Search Results
Found 2 results
510(k) Data Aggregation
(73 days)
TERUMO GAS FILTER
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
(197 days)
GAS FILTER
The Gas Filter is intended to remove particulate matter from medical gases flowing into the cardiopulmonary bypass circuit for periods up to 6 hours.
The proposed gas filter and the Gish filter are each made of materials that are commonly used in cardiopulmonary bypass devices and circuits. The Gish filter is made of ABS, and Versapor (Acrylic); the proposed devices are made of hydrophobic laminated glass media, Versapor (Acrylic) and polypropylene.
Here's an analysis of the provided 510(k) submission for the Gas Filter, focusing on acceptance criteria and supporting studies:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Filtration efficiency (0.3 µm particles) | 99.98% efficiency (certified by original manufacturer) |
| Sterility Assurance Level (SAL) | 10⁻⁶ (validated per AAMI guidelines) |
| Ethylene Oxide Residuals | Will not exceed maximum residue limits (21 CFR Part 821) |
| Expiration Dating | Controlled by shortest expiry component or 2 years |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a distinct "test set" in the context of typical AI/ML device testing. Instead, it relies on:
- Manufacturer Certification for Filtration Efficiency: The 99.98% efficiency for 0.3 µm particles is stated to be a "certification from original manufacturer." This implies no new testing was performed for this 510(k) submission. Therefore, details on sample size, "test set," or data provenance (country of origin, retrospective/prospective) are not applicable or provided in this document directly related to the filtration efficiency claim. It's likely based on the predicate device's performance data.
- Validation for Sterility and EO Residuals: These are standard regulatory tests. While they involve samples, the specific 'test set' sample sizes and data provenance are not detailed in this summary. These would typically be part of a separate validation report.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document does not describe the use of experts to establish a "ground truth" for a test set, as this is a mechanical filtration device, not an AI/ML diagnostic system. The performance claims are based on direct physical measurements or established manufacturing certifications.
4. Adjudication Method for the Test Set
Not applicable, as there's no "ground truth" established by experts in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or described. This type of study is typically relevant for interpretative AI/ML devices where human reader performance is a key metric. This device is a passive mechanical filter.
6. Standalone (Algorithm Only) Performance Study
No standalone algorithmic performance study was conducted. This device is not an algorithm, but a physical component. The "performance" refers to its mechanical capabilities.
7. Type of Ground Truth Used
The 'ground truth' for the performance metrics is:
- Filtration Efficiency: Manufacturer certification, which would have been based on established standardized test methods using calibrated particle counters and known particle sizes (e.g., using a test aerosol).
- Sterility: Achieved through validated sterilization cycles (e.g., bioburden testing, sterility testing after terminal sterilization), adhering to AAMI guidelines.
- Ethylene Oxide Residuals: Measured through analytical chemistry methods to ensure levels are below regulatory limits.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Ask a specific question about this device
Page 1 of 1