(178 days)
The Intersurgical In-line single patient use manometer is intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems and Mapleson C breathing circuits.
The Intersurgical 7160030 Manometer is an inline manometer for monitoring the pressure delivered to patients via resuscitation systems and Mapleson C breathing circuits. The 7160030 manometer has an operating range of 0 - 60 mbar and a stated accuracy. of +/- 10mbar. The pressure is read where the internal red indicator disk lines up with the pressure indication mark on the outside of the transparent manometer cylinder. The 7160030 manometer specify the patient pressure via a brightly colored indicator. The indicator moves in one axis along a transparent cylinder. The diameter of the indicator is similar to that of the cylinder. A balance of the force exerted by the air in the system and the force exerted by a calibrated spring defines the indicator position. The display on each manometer is a similar size and the pressure is specified where the indicator lines up with number marked on the outside of the transparent cylinder. The Manometer connects to the resuscitator / Mapleson C system via a 3 way, 15mm Female/22mm Male - 22mm Female connector. The 3-way connector tapers are compliant with ISO 5356-1. The manometer can be rotated to the desired orientation for ease of use via a friction fit elastomeric elbow. The 7160030 Manometer is single patient use.
The Intersurgical 7160030 Manometer's acceptance criteria and performance are detailed in the provided document.
1. Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (from Predicate Device Ambu 322004000) | Reported Device Performance (Intersurgical 7160030) |
|---|---|---|
| Measurement limits | 0 - 60 cmH2O | 0 - 60 cmH2O |
| Display Increments | 5, 10, 15, 20, 30, 40, 60 cmH2O | 0, 10, 20, 30, 40, 50, 60 cmH2O |
| Stated Accuracy: | ||
| - at 10 cmH2O | ± 2 mbar | + 2 mbar |
| - at 20 cmH2O | ± 2 mbar | ± 4 mbar |
| - at 30 cmH2O | ± 2 mbar | ± 5 mbar |
| - at 40 cmH2O | ± 3 mbar | + 5 mbar |
| - at 50 cmH2O | N/A | ± 7 mbar |
| - at 60 cmH2O | ± 5 mbar | ± 7 mbar |
| Measured Accuracy: | ||
| - at 10 cmH2O | ± 2 mbar | ± 2 mbar |
| - at 20 cmH2O | ± 2 mbar | ± 4 mbar |
| - at 30 cmH2O | ± 2 mbar | ± 5 mbar |
| - at 40 cmH2O | ± 4 mbar | ± 5 mbar |
| - at 50 cmH2O | N/A | ± 7 mbar |
| - at 60 cmH2O | ± 6 mbar | ± 7 mbar |
| Standards Met | N/A | ISO 5356-1 |
| Biocompatibility | Unknown (for predicate) | ISO 10993 (testing for cytotoxicity, sensitization, and irritation) |
| Connectors | Proprietary ID 3.7mm | ISO 5356-1 (22M/15F - 22F) |
Note: The document only provides "stated accuracy" for the predicate at 10, 20, & 30 cmH2O as ± 2 mbar (singular value). It's assumed for clarity in the table that this applies individually. Similarly, "measured accuracy" for the predicate at 10, 20, & 30 cmH2O is also given as ± 2 mbar.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set regarding the accuracy measurements. It mentions "Nonclinical tests submitted to demonstrate substantial equivalence for the Manometers include Vertical and Horizontal Pressures, Weight and Size and Tapers when compared to the legally marketed device." However, the number of devices or measurements taken during these tests is not specified.
The data provenance is not explicitly mentioned as a country of origin or whether it was retrospective or prospective. It is implied to be from internal testing conducted by Intersurgical Incorporated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The ground truth for device performance (e.g., pressure accuracy, physical dimensions) is established through instrument-based measurements and compliance with engineering standards, not through expert consensus.
4. Adjudication Method for the Test Set:
Not applicable. As the testing concerns objective device performance metrics, adjudication by experts for discrepancies is not relevant.
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 typically used for diagnostic or interpretive devices that involve human analysis of output (e.g., imaging devices with radiologists). The Intersurgical Manometer is a physical measurement device, so such a study would not be applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance assessment was done. The "Summary of Testing" section describes nonclinical tests for Vertical and Horizontal Pressures, Weight, Size, and Tapers, as well as biocompatibility and connector compliance, all demonstrating the device's inherent performance.
7. The Type of Ground Truth Used:
The ground truth used for performance validation was based on established measurement standards (e.g., pressure calibrations), physical measurements, and regulatory standards (ISO 10993-1 for biocompatibility, ISO 5356-1 for connectors).
8. The Sample Size for the Training Set:
Not applicable. The Intersurgical 7160030 Manometer is a mechanical device, not an AI/algorithmic system. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).