(80 days)
The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.
The V8 Transluminal BAV Catheter System features an hour-glass shaped dilatation balloon on the distal end of a catheter. The catheter is inserted through a percutaneous entry site into the common femoral artery via an introducer sheath and advanced retrograde to the aortic valve. The catheter is always delivered over a guidewire. The balloon is then inflated to dilate the stenotic aortic valve leaflets in an effort to increase valve opening dimensions and systemic blood flow by improving leaflet mobility. The hour-glass shaped balloon with the undersized waist segment is intended to minimize over-dilatation of the valve annulus while allowing the full dilation of the valve leaflet. The bulbous proximal balloon segment is appropriately sized for the patient's aortic root dimensions to maximize valve leaflet opening.
The provided text describes a 510(k) submission for the InterValve V8 Transluminal BAV Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish efficacy and safety from scratch. Therefore, the information typically found in acceptance criteria tables and detailed study descriptions for novel devices is not fully present.
Based on the provided text, here's what can be extracted and inferred regarding acceptance criteria and the supporting study:
1. A table of acceptance criteria and the reported device performance
The submission demonstrates substantial equivalence based on technological characteristics and performance data from predicate devices, with relevant design verification testing repeated for minor modifications.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Composition (V8 balloon) | Made of clear non-compliant polymeric material. (Identical to predicate K123111) |
| Balloon Sizes (Available diameters) | 22mm, 24mm, 28mm. (New dimensions for 24mm and 26mm are within bounds of original K123111 and do not change technological characteristics). |
| Balloon Waist Design | Hour-glass shaped with undersized waist segment, smaller than bulb diameter up to rated burst pressure. (Identical to predicate K123111) |
| Catheter Working Lengths | Standard working lengths (107cm - 113cm). (Identical to predicate K123111) |
| Introducer Sheath Compatibility | Compatible with a 12F or 14F introducer sheath. (Identical to predicate K123111) |
| Guidewire Compatibility | Tracked over a 0.035" wire. (Identical to predicate K123111) |
| Radiopaque Markers | Platinum iridium marker bands on inner shaft beneath the balloon (center of waist, outside edges of proximal and distal balloon shoulders). (Identical to predicate K123111) |
| Packaging & Sterilization | Packaged in heat-sealed Tyvek pouch, provided sterilized. (Identical to predicate K123111) |
| Intended Use | Balloon Aortic Valvuloplasty. (No change from predicate K123111 and K082776) |
| Safety & Effectiveness Profile | The clinical experience used to support the change to the device labeling indicates that the change does not affect the safety and effectiveness profile of the device. The minor differences do not raise new questions of safety or efficacy. |
| Physician Discretion for Rapid Ventricular Pacing | Revised wording on labeling to allow physician discretion (consistent with how devices are used, similar to predicate devices, and accepted industry practice). |
| Bonds and Balloon Characteristics (following redesign) | "Relevant design verification testing was repeated. These tests included all bonds and balloon characteristics of the redesigned balloon." "The results demonstrated that the device functions as intended." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission does not detail a specific "test set" in the context of a new clinical study. Instead, it relies on:
- Design Verification Testing: For the minor modifications to the 24mm and 26mm balloons, all bonds and balloon characteristics were tested. The sample size for this specific testing is not provided. This would typically involve engineering tests on a batch of manufactured devices, not patient data.
- Clinical Experience of Predicate Device: The submission refers to "clinical experience used to support the change to the device labeling" and "Predicate device clinical experience showed that physicians may or may not employ the use of concomitant rapid ventricular pacing." The sample size, country of origin, or retrospective/prospective nature of this predicate clinical experience are not detailed in the provided text, as this information would have been associated with the original clearance of the predicate device (K123111).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as a formal clinical study with expert adjudication for a ground truth establishing accuracy was not conducted for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/none as a formal clinical study with expert adjudication was not conducted. The assessment relies on engineering testing and the established safety/efficacy profile of the predicate devices.
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 is not applicable. This submission is for a medical catheter, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the design verification testing of the modified balloon characteristics, the "ground truth" would be engineering specifications and performance standards for medical balloons (e.g., burst pressure, diameter at specified pressure, material integrity). For the labeling change regarding physician discretion, the ground truth appears to be current clinical practice and accepted industry standard ("The revised wording on the device labeling was changed to be consistent with how the devices are used by physicians, giving the physician the discretion... This is similar to the predicate devices and is accepted practice in the industry.").
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable.
§ 870.1255 Balloon aortic valvuloplasty catheter.
(a)
Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.