonstrated clinically acceptable safety and effectiveness.
Adults:
- Study: Doshi et al. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial, Annals of Emergency Medicine, 2017.
- Study type: Multi-center, prospective, randomized clinical trial
- Sample size: 204 adult patients (104 in high flow therapy, 100 in non-invasive ventilator support).
- Key results:
- Primary endpoint: Treatment failure rate, defined as the need for intubation, and arm failure rate, defined as the decision for crossover to the alternate therapy, within 72 hours of initiation of assigned therapy.
- Intubation within first 72 hrs: 7% (7/104) in high flow therapy vs 13% (13/100) in Bilevel therapy independent of whether patients were determined to have failed their assigned therapy arm, (non-inferior, Wald p
§ 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.
0
DE NOVO CLASSIFICATION REQUEST FOR Precision Flow® HVNI
REGULATORY INFORMATION
FDA identifies this generic type of device as:
High flow humidified oxygen delivery device. 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.
NEW REGULATION NUMBER: 21 CFR 868.5454
CLASSIFICATION: Class II
PRODUCT CODE: OAV
BACKGROUND
DEVICE NAME: Precision Flow® HVNI
SUBMISSION NUMBER: DEN170001
DATE OF DE NOVO: January 3, 2017
CONTACT: Vapotherm, Inc. 22 Industrial Dr. Exeter, NH 03833
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.
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LIMITATIONS
For prescription use only.
The Precision Flow® HVNI is intended to be used with oxygen at hospital for augmenting breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia.
The Precision Flow® HVNI is not intended to provide total ventilatory support.
The Precision Flow® HVNI is not intended to be used for monitoring patients who are suffering from respiratory distress and /or hypoxemia.
The Precision Flow® HVNI is 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.
The Precision Flow® HVNI is not for treating Obstructive Sleep Apnea (OSA) and snoring.
Not for use in an MR environment
Warnings
If the Precision Flow® HVNI is used to give supplementary oxygen, patients receiving supplemental high flow oxygen are acute and require appropriate monitoring to include continuous pulse oximetry.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Precision Flow® HVNI system delivers high flow rates of heated and humidified blended breathing gas through high flow nasal cannulas. The Precision Flow® HVNI system can connect to air and oxygen source. The Precision Flow® HVNI may be operated with limited performance at gas inlet pressures as low as 4 psi (28 kPa). For the full specified range of gas flows and oxygen percentages, both gas inlet pressures must be at minimum 40 psi (276 kPa).The main unit contains an integrated blender that delivers the targeted gas mixture to the disposable patient circuit (DPC). The Disposable Patient Circuit contains:
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- Water path: tubing from sterile water supply to vapor transfer cartridge
- . Vapor transfer (humidification) cartridge: 2 types; low flow (1-8 lpm) and high flow (5-40 lpm)
- Delivery Tube: triple lumen tubing
- . Nasal Cannula
The device automatically senses cartridge type. The available set temperature range is 33 °C to 39 °C. The device also contains a backup battery to provide power only for 15 minutes.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The Precision Flow® HVNI includes components that have externally communicating patient contact via gas pathway for permanent duration. The main unit of the subject device also has contact with dry gas path.
The complete device in its final, finished form was subjected to biocompatibility testing in accordance with the FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The following tests were conducted to assess biocompatibility of the device for the externally communicating components for permanent duration:
- Cytotoxicity ●
- Sensitization ●
- Intracutaneous Reactivity ●
- Extractables and Leachables testing with a risk assessment
The following additional tests were leveraged from K072845d for the dry gas contacting components:
- Volatile Organic Compounds (VOC), EPA Compendium Method TO-15
- Particulate Matter EPA PM2.5
All tests passed. The results demonstrated the biocompatibility of the device.
SHELF LIFE/REPROCESSING/STERILITY
Disposable patient circuit (DPC) is single patient use and is not provided sterile. Main unit is reusable and includes adequate cleaning and disinfection instructions.
The label cleaning and disinfection procedures for the reusable main unit were validated following the recommendations of the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", AAMI TIR30 "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices", and AAMI TIR12:2010 "Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers". The cleaning validation study was performed using defibrinated blood soil. The test results met the acceptance criteria of a) no visible soil on test articles.
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b) protein level 18 years of age) of either gender ●
- Presentation with acute respiratory failure .
- Clinical decision to escalate therapy to non-invasive ventilatory support, or to . maintain non-invasive ventilatory support if delivered to the ED on such.
Exclusion criteria:
- Suspected drug overdose ●
- . Cardiovascular instability as demonstrated by hypotension relative to initial clinical presentation that requires immediate intervention
- . End stage cancer
- . Life expectancy 88% or Pa02 > 60mmHg despite 100% Fi02; 3) failure to ventilate with acute hypercarbia; 4) failure to relieve respiratory distress; or 5) deteriorating medical status.
Image /page/8/Figure/3 description: The image shows two flow charts that describe the results of an analysis. The first flow chart shows that 104 subjects were analyzed, with 77 being a success and 27 resulting in arm failure. Of the 77 successes, 23 had a crossover and of those 23, 20 were not intubated and 3 were intubated. Of the 27 arm failures, 4 were intubated. The second flow chart shows that 100 subjects were analyzed, with 83 being a success and 17 resulting in arm failure. Of the 17 arm failures, 11 were intubated. Of the 83 successes, 6 had a crossover and of those 6, 2 were intubated and 4 were not intubated.
- Intubation within first 72 hrs: 7% (7/104) in high flow therapy vs 13% (13/100) in ● Bilevel therapy independent of whether patients were determined to have failed their assigned therapy arm, (non-inferior, Wald p