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510(k) Data Aggregation
(219 days)
OPT96X Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a hospital, sub-acute facility, or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
MYDUETXXX Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
The F&P Optiflow+ Duet Nasal Cannula is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy to spontaneously breathing patients. The F&P Optiflow+ Duet Nasal Cannula is a prescription-only device, provided in a non-sterile state and intended to be used in a hospital, sub-acute facility, or long-term (managed) care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. The device is single patient use only for up to 14 days in the hospital and up to 30 days in the home/long-term care facilities.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the F&P Optiflow+ Duet Nasal Cannula. It focuses on demonstrating the device's substantial equivalence to a legally marketed predicate device, rather than proving that an AI/ML powered device meets specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test/training sets, expert consensus for ground truth, and MRMC studies for AI assistance cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.
The document provides information on the non-clinical performance tests conducted for the F&P Optiflow+ Duet Nasal Cannula to demonstrate its substantial equivalence to its predicate device (F&P Optiflow+ Nasal Cannula OPT94X, K162553).
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present acceptance criteria in a quantitative table format that shows a direct "acceptance criteria vs. reported performance" for the device's primary function in terms of a specific output (like an AI model's accuracy, sensitivity, or specificity). Instead, the "performance" is demonstrated through compliance with various international standards and general performance specifications like flow ranges.
However, we can infer some "performance" aspects from the comparison table on pages 6-7, although they are mostly qualitative or specify operating ranges.
| Characteristic / Test | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (F&P Optiflow+ Duet Nasal Cannula) |
|---|---|---|
| Product Code | BTT (Same as predicate) | BTT |
| Device Classification | 21 CFR §868.5450 (Same as predicate) | 21 CFR §868.5450 |
| Classification Panel | Anesthesiology (Same as predicate) | Anesthesiology |
| Indications for Use (General Equivalence) | Equivalent to predicate | More specific than predicate, but within its scope |
| Availability | Prescription Use (Same as predicate) | Prescription Use |
| Patient Population | Pediatric (10+) to Adult (More specific than predicate) | Pediatric (10 years and up) to adult. |
| Patient Acuity | Spontaneously breathing (Same as predicate) | Spontaneously breathing patients. |
| Patient Monitoring | Appropriate monitoring required (Same as predicate) | Appropriate patient monitoring must be used at all times. |
| Use Environment | Home, Hospital, sub-acute, long-term care facilities | Home and Hospital environment, sub-acute facilities, long-term (managed) care facilities (OPT96X Series); Home and long-term (managed) care facilities (MYDUET Series) |
| Reusability | Single patient-use only, < 14 days in hospital, < 30 days in home/long-term | Single patient-use, < 14 days in hospital/sub-acute, < 30 days in home/long-term |
| Number of Cannula Sizes | Small, Medium, Large (Same as predicate) | Small, Medium, Large |
| Headgear Adjustment Method | Identical to predicate | Headstrap through slots on Headstrap Buckle |
| Size Identification Color Coding | Identical to predicate | Small: Orange; Medium: Blue; Large: Green |
| F&P Airvo 2 System Flow Range | Small: 10–50 L/min; Medium/Large: 10–60 L/min | OPT962 (Small): 10–50 L/min; OPT964 (Medium): 10–60 L/min; OPT966 (Large): 10–60 L/min |
| F&P Airvo 3 System Flow Range | Small: 10–60 L/min; Medium/Large: 10–70 L/min | OPT962 (Small): 10–60 L/min; OPT964 (Medium): 10–70 L/min; OPT966 (Large): 10–70 L/min |
| MR850 System Flow Range | All sizes: 5-60 L/min | OPT962 (Small): 5-60 L/min; OPT964 (Medium): 5-60 L/min; OPT966 (Large): 5-60 L/min |
| F&P 950 System Flow Range | (Predicate not cleared for this system) | OPT962 (Small): 5-70 L/min; OPT964 (Medium): 5-70 L/min; OPT966 (Large): 5-70 L/min |
| F&P myAirvo System Flow Range | Small: 10-50 L/min; Medium/Large: 10-60 L/min | MYDUETSMALL: 10-50 L/min; MYDUETMEDIUM: 10-60 L/min; MYDUETLARGE: 10-60 L/min |
| Shelf life | Not claimed on predicate labeling | 3 years |
| Transport and Storage Temperature Range | -10 °C to +50 °C | -10 °C to +50 °C |
| Sterility | Device not provided sterile | Device not provided sterile |
| Biocompatibility (ISO 10993-1:2018; ISO 18562-1:2017) | Compliance with standards | Tested to standards |
| Conical Connectors (ISO 5356-1:2015) | Compliance with standard | Tested to standard |
| Usability Engineering (IEC 62366-1:2015+A1:2020) | Compliance with standard | Tested to standard |
| Packaging Integrity (ISTA 2A:2011) | Compliance with standard | Tested to standard |
2. Sample size used for the test set and the data provenance:
- This document does not specify a "test set" or "sample size" in the context of an AI/ML study.
- The "testing" mentioned refers to non-clinical bench testing and compliance with recognized standards. For these types of tests, sample sizes would be determined by the specific standard's requirements for the particular test (e.g., number of devices for flow rate testing, number of samples for biocompatibility).
- Data provenance (country of origin, retrospective/prospective) is not applicable here as it's not a clinical data study for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The device is a physical medical device (nasal cannula), not an AI/ML algorithm requiring expert ground truth for image or data interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable, as there is no "test set" adjudicated by experts for an AI/ML algorithm.
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 information is not applicable. This is not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not applicable in the context of an AI/ML device. For this physical device, "ground truth" would equate to established physical, chemical, and biological properties, and performance characteristics measured against industry standards.
8. The sample size for the training set:
- This information is not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- This information is not applicable. This is not an AI/ML device.
In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (nasal cannula) demonstrating substantial equivalence to a predicate device through non-clinical performance data and compliance with standards. It does not contain information related to AI/ML device acceptance criteria or studies.
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(294 days)
The BONHAWA Respiratory Humidifier is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing patients 20 kg and up, child to adults in hospitals. It adds heat and moisture to the flow of gases. The flow may be from 2 to 70 L/min depending on the patient interface.
The BONHAWA Respiratory Humidifier provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients without bypassed upper airways in hospitals.
The BONHAWA Respiratory Humidifier is a heated humidifier with integrated blower, heater plate and heated breathing circuit that delivers warm and humidified respiratory gas to a patient via nasal cannula. A blower inside the device blends the externally provided oxygen with entrained filtered air and controls the gas flow rate delivered to the patient per the professional user established setting. An internal oxygen sensor monitors and reports the delivered oxygen concentration. The patient interface, heated breathing circuit chamber and chamber adapter are single use.
The provided text is a 510(k) Premarket Notification for the BONHAWA Respiratory Humidifier. It focuses on demonstrating substantial equivalence to a predicate device (Airvo 2 Humidifier series) and a reference device (Airvo 3 High Flow Humidified Oxygen Delivery Device) based on technical characteristics and performance testing against recognized consensus standards.
However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device. The device described is a physical medical device (a respiratory humidifier), not an AI/ML-driven diagnostic or therapeutic software. Therefore, the specific questions related to AI/ML device performance metrics (e.g., sample size for test sets, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable and are not addressed in this filing.
The "Performance Testing" section (Page 11) states that substantial equivalence is based on:
- Product validation and risk mitigation verification testing.
- Meeting pertinent recognized consensus standards:
- ISO 80601-2-74:2017 (Respiratory humidifying equipment)
- IEC 60601-1:2005+AMD1:2012 (General requirements for basic safety and essential performance)
- IEC 60601-1-2:2014 +A1:2020 (Electromagnetic disturbances)
- IEC 60601-1-8 (Alarm systems)
- ISO 10993-1 (Biocompatibility)
- ISO 18562-1 (Biocompatibility of breathing gas pathways).
The table "Comparison of Technological Characteristics" (Pages 6, 7, 8, 9) effectively serves as the "acceptance criteria" through a direct comparison to the predicate and reference devices, demonstrating that the subject device's specifications are either identical or offer non-inferior performance without raising new safety or effectiveness concerns.
Given the nature of the device, the following points address the relevant aspects of your request based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate and reference devices, and adherence to relevant consensus standards. The "reported device performance" is presented through direct specifications and the claim of meeting the standards.
| Attribute | Acceptance Criteria (Predicate/Reference Standard) | Reported Device Performance (BONHAWA Respiratory Humidifier) | Notes/Differences |
|---|---|---|---|
| Classification Name | Humidifier, Respiratory Gas (Direct Patient Interface) (Predicate) | Humidifier, Respiratory Gas (Direct Patient Interface) | Similar to the predicate. |
| Regulation Number | 21 CFR 868.5450 (Predicate) | 21 CFR 868.5450 | Similar. |
| Indications for Use | High flow warmed and humidified respiratory gases for spontaneously breathing patients. (Predicate similar, Reference broader to include infants and sub-acute facilities, and bypassed upper airways). | High flow warmed and humidified respiratory gases for administration to spontaneously breathing patients 20 kg and up, child to adults in hospitals. Without bypassed upper airways. | The subject device includes a more specific lower weight limit (20kg and up) and explicitly excludes use with bypassed upper airways, aligning more closely with the predicate's narrower scope for non-bypassed upper airways. The overall intended use of delivering high flow breathing gases with humidification remains similar. |
| Environment of Use | Hospitals (Predicate: Hospitals and long-term care facilities; Reference: Hospitals and sub-acute facilities) | Hospitals | Similar but not for long-term facility use as the predicate. |
| Patient Population | Pediatric to Adult (Predicate) / Infant to Adults (Reference) | Pediatric patients, 20kg and above, and Adult | Similar. More specific starting weight. |
| Breathing Type | Spontaneously breathing | Spontaneously breathing | Similar. |
| Flow Rate | Predicate: up to 60 L/min; Reference: up to 70 L/min | Pediatric: 2 - 25 L/min, Adults: 10 - 70 L/min | Subject device's adult flow rate (70 lpm) matches the reference device and is higher than the predicate (60 lpm), which is considered acceptable for achieving intended FiO2 by matching patient inspiratory demand. |
| Operating Principle | Constant flow of warmed, humidified gas delivery via blower and humidifier | Constant flow of warmed, humidified gas delivery via blower and humidifier | Similar. |
| Oxygen Input Source | Low-Pressure Oxygen (LPO) low-pressure connector (from rotameter) | Low-Pressure Oxygen (LPO) low-pressure connector (from rotameter) | Similar. The reference device also has a High-Pressure Oxygen (HPO) inlet. |
| Humidity Source | Heated humidification chamber | Heated humidification chamber | Similar. |
| Humidity Performance | At 37°C >= to 33mg/L, At 34°C >= to 12mg/L, At 31°C >= to 12mg/L | At 37°C >= to 33mg/L, At 34°C >= to 12mg/L, At 31°C >= to 12mg/L | Similar. |
| Temperature Range | 31 - 37 °C | 31 - 37 °C (Adult: 37°C, 34°C, 31°C; Pediatric: 34°C) | Similar. |
| Ambient Operating Temp | 18 – 28 °C | 18 – 28 °C | Similar. |
| Alarms | Visual and audible alarm system; Mute button | Visual and audible alarm system; Mute button | Similar. |
| Patient Interfaces | Nasal cannula, Unsealed tracheostomy connector, Unsealed mask adapter (Predicate/Reference) | Nasal cannula | Similar for the patient without bypassed airway (which is the stated indication). The subject device does not include tracheostomy or mask adapter interfaces. |
| Heated Breathing Tube | Single-lumen, spiral heater wires | Single-lumen, spiral heater wires | Similar. |
| Duration of Use | 14 Days single patient use | 14 Days single patient use | Similar. |
| Oxygen Concentration | Input Oxygen < 60 lpm (Predicate); Input Oxygen < 70 lpm (Reference) | Input Oxygen < 80 lpm; O2 concentration mixing of 21 to 100% | Substantially equivalent, allowing for a greater O2 flow input, which facilitates attainment of intended FiO2 by matching patient inspiratory demand. |
| Non-Clinical Testing | Compliance with IEC 60601-1, IEC 60601-1-2, ANCSI/AAMI ES 60601-1, EN 60601-1, IEC 60601-1-8, ISO 80601-2-74 (Predicate/Reference) | Compliance with listed standards (IEC 60601-1, IEC 60601-1-2, ANSI/AAMI ES 60601-1, EN 60601-1, IEC 60601-1-8, ISO 80601-2-74, ISO 80601-2-55 (additional)) | Similar, demonstrating adherence to recognized safety and performance standards. The subject device specifically lists ISO 80601-2-55:2018 (Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors) in its non-clinical testing section, which is not explicitly listed for the predicate/reference in the table but aligns with its function. |
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10 (Predicate/Reference also include ISO 10993-11, ISO 10993-18 and ISO 18562-1) | Compliance with ISO 10993-5:2009, ISO 10993-10:2010, ISO 18562-1 | Similar patient contact and duration of use, demonstrating materials safety. |
| System Components | Device, power cord, water chamber, water chamber adapter, heated breathing circuit, cannula (Similar for predicate/reference) | Device, power cord, water chamber, water chamber adapter, heated breathing circuit, cannula | Same. Substantially equivalent. |
| Device Weight | 4.8 lb (predicate) / 9.8 lb (reference) | 5.7 lb (unit) | Falls within the range of the predicate and reference, considered substantially equivalent as it does not raise new safety or effectiveness concerns. |
| Dimensions (H x W x D) | 11.6" x 6.7" x 6.9" (predicate) / 11.6" x 8.1" x 7.5" (reference) | 12.5" x 8.7" x 7.2" | Considered substantially equivalent. |
| Technological Characteristics | Intake from User chosen flowmeter is mixed by a blower and gas is delivered to the patient after mixing by passing over a heated water chamber to add humidity. Gas is delivered via a heated breathing circuit and cannula interface. (Predicate/Reference) | Intake from User chosen flowmeter is mixed by a blower and gas is delivered to the patient after mixing by passing over a heated water chamber to add humidity. Gas is delivered via a heated breathing circuit and cannula interface. | Similar. There are no fundamental scientific principle differences. The differences (e.g., higher flow rate, graphical user interface) do not alter the safety or effectiveness or raise new concerns. |
| Graphical User Interface | Not explicitly mentioned in predicate/reference comparison table, but implied by functional description. | Graphical user interface - to better inform users of the device function and attainment of intended use. | This is a key characteristic differing from the predicate, intended to improve user information and use. The document states this difference does not alter safety or effectiveness. |
| User Supplied Accessories | Oxygen source, oxygen flowmeter, oxygen tubing | Oxygen source, oxygen flowmeter, oxygen tubing | Identical. |
| Power Input | 110-115 V, 50-60 Hz, 2.2-2.4 A max (Predicate/Reference) | 110-120 V, 50-60 Hz, 1.2 A (1.4 A max) | Substantially equivalent. The subject device has a lower maximum current (1.4A vs 2.4A). |
| Heater Plate Max Power | 160 W (Predicate); Not stated (Reference) | 150 W | Lower wattage reduces heat and power compared to the predicate, but is still considered substantially equivalent as it does not raise new safety/effectiveness concerns regarding the humidification performance (which is met). |
| Battery | None (Predicate) / Lithium Ion (Reference) | None | Similar to the predicate. |
| Operating Conditions | Ambient temperature 18-28°C, Humidity 10-95%, Altitude 0-2000m (Predicate) | Ambient temperature 18-28°C, Humidity 10-95%, Altitude 0-2000m (6,000 ft) | Similar to the predicate. |
2. Sample sized used for the test set and the data provenance:
This information is not provided as it's a physical device and not an AI/ML model evaluated on a data set. The performance testing relies on engineering verification and validation against specified standards. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is not an AI/ML device requiring expert annotation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable, as this is not an AI/ML-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no AI/ML algorithm involved to be evaluated in standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of AI/ML. The "ground truth" for this device's performance is objective measurement against specified engineering standards (e.g., flow rate, temperature, humidity output) and safety benchmarks, as well as biocompatibility testing.
8. The sample size for the training set:
Not applicable, as there is no AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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