(62 days)
The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.
The Selectra CS lead introducer system is a family of guiding catheters specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus.
The provided text describes a Special 510(k) submission for the Selectra Lead Introducer System. This type of submission relies on the substantial equivalence to a previously cleared predicate device, rather than new clinical studies with defined acceptance criteria and performance metrics. Therefore, the information requested in the prompt regarding acceptance criteria, study details, and ground truth for a novel device is not explicitly present in the provided text.
However, based on the nature of a 510(k) submission for a device modification, we can infer some aspects and address the questions to the extent possible.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or detailed performance results from a new study for the Selectra Lead Introducer System. The basis for this 510(k) is "minor changes in design" and the device's "usage remains unchanged and the product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared ScoutPro ACS guiding catheters."
Therefore, the acceptance criteria are implicitly that the modified Selectra device performs at least as safely and effectively as the predicate device (ScoutPro ACS) across its intended uses. The reported device performance is not explicitly quantified in this document, but the FDA's clearance implies that it meets this inferred criterion.
| Acceptance Criteria (Inferred from 510(k) purpose) | Reported Device Performance (Inferred from 510(k) clearance) |
|---|---|
| Equivalence in safety and effectiveness to the predicate device (ScoutPro ACS Catheters, K101776) for facilitating lead implantation in the left side of the heart via the coronary sinus. | The device is deemed "substantially equivalent" to the predicate device by the FDA, indicating it meets the safety and effectiveness profile of the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
No new clinical "test set" data for the Selectra Lead Introducer System is described. The 510(k) submission relies on the demonstrated safety and effectiveness of the predicate device (ScoutPro ACS) and the minor nature of the design changes. Modifications related to dimensions are mentioned (e.g., changes from 50cm to 55cm lengths), but no new clinical data or studies are presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as no new clinical studies with a test set requiring expert-established ground truth are described for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical studies with a test set requiring adjudication are described for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is not typically required for a Special 510(k) submission focusing on minor design changes and substantial equivalence to a predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The Selectra Lead Introducer System is a physical medical device, not an algorithm, so a "standalone" or "algorithm only" performance study is not relevant.
7. The Type of Ground Truth Used
For this 510(k) submission, the "ground truth" is largely established by the regulatory clearance and performance history of the predicate device (ScoutPro ACS Catheters, K101776). The modifications to the Selectra system are considered minor enough that the performance and safety of the predicate are considered to be representative of the modified device. This is a regulatory "ground truth" based on prior approval and assumed equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/algorithm-based device requiring a training set.
§ 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).