(119 days)
The Model 1000 Omni Oxygen System is indicated for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
The SeQual Model Number 1000 OMNI Portable Oxygen Concentrator is a 3 Liter per minute (LPM) continuous flow and 6 LPM demand flow oxygen concentrator that is of the pressure swing adsorption (PSA) type. The OMNI Portable Oxygen Concentrator operates from AC power, DC power or rechargeable batteries. This device delivers supplemental oxygen for patients through the molecular sieve beds and is designed to conserve the use of oxygen while operating in a demand flow mode. During the demand flow mode, oxygen is delivered to the patient through a demand flow valve when the start of inhalation is detected. The Model Number 1000, OMNI Portable Oxygen System consists of pneumatic and electrical components. The system has 5 major pneumatic components: inlet filtration, air compressor and heat exchanger, Synthetic Zeolite molecular sieve beds with a distribution valve module, outlet filtration, and flow delivery and measurement components. The electrical system consists of: motor controls, power sources for AC and DC power, rechargeable batteries, sensing systems to measure pressure, temperature, flow and oxygen concentration, and a software controlled user interface. The unit is double insulated and uses a two-conductor power cable. In the event of a malfunction, the unit will activate visual and audio alarms and if, necessary, shut down. Device monitoring circuits are included to measure oxygen concentration, flow rates, battery capacity and internal temperatures.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
The document is a 510(k) premarket notification for the SeQual Model 1000 OMNI Portable Oxygen Concentrator. It aims to demonstrate substantial equivalence to previously marketed devices. However, it's important to note that this document does not detail specific acceptance criteria with numerical targets and corresponding measured device performance in a table format, nor does it describe a detailed clinical study with human subjects validating the device against specific ground truth.
Instead, the submission relies on technical specifications, bench testing, and comparison to predicate devices to assert substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Provides supplemental oxygen to patients. | Delivers supplemental oxygen. |
| Continuous flow: 3 Liters per minute (LPM). | Device Specification: "3 Liter per minute (LPM) continuous flow" |
| Demand flow: 6 Liters per minute (LPM). | Device Specification: "6 LPM demand flow oxygen concentrator" |
| Oxygen concentration: Greater than 90%. | Device Specification: "delivers flow rates between .5 and 6 liters per minute of oxygen over 90% concentration." Testing: "Device monitoring circuits are included to measure oxygen concentration..." "The results of the oxygen concentration testing... will confirm that the device will meet the specifications..." |
| Operates from AC power. | Device Specification: "operates from AC power" |
| Operates from DC power. | Device Specification: "operates from DC power" |
| Operates from rechargeable batteries. | Device Specification: "operates... or rechargeable batteries." "The major changes to the device have been the reduction in the size of the molecular sieve tanks and the capability to operate on rechargeable batteries." |
| Incorporates molecular sieve beds for oxygen concentration. | Device Description: "delivers supplemental oxygen for patients through the molecular sieve beds" "Synthetic Zeolite molecular sieve beds with a distribution valve module" |
| Includes demand flow valve (similar to predicate). | Device Description: "designed to conserve the use of oxygen while operating in a demand flow mode. During the demand flow mode, oxygen is delivered to the patient through a demand flow valve when the start of inhalation is detected. This conserving feature is similar to the Sim Italia Travelair." "operates comparably to the SeQual Integra concentrators with the addition of a demand flow valve delivery system" |
| Not life-supporting nor life-sustaining. | Intended Use: "Oxygen concentrators are not life-supporting nor life sustaining devices." "The Model 1000 Omni Oxygen System is indicated for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities." |
| Activates visual and audio alarms in case of malfunction. | Device Monitoring: "In the event of a malfunction, the unit will activate visual and audio alarms and if, necessary, shut down." |
| Device monitoring for oxygen concentration, flow rates, battery capacity, internal temperatures. | Device Monitoring: "Device monitoring circuits are included to measure oxygen concentration, flow rates, battery capacity and internal temperatures." |
| Conforms to ISO 8359 and ASTM F1464 standards. | Performance Data: "The results of the oxygen concentration testing and thorough series of testing, ISO 8359 and ASTM F1464 will confirm that the device will meet the specifications and will be substantially equivalent to the predicate devices." |
| Substantially equivalent to predicate devices. | Conclusion: "Based on the design, performance specifications, testing and intended use, the Model 1000, OMNI Portable Oxygen Concentrator will be substantially equivalent to the currently marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document refers to "thorough series of testing" and "oxygen concentration testing" using the device itself, not a dataset of patient data.
- Data Provenance: Not applicable. The testing appears to be primarily laboratory/bench testing of the device's technical specifications and electrical safety, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth, in the context of clinical expert consensus for AI/diagnostic devices, is not relevant here as this is a physical medical device (oxygen concentrator) and the testing described is primarily bench testing for functionality and safety, not a diagnostic task.
4. Adjudication Method for the Test Set
- Not applicable. There is no mention of adjudication, as there isn't a complex diagnostic outcome requiring multiple expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document describes technical testing of the device's physical and functional characteristics, not a clinical study involving human readers or comparative effectiveness with or without AI assistance.
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 medical device, not an algorithm or AI system. Its performance is inherent to its mechanical and electrical design.
7. The Type of Ground Truth Used
- Device Specifications and Industry Standards: The "ground truth" for this type of device and submission is implicitly its own stated technical specifications (e.g., flow rate, oxygen concentration) and adherence to recognized industry standards (ISO 8359, ASTM F1464).
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set.
§ 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).