Search Results
Found 1 results
510(k) Data Aggregation
(73 days)
The Terumo Gas Filter is intended to remove particulate matter from the gases flowing into the cardiopulmonary bypass circuit.
The Terumo Gas Filter is intended for use in procedures lasting up to 6-hours in duration.
The Terumo Gas Filter is a 47mm borosilicate glass microfiber screen that is contained within a polypropylene housing. The filter provides a 13 cm2 filtration area which yields a filtration efficiency level of greater than 99% of particles greater than 0.2 um. The housing measures 2.16 inches in length (nominal) and 2.05 inches in diameter width (nominal). The inlet and outlet ports are identical (device is bi-directional), and each port measures .320 - .438 inches to allow for the connection of tubing from ¼" to 3/8".
This is a 510(k) premarket notification for a medical device (Terumo Gas Filter) and primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed acceptance criteria and performance against those. Therefore, much of the requested information (like expert involvement, MRMC studies, training set details) is not applicable or not provided in the given text.
However, I can extract the available information related to acceptance criteria and device performance based on the provided text.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Terumo Gas Filter) | Predicate Device (Gasline Filter - Gish Biomedical) Performance |
|---|---|---|
| Intended Use Duration | Up to 6-hours in duration | Not explicitly stated but assumed to be equivalent as part of substantial equivalence claim. |
| Filtration Efficiency for Particulate Matter | >99.99% effective in removing particulate matter down to 0.1 µm | Effective in removing particulate matter down to 0.45 microns |
| Sterility Assurance Level (SAL) | 10-6 (validated in accordance with AAMI guidelines) | Not explicitly stated, but sterilization validation would be expected for a sterile device. |
| Ethylene Oxide Residues | Will not exceed maximum residue limits proposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended). | Not explicitly stated, but compliance with residue limits would be expected. |
| Visual Analysis | Passed (demonstrated safety and efficacy) | Not explicitly stated, but assumed to be satisfactory. |
| Leakage Testing/Mechanical Integrity | Passed (demonstrated safety and efficacy) | Not explicitly stated, but assumed to be satisfactory. |
| Impact of Aging | Performance evaluations conducted on non-aged and aged devices demonstrated no adverse impact. | Not explicitly stated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance evaluations (Visual Analysis, Leakage Testing/Mechanical Integrity, Filtration Efficiency). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these tests. These are typically laboratory-based engineering tests rather than clinical studies with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The performance evaluations described are laboratory/engineering tests (e.g., filtration efficiency, leakage). They do not involve expert interpretation or establishing "ground truth" in the way a diagnostic AI device would.
4. Adjudication Method for the Test Set
Not applicable, as no expert "ground truth" establishment or interpretation tasks are described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes a medical device (a gas filter), not an AI algorithm for diagnostic interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical filter, not an algorithm. Its performance is inherent to its design and material properties.
7. Type of Ground Truth Used
The "ground truth" used for the performance evaluations appears to be based on:
- Physical Measurements/Standards: For filtration efficiency (e.g., using particle counters and known particle sizes).
- Engineering Specifications: For leakage testing, mechanical integrity, and visual analysis.
- Regulatory Standards: For sterility assurance level (AAMI guidelines) and Ethylene Oxide residues (Federal Register).
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for a physical filter device.
Ask a specific question about this device
Page 1 of 1