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510(k) Data Aggregation
(170 days)
Respond OC Conserving Regulator (130-0800)
The Respond OC Conserving Regulator (130-0800) is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use. It may also be used to deliver a constant flow of oxygen to the patient.
The Respond OC Conserving Regulator (130-0800) is a dual mode high pressure oxygen regulator and conserving device that allows for either a continuous or conserve flow of medical grade oxygen to the patient. The device is designed with a CGA 870 style yoke for use with ambulatory oxygen cylinders. The integrated regulator reduces cylinder pressure to 22psig (+/-3psi) to the sensing diaphragm which allows the Respond OC to sense the start of inhalation by the patient and release a controlled amount of oxygen by pneumatic timing in short bursts into the lungs via an oxygen cannula. The Respond OC supports a delivered oxygen equivalency of 1 to 5 LPM in the conserve mode, which extends the ambulatory time of cylinders up to 6:1 based on the cylinder pressure and selected setting. The continuous flow mode offers settings of 2, 3 and 4 LPM if the patient requires a constant flow of oxygen.
The provided FDA 510(k) clearance letter and summary for the Respond OC Conserving Regulator (K250322) outlines the device, its intended use, and its substantial equivalence to a predicate device. However, this documentation does not contain the detailed information typically found in a clinical study report or a comprehensive test report regarding acceptance criteria and the study that proves the device meets them, especially in the context of AI/ML-based medical devices or diagnostic tools.
The device described (an oxygen conserving regulator) is a mechanical device, not an AI/ML-driven diagnostic or treatment device. Therefore, many of the typical requirements for AI/ML device studies (such as MRMC, expert consensus for ground truth, training set details, and specific performance metrics like sensitivity/specificity/AUC) are not applicable here.
The document primarily focuses on bench testing and biocompatibility to demonstrate substantial equivalence to a predicate mechanical device.
Here's an analysis based on the provided document, highlighting what is and is not present concerning "acceptance criteria" and "study proof":
Analysis of Acceptance Criteria and Study Proof for Respond OC Conserving Regulator (K250322)
Based on the provided FDA 510(k) Summary, the device is a mechanical oxygen conserving regulator. The "acceptance criteria" and "study proof" are framed in the context of demonstrating substantial equivalence to a predicate mechanical device through non-clinical (bench) testing and biocompatibility assessments, rather than clinical efficacy studies or AI/ML performance evaluations.
1. Table of Acceptance Criteria and Reported Device Performance
The document summarizes the types of tests conducted and states that the device "met its acceptance criteria" and "performs similarly to the predicate device." However, it does not explicitly list the specific quantitative acceptance criteria for each test (e.g., a specific tolerance for oxygen flow, a defined pass/fail for impact resistance) nor does it present the raw, quantitative reported performance results against these criteria. Instead, it provides qualitative statements of compliance.
| Acceptance Criteria (Inferred from Test Types) | Reported Device Performance (as stated in document) |
|---|---|
| Biocompatibility: | |
| ISO 18562-2 – Emissions of Particulate Matter | "met the applicable requirements for biocompatibility safety" |
| ISO 18562-3 – Emissions of VOCs with Toxicological Risk Assessment | "met the applicable requirements for biocompatibility safety" |
| Bench Testing: | |
| Accelerated Aging performance | "demonstrated that the subject device met its acceptance criteria" |
| Flow Comparison with predicate | "performs similarly to the predicate device" |
| Flow Regulation Test performance | "demonstrated that the subject device met its acceptance criteria" |
| Conservation Testing savings ratio (e.g., 6:1) | "demonstrated that the subject device met its acceptance criteria" (specifically states 6:1 savings ratio achieved, similar to predicate) |
| Promoted Ignition Burst Pressure Test (ASTM G 175-24) | "Passed ASTM G 175-24" (similar to predicate's G 175-03) |
| Environmental Testing (e.g., temperature, humidity) | "demonstrated that the subject device met its acceptance criteria" |
| Altitude Test performance | "demonstrated that the subject device met its acceptance criteria" |
| Flow Response Test (e.g., bolus delivery, trigger) | "performs similarly to the predicate device"; "Conserve mode: Senses a breath and delivers in first 1/3 of breath cycle" |
| Impact Test performance | "demonstrated that the subject device met its acceptance criteria" |
| Functional Equivalence: | |
| Selectable Outlet Flow (Continuous: 2, 3, 4 lpm); (Conserve: 1-5 lpm) | Match stated levels (Implicitly met for substantial equivalence claim) |
| Oxygen Bolus Size (ml) at 20 BPM (specific ml per lpm setting) | Conserve 1 lpm: 11 ml; 2 lpm: 24 ml; 3 lpm: 37 ml; 4 lpm: 46 ml; 5 lpm: 54 ml (Similar to predicate) |
| Regulator Outlet Pressure (22 PSI) | Match stated 22 PSI (Similar to predicate's 25 PSI) |
| Breaths Per Minute (bpm) support (Up to 35 bpm) | Met (Predicate: 14 to 40 bpm) |
2. Sample Size for the Test Set and Data Provenance
Given this is a physical device, the "test set" refers to the manufactured units subjected to bench testing. The document does not specify the sample size (number of devices) used for each of the non-clinical tests (e.g., how many units were subjected to accelerated aging, or impact testing).
Data Provenance: The data provenance is from non-clinical bench testing conducted by the manufacturer, Responsive Respiratory, Inc. It's not clinical data or retrospective/prospective human data. The country of origin for the testing itself is not explicitly stated but would typically be where the manufacturer's testing facilities are located.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable as the device is a mechanical oxygen regulator, not an AI/ML-driven diagnostic or classification device requiring expert-established ground truth from medical images or patient data. Ground truth for its performance would be established through calibrated laboratory equipment measuring physical parameters (flow, pressure, timing, etc.) against engineering specifications.
4. Adjudication Method for the Test Set
This question is not applicable for a mechanical device undergoing bench testing. Adjudication typically refers to resolving discrepancies between human readers or between AI and human readings. Test results for mechanical parameters are either within specification or not, based on objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI/ML) where human readers (e.g., radiologists) interpret cases, and the effectiveness of AI assistance on their performance is evaluated. The Respond OC Conserving Regulator is a therapeutic/delivery device, not a diagnostic one.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable in the typical sense for this device. There is no "algorithm" in the way an AI/ML device would have one. The device's "performance" is its mechanical function. The "bench testing" described in the summary is the standalone performance assessment of the device's mechanical and pneumatic operation (e.g., flow rates, bolus timing, pressure regulation) without human intervention beyond setting the controls for the test.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" would be physical measurements against engineering specifications and industry standards. For example:
- Flow rates: Measured by calibrated flow meters against specified LPM settings.
- Pressure: Measured by calibrated pressure gauges against specified PSI output.
- Timing of bolus delivery: Measured by sensors and timers to confirm delivery within the specified inspiratory cycle.
- Biocompatibility: Confirmed by laboratory analysis against ISO standards.
- Ignition Sensitivity: Confirmed by testing against ASTM standards.
It is not expert consensus, pathology, or outcomes data, as these are related to clinical diagnosis or patient outcomes, not the performance of a mechanical oxygen delivery device.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is not an AI/ML device that requires data for model training.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8.
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