Search Results
Found 420 results
510(k) Data Aggregation
(213 days)
Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
Regulation Number: 21 CFR 868.5905
, DC 20001
Office: 202.552.5800
Date Prepared: January 15, 2026
Classifications: 21 CFR 868.5905
Healthcare Ltd |
| 510(k) Number | K251847 | K153563 | K212371 |
| Classification | 21 CFR 868.5905
| 21 CFR 868.5905 | 21 CFR 868.5905 |
| Product Code | BZD | BZD | BZD |
| Common/Usual Name
| 21 CFR 868.5905 | Identical |
| Product Code | BZD | BZD | Identical |
| Common/Usual Name
The Sleepnet Arie Full Face Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 4 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital, or institutional environment.
The Sleepnet Arie Nasal Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 4 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital, or institutional environment.
The Sleepnet Arie Full Face Vented and Nasal Mask are designed based on the human facial shape, and the operating characteristics during application. The Sleepnet mask utilizes a Liquid Silicone Rubber (LSR) cushion design. The device is composed of medical-grade injection molded thermoplastics & clear liquid silicone rubber. The device is used as the interface between a CPAP/BiPAP machine and the end user. The masks are held in place with adjustable headgear that straps the mask to the face.
The Arie Full Mask is accompanied by a vented frame/tubing assembly which includes the Arie Full Face Vented Mask Headgear connector, valve, swivel ball, tubing, swivel connector assembly (swivel connector and clear swivel), and the JustFit Full Face Headgear with clips.
N/A
Ask a specific question about this device
(29 days)
33704
Re: K253939
Trade/Device Name: DeltaWave Nasal Pillow System
Regulation Number: 21 CFR 868.5905
Name:** Ventilator, Non-Continuous(Respirator)
Product Code: BZD
Regulation Number: 21 CFR 868.5905
Name:** Ventilator, Non-Continuous(Respirator)
Product Code: BZD
Regulation Number: 21 CFR 868.5905
K#* | K253939 | K233415 | K210844 | |
| Product Code | BZD | BZD | BZD | |
| CFR | 21 CFR 868.5905
| 21 CFR 868.5905 | 21 CFR 868.5905 | |
| Indications for Use | The DeltaWave™ Nasal Pillow System
The DeltaWave Nasal Pillow System channels airflow noninvasively to a patient from a noninvasive positive airway pressure device (PAP) such as CPAP, bi-level.
It is intended for adult patients weighing ≥66lbs (30 Kg), and for whom positive airway pressure has been prescribed. It is intended for single patient reuse in the home and hospital/institutional/sleep center environment.
The DeltaWave Nasal Pillow System is a non-invasive medical device that directs pressurized air from a Continuous Positive Airway Pressure (CPAP) or Bi-level medical device to the patient. The subject device is a type of medical device prescribed by a physician or authorized professional for patients who have been diagnosed with Sleep Apnea. The subject device is designed to prevent pressure drop from the CPAP machine to the patient's nasal passages. That is accomplished by maintaining the same, or greater flow space from the machine output to the patient's nostrils. To further ensure the least amount of pressure drop the nasal pillows are designed to gently dilate the patient's nostrils to avoid restrictions to incoming air entering the nostrils. This allows air to enter the patient's nostrils at a lower driving pressure.
N/A
Ask a specific question about this device
(188 days)
33704
Re: K251770
Trade/Device Name: SleepRes PAP System
Regulation Number: 21 CFR 868.5905
or Trade Name:** SleepRes PAP system
Common/Usual Name: CPAP
Classification Name: BZD – 868.5905
:** Philips DreamStation 2 - K200480
Common/Usual Name: CPAP
Classification Name: BZD – 868.5905
Noncontinuous Ventilator (IPPB) BZE – 868.5270 Breathing System Heater | BZD – 868.5905 Noncontinuous
Reference Exceleron Thermalite CPAP Heated Tubing K241268** |
|---|---|---|
| Product Code | BZD – 868.5905
The SleepRes PAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lbs. (30 kg.). The SleepRes PAP system is intended for home, hospital / institutional and sleep center settings.
The SleepRes PAP system consists of a firmware-controlled console, power cable and power adapter, air filter, water tank, and heated breathing tube. The PAP console is composed of a control system, motor system, and heating system. The control system includes the main board, buttons, screen, and sensor. The motor system includes the motor, fan blade, motor outer shell, and silence box. The heating system includes a heating plate and temperature sensor. The PAP console of the subject device does not include foam.
The SleepRes PAP system also includes the following components of PAP therapy systems:
- Water tank
- Air filter
- Breathing Tube
The SleepRes PAP system offers several modes:
- CPAP
- Provides continuous positive airway pressure at the prescribed pressure
- APAP
- Functions to titrate the pressure up (and down as well) to balance reducing or eliminating sleep events while using the lowest effective pressure. Pressure limits are pre-set by the prescribing clinician.
- Kairos Positive Airway Pressure (KPAP)
- This algorithm reduces airway pressure during both inspiration and during most of expiration, only returning pressure to the prescribed treatment level towards the end of expiration.
Connectivity to a Cloud platform via Wi-Fi connection.
The provided FDA 510(k) clearance letter and summary for the SleepRes PAP System (K251770) offer some details about acceptance criteria and the study that proves the device meets these criteria. However, it's important to note that a 510(k) summary is a high-level overview and does not typically contain all the granular details of a full study report.
Here's an attempt to extract and present the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary broadly asserts that the device met performance and safety requirements. Specific, quantifiable acceptance criteria with corresponding performance outcomes are not explicitly listed in a detailed format within the provided document, beyond the comparison table with the predicate.
| Acceptance Criteria (Inferred from Predicate Comparison & Testing) | Reported Device Performance (SleepRes PAP System) |
|---|---|
| Pressure Range | 4 to 20 cmH2O |
| Pressure Accuracy (Static) | +/- 0.5 cmH2O |
| Pressure Accuracy (Dynamic) | +/- 1.0 -1.5 cmH2O from 10-20 BPM |
| Flow Range | 10-60 lpm |
| Flow Accuracy | +/- 2 lpm or 10% of reading |
| Operating Temperature Range | 5℃ to 32℃ (41˚F to 95˚F) |
| Storage Temperature Range | -20℃ to 55℃ (-13˚F to 158˚F) |
| Atmospheric Pressure Range | 700 to 1060 hPa (0-3000m / 0-9880ft) |
| Noise / Sound | <35 dB(A) (Note: Higher than predicate's 27 dB(A), addressed by labeling mitigation) |
| Therapy Algorithm Effectiveness (Comparative Sleep Studies) | Substantially equivalent to predicate in disordered breathing events (AHI3a), sleep quality, and sleep architecture. |
| Biocompatibility | Met ISO 10993 and ISO 18562 series requirements, including post-accelerated aging tests. |
| Electrical Safety and EMC | Complied with IEC 60601-1 and related collateral standards. |
| Software Verification and Validation | Conducted as per FDA guidances. |
| Human Factors Validation | Conducted as per FDA guidances. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 50 OSA patients.
- Data Provenance: The document states "Each patient underwent a full night polysomnogram." It does not specify the country of origin of the data. The study involved patients "all of whom were on standard APAP in the home," implying they were existing patients.
- Retrospective or Prospective: Implied to be prospective for the clinical validation part, as it describes a protocol where patients "underwent a full night polysomnogram" with different treatment conditions (CPAP, APAP, and APAP + KPAP) specifically for the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set (polysomnogram scoring). It only mentions "PSG sleep studies."
4. Adjudication Method for the Test Set
The document does not specify the adjudication method for the test set (PSG scoring).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- Was an MRMC study done? No, an MRMC study was not explicitly described. The clinical study focused on patient outcomes comparing devices/algorithms, not on human readers' performance with or without AI assistance.
- Effect size of human readers improvement: Not applicable, as this was not an MRMC study assessing human reader performance. The study compared the device's therapy algorithms directly through patient outcomes.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
While the clinical study evaluated the device's algorithms (APAP and KPAP) directly through patient polysomnography, it's not described as a "standalone algorithm-only" performance evaluation in the context of interpretation often seen in AI/ML applications. Rather, it evaluated the therapy delivered by the device to patients. The outcomes (AHI3a, sleep quality, sleep architecture) are direct measures of the device's therapeutic effect.
7. The Type of Ground Truth Used
- Type of Ground Truth: Polysomnography (PSG) results, specifically metrics like AHI3a (Apnea-Hypopnea Index with 3% desaturation or arousal criterion), sleep quality, and measures of sleep architecture. These are clinical outcomes obtained from detailed sleep studies.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set. It only describes the clinical validation study's test set.
9. How the Ground Truth for the Training Set Was Established
Since no training set details are provided, the method for establishing its ground truth is not mentioned.
Ask a specific question about this device
(189 days)
K251657**
Trade/Device Name: Personalized Therapy Comfort Settings (PTCS)
Regulation Number: 21 CFR 868.5905
PAP therapy device. |
| Classification | Class II | Class II |
| Regulation Number | 21 CFR §868.5905
| 21 CFR §868.5905 |
Page 9
510(k) Summary
**Table 1: Substantial Equivalence Table (Subject
Similar |
| Classification | Class II | Class II | Identical |
| Regulation Number | 21 CFR §868.5905
| 21 CFR §868.5905 | Identical |
Page 10
510(k) Summary
| Characteristic | Primary Predicate
Personalized Therapy Comfort Settings ("PTCS") is an optional software accessory indicated for use by healthcare professionals and patients, providing recommended non-prescription comfort settings options to support patients when using their compatible Resmed PAP therapy device. The outputs provided by PTCS are optional recommendations and are not required to use the therapy device. It is intended for use in a home or clinical environment.
The subject device, Personalized Therapy Comfort Settings (PTCS), is an AI-enabled software accessory intended for use with compatible ResMed positive airway pressure (PAP) therapy devices. PTCS provides optional, non-prescription comfort setting (e.g., ramp, EPR and AutoSet Response) recommendations within the cleared configuration limits of the connected device. It is designed to support patients in personalizing comfort settings during onboarding and early therapy adaptation.
PTCS functions as a stand-alone, machine learning (ML)-based algorithm that generates individualized comfort setting recommendations based on patient-specific input data. The software outputs a limited set of predefined configuration options that can be reviewed by the patient or healthcare provider. PTCS does not automatically adjust device settings, modify prescribed therapy parameters, create new settings, or alter configuration limits. The recommendations are optional and may be accepted, disregarded, or further adjusted according to personal preference or clinical guidance. PTCS is integrated into compatible ResMed products through an application programming interface (API) and has no direct user interface or end-user access.
The provided FDA 510(k) clearance letter and summary for the Personalized Therapy Comfort Settings (PTCS) device contains only limited information regarding specific acceptance criteria and the detailed study that proves the device meets these criteria. Much of the information requested in your prompt is not explicitly stated in the provided text.
Based on the available text, here's what can be extracted and what remains unknown:
Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with specific numerical targets. It broadly states that "PTCS met all acceptance criteria and passed testing requirements," and that "Analytical validation demonstrated robust sensitivity, specificity, and generalizability." It also mentions "measurable improvements in patient therapy engagement, including increased nightly usage and additional usage days, while maintaining comparable residual AHI and mask leak."
Without specific numerical acceptance criteria, the table below provides what can be inferred.
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Reliable, safe, and effective AI algorithm performance for intended use. | "PTCS met all acceptance criteria and passed testing requirements." "Analytical validation demonstrated robust sensitivity, specificity, and generalizability, thereby establishing safety and effectiveness without prospective clinical study." |
| Consistent and reliable model performance across large, representative datasets. | "Analytical validation confirmed consistent and reliable model performance across large, representative datasets, with consistent treatment-effect results and no identified safety concerns." |
| Measurable improvements in patient therapy engagement. | "Retrospective comparisons of PTCS recommended settings to default configurations showed measurable improvements in patient therapy engagement, including increased nightly usage and additional usage days." |
| Comparable residual AHI (Apnea-Hypopnea Index). | "maintaining comparable residual AHI" |
| Comparable mask leak. | "maintaining comparable residual AHI and mask leak." |
| User-comprehensible decision support without impacting therapy delivery or patient safety. | "Usability evaluations with both clinical and non-clinical users confirmed clear comprehension of PTCS recommendations, appropriate application of judgment, and no critical tasks or use-related risks." |
Study Details
1. Sample sized used for the test set and the data provenance:
* Sample Size: Not specified. The document only mentions "large, representative datasets."
* Data Provenance: "Retrospective, de-identified clinical data representative of the intended population." The country of origin is not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not specified. The document does not detail how ground truth for the test set was established.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not specified.
4. 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:
* No MRMC comparative effectiveness study involving human readers is mentioned. The study referenced "Usability evaluations with both clinical and non-clinical users confirmed clear comprehension of PTCS recommendations, appropriate application of judgment, and no critical tasks or use-related risks," but this is not a comparative effectiveness study measuring human reader improvement with AI assistance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes, a standalone performance evaluation was done. The document states: "PTCS functions as a stand-alone, machine learning (ML)-based algorithm that generates individualized comfort setting recommendations based on patient-specific input data." And "Analytical validation demonstrated robust sensitivity, specificity, and generalizability, thereby establishing safety and effectiveness without prospective clinical study." This refers to the algorithm's performance independent of human input during the core recommendation generation.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not explicitly stated for the "ground truth" of the comfort settings. However, for evaluating the impact of the recommendations, "outcomes data" were used, specifically "patient therapy engagement, including increased nightly usage and additional usage days, while maintaining comparable residual AHI and mask leak."
7. The sample size for the training set:
* Not specified. The document mentions "large, representative datasets" for model performance validation but does not differentiate between training and test sets in terms of size.
8. How the ground truth for the training set was established:
* Not specified. The document only mentions that the model is "ML-based" and that "Analytical validation demonstrated robust sensitivity, specificity, and generalizability." It does not provide details on how the training data was curated or how its ground truth was established.
Ask a specific question about this device
(170 days)
Trade/Device Name: Respond OC Conserving Regulator (130-0800)
Regulation Number: 21 CFR 868.5905
Regulator (130-0800)
Classification Name: Conserver, Oxygen
Product Code: NFB
CFR: 21 CFR 868.5905
800 – K070740
Classification Name: Conserver, Oxygen
Product Code: NFB
CFR: 21 CFR 868.5905
Therapeutics | |
| Prescription Device | Yes | Yes | Similar |
| Device classification and Product Code | NFB 868.5905
| NFB 868.5905 | Similar |
| Indications for Use | The Respond OC Conserving Regulator is intended for
The Respond OC Conserving Regulator (130-0800) is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use. It may also be used to deliver a constant flow of oxygen to the patient.
The Respond OC Conserving Regulator (130-0800) is a dual mode high pressure oxygen regulator and conserving device that allows for either a continuous or conserve flow of medical grade oxygen to the patient. The device is designed with a CGA 870 style yoke for use with ambulatory oxygen cylinders. The integrated regulator reduces cylinder pressure to 22psig (+/-3psi) to the sensing diaphragm which allows the Respond OC to sense the start of inhalation by the patient and release a controlled amount of oxygen by pneumatic timing in short bursts into the lungs via an oxygen cannula. The Respond OC supports a delivered oxygen equivalency of 1 to 5 LPM in the conserve mode, which extends the ambulatory time of cylinders up to 6:1 based on the cylinder pressure and selected setting. The continuous flow mode offers settings of 2, 3 and 4 LPM if the patient requires a constant flow of oxygen.
The provided FDA 510(k) clearance letter and summary for the Respond OC Conserving Regulator (K250322) outlines the device, its intended use, and its substantial equivalence to a predicate device. However, this documentation does not contain the detailed information typically found in a clinical study report or a comprehensive test report regarding acceptance criteria and the study that proves the device meets them, especially in the context of AI/ML-based medical devices or diagnostic tools.
The device described (an oxygen conserving regulator) is a mechanical device, not an AI/ML-driven diagnostic or treatment device. Therefore, many of the typical requirements for AI/ML device studies (such as MRMC, expert consensus for ground truth, training set details, and specific performance metrics like sensitivity/specificity/AUC) are not applicable here.
The document primarily focuses on bench testing and biocompatibility to demonstrate substantial equivalence to a predicate mechanical device.
Here's an analysis based on the provided document, highlighting what is and is not present concerning "acceptance criteria" and "study proof":
Analysis of Acceptance Criteria and Study Proof for Respond OC Conserving Regulator (K250322)
Based on the provided FDA 510(k) Summary, the device is a mechanical oxygen conserving regulator. The "acceptance criteria" and "study proof" are framed in the context of demonstrating substantial equivalence to a predicate mechanical device through non-clinical (bench) testing and biocompatibility assessments, rather than clinical efficacy studies or AI/ML performance evaluations.
1. Table of Acceptance Criteria and Reported Device Performance
The document summarizes the types of tests conducted and states that the device "met its acceptance criteria" and "performs similarly to the predicate device." However, it does not explicitly list the specific quantitative acceptance criteria for each test (e.g., a specific tolerance for oxygen flow, a defined pass/fail for impact resistance) nor does it present the raw, quantitative reported performance results against these criteria. Instead, it provides qualitative statements of compliance.
| Acceptance Criteria (Inferred from Test Types) | Reported Device Performance (as stated in document) |
|---|---|
| Biocompatibility: | |
| ISO 18562-2 – Emissions of Particulate Matter | "met the applicable requirements for biocompatibility safety" |
| ISO 18562-3 – Emissions of VOCs with Toxicological Risk Assessment | "met the applicable requirements for biocompatibility safety" |
| Bench Testing: | |
| Accelerated Aging performance | "demonstrated that the subject device met its acceptance criteria" |
| Flow Comparison with predicate | "performs similarly to the predicate device" |
| Flow Regulation Test performance | "demonstrated that the subject device met its acceptance criteria" |
| Conservation Testing savings ratio (e.g., 6:1) | "demonstrated that the subject device met its acceptance criteria" (specifically states 6:1 savings ratio achieved, similar to predicate) |
| Promoted Ignition Burst Pressure Test (ASTM G 175-24) | "Passed ASTM G 175-24" (similar to predicate's G 175-03) |
| Environmental Testing (e.g., temperature, humidity) | "demonstrated that the subject device met its acceptance criteria" |
| Altitude Test performance | "demonstrated that the subject device met its acceptance criteria" |
| Flow Response Test (e.g., bolus delivery, trigger) | "performs similarly to the predicate device"; "Conserve mode: Senses a breath and delivers in first 1/3 of breath cycle" |
| Impact Test performance | "demonstrated that the subject device met its acceptance criteria" |
| Functional Equivalence: | |
| Selectable Outlet Flow (Continuous: 2, 3, 4 lpm); (Conserve: 1-5 lpm) | Match stated levels (Implicitly met for substantial equivalence claim) |
| Oxygen Bolus Size (ml) at 20 BPM (specific ml per lpm setting) | Conserve 1 lpm: 11 ml; 2 lpm: 24 ml; 3 lpm: 37 ml; 4 lpm: 46 ml; 5 lpm: 54 ml (Similar to predicate) |
| Regulator Outlet Pressure (22 PSI) | Match stated 22 PSI (Similar to predicate's 25 PSI) |
| Breaths Per Minute (bpm) support (Up to 35 bpm) | Met (Predicate: 14 to 40 bpm) |
2. Sample Size for the Test Set and Data Provenance
Given this is a physical device, the "test set" refers to the manufactured units subjected to bench testing. The document does not specify the sample size (number of devices) used for each of the non-clinical tests (e.g., how many units were subjected to accelerated aging, or impact testing).
Data Provenance: The data provenance is from non-clinical bench testing conducted by the manufacturer, Responsive Respiratory, Inc. It's not clinical data or retrospective/prospective human data. The country of origin for the testing itself is not explicitly stated but would typically be where the manufacturer's testing facilities are located.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable as the device is a mechanical oxygen regulator, not an AI/ML-driven diagnostic or classification device requiring expert-established ground truth from medical images or patient data. Ground truth for its performance would be established through calibrated laboratory equipment measuring physical parameters (flow, pressure, timing, etc.) against engineering specifications.
4. Adjudication Method for the Test Set
This question is not applicable for a mechanical device undergoing bench testing. Adjudication typically refers to resolving discrepancies between human readers or between AI and human readings. Test results for mechanical parameters are either within specification or not, based on objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI/ML) where human readers (e.g., radiologists) interpret cases, and the effectiveness of AI assistance on their performance is evaluated. The Respond OC Conserving Regulator is a therapeutic/delivery device, not a diagnostic one.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable in the typical sense for this device. There is no "algorithm" in the way an AI/ML device would have one. The device's "performance" is its mechanical function. The "bench testing" described in the summary is the standalone performance assessment of the device's mechanical and pneumatic operation (e.g., flow rates, bolus timing, pressure regulation) without human intervention beyond setting the controls for the test.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" would be physical measurements against engineering specifications and industry standards. For example:
- Flow rates: Measured by calibrated flow meters against specified LPM settings.
- Pressure: Measured by calibrated pressure gauges against specified PSI output.
- Timing of bolus delivery: Measured by sensors and timers to confirm delivery within the specified inspiratory cycle.
- Biocompatibility: Confirmed by laboratory analysis against ISO standards.
- Ignition Sensitivity: Confirmed by testing against ASTM standards.
It is not expert consensus, pathology, or outcomes data, as these are related to clinical diagnosis or patient outcomes, not the performance of a mechanical oxygen delivery device.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is not an AI/ML device that requires data for model training.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8.
Ask a specific question about this device
(210 days)
New Zealand
Re: K243583
Trade/Device Name: F&P Nova Nasal Mask
Regulation Number: 21 CFR 868.5905
Classification Name: Non Continuous Ventilator (IPPB)
Regulatory Class: Class II (21 CFR §868.5905
Healthcare Limited | |
| Product Code | BZD | BZD | Identical. |
| Device Classification | 21 CFR §868.5905
| 21 CFR §868.5905 | |
| Classification Panel | Anaesthesiology | Anaesthesiology | |
| **Indications
A-Model
The F&P Nova Nasal Mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 ks) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home.
SLA-Model
The F&P Nova Nasal mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
The F&P Nova Nasal Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal mask that features an over-the-nose cushion that seals the patient's nose, held in place by adjustable headgear straps. The mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The F&P Nova Nasal Mask is a prescription-only device, provided in a non-sterile state.
The Nova Nasal Mask range is available in three cushion sizes – Small, Medium, and Large.
The mask has two models: A-Model and Sleeplab (SL) A-Model. Both models are identical except for their Indications for Use, Operating Environment, and Reusability. The A-Model is intended to be single-patient use in the home, while the SL A-Model is intended to be used on multiple patients in a hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
I am sorry, but based on the provided FDA 510(k) Clearance Letter and the accompanying 510(k) Summary, there is no information provided regarding acceptance criteria for an AI/ML powered medical device, nor any study details that would prove such a device meets these criteria.
The document describes the clearance of a physical medical device, the F&P Nova Nasal Mask, which is a non-invasive positive airway pressure (PAP) therapy nasal mask. The performance data section lists standard engineering and biocompatibility tests typically performed on such devices (e.g., cleaning validation, leak, CO2 rebreathing, resistance to flow, vibration and noise, dead space analysis, human factors, mechanical integrity, shelf-life, and various ISO standards related to masks and biological evaluation).
Therefore, I cannot fulfill your request to describe acceptance criteria and a study for an AI-powered device using this document. The information you are asking for (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are specifically relevant to the validation of AI/ML algorithms in medical devices, which this document does not cover.
Ask a specific question about this device
(86 days)
San Diego, California 92123
Re: K250624
Trade/Device Name: myAir
Regulation Number: 21 CFR 868.5905
not raise new questions of safety or efficacy for the subject device. |
| Regulation Number | 21 CFR §868.5905
| 21 CFR §868.5905 | Identical |
| Classification Name | Noncontinuous ventilator (IPPB) | Noncontinuous
The myAir app is indicated for patients:
- prescribed with a compatible ResMed Air11 platform device to simulate therapy prior to using their device with their prescribed settings, and to configure their settings to support therapy. It is an optional software accessory to allow patients to acclimate to and operate their therapy device.
- prescribed a NightOwl wearable device to provide the user interface to operate the connected device and aid in the home sleep testing process.
The device is intended for home and hospital use for:
- new and existing patients of ResMed Air10 and Air11 PAP therapy devices and
- new users who are prescribed a compatible NightOwl home sleep test (HST).
myAir is a companion mobile medical application ("app") that serves as a patient self-monitoring, therapy usage tracking, and engagement platform for patients prescribed with compatible ResMed PAP therapy devices and the NightOwl home sleep test (HST) sensors. The app allows the patient to connect via Bluetooth to a compatible hardware device for control of their prescribed PAP or HST device and to allow self-tracking of device usage data. myAir can also be used as a communication pathway using the Bluetooth connection with the compatible device in order to send or receive data. Analysis of patient diagnostic data or display of diagnostic results are not in scope of myAir features.
The myAir subject device for this premarket submission adds device software functions related to starting and stopping therapy, and control of comfort settings (collectively referred to as "device control"). The addition of these device software functions within the myAir subject device is a modification to the K241216 myAir predicate device, in addition to sustaining previously cleared medical device functions.
It appears the provided document is an FDA Clearance Letter for the "myAir" device, specifically a 510(k) summary. This type of document primarily focuses on establishing substantial equivalence to a predicate device, rather than detailing the full scope of acceptance criteria and the comprehensive study results typically found in a clinical study report or a more detailed technical submission.
Based on the provided text, the device "myAir" is a companion mobile medical application. The submission is for a modified device, adding "device software functions related to starting and stopping therapy, and control of comfort settings (collectively referred to as 'device control')".
Therefore, the study detailed is primarily non-clinical verification and validation testing of software functions introduced with these modifications. The document states:
"Non-clinical verification and validation testing completed for device software functions under review introduced with the modifications to the myAir app demonstrated that the device met all intended performance requirements. Testing included:
- Software verification and validation, including non-functional requirements and end-to-end functional testing."
Given this, I cannot provide detailed information about acceptance criteria and study results for clinical performance or human-in-the-loop studies (MRMC, effect size, etc.), as such studies are not described in this 510(k) summary for a software modification. The focus is on the software's functional performance and adherence to guidance documents for software and cybersecurity.
Here's what can be extracted from the provided text according to your request, with a clear indication where information is not available in the document:
Acceptance Criteria and Device Performance for "myAir" (K250624)
The "myAir" device is a mobile application that received FDA 510(k) clearance (K250624) as a modified device, primarily adding "device control functions" (starting/stopping therapy, controlling comfort settings) for compatible ResMed Air11 platform devices. The acceptance criteria and performance detailed below pertain specifically to the non-clinical verification and validation of these new software functions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from document) | Reported Device Performance (As stated/inferred from document) |
|---|---|---|
| Software Functionality | Device control functions (starting/stopping therapy, comfort settings) operate as intended. | "device met all intended performance requirements." "Software verification and validation, including non-functional requirements and end-to-end functional testing." |
| Interoperability | myAir app successfully connects and operates with compatible ResMed Air11 platform devices. | "Device Interoperability and V&V: Identical [to predicate] - ResMed Air11 platform devices and NightOwl HST." "myAir app must be connected to a compatible AS11 or HST device to operate device functions as intended." |
| Compliance with FDA Guidance | Adherence to relevant FDA guidance for medical device software and cybersecurity. | "The following FDA guidance were conformed to: Content of Premarket Submissions for Device Software Functions: June 2023; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: September 2023." |
| Safety and Effectiveness | The additions to the device do not raise new questions of safety or effectiveness. | "The differences [from predicate] do not raise any new questions of safety or effectiveness; and It is as safe and effective as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "Software verification and validation, including non-functional requirements and end-to-end functional testing." This typically involves a range of test cases, but the specific number is not disclosed in this summary.
- Data Provenance: The document describes "non-clinical verification and validation testing." This implies internal testing conducted by the manufacturer (ResMed Corp, USA). It does not involve patient data or clinical datasets. Therefore, provenance (country, retrospective/prospective) is not applicable in the typical sense of a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable/Not specified. For non-clinical software verification and validation, "ground truth" is typically defined by functional requirements specifications and design documents. The testing validates that the software performs according to these pre-defined specifications. Expert human readers or adjudicators are not typically involved in establishing ground truth for this type of testing.
4. Adjudication Method for the Test Set
- Not Applicable/None stated. As the testing is non-clinical software verification, adjudication methods like 2+1 or 3+1 (common in image interpretation studies) are not relevant here. The success or failure of a test case is determined by whether the software performs as specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not conducted as part of this submission, based on the provided document. The submission pertains to software functionality and its substantial equivalence, not to comparative effectiveness for human readers.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study or human reader performance evaluation was described. The "myAir" app is an accessory for device control and patient engagement, not an AI diagnostic tool assisting human readers.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, implicitly. The "non-clinical verification and validation testing" is a form of standalone testing for the software's functional performance. The software is tested to operate its intended device control functions (starting/stopping therapy, comfort settings) without direct human intervention in the execution of those specific software commands once initiated. However, this is not "standalone performance" in the sense of a diagnostic algorithm's accuracy, sensitivity, or specificity. It's about the software performing its programmed tasks correctly.
7. The Type of Ground Truth Used
- Functional Requirements and Design Specifications. For this type of software verification, the "ground truth" is established by the detailed specifications of how the software functions are designed to operate. Test cases are then executed to confirm that the actual software behavior matches these expected behaviors. No clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient conditions) is mentioned as being used for the specific software modifications under review.
8. The Sample Size for the Training Set
- Not Applicable/Not disclosed. Since this is software functional verification and validation for a non-AI/ML application (it controls a medical device and provides user interface), there is no "training set" in the sense of data used to train a machine learning model. The software's logic is developed through traditional programming methods, not data training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8. No training set for an AI/ML model is indicated, so no ground truth establishment process for a training set is relevant or described.
Ask a specific question about this device
(238 days)
Re: K243023
Trade/Device Name: WiZARD 520 Full Face Mask
Regulation Number: 21 CFR 868.5905
Face Mask |
|---|---|
| Classification product Code: | BZD |
| Regulation number: | 21 CFR 868.5905
Manufacturer:** | Wellell Inc. |
| Classification product code: | BZD |
| Regulation number: | 21 CFR 868.5905
Comments** |
|---|---|---|---|
| Product Code | BZD | BZD | Equivalent |
| Regulation Number | 868.5905
| 868.5905 | Equivalent |
| Indications for Use | WIZARD 310/320 series CPAP Mask is intended to
The Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The Mask is intended for single-patient reuse in the home and multi-patient multi-use in the hospital environment.
The Mask is to be used by adults weighing ≥ 30 kg whom positive airway pressure (CPAP or bi-level system) has been prescribed.
WiZARD 520 Full Face Mask's cushion and frame provide a secure interface between the mask and the patient's face and the flexible cushion improves seal. A series of vents on the elbow, serve as an exhalation vent to purge the exhaled carbon dioxide from the mask. The mask is designed to maintain a continuous airflow to minimize the amount of CO2 rebreathed by the patient. The mask features a wider visibility design that ensures a clear line of sight. It also includes a fabric frame equipped with 3D-shaped headgear for enhanced comfort and stability.
WiZARD 520 Full Face Mask is intended for connection to a positive air pressure source such as CPAP or bi-level for the treatment of Obstructive Sleep Apnea. WiZARD 520 Full Face Mask can be linked to the CPAP or bi-level system's standard 22 mm breathing tube using a swivel hose, flexible tube, and tubing connector. Various sizes (small, medium, and large) are offered to ensure adequate fit over the extended patient population.
The provided text is an FDA 510(k) clearance letter for the WiZARD 520 Full Face Mask. This document describes the substantial equivalence of the new device to a predicate device, focusing on its physical and functional characteristics. It does not describe a study proving the device meets acceptance criteria related to an AI/Machine Learning model, nor does it provide information relevant to a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or the establishment of ground truth by expert consensus.
The clearance is for a physical medical device (a CPAP mask), not a software or AI-driven diagnostic tool. Therefore, the concepts of "acceptance criteria for an AI model," "sample size for test/training sets," "number of experts for ground truth," "adjudication method," "MRMC study," or "standalone algorithm performance" are not applicable to this document.
The document discusses performance tests that are standard for a physical medical device, such as CO2 rebreathing, pressure-flow characteristics, resistance to flow, anti-asphyxia valve operating pressures, and sound levels. These are engineering and physiological performance metrics, not metrics for an AI's diagnostic accuracy or expert agreement.
Therefore, I cannot fulfill your request using the provided input, as the input material does not contain the type of information you've asked for. It's crucial to understand that a 510(k) for a physical medical device like a CPAP mask does not involve AI development or validation processes.
Ask a specific question about this device
(265 days)
Trade/Device Name:** AirFit F20 Mask System; AirFit F20 NM Mask System
Regulation Number: 21 CFR 868.5905
Device Common Name: Vented Full Face Mask
Classification and Classification Name: 21 CFR 868.5905
AirFit F20 Mask System:
The AirFit F20 mask has two product variants:
- AirFit F20 mask is intended for single-patent reuse in the home environment.
- AirFit F20 SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.
AirFit F20 NM Mask System:
The AirFit F20 Non Magnetic mask has two product variants:
- The AirFit F20 Non Magnetic variant is intended for single-patient reuse in the home environment.
- The AirFit F20 Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
This mask is for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.
The AirFit F20 and AirFit F20 NM Mask Systems are both full-face masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices. CPAP & Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or ventilatory support. Both treatments deliver pressurized air from a flow generator to the patient. Such delivery of pressurized air relies on the Patient Interface; commonly known as the mask. Full face masks are a common type of Patient Interface (Mask) and are known to efficaciously support the delivery of pressurized air by providing a seal around the patient's nose and mouth.
The AirFit F20 mask system has two product variants:
- AirFit F20 Mask: This is the home use variant that is intended for single patient re-use.
- AirFit F20 SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.
AirFit F20 (K170924) had a "For Her" variant which was cleared with aesthetic colour pops, the AirFit F20 Mask and AirFit F20 SLM also have the same "For Her" variant.
The AirFit F20 NM mask system has two product variants:
- AirFit F20 NM Mask: This is the home use variant that is intended for single patient re-use.
- AirFit F20 NM SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.
The AirFit F20 and AirFit F20 NM Mask Systems share a common design architecture as the predicate AirFit F20 (K170924), except that the AirFit F20 NM Mask System has non-magnetic clips.
The AirFit F20 and AirFit F20 NM mask systems are made up of the following four main component assemblies: cushion, elbow, frame, and headgear. The cushion and headgear are available in various sizes to allow for adequate mask fit over the intended patient population.
The AirFit F20 and AirFit F20 NM mask systems are prescription devices supplied non-sterile.
The provided FDA 510(k) clearance letter and associated summary pertain to the AirFit F20 Mask Systems, which are non-continuous ventilators (CPAP/Bi-Level masks). This type of device does not typically involve complex diagnostic algorithms or AI components that would necessitate the study structure outlined in your request (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance for AI).
Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (AirFit F20, K170924) through non-clinical performance and safety testing, adherence to recognized standards, and biocompatibility evaluations.
Therefore, many of the specific questions you've asked cannot be directly answered from this document as they are not relevant to the type of device and clearance process involved.
Here's an attempt to extract the relevant information and address your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a format typically used for diagnostic algorithm validation. Instead, it compares specific design parameters and performance characteristics of the new devices (AirFit F20 Mask System and AirFit F20 NM Mask System) against the predicate device (AirFit F20, K170924). The "Comments" column often indicates that the performance is "Equivalent" or "Identical," implying that the new devices meet or perform similarly to the established safety and performance profile of the predicate, which serves as the de facto acceptance benchmark.
Here's a summary derived from the comparison table (Pages 9-12 of the provided document):
| Design parameter or feature | Predicate device: AirFit F20, K170924 (Performance/Criteria based on predicate) | Modified device: AirFit F20 Mask System (Reported Performance) | Modified device: AirFit F20 NM Mask System (Reported Performance) | Acceptance Criteria (Implied) |
|---|---|---|---|---|
| Indications for Use | Specified for CPAP/bi-level, >66lb (30kg), single-patient home, multi-patient hospital use. | Equivalent to predicate, with variants for home/sleep lab use. | Equivalent to predicate, with variants for home/sleep lab use. | Equivalent to predicate |
| Intended Use | Interface for CPAP/bi-level devices. | Identical | Identical | Identical to predicate |
| FDA Product Code | BZD | BZD | BZD | Identical to predicate |
| Patient population | Weighing more than 66 lb (30 kg) | Patients weighing more than 66lb (30kg) | Patients weighing more than 66lb (30kg) | Identical to predicate |
| Environment of Use | Home or health institution | Home or health institution | Home or health institution | Identical to predicate |
| Reprocessing claims | Single patient re-use or multi-patient re-use. | Identical | Identical | Identical to predicate |
| Sterility state as provided | Non-sterile | Non-sterile | Non-sterile | Identical to predicate |
| Validated reprocessing methods | High-Level Thermal disinfection, Sterilization | High-Level Thermal disinfection, Sterilization | High-Level Thermal disinfection, Sterilization | Identical to predicate |
| Vent type | Multi-hole vent | Multi-hole vent and diffuser vent | Multi-hole vent and diffuser vent | Equivalent to predicate's safety/efficacy profile |
| PAP tubing connection point | ISO 5356-1 (22mm) | ISO 5356-1 (22mm) | ISO 5356-1 (22mm) | Identical to predicate |
| Construction material | Polymeric, Textile, magnets | Polymeric, Textile, magnets | Polymeric, Textile | Equivalent to predicate's safety/efficacy profile (NM variant removes magnets) |
| Operating pressure range (cmH2O) | 3 - 40 | 3 – 40 | 3 – 40 | Identical to predicate |
| Sizes | Cushion (3), Headgear (3), Frame (1) | Identical | Identical | Identical to predicate |
| Mask exhaust flow (Nominal) ISO 17510:2015 Annex B | Pressure (cm H2O): 3, 20, 40 -> Flow (L/min) 'Full Face' curve: 20.1, 55.5, 82.4 | Pressure (cm H2O): 3, 20, 40 -> Flow (L/min) 'Full Face' curve: 19, 54, 82 | Pressure (cm H2O): 3, 20, 40 -> Flow (L/min) 'Full Face' curve: 19, 54, 82 | Equivalent to predicate (minor differences within acceptable range for substantial equivalence) |
| CO2 rebreathing performance (normal condition) ISO 17510:2015 Annex F | Pressure (cm H2O): 3, 5, 10 -> Relative CO2 increase Non-SLM: 14.8%, 7.5%, 6.8% SLM: 11.7%, 7.3%, 2.9% | Pressure (cm H2O): 3, 5, 10 -> Relative CO2 increase Non-SLM: ≤ 11.4%, ≤ 11.4%, - SLM: 11.7%, 7.3%, 2.9% | Pressure (cm H2O): 3, 5, 10 -> Relative CO2 increase Non-SLM: ≤ 11.4%, ≤ 11.4%, - SLM: 11.7%, 7.3%, 2.9% | Equivalent (<20%) (as per ISO standard for substantial equivalence) |
| CO2 rebreathing performance (single fault condition) ISO 17510:2015 Annex F | Fault (ISO 17510:2015) -> Relative CO2 increase Non-SLM: 32.3%, 39.5% SLM: 40.5%, 52.7% | Fault (ISO 17510:2015) -> Relative CO2 increase Non-SLM: ≤ 53.1%, ≤ 53.1% SLM: 40.5%, 52.7% | Fault (ISO 17510:2015) -> Relative CO2 increase Non-SLM: ≤ 53.1%, ≤ 53.1% SLM: 40.5%, 52.7% | Equivalent (<60%) (as per ISO standard for substantial equivalence) |
| Resistance to flow (Pressure drop across mask in cmH2O) ISO 17510:2015 Annex C | @50 L/min: <0.8 cmH2O @100 L/min: <1.6 cmH2O | @50 L/min: <0.8 cmH2O @100 L/min: <1.6 cmH2O | @50 L/min: <0.8 cmH2O @100 L/min: <1.6 cmH2O | Equivalent (Identical performance) |
| Breathing Resistance (cmH2O) ISO 17510:2015 Annex E | Inspiratory: 0.44 @ 50L/min Expiratory: 0.60 @ 50L/min | Inspiratory: 0.6 @ 50L/min Expiratory: 0.80 @ 50L/min | Inspiratory: 0.6 @ 50L/min Expiratory: 0.80 @ 50L/min | Equivalent (within acceptable limits for substantial equivalence) |
| AAV Operating Pressures ISO 17510:2015 Annex D | De-activation: 1.5 cm H2O Activation: 1.0 cm H2O | De-activation: 2.0 cm H2O Activation: 1.5 cm H2O | De-activation: 2.0 cm H2O Activation: 1.5 cm H2O | Equivalent (within acceptable limits for substantial equivalence) |
| Flow generator setting on compatible ResMed CPAP and Bi-level flow generators | "Full face" | "Full face" | "Full face" | Identical to predicate |
| Sound | Sound power level: 30 dBA Sound pressure level: 23 dBA | Multi-hole vent: 30 dBA power, 22 dBA pressure. Diffuser vent: 21 dBA power, 13 dBA pressure. | Multi-hole vent: 30 dBA power, 22 dBA pressure. Diffuser vent: 21 dBA power, 13 dBA pressure. | Equivalent to predicate (Diffuser vent improves sound) |
| Operating and storage temperature | Operating: 5°C to 40°C Storage: -20°C to +60°C | Identical | Identical | Identical to predicate |
| Magnetic Clips | Number: 4, Surface Strength: <400 mT, 50mm distance: <0.5 mT | Number: 4, Surface Strength: <400 mT, 50mm distance: <0.5 mT | Number: 0, Surface Strength: N/A, 50mm distance: N/A | Equivalent (NM variant removes magnets for specific patient needs) |
2. Sample size used for the test set and the data provenance
The document states that "Non-clinical verification and validation testing completed for the AirFit F20 and AirFit F20 NM Mask Systems demonstrated that the mask systems met all intended performance requirements." This primarily refers to bench testing and in-vitro studies.
- Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of diagnostic performance. For physical device performance, testing involves multiple units of the product to ensure consistency and reliability, but specific sample sizes for tests (e.g., number of masks tested for exhaust flow, CO2 rebreathing, resistance) are not detailed in this summary.
- Data Provenance: This is not a clinical study in the typical sense. The data comes from non-clinical bench testing conducted by the manufacturer (ResMed Pty Ltd, Australia, with a US office). It is not retrospective or prospective patient data from a particular country, but rather laboratory test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a medical mask system, not a diagnostic algorithm that requires expert interpretation for a "ground truth." The "ground truth" for performance is established by recognized international standards (e.g., ISO 17510:2015 for mask performance, ISO 10993 for biocompatibility) and engineering specifications. Compliance is measured against these standards, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set
This question is not applicable for the same reasons as #3. Performance is determined by objective measurements against established standards.
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
This question is not applicable. This clearance is for a physical medical device (CPAP/Bi-Level mask), not an AI-powered diagnostic tool. There are no "human readers" or "AI assistance" in the context described for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on:
- Compliance with international standards: For physical performance (e.g., CO2 rebreathing, exhaust flow, resistance, AAV pressures, sound) as defined by ISO 17510:2015 and other relevant ISO standards.
- Biocompatibility testing: According to ISO 10993 series and ISO 18562 series.
- Mechanical integrity testing: To ensure durability after various environmental stressors (home cleaning, transport, storage, operation, free fall, reprocessing).
- Cleaning and reprocessing validation: Against standards like ISO 17664-1, ISO 17664-2, ST98, and AAMI TIR12.
Essentially, the ground truth is objective measurement against established engineering and safety standards.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is not a machine learning or AI algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
Ask a specific question about this device
(273 days)
Molnlycke, 435 33
Sweden
Re: K242438
Trade/Device Name: Clearo
Regulation Number: 21 CFR 868.5905
IPPB) |
| Classification Name | Non-continuous ventilator |
| Regulation Number | 21 C.F.R. §868.5905
Clearo is indicated for use on adult or pediatric patients unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.
The Breas Medical Clearo is an airway clearance device that provides Mechanical Insufflation-Exsufflation (MI-E) therapy. Clearo is indicated for use on adult or pediatric patients who are unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.
The Clearo device is not intended to be used in line with a ventilator.
Clearo must be prescribed by a licensed physician and must be used only as directed by a physician or healthcare provider.
Clearo must be used with a single-limb patient circuits fitted an anti-bacterial filter.
Clearo functions by delivering ambient air at a defined positive pressure to the patient's airways (insufflation), followed by a rapid shift to negative pressure (exsufflation). This quick transition—known as "time through zero" – creates a high expiratory flow that stimulates or simulates a natural cough.
Optional oscillatory vibrations may further aid in loosening and mobilizing secretions. The continued rapid transition to negative pressure helps generate sufficient expiratory flow from the central airways, supporting the clearance of respiratory secretions.
Clearo achieves its intended use through a blower, which compresses air, a solenoid-controlled valve to manage air flow and pressure, and microcontroller electronics to control and monitor the operation. Clearo is powered from either a mains source or an internal battery.
Clearo includes the following device modes to accommodate both clinical and patient use:
- Unlocked (Clinical) Mode: Provides full access to all treatment settings and mode configurations, intended for use by healthcare professionals. Clinicians can enable specific modes for patient use and customize treatment protocols.
- Locked (Patient) Mode: Restricts access to pre-selected modes as set by the clinician. Patients cannot modify treatment parameters but may view compliance data and alarm history.
Clearo provides the following Treatment Modes:
- Manual Mode: The user controls the cycling between insufflation and exsufflation via a manual switch. This mode supports "Insufflation Rise" to control pressure ramp-up. Sessions can be recorded and stored for repeated use using the Treat-Repeat feature.
- Basic Auto Mode: Provides repeated, automatic cycling of insufflation, pause, and exsufflation, with configurable recruitment breaths, pause intervals, rise time, and optional patient-triggered breaths. Optional Stepped Insufflation Breaths gradually increases insufflation pressure across breaths for comfort.
- Program Auto Mode: Similar to Basic Auto but with a customizable, repeatable sequence of multiple insufflations followed by one exsufflation. Includes all features of Basic Auto Mode.
This FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence through technical comparisons and compliance with relevant standards rather than a typical clinical study with acceptance criteria and reported device performance metrics in a tabular format. The document emphasizes performance testing which verifies conformance with requirements, but these are primarily engineering-level tests, not direct clinical performance metrics.
Therefore, many of the requested points regarding sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for clinical data are not explicitly detailed in this provided text because the clearance relies on non-clinical performance and substantial equivalence to a predicate device.
However, I can extract and infer information about the acceptance criteria and study proving device meets them based on the provided text, focusing on the engineering and non-clinical aspects:
1. A table of acceptance criteria and the reported device performance:
Based on the provided text, the "acceptance criteria" discussed are primarily adherence to specified technical characteristics and performance within defined ranges, as well as compliance with various medical device standards. The "reported device performance" is framed as the device meeting these specifications and showing comparable waveforms to the predicate.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Intended Use | Same as predicate device (CoughAssist T70) | "Clearo is indicated for use on adult or pediatric patients unable to cough or clear secretions effectively... Same" |
| Patient Population | Pediatric through adult patients | "Pediatric through adult patients... Same" |
| Use Environment | Home, institutions, hospital | "Home, institutions, hospital... Same" |
| Pressure Range | Insufflation: 3 to 70 cmH2O; Exsufflation: -3 to -70 cmH2O | Tested across full range (70 cmH2O, -70 cmH2O) at 10 cmH2O intervals, also 3 cmH2O and -3 cmH2O. Implies performance within these ranges. |
| Flow | Maximum flow of at least 300 l/min | Tested to ensure max flow of at least 300 l/min. Implies acceptance criteria met. |
| Timing Parameters | Ti (Inhale Time): 0.5 to 5.0 sec; Te (Exhale Time): 0.5 to 5.0 sec; Pause Time: 0 to 5.0 sec between insufflation breaths | Tested across their full ranges. Implies performance within these ranges. |
| Oscillation Performance | Frequency range: 1 to 20 Hz; Amplitude range: 1 to 10 cmH2O | Tested at all combinations of frequency and amplitude ranges. Implies performance within these ranges. |
| Waveform Comparison | Comparable waveforms to predicate device (CoughAssist T70) across various modes | "Results confirm that the Clearo and the CoughAssist T70 predicate have comparable waveforms across the various modes for mechanical insufflation-exsufflation therapy." |
| Electrical Safety | Conformance to IEC 60601-1:2020 Edition 3.2 | "verified conformance with all requirements specifications and applicable standards" includingIEC 60601-1:2020. |
| EMC | Conformance to IEC 60601-1-2:2020 Edition 4.1 | "verified conformance with all requirements specifications and applicable standards" including IEC 60601-1-2:2020. |
| Usability | Conformance to IEC 60601-1-6:2020 Edition 3.2 and FDA Guidance | "Human factors validation testing was conducted according to the FDA Guidance" and "verified conformance with all requirements specifications and applicable standards" including IEC 60601-1-6:2020. |
| Alarms systems | Conformance to IEC 60601-1-8:2020 Edition 2.2 | "verified conformance with all requirements specifications and applicable standards" including IEC 60601-1-8:2020. |
| Home Healthcare Environment | Conformance to HA60601-1-11:2015+A1:2021 | "verified conformance with all requirements specifications and applicable standards" including HA60601-1-11:2015+A1:2021. |
| Pulse Oximeter (if applicable) | Conformance to ISO 80601-2-61:2017 | "verified conformance with all requirements specifications and applicable standards" including ISO 80601-2-61:2017 for accessory. |
| Biocompatibility | Conformance to ISO 10993-1, ISO 18562-1, -2, -3 | "Biological evaluation was conducted according to FDA Guidance "Use of International Standard ISO 10993-1" and "Principles of ISO 18562-1:2017... applied". Particulate matter and VOC emissions evaluated and yielded "acceptable... level". |
| Cleaning Validation | Conformance to FDA Guidance | "Cleaning Validation was performed according to FDA Guidance". |
| Software V&V | Conformance to FDA Guidance; System-level validation to user requirements. | "Software information included Verification and Validation testing per FDA Guidance... System-level validation against user requirement specifications were performed... and have met all acceptance criteria." |
| Cybersecurity | Conformance to FDA Guidance | "Security Risk Management is employed in conformance to FDA's Guidance for Cybersecurity in Medical Devices". |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of patients or cases. The testing described is primarily non-clinical performance testing (e.g., pressure, flow, timing, oscillation measurements on the device itself, EMC, electrical safety) and waveform comparison against a predicate device.
- Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective study for clinical data, as this filing relies on engineering performance tests and comparative technological characteristics. It's safe to assume the testing was conducted in a laboratory/engineering environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned, as the "ground truth" for this submission are the engineering specifications, relevant IEC and ISO standards, and the performance of the predicate device (CoughAssist T70). Expert opinion on clinical efficacy/diagnosis is not the basis for this 510(k) clearance documentation.
4. Adjudication method for the test set:
- Not applicable/Not mentioned. Adjudication methods are typically associated with clinical studies involving reader-based interpretations (e.g., radiology images). This submission focuses on objective engineering measurements and compliance with standards.
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:
- No, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI/radiology devices where human interpretation is assisted by AI. The Clearo device is a therapeutic device (mechanical insufflation-exsufflation device), not an AI diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a mechanical medical device, not an AI algorithm. While it has software and microcontroller electronics, its "performance" is its mechanical function, regulated by its design parameters and confirmed through physical measurements and standard compliance.
7. The type of ground truth used:
- The "ground truth" for this submission is primarily:
- Engineering Specifications and Design Requirements: The device's internal design parameters for pressure, flow, timing, oscillation, etc.
- International Standards: Conformance to standards like IEC 60601 series, ISO 18562 series, etc., which define safety and performance benchmarks.
- Predicate Device Performance: The established, legally marketed performance of the Respironics CoughAssist T70 provides the benchmark for "comparable waveforms" and technological characteristics.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a "training set" of data in the typical sense for algorithm development.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" as understood in the context of AI/machine learning.
Ask a specific question about this device
Page 1 of 42