(75 days)
The 1st Response 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 25 kg (55 lbs) or more.
The 1st Response 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 three types of reservoirs; bag reservoir, expandable tube reservoir, or flexible length tube reservoir. These 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 and exhalation port. 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 breathing mask and with or without a PEEP valve. Special configurations are available which could include; pre-attached components, exhalation filter, varying lengths of oxygen lines, varying sizes of breathing masks, and oropharyngeal airways (Berman and Guedel). The breathing mask consists of a clear flexible cone that features a 22 mm ID port and a clear tacky cushion that contacts the patient's face. The PEEP valve features a 30 mm ID port and a knob to allow the care provider the ability to adjust the amount of PEEP. The PEEP valve can be adjusted from 5-20 cm H2O and uses two springs and a silicone rubber diaphragm to regulate the exhaust pressure.
This document describes a 510(k) submission for a manual resuscitator, which primarily relies on substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria, sample sizes, and expert review as typically seen in submissions for AI/ML devices or novel technologies. Therefore, many of the requested details are not applicable or explicitly stated in this type of submission.
Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:
Acceptance Criteria and Device Performance
The submission focuses on establishing equivalence to a predicate device (Portex, Inc., 1st Response Manual Resuscitators, K992057). The "acceptance criteria" are implied by adherence to recognized standards and the demonstration that the new device has "the same technical characteristics" as the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Consistency with ASTM 920 standards | "Performance and specifications... consistent with all requirements for this device type specified by: ASTM 920" |
| Consistency with ISO 8382:1988 (E) standards | "Performance and specifications... consistent with all requirements for this device type specified by: ... ISO 8382:1988 (E)" |
| Consistency with ISO 5356-1:1987 standards | "Performance and specifications... consistent with all requirements for this device type specified by: ... ISO 5356-1:1987" |
| Technical characteristics identical to predicate device (K992057) | "The device has the same technical characteristics as the device we have authorization to market under premarket notification K992057." |
Study Details
Given this is a 510(k) for a manual resuscitator based on equivalence to a predicate, a "study" in the sense of a clinical trial or a performance validation for an AI/ML device is not described. The "study" here refers to the non-clinical data assessment and comparison.
- Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation. The document refers to non-clinical data related to product specifications and standards adherence.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a traditional device like a manual resuscitator is not established by expert consensus on data interpretation, but by engineering specifications and physical testing against standards.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, a MRMC study was not done. This type of study is typically for evaluating diagnostic or imaging devices where human readers interpret results, often with AI assistance. This device is a manual resuscitator.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.
- The type of ground truth used: For a manual resuscitator, "ground truth" would be objective measurements against performance standards (e.g., flow rates, pressures, valve function) and material specifications, as outlined by ASTM and ISO standards. The submission states that the device's performance and specifications are "consistent with all requirements for this device type" as specified by these standards.
- The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of medical device submission.
- 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).