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510(k) Data Aggregation
(428 days)
NS 120P-TRS Airway Pressure Gauge
The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used to monitor patient arway pressure during ventilation with a manual resuscitation device or bag/mask unit. These devices are intended to be used by or on the order of a physician.
The Instrumentation Industries, Inc. NS 120P-TRS airway pressure monitor measures positive pressures from 0-120cm H2O during manual ventilation. The device contains a diaphragm capsule which inflates when positive pressure is introduced and collapses when the pressure decreases. Through several internal, interconnected, movements caused by the inflating/deflating diaphragm, the pointer on the face of the gauge moves to indicate accurate pressure.
The acceptance criteria and the study that proves the device meets those criteria for the NS 120P-TRS Airway Pressure Gauge are detailed below based on the provided FDA submission document.
This device is an airway pressure monitor, not an AI/ML diagnostic device, so many of the requested fields (such as multi-reader multi-case studies, expert consensus for ground truth, training set details) are not applicable to this type of medical device submission. The study focuses on direct performance measurements (accuracy and responsiveness) against engineering specifications and a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Objective | Acceptance Criteria | Reported Device Performance (NS 120P-TRS Subject Device) | Pass/Fail |
|---|---|---|---|
| Accuracy | ≤ ± 1.9 cm H₂O (1.6% of full scale) | Average Accuracy Difference at 60 cm H₂O: 0.6 cm H₂O | Pass |
| Average Accuracy Difference at 120 cm H₂O: 0.9 cm H₂O | Pass | ||
| Responsiveness of Needle Movement | Must respond instantly to pressurization changes. | Responds instantly to pressure | Pass |
Comparison to Predicate Device (NS 120-TRS):
While not directly an acceptance criterion for the subject device, the study also compared its performance to the predicate device.
| Test Objective | Predicate Device Acceptance Criteria / Specification | Reported Predicate Device Performance (NS 120-TRS) | Pass/Fail |
|---|---|---|---|
| Accuracy | ≤ ± 3.8 cm H₂O (1.6% of full scale) | Average Accuracy Difference at 60 cm H₂O: 0.8 cm H₂O | Pass |
| Average Accuracy Difference at 120 cm H₂O: 1.8 cm H₂O | Pass | ||
| Responsiveness of Needle Movement | Must respond instantly to pressure and vacuum changes. | Responds instantly to pressure and vacuum. (Vacuum readings noted as not relevant for comparison with subject device) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Subject Device (NS 120P-TRS) Test Sample Size: 50 units
- Predicate Device (NS 120-TRS) Test Sample Size: 10 units
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, based on the context of a 510(k) submission for mechanical device testing, it is implicitly a prospective performance validation study conducted by the manufacturer, Instrumentation Industries, Inc., likely at their facilities in Bethel Park, Pennsylvania, USA.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a performance validation study for a mechanical medical device, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for accuracy would be derived from a high-precision reference pressure measurement system.
4. Adjudication Method for the Test Set
- Not Applicable. As a mechanical device testing, there's no "adjudication" in the sense of human interpretation or consensus. The performance metrics (accuracy and responsiveness) are objectively measured against predefined engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This device is a physical instrument for measuring airway pressure. It does not involve human readers interpreting images or data to make a diagnosis, nor does it use AI assistance for that purpose. Therefore, an MRMC study is not relevant.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
- Not Applicable. This is a standalone device, but it does not employ an algorithm or AI. Its performance is measured directly as a physical instrument.
7. Type of Ground Truth Used
- Reference Measurement/Engineering Specification. For accuracy, the ground truth would be established by a precisely calibrated reference pressure source. For responsiveness, it's a qualitative observation of "instant" response against a set pressure change. This is standard for validating the performance of pressure gauges.
8. Sample Size for the Training Set
- Not Applicable. This device is a mechanical pressure gauge and does not involve AI/ML components requiring a "training set" for model development.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
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