(167 days)
The BRKTM Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
The St. Jude Medical BRKTM Transseptal Needle consists of a luminal stainless steel needle and solid stainless steel stylet. The distal section of the needle is curved to facilitate positioning within the heart when used with a St. Jude Medical Transseptal Introducer set. Within this curved section, there is an abrupt step down in the outer diameter of the needle to mate with the internal diameter of the dilator of the St. Jude Medical Transseptal Introducer set. The distal tip of the needle is beveled to facilitate the puncture process.
The proximal end of the needle is configured with a pointer flange (indicating distal curve orientation) and is fitted with a 2-way stopcock to provide needle lumen access for aspiration, fluid injection/infusion, blood sampling, pressure monitoring, and stylet and/or guidewire insertion.
The stylet is straight and isodiametric throughout its length. The proximal end of the stylet is fitted with a curved clip to lock onto the proximal needle hub when inserted into the needle lumen. The stylet is designed to facilitate needle advancement within the dilator.
The BRK™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. This device is a modification of the predicate device (BRK™ Transseptal Needle (K072278)) due to an adhesive change. The study conducted for this device was a non-clinical study involving bench testing and biocompatibility testing to verify the device modification. The study aimed to demonstrate substantial equivalence to the predicate device and ensure the modification did not adversely affect safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Product Specification Compliance | Modified BRK™ Transseptal Needle meets product specification and intended use. |
| Biocompatibility | Confirmed in accordance with ISO 10993-1. |
| Safety and Effectiveness of Adhesive Change | Demonstrated that the adhesive change does not adversely affect safety and effectiveness. |
| Substantial Equivalence to Predicate Device | Modified BRK™ Transseptal Needle has the same indications for use and technological characteristics as the predicate, hence demonstrated substantial equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes non-clinical bench testing and biocompatibility testing. It does not specify a sample size for a "test set" in the context of clinical data or patient studies. The testing was performed on the device itself.
Data provenance: The testing was described as "bench testing and biocompatibility testing," implying laboratory-based testing rather than human clinical data. No country of origin for data or retrospective/prospective nature is applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the study was non-clinical (bench and biocompatibility testing). Ground truth, in the context of expert review, typically refers to clinical diagnosis or assessment.
4. Adjudication Method for the Test Set
This information is not applicable as there was no test set requiring expert adjudication for clinical outcomes. The evaluation involved direct product testing against specifications and standards.
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 performed. This device is a medical needle, and the study was focused on the impact of a material change (adhesive) through non-clinical testing, not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not conducted. This device is a physical medical instrument, not an AI or software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical study was established by product specifications, intended use, and international standards (ISO 10993-1 for biocompatibility). The performance was measured against these established engineering and safety criteria, not against clinical outcomes or pathology from patients.
8. The Sample Size for the Training Set
This information is not applicable as there was no "training set" in the context of machine learning or AI. The study involved non-clinical testing of a physical medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there was no "training set" or AI component involved in this device's evaluation.
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.