(93 days)
The TrueTM Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
The True™ Dilatation Balloon Valvuloplasty Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The catheter is 110 cm long and 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. The balloon is noncompliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque marker bands are provided for fluoroscopic positioning of the device across the aortic valve. These bands are positioned at the proximal and distal balloon shoulders. Balloon catheter dimensions, balloon nominal pressure, maximum inflation pressure, recommended introducer size, and recommended guidewire size are indicated on the package label.
This document describes a 510(k) premarket notification for the True™ Dilatation Balloon Valvuloplasty Catheter. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K133569).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria with corresponding performance values in a side-by-side format. Instead, it lists the types of in vitro tests performed and states that the device "met all predetermined acceptance criteria." The acceptance criteria would likely be specified in the internal test protocols.
Given the information in the document, we can infer some of the tests that would have had acceptance criteria:
| Test Type | Reported Device Performance |
|---|---|
| Dimensional Testing (catheter shaft length, balloon OD, balloon length) | Met predetermined acceptance criteria (implies dimensions are within specified tolerances) |
| Marker Band Alignment | Met predetermined acceptance criteria (implies marker bands are correctly positioned) |
| Visual Inspection of Product | Met predetermined acceptance criteria (implies no visible defects) |
| Visual Inspection of Sterile Barrier Packaging Heat Seals | Met predetermined acceptance criteria (implies seals are intact and meet specifications) |
| Trackability | Met predetermined acceptance criteria (implies catheter navigates effectively) |
| Sheath Compatibility | Met predetermined acceptance criteria (implies compatibility with specified introducer sheath sizes) |
| Inflation/Deflation | Met predetermined acceptance criteria (implies proper balloon inflation/deflation within specified pressures) |
| Fatigue | Met predetermined acceptance criteria (implies durability under repeated stress) |
| Tip to Balloon Tensile | Met predetermined acceptance criteria (implies secure attachment of tip to balloon) |
| Balloon Burst | Met predetermined acceptance criteria (implies burst pressure meets safety margins) |
| Catheter Leak | Met predetermined acceptance criteria (implies no leaks in lumens) |
| Failure Mode | Met predetermined acceptance criteria (implies analysis of potential failures and mitigations) |
| Shaft Burst | Met predetermined acceptance criteria (implies shaft integrity under pressure) |
| Radiopacity (inflated) | Met predetermined acceptance criteria (implies visibility under fluoroscopy when inflated) |
| Balloon Distensibility | Met predetermined acceptance criteria (implies consistent diameter at specified pressures) |
| Reinsertion | Met predetermined acceptance criteria (implies durability for reinsertion if applicable) |
Notes on "predetermined acceptance criteria": These criteria would be derived from applicable standards, guidance documents, internal test protocols, and customer input. For a 510(k) submission, the primary goal is to show the new device performs as safely and effectively as the predicate, so acceptance criteria often reflect performance parameters established for the predicate or industry standards.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the "test set" (i.e., the units tested for performance). It only refers to "the subject device" and "the predicate device" in general terms. The tests listed are "in vitro tests," meaning they were conducted in a lab environment. The document does not provide information on the country of origin of the data or whether it was retrospective or prospective. Since these are in vitro tests, the concepts of retrospective/prospective clinical data are not directly applicable.
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 section is not applicable. The document describes "in vitro tests" of a physical medical device (catheter). It does not involve human subjects, imaging data, or expert interpretations requiring a "ground truth" established by clinical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of diagnostic outputs. The described tests are laboratory-based performance evaluations of a medical 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
This section is not applicable. The submission is for a balloon valvuloplasty catheter, a mechanical device used in a medical procedure, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a physical catheter, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This section is not applicable. As explained in point 3, the tests concern the physical and mechanical performance of a device, not diagnostic accuracy requiring a "ground truth" in the clinical sense. The "ground truth" for these tests would be the engineering specifications and tolerances to which the device must conform.
8. The sample size for the training set
This section is not applicable. The document describes a traditional 510(k) submission for a physical medical device, not an AI/Machine Learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This section is not applicable. As explained in point 8, 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.