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510(k) Data Aggregation
(260 days)
The Reprocessed Inquiry Optima and Inquiry Optima Plus Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic studies. The reprocessed Inquiry Optima catheters are to be used to map the atrial regions of the heart.
The Reprocessed Inquiry Optima and Inquiry Optima Plus Steerable Diagnostic Electrophysiology (EP) Catheter incorporates both a distal end with a variable loop diameter, which allows selection of diameters within a specific range, and a deflectable shaft steering mechanism. The diameter of the distal loop may be contracted or expanded by turning the rotating knob. The distal shaft may be deflected by pushing and pulling the thumb control.
The provided text describes a 510(k) premarket notification for reprocessed electrophysiology catheters. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific acceptance criteria through a traditional clinical study with performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and training set details) are not applicable in the context of this regulatory filing for a reprocessed medical device.
The "acceptance criteria" here refer to the tests and validations performed to ensure the reprocessed device maintains the same safety and effectiveness as the original predicate device. The "study" proving this involves a series of bench and laboratory tests.
Here's the information that can be extracted and a clear indication of what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists the types of tests performed rather than specific quantitative acceptance criteria or performance metrics in a table. The "reported device performance" is implicitly that the reprocessed device meets the standards of the predicate device.
| Acceptance Criteria Category | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Biocompatibility | Demonstrated equivalent biocompatibility. |
| Cleaning Validation | Demonstrated effective cleaning. |
| Sterilization Validation | Demonstrated effective sterilization. |
| Functional Testing (Visual) | Passed visual inspection. |
| Functional Testing (Dimensional) | Passed dimensional verification. |
| Functional Testing (Electrical) | Passed electrical continuity and resistance tests. |
| Functional Testing (Simulated Use) | Performed equivalently during simulated use. |
| Functional Testing (Mechanical) | Maintained mechanical characteristics. |
| Electrical Safety Testing | Passed dielectric and current leakage tests. |
| Packaging Validation | Passed packaging validation. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable for a reprocessing submission in this format. The device is reprocessed; the tests are laboratory/bench-based, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This pertains to diagnostic accuracy studies, which are not described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This pertains to diagnostic accuracy studies, which are not described here.
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 is a medical device reprocessing submission, not an AI or diagnostic imaging study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. Ground truth generation is relevant for diagnostic performance assessments. For this device, the "ground truth" for comparison is the performance and safety profile of the original, new predicate device.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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(109 days)
The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheter is a steerable electrophysiology catheter used for recording intracardiac stimulation during diagnostic electrophysiological studies. The catheters are to be used to map the atrial regions of the heart.
The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology (EP) Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle at the proximal end of the catheter.
The provided text is a 510(k) summary for a reprocessed medical device, specifically, the Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheters. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device or an AI/ML powered device.
Therefore, the information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML powered device is not available in this document. The document describes a traditional medical device (a catheter) and its reprocessing.
However, I can extract the safety and functional testing performed for this reprocessed device, which serves as its "demonstration of performance" to support its substantial equivalence claim.
Device Type: Reprocessed Steerable Diagnostic Electrophysiology Catheters (not an AI/ML powered device).
Summary of Device Performance and Testing (as described in the document):
The document lists "Functional and Safety Testing" conducted to demonstrate the performance, safety, and effectiveness of the reprocessed catheters. This is the closest equivalent to "proving the device meets acceptance criteria" for this type of device.
| Acceptance Criteria Category | Reported Test Performed / Device Performance |
|---|---|
| Biocompatibility | Biocompatibility testing was performed. |
| Cleaning Validation | Cleaning validation was performed. |
| Sterilization Validation | Sterilization validation was performed. |
| Visual Inspection | Visual inspection was performed. |
| Dimensional Verification | Dimensional verification was performed. |
| Electrical Continuity and Resistance | Electrical continuity and resistance testing was performed. |
| Simulated Use | Simulated use testing was performed. |
| Mechanical Characteristics | Mechanical characteristics testing was performed. |
| Dielectric and Current Leakage | Dielectric and current leakage testing was performed. |
| Packaging Validation | Packaging validation was performed. |
Additional Details from the Document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The document only states that "Bench and laboratory testing was conducted."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for this type of device and testing. The testing is laboratory-based physical and electrical property assessment rather than expert evaluation of diagnostic output.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI/ML powered device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML powered device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the tests performed (e.g., electrical continuity, mechanical characteristics), the "ground truth" would be established engineering specifications, performance standards, and established laboratory test methodologies for the predicate device.
- The sample size for the training set: Not applicable. This is not an AI/ML powered device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML powered device.
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