(28 days)
The St. Jude Medical Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
The St. Jude Medical 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 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 provided 510(k) summary for the BRK™ Transseptal Needle does not contain detailed information regarding acceptance criteria or the specifics of a study proving the device meets those criteria in the way typically expected for complex diagnostic or AI-driven devices.
The submission focuses on establishing substantial equivalence based on performance requirements for a medical instrument rather than a "device" in the context of diagnostic algorithms or imaging. Therefore, many of the requested categories (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth for training) are not applicable or not provided in this type of submission.
Here's an attempt to address the request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary broadly states that "Bench testing of the BRK™ Transseptal Needle was performed to support substantial equivalence. Results of the testing demonstrate that the BRK™ Transseptal Needle design meets product specifications and performance requirements."
Specific acceptance criteria and quantitative performance metrics are not detailed in this summary. For a device like a transseptal needle, these typically involve:
- Mechanical Strength: Withstand forces during insertion and manipulation.
- Dimensional Accuracy: Meet specified outer diameter, length, and curve.
- Material Biocompatibility: Non-toxic and compatible with human tissue.
- Sterility: Absence of viable microorganisms.
- Functionality: Smooth stylet/guidewire passage, effective puncture capability, secure stopcock.
- Tip Integrity: No damage or dulling after puncture.
Since the document provided is a summary, the detailed test reports outlining these specific criteria, methods, and acceptance ranges would be in the full submission, but are not included here.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Device meets product specifications. | "BRK™ Transseptal Needle design meets product specifications..." |
| Device meets performance requirements (e.g., mechanical, functional). | "...and performance requirements." |
| Device is substantially equivalent to predicate devices. | "Results of the testing demonstrate that the BRK™ Transseptal Needle design meets product specifications and performance requirements." "The St. Jude BRK™ Transseptal Needle has similar indications for use and technological characteristics as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The summary mentions "Bench testing of the BRK™ Transseptal Needle." This implies a series of laboratory tests on physical samples of the device.
- Sample Size for Test Set: Not specified. Testing would likely involve multiple units manufactured to ensure consistency.
- Data Provenance: The testing was "bench testing," meaning in a laboratory environment, likely at St. Jude Medical's facilities (United States, given the submitter address). It is a prospective test in the sense that the new device's performance was evaluated against pre-defined criteria. It is not clinical data from patients or retrospective patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not relevant for a physical medical instrument like a transseptal needle. "Ground truth" (in the context of expert review) is typically for diagnostic assessments (e.g., interpreting images). For a physical device, performance is measured against engineering specifications and functional benchmarks, not expert-established ground truths.
4. Adjudication Method for the Test Set
Not applicable. This is typically used in clinical trials or diagnostic studies involving human interpretation. Bench testing results are usually objective measurements against engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are for evaluating diagnostic accuracy, especially when comparing human readers with and without AI assistance on a set of cases. This device is a physical instrument, not a diagnostic algorithm.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
Not applicable. This refers to the performance of an AI algorithm independently. The BRK™ Transseptal Needle is a manual surgical instrument.
7. The Type of Ground Truth Used
The "ground truth" for a physical medical device's performance is its adherence to engineering specifications, design requirements, and recognized industry standards for safety and efficacy. This is established through objective measurements and validated test methods. It is not expert consensus, pathology, or outcomes data in the usual sense for diagnostic devices.
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a "training set." Its design is based on engineering principles and existing predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.