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510(k) Data Aggregation
(434 days)
The Longfian Oxygen Concentrator, Model Jay-5 is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model Jay-5 can be used in a home, institution, vehicle, and various mobile environments. The Longfian Oxygen Concentrator, Model Jay-5 does not nor is it intended to sustain or support life.
JAY-5 medical oxygen concentrator adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.
The concentrator can supply 1-2 patients simultaneously, with steady oxygen flowing out and reliable, adjustable flow. The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The key parts of the generator adopt anti-tiring and anti-aging design, and the planned life of the whole generator reaches up to 20,000 hours. The weight of Jay-5 is around 25kg (~55lbs). There is no influence on indoor oxygen percent during the generator operating.
JAY-5 medical oxygen concentrator contains the following items:
- · One (1) Jay-5 Oxygen Concentrator Unit
- · One (1) AC Power Supply
- · One (1) Nasal Oxygen Tube
- One (1) Humidifier
- One (1) Operation Manual
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:
Device: OXY.LIFE Oxygen Concentrator, Models Jay-5 (referred to as Longfian Oxygen Concentrator, Model Jay-5 in the deeper sections)
Predicate Device: Yuyue OxygenMax™ 7F-5 Oxygen Concentrator (K083559)
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a separate list with corresponding performance data in the same way one might see for a diagnostic AI device's sensitivity/specificity. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through meeting relevant performance standards and having comparable technical characteristics. The "reported device performance" is embedded within the comparison table and the list of standards the device was tested against.
| Category | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Summary) |
|---|---|---|
| Intended Use | Same as predicate | Same intended use: for patients with respiratory disorders requiring supplemental oxygen in home, institution, vehicle, and mobile environments. Not life-sustaining. |
| Operating Principle | Same as predicate (Pressure Swing Adsorption) | Same operating principle (Pressure Swing Adsorption) |
| Basic Design | Same as predicate | Incorporates the same basic design |
| Technological Characteristics | Similar to predicate (see detailed table below) | Similar technological characteristics to predicate. Differences do not affect safety/effectiveness. |
| Oxygen Concentration | Predicate: 90%-94% | JAY-5: 93%±3% (within or comparable to predicate range) |
| Oxygen Flow | Predicate: 0.5~5L/min | JAY-5: 0~5L/min (comparable to predicate) |
| Outlet Pressure | Predicate: 40~70kPa | JAY-5: 40~70kPa (matches predicate) |
| Noise | Predicate: ≤53dB(A) | JAY-5: ≤53dB(A) (matches predicate) |
| Input Power | Predicate: 500W | JAY-5: 500W (matches predicate) |
| Electrical Safety | IEC 60601-1, IEC 60601-1-2 | Tested to IEC 60601-1 and IEC 60601-1-2 (meets relevant standards) |
| Oxygen Concentrator Safety | ISO 8359:1996, ASTM F 1464-93:2005 | Tested to ISO 8359:1996 and ASTM F 1464-93:2005 (meets relevant standards) |
| Biocompatibility | ISO 10993-1:2009 | Tested to ISO 10993-1:2009 (implies assessment of materials like PVC for nasal oxygen tube) |
| Environmental Performance | Not explicitly stated but implied by operating/storage conditions | Tested for performance, physical attributes, environmental conditions (e.g., ambient temperature, relative humidity, atmospheric pressure ranges for operating and transport/storage) |
| Air Quality (VOC, PM2.5, Ozone) | EPA TO-15, US EPA requirement, 21 CFR 801.415 | Tested for Volatile Organic Compounds (VOC), PM 2.5, and Ozone. (Implies compliance with relevant air quality standards for medical devices). |
| Software Validation | Standard requirement for devices with software | Software validation performed. |
| Life Expectancy | Not explicitly compared to predicate | Planned life of the whole generator reaches up to 20,000 hours. |
Summary of Comparison to Predicate (JAY-5 vs. Yuyue OxygenMax™ 7F-5)
| Feature | Predicate Device (K083559) | Subject Device (K131968) | Comparison |
|---|---|---|---|
| Power supply | AC 220±22V, 50±1Hz | AC 230±23V, 50±1Hz | Minor voltage difference, same frequency. Considered substantially equivalent. |
| Input power | 500W | 500W | Identical |
| Oxygen concentration | 90%-94% | 93%±3% | Comparable (90-96% vs 90-94%) |
| Oxygen flow | 0.5~5L/min | 0~5L/min | Comparable |
| Outlet pressure | 40~70kPa | 40~70kPa | Identical |
| Noise | ≤53dB(A) | ≤53dB(A) | Identical |
| Alarms | Low & high pressure | Low & high pressure; Power failure | Subject device has additional alarm (power failure), enhancing safety. |
| LCD display | Accumulating timing | Accumulating timing; present timing; timing | Subject device has more detailed display, not a safety concern. |
| Dimensions | 445×372×680mm | 365×375×600mm | Different, but not impacting fundamental equivalency. |
| Net weight | 25.8Kg | 26Kg | Highly similar |
| Materials (Sieve Bed, Nasal Tube) | Synthetic Zeolite; PVC | Synthetic Zeolite; PVC | Identical |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a "test set" in the context of patient data or clinical trials. This device is an oxygen concentrator, and its evaluation relies on bench testing against engineering standards rather than clinical performance data from human subjects. Therefore, there's no sample size of patients or data provenance in the way one would describe for an AI/diagnostic device.
- Data Provenance: Not applicable as it's primarily bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for this device is based on established engineering standards (IEC, ISO, ASTM, EPA, CFR) and the performance characteristics of a legally marketed predicate device.
- Qualifications of Experts: The ground truth is embedded in the standards themselves, developed by expert committees, and the regulatory review process (FDA reviewers like Tejashri Purohit-Sheth, M.D. and Erin I. Keith, M.S. who are Clinical Deputy Director and Director, respectively, in relevant divisions).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "tests" are objective measurements against established technical specifications and performance limits defined in the referenced standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This is not an AI/diagnostic device that relies on human interpretation for its primary function. It's a medical device for oxygen delivery, evaluated through engineering and performance testing.
- Effect Size of AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
- Standalone Study: Not applicable. This device is a hardware product. Its performance is inherent in its operation, not an algorithm being evaluated separately.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for evaluating this oxygen concentrator is primarily based on:
- Established engineering and performance standards: Such as ISO 8359, ASTM F 1464-93, IEC 60601 series, ISO 10993-1, and EPA/CFR requirements for air quality (VOC, PM2.5, Ozone).
- Performance data of a legally marketed predicate device (Yuyue OxygenMax™ 7F-5): The subject device must demonstrate performance comparable to, or better than, the predicate for the same intended use.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that requires a "training set" of data. Its development would involve engineering design, prototyping, and testing phases, but not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of medical device.
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