(112 days)
The Nellcor INdGO Manual Resuscitator is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The Nellcor INdGO Manual Resuscitator is available with or without an integrated CO2 detector. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.
The Nellcor INdGO Manual Resuscitator is available in two sizes and is for use on the following patient populations:
- Adult size is for use on adults > 30kg. .
- Child size is for use on children 10 30 kg. .
The Nellcor INdGO Manual Resuscitator is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated, such as hospital, transport, mobile, and home. This device is for prescription use only.
Nellcor INdGO Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air by connecting the supply tubing to a metered oxygen source.
The Nellcor INdGO Manual Resuscitator is available with and without integrated breath-to-breath CO2 detection. The integrated CO2 detector model incorporates an integral CO2 detector cartridge called INdCAP™ attached to the expiratory port of the resuscitator.
The Nellcor INdGO Manual Resuscitator is single-patient use, non-sterile, latex-free, and available in two sizes: adult and child. It has a double-swivel elbow, three oxygen accumulator styles, and comes in a variety of configurations.
The document provided is a 510(k) summary for the Nellcor INdGO Manual Resuscitator, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed information typically found in a clinical study report that would include acceptance criteria, specific device performance metrics, sample sizes, expert qualifications, or ground truth establishment methods in the way a diagnostic AI device submission would.
Based on the information available in the provided text:
1. Table of acceptance criteria and the reported device performance:
The document states that "Performance and testing are consistent with the requirements for this device type specified by ASTM F920 and ISO 8382." However, it does not explicitly list the acceptance criteria or the specific numerical performance results against these standards. It implies that the device met these standards, which serves as the "reported device performance."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ASTM F920 | Met requirements |
| Compliance with ISO 8382 | Met requirements |
2. Sample size used for the test set and the data provenance:
Not specified in the provided text. This document focuses on design modifications and general compliance with standards, not a specific clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a manual resuscitator device evaluated against engineering standards, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set:
Not applicable. This is a manual resuscitator device evaluated against engineering standards.
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 manual resuscitator device, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a manual resuscitator device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device would be established by the engineering and performance specifications defined in ASTM F920 and ISO 8382. These standards define physical and functional requirements (e.g., ventilation volume, resistance, oxygen delivery performance) that the device must meet, rather than a diagnostic 'truth' based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
Not applicable. This is a hardware medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a hardware medical device.
§ 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).