(69 days)
The stylet is intended to aid in the placement of St. Jude Medical transvenous leads.
The document describes several models of stylets made of stainless steel with molded ABS thermoplastic hubs. They vary in diameter, flexibility (soft, firm, extra firm, extra soft), and length. Some models are ball-tipped. Accessory kits may include tools like a fixation tool or clip-on tool, and a stylet ring holder. The Locator Plus stylet is a deflectable implantation tool.
The provided document is a 510(k) Premarket Notification for various models of St. Jude Medical stylets. The purpose of this notification is to demonstrate substantial equivalence to previously approved predicate devices, not to introduce a new device requiring extensive clinical trials to establish efficacy and safety from scratch. Therefore, the information typically requested for AI-driven diagnostic devices or novel medical technologies (e.g., sample sizes for test/training sets, number of experts, MRMC studies, standalone performance) is not applicable or present in this type of submission.
Instead, the acceptance criteria are primarily based on substantial equivalence to legally marketed predicate devices, meaning the new devices are as safe and effective as existing ones. The "study" proving this involves referencing the previous approvals (PMAs) and demonstrating that the current devices' design, intended use, labeling, packaging, and sterilization are substantially equivalent to those predicates, often through engineering tests rather than clinical studies.
Here's an attempt to structure the available information, noting where specific requested criteria are not applicable in this context:
Acceptance Criteria and Device Performance for St. Jude Medical Stylets (K090163)
The acceptance criteria for the devices listed in this 510(k) submission primarily revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the stylets (new models or versions of existing ones) are shown to be as safe and effective as their predecessors through comparison of their characteristics, intended use, and performance, often supported by engineering tests rather than de novo clinical trials.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance and Evidence Provided |
|---|---|---|
| Intended Use | The proposed device's intended use must be the same as the predicate device. | "The stylet is intended to aid in the placement of St. Jude Medical transvenous leads." This statement is consistently applied across all stylet models and is identical to the intended use of their respective predicate devices. |
| Technological Characteristics | The proposed device should have similar technological characteristics (e.g., material, design, dimensions, performance attributes) to the predicate device, or any differences must not raise new questions of safety or effectiveness. | The submission details similar materials (e.g., 304 stainless steel, ABS thermoplastic hubs), dimensions (e.g., wire diameters), and design features (e.g., soft, firm, extra firm, extra soft, J-shaped, straight, ball-tipped, tapered). For each stylet model, the submission explicitly states that the devices are either currently commercially available or have been previously reviewed and approved by FDA with specific PMA numbers (e.g., P960030/S10, P960013/S15, P030054/S49, P960013/S022, P950022/S14, P950022/S16, P950022/S17, P950022/S34). For the newer "extra soft" stylets (S-60-XS, S-65-XS, S-75-XS), differences in taper length and taper diameter at the tip are noted, but these variations are shown to provide a more flexible distal end, which presumably does not raise new safety or effectiveness concerns as they were already approved under PMA P950022/S34. |
| Performance Data (Non-Clinical) | Non-clinical testing (e.g., mechanical, electrical, biocompatibility, sterilization, packaging, shelf-life) should demonstrate that the device performs as intended and is equivalent to the predicate, or that any differences are well-understood and do not compromise safety or effectiveness. | Stylet Insertion/Extraction Testing: Performed for various models, referencing specific Qualification Test Reports (QTRs): |
- For 4060, 4062, 4064: QTR 0210866, QTR 02109049
- For 4090, 4091: QTR 1861
- For 4078: QTR 2019 (for 1156T Quickflex leads) and QTR 2020 (for 1158T Quickflex leads)
- For S-65-S/F/X: QTR OTR1403
- For S-60-S/X/F: QTR OTR1472 (Riata 1572), QTR1462 (Riata 1582)
- For S-75-X/S/F: QTR 1606 (Riata 1580/1581)
- For S-60-XS, S-65-XS, S-75-XS: QTR 2041
Sterilization & Packaging Validation: References various QTRs and OTRs (e.g., OTR 1392-A, QTR2264, OTR 1861, QTR 1511, QTR 1392-G), confirming that sterilization and packaging are substantially equivalent to predicate devices or previously validated methods. Locator Plus stylets are double-packaged to maintain sterility.
Shelf Life: Approved shelf lives are specified for each stylet model (e.g., 3 years for many, 2 years for Locator Plus) based on prior PMA approvals, indicating stability and sterility are maintained over time.
Labeling: Labels for commercially available models are included as appendices, demonstrating consistency with predicate device labeling. |
| Clinical Performance | If applicable, clinical data may be required to demonstrate substantial equivalence, especially if there are significant technological differences or new indications. | For this type of device (stylets for lead placement), the submission relies on the established safety and efficacy of the predicate devices, which were approved via PMAs (Premarket Approvals) that would have included significant clinical data. No new clinical studies are presented in this 510(k) submission, as the claim is for substantial equivalence to already approved devices. The previous PMAs themselves served as the evidence for clinical performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is Not Applicable in the context of this 510(k) submission. 510(k) applications for devices like stylets typically rely on non-clinical (bench) testing and comparison to predicate devices, rather than new clinical trials with patient test sets. The studies referenced (QTRs, OTRs) are engineering/performance qualification tests. The provenance of data for these engineering tests would typically be internal to the manufacturer (St. Jude Medical).
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 is Not Applicable. The determination of "ground truth" by clinical experts is relevant for diagnostic devices interpreting medical images or other clinical data. For a mechanical device like a stylet, "ground truth" pertains to its physical performance meeting engineering specifications, which is verified through objective measurements and validated test methods, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is Not Applicable. Adjudication methods are typically employed in clinical studies where subjective expert assessment is involved. The testing performed for these stylets is objective and prescriptive, based on defined physical parameters and test protocols.
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 is Not Applicable. MRMC studies are specific to evaluating diagnostic imaging systems, particularly those that involve human interpretation, often in conjunction with AI. This 510(k) is for a simple mechanical accessory (stylet) used in lead placement, not a diagnostic or AI-powered system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is Not Applicable. This document is for a medical device (stylet) that is a physical tool, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is the established performance and safety profiles of the predicate devices, as determined through their original PMA approvals. For the physical testing conducted for this 510(k), the "ground truth" consists of engineering specifications and validated test methods (e.g., for insertion/extraction forces, sterilization efficacy, packaging integrity, and material properties). The device's performance is measured against these objective, predefined standards.
8. The sample size for the training set
This is Not Applicable. There is no "training set" in the context of a 510(k) submission for a non-AI mechanical device. The term "training set" refers to data used to train machine learning models.
9. How the ground truth for the training set was established
This is Not Applicable for the same reason as point 8.
Summary of the Study Proving Substantial Equivalence:
The "study" within this 510(k) notification is a comprehensive compilation of existing approvals and non-clinical engineering test data, rather than a new clinical trial. For each stylet model, St. Jude Medical demonstrates substantial equivalence by referencing its previous approval under a specific Premarket Approval (PMA) number, often with amendments (e.g., P960030/S10).
The core of the submission involves:
- Referencing Predicate Devices: Every stylet model presented (4060, 4062, 4064; 4090, 4091; 4078; Locator Plus; S-60 series; S-65 series; S-75 series) is explicitly stated to be substantially equivalent to a previously FDA-approved predicate device, often the same model number that was approved under an earlier PMA.
- Description of Device: Providing detailed descriptions of the stylets, including materials, dimensions, and intended use, and confirming these are consistent with the predicate.
- Performance Testing: Citing Qualification Test Reports (QTRs) for various aspects like stylet insertion/extraction, indicating that the devices perform according to established engineering standards for their intended use. These are mechanical performance tests.
- Sterilization and Packaging Validation: Referencing QTRs and OTRs demonstrating that the devices' sterilization and packaging methods are validated and consistent with predicate devices, ensuring sterility is maintained.
- Shelf Life: Confirming the approved shelf life based on prior PMA submissions.
- Labeling: Showing that the labeling is consistent with the predicate devices.
The conclusion for each section explicitly states that "The information presented supports a determination of substantial equivalence and therefore clearance of the SJM stylet models... through this 510K Pre- Market Notification." The FDA's letter concurs with this finding of substantial equivalence, allowing the devices to be marketed.
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).