(92 days)
The CARE ZY5BA Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The CARE ZY5BA Oxygen Concentrator is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.
The CARE ZY5BA is an AC power electrically operated device. The unit separates oxygen from room air (ambient air), which allows high-purity supplemental oxygen to be delivered through the oxygen outlet, although the concentrator filters the oxygen in a room. It will not affect the normal amount of oxygen in user's room. Air is drawn into the device with a compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized valve and protected from over pressurization by the compressor's pressure relief valve. Oxygen provided by the CARE ZYSBA Oxygen Concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or oxygen mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy. The front panel of the CARE ZY5BA contains the controls and indicators. These include the status lights (included power light, normal oxygen light, low oxygen light and service required light), standard power switch, flow meter and the flow meter knob, a circuit breaker which could reset the device after electrical overload shutdown, an oxygen outlet which oxygen is dispersed through, a monitor display which indicates the condition of system status (included pressure status, oxygen purity status and electric hour meter, etc). The user could operate the device conveniently according the instructions.
Acceptance Criteria and Device Performance Study (CARE ZY5BA Oxygen Concentrator)
This medical device submission is for an oxygen concentrator, not an AI-powered diagnostic device. Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set ground truth) are not applicable as they pertain to the evaluation of algorithms for diagnostic accuracy.
The acceptance criteria for this device are based on its substantial equivalence to a predicate device and compliance with relevant performance and safety standards.
1. Acceptance Criteria and Reported Device Performance
The key "performance" for an oxygen concentrator relates to its ability to reliably produce oxygen and meet safety standards. The document outlines these by demonstrating compliance with established standards and substantial equivalence to a predicate device.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Equivalence to predicate device (A&J-POCA01 Oxygen Concentrator K071608) in technological characteristics and intended use. | "Bench performance testing has demonstrated that the CARE ZY5BA Oxygen Concentrator is substantially equivalent to the predicate device." |
| Environmental Testing | All environmental testing identified in FDA's "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (October 1, 1993)". | Device met all design specifications and was verified to be substantially equivalent. |
| Oxygen Concentrator Performance | Compliance with ASTM F1464 and ISO 8359 standards. | Testing demonstrated compliance with these standards. |
| Electrical Safety | Compliance with IEC60601-1, IEC60601-1-2, IEC60601-1-4 standards. | Testing assured compliance with these standards. |
| Risk Management | Compliance with ISO14971 (Hazard Analysis). | A hazard analysis was performed, and testing was conducted to validate overall operation. |
| General Device Operation | Meets all design specifications. | Testing was conducted to validate and verify that the CARE ZY5BA Oxygen Concentrator met all design specifications. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission focuses on the performance and safety of a medical device (oxygen concentrator), not on the evaluation of a diagnostic algorithm or AI model requiring a "test set" in the context of image analysis or similar diagnostic applications. The testing involved physical device performance and compliance with engineering and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. There is no diagnostic "ground truth" to be established by experts for this type of device. The "ground truth" is defined by the technical specifications and performance standards for oxygen concentrators.
4. Adjudication Method for the Test Set
Not applicable. As there is no "test set" in the diagnostic sense, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is for evaluating the comparative effectiveness of human readers, often aided by AI, in diagnostic tasks. For an oxygen concentrator, this is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an oxygen concentrator, a physical piece of medical equipment, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is established by:
- Engineering Specifications and Design Requirements: The device must meet its intended design specifications for oxygen purity, flow rate, pressure, and operational parameters.
- International and Industry Standards: Compliance with standards such as ASTM F1464, ISO 8359 (for oxygen concentrators), IEC 60601-1 series (for electrical safety), and ISO 14971 (for risk management) defines the acceptable performance and safety.
- Predicate Device Performance: The predicate device serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML algorithm requiring training data, there is no "training set." The development of the device would involve engineering design, prototyping, and iterative testing, not "training" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).