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510(k) Data Aggregation
(274 days)
The Greatbatch Scicntific MR Fiber Optic Laryngoscope Handle when used with a green color marking blade system, is intended to facilitate and aid in tracheal . - intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnet field.
The MR Fiber Optic Intubating Laryngoscope consists of a handle which is manufactured from brass and is chrome plated. The cell used to provide the light source energy is a proprietary "c" size cell.
The provided document describes the 510(k) premarket notification for the "MR Fiber Optic Intubating Laryngoscope Handle." This is a medical device submission, and the focus of the testing and acceptance criteria is on demonstrating the device's substantial equivalence to existing predicate devices, particularly its safety for use in an MRI environment.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria & Test | Specified Limit/Target | Reported Device Performance |
|---|---|---|
| Artifact Level in 1.5 Tesla Static Magnetic Field (tested in the center of the field) | Not explicitly stated as a numerical limit, but implied acceptable. | "The device displayed an artifact level of twice the size of the device." (This is presented as a characteristic, not a pass/fail against a specific numerical limit, but considered acceptable within the context of substantial equivalence.) |
| RF Heating in 1.5 Tesla Static Magnetic Field | < 1° C (less than 1 degree Celsius) | "< 1° C of RF Heating" (The device exhibited less than 1° C of RF Heating, meeting the specified criteria.) |
| Attraction to Magnet (Angle of Attraction at center of 1.5 Tesla field) | Not explicitly stated as a numerical limit, but implied acceptable. | "a 4° angle of attraction." (This is presented as a characteristic, not a pass/fail against a specific numerical limit, but considered acceptable within the context of substantial equivalence.) |
| Attraction to Magnet (Angle of Attraction at portal and 15cm outside the magnet) | 0° (zero degrees) | "The device exhibited a 0° angle of attraction at the portal and at 15cm outside the magnet, which is the area of intended use." (Meets the 0° criteria in the intended use areas.) |
| Compliance with ASTM Standards (General Safety/Performance) | ASTM F965 and F1185 compliance | "This device has been tested according to ASTM Standards F 965 and F 1185 and MR safety testing" (Implies compliance with these standards.) |
| Substantial Equivalence to Predicate Devices | Similar design and intended use to predicate devices | "The Greatbatch Scientific MR Fiber Optic Intubating Laryngoscope Handle is substantially equivalent in design and intended use to the predicate devices listed above. The only difference is that the Greatbatch Scientific MR Fiber Optic Laryngoscope can be safely used in a MRI or an interventional MR environment, not to exceed a 1.5 Tesla static magnetic field." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in terms of multiple devices being tested. It refers to "The Greatbatch Scientific MR Fiber Optic Intubating Laryngoscope" (singular) being tested. This suggests that at least one representative sample of the device was subjected to the described tests.
- Sample Size: A limited number of device samples (likely one or a few for verification) were tested. The text refers to "The Greatbatch Scientific MR Fiber Optic Intubating Laryngoscope" as the subject of the tests, implying a focus on the device model rather than a large statistical sample.
- Data Provenance: The study was conducted by the submitter, Greatbatch Scientific. The testing likely occurred at their facilities or a contracted testing lab. The document does not specify a country of origin for the data beyond that. The nature of the testing (device performance, not clinical) means it's not "retrospective or prospective" in the sense of patient data. It's a technical performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission (510(k) for a basic medical device like a laryngoscope handle, particularly for MR compatibility) typically does not involve human "experts" establishing a clinical ground truth for a test set in the way a diagnostic AI algorithm would.
- Experts: Not applicable in the context of clinical ground truth for a test set. The validation relies on engineering and physics principles relevant to MRI compatibility.
- Qualifications of Experts: Not applicable. The "expert" evaluation would be the engineering and testing personnel who conducted the MR safety tests and interpreted ASTM standards.
4. Adjudication Method for the Test Set
Not applicable. This is a technical performance test, not an evaluation where human adjudicators reconcile differences in medical assessments. The results are objective measurements (e.g., temperature rise, angle of attraction, artifact size).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is not a diagnostic device or an AI-assisted tool requiring a MRMC study. The device is a physical instrument for intubation, and the study focuses on its physical properties and safety in an MRI environment.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an algorithm or software device. It's a physical medical instrument.
7. The Type of Ground Truth Used
The "ground truth" here is based on accepted engineering standards and physical principles for MRI compatibility and safety.
- MRI Safety Ground Truth: The physical laws governing magnetic attraction, RF heating, and artifact generation in an MRI environment, as well as the established safety limits (e.g., temperature rise, attraction limits).
- ASTM Standards Ground Truth: The requirements defined in ASTM F965 (Standard Guide for Care and Handling of Anesthesia and Respiratory Equipment for Tissue Banks) and F1185 (Standard Specification for Anesthetic and Respiratory Equipment - Laryngoscopes). These are consensus standards representing accepted safe performance.
8. The 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, as there is no training set for this type of device.
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