(44 days)
Ambu® Mark IV Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support. Ambu® Mark IV Resuscitator is intended for use on patients with a body weight of more than 33 lbs (15 kg), approx. 3 years of age.
Ambu Mark IV Resuscitator is a reusable resuscitator.
Mark IV Resuscitator should only be used by persons trained in resuscitation. The use of the Ambu Mark IV Resuscitator product is well known to trained users. The product is intended for manual pulmonary resuscitation of patients with a body weight of more than 33 lbs (15 kg), approx. 3 years of age.
Ambu - Hark II - Resubertano is a reusable device. The product can be Cleaned areer use according to the description in the direction for use. rne produce consists of a bon inflating double walled resuscitator bag, with a sell expanding inner bag and in a thin-walled outer cover. The outer cover nds an all tight connections in the neck of the inner bag supported by the valve end. At the opposite end of the bag the outer cover has an all air airtight connection with the inlet valve housing. rne intervalve anows ambient air or supplementary oxygen to flow into the bug and prevents an a backwards from the bag through the inlet the bug and prevents an An oxygen reservoir bag can be mounted to the Ambu® Mark IV Resuscitator.
Amba - Flank IV Resubliation
The patient valve housing is attached to the bag by a turn able airtight The patient valve neasing the ventilation air through patient connector into the patient t nirway and directs the patient expiration air through the expiration connector.
the patient- and expiration connectors are standard connectors to avoid unsuitable connections with other devices.
dhisultuble connector, patient valve housing and inlet valve housing is rne patient connector, patient inflating bag is made of silicone rubber that made of hard plastic. Ind and returns to normal state when the hand is removed.
The Ambu® Mark IV Resuscitator has an oxygen reservoir bag volume of 1500 ml. The stroke volume with one hand is > 600 ml and max. 1300 ml.
This document describes the Ambu® Mark IV Resuscitator, a manual emergency ventilator. The information provided is primarily focused on its substantial equivalence to previously marketed devices and does not detail a study with specific acceptance criteria and performance metrics for the device itself. Instead, it relies on demonstrating that the new device has "equivalent functionality" to predicate devices.
Therefore, many of the requested elements for a study proving device performance or acceptance criteria are not directly applicable or available in the provided text.
Here is a summary based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, no specific quantitative acceptance criteria or detailed performance metrics are given for the Ambu® Mark IV Resuscitator as a new device. The submission relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly tied to meeting recognized consensus standards for manual resuscitators and having "equivalent functionality" to the predicate devices.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance (Implicit/Explicit) |
|---|---|---|
| Safety | No adverse events; complies with applicable standards. | Concluded to be a safe device. |
| Effectiveness | Equivalent functionality to predicate devices. | Concluded to be an effective device with equivalent functionality to predicate devices. |
| Material Properties | Silicone rubber for inflating bag, hard plastic for connectors. | Device made of specified materials. |
| Dimensions/Capacity | Oxygen reservoir bag: 1500 ml; Stroke volume (one hand): > 600 ml and max. 1300 ml. | Device meets these specifications. |
| Intended Use | For manual pulmonary resuscitation and emergency respiratory support for patients > 33 lbs (15 kg), approx. 3 years of age. | Device meets this intended use. |
| Cleaning/Reuse | Reusable; can be cleaned according to instructions for use. | Device is reusable and can be cleaned as directed. |
| Compatibility | Patient and expiration connectors are standard. | Connectors are standard to avoid unsuitable connections. |
| Biocompatibility | Established. | Biocompatibility established. |
| Consensus Standards | Product meets recognized consensus standards for manual resuscitators. | Product meets recognized consensus standards. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. No dedicated "test set" in the sense of patient data or clinical samples was used as no clinical tests were performed. The "tests" were laboratory tests comparing to predicate devices.
- Data Provenance: Not applicable. No human data (clinical or retrospective) used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. No human test set requiring expert ground truth was utilized.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No human test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- Was an MRMC study done? No. The submission explicitly states "No clinical tests are performed." This product is a physical medical device, not an AI or imaging diagnostic tool that would typically undergo an MRMC study.
- Effect Size of AI vs. without AI assistance: Not applicable. This is not an AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Was a standalone study done? No. This product is a physical manual resuscitator, not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: For the non-clinical tests (laboratory and comparison tests), the "ground truth" would be objective measurements and established standards for manual resuscitators, as well as the known specifications and performance of the legally marketed predicate devices (Ambu® SIR 2, Ambu® Mark III, Ambu® SPUR® II Adult). The comparison tests to predicate devices implicitly used the predicate devices' established performance as a benchmark.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is not an AI algorithm that requires a "training set." The development process likely involved engineering and design iterations, but not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set was Established:
- How Ground Truth for Training Set was Established: Not applicable. As it's not an AI device, there's no "training set" or corresponding ground truth to establish in that context.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).