(30 days)
The ScoutPro CS lead introducer system and its separately available accessories are used to facilitate lead implantation in the left side of the heart via the coronary sinus.
ScoutPro 7F is a delivery system for coronary sinus leads. It is designed to assist with introducing leads into the vessels of 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 system contains guiding catheters with seven distal arc shapes and accessories to facilitate the lead implantation. This Special 510(k) introduces additional catheters as shown below, which have the same distal arc shapes but are 5 cm longer in length: ScoutPro 7F Sheath Hook L, ScoutPro 7F Sheath Multipurpose Hook L, ScoutPro 7F Sheath Amplatz 6.0 L, ScoutPro 7F Sheath BIO2 L, ScoutPro 7F Sheath MPEP L, ScoutPro 7F Sheath Extended Hook L, ScoutPro 7F Sheath Extended Hook Right L. Each of these catheters is separately available from the ScoutPro 7F kit and contains the following components: 1 guiding catheter, 1 (long) dilator for the guiding catheter. The main difference between the predicate device ScoutPro 7F catheters and the ScoutPro 7F long catheters described in this documentation is the long catheters also utilize a modified X-ray marker which is described in this document; however the patient contacting materials remain identical to the predicate. Additionally, a new dilator which is identical to the predicate but differs in length is also described.
The provided document is a 510(k) Premarket Notification for a medical device, specifically the ScoutPro 7F Long Catheters by BIOTRONIK. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study in the way an AI diagnostic device would.
Therefore, much of the requested information (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) is not applicable to this type of device and submission. The document focuses on modifications to existing predicate devices (primarily length of catheters and a modified X-ray marker) and their substantial equivalence.
Here's what can be extracted and what is not applicable:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Material Composition | Patient contacting materials remain identical to the predicate device. |
| Functional Design | Same distal arc shapes as predicate devices, but 5 cm longer. |
| Radiographic Visibility | Utilizes a modified X-ray marker. |
| Accessory Compatibility | Connects with a new dilator, identical to the predicate's but differing in length. |
| Intended Use | Used in conjunction with the ScoutPro 7F CS Lead Introducer System to facilitate lead implantation in the left side of the heart via the coronary sinus. (Identical to predicate's indication). |
| Safety and Effectiveness | Deemed substantially equivalent to predicate devices (K060807, K072329), implying similar safety and effectiveness profile. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is based on engineering design, material equivalence, and functional equivalence to predicate devices, not on a clinical test set with human subjects as would be used for an AI diagnostic device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission does not involve "ground truth" derived from expert interpretation of data. Substantial equivalence for this type of device relies on engineering specifications and comparison to existing, cleared devices.
4. Adjudication method for the test set:
- Not applicable. No test set or expert adjudication process 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 device is a guiding catheter, not an AI diagnostic device. No human reader studies or AI assistance are involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (catheter), not an algorithm.
7. The type of ground truth used:
- Not applicable. The concept of "ground truth" as it applies to diagnostic accuracy studies is not relevant here. The "truth" for this submission revolves around demonstrating that the modified device maintains the same safety and effectiveness profile as its predicate, primarily through engineering and material comparisons.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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).