Search Results
Found 1 results
510(k) Data Aggregation
(132 days)
NEO-STAT CO2
The Neo-StatCO2
Mercury Medical, Inc. Neo-StatCO2
This document describes the Neo-StatCO2 device, a colorimetric breath indicator for CO2 that helps verify proper intubation. The submission aims to demonstrate substantial equivalence to predicate devices, particularly the Mercury Medical Mini-StatCO2 (K031411).
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria by comparing the new device (Neo-StatCO2) to predicate devices in terms of its physical, performance, and operating characteristics. The primary new "performance" aspect is the expanded patient population, which required specific testing.
| Feature / Criteria (Derived from Predicate Comparison) | Acceptance Criteria (Predicate) | Reported Device Performance (Neo-StatCO2) |
|---|---|---|
| Indications for Use | "semi-quantitative visualization of the CO2 in the patient airway. Adjunct in patient assessment... in conjunction with other methods... by or on the order of a physician." | Identical to predicate (Mercury Mini-StatCO2 K031411) |
| Environment of Use | Hospital, sub-acute, pre-hospital & transport | Identical to predicate (Mercury Mini-StatCO2 K031411) |
| Patient Population | Neonate and Pediatric (Mini-StatCO2), Adult, Pediatric, Infant/Neonatal (Oridion MicroCap) | Neonate and infant (250g to 6 kg) Expanded from predicate, similar to Oridion MicroCap. |
| Weight | 5 g | 3 g |
| Internal Volume | 3 cc | 1 cc |
| Resistance to Flow | 1.23 cm H2O @ 10 Lpm; 8.8 cm H2O @ 30 Lpm | 1.86 cm H2O @ 10 Lpm; 15.6 cm H2O @ 30 Lpm |
| Duration of CO2 Detection | Up to 24 hours | Up to 24 hours |
| Operating Conditions | -10°C to +50°C | -10°C to +50°C |
| Storage Conditions | Color change function after storage at 0°C and 60°C | Color change function after storage at 0°C and 60°C |
| Contraindications & Warnings | Do not use for detection of hypercapnia, main-stem bronchial intubation, mouth-to-tube ventilation, oropharyngeal tube placement. Standard clinical assessment must be used. | Same as predicate |
| Effectiveness of color change for intended population | Demonstrated ability of color change for predicate's population. | Performance testing to demonstrate ability of indicator to change color for the intended body weight, tidal volume and breath rate under conditions of use. (This is the specific study mentioned). |
Study Proving Device Meets Acceptance Criteria:
The document explicitly states: "The only difference between the Mercury Mini-Stat CO2 is the expansion of the patient population to include patients with a body weight of 250 g to 6 Kg which we have demonstrated as being effective via comparative bench testing."
This implies that the "comparative bench testing" was the study conducted to ensure the device's effectiveness for the expanded patient population (neonate and infant - 250g to 6 kg) under the specified tidal volumes and breath rates.
Additional Information (Based on the Provided Text):
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document mentions "comparative bench testing" but does not give specific numbers for the test set used in this bench testing.
- Data provenance: The testing was described as "bench testing," suggesting a laboratory environment. There is no information about the country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the testing was "bench testing." Ground truth would likely be established by objective measurements of CO2, tidal volume, and breath rate, rather than expert interpretation of the device's color change.
4. Adjudication method for the test set:
- Not applicable for bench testing. The evaluation would be based on direct measurement outcomes rather than human adjudication.
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:
- No. This device is a colorimetric indicator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "comparative bench testing" would be a standalone performance evaluation of the device's ability to change color under specific simulated conditions, independent of human interpretation for the physical manifestation of the color change itself. The human-in-the-loop aspect refers to a clinician interpreting the color output. The bench testing would confirm the device produces the correct color change.
7. The type of ground truth used:
- For the "comparative bench testing," the ground truth would be precise, known values of CO2 concentration, tidal volume, and respiratory rate, simulated in a controlled environment. The device's color change would then be observed and compared against these known conditions to verify its accuracy.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/machine learning algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1