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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 <82% (yellow light), <75% (red light/beep), Blocked flow, No breath detected (Predicate K081468) | Concentration <86% (yellow light), <85% (yellow light/beep), Blocked flow, No breath detected (Subject Device). Note: "Same number of Alerts as iGo 306DS." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical bench testing rather than clinical studies with patient test sets. Therefore, the concept of "sample size used for the test set" in the context of human subjects is not applicable here. The testing was conducted on the device itself.
Data provenance: Not explicitly stated, but assumed to be internal testing by DeVilbiss Healthcare, LLC, based in Somerset, Pennsylvania, USA. The testing is prospective in the sense that the device was designed and then tested against pre-defined standards and requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. For non-clinical bench testing of a medical device like an oxygen concentrator, "ground truth" is typically established by engineering specifications, validated measurement equipment, and compliance with recognized industry standards (e.g., ISO, IEC). There are no "experts" establishing a "ground truth" for a test set in the way a radiologist would for an imaging study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically employed in clinical studies where there's subjectivity in interpreting results (e.g., by human readers). Bench testing relies on objective measurements against engineering specifications and standards, negating the need for adjudication by multiple experts.
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
Not applicable. This is a medical device for oxygen delivery, not an AI-assisted diagnostic or therapeutic tool with "human readers" or AI components in that sense. The filing is for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a hardware product. While it has software/firmware for control ("Smart Dose" feature operates automatically, "over-pressure protection achieved through software and electronic control"), it's not an AI algorithm that functions standalone in the way a diagnostic AI would. The "standalone" performance here refers to the device's functional operation meeting its specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing, the "ground truth" is established by:
- Engineering Specifications: The design parameters and target performance levels set by the manufacturer.
- International and National Standards: Compliance with recognized standards such as ISO 80601-2-69 (Oxygen Concentrator Equipment), ISO 80601-2-67 (Oxygen Conserving Equipment), and various IEC 60601 series standards for medical electrical equipment safety and essential performance.
- Validated Measurement Equipment: The actual measurements obtained during bench testing using calibrated instruments are compared against these specifications and standards.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning or AI development.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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