(30 days)
Disposable manual resuscitator with CO2 detection for use with patients requiring manual ventilatory support. The CO2 detector is located on the expiratory port. It may be supplied separately and attached to any resuscitator expiratory port. The CO2 detector assists in verification of the endotracheal tube placing during endotracheal or nasotracheal intubation. The CO2 detector detects approximate ranges of CO2 by color comparison. It is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as in the hospital, transport, mobile or home settings.
The EMS Disposable Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. It incorporates a feature CO2 detection.
Here's a breakdown of the acceptance criteria and study information for the EMS Disposable Manual Resuscitator with CO2 Detection, based on the provided text:
Preamble:
It's important to note that this document is a 510(k) submission, not a full clinical study report. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, rather than proving novel efficacy or conducting extensive new performance studies. Therefore, the "study" referred to here is primarily a comparison to existing, legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the attributes of the predicate devices. The "reported device performance" is the statement of equivalence to these attributes.
Attribute | EMS DMR with CO₂ (Modification) | Predicate Devices (EMS DMR K912203B, K924610A, NPB DMR Plus with CO₂ K973419) | Acceptance Criteria (implied by predicate) | Reported Device Performance |
---|---|---|---|---|
Use | ||||
Intended to provide manual ventilatory support | Yes | Yes | Yes | Yes |
Intended to assist in verification of tube placement by expired CO₂ detection | Yes | Yes (for CO₂-enabled predicates) | Yes | Yes |
Used in hospitals, home, transport, mobile settings | Yes | Yes | Yes | Yes |
Single Patient Use | Yes | Yes | Yes | Yes |
Design | ||||
CO₂ detector placed on expiratory port of manual resuscitator | Yes | Yes (for CO₂-enabled predicates) | Yes | Yes |
CO₂ detection by color comparison | Yes | Yes (for CO₂-enabled predicates) | Yes | Yes |
CO₂ detector good for up to 2 hours | Yes | Yes (for CO₂-enabled predicates) | Yes | Yes |
Can be replaced if needed | Yes | Yes (for CO₂-enabled predicates) | Yes | Yes |
Materials | ||||
Materials in CO₂ detection media exactly the same as predicate | Yes | Yes (for CO₂-enabled predicates) | Yes | Yes |
All other materials exactly the same as predicate | Yes | Yes (for non-CO₂ enabled predicates) | Yes | Yes |
Packaging | ||||
Provided clean, non-sterile | Yes | Yes | Yes | Yes |
Performance Standards / Specifications | ||||
None applicable under Section 514 | Yes | Yes | Yes | Yes |
Summary of Device Performance:
The document explicitly states: "There are no differences between the proposed modification, that of adding CO2 detection capabilities to the exhalation port of the manual resuscitator, and the predicates." This statement implies that the EMS Disposable Manual Resuscitator with CO₂ Detection meets all the acceptance criteria by being functionally and materially identical or equivalent to the predicate devices with CO₂ detection capabilities, and other attributes identical to other predicates.
Regarding "The Study That Proves the Device Meets the Acceptance Criteria":
The provided text doesn't describe a traditional "study" with a test set, experts, and ground truth in the way one might expect for a novel device's performance evaluation. Instead, the "proof" for a 510(k) submission primarily relies on:
- Comparison to legally marketed predicate devices: The core argument is that the device is substantially equivalent to existing devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
- Verification of attributes: The table explicitly compares attributes of the new device to predicates, indicating "Yes" for matching characteristics.
- Statement of no differences: The crucial statement "There are no differences between the proposed modification... and the predicates" serves as the primary evidence.
Given this context, the following points address your specific questions:
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission based on predicate device comparison. There isn't a "test set" of patient data or device performance data gathered for this specific submission beyond the functional demonstration inherent in comparing specifications.
- Data Provenance: Not applicable. The "data" here is the descriptive comparison of the device's design, materials, and intended use against legally marketed predicate devices (EMS DMR K912203B, K924610A, and Nellcor Puritan Bennett DMR2 Plus with CO2 Detection K973419, and Nellcor Puritan Bennett EasyCap CO₂ Detector K894053 and K944400). This is a retrospective comparison of device specifications/features to already approved devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. Ground truth, in the sense of expert consensus on patient data or clinical outcomes, is not established for this type of submission. The "ground truth" is effectively the established safety and effectiveness of the predicate devices as determined by their prior FDA clearances.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication method" in the context of this 510(k) submission. The comparison is a direct assessment of device characteristics against pre-defined market standards (the predicate devices).
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 device is a manual medical device (resuscitator with CO₂ detection), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a manual medical device, not an algorithm. Its function inherently involves human operation.
7. The Type of Ground Truth Used
- Implicit "Ground Truth": The "ground truth" is the established safety and effectiveness of the predicate devices (EMS Disposable Manual Resuscitator K912203B, K924610A, and Nellcor Puritan Bennett DMR2 Plus Manual Resuscitator with CO2 Detection K973419, and Nellcor Puritan Bennett EasyCap CO₂ Detector K894053 and K944400). The current device is deemed safe and effective because its characteristics are substantially equivalent to these already approved devices.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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).