(65 days)
Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of the Iliac, Femoral and Renal Arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Blue MaxTM Balloon Dilatation Catheter, styled after the Gruentzig technique, is a double lumen catheter with a non-compliant balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow vessel segments. The Blue MaxTM balloon dilation catheter is designed to deliver maximum force in calcified or fibrotic lesions, or in lesions or strictures that are resistant to dilatation. The Catheter body has two lumens. The lumen marked "distal" is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. The lumen can also be used for infusion of contrast medium. The lumen marked "Balloon" is the balloon inflation lumen. The catheter shaft tapers beneath the balloon segment to achieve the lowest possible deflated profile. Radiopaque markers are placed under the balloon segment of the catheter to provide visual reference points for balloon positioning within the vessel. Each balloon inflates to its stated diameter and length over a range of 4 atm (405 kPa) to its rated burst pressure. The minimal dilating force required to dilate should be applied, minimizing risks of balloon over-inflation or rupture.
The provided 510(k) summary (K07/309 for the Blue MaxTM Balloon Dilatation Catheter) does not describe an AI-powered device or a study involving acceptance criteria for device performance based on metrics like sensitivity, specificity, or AUC. The submission focuses on establishing substantial equivalence to a predicate device, which is a common pathway for medical devices that are not significantly different from already approved devices.
Instead of clinical performance criteria, the "acceptance criteria" for this device are related to manufacturing specifications and functional performance of the balloon catheter itself, ensuring it meets its intended design. The "study" mentioned is a demonstration of these physical characteristics rather than a clinical trial or AI model validation study.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the statement: "Each balloon inflates to its stated diameter and length over a range of 4 atm (405 kPa) to its rated burst pressure." This indicates that the device must perform according to its specified dimensions and pressure capabilities.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Inflation to stated diameter | Balloon inflates to its stated diameter (implied conformance) |
| Inflation to stated length | Balloon inflates to its stated length (implied conformance) |
| Inflation over pressure range | Inflation occurs over a range of 4 atm (405 kPa) to rated burst pressure (implied conformance) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not mention a "test set" in the context of clinical data or patient samples. The assessment is based on the device's physical characteristics. Therefore, there is no information about data provenance (e.g., country of origin, retrospective/prospective). The "study" would have involved testing units of the catheter to verify their physical performance. The sample size for such engineering tests is not disclosed but would typically be a statistical sample of manufactured units.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a physical medical device, not an AI or diagnostic tool requiring expert ground truth for a test set. The validation would be based on engineering specifications and testing.
4. Adjudication Method for the Test Set
This information is not applicable. There is no "adjudication" in the context of a clinical test set for this type of 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 information is not applicable. This is not an AI-powered device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI-powered device, so there is no algorithm or standalone performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for this device is its design specifications and physical performance characteristics. For example, the "ground truth" for its diameter is the manufacturing specification for that diameter, and the "ground truth" for its inflation pressure range is the specified functional range.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI-powered device, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set.
Summary of the Study Proving Device Meets Acceptance Criteria:
The provided document describes a 510(k) submission for the Blue MaxTM Balloon Dilatation Catheter. The primary "study" or justification for approval is based on demonstrating substantial equivalence to a previously cleared predicate device (Blue Max™ Balloon Dilatation Catheter cleared April 13, 2000, K000570).
The core of this submission is not about clinical effectiveness or advanced performance metrics but rather confirming that the materials and design characteristics of the new device are identical to those of the predicate. The only change mentioned is the addition of a contraindications section and moving existing precautions in the Directions for Use.
Therefore, the "proof" that the device meets "acceptance criteria" is an assertion of its identical nature to an already approved device and its ability to meet standard engineering and functional specifications for balloon catheters (e.g., inflation to stated diameter and length within a specified pressure range), which are implied to have been verified through internal testing (though no specific study protocol or data is included in this summary). This type of submission relies heavily on the established safety and effectiveness of the predicate device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).