Search Results
Found 346 results
510(k) Data Aggregation
(258 days)
K252078**
Trade/Device Name: BreathePal Bilevel (GFM50-MD2201)
Regulation Number: 21 CFR 868.5895
Continuous, Non-Life-Supporting
Device Classification: Class II
Regulation Number: 21 CFR 868.5895
The BreathePal Bilevel is intended to provide non-invasive ventilator (NIV) support for adult patients weighing over 30 kg (66lbs) who suffer from Obstructive Sleep Apnea (OSA) and Respiratory Impairment. It is intended for use in both home and clinical environment, including hospitals, sleep laboratories, and sub-acute care institutions.
BreathePal Bilevel devices are blower-based positive airway pressure systems designed to provide non-invasive ventilation only. These devices deliver two distinct pressure levels: a higher pressure during inhalation (IPAP) and a lower pressure during exhalation (EPAP). This pressure differential facilitates the flow of air into and out of the lungs. The system can also be configured to provide a single, constant pressure level, known as Continuous Positive Airway Pressure (CPAP).
The BreathePal Bilevel utilizes a microprocessor-controlled blower along with integrated pressure and flow sensors to detect patient breathing patterns and deliver precise therapeutic pressure. The device includes a comprehensive alarm system, featuring both therapeutic alerts (e.g., large leak) and technical alarms (e.g., system fault). A user interface allows for the adjustment of clinical parameters and the display of monitored therapy data. Additionally, the device features comfort settings, such as iBreath (FLEX), which provides adaptive pressure relief during the initial phase of exhalation to enhance patient comfort.
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(265 days)
Taiwan
Re: K251888
Trade/Device Name: VPAP Pediatric Face Mask
Regulation Number: 21 CFR 868.5895
Product Name:** AF531 SE Full Face Mask
Common or Usual Name: Face mask
Regulation Number: 868.5895
Product Name: Hsiner NIPPV Masks
Common or Usual Name: Face mask
Regulation Number: 868.5895
|
|---|---|---|---|
| Class | II | II | Substantially equivalent |
| Regulation No | 21 CFR 868.5895
| 21 CFR 868.5895 | Substantially equivalent |
| Product Code | CBK | CBK | Substantially equivalent
The mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency.
The mask is for single patient use in the hospital/institutional environment only.
The mask is to be used on patients 7 years or older (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.
The VPAP Pediatric Face Mask is designed for pediatric patients in hospital and institutional settings, serving as an interface for Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure (BiPAP) therapy. Available in two sizes to accommodate varying facial dimensions of pediatric patients, these masks ensure a comfortable and secure fit. The VPAP Pediatric Face Mask is intended for single-patient, supporting consistent and reliable noninvasive ventilation.
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(269 days)
K251661**
Trade/Device Name: Mariana Minerva; Mariana Nimbus
Regulation Number: 21 CFR 868.5895
** Ventilator, continuous, non-life supporting
Classification and Classification Name: 21 CFR §868.5895
|
|---|---|---|---|
| Regulatory Classification | 73MNS Class II 21 CFR 868.5895 | 73MNS Class II
21 CFR 868.5895 | YES |
| Intended Use | The Juno VPAP ST-A is intended to provide noninvasive ventilation
The Mariana Minerva is intended to provide non-invasive ventilation, for patients weighing more than 30 lb (13 kg) or more than 66 lb (30 kg) in iVAPS mode with respiratory impairment or obstructive sleep apnoea (OSA). It is intended for home and hospital use.
The Mariana Nimbus is intended to provide non-invasive ventilation, for patients weighing more than 30 lb (13 kg) or more than 66 lb (30 kg) in iVAPS mode with respiratory impairment or obstructive sleep apnoea (OSA). It is intended for home and hospital use.
The Mariana devices, that is Mariana Minerva and Mariana Nimbus, are non-invasive ventilation (NIV) devices that use a microprocessor controlled blower, along with pressure and flow sensors, to achieve pressure, flow and time regulation of air delivery. They have an integrated alarms module. The Mariana devices also include optional humidification, with air delivery to the patient via heated or non-heated breathing circuits. The devices provide both therapeutic (e.g. tidal volume) and technical data (e.g. system fault), and a user interface allowing adjustment of device parameters. The devices use an external AC power supply and allow the addition of low pressure supplemental oxygen.
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(266 days)
Re: K251165
Trade/Device Name: Saans (F4-01-00-000-000)
Regulation Number: 21 CFR 868.5895
Saans
Common or Usual Name: CPAP System
Classification Name: Continuous Ventilator (21 CFR 868.5895
The Saans System is intended to provide continuous positive airway pressure (CPAP) support to spontaneously breathing neonates and infants weighing up to 10 kg who require respiratory assistance, including those with conditions associated with prematurity such as Respiratory Distress Syndrome (RDS). The device is intended for use in hospital environments.
The Saans System is a medical device designed to deliver Continuous Positive Airway Pressure (CPAP) therapy. The Saans System consists of the Saans device and accessories that work together to deliver the required therapy to the patient. This submission covers the Saans Device. The Saans device takes ambient air and oxygen as input and provides the mixed gas as output. This gas mixture is supplied to the humidifier, the output of which is connected to the breathing circuit. The breathing circuit is connected to the patient interface and the Bubble CPAP Generator.
The key features and functionalities of the Saans System are:
Gas Source and Mixture: The system utilizes an oxygen source and ambient air to create the required gas mixture for therapy. This blending approach allows for oxygen delivery to the patient.
User Interface and Control: The system incorporates a user interface enabling users to adjust and monitor various therapy parameters. Users can set the desired flow rate and oxygen concentration (FiO2).
Pressure Regulation: A Bubble CPAP Generator is employed to achieve the desired pressure levels within the system. The generator provides a continuous positive pressure in the patient's airways.
Monitoring: The Saans System provides displays of parameters such as delivered flow, pressure, and FiO2. The pressure is measured at the end of the inspiratory limb, right before the patient interface.
Safety: The Saans System provides safety alarms like blockage, leakage and FiO2 alarms
Delivery Mechanism: Heated and humidified respiratory gas is delivered to the patient through an inspiratory breathing circuit (Inspiratory Limb) connected to a nasal interface (Patient Interface). An expiratory circuit (Expiratory Limb) completes the loop, connecting the nasal interface to the Bubble CPAP Generator for pressure regulation.
Humidification and Accessories: An external humidifier is used to provide humidified gas. The details for the breathing circuits, nasal interface, humidification chamber, and Bubble CPAP generator are all a part of the information provided to the user in the User Manual.
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(865 days)
Massachusetts 02180
Re: K232365
Trade/Device Name: Vivo 45 LS
Regulation Number: 21 CFR 868.5895
ventilators, home use
Classification Name
Continuous ventilators, facility use;
21 C.F.R. §868.5895
The Vivo 45 LS ventilator (with or without the SpO2 and CO2 sensors) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.), however, the mouthpiece ventilation and Auto EPAP modes are only for adult patients during non-invasive ventilation.
The Vivo 45 LS with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.
The Vivo 45 LS with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.
The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator. The Auto EPAP feature is for use with PSV+TgV+AE mode in hospital use only.
The Vivo 45 LS Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.
Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.
Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.
The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.
The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.
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(260 days)
36cm (OPTIPAPB2936); OptiPAP Junior Bonnet Kit 34-45cm (OPTIPAPB3445)
Regulation Number: 21 CFR 868.5895
|
| Classification Name | Ventilator, Continuous, Facility Use |
| Classification | 21 CFR 868.5895
--|---|---|---|---|
| Classification | | | | |
| Device Classification | Regulation: 21 CFR 868.5895
Class II | Regulation: 21 CFR 868.5895 Class II | Regulation: 21 CFR 868.5895 Class II | Equivalent
Fisher & Paykel Healthcare OptiPAP Junior is for single-patient use and is intended to deliver noninvasive positive airway pressure (PAP) therapy to spontaneously breathing patients who require respiratory support.
OptiPAP Junior is designed for use in hospital environments where the patient is continually monitored and must be prescribed by a physician. It is intended for use by trained medical professionals on a pediatric subpopulation that includes neonates and infants from birth up to two years of age.
The F&P OptiPAP Junior is intended to deliver heated and humidified Positive Airway Pressure (PAP) therapy to neonates and infants requiring respiratory support.
The F&P OptiPAP Junior is a prescription-only device provided in a non-sterile state and intended to be used in a hospital environment and must be prescribed by a physician. The F&P OptiPAP Junior is for single- patient-use up to 14 days. The F&P OptiPAP Junior will be offered in multiple size variants.
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(61 days)
Expiratory Filter Compatible with Single-limb Circuits - Size C (ONIV117C-F)
Regulation Number: 21 CFR 868.5895
Classification Name**
Ventilator, Continuous, Facility Use
Regulatory Class
Class II (21 CFR §868.5895
The Fisher & Paykel Healthcare single-patient use masks are intended for use as an accessory to ventilators to enable non-invasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained, by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.
The F&P OptiNIV Vented Full Face Masks are oro-nasal full face masks that are intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as part of a non-invasive ventilation system.
The OptiNIV Vented Full Face Masks are prescription-only, provided in a non-sterile state.
The F&P OptiNIV Vented Full Face Mask consists of a plastic shell with a seal to allow cushioning onto the patient's face, and straps to enable the mask to be secured over the head. The mask fits under the patient's nose and covers the nares of the nose and the mouth, with a soft seal to maintain pressure inside the mask whilst minimizing discomfort to the user.
The subject device is available in three sizes – A, B, and C to denote the seal sizes.
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(265 days)
518057
China
Re: K243767
Trade/Device Name: SV600, SV800 Ventilator
Regulation Number: 21 CFR 868.5895
** SV600, SV800 Ventilator
Common Name: Continuous Ventilator
Regulation Number: 21 CFR 868.5895
The SV600, SV800 Ventilator is intended to be used in intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilator is intended to provide ventilation assistance and breathing support for adult, pediatric and neonate patients with a minimum body weight of 0.5 kg. The SV600, SV800 Ventilator should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.
The SV600 and SV800 Ventilators are pneumatically-driven and electronically-controlled ventilators. The Ventilators consists of a main unit (including pneumatic circuit, electronic system, mechanical structure, display, CO2 module, SpO2 module), trolley and support arm. The device also includes a neonatal flow sensor and neonatal flow sensor cable, which are used to measure the patient inspiration/expiration flow in neonatal ventilation modes.
The provided FDA 510(k) Clearance Letter for the SV600, SV800 Ventilator describes modifications to an existing device, primarily the addition of neonatal ventilation capabilities and updated monitoring modules. However, the document does not contain the level of detail typically found in a clinical study report for evaluating acceptance criteria and device performance in the way you've requested for studies involving AI algorithms, image analysis, or expert consensus with specific metrics like sensitivity, specificity, or AUC.
This document focuses on providing evidence of substantial equivalence to predicate devices through technical comparisons and various forms of bench testing, software verification, and compliance with consensus standards. It does not present a performance study with acceptance criteria specific to an AI device's output (e.g., accuracy against ground truth, reader performance improvements).
Therefore, I cannot fill out your requested table and answer many of your specific questions as the information is not present in the provided text.
Here's what can be extracted based on the document's content:
Acceptance Criteria and Device Performance (Based on available information)
The document doesn't define "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) that would be typically found for an AI or diagnostic device. Instead, "acceptance criteria" are implied by compliance with various technical specifications and international standards. Device performance is generally reported as "meets specifications" or "is equivalent to the predicate."
| Acceptance Criteria (Implied by Standards/Specifications) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: Conformance to ISO 10993 and ISO 18562 series. | Testing performed, device meets standards. |
| Software Verification & Validation: Conformance to FDA Guidance for Software. | Verification and validation conducted; product works as designed and meets design/performance checks. |
| Electromagnetic Compatibility (EMC) & Electrical Safety: Conformance to IEC 60601-1 and related collateral standards. | Testing performed, device meets standards. |
| Functional & System Level Performance (Bench Testing): Meets accuracy specifications and demonstrates equivalence to predicate for new/modified features (e.g., neonatal ventilation parameters, CO2/SpO2 modules). | Bench testing shows device meets accuracy specifications and is substantially equivalent to the predicate. |
| Usability: Conformance to IEC 60601-1-6. | Testing performed, ensuring usability. |
| Alarm Systems: Conformance to IEC 60601-1-8. | Testing performed, ensuring alarm system effectiveness. |
| Critical Care Ventilator Specifics: Conformance to ISO 80601-2-12. | Testing performed, device meets standards. |
| Respiratory Gas Monitors: Conformance to ISO 80601-2-55. | Testing performed, device meets standards. |
| Pulse Oximeter Equipment: Conformance to ISO 80601-2-61. | Testing performed, device meets standards. |
| Ventilator Endurance: Conformance to ASTM F1100-90. | Testing performed, ensuring endurance. |
| Key Technical Parameters (e.g., TV range, O2% range, SpO2 accuracy): Achieves specified ranges and accuracies (as detailed in the comparison tables). | The comparison tables indicate specific ranges and accuracies for various parameters, demonstrating the device's adherence to these specifications (e.g., SpO2 accuracy of ±2% for adult/pediatric, ±3% for neonate in certain ranges). |
Study Details (Based on available information in the 510(k) Summary)
-
Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for test sets in the context of clinical performance evaluation (e.g., number of patients, number of readings). The "testing" mentioned refers to engineering, software, and standards compliance evaluations.
- Data provenance is not provided, as this is not a clinical study report.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document describes engineering and standards compliance testing, not a clinical study involving expert-established ground truth for performance evaluation of an AI component or diagnostic output.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a clinical study with an adjudication process for ground truth.
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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 was done. This document describes a ventilator, not an AI diagnostic or assistance tool in that context. While it includes "Intellicycle" and "Lung Recruitment (SI)" features, these are not presented as AI assistance augmenting human reader performance in a diagnostic capacity.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies standalone performance testing for various technical aspects of the ventilator and its integrated modules (CO2, SpO2 sensors) against their respective specifications and standards. For example, SpO2 sensor accuracy is stated as "Measurement accuracy: 70 to 100%: ±2% (adult/pediatric mode)" for the Mindray SpO2 module. However, this is for sensor performance, not a complete "algorithm only" evaluation in the context of AI diagnostic output as typically measured.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the technical and performance testing, the "ground truth" would be established by reference standards, calibrated equipment, and design specifications. For example, a flow sensor's accuracy would be tested against a known, precise flow rate. For biocompatibility, the ground truth is defined by the toxicological profiles dictated by the ISO standards. For software, the ground truth is the functional requirements and design specifications.
- There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for clinical performance evaluation of an AI component.
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The sample size for the training set:
- Not applicable. This document does not describe the development or validation of an AI algorithm with a training set. The "Intellicycle" feature is mentioned, but no details regarding its development, training data, or validation as an AI algorithm are provided.
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How the ground truth for the training set was established:
- Not applicable, as no AI training set is described.
Summary Limitations:
The provided text is a 510(k) summary, which aims to demonstrate substantial equivalence to legally marketed predicate devices. It details technical changes, compliance with regulatory standards (e.g., biocompatibility, electrical safety, EMC, software V&V), and functional testing results. It does not outline a clinical performance study with the types of metrics and methodologies commonly associated with evaluating AI-driven diagnostic devices or those requiring expert consensus for ground truth. Therefore, many of your specific questions are not addressed by the provided document.
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(272 days)
Molnlycke, 45333
Sweden
Re: K242485
Trade/Device Name: EveryWare
Regulation Number: 21 CFR 868.5895
Usual Name**
(Accessory to) Continuous Ventilator
Classification Name
Regulation: 21 C.F.R. §868.5895
EveryWare is indicated to support clinicians by managing data of patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. EveryWare provides remote patient data collection & viewing and is intended to be used by healthcare representatives in conjunction with compatible non-life support therapy devices to adjust prescription and/or performance settings. EveryWare is intended to be used in hospital, institutional, provider, and home care settings.
EveryWare is a platform that gathers treatment information from Breas respiratory devices in a secure cloud-based system. The data from ventilator is sent over a cellular modem through a cellular network to a cloud-hosted secure data storage system. The authenticated users access this cloud hosted system from a browser in their computer.
EveryWare securely connects compatible medical devices located at the point of patient care to the cloud, and provides authorized healthcare representatives the means to manage patient and device information and settings. EveryWare does NOT alter the intended use of connected medical devices or provide functions to automate diagnosis or therapy.
This document is a 510(k) clearance letter for the medical device "EveryWare." It focuses on establishing substantial equivalence to previously cleared predicate devices. Therefore, it does not contain the detailed study information typically found in a clinical trial report or a performance validation study for a novel device.
Based on the provided text, here's what can be extracted and what is NOT available:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics (e.g., "sensitivity $\ge 90%$"). The document primarily focuses on demonstrating that EveryWare's functionalities and technical characteristics are similar to its predicates, and that its differences "do not raise new questions of safety and effectiveness."
- Reported Device Performance: Instead of performance metrics, the document lists functional and technological characteristics and states their similarity or difference compared to predicates. Performance is broadly assessed through "non-clinical testing" listed below.
| Characteristic | Acceptance Criterion (Implied) | EveryWare Performance (Reported) |
|---|---|---|
| Intended Use | Must be within or similar to predicate devices. | "EveryWare is indicated to support clinicians by managing data of patients... provides remote patient data collection & viewing and is intended to be used by healthcare representatives... to adjust prescription and/or performance settings." Similar to predicates. |
| Environment of Use | Must be similar to predicate devices. | "EveryWare is intended to be used in hospital, institutional provider, and home care settings." Similar to predicates. |
| User Population | Must be similar to predicate devices. | "EveryWare is intended to be used by... Prescribing physicians, nurses, respiratory therapists, physiotherapists and technicians - Durable Medical Equipment (DME)/Homecare providers (HCPs)/Home Medical Equipment providers (HMPs)." Similar to predicates. |
| Application Type | Must be similar to predicate devices. | "Web-based application." Same as predicates. |
| Product Codes Supported by Remote Prescription Change Functionality | Must support relevant product codes, with differences not raising new safety/effectiveness questions. | MNS, MNT. Similar to K152356 (which supports MNS, MNT, BZD), but EveryWare does not support BZD. This difference is not presented as raising safety/effectiveness concerns. |
| Product Codes NOT Supported by Remote Prescription Change Functionality | Must align with predicates or have justified differences. | NOU, CBK. Similar to predicates. |
| Data Transfer Technology | Must be robust and achieve remote data transfer. | Wireless (cellular modem), SD Card, File upload/Internet. Uses iLink cellular modem. Similar to predicates. |
| Functionality | Must include core features of data management and settings. | Centralized database, Patient Management, Display therapy data, Generate reports, Settings management for non-life supporting devices. Same as predicates. |
| Therapy Mode Change (for non-life support devices) | Justified difference from predicates if not raising new safety/effectiveness questions. | No. Predicates Yes. Different, but "The absence of Therapy Mode Change does not raise new questions of safety and effectiveness." |
| Target Volume Setting | Must be present if offered by predicates. | Yes. Same as predicates. |
| IPAP & EPAP Settings | Must be present if offered by predicates. | Yes. Same as predicates. |
| Breath Rate and Insp. Time Setting | Must be present if offered by predicates. | Yes. Same as predicates. |
| Rise Time & Ramp Pressure Setting | Must be present if offered by predicates. | Yes. Same as predicates. |
| Humidifier Setting | Justified difference from predicates if not raising new safety/effectiveness questions. | No. Predicates Yes. Different, but "The absence of Humidifier Setting does not raise new questions of safety and effectiveness." |
| High Minute Volume, Disconnection & Apnea alarm | Must be present if offered by a predicate and relevant. | Yes. Similar to K152356. |
| Mask Resistance & Mask Resistance Lock | Must align with predicates or have justified differences. | No. Similar to K151901. |
| View Optional Screen | Must align with predicates or have justified differences. | No. Similar to K151901. |
| Tubing Type & Tubing Type Lock | Must align with predicates or have justified differences. | No. Similar to K151901. |
| Automated Airway Management | Must align with predicates or have justified differences. | No. Similar to K151901. |
| Reports | Must provide compliance reports. | Detailed report (includes compliance information). Same as predicates. |
| Labeling | Must include online help. | Online help file within the application. Same as predicates. |
| Viewing of data | Must allow interactive viewing based on date range. | Interactive viewing of data based on user selected date range. Same as predicates. |
| Safety and Effectiveness | Must be demonstrated through compliance with recognized standards and lack of new safety/effectiveness questions. | EveryWare was designed and subjected to performance testing in accordance with listed non-clinical standards (e.g., Software, Cybersecurity, Human Factors, EMC). "EveryWare, by itself, is not intended for diagnosis and treatment of disease or medical condition. EveryWare does not change the performance specification of the connected therapeutic devices. Therefore, no further performance data is required to demonstrate substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the clearance letter. The document mentions "performance testing" and adherence to various standards but does not detail a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective nature). The focus is on software and system validation rather than clinical dataset performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. As the device is primarily a data management and remote settings platform aiming for "substantial equivalence" based on functional and technical characteristics, and not for diagnostic or therapeutic AI, there is no mention of experts establishing a clinical ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the device and the presented documentation, it's unlikely an adjudication method for a clinical test set would be applicable or detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A MRMC study was not performed nor mentioned. EveryWare is a data management and settings adjustment platform, not an AI-assisted diagnostic or therapeutic tool that would typically involve human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a "platform that gathers treatment information from Breas respiratory devices in a secure cloud-based system" and allows "authorized healthcare representatives the means to manage patient and device information and settings." It does not involve a "standalone algorithm" in the typical sense of a diagnostic or predictive AI. Its performance is tied to its functionality in securely collecting, displaying, and allowing modification of therapy data, which relies on system integrity rather than algorithmic output interpretation. Therefore, a standalone algorithmic performance study in the context of AI was not done or reported.
7. The Type of Ground Truth Used
For EveryWare, the "ground truth" relates to:
- The accurate and secure transmission, storage, and display of patient data from compatible devices.
- The correct implementation of remote prescription/performance settings onto compatible devices.
- Compliance with various software, cybersecurity, human factors, and electromagnetic compatibility standards.
This is fundamentally different from a clinical ground truth (e.g., pathology, outcomes data, or expert consensus for disease detection). The ground truth for this type of device would be defined by technical specifications, data integrity, security protocols, and successful functional validation against a known correct behavior.
8. The Sample Size for the Training Set
This information is not provided. EveryWare is described as a data management platform rather than a machine learning model that would require a "training set" in the context of AI. The development would involve software engineering and validation practices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" mentioned in the context of an AI/ML model for this device. The development process would have involved establishing requirements and validating the software against those requirements, rather than training against a ground-truth dataset.
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(232 days)
Petersburg, Florida 33704
Re: K242931
Trade/Device Name: Hft750u
Regulation Number: 21 CFR 868.5895
Common/Usual Name:** Continuous Ventilator
Classification Name: Continuous Ventilator
CFR: 868.5895
Device:** Nihon Kohden NKV-330 - K213521
Classification Name: Continuous ventilator
CFR: 868.5895
Fisher and Paykel – Airvo 3 NIV – K233643
Classification Name: Continuous ventilator
CFR: 868.5895
The HFT750U ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency.
The device provides heated and humidified gas to the patient.
The device is intended for pediatric patients weighing 12.5 kg or greater to adult patients in non-invasive respiratory therapy. Patients with their upper airways bypassed are included.
The High Flow mode has a flow range from 1 to 60 lpm.
The HFT750U is intended for use in hospitals, hospital-type facilities, and in hospital transportation by qualified and trained users under the directions of a physician.
It is not intended for life support.
This HFT750U is a Continuous Ventilator, intended to provide the patient with a high flow of gas that contains a constant amount of oxygen in a non-invasive method, thereby assisting or regulating the patient's respiration use in a hospital or medical institutions.
It can be used by the upper airways bypassed patients. Equipped with various alarm and safety functions, High flow (HF), the Continuous Positive Airflow Pressure (CPAP) and Bilevel Positive Airway Pressure (bilevel) modes regulate the patient's respiration, but for correct diagnosis it should be used together with clinical information.
The provided FDA 510(k) clearance letter for the HFT750U Continuous Ventilator does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.
The document is primarily a clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and safety and performance standards. It lists types of performance testing conducted (e.g., Software Verification, Performance of Ventilation Modes), but it does not provide:
- Specific quantifiable acceptance criteria for device performance.
- Reported device performance data against those criteria.
- Details about the test set (sample size, provenance).
- Information on expert involvement in ground truth establishment or adjudication for performance studies.
- Details of any MRMC studies, standalone AI performance, or ground truth types used in specific performance evaluations.
- Training set information for any AI/ML component (which isn't explicitly mentioned as a core feature of this ventilator model, but could be implied by "Software Verification").
Given the limitations of the provided text, I will answer what can be inferred and highlight what information is missing.
Inferred Acceptance Criteria and Reported Device Performance (Table)
Based on the general nature of a continuous ventilator and the standards it claims to comply with, the acceptance criteria would revolve around meeting the specifications and a lack of hazardous function or failure. However, specific numerical acceptance criteria and direct performance metrics are not explicitly stated in the provided text.
The document implies that the device met acceptance criteria because it was cleared by the FDA and states "The sponsor has demonstrated through performance testing, design and non-clinical testing that the proposed device and predicates have been found to be substantially equivalent."
Here's an attempt to structure a table based on the types of performance aspects mentioned, acknowledging that specific data and criteria are absent:
| Acceptance Criterion (Inferred from testing types) | Reported Device Performance (Inferred from clearance) |
|---|---|
| Accuracy & Stability of Ventilation Modes/Settings: (e.g., flow rate, pressure, oxygen concentration delivery) | Conforms to set parameters; deemed substantially equivalent to predicate devices for intended function. |
| Alarm Functionality: (Timeliness, accuracy, and appropriate notification for critical events) | Alarms (visual and audible) function as intended; similar to predicate devices. |
| Power Performance: (Operation with AC mains and reserve battery) | Meets performance requirements for both AC and battery power, demonstrating adequate power functionality. |
| Endurance/Reliability/Service-life: (Device longevity and consistent function over time) | Demonstrated adequate service-life and reliability through testing. |
| Environmental Performance: (Functionality within specified temperature, humidity ranges) | Operates within specified environmental conditions (e.g., 5°C to 40°C operating temperature, 0-95% storage humidity). |
| Biocompatibility: (Materials in contact with patient are safe) | Complies with ISO 10993-1 and ISO 18562-1, indicating material safety. |
| Electrical Safety & EMC: (Safety against electrical hazards and electromagnetic interference) | Complies with relevant IEC 60601 series standards for electrical safety and EMC. |
| Software Verification: (Software functions as intended, free from critical bugs) | Software functionality verified as per testing. |
| Human Factors/Usability: (Safe and effective for expected users) | Found to be usable and safe. |
| Cleaning & Disinfection Efficacy: (Ability to be effectively cleaned and disinfected) | Cleaning and disinfection protocols deemed effective. |
| Risk Management: (Identification and mitigation of risks) | Risks managed and mitigated to an acceptable level. |
| Accessory Compatibility: (Proper function with specified accessories) | Found compatible with required accessories (e.g., heated wire circuits, water chambers, patient interfaces). |
| Waveform Comparison: (Output waveforms match predicate device's expected performance) | Waveforms are comparable to the predicate, indicating similar operational characteristics. |
Missing Information from the Provided Document:
- Sample size used for the test set and the data provenance: Not mentioned. The document only lists types of tests, not the datasets or sample sizes for those tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This device is a ventilator, not an AI diagnostic tool requiring expert ground truth for image or signal interpretation. Performance is typically assessed against engineering specifications and physiological models.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not mentioned. Adjudication methods are typically used for establishing ground truth in human-in-the-loop or standalone AI studies for diagnostic/interpretive tasks, which is not the primary function of this device's "performance testing" as described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI diagnostic or assistive device in the context of "human readers" interpreting medical images or signals. Its "performance testing" would involve engineering and software validation, not human reader studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Performance of Ventilation Modes and Control Settings" and "Software Verification" which are forms of standalone testing for the device's core functionality and software. However, no specific metrics or study design for "standalone performance" (as it relates to AI algorithm performance) are provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a ventilator, "ground truth" would typically be established by:
- Engineering specifications: The device's output (flow, pressure, oxygen concentration) is measured against the design specifications.
- Standardized test lung models: Simulation of patient physiology (e.g., lung compliance, resistance) to assess how the ventilator responds in different scenarios.
- Reference measurement devices: Highly accurate external sensors to verify the device's internal measurements and deliveries.
- Compliance with recognized standards: Adherence to standards like ISO 80601-2-12 for basic safety and essential performance of ventilators.
The document does not explicitly state the specific "ground truth" methods used, but these are the common practices for such devices.
- The sample size for the training set: Not applicable/not mentioned. The document describes a traditional medical device (ventilator) and its conformity to engineering and safety standards. There is no indication of a machine learning model that would require a "training set" in the context of an AI/ML device submission. The software verification refers to traditional software development and testing.
- How the ground truth for the training set was established: Not applicable, for the same reason as point 7.
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