(88 days)
The COOPDECH ENDOBRONCHIAL BLOCKER TUBE is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Patient Population: Patients requiring one lung isolation.
Environment of Use: Hospitals-OR and ICU.
The "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" consists of a bronchial blocker tube; advanced through an endotracheal catheter, and a joint connector, connecting the bronchial blocker tube to the endotracheal catheter. A cuff, incorporated at the distal tip of the tube, is inflated to block the targeted bronchus.
The provided document is a 510(k) summary for a medical device called the "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria through a clinical study.
Therefore, many of the requested elements (like sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or not present in the provided text.
The document primarily details bench testing and biocompatibility testing to show that changes in materials did not adversely affect the device's safety and performance compared to the predicate device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative manner with pass/fail thresholds for clinical performance. Instead, it describes tests performed to ensure the "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" is substantially equivalent to its predicate device due to material changes. The "reported device performance" is essentially that the modified device yielded "almost the same results" as the predicate device in these tests.
| Item | Predicate Device Performance/Characteristics | "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" Performance/Characteristics |
|---|---|---|
| Bench Tests - Cuff Characteristics | ||
| Analysis of Cuff Pressure at Various Inflation Volumes | Test performed. | Almost the same results as predicate. |
| Balloon Burst Testing | Test performed. | Almost the same results as predicate. |
| Analysis of Balloon Cuff Inflation Retention | Test performed. Gas barrier property was tested by analyzing the balloon cuff inflation retention time. | Almost the same results as predicate. |
| Biocompatibility | No biocompatibility concern was raised for the predicate device. | No biocompatibility concern raised, showing substantial equivalence. |
| Intended Use | To isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. | Same |
| Materials | Nylon, Silicone, PP, Nitrile rubber | Nylon, Silicone, PP, Isoprene rubber, Polyurethane |
| Design features | Double lumen shaft, multi-port adaptor, 2 cuffs. | Same |
| Length | 30, 40, 50, 60, 70, 80 cm | Same |
| Sterilization Method | EtO Sterilized | Same |
2. Sample size used for the test set and the data provenance (country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for any of the bench or biocompatibility tests.
- Data Provenance: Not specified. The company is based in Japan, so it's likely the tests were conducted there, but this is not explicitly stated.
- Retrospective/Prospective: Not applicable. These were bench and lab-based tests, not clinical studies on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No human experts were used to establish ground truth for these engineering and material science tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication was involved in these non-clinical tests.
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 device is an endobronchial blocker tube, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench tests (cuff pressure, burst testing, inflation retention), the "ground truth" was derived from the performance characteristics of the legally marketed predicate device. The goal was to show that the modified device's performance was "almost the same."
- For biocompatibility testing, the ground truth was established by standard biocompatibility testing protocols, and the results were compared to the predicate device, which had no prior biocompatibility concerns.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists.
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).