(184 days)
The TRUE Dilatation™ Catheter is indicated for balloon aortic valvuloplasty.
The Loma Vista Medical (LVM) TRUE Dilatation™ Catheter is a coaxial catheter with a balloon fixed at the tip used for Balloon Aortic Valvuloplasty (BAV) of the aortic valve. The effective length of the catheter is 110 cm and it has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
Device: TRUE Dilatation™ Balloon Valvuloplasty Catheter
K Number: K121083
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | TRUE Dilatation Acceptance Criteria | TRUE Dilatation Results |
|---|---|---|
| Visual Inspection | When examined with 2.5X magnification, the external surface of the effective length of the catheter shall appear free from extraneous material, and process and surface defects. | 61 of 61 catheters passed. |
| Balloon Preparation Test | Each catheter shall be prepped per the procedure without functional difficulties or anomalies. | 61 of 61 catheters passed. |
| Diameter and Profile Test | Balloon diameter shall not deviate from stated balloon diameter by more than 1mm when inflated to 6 atm. | 61 of 61 catheters passed. |
| Balloon Distensibility | Inflated balloon diameter shall not increase more than 2% between nominal inflation pressure (3 atm) and maximum inflation pressure (6 atm). | 61 of 61 catheters passed. |
| Repeated Balloon Inflation | The balloon catheter shall not herniate or rupture after 10 inflation/deflation cycles to the maximum inflation pressure of 6 atm. | 61 of 61 catheters passed. |
| Balloon Minimum Burst Strength | The results must show statistically that with at least 95% confidence, 99.9% of the balloons will not burst at or below the maximum recommended rated burst pressure. All sizes must withstand a minimum of 6 atm. | A total of 98 samples across all device sizes tested and passed 95% confidence with 99.9% reliability. |
| Balloon Inflation / Deflation Test | The balloon shall inflate in no more than 5 seconds and deflate in no more than 10 seconds. | 60 of 60 catheters met acceptance criteria. |
| Balloon Deflatability Test | There should be no interference with balloon deflation. | As evidenced by observed deflation, 60 of 60 samples passed. |
| Tip Pull and Torque Test | Must withstand at least 10 turns without breaking. | 20 of 20 catheters passed. No reported breaks. There is only 1 shaft size. |
| Bond Strength Test | All bonds must withstand at least 15N (3.4 lbs) pull strength. | 29 of 29 samples passed. |
| Catheter Body Maximum Pressure Test | All samples must withstand 30 ATM (400 psi). | 20 of 20 catheters withstood 30 ATM. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing (Test Set):
- Visual Inspection, Balloon Preparation, Diameter and Profile, Balloon Distensibility, Repeated Balloon Inflation: 61 catheters.
- Balloon Minimum Burst Strength: 98 samples across all device sizes.
- Balloon Inflation/Deflation, Balloon Deflatability: 60 catheters.
- Tip Pull and Torque: 20 catheters (for the single shaft size).
- Bond Strength: 29 samples.
- Catheter Body Maximum Pressure: 20 catheters.
- In Vivo Performance Testing (Clinical Study):
- 69 devices used in 69 clinical procedures.
- Data Provenance: The document states "Two separate European clinical studies were performed." This indicates the data is from Europe and is prospective as it was collected to confirm bench test data and ensure design features meet clinical needs. Additionally, there are mentions of "European commercial launch" further supporting European provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Bench Testing: The document does not specify the number or qualifications of experts used to establish ground truth for the bench tests. These tests are typically performed by engineers or technicians following standardized protocols, not clinical experts for "ground truth" as might be defined in an imaging or diagnostic study.
- In Vivo Performance Testing (Clinical Study): The document does not explicitly state how many experts established the "ground truth" (clinical outcomes). However, it mentions "Data collected included device performance, procedural data, and clinical outcomes." This data would have been collected and assessed by the medical staff (e.g., cardiologists, interventional specialists) performing and monitoring the Balloon Aortic Valvuloplasty (BAV) procedures. Their specific qualifications are not detailed, but it's implied they are qualified medical professionals experienced in these procedures.
4. Adjudication Method for the Test Set
- Bench Testing: Adjudication is not applicable in the typical sense (e.g., 2+1, 3+1). These are objective physical and functional tests with predefined pass/fail criteria.
- In Vivo Performance Testing (Clinical Study): The document does not specify an adjudication method for the clinical outcomes data. It simply states that data was collected, and the results provide "objective evidence" of safe and effective use.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided text describes bench testing and a clinical study comparing the device's performance to a predicate device in terms of safety and effectiveness in BAV procedures, including pre-dilatation for TAVI. It does not describe an MRMC comparative effectiveness study where human readers interpret cases with and without AI assistance. Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance, as AI is not a component of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No. This device is a physical medical device (catheter), not an algorithm or AI. Standalone performance studies in this context are not applicable.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth for bench tests is based on objective, measurable physical and functional properties defined by engineering specifications and industry standards (e.g., balloon diameter, inflation/deflation time, burst pressure).
- In Vivo Performance Testing (Clinical Study): The ground truth for the clinical study was based on observed device performance, procedural data, and clinical outcomes during actual patient procedures. This would include direct observation by clinicians and potentially objective measurements taken during the procedure (e.g., pressure gradients, imaging results) and subsequent follow-up for adverse events. The key indicators of success were safe and effective use in BAV procedures, lack of adverse events, and successful subsequent TAVI where applicable.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device. It does not involve machine learning or AI, and therefore, no "training set" in the computational sense is mentioned or implied.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.