(90 days)
The 1st Response Pediatric Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to patients suffering from respiratory distress. It is intended for use on patients with a body mass of between 10 kg (22 lbs) and 40 kg (88 lbs).
The 1st Response Pediatric manual resuscitator is a disposable, single use emergency manual ventilator. It is intended for single patient use only. Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends. The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of two types of reservoirs; bag reservou or tube reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used. The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15 mm ID x 22 mm OD patient connector, exhalation port, manometer port and a pressure-limiting valve (PLV). The patient port has a swivel feature to allow the care provider to move the bag around the patient, as needed. Standard configurations of the device are provided with or without a face mask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.
This document describes a 510(k) premarket notification for the "1st Response Pediatric Manual Resuscitator." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's efficacy through extensive clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and training set information is not typically found in this type of regulatory submission.
Specifically, for this 510(k) K023793:
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Acceptance Criteria and Reported Device Performance:
- The document states that "Performance and specifications of the modified device are consistent with all requirements for this device type specified by: ASTM 920; Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans, ISO 8382:1988 (E) Resuscitators intended for use with humans, and ISO 5356-1: 1987 - Anaesthetic and respiratory equipment - Conical connectors - Part 1; Cones and sockets."
- Interpretation: The acceptance criteria are defined by compliance with these established national and international standards for manual resuscitators. The reported device performance is implicitly stated as meeting these standards, as the submission concludes substantial equivalence. However, no specific performance metrics are provided in a table format in the document to directly compare against numerical acceptance criteria.
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Sample Size used for the test set and the data provenance: Not applicable. This is a non-clinical submission relying on engineering and performance standards compliance, not a clinical study with a test set of patients/data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established by experts for a test set.
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Adjudication method for the test set: Not applicable. No clinical test set was used.
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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 resuscitator, not an AI-assisted diagnostic tool or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and effectiveness determination is established by its adherence to recognized industry standards (ASTM and ISO as listed above) and by demonstrating substantial equivalence to predicate devices that have previously met regulatory requirements.
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The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/machine learning device. The design and testing are based on engineering principles and regulatory standards.
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How the ground truth for the training set was established: Not applicable.
§ 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).