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510(k) Data Aggregation
(218 days)
Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
The Portable Oxygen Concentrator (Model: P2-K4.P2-S4. P2-S3) is intended to provide supplemental oxygen in a home, institutional, or travel environment. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator(Model:P2-K4,P2-K3,P2-S4,P2-S3) is small, portable and may be used in home, institution and various mobile environments. However, there is not any type of humidifier that is suitable for use with this device because of its pulse dose delivery mode.
Portable Oxygen Concentrator (Model:P2-K4,P2-K3,P2-S4,P2-S3) is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.
This document describes acceptance criteria and testing for a Portable Oxygen Concentrator (Models: P2-K4, P2-K3, P2-S4, P2-S3).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by compliance with various international and national standards for medical electrical equipment, biocompatibility, and specific oxygen concentrator requirements. The reported device performance is demonstrated by the successful completion of tests against these standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance Status) |
|---|---|
| Electrical Safety (AAMI ANSI ES 60601-1, IEC 60601-1, IEC 60601-1-8, IEC 60601-1-6, IEC 60601-1-11) | Complies |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies |
| Oxygen Concentrator Specific Safety & Performance (ISO 80601-2-69) | Complies |
| Oxygen-Conserving Equipment Specific Safety & Performance (ISO 80601-2-67) | Complies |
| Biocompatibility - Cytotoxicity (ISO 10993-5) | Complies |
| Biocompatibility - Skin Sensitization (ISO 10993-10) | Complies |
| Biocompatibility - Irritation (ISO 10993-23) | Complies |
| Biocompatibility - Particulate matter (ISO 18562-2) | Complies |
| Biocompatibility - Volatile organic Compounds (ISO 18562-3) | Complies (VOC's less than ambient) |
| Battery Safety (IEC 62133) | Complies |
| Software Verification and Validation (FDA Guidance for Software in Medical Devices) | Ensures compliance to recognized consensus standards |
Differences Noted in Comparison to Predicate Device and their Mitigation:
| Difference ID | Description of Difference | Mitigation (Tests Performed) |
|---|---|---|
| ID_22 & ID_23 | Smaller number of gear settings and smaller pulse mode bolus size compared to predicate. | Verified by tests according to ISO 80601-2-69: 2020, ISO 80601-2-67: 2020, ISO 18562-2: 2017, ISO 18562-3: 2017, ISO 10993-5:2009, ISO10993-10:2021, and ISO10993-23:2021. |
| ID_29 | Different maximum oxygen discharge pressure. | Verified by tests against ISO 80601-2-69: 2020 with positive result. |
| ID_32 | Slightly lower acoustic noise. | Verified by tests against ISO 80601-2-69: 2020 and ANSI AAMI ES 60601-1: 2005 /A1:2012 and A2:2020 with positive result. |
| ID_46 | Different battery durations and multiple battery types. | Verified by tests according to IEC 62133: 2017. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical trials or AI model validation with a specific number of cases. Instead, it refers to conformity testing against established standards. For such conformity testing, the "sample size" typically refers to the number of devices or components tested to ensure consistent performance across the production. This information (specific number of devices tested for each standard) is not provided in this summary.
Data provenance: The testing appears to be primarily non-clinical bench testing and verification, likely conducted at the manufacturer's facility or by a certified testing laboratory. There is no mention of country of origin of data for a "test set" as understood in a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not an AI/ML-driven diagnostic device that requires expert-established ground truth on a test set of medical images or patient data. The device's performance is validated against engineering and medical device standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not a diagnostic device requiring adjudication of expert interpretations for ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is a medical device for oxygen delivery, not a diagnostic AI system, therefore, an MRMC comparative effectiveness study is not relevant or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware-based oxygen concentrator with embedded software; it is not a standalone AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by compliance with a comprehensive set of international and national standards for medical devices, electrical safety, EMC, biocompatibility, and specific oxygen concentrator requirements (e.g., ISO 80601-2-69, ISO 80601-2-67). This is a technical and performance-based "ground truth" rather than clinical diagnostic ground truth.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device trained on data, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" or associated ground truth for this device.
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