(30 days)
The Disposable Pressure Manometer will be used to provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP Mask or CPAP Circuits.
The VSI disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation. The device consists of: A flexible nipple for attachment to a sampling/pressure port, Clear polycarbonate (PC) housing with a printed pressure scale, PC float with indication and a double ended stainless steel spring.
The K022402 submission is for a Disposable Manometer, not an AI/ML device, so many of the requested categories (e.g., training set, number of experts, MRMC study) are not applicable. I will provide the information that is relevant to this traditional medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device K003497) | Reported Device Performance (VSI Disposable Manometer) |
|---|---|
| +/- 1 cm H2O / 0-10 cm H2O | +/- 1 cm H2O / 0-10 cm H2O |
| +/- 2 cm H2O / 10-40 cm H2O | +/- 2 cm H2O / 10-40 cm H2O |
| +/- 3 cm H2O / > 40 cm H2O | +/- 3 cm H2O / > 40 cm H2O |
| Range of Pressures Measured: 0-60 cm H2O | Range of Pressures Measured: 0-60 cm H2O |
| Intended Use: To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP Mask, or CPAP Circuits. | Intended Use: To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP Mask, or CPAP Circuits. |
| Intended for Single Patient, Multi-Use: Yes | Intended for Single Patient, Multi-Use: Yes |
| Prescription: Yes | Prescription: Yes |
| Intended Population: Any patient requiring airway pressure measurement. | Intended Population: Any patient requiring airway pressure measurement. |
| Intended Environment of Use: Home, Hospital, Physician Office, Sub-Acute Institutions, Emergency Services, anywhere airway pressure is measured. | Intended Environment of Use: Home, Hospital, Physician Office, Sub-Acute Institutions, Emergency Services, anywhere airway pressure is measured. |
| Materials (Polycarbonate, PC): Polycarbonate for manometer body and float. | Materials (Polycarbonate, PC): Polycarbonate to be used for manometer body and float. |
| Contains Latex: No | Contains Latex: No |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for performance testing or the exact data provenance (e.g., country of origin, retrospective/prospective). Instead, the submission relies on direct comparison of the proposed device's specifications and performance to a legally marketed predicate device (Engineered Medical System, Inc. - Pressure Manometer - K003497). The "Performance Accuracy" values listed in the table are the specified performance of the device, implying that testing was conducted to demonstrate conformance to these specifications to establish substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is a hardware medical device; its performance is based on physical accuracy measurements rather than expert-established ground truth in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable. This is a hardware medical device where performance is measured objectively.
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 imaging or AI devices where human reader performance is being evaluated, often with and without AI assistance. This device is a measurement tool.
6. If a Standalone Study Was Done
Yes, implicitly a "standalone" performance evaluation was done in the sense that the VSI Disposable Manometer was tested to confirm it met the specified accuracy criteria. The submission states the device's performance accuracy:
- +/- 1 cm H2O / 0-10 cm H2O
- +/- 2 cm H2O / 10-40 cm H2O
- +/- 3 cm H2O / > 40 cm H2O
These values are identical to the predicate device, indicating that the device's performance was measured and found to meet these specifications.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is objective physical measurement of pressure accuracy against a calibrated standard.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device and does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device and does not have a "training set."
§ 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).