(266 days)
The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment.
The GCE Zen-O™ (Model RS-00500) POC is the latest design of POC from Oxus, Inc. The GCE Zen-O™ POC delivers 87% - 96% oxygen to a patient through a standard singlelumen nasal cannula. The GCE Zen-O™ POC detects a patient breath and operates by delivering a bolus of oxygen during the inhalation period (pulse mode) or can provide a continuous flow of oxygen (continuous mode). The device is portable, enabling patients who need an oxygen device to be treated at home according to a clinician's prescription or direction. The GCE Zen-O™ POC can be set to deliver flowrates between 1-6 LPM in pulse mode and 0.5-2 LPM in continuous mode; both with increments of 0.5 LPM to a patient. The device can be operated when powered by the 100-240VAC AC/DC power supply provided with the unit and designed to operate with a DC automotive adaptor. In addition, the device contains a rechargeable battery allowing it to be carried by a patient while traveling.
The provided text is a 510(k) Summary for a GCE Zen-O™ Portable Oxygen Concentrator Model RS-00500 (K162433). This document primarily focuses on demonstrating substantial equivalence to a predicate device (Oxus, RS-00400 Portable Oxygen Concentrator, K073242), rather than detailing specific acceptance criteria and a comprehensive study for meeting them in the way one might expect for a novel or high-risk device.
Therefore, the information requested in the prompt, especially regarding sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training sets, is not explicitly available in this type of regulatory submission. The submission relies on comparative bench testing and compliance with recognized standards.
Here's a breakdown of the available information based on your request:
1. Table of acceptance criteria and the reported device performance
The document focuses on comparing attributes to a predicate device (Oxus, RS-00400, K073242) and meeting recognized standards, rather than setting explicit acceptance criteria with specific performance metrics for this particular device in a tabular format. The "performance" is largely demonstrated by meeting these standards and showing equivalence to the predicate.
| Attribute | Predicate Device (K073242 RS-00400) Reported Performance/Specification | Proposed Device (GCE Zen-O™ RS-00500) Reported Performance/Specification | Underlying "Acceptance Criteria" (Implied) |
|---|---|---|---|
| Indications for Use | Provides supplemental oxygen in home, institutional, or travel environment. | Provides supplemental oxygen in home, institutional, or travel environment. | Equivalent to predicate. |
| Environments of Use | Travel, Home or Institution | Travel, Home or Institution | Equivalent to predicate. |
| Prescriptive | Yes | Yes | Equivalent to predicate. |
| Patient Population | Adult | Adult | Equivalent to predicate. |
| Single Patient, multi-use | Yes | Yes | Equivalent to predicate. |
| Patient Interface | Cannula port | Cannula port | Equivalent to predicate. |
| Technology | Pressure Swing Adsorption with molecular sieve | Pressure Swing Adsorption with molecular sieve | Equivalent to predicate, "oxygen producing operations are similar". |
| Dimensions | 4.6" H x 7.5" W x 11.6" L | 6.6" H x 8.3" W x 12.3" L | Within acceptable variations for a similar device. |
| Weight | 10 lbs | 10.25 lbs | Within acceptable variations for a similar device. |
| Oxygen Concentration | 87% - 96% | 87% - 96% | 87% - 96% oxygen concentration (matching predicate). |
| Equivalent Flow Rates | 1-5 LPM, increments of 0.5 LPM | 1-6 LPM, increments of 0.5 LPM (pulse) | |
| 0.5 - 2 LPM, increments of 0.5 L (continuous) | Acceptable range and increments, including additional continuous mode. | ||
| Dose at Specified Flow | 8.5 mL per setting | 11 mL per setting | Within acceptable physiological range for oxygen delivery. |
| Filters | Input, Intermediate, Patient Filter | Input, Patient Filter | Appropriate filtration for oxygen delivery. |
| User Interface | Buttons, LCD Display | Buttons, LCD Display | Equivalent to predicate. |
| Electrical | 100-240VAC, 50/60 Hz, 1.6A; 18VDC, 7A | 100-240VAC, 50/60 Hz, 2.5A; 24VDC, 6.25A | Meets electrical safety standards (IEC 60601-1, etc.). |
| Software | Embedded | Embedded | Software verification and validation conducted (moderate level of concern). |
| Acoustic Noise | 42 dBA at 2 LPM | 42 dBA at 2 LPM | 42 dBA at 2 LPM (matching predicate). |
| Alarms | Various (Battery empty, Low Pressure, No pulse, High temp, etc.) | Various (Battery empty, Low Pressure, Motor communication, No pulse, etc.) | Comprehensive alarm system for safety and functionality. |
| Status Indicators | Flowrates, Battery Condition, Alarms, History Log, Diagnostics | Flowrates, Battery Condition, Alarms, History Log, Diagnostics | Equivalent to predicate for user information. |
| Battery Duration | Approximately 4 hours at 2LPM (pulse) | Approximately 4 hours at 2LPM (pulse) | Approximately 4 hours at 2LPM (pulse) (matching predicate). |
| Operating Environment | 5 to 40° C; Altitude: 0-8000 ft; RH: 5 - 95 % | 5 to 40° C; Altitude: 0-9000 ft; RH: 5 - 93 % | Within acceptable environmental operational conditions. |
| Shipping / Storage Conditions | Temperature: -20 to 60°C; Humidity: 0 - 95 % RH | Temperature: -20 to 60°C; Humidity: 0 - 93 % RH | Within acceptable environmental storage/shipping conditions. |
| Safety | IEC 60601-1-2 | IEC 60601-1; IEC 60601-1-2 | Compliance with relevant IEC standards. |
| Mechanical Safety | IEC 60601-1 | IEC 60601-1 | Compliance with IEC 60601-1. |
| Chemical Safety | Not Applicable | Not Applicable | N/A. |
| Thermal Safety | IEC 60601-1 | IEC 60601-1 | Compliance with IEC 60601-1. |
| Biocompatibility | 4 VOC's less than ambient | 4 VOC's less than ambient | PM2.5 less than EPA limit; Ozone |
§ 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).