(232 days)
The Fisher & Paykel Healthcare Oracle 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 for the treatment of Obstructive Sleep Apnea (OSA). It constitutes the patient to ventilator interface in a noncontinuous ventilator system. The device administers positive airway pressure orally. The Oral Mask is a reusable device for use on the prescription of a suitably qualified physician. The Oral Mask may be reprocessed for multi-patient use.
The Oracle 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 Oracle 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 - 19 cm H2O) which is 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.
This document describes a 510(k) submission for the Fisher & Paykel Healthcare Oracle Oral Mask, an accessory to a noncontinuous ventilator. The submission aims to demonstrate substantial equivalence to a predicate device (Fisher & Paykel Healthcare, LTD., Oracle Oral Mask, Model 900HC451. K003894). As such, the "acceptance criteria" are implicitly met by demonstrating this substantial equivalence through non-clinical testing.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Equivalence Claim) | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Safe for patient-to-ventilator interface | Demonstrated effective performance in terms of strength, durability, and biocompatibility. |
| Effective in delivering positive airway pressure for OSA treatment | Effective performance demonstrated through testing. |
| Reliable device when used and maintained as specified | Effective performance demonstrated through testing. |
| Reprocessable to achieve a sterile product for multi-patient use | Testing showed the Oral Mask can be effectively sterilized and this process does not adversely affect function, durability, or safety. |
| Unobstructed access to the patient's airway | Mouthpiece designed to assure unobstructed access. |
| Creation of an air-seal around the patient's mouth for sustained positive airway pressure | Mouthpiece designed to create an air-seal. |
| Retention of mouthpiece in the mouth during sleep (minimal leakage) | SnapFlap™ rests against the patient's cheeks to retain the mouthpiece, with adjustable positions for improved fit. |
| Means to purge exhaled gases (exhaust port) | Elbow incorporates a pattern of holes for an exhaust port. Labeling states it must be connected to a ventilator with sufficient bias airflow to guarantee minimal re-breathing. |
| Freedom of movement for the patient (flexible breathing tube) | Flexible breathing tube with elbow and swivel joint rotation, and tubing flexure provides freedom of movement. |
| Connector to industry-standard breathing tubes | Swivel joint is a press fit to industry standard breathing tube (ISO 5356-1, ASTM F1054: 22mm conical fitting). |
| Biocompatible materials | Manufactured from materials that meet appropriate requirements of ISO 10993-1. |
| Functional for up to 12 months of daily use | Designed to function as intended for up to 12 months. (Performance based on design, not explicitly tested for this duration in the summary). |
| Reprocessable up to 20 times | Designed to be reprocessed up to 20 times. (Performance based on design and reprocessing test, not explicitly for 20 cycles in the summary). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size in terms of patient numbers or the number of masks tested for each non-clinical test. The testing mentioned refers to "tests, relevant to the modifications, were performed on the new Oral Mask."
- Sample Size: Not specified. It generally refers to samples of the device itself rather than patient data in this context.
- Data Provenance: The document does not specify the country of origin of the data. It's a submission from Fisher & Paykel Healthcare Ltd, based in New Zealand. The tests are non-clinical, likely performed in-house or by a third-party lab. The data is retrospective in the sense that the tests were performed to support the 510(k) submission, not as a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a 510(k) submission for a Class II medical device (accessory to a non-continuous ventilator) demonstrating substantial equivalence based on non-clinical tests (strength, durability, biocompatibility, sterilization effectiveness). It does not involve human users or a "ground truth" derived from expert interpretation of medical images or patient outcomes in the way an AI/ML device would.
4. Adjudication Method for the Test Set
Not applicable. As this involves non-clinical testing of physical and material properties, there would be no adjudication method in the context of expert consensus found in clinical or AI/ML studies. Test results would be objectively measured against predefined specifications.
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. This is not an AI/ML device. It's a physical medical device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this submission are objective performance specifications and regulatory standards relevant to the device's physical properties, material composition, and intended function. These include:
- Objective Test Results: Measurements of strength, durability, and effectiveness of sterilization.
- Biocompatibility Standards: Compliance with ISO 10993-1.
- Industry Standards: Compliance with ISO 5356-1, ASTM F1054 for connecting tubes.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is the previously cleared predicate device, meaning the new device must perform comparably in relevant aspects.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
§ 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).