(85 days)
The modified devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.
The modified devices are substantially equivalent to the predicate devices. Modifications were made to improve reliability, ease of assembly and serviceability The compressor was changed from a vertically oriented tension spring supported configuration to a horizontally oriented compression spring supported configuration to minimize damage from shipment and handling. The cabinet back was changed from a single part to two parts to simplify assembly and serviceability. Labeling was changed to increase type size for improved readability and to correct some clerical errors. The motor run capacitor was changed to a type that includes an internal protective device. The device circuit breaker was changed from a 10 A rating to a 5 A rating. The modified devices continue to be AC powered devices that provide a high level of inspired oxygen, using the same method as that of the predicate devices, by separating oxygen from ambient air with the pressure swing adsorption (PSA) process. Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components that are released when the pressure is vented to the atmosphere. This cycle is controlled by an electronic valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. The modified device is a durable, reusable, semi-portable unit weighing approximately 32 pounds [14.5 kg.]. The device is available in both 115V and 230V models. The device status indicators are the same as in the predicate devices: They are controlled by a printed circuit board which is device model specific. For the OCSI model, device status indicators are mains power and oxygen concentration. For the STD model, device status indicators are mains power and system pressure. The modified device is not life supporting, life sustaining or sterile. The modified devices may be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. Recommended accessory devices are described in the User's Guide. One of these devices may optionally be included with the device.
The provided document is a 510(k) summary for the Mark 5 Nuvo Lite OCSI and Mark 5 Nuvo Lite STD oxygen concentrators. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study against predefined metrics.
Therefore, most of the requested information (items 1-9) regarding acceptance criteria and a study to prove meeting those criteria is not directly applicable or available in this 510(k) summary. The summary details modifications made to existing predicate devices and argues for substantial equivalence based on technological characteristics and non-clinical performance (bench testing against relevant standards).
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present explicit "acceptance criteria" in the traditional sense of a clinical trial or performance study with numerical targets. Instead, it compares the modified devices' characteristics to those of the predicate devices to demonstrate substantial equivalence. The "performance" is implicitly deemed acceptable if it matches or is within an acceptable range of the predicate device's performance, along with meeting certain non-clinical standards.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Modified Devices) |
|---|---|---|
| Intended Use | Intended solely for medical use in | |
| oxygen therapy programs under the | ||
| supervision of a physician. This | ||
| device is available by prescription | ||
| only and is not intended to support | ||
| or sustain life. | Same as Predicate | |
| Operating Life | 5 years | 3 years (This is a difference, not an acceptance criterion met. The rationale for acceptance despite this difference is based on overall substantial equivalence.) |
| Oxygen Concentration | 90% (±6.5/-3%) | |
| 0.125 to 5 lpm | Same as Predicate | |
| Oxygen Concentration Status Indicator | OSCI - Yes | |
| STD - No | Same as Predicate | |
| Compressor | Self-lubricated piston type | |
| Vertical axis | Self-lubricated piston type; | |
| Horizontal axis | ||
| Compressor Support | Tension Steel Springs | |
| Vertical Axis | Compression Steel Springs | |
| Horizontal Axis | ||
| Capacitor | P0 Class Protection per IEC 20252 | P2 Protection per IEC20252 |
| Circuit Breaker | 10 Amp | 5 Amp |
| Other Characteristics | (Refer to the table in the document for many others listed as "Same as Predicate") | Same as Predicate |
Notes on the "Acceptance Criteria" column: For a 510(k) demonstrating substantial equivalence, the "acceptance criteria" are generally that the modified device performs comparably to the predicate device, or that any differences do not raise new questions of safety or effectiveness. The values listed in the "Predicate Devices" column serve as the benchmark for comparison.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This summary presents engineering and design changes and bench testing results, not a study with a "test set" of patients or clinical data. The "test set" implicitly refers to the modified device prototypes and components during iterative development and verification.
- Data Provenance: Not applicable in the context of clinical data. The data provenance relates to the non-clinical testing against standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. As this is a 510(k) for device modifications and substantial equivalence, there is no mention of experts establishing a "ground truth" for a clinical test set. The determination of substantial equivalence is made by regulatory bodies (FDA) based on the submitted technical documentation and performance data against established standards and predicate devices.
4. Adjudication Method:
- Not applicable. No clinical test set or expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. These are oxygen concentrators, not diagnostic imaging devices where MRMC studies are common to assess human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. These are medical devices with mechanical and electronic components, not AI algorithms. Performance testing focuses on the physical device's specifications (e.g., oxygen concentration, flow rate, safety features) rather than algorithm standalone performance.
7. The Type of Ground Truth Used:
- Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission is adherence to engineering specifications, safety standards (ISO 8359:1996, EN 60601-1-2:2001, IEC 60601-1:1988, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90), and comparability to the predicate device's established performance characteristics.
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve machine learning or AI algorithms requiring training sets.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI algorithm.
Summary of the Study provided:
The "study" presented in this 510(k) is a non-clinical performance evaluation and comparison report. The manufacturer conducted various tests to ensure the modified devices continued to meet relevant safety and performance standards and were substantially equivalent to their predicate devices despite the changes.
- Non-Clinical Performance: "The device was tested to applicable requirements ISO 8359:1996, EN 60601-1-2:2001, IEC 60601-1:1988 + A1:1991 + A2:1995, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90, and FDA Reviewer Guidance document 'Excerpts Related to EMI from November 1993' as appropriate to the area of usage."
- Conclusion: "The modified devices include all the same or similar materials, operate with the same technology and demonstrate the same performance so are substantially equivalent to the legally marketed predicate devices."
This indicates that various bench tests and measurements were performed to verify that changes to components (compressor, capacitor, circuit breaker, etc.) did not negatively impact the overall performance (e.g., oxygen concentration, flow rate, noise level, operating ranges) or safety of the device when compared to the established performance of the predicate device and relevant industry standards.
§ 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).