(213 days)
The Cheen Houng Pocket Rescue is indicated for mouth to mask ventilation of a nonbreathing adult.
Exhaled Air Pulmonary Resuscitators
The provided text is a 510(k) summary for the "Pocket Rescue" Exhaled Air Pulmonary Resuscitator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical study data with acceptance criteria and performance metrics in the way a new, high-risk device might.
Based on the provided document, here's what can be extracted and what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) summary states, "The Cheen Houng Enterprise Co., Ltd. Exhaled Air Pulmonary Resuscitators are similar in intended use, design, material selection, performance and function to Exhaled Air Pulmonary Resuscitators which are currently legally and safely marketed in the United States. No new technological characteristics that could affect safety or effectiveness have been introduced." This indicates a comparison to a predicate device's existing performance, but no specific acceptance criteria or new performance data for the Pocket Rescue are detailed.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission is a 510(k) for substantial equivalence, not a report of a new clinical study with a specified test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. There is no mention of an expert panel or ground truth establishment relevant to a clinical study for this device.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided. A 510(k) for a device like a manual resuscitator is unlikely to involve an MRMC study.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. The device is a manual resuscitator, not an AI algorithm.
7. Type of Ground Truth Used
This information is not provided. Given the nature of the device and the 510(k) submission, a "ground truth" as typically understood in AI/imaging studies is not relevant here.
8. Sample Size for the Training Set
This information is not applicable. The device is a manual medical tool, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable.
Summary of Device and Approval Process:
The Cheen Houng Enterprise Co., Ltd. "Pocket Rescue" Exhaled Air Pulmonary Resuscitator was granted 510(k) clearance (K970688) by the FDA on September 26, 1997. The basis for clearance was a demonstration of substantial equivalence to existing legally marketed Exhaled Air Pulmonary Resuscitators. The submission argues that the device is "similar in intended use, design, material selection, performance and function" and introduces "no new technological characteristics that could affect safety or effectiveness."
The indicated use for the Cheen Houng Pocket Rescue is "for mouth to mask ventilation of a nonbreathing adult," with an optional oxygen port. This process relies on a comparison to a predicate device's established safety and effectiveness, rather than new, independent clinical trials with explicit acceptance criteria and performance data for the submitted device itself.
§ 868.5570 Nonrebreathing mask.
(a)
Identification. A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.