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The Boosting Catheter is intended for use in conjunction with guiding catheters or sheaths during coronary and peripheral interventional procedures to guide and support interventional devices, including guidewires, traverse discrete portions of the vasculature, allow for interventional device exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.

The Boosting Catheter is an over-the-wire percutaneous catheter with an atraumatic tip. The catheter has an effective length of 150cm and available in four (4) diameter models; each compatible with various guiding catheters or sheaths as shown in the following table:

| Catalog
Number | Model
Number | Catheter
I.D. | Catheter
O.D. | Compatible
Guiding Catheter | Compatible
Sheath |
|-------------------|-----------------|------------------|------------------|--------------------------------|------------------------|
| BC52-150 | 9005-001 | 0.052" | 0.064" | 6 Fr (0.066" MIN ID) | 5 Fr (0.066" MIN ID) |
| BC57-150 | 9005-002 | 0.057" | 0.068" | 6 Fr (0.070" MIN ID) | 5.5 Fr (0.072" MIN ID) |
| BC63-150 | 9005-003 | 0.063" | 0.076" | 7 Fr (0.078" MIN ID) | 6 Fr (0.079" MIN ID) |
| BC72-150 | 9005-004 | 0.072" | 0.086" | 8 Fr (0.088" MIN ID) | 7 Fr (0.092" MIN ID) |

The Boosting Catheter is constructed with a proximal manipulation shaft connected to a distal tube or guiding catheter segment. The manipulation shaft is used to advance the distal tube segment over a guidewire and through a guiding catheter (or sheath) to a desired location in the coronary or peripheral vasculature. Once positioned, diagnostic or interventional devices (including guidewires) may be delivered or exchanged though the guiding catheter and the Boosting Catheter distal tube segment. Further, procedural fluids (such as saline, contrast agents or therapeutic agents) can be delivered through the guiding catheter and the distal tube segment to a desired location in the coronary or peripheral vasculature. The distal tube segment has two (2) radiopaque markers to facilitate fluoroscopic guidance and a lubricious outer coating to assist with catheter advancement. The manipulation shaft has a molded handle and strain relief to assist with handling. The strain relief is printed with the catheter dimensional information. The device is supplied sterile and intended for single use only.

This document is a 510(k) premarket notification for a medical device called the "Boosting Catheter." It is a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices, and therefore does not require a premarket approval application (PMA).

Here's an analysis of the provided text with respect to acceptance criteria and supporting studies:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a pass/fail format, which is typical for a detailed engineering report. Instead, it states that the device underwent various non-clinical tests to demonstrate substantial equivalence. The overall "acceptance criteria" can be inferred as meeting the performance that allows for a substantial equivalence determination to the predicate devices.

The "reported device performance" is summarized in general terms under the "Summary of Non-Clinical Testing" section. The document claims that these tests "provide reasonable assurance that the device meets the established performance criteria and will perform as intended."

Inferred Acceptance Criteria & Reported Performance (from the document):

Specific Information Requested and Located:

1. A table of acceptance criteria and the reported device performance: As described above, an explicit table is not provided. The document lists the types of tests performed (mechanical, performance, and biocompatibility) and states that the device "meets the established performance criteria and will perform 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):

   • Sample Size for Test Set: This information is not provided in the document for any of the non-clinical tests.
   • Data Provenance: This information is not specified for the non-clinical tests. Since it's a device submission, the testing would typically be conducted by the manufacturer or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The document describes non-clinical, laboratory-based testing (mechanical, performance, biocompatibility). These types of tests do not typically involve human experts establishing "ground truth" in the way a clinical study or image interpretation study would. Ground truth for these tests is based on objective measurements and established scientific/engineering methodologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This concept typically applies to clinical studies where expert consensus is needed for diagnoses or outcome assessments. For non-clinical device testing, results are usually objectively measured and compared against specifications.

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:

   • No, an MRMC comparative effectiveness study was not done. The device is a "Boosting Catheter" (a physical medical device, not an AI or imaging device).
   • No AI component is mentioned, so improvement with AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This question is not applicable as the device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the non-clinical tests (mechanical, performance, biocompatibility), the "ground truth" refers to objective physical and chemical measurements compared against predefined engineering specifications and regulatory standards. For example, tensile strength would be measured by a machine and compared to a specified minimum strength. Biocompatibility would be assessed against ISO 10993 standards and measured cytotoxicity, hemolysis, etc.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning model.

9. How the ground truth for the training set was established:

   • Not applicable. As stated above, there is no training set mentioned for this device.

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