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The 6500 Series V2masks are disposable, single-patient-use, adult oro-nasal masks intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to continuous ventilators which have adequate alarms and safety systems for ventilator failure. The masks are specifically indicated for use on adult patients (> 30 kilograms weight) to administer positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. They are intended for use on patients who are appropriate candidates for noninvasive ventilation, in the home, hospital, or other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect.

The 6600 Series V2masks are disposable, single-patient-use, adult oro-nasal CPAP/NIPPV masks which incorporate passive, continuous flow exhaust ports into the mask itself. They are intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that use this exhaust port configuration providing a minimum of 3 cm H20 pressure measured at the mask. The masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures >3.0 cm H20 at the mask) in homes, hospitals, or other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect.

The 6700 Series V2masks are disposable, single-patient-use, adult oro-nasal CPAP/NIPPV masks without any passive, continuous flow exhaust port built into the mask. They are intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that incorporate the patient vent into the patient circuit instead of the mask. These masks provide a minimum of 3 cm H20 pressure measured at the mask. The masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures >3.0 cm H20 at the mask) in homes, hospitals, or other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect.

The Disposable Single-Patient-Use Oro-Nasal V2mask™ devices consist of the following basic components: 1. Mounting Head Gear 2. Face Piece 3. Swivel Port Assembly. The Face Piece and the Swivel Port Assembly are cleanable and are disposable after 7 days of singlepatient treatment. However, they are not reusable after this time. The Mounting Head Gear is also cleanable and disposable after multiple uses. The Mounting Head Gear which comes in two sizes has straps which are adjustable in both length and tension. It holds the Face Piece against the patient's face to prevent any gas leakage. The Elbow of the Swivel Port Assembly for the 6600 Series V2masks™ incorporate a series of vent holes to provide a continuous air leak to flush out the dead space CO2 and prevent it from being rebreathed by the patient during CPAP or noninvasive positive pressure ventilation (NIPPV) therapy using the required single-limb patient circuit. The Face Piece for all sizes of the 6500 and 6700 Series V2masks™ are nonvented. They do not incorporate vent holes in the Elbow. However, the 6500 Series requires the incorporation of a an active exhalation valve into the expiratory limb of the patient circuit used with the continuous ventilation device providing the noninvasive ventilation. The 6700 requires the incorporation of an exhaust valve into the single-limb patient circuit of the CPAP or NIPPV device. This provides the required air flow to flush out the dead space CO2 and prevent it from being rebreathed. The Swivel Port Assembly for the 6600 Series and the 6700 Series V2masks™ consists of the following pieces: 1. Mask Adapter 2. Elbow with Ant--Asphyxia Valve (AAV) 3. 22 mm OD Swivel Port. The AAV functions as a safety mechanism which allows the patient to breathe fresh air if the NIPPV or CPAP output ceases. It allows a minimum IPAP, EPAP or CPAP pressure of 3 cm H20. The 6500 Series V2mask™ Swivel Port Assembly consists of the same pieces except the Elbow does not incorporate an AAV. The safety mechanism provided by an AAV is already provided by the continuous ventilator which would recognize an AAV in the mask as a patient circuit leak.

The provided text is a 510(k) summary for a medical device (V2masks™), which focuses on establishing substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the manner of an AI/algorithm-focused study. Therefore, most of the requested information regarding AI study design (sample sizes, expert consensus, MRMC, standalone algorithm performance, training set details) is not applicable or cannot be extracted from this document.

However, I can extract the general acceptance criteria inferred from the substantial equivalence claim and the reported device performance as described.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly state numerical "acceptance criteria" for performance metrics in the typical sense of an AI study. Instead, it asserts substantial equivalence to predicate devices based on:

1. Intended Use, Indications for Use, and Intended Patient Population: The V2masks™ possess the same as predicate devices.
2. Safety and Effectiveness: No new questions regarding safety or effectiveness are raised compared to predicate devices.

The "reported device performance" is demonstrated through the evidence presented to support this equivalency:

• Biocompatibility confirmation: All mask materials successfully underwent biocompatibility testing. The mask Face Piece (patient skin contact) is injection grade thermoplastic elastomer (TPE). The anti-asphyxia valve (breathed gases contact) is latex-free silicone rubber. Other Swivel Port Assembly components (breathed gases contact) are acrylic-based multipolymer. Head Gear materials are nylon, polyester straps, and polycarbonate clips.
• Verification and Validation Testing performed.
• Hazard Analyses performed. |
  | Effectiveness - No new questions of effectiveness raised | - Laboratory studies comparing the performance of the V2masks™ to the predicates.
• Laboratory performance verification and validation data.
• 6600 Series V2masks™ (Vented): Incorporate passive, continuous flow exhaust ports. The AAV allows a minimum IPAP, EPAP or CPAP pressure of 3 cm H2O. Vent holes provide continuous air leak to flush CO2 and prevent rebreathing.
• 6500 Series V2masks™ (Non-vented): Nonvented. Requires active exhalation valve in expiratory limb of patient circuit for continuous ventilation devices.
• 6700 Series V2masks™ (Non-vented): Nonvented. Requires exhaust valve into single-limb patient circuit of CPAP or NIPPV device. These masks provide a minimum of 3 cm H2O pressure measured at the mask.
• Swivel Port Assembly with Anti-Asphyxia Valve (AAV) for 6600 & 6700: AAV functions as a safety mechanism, allowing patient to breathe fresh air if NIPPV/CPAP output ceases. Enables minimum IPAP, EPAP, or CPAP pressure of 3 cm H2O. |

Regarding an AI/Algorithm Study:

As the provided document is a 510(k) summary for physical medical masks and not an AI/software as a medical device (SaMD), the following items are not applicable (N/A) or cannot be extracted:

2. Sample size used for the test set and the data provenance: N/A - Not an AI study using a test set in this context. The "test set" here refers to physical performance testing, not a dataset for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A - The ground truth for mask performance would be established through engineering and medical device standards, not expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A - Not an AI study relying on expert adjudication.
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: N/A - This is entirely irrelevant for a physical medical device like a mask.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A - This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical device, the "ground truth" would be established by objective measurements against engineering specifications, biocompatibility standards, and clinical performance parameters (e.g., pressure maintenance, CO2 clearance, seal integrity) demonstrated in laboratory settings.
8. The sample size for the training set: N/A - No AI training set.
9. How the ground truth for the training set was established: N/A - No AI training set.

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