(28 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.
This document is a 510(k) premarket notification for a medical device called the "Selectra CS Lead Introducer System 5F Guiding Catheters." This is a "Special 510(k)" submission, which typically means the device is a modification of a previously cleared device, and the modifications do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or detailed device performance metrics in the way a traditional clinical study report might. Instead, it relies on the concept of "substantial equivalence" to a predicate device. The primary "acceptance criteria" for a Special 510(k) are that the proposed changes are limited to minor dimensional changes and that the usage, indications for use, contraindications, materials, and functions remain identical to the previously cleared predicate device.
| Acceptance Criteria (Implied for Special 510(k)) | Reported Device Performance (as stated in the document) |
|---|---|
| Changes limited to minor dimensional changes. | "The changes made to the Selectra 5F guiding catheters compared to the previously cleared Selectra 7F guiding catheters are limited to minor dimensional changes." |
| Usage remains unchanged. | "The usage of the Selectra 5F guiding catheters remains unchanged." |
| Product characteristics (indications for use, contraindications, materials, functions) are identical to the predicate device. | "and the product characteristics including the indications for use, contraindications, materials, and functions are identical to the previously cleared Selectra guiding catheters in submission K110461, cleared on April 20, 2011." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the traditional sense, as it is a Special 510(k) for a device with minor dimensional changes. Therefore, there is no mention of a sample size for a test set or data provenance (country of origin, retrospective/prospective). The submission relies on the existing clearance of the predicate device (K110461) and a demonstration that the new device is substantially equivalent and performs identically.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As explained above, there is no "test set" or ground truth established via expert review described in this submission. The device's safety and effectiveness are established through substantial equivalence to a predicate.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or adjudication method described.
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
Not applicable. This document pertains to a guiding catheter, not an AI-powered diagnostic device, and therefore no MRMC study or AI assistance is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for this Special 510(k) submission is the demonstration of substantial equivalence to the predicate device (Selectra 7F Guiding Catheters, K110461). This implies that the predicate device's safety and efficacy, established through its own clearance process, serve as the basis for the current device's acceptance, given the minor nature of the changes.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no training set mentioned.
9. How the Ground Truth for the Training Set was Established
Not applicable. As no training set is involved, there is no ground truth establishment for 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).