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510(k) Data Aggregation
(22 days)
The MTI HyperForm™ Occlusion Balloon Catheter is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The MTI Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.
The HyperForm™ Occlusion Balloon Catheter is a single lumen tapered catheter with a non-detachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over the MTI 0.010" guidewire, and requires insertion of the guidewire to occlude the catheter shaft lumen to allow inflation of the balloon. Two platinum markers provide angiographic visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The catheter shaft is hydrophilically coated to assist catheter advancement within the vasculature. The HyperForm catheter is supplied sterile for single use as a system, which includes the required 0.010" guidewire.
The provided document describes the HyperForm™ Occlusion Balloon Catheter and its clearance through the FDA's 510(k) process, which relies on demonstrating substantial equivalence to a predicate device. This type of submission focuses on comparing the new device's characteristics and performance to an already legally marketed device, rather than establishing absolute performance targets through a standalone clinical study with predefined acceptance criteria for a novel AI algorithm.
Therefore, many of the requested elements pertaining to acceptance criteria and detailed study design for AI devices (like sample sizes for test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable to this traditional medical device submission.
However, I can extract information related to the device's testing and substantial equivalence.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a catheter), the "acceptance criteria" are generally met by demonstrating compliance with recognized standards and substantial equivalence to a predicate device in terms of performance characteristics. There are no explicit quantitative "acceptance criteria" like sensitivity/specificity thresholds for an AI product.
| Performance Characteristic/Test | Acceptance Criteria (Implied by Standards/Predicate) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 for external communicating, blood contact, short duration (<24 hrs.) device. | "Test results confirmed biocompatibility of the HyperForm catheter when tested as an external communicating, blood contact, short duration (<24 hrs.) device." |
| Dimensional Verification | Compliance with ISO 10555 (Parts 1 & 4) requirements. | "Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device." |
| Balloon Compliance | Compliance with ISO 10555 (Parts 1 & 4) requirements. | "Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device." |
| Balloon Integrity | Compliance with ISO 10555 (Parts 1 & 4) requirements. | "Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device." |
| Catheter Tensile Strength | Compliance with ISO 10555 (Parts 1 & 4) requirements. | "Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device." |
| Torque Strength | Compliance with ISO 10555 (Parts 1 & 4) requirements. | "Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device." |
| Flexibility | Compliance with ISO 10555 (Parts 1 & 4) requirements. | "Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device." |
| Trackability | Compliance with ISO 10555 (Parts 1 & 4) requirements. | "Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device." |
| Coating Integrity | Compliance with ISO 10555 (Parts 1 & 4) requirements. | "Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate device." |
| Substantial Equivalence | Device is substantially equivalent to predicate device in intended use and principle of operation. | "The MTI HyperForm™ Occlusion Balloon Catheter is substantially equivalent to the predicate device in intended use and principles of operation." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as this is not a study involving human data or image analysis where such details would be typically reported. The testing described is primarily bench and biocompatibility testing.
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)
This information is not applicable as the clearance is not based on expert-adjudicated ground truth for a diagnostic or AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable.
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
This information is not applicable as this is a physical medical device (catheter), not an AI diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance tests, the 'ground truth' is compliance with the specified ISO standards (e.g., ISO 10555). For biocompatibility, the 'ground truth' is compliance with ISO 10993-1. These are measurable physical or biological properties, not clinical ground truth derived from expert consensus or pathology in the context of AI.
8. The sample size for the training set
This information is not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/machine learning device.
Summary of the Study/Evidence:
The study proving the device meets its "acceptance criteria" (which in this context means demonstrating safety and effectiveness for a 510(k) submission) is a series of performance tests and biocompatibility assessments coupled with a declaration of substantial equivalence to an existing predicate device.
- Biocompatibility Testing: Verified according to ISO 10993-1.
- Performance Testing: Conducted in accordance with ISO 10555 (Sterile, single use intravascular catheters - Parts 1 and 4). This included:
- Dimensional verification
- Balloon compliance and integrity
- Catheter tensile strength
- Torque strength
- Flexibility
- Trackability
- Coating integrity
- Substantial Equivalence: The manufacturer asserted, and the FDA agreed, that the HyperForm™ Occlusion Balloon Catheter is substantially equivalent to the MTI Equinox™ Occlusion Balloon Catheter in intended use and principles of operation, based on the testing and device description.
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