(22 days)
The TightRail Mini Rotating Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters and foreign objects.
The TightRail Mini Rotating Dilator Sheaths is an intra-operative device. The device consists of a proximal handle drive mechanism with a distal dilation sheath. The sheath is packaged with an outer support sheath. The dilator sheath is advanced, withdrawn and rotated about the lead, catheter or foreign object to be removed. Actuating the trigger on the proximal handle activates a rotary dilation mechanism sheathed at the distal terminus of the sheath. Rotation of the inner shaft is translated to axial actuation of the dilation mechanism via a cam path contained within the distal components. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the object targeted for removal thereby facilitating removal of said object. The diameter sizes range from 9 French (F) to 11 F. The nominal effective length of the effective length of the TightRail Mini is 15.5 cm (6.1").
The provided text describes a 510(k) submission (K141131) for the Spectranetics TightRail Mini Rotating Dilator Sheath. This is a medical device for percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects. The device is a modification of an existing predicate device (TightRail Device K140047), with the primary change being a shorter working length.
Given that this is a 510(k) submission for a Class II device that is substantially equivalent to a predicate device, the regulatory pathway relies heavily on demonstrating performance through design verification and validation testing, not necessarily clinical studies with human subjects or a direct measure of AI performance.
Therefore, many of the requested categories for AI-based device evaluations (such as sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone AI performance) are not applicable or not explicitly detailed in this type of submission. The "acceptance criteria" here relate to engineering and performance specifications for the device itself, rather than diagnostic accuracy or AI algorithmic performance metrics.
I will populate the table and answer the questions based on the information available and note when information is not provided due to the nature of the device and submission type.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test / Requirement | Reported Device Performance / Outcome |
|---|---|---|
| Mechanical Performance | Dimensional Verification (Working Length) | Met requirements; working length verified at 15.5 cm (6.1"). |
| Dimensional Verification* | Met requirements (leveraged from K140047). | |
| Tri Coil Tensile Test* | Met requirements (leveraged from K140047). | |
| Tri Coil Torsional Test* | Met requirements (leveraged from K140047). | |
| Axial Load Test* | Met requirements (leveraged from K140047). | |
| Outer Sheath Axial Load Test* | Met requirements (leveraged from K140047). | |
| Outer Sheath Axial Load Test at 2 years* | Met requirements (leveraged from K140047 and demonstrated long-term stability). | |
| Material & Safety | Radio-Detectability Test* | Met requirements (leveraged from K140047). |
| Corrosion Resistance Test* | Met requirements (leveraged from K140047). | |
| Functional Performance | Simulated Use Testing* | Met requirements (leveraged from K140047). |
| Simulated Use Test at 2 years* | Met requirements (leveraged from K140047 and demonstrated long-term stability). | |
| Packaging & Sterilization | Package Integrity at 2 years* | Met requirements (leveraged from K140047 and demonstrated long-term stability). |
| Simulated Distribution (Shipping and Simulated Environmental Conditioning) Test* | Met requirements. | |
| Sterilization | Product adoption equivalency per AAMI TIR:28-2009. | |
| Biocompatibility | Cytotoxicity* | Met requirements (leveraged from K140047). |
| Sensitization* | Met requirements (leveraged from K140047). | |
| Intracutaneous Reactivity* | Met requirements (leveraged from K140047). | |
| Acute Systemic Toxicity* | Met requirements (leveraged from K140047). | |
| C3a Complement Activation* | Met requirements (leveraged from K140047). | |
| SC5b-9 Complement Activation* | Met requirements (leveraged from K140047). | |
| Direct Hemolysis* | Met requirements (leveraged from K140047). | |
| Indirect Hemolysis* | Met requirements (leveraged from K140047). | |
| In Vivo Thrombogenicity-Ovine Model* | Met requirements (leveraged from K140047). | |
| Genotoxicity Ames Test* | Met requirements (leveraged from K140047). | |
| Material Mediated Pyrogenicity* | Met requirements (leveraged from K140047). |
Note: All tests marked with an asterisk () are leveraged from the predicate device K140047, indicating the subject device is considered to have the same performance characteristics for these aspects.*
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes technical and biological verification testing for a physical medical device, not a software algorithm or AI. Therefore, there isn't a "test set" in the context of data used for an algorithm. The testing described (e.g., dimensional verification, tensile tests, biocompatibility tests) would involve physical samples of the device components or final product. The document does not specify the number of samples used for each test individually or their geographical origin, but rather states that these tests were conducted to validate and verify the device. These are generally prospective tests conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. This is a physical medical device, not an AI or diagnostic imaging device that relies on expert interpretation to establish ground truth for a test set. Ground truth for these tests would be objective measurements against engineering specifications (e.g., dimension, force, chemical analysis).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of physical device testing. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data for diagnostic purposes.
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 is not an AI-assisted diagnostic device. A comparative effectiveness study against human readers would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a standalone physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the listed design verification and validation tests, the "ground truth" would be established by:
- Engineering specifications and standards: For dimensional verification, tensile/torsional/axial load tests, corrosion resistance, radio-detectability.
- Established biological testing protocols: For biocompatibility tests (cytotoxicity, sensitization, hemolysis, thrombogenicity, etc.), adherence to defined test methods and acceptance criteria from standards (e.g., ISO 10993 series).
- Simulated conditions: For simulated use testing, package integrity, and simulated distribution, performance is assessed against defined environmental stresses and functional requirements.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria is a comprehensive set of Design Verification and Validation testing. This testing demonstrates that the TightRail Mini Rotating Dilator Sheath performs as intended and is as safe and effective as its predicate device (TightRail Device K140047).
The core of the "proof" for this 510(k) submission lies in demonstrating substantial equivalence to the predicate device. This was achieved by:
- Identifying the technological characteristics of the predicate device and confirming the subject device shares these, with the only significant change being the shorter working length.
- Performing new tests specific to the subject device (e.g., Dimensional Verification of TightRail Mini Working Length).
- Leveraging existing test data from the predicate device (K140047) for a wide range of tests including mechanical properties (tensile, torsional, axial load tests), material characteristics (radio-detectability, corrosion resistance), functional performance (simulated use testing), long-term stability (2-year tests), packaging, sterilization equivalency, and extensive biocompatibility testing. The justification for leveraging this data is that the subject and predicate devices are otherwise identical in technological characteristics.
The conclusion drawn from this combination of new and leveraged testing was that "The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device." This formed the basis for the FDA's determination of substantial equivalence.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).