(224 days)
The Fisher & Paykel Healthcare Single Use Oral Mask is an accessory to a Noncontinuous ventilator (IPPB) as per 73 BZD, 21 CFR §868.5905.
The Oral Mask is indicated for use by adults requiring CPAP or Bilevel ventilator treatment in home, hospital and laboratory environments. It constitutes the patient to ventilator interface in a noncontinuous ventilator system. The device administers positive airway pressure orally. The Oral Mask is for single patient use, for up to 30 days, on the prescription of a physician.
The Oral Mask is an accessory to a Noncontinuous ventilator (IPPB) according to 21 CFR §868.5905. It constitutes the patient to ventilator interface in a noncontinuous ventilator system.
The Oral Mask consists of a mouthpiece and flexible breathing tube. The flexible breathing tube is connected to the output breathing tube of the ventilator. The ventilator supplies air at CPAP or Bilevel pressures, typically in the range 3 - 20 cm H2O, which are available at the Oral Mask mouthpiece.
The mouthpiece is positioned in the patient's mouth during CPAP or Bilevel treatment. Features of the mouthpiece ensure the desired positive airway pressure is delivered to the patient with minimal leakage and that the mouthpiece is retained in the mouth while asleep.
The flexible breathing tube provides a transition between the more rigid output tube of the ventilator and the mouthpiece, facilitating freedom of movement while maintaining circuit integrity. An exhaust port adjacent to the mouthpiece provides a means to purge exhaled gases from the breathing circuit.
The Oral Mask mouthpiece is designed to assure unobstructed access to the patient's airway and to create an air-seal around the patient's mouth to facilitate sustained delivery of positive airway pressure. The Oral Mask mouthpiece is retained inside the mouth during sleep by action of the SnapFlap™ which rests against the patient's cheeks. The SnapFlap™'s flexibility allows the mouthpiece to accommodate a wide range of face shapes and sizes. Additionally, the tightness of the SnapFlap™ maybe easily adjusted by the patient.
The mouthpiece is connected to the elbow of a flexible breathing tube. The elbow incorporates a pattern of vent holes which constitute the exhaust port for bias airflow. The exhaust port allows the purging of exhaled gases. Product labeling states that the Oral Mask must not be used unless connected to a ventilator supplying the minimum specified ventilation pressure at which sufficient bias airflow is available to quarantee minimal re-breathing. Additional warnings state that the mask should only be used with CPAP systems recommended by the patient's physician or respiratory therapist, and that the vent holes in the exhaust port should never be blocked.
The flexible breathing tube allows the patient freedom of movement by way of the elbow and swivel joint rotation and flexure of the tubing itself. The swivel joint at the end of the flexible breathing tube is a press fit to industry standard breathing tubes (ISO 5356-1, ASTM F1054: 22mm conical fitting). This allows effective connection to a wide range of CPAP and Bilevel ventilators.
An adaptor, incorporating two ports, may be connected to the swivel joint at the ventilator end of the flexible breathing tube. This adaptor may be used optionally to gain access to the breathing tube gas flow. For example, oxygen may be added through one port while the other port accommodates a pressure transducer. Typically, this type of operation is performed by a sleep laboratory during patient diagnosis and titration. When not in use, the swivel adaptor ports may be blocked off by the port caps. The swivel adaptor is provided with the mask as an accessory.
The Oral Mask is manufactured from materials that meet appropriate requirements of ISO 10993-1.
This document is a 510(k) summary for the Fisher & Paykel Healthcare Single Use Oral Mask (Model HC455A). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on novel performance criteria and detailed study results as might be seen for devices requiring PMA or de novo clearance. Therefore, some of the requested information, particularly regarding specific performance metrics, detailed study designs, and ground truth establishment, is not explicitly provided in the available text.
Here's the information that can be extracted or inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in a table format with specific thresholds. Instead, it states that "Tests, relevant to the modifications, were performed on the new Oral Mask to demonstrate substantial equivalence to the predicate device. These demonstrated effective performance in terms of strength, durability, and biocompatibility."
The "reported device performance" is described qualitatively as:
- "effective performance in terms of strength, durability, and biocompatibility."
- "Clinical evaluations have shown the mask to be safe and effective in delivering positive airway pressure to patients."
- "The Oral Mask is a safe 'patient to ventilator' interface when used as an accessory to a Noncontinuous ventilator."
- "The Oral Mask is an effective means of delivering positive airway pressure to adults requiring CPAP or Bilevel ventilator treatment in the home, hospital and laboratory environments."
- "The Oral Mask is a reliable device when used and maintained as specified in the Instructions for Use."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for any clinical evaluations or tests performed. It broadly refers to "clinical evaluations" without giving numbers. The country of origin for the data is not specified, but the manufacturer is based in Auckland, New Zealand. The nature of the studies (retrospective or prospective) is also not specified, although typical clinical evaluations for 510(k) submissions are prospective or concurrent to demonstrate performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document refers to "clinical evaluations" but does not detail how ground truth was established or how many experts were involved.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
An MRMC comparative effectiveness study, particularly one involving AI assistance, is not mentioned. This device is a physical medical device (an oral mask), not an AI diagnostic or assistance system, so such a study would not be applicable or expected for this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical accessory, not an algorithm or AI system.
7. The Type of Ground Truth Used
The document states that "Clinical evaluations have shown the mask to be safe and effective in delivering positive airway pressure to patients." The ground truth for "safety and effectiveness" would likely be derived from a combination of:
- Clinical observation and assessment: Direct observation of patient comfort, fit, seal, and proper functioning during use.
- Physiological measurements: Monitoring of delivered pressure, leakage rates, and patient respiratory parameters (e.g., in sleep labs) to ensure effective therapy delivery, though specific metrics are not detailed here.
- User feedback: Efficacy in retaining the mouthpiece and accommodating various face shapes.
- Biocompatibility testing results: Ensuring materials are safe for patient contact.
However, the specific methods for establishing this ground truth (e.g., expert consensus on specific metrics, pathology, or outcomes data) are not detailed.
8. The Sample Size for the Training Set
No information is provided regarding a "training set." This term is typically associated with machine learning or AI development, which does not appear to be relevant to this physical device submission. The clinical evaluations mentioned likely refer to a testing or validation set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no mention of a training set for an AI/algorithm.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).