(89 days)
To ventilate the apnoeic patient and to augment ventilation and / or oxygen delivery to the spontaneously breathing patient. For use as an adjunct to artificial respiration and cardiopulmonary resuscitation.
Environment of use: Hospital - Emergency Medical Services, Operating Room, during patient transport, Intensive Care Units, where patient assisted ventilation may be administered or required.
The Datex Engstrom manual resuscitator is designed for use as an adjunct to artificial respiration and CPR. It can be used to ventilate the apnoeic patient and to augment ventilation and / or oxygen delivery to the spontaneously breathing patient.
The provided document, K970991, describes the Datex Engstrom Reusable Manual Resuscitator and its substantial equivalence to predicate devices, not an AI or algorithm-based device. Therefore, many of the requested categories related to AI performance, ground truth, and expert studies are not applicable.
Based on the available information for this medical device, here's an analysis of the acceptance criteria and the study proving compliance:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Datex Engstrom Reusable Manual Resuscitator are primarily based on demonstrating substantial equivalence to legally marketed predicate devices (Hudson RCI - Durable Manual resuscitator - K895589 and Hudson RCI - PEEP valves - K902062) by meeting established performance standards and design characteristics.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Datex-Engstrom) | Predicate Device Performance (Hudson RCI) |
|---|---|---|---|
| Intended Use | Adjunct to artificial respiration and CPR | Yes | Yes |
| Ventilate apnoeic patients | Yes | Yes | |
| Augment ventilation and/or oxygen delivery to spontaneously breathing patients | Yes | Yes | |
| Environment of Use | Hospital, OR, anesthesia, PACU, ICU, transport, EMS, etc. | Yes | Yes |
| User Qualification | Qualified medical and emergency personnel trained in pulmonary ventilation and ACLS | Yes | Yes |
| Reuse | Indicated for cleaning and reuse | Yes | Yes |
| Patient Population | Adult, child, infant | Yes | Yes |
| Design/Theory of Operation | Connects to face mask or endotracheal tube | Yes | Yes |
| Four major components: Rebreathing valve, Silicone bag, Reservoir valve, Oxygen reservoir | Yes | Yes | |
| May incorporate a PEEP valve | Yes | Yes | |
| Available in three (3) sizes | Yes | Yes | |
| Has available oxygen reservoir | Yes | Yes | |
| Fits standard 15/22 mm patient end fittings | Yes | Yes | |
| Offered with standard reusable face mask - various styles | Yes | Yes | |
| May be taken apart and cleaned | Yes | Yes | |
| Cleaning methods - autoclave, EtO | Yes | Yes | |
| Materials | Bag and duckbill valve - silicone | Yes | Yes |
| Patient connector, housing parts - Polysulfone | Yes | Yes | |
| Pop-off valve - aluminum | Yes | Yes | |
| PEEP valve spring - stainless steel | Yes | Yes | |
| Face mask - silicone or PVC | Yes | Yes | |
| Reservoir bag - PVC | Yes | Yes | |
| Performance Standards | Patient fittings - 15/22 mm (ASTM 1054 / ISO 5356) | Yes | Yes |
| Meets all specifications, testing, and requirements of ASTM 920 / ISO 8382 | Yes | Yes |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of an algorithm or AI. The assessment for this device is based on a comparison of design, materials, intended use, and adherence to recognized performance standards (ASTM, ISO). The provenance of this information is from the manufacturer's submission to the FDA for a 510(k) premarket notification in Sweden (Datex Engstrom AB is in Bromma, Sweden). The data is retrospective in the sense that it describes existing design features and compliance with established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device submission. The "ground truth" for a manual resuscitator is its physical properties, compliance with design specifications, and functioning according to established medical device standards. This is typically assessed through engineering design, materials testing, and adherence to international performance standards, rather than expert consensus on a test set of data.
4. Adjudication method for the test set
Not applicable. There is no "test set" or adjudication method as would be applied to an AI or diagnostic algorithm evaluation.
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
Not applicable. This is a traditional medical device (manual resuscitator), not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a traditional medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's acceptance is based on adherence to:
- Established Performance Standards: Specifically, ASTM 1054 / ISO 5356 for patient fittings and ASTM 920 / ISO 8382 for overall manual resuscitator performance. These standards define the expected physical and functional characteristics a device must possess.
- Material Specifications: The use of specific, known biocompatible and durable materials like silicone, polysulfone, aluminum, and stainless steel.
- Predicate Device Equivalence: The primary method for establishing effectiveness and safety is by demonstrating that the new device shares the same intended use, fundamental technological characteristics, and performance profile as legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.
8. The sample size for the training set
Not applicable, as this is not an AI or algorithm-based device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI or algorithm-based device.
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is not a clinical trial or an AI performance study in the modern sense. Instead, it's a technical comparison and declaration of compliance documented by the manufacturer as part of their 510(k) submission.
The document explicitly states:
- "The Datex Engstrom manual resuscitator proposes to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976." (Implied by the 510(k) submission process itself and the FDA's final letter).
- The comparison table (under "Device Description" and "Comparison to Predicate Devices") systematically details various attributes (Use, Environment of Use, Patient Population, Design/Theory of Operation, Materials, Performance Standards) for the Datex-Engstrom device and the predicate Hudson RCI device. In every listed attribute, the Datex-Engstrom device's performance or characteristic is marked "Yes," indicating it meets or is equivalent to the predicate.
- A key statement is found in the "Performance Standards / Specifications" section: "Meets all specifications, testing and requirements of ASTM 920 / ISO 8382." This indicates that engineering tests were likely conducted to ensure compliance with these recognized safety and performance standards for manual resuscitators.
- Finally, the document explicitly states under "Differences between Other Legally Marketed Predicate Devices": "There is no differences between the intended device and the predicate devices which would be significant to patient safety or effectiveness."
In summary, the device's acceptance is proven by demonstrating its substantial equivalence to predicate devices through a detailed comparison of its characteristics to those of the predicates and by confirming its adherence to relevant ASTM and ISO performance standards. This information would have been supported by internal testing and design documentation provided by Datex Engstrom AB to the FDA.
§ 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).