(243 days)
The Infant Resuscitation System provides the basic equipment required for pulmonary resuscitation during infancy. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen and/or manual ventilation to the infant. These practices are well-described in collaborative guidelines established by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP).
Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide.
The Infant Resuscitation System incorporates the following features for the practice of infant resuscitation: a suction device for routine clearance of the trachea and nasal passages; an oxygen flowmeter to deliver 100% oxygen to the infant requiring such therapy; and an airway pressure manometer with an adjustable pressure relief valve (12-55 cm H2O). The airway pressure manometer may be attached to a resuscitation bag (not included) and is used to measure the pressure belivered to the infant in order to facilitate adequate pressurization of the lungs. An adjustable pressure relief valve is a safety feature which helps prevent the user from over-inflating the infant's lungs, which could result in rupture of the alve may be adjusted to release excess gas at a user selected pressure point. The ability to adjust the pressure relief valve facilitates optimal oxygen delivery as lung compliance changes dynamically after birth during the trauterine life. The operative range (12-55 cm H2O) of this feature meets the recommendations by the AHA and AAP. The Infant Resuscitation System is outfitted with unregulated air and oxygen outlet connection which may be attached to an optional gas blender for the purposes of delivering air and oxygen mixes in the user selected percentages. The Resuscitation System may be equipped with optional hoses to connect the system to wall or cylinder outlets and/or yoke assemblies.
The Infant Resuscitation System does not include the resuscitation bag for manual ventilation.
The Ohmeda Infant Resuscitation System (IRS) is a combination of existing medical devices and is intended for pulmonary resuscitation of infants. The performance data section of the submission states that "Pulmonary resuscitation of infants includes well established clinical practices. These practices are well-described in collaborative guidelines established by the American Heart Association and the American Academy of Pediatrics. The IRS provide clinicians with the means to implement these practices. Consequently, clinical testing to demonstrate safety and effectiveness is not required. Bench testing will be conducted to ensure that the device meets its specifications."
Based on the provided text, the submission does not contain specific acceptance criteria or a detailed study report that would typically be expected for a novel device. Instead, the FDA's decision for substantial equivalence is based on the device being a combination of already cleared predicate devices and adherence to established clinical guidelines.
For the purpose of your request, I will extract relevant information about the device's functional description and how its specifications align with clinical guidelines, which serve as a de-facto acceptance criteria in the absence of explicit quantitative benchmarks.
Here's the information structured as requested, based strictly on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from functional description & guidelines) | Reported Device Performance |
|---|---|
| Suction Device: Routine clearance of mucous and debris from trachea and nasal passages. | Incorporates a suction device for routine clearance of mucous and debris from the trachea and nasal passages. |
| Oxygen Flowmeter: Delivery of oxygen to the infant. | Includes one oxygen flowmeter for delivery of oxygen to the infant requiring such therapy. |
| Airway Pressure Manometer: Measures pressure delivered to the infant to facilitate adequate pressurization of the lungs. | Attached to a resuscitation bag (not included) and measures the pressure delivered to the infant. |
| Airway Pressure Manometer Adjustable Pressure Relief Valve: Safety feature to prevent over-inflation; operative range 12-55 cm H2O, meeting AHA and AAP recommendations. | Has an adjustable pressure relief valve (12-55 cm H2O). Operative range (12-55 cm H2O) meets AHA and AAP recommendations. |
| Optional Gas Blender: Mixes air and oxygen in user-selected percentages. | An optional gas blender mixes air and oxygen in percentages selected by the user. |
| Hoses/Connections: To connect to wall/cylinder outlets and/or assemblies. | Includes hoses to connect the system to wall or cylinder outlets and/or assemblies. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Consequently, clinical testing to demonstrate safety and effectiveness is not required. Bench testing will be conducted to ensure that the device meets its specifications."
- Sample size for the test set: Not applicable (no clinical testing was performed; bench testing details are not provided).
- Data provenance: Not applicable (no clinical test data is mentioned).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No clinical testing was done to establish ground truth with experts. The device's design is stated to align with "collaborative guidelines established by the American Heart Association and the American Academy of Pediatrics."
4. Adjudication Method for the Test Set
Not applicable. No clinical testing or adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document states that clinical testing was not required.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an AI algorithm. The performance evaluation was based on the device conforming to its "specifications" via "bench testing" and alignment with established clinical practices.
7. The Type of Ground Truth Used
The "ground truth" for the device's design and functionality is implicitly based on:
- Expert Consensus / Clinical Guidelines: "collaborative guidelines established by the American Heart Association and the American Academy of Pediatrics."
- Predicate Device Equivalence: The device is a combination of legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model; therefore, there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set mentioned for this 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).