(305 days)
In conjunction with the Selectra accessory kit, Selectra guiding catheters are used to facilitate lead implantation in the heart chambers or in the coronary veins via the coronary sinus.
BIOTRONIK's Selectra lead introducer system is a combination of quiding catheters and implantation accessories used to facilitate access to the heart for suitable leads and catheters. The Selectra lead introducer system consists of several individually available guiding catheters with various different curve shapes and the Selectra accessory kit.
The catheters are available as inner (5F) and outer (7F) catheters which jointly form a telescopic system, and facilitate implantation of leads into the heart. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.
The provided text describes a 510(k) premarket notification for the BIOTRONIK Selectra 3D Outer Guiding Catheters (K193474). This device is a percutaneous catheter used to facilitate lead implantation in the heart. The submission asserts substantial equivalence to a predicate device (BIOTRONIK's Selectra 7F Guiding Outer Catheters, K192996).
Crucially, the provided document explicitly states that "No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence." This means that the device's acceptance criteria and proven performance are based on non-clinical data.
Therefore, for aspects related to clinical performance, a multi-reader multi-case (MRMC) study, or human-in-the-loop performance, the information is not available in the given text. The "acceptance criteria" and "study proving the device meets the acceptance criteria" in this context refer to engineering and biocompatibility testing, not clinical effectiveness or human interpretability.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a detailed table with specific numerical acceptance criteria and corresponding reported performance for each test. Instead, it broadly states that the modified devices were tested against "the same test methods and acceptance criteria for the predicate devices" and that they "meet the same functional acceptance criteria."
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Compatibility Testing | Meets the same performance criteria as predicate devices. |
| Functional Testing | Meets the same performance criteria as predicate devices; "the subject device meet the same functional acceptance criteria for the same intended use." |
| Biocompatibility | Meets the same performance criteria as predicate devices. |
| Microbiology and Sterilization | Meets the same performance criteria as predicate devices. |
| Packaging Testing | Meets the same performance criteria as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of devices or test samples. The document states "the following tests were conducted."
- Data Provenance: Not explicitly stated, but given it's a submission to the U.S. FDA by BIOTRONIK, Inc. (Lake Oswego, Oregon), it's highly likely the testing was conducted in the US or in compliance with US standards. The data is retrospective in the sense that it's reported after the completion of the tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- Applicability: Not applicable given that no clinical studies involving human interpretation or subjective 'ground truth' were performed. The testing described is engineering and laboratory-based.
4. Adjudication Method for the Test Set
- Applicability: Not applicable for the same reason as #3. Adjudication methods are relevant for studies involving human assessment where consensus or arbitration is needed to establish ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Answer: No. The document explicitly states: "No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence." Therefore, an MRMC study related to human reader improvement with AI assistance was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Answer: No. This device is a physical medical device (catheter), not an AI algorithm. "Standalone performance" in the context of AI refers to the algorithm's performance independent of a human. This concept does not apply to this device.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's performance is established by engineering specifications, material science standards, and biocompatibility requirements. For example, a "functional test" for catheter flexibility would have a predefined acceptable range of force or deflection, which serves as the "ground truth" for that test. Similarly, sterility testing has specific pass/fail criteria based on absence of microbial growth.
8. The Sample Size for the Training Set
- Applicability: Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for physical medical devices in this context.
9. How the Ground Truth for the Training Set Was Established
- Applicability: Not applicable for the same reason as #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).