(173 days)
The provided text explicitly states that the "Predicate Device(s)" section is "Not Found." Therefore, there are no predicate device K/DEN numbers to list from this text.
Not Found
No
The description focuses on mechanical components (valve, flow generator) and their interaction with the patient's breathing and disordered breathing events. There is no mention of algorithms, learning, or adaptive behavior based on data that would indicate AI/ML. The device's response appears to be based on pre-defined pressure and flow thresholds.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient." The device provides continuous positive airway pressure to address a medical condition, which classifies it as therapeutic.
No
The device is described as a treatment system (Positive Airway Pressure System) intended to deliver therapeutic breathing pressure, not to diagnose a condition.
No
The device description clearly outlines multiple hardware components including a flow generator, nasal pillow, headgear, valve, and hose. It is a physical system for delivering positive airway pressure.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to treat Obstructive Sleep Apnea by delivering therapeutic breathing pressure to a patient. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a mechanical system that provides airflow and pressure. It does not involve the analysis of biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample collection, or analysis of biological markers.
- Clinical Study: The clinical study described focuses on the therapeutic effectiveness of the device in treating OSA by measuring physiological parameters (AHI and ODI) during sleep, not on diagnosing the condition itself through in vitro analysis.
In summary, the CURVE™ Positive Airway Pressure System is a therapeutic device used to manage a medical condition, not a diagnostic device used to identify or characterize a disease through in vitro testing.
N/A
Intended Use / Indications for Use
The CURVE™ Positive Airway Pressure System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and also during an incipient apnea. The system includes a dedicated flow generator and a patient interface, and is intended for use in the home environment. This system is to be used by adult patients weighing more than 66 lbs (30 kg).
Product codes
QBY
Device Description
The CURVE™ Positive Airway System is comprised of five components: a Nasal Pillow, Headgear, Valve, Hose, and Flow Generator.
The CURVE™ System Airbox is a flow generator that provides airflow and pressure to the mask and delivers therapeutic pressure to the patient's airway during disordered breathing. The valve allows positive airway pressure to be generated during expiration but at the same time it (1) reduces the airflow required to provide positive airway pressure during inspiration and expiration, and (2) utilizes the patient's own breathing effort during both normal inspiration and expiration. During disordered breathing events, such as apnea or hypopnea, the valve opens to allow positive airway pressure to be provided to the patient directly from the flow generator. In addition, the valve is designed to channel excess airflow directly into the room, thereby minimizing spikes in pressure and preventing carbon dioxide rebreathing from the hose.
The CURVE™ System patient interface consists of a nasal pillow mask, headgear and a hose. The nasal pillow mask includes the valve and the mask is held in contact with the patient's nares via the headgear. The nasal pillow mask is available in three sizes (small. medium and large). The hose connects the flow generator to the valve in the mask to deliver air from the flow generator to the mask.
The CURVE™ System is designed to have pressurized air from the flow generator always available to provide airway support. During treatment, the flow generator is never "off" or paused. Pressurized air is always being delivered through the hose to the valve, and flows into the mask whenever there is a drop in pressure or flow rate.
The CURVE™ System flow generator can only be used with the CURVE™ System patient interface and vice versa. The size and configuration of the Curve System hose and flow generator connectors are designed to prevent connection to a standard Continuous Positive Airway Pressure (CPAP) hose, mask or flow generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway, nares, nasopharynx
Indicated Patient Age Range
Adult patients. Specific criteria for clinical study: Male or Female 18-70 years old.
Intended User / Care Setting
Home environment
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)
A. Nonclinical/Bench Studies:
Biocompatibility/Materials: The CURVE™ Positive Airway System includes components that have externally communicating patient contact via gas pathway for permanent duration. The flow generator, mask, hose and valve of the subject device also have contact with the dry gas pathway. Tested in accordance with FDA guidance "Use of International Standard ISO 10993-1" for cytotoxicity, sensitization, intracutaneous reactivity, extractables and leachables testing. Additional tests for dry gas contacting components: volatile organic compounds (VOC), particulate matter EPA PM2.5, ozone gas analysis, carbon monoxide and carbon dioxide gas analysis. All tests passed.
Shelf Life/Reprocessing/Sterility: Single patient, multi-use device, not sterile. Reusable for up to 90 days. Cleaning and disinfection instructions provided. Cleaning procedures for main unit validated following FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", AAMI TIR30, and AAMI TIR12:2010. Cleaning validation study included 6 simulated use cycles of soiling and cleaning. Results showed no visible soil and residual soil reduced.
Electromagnetic Compatibility and Electrical Safety: Tested in accordance with IEC 60601-1-2:2014, AAMI / ANSI ES60601-1:2005/(R) 2012 and A1:2012, and IEC 60601-1-11 Edition 2.0 2015-01. Tested for static magnetic field.
MRI Compatibility: Device has not been tested for MRI compatibility and should not be used in an MRI suite.
Software: Adequate software documentation consistent with "Moderate" level of software concern. Software validation and verification testing demonstrated device met design, implementation, and cybersecurity specifications.
Performance Testing - Bench: Verification and validation testing of hardware and software. Tests performed:
- Device integrity testing for hose crush force.
- Hose torsion force testing.
- Verification of appropriate hose removal force at mask-valve and generator interfaces.
- Testing of valve removal force, pillow crush force, side strap removal force, backstrap removal force.
- Acoustics test: noise level ≤30dB at 10cmH2O setting.
- Carbon dioxide rebreathing test: increase in CO2 from baseline ≤ 20% under normal conditions, ≤ 60% for single fault conditions.
- System testing: Flow rate (> 10 l/minute), Maximum expiratory pressure (≤2 cm H2O pressure drop), Inhalation pressure (≥ -1.0 cm H2O pressure drop), Intra-mask static pressure, Air bolus testing.
- Packaging testing: simulated shipping challenges (ISTA 2A) with no impact.
- Use Life Testing: 712,800 simulated breathing cycles and 100 cleaning cycles, device met performance specifications.
- Maximum limited pressure testing: maximum pressure output not exceeding 20 cm H2O under normal use and 30 cm H2O under simulated fault conditions.
- Maximum output temperature testing of humidified gas: Not required (device does not output humidified gas).
- Waveform testing: conducted during simulated breathing conditions for evaluating pressure and airflow response over a range and combination of high and low breath rates and tidal volumes. Four simulated "patients" at 4, 12, and 20 cmH2O under normal breathing, hypopnea (30-40%, 50-60%, 70-80% airway reduction), and apnea conditions.
B. Clinical Study:
Purpose/Study Design: Prospective, controlled, randomized, cross-over clinical study to demonstrate non-inferiority of the subject device (FRESCA mask) to the patient's prescribed CPAP mask for OSA treatment.
Materials and Methods: Patients successfully treated for OSA with commercial CPAP devices were randomized to Sequence 1 (PSG control night with existing CPAP mask, then PSG treatment night with FRESCA mask) or Sequence 2 (PSG treatment night with FRESCA mask, then PSG control night with existing CPAP mask). Both nights in sleep lab, up to 14 days apart, using the same in-lab CPAP blower. Efficacy determined by non-inferiority (difference 5 events/h of sleep; titration PSG with AHI 1 month; current nasal mask or nasal pillow mask user; regular CPAP usage (> 4 hours of mask use); no significant health changes/weight change ( 500mg/day; pregnant; currently in other research study.
Selection of Doses: FRESCA mask intended for use with positive airway pressure devices operating at 4-20 cm H2O. Patient's prescribed pressure from historical titration PSG used for all nights.
Primary Efficacy Variable(s): Co-primary efficacy assessments were AHI and ODI by PSG. Both needed to be non-inferior for study success.
Results: 36 out of 47 enrolled patients completed both study nights with valid PSG results (26 men; mean age 51, range 32-69). Mean AHI of 26.1 events/h (range: 5.7-74.4) and mean ODI of 16.4 events/h (range: 0.0-74.4) prior to treatment.
Table 1: AHI and ODI endpoint analyses
| N=36 patients | FRESCA Mean Range | Commercial CPAP Mask Mean Range | Difference between the means | p-value of non-inferiority test |
|---|---|---|---|---|
| AHI results (events per hour) | 3.0 0.0 – 23.5 | 2.4 0.0 - 33.7 | 0.6 | p |
§ 868.5273 Positive airway pressure delivery system.
(a)
Identification. A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.(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 of use, including the following:
(i) Waveform testing must simulate breathing conditions and evaluate pressure and airflow response over a range and combination of high and low breath rates and tidal volumes.
(ii) Use life testing must demonstrate adequate device performance over the labeled use life of the device.
(iii) Device integrity testing must demonstrate that the device can withstand typical forces expected during use.
(iv) Carbon dioxide rebreathing testing must be performed.
(v) System flow rate, maximum expiratory pressure, inhalation pressure, and intra-mask static pressure testing must be performed.
(vi) Air bolus testing must demonstrate that the device can withstand worst-case scenario air pressures.
(vii) Maximum limited pressure testing of the flow generator in single fault condition must be performed.
(viii) Maximum output temperature testing of delivered gas, if humidified, must be performed.
(3) Performance data must validate reprocessing instructions for any reusable components of the device.
(4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include the following:
(i) Therapy pressure range;
(ii) Use life and replacement schedule for all components;
(iii) Cleaning instructions; and
(iv) Instructions for assembly and connection of device components.
0
DE NOVO CLASSIFICATION REQUEST FOR CURVE™ POSITIVE AIRWAY PRESSURE SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Positive airway pressure delivery system. A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.
NEW REGULATION NUMBER: 21 CFR 868.5273
CLASSIFICATION: Class II
PRODUCT CODE: QBY
BACKGROUND
DEVICE NAME: CURVE™ Positive Airway Pressure System
SUBMISSION NUMBER: DEN170089
DATE OF DE NOVO: December 14, 2017
- FRESCA Medical, Inc. CONTACT: 1291 Puerta Del Sol, Suite 200 San Clemente, CA 92673
INDICATIONS FOR USE
The CURVE™ Positive Airway Pressure System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and also during an incipient apnea. The system includes a dedicated flow generator and a patient interface, and is intended for use in the home environment. This system is to be used by adult patients weighing more than 66 lbs (30 kg).
LIMITATIONS
For prescription use only.
1
The CURVE™ Positive Airway Pressure System should only be used with the dedicated flow generator (CURVE™ System Airbox) and patient interface (CURVE™ Mask, Hose and Accessories). The flow generator and patient accessories of the CURVE™ Positive Airway Pressure System are not compatible with any other respiratory systems or accessories.
The CURVE™ Positive Airway Pressure System is not to be used with supplemental oxygen.
The CURVE "1" Positive Airway Pressure System should not be used in patients with severe bullous lung disease, a pneumothorax, pathologically low blood pressure, dehydration and cerebrospinal fluid leak, recent cranial surgery or trauma.
Not for use in an MR environment.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The CURVE™ Positive Airway System is comprised of five components: a Nasal Pillow, Headgear, Valve, Hose, and Flow Generator.
The CURVE™ System Airbox is a flow generator that provides airflow and pressure to the mask and delivers therapeutic pressure to the patient's airway during disordered breathing. The valve allows positive airway pressure to be generated during expiration but at the same time it (1) reduces the airflow required to provide positive airway pressure during inspiration and expiration, and (2) utilizes the patient's own breathing effort during both normal inspiration and expiration. During disordered breathing events, such as apnea or hypopnea, the valve opens to allow positive airway pressure to be provided to the patient directly from the flow generator. In addition, the valve is designed to channel excess airflow directly into the room, thereby minimizing spikes in pressure and preventing carbon dioxide rebreathing from the hose.
The CURVE™ System patient interface consists of a nasal pillow mask, headgear and a hose. The nasal pillow mask includes the valve and the mask is held in contact with the patient's nares via the headgear. The nasal pillow mask is available in three sizes (small. medium and large). The hose connects the flow generator to the valve in the mask to deliver air from the flow generator to the mask.
The CURVE™ System is designed to have pressurized air from the flow generator always available to provide airway support. During treatment, the flow generator is never "off" or paused. Pressurized air is always being delivered through the hose to the valve, and flows into the mask whenever there is a drop in pressure or flow rate.
The CURVE™ System flow generator can only be used with the CURVE™ System patient interface and vice versa. The size and configuration of the Curve System hose and
2
flow generator connectors are designed to prevent connection to a standard Continuous Positive Airway Pressure (CPAP) hose, mask or flow generator.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The CURVE™ Positive Airway System includes components that have externally communicating patient contact via gas pathway for permanent duration. The flow generator, mask, hose and valve of the subject device also have contact with the dry gas pathway.
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 conducted for the dry gas contacting components:
- . Volatile organic compounds (VOC) (EPA Compendium Method TO-15) to demonstrate that Total VOCs 10 1/minute confirmed that airflow path is not occluded or restrictive.
- Maximum expiratory pressure: the pressure drop into the mask was o measured. A ≤2 cm H2O pressure greater than the measured flow generator pressure confirmed sufficient ease of exhalation.
- Inhalation pressure: the pressure drop into the mask was measured. A ≥ - O 1.0 cm H2O pressure drop at an inhalation flow rate of 25 1/minute confirmed ease of inspiration.
- Intra-mask static pressure: the measured pressure in the mask resulted in O therapeutic pressure to the patient.
- Air bolus testing: an air bolus of 2 liters over 1 second was applied. No o impact on specifications for generator and mask pressures, airflow, exhaust pressure and inspiratory resistance was recorded.
- . Packaging testing subjected devices to simulated shipping challenges (as per the International Safe Transit Association Standards 2A) with no impact on specifications for the flow generator, mask pressures, minimum airflow, exhaust pressure and inspiratory resistance.
- . Use Life Testing was conducted to verify the recommended use life of the mask for up to 90 days. Testing included 712.800 simulated breathing cycles and 100 cleaning cycles and the device continued to meet the performance specifications following testing.
- . Maximum limited pressure testing was performed. Under normal use conditions, testing confirmed that the maximum pressure output of the flow generator did not exceed 20 cm H2O. Under simulated fault conditions, testing confirmed that the maximum pressure output of the flow generator did not exceed 30 cm H2O.
5
- . Maximum output temperature testing of humidified gas was not required for this submission because the device does not output humidified gas.
- . Waveform testing was conducted during simulated breathing conditions for evaluating pressure and airflow response over a range and combination of high and low breath rates and tidal volumes and a quantitative analysis of differences in waveform characteristics (e.g. shape: periodicity; inflection points; slope; and magnitude) to support pressure and flow responses were equivalent between clinical device configuration and final device configuration. Four simulated "patients" were defined for purposes of evaluating the pressure and airflow response over a range and combination of high and low breath rates and tidal volumes. Waveforms were obtained for each of the four simulated "patients" at set pressures of 4, 12 and 20 cmH2O during the following simulated breathing conditions:
- 0 Normal breathing.
- Hypopnea (with an airflow reduction of 30-40%). o
- Hypopnea (with an airflow reduction of 50-60%). O
- Hypopnea (with an airflow reduction of 70-80%). O
- o Apnea (at end of expiration).
- o Apnea (mid-inspiration)
SUMMARY OF CLINICAL INFORMATION
A clinical study in adults was used to support a reasonable assurance of safety and effectiveness for the use of this device for treatment of Obstructive Sleep Apnea.
Purpose/Study Design
Obstructive sleep apnea (OSA) is effectively treated using continuous positive airway pressure (CPAP) devices. This prospective, controlled, randomized, cross-over clinical study was designed to demonstrate whether the resultant OSA treatment with the subject device (clinical study configuration, referred as FRESCA) mask is non-inferior to treatment with the patient's prescribed CPAP mask.
Materials and Methods
Patients that were being successfully treated for OSA with a commercial CPAP device were randomized to Sequence 1 (polysomnography (PSG) control night with their existing CPAP mask followed by a PSG treatment night with the FRESCA mask) or Sequence 2 (PSG treatment night with the FRESCA mask followed by a PSG control night using their existing CPAP mask). Both nights were conducted in the sleep lab up to 14 days apart. Both nights utilized the same inlab CPAP blower.
If the patient completed both study nights (i.e. sleeping >4 hours without technical PSG difficulty), then their apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) data were entered into the database to determine whether the mean results of all FRESCA mask treatment nights were non-inferior (difference 5 events/h ● of sleep:
- Qualifying titration PSG: In lab titration within the past 12 months and therapeutic . pressure resulting in AHI 1 ● month:
- Current user of nasal mask or nasal pillow mask;
- Have regular usage of their CPAP machine (sufficient amount of mask use to enable tolerance of at least 4 hours of mask use for study nights) confirmed by SD card download:
- No significant changes in the subject's general health and no change in weight greater than ±10 lbs since titration PSG was performed and CPAP therapy initiated (confirmed from medical records);
- . BMI 500mg caffeine per day (e.g. > 8 cola-type beverages, > 5 cups of coffee):
- Pregnant (confirmed verbally);
- Currently enrolled in any other research study.
Selection of Doses in The Study
The FRESCA mask is intended to be used with positive airway pressure devices, such as CPAP, operating at or above 4 cm H2O and up to 20 cm H2O (i.e. ranges of pressure across which CPAP machines are titrated). The pressure used for each patient was their prescribed pressure as determined by his/her historical titration PSG study. Each patient's prescribed pressure setting was used for all nights of treatment.
Primary Efficacy Variable(s)
The co-primary efficacy assessments are AHI and ODI as determined by a valid PSG study. These primary assessments are compared between the control CPAP mask and the FRESCA mask treatments, and both AHI and ODI assessments needed to be non-inferior for primary study success.
Results
Of the 47 subjects enrolled in the study, thirty-six (36) patients (26 men; mean age 51 years, range 32 - 69) completed both study nights with valid PSG results. Prior to being treated for their OSA, the patients were documented in a diagnostic PSG with a mean AHI of 26.1 events/h (range: 5.7 - 74.4) and a mean ODI of 16.4 events/h (range: 0.0-74.4). The summary of the results is presented in Table 1.
| N=36 patients | FRESCA
Mean
Range | Commercial
CPAP
Mask
Mean
Range | Difference
between
the
means | p-value of
non-
inferiority
test |
|----------------------------------|-------------------------|---------------------------------------------|---------------------------------------|-------------------------------------------|
| AHI results
(events per hour) | 3.0
0.0 – 23.5 | 2.4
0.0 - 33.7 | 0.6 | p