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510(k) Data Aggregation
(203 days)
The Drive DeVilbiss iGo2 Portable Oxygen Concentrator is indication of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities.
The proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator (POC) is similar to the predicate devices, pressure-vacuum swing adsorption based on molecular sieve technology using two containers filled with molecular sieve (sieve beds). Ambient air is drawn into the concentrator via a piston style compressor and compressed into a single sieve bed. As pressure increases nitrogen is adsorbed and concentrated oxygen exits one end of the bed and is collected in a product tank. Simultaneously in the other sieve bed, nitrogen is desorbed as the pressure decreases to a vacuum and is exhausted into the atmosphere. Once the pressure or vacuum reaches a defined maximum a valve switches the compressor connections to the sieve beds. The sieve bed previously connected to the pressure head will be connected to vacuum. The oxygen collected in the product tank is then dispensed to the patient upon detecting a patient inhalation, much like an oxygen conserving device.
The proposed Drive DeVilbiss iGo2 POC provides pulse dose oxygen in the same manner as primary predicate device (DeVilbiss Model 306 POC, K081468). The "Smart Dose" feature has been added to the proposed device, which is substantially equivalent to the feature in the reference device (Model 350G gas conserver, K090421). Smart Dose will automatically increase the patient's prescription setting by one if the system determines the patient has increased rate of breathing.
This document describes the regulatory filing for the Drive DeVilbiss iGo2 Portable Oxygen Concentrator (POC). It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study proving the device meets specific acceptance criteria in a traditional clinical research sense.
However, based on the provided text, we can extract information regarding acceptance criteria for performance testing (non-clinical) and the types of studies conducted.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document states: "All bench tests confirmed that the predetermined acceptance criteria were met. This includes oxygen output and breathing detection." and "The proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator was designed and tested to demonstrate compliance with the applicable sections of the following standards: ... passing all test protocols."
While specific numerical acceptance criteria and precise performance values are not fully detailed in a table format within the provided text, the document lists key performance specifications under the "Comparison of Substantial Equivalence and Differences" table. We can infer the acceptance criteria are met by confirming these specifications are in line with the predicate device or standards.
| Characteristic | Acceptance Criteria (Inferred from Predicate/Standards and "Same" or "No different questions") | Reported Device Performance (Subject Device) |
|---|---|---|
| Oxygen Performance | 90% +/-3% at 1 lpm to 3 lpm at sea level (Predicate K081468) | 87-94% at all settings (Subject Device) |
| Breathing Detection | Functionality as per predicate device (implied as "no different questions of safety or effectiveness") | The device detects patient inhalation and dispenses oxygen (implied, confirmed as "breathing detection" bench test met acceptance criteria). "Smart Dose" feature automatically increases prescription if increased rate of breathing is detected. |
| Output Capacity/Delivery Modes | Pulse flow settings: 1.0 to 3.0 in 0.5 increments; 3.0 to 6.0 in 1.0 increments (Predicate K081468) | Pulse flow settings: 1.0 to 5.0 in 1.0 increments (Subject Device). Note: "Does not support Continuous flow. Pulse mode like iGo 306DS but supports a smaller set of the patient population because of smaller bolus volume." |
| Standards Compliance | Compliance with IEC 60601-1 2nd Ed, IEC 60601-1-1, IEC 60601-1-2, ISO 8359, ISO 14971, ISO 13485 (Predicate K081468) | Compliance with IEC 60601-1 3rd Ed, IEC 60601-1-1, IEC 60601-1-2, ISO 80601-2-69, ISO 80601-2-67, ISO 14971, ISO 13485. "New device conforms to newer revisions of standards." |
| Patient Oxygen Outlet Pressure | 5 psig (Predicate K081468) | 15 psig (Subject Device). Note: "Higher pulsed output pressure than iGo but lower than 350G. Will deliver oxygen faster than iGo but there is no different questions of safety or effectiveness." |
| Noise Level | 40 dBA at pulse flow setting 3; 47 dBA overall maximum at 3 LPM continuous flow (Predicate K081468) | 46 dBA at pulse flow setting 2 (Subject Device). Note: "Louder than iGo 306DS but no different questions of safety or effectiveness." |
| Power Consumption | 31 Watts at 1.0 pulse flow setting (20 BPM); 62 Watts at 6.0 pulse flow setting (20 BPM) (Predicate K081468) | Approximately 30 Watts at setting of 2 (20 BPM) (Subject Device). Note: "Pulse dose efficiency is better." |
| Battery Run Time | Tested times: 5.8 hours at 1.0 LPM (10 BPM); 2.0 hours at 6.0 LPM (30 BPM) (Predicate K081468) | 4.5 hours at a setting of 2 (20 BPM) (Subject Device). Note: "Same as iGo 306DS at equivalent pulse output." |
| Patient Alert Indications | Concentration |
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