(130 days)
The Respironics BiPAP AVAPS Ventilatory Support System is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of age; > 40 lbs) patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. BiPAP AVAPS Ventilatory Support System may be used in the hospital or home.
The Respironics BiPAP AVAPS Ventilatory Support System is a microprocessor controlled blower based positive pressure ventilatory system with integrated heated humidifier. The device platform being used as the key topic for this submission was previously cleared in K091319. The same ventilation modalities and therapy features, previously cleared in K071509 is also included in the BiPAP AVAPS Ventilatory Support System, which is the topic of this submission. These modes and therapy features include: CPAP, Spontaneous/Timed, Timed, Timed, Pressure Control modes with Bi-Flex or AVAPS therapy features available if enabled by the health care professional.
A Graphical user interface displays device data and device settings.
The BiPAP AVAPS Ventilatory Support System is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.
Like its predicates, the BiPAP AVAPS Ventilatory Support System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen tubing, an exhalation device, and a patient interface device.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Respironics BiPAP AVAPS Ventilatory System:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly list specific numerical acceptance criteria for performance metrics. Instead, it makes a general statement about meeting required criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions as intended and safely | Design verification tests performed and verified to meet required acceptance criteria. Modifications have no impact on safety and effectiveness. |
| Compliance with applicable standards | Complies with "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices," May 2006. |
| Substantially equivalent to predicate devices | Determined to be substantially equivalent to predicate devices based on intended use, operating principle, technology, and manufacturing process. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a separate "test set" and thus does not provide a sample size for it. The verification tests performed are mentioned generally, implying internal testing without a specific patient or image-based test set from external data.
- Data Provenance: Not applicable, as a distinct test set with external data is not described. The document discusses design verification tests, which are typically conducted internally.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. The document does not describe the establishment of a "ground truth" for a test set using external experts. The verification appears to be against internal specifications and safety/effectiveness standards.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The document does not describe a process involving multiple reviewers or an adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- MRMC Study: No. The document does not mention any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device itself is a ventilatory support system, not an AI-assisted diagnostic tool.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
- Standalone Study: The document describes "Design verification tests" performed on the BiPAP AVAPS System. While this implies testing of the device's functionality, it's not a "standalone algorithm-only study" in the context of typical AI/software performance evaluations. The device's primary function is mechanical ventilation, and the "software" aspect is inherent to its control system. The stated compliance with software guidance does not equate to an AI algorithm performance study.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The "ground truth" for this device's performance appears to be based on:
- Internal design specifications and requirements: The device was designed to meet certain functional and safety standards.
- Industry standards and regulations: Compliance with applicable medical device standards and FDA guidance.
- Substantial equivalence to predicate devices: The functionality and safety are indirectly validated by demonstrating similarity to previously cleared devices.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This document describes a ventilatory support system, not a device that employs machine learning or AI algorithms with a "training set" of data in the typical sense. The software and control logic are likely based on engineering principles and pre-programmed algorithms, not data-driven machine learning models.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for machine learning. The "ground truth" in the context of this device's development would be the fundamental physiological principles of ventilation and the desired performance characteristics of the system, established through engineering design, medical knowledge, and regulatory requirements.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).