(203 days)
The intended function and use of the Jumao Oxygen Concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
The Jumao Oxygen Concentrator is a Pressure Swing Adsorption (PSA) type oxygen concentrator. The output of oxygen is 0.5 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of adsorption material - molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed bottom. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the bottom of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 90% oxygen to the patient.
Oxygen is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula, which are not supplied with the device. A standard humidifier bottle may be used with the JM-07000i/ JM-07000 models, if desired.
The JM-07000Hi model incorporates the Humidifier to provide humidified oxygen to the user. The Humidiflow attaches to the inlet of the air compressor and to the outlet oxygen used in oxygen concentrators and operates as a mass exchanger to transfer the room air humidity to the patient gas. The Humidifier has been cleared by FDA (K062091).
The front panel of the device contains the controls and indicators. These include a standard barb fitting for attaching the oxygen tubing, the adjustable flow meter, a power light indicator, an elapsed time meter, and a standard on/off rocker type power switch.
The basic technology of the JuMao oxygen concentrator is equivalent to the other approved oxygen concentrator. The principles of operation are equivalent to the noted predicate device, Invacare Platinum 5 Oxygen Concentrator by Invacare Corporation, 510(k) K020386.
The provided text describes the JUMAO OXYGEN CONCENTRATOR and its submission for 510(k) clearance, asserting substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving those criteria are met for a novel AI/software device.
Therefore, many of the requested categories are not applicable to this document. However, I can extract the information that is present.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for performance in terms of specific thresholds for oxygen concentration or delivery rate. Instead, it leverages "substantial equivalence" to predicate devices. The performance is presented as being "same" or comparable to the predicate.
| Feature | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Jumao Oxygen Concentrator) |
|---|---|---|
| Oxygen Concentration Levels | 95.6% to 87% at all flow rates (Invacare Platinum XL 5-Liter O2 Concentrator) | Same (as predicate) |
| Delivery Rate | 0.5 to 5 LPM (Invacare Platinum XL 5-Liter O2 Concentrator) | Same (as predicate) |
| Outlet Pressure | 5 psi +/- 0.5 psi (Invacare Platinum XL 5-Liter O2 Concentrator) | Same (as predicate) |
| Sound Level | 50dBA average (Invacare Platinum XL 5-Liter O2 Concentrator) | 52dBA average |
| Intended Use | Provide supplemental oxygen to patients with respiratory disorders; not intended to sustain or support life. | Same |
Note: The "acceptance criteria" here are implied by the attributes of the predicate device to which the JUMAO device claims substantial equivalence. The document states, "There are some small differences in the size, sound level, and compressor pressure between the Jumao Oxygen Concentrator and the predicate device, which do not affect the safety and effectiveness of the device." This suggests that the measured sound level of 52dBA, while higher than the predicate's 50dBA, was deemed acceptable in the context of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document describes a medical device (oxygen concentrator) and compares its technical specifications to predicate devices. It does not involve a "test set" of patient data in the way an AI/software device would. The testing mentioned is related to engineering standards (e.g., ASTM, ISO, IEC, UL).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided and is not applicable. The device is hardware-based, and its performance evaluation for 510(k) clearance is based on engineering specifications and adherence to recognized standards, not on expert-adjudicated ground truth from a test set.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or interpretive AI/software devices involving human readers. The JUMAO Oxygen Concentrator is a hardware device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
No, a "standalone" study in the context of an algorithm's performance was not done. The performance evaluation is based on the physical device's specifications and adherence to engineering standards.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI/software devices (e.g., pathology, outcomes data) is not applicable here. The "ground truth" for this device's performance is its measured physical characteristics and output (e.g., oxygen concentration, flow rate, pressure) as assessed against engineering standards and compared to a predicate device's established performance.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device is a hardware oxygen concentrator, not an AI/software algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable.
§ 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).