(56 days)
The Selectra Accessory Kit / Selectra Slitter Tool is used in conjunction with the Selectra CS lead introducer system to facilitate lead implantation in the left side of the heart via the coronary sinus.
The legally marketed Selectra Accessory Kit and Selectra Slitter Tool are accessories to the Selectra lead introducer system, which is specifically used for the placement of coronary sinus leads. The modifications made to the legally marketed devices include a newly designed TVI tool, shelf life extension for the Selectra Accessory Kit/Selectra Slitter Tool, and new sterile packaging for the Selectra Slitter Tool.
The provided document describes modifications to medical devices—the Selectra Accessory Kit and Selectra Slitter Tool—and their clearance through a Special 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove efficacy against specific acceptance criteria.
Therefore, the document does not contain information about:
- A table of acceptance criteria and reported device performance through clinical studies.
- Sample sizes used for test sets, data provenance, or details about training sets.
- The number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or associated effect sizes.
- Standalone (algorithm-only) performance.
- The type of ground truth used in a new clinical study.
- How ground truth for a training set was established.
Instead, the submission demonstrates substantial equivalence primarily through non-clinical testing and a comparison of technological characteristics between the modified devices and their predicate devices.
Here's the information that is available:
1. A table of acceptance criteria and the reported device performance:
The document provides a table outlining the technical specifications of the predicate and proposed devices, demonstrating that the proposed device maintains similar functionality, or improvements that do not raise new questions of safety or effectiveness. This is a comparison for substantial equivalence, not a performance study against acceptance criteria.
| Technical Data | Selectra Accessory Kit (Predicate) | Selectra Accessory Kit (Proposed) |
|---|---|---|
| Configuration | 1 Accessory Kit Including: - 1 Guide Wire - 4 Transvalvular Insertion (TVI) Tools - 1 Selectra Slitter Tool - 1 Torquer - 2 Check-valves - 2 Stop-cocks - 2 Sealing Caps - 1 Syringe - Technical Manual | 1 Accessory Kit Including: - 1 Guide Wire - 4 Transvalvular Insertion (TVI) Tools (subject of this Special 510(k)) - 1 Selectra Slitter Tool - 1 Torquer - 2 Check-valves - 2 Stop-cocks - 2 Sealing Caps - 1 Syringe - Technical Manual |
| TVI Tool Design | Image: TVI Tool Design Predicate (visual) | Image: TVI Tool Design Proposed (visual) |
| Dimensions | Outer Diameter: 5 F Inner Diameter: 3 F | Outer diameter: 4.8 F Inner diameter: 1.26 F |
| Materials | PTFE, PP | PEBAX 7233 |
| Manufacturer | Galt Medical Corp. | BIOTRONIK SE & Co. KG |
| Product Packaging | The products are packaged in a sterile blister within a sterile pouch. The blister and pouch are placed in an outer cardboard box with label and a quality seal. | (Same as predicate for Accessory Kit) |
| EtO Sterilization | EtO sterilization for single use only. The sterilization process is validated at least bi-annually. | (Same as predicate for Accessory Kit) |
| Shelf Life | 6 months | 2 years |
| Technical Data | Selectra Slitter Tool (Predicate) | Selectra Slitter Tool (Proposed) |
| Selectra Slitter Tool Design | Image: Selectra Slitter Tool Predicate (visual) | Image: Selectra Slitter Tool Proposed (visual) |
| Compatibility | Can be used with all coronary sinus leads with a diameter of 4.6F to 5.8 F. | (Same as predicate for Slitter Tool) |
| Materials | Body Material - Acrylonitrile Butadiene Blade Material - Stainless Steel | (Same as predicate for Slitter Tool) |
| Manufacturer | Creganna | (Same as predicate for Slitter Tool) |
| Product Packaging | The products are packaged in a sterile blister within a sterile pouch. The blister and pouch are placed in an outer cardboard box with label and a quality seal. | The products are packaged in two sterile pouches. Both pouches are placed in an outer cardboard box with label and a quality seal. |
| EtO Sterilization | EtO sterilization for single use only. Sterilization process is validated at least bi-annually. | (Same as predicate for Slitter Tool) |
| Shelf Life | 6 months | 2 years |
Study that proves the device meets the acceptance criteria:
The "study" conducted for this 510(k) submission is a series of non-clinical tests designed to validate the safety and performance of the modified devices and to justify the shelf-life extension and new packaging. These tests implicitly serve as "acceptance criteria" for demonstrating substantial equivalence. The document states:
"Summary of Non-Clinical Testing: The substantial equivalence claim between the subject and the predicate devices is supported by the information included in this premarket notification. This includes the following:
- Comparison of the attributes and specifications of the subject and predicate devices -
- Subject device risk analysis
- Subject device validation testing which includes the following testing:"
Non-Clinical Validation Testing Performed:
For the New TVI Tool:
- Cytotoxicity
- Sensitization Local Lymph Node Assay (LLNA)
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity in the Mouse with 4 Extracts
- Material Mediated Pyrogenicity Rabbit Pyrogen Test
- Hemocompatibility Evaluation
- Compendium of Biological Evaluation
- EtO Residual Gas Analysis
- Environmental Preconditioning
- Release of Particulate Matter
- Tests After Environmental Preconditioning and Shelf Life (25 months)
- Labeling on Sales / Sterile Package Accompanying Documentation
For the Extended Shelf-Life for the Selectra Accessory Kit and Selectra Slitter Tool:
- Determination of Shelf Life (25 months) Transport Test, Drop Test, Completeness of Unit
- Inspection of Seldinger Guide Wire
- Inspection of Syringe
- Inspection of Check Valve, Stop-Cock, and Sealing Caps
- Inspection of TVI and slitter tool
- Proof of Sterilization after Accelerated Aging of 25 Months
For the New Sterile Packaging for the Selectra Slitter Tool:
- Labelling on Sales / Sterile Package Accompanying Documentation
- Environmental Preconditioning
- Determination of Shelf Life (25 months) and Integrity of Sterile Packaging
- EtO Sterilization Cycle Product Adoption
- Tests after Environmental Preconditioning and Accelerated Aging (25 Months)
2. Sample sized used for the test set and the data provenance: Not applicable. These are non-clinical (laboratory/mechanical/biological) tests, not human studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established as this is a non-clinical submission for device modifications.
4. Adjudication method for the test set: Not applicable. See above.
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 catheter accessory, not an AI or imaging device involving human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. See above.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for the non-clinical tests is based on established scientific and engineering standards, and documented test methods to verify material properties, sterility, mechanical integrity, and biological compatibility.
8. The sample size for the training set: Not applicable. No "training set" in the context of machine learning or AI is relevant here.
9. How the ground truth for the training set was established: Not applicable. See above.
§ 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).