(78 days)
The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.
The V8 Transluminal BAV Catheter System features a figure-8 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 figure-8 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.
This K133607 submission is for a device modification (V8 Transluminal BAV Catheter System), not for a new AI/ML-driven device. Therefore, the traditional acceptance criteria and study designs typically associated with AI/ML device evaluations (e.g., performance metrics like sensitivity/specificity, reader studies, etc.) are not directly applicable in this context.
The submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, function, and identical intended use. The "acceptance criteria" here are the Special Control Requirements for Balloon Aortic Valvuloplasty (BAV) devices, and the "study" is the collection of design verification and shelf-life testing.
Here's the information broken down based on the provided document, adapted to the context of a device modification and substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Special Control Requirement (Acceptance Criteria) | Reported Device Performance (Evidence of Conformity) |
|---|---|
| The device should be demonstrated to be biocompatible. | The proposed change does not affect the biocompatibility of the device, as no new materials were added. Biocompatibility test data from predicate device K123111 were provided and deemed applicable. |
| Sterility and shelf life testing should demonstrate the sterility of patient-contacting components and the shelf-life of these components. | The sterile packaging and shelf carton are identical to predicate V8 devices. The worst-case device is identical, so sterility data from K123111 is applicable. Shelf life testing was repeated and provided in this submission, and aging data for sterile barrier seal from the predicate device submission was also provided. |
| Non-clinical performance evaluation of the device should demonstrate substantial equivalence in terms of safety and effectiveness for device delivery, inflation, deflation, and removal. | Design verification testing was repeated and provided in the submission, including data for delivery, inflation, deflation, and removal. Specific tests performed before and after accelerated aging included: Balloon rated burst pressure, Balloon compliance, Critical dimension verifications, Guidewire and introducer compatibility, Deflation times, Repeat inflation, Leak, Tensile, Kink, and Torque. The testing showed the device meets its specifications both before and after aging. |
| In vivo evaluation of the device should demonstrate device performance, including the ability of the device to treat aortic stenosis. | The general shape and principles of operation have not changed. Device dimensions are identical to the predicate device in K132728. The submission states that the slight changes in balloon geometry and compliance are within the bounds of original V8 balloon dimensions, and nominal dimensions are identical to V8 from K132728, possessing the same technical characteristics of cleared predicate V8 balloons. This implies that previous in vivo evaluations for the predicate devices are considered sufficient and applicable, given the demonstrated equivalence in key performance characteristics. |
| Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to use of the device. | The Instructions For Use (IFU) contains a "Potential Complications, Outcomes, Adverse Events" section. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of an AI/ML test set. The "testing" refers to bench testing (design verification and shelf life testing) of the physical device and its components. The document does not specify exact sample sizes for each type of bench test, but indicates tests were repeated and performed before and after accelerated aging. This implies multiple units were tested.
- Data Provenance: Not applicable for a traditional test set as described for AI/ML. All data generated came from in-house device testing (bench testing and compatibility assessments). No patient data or external datasets were used to "test" the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The acceptance criteria and performance are based on engineering specifications and physical measurements, not on expert interpretations of data like in medical imaging.
4. Adjudication method for the test set
Not applicable. There was no need for expert adjudication, as the performance was evaluated against predefined engineering specifications for the physical device.
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, as this is a physical medical device (catheter), not an AI/ML-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by engineering specifications and ISO/ASTM standards for medical device components and performance (e.g., burst pressure, compliance, tensile strength, sterility, etc.). Data is compared against these predetermined, objective, quantitative metrics.
8. The sample size for the training set
Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a physical medical device, not an AI/ML algorithm.
§ 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.