(65 days)
The Delivery Catheter is intended for the venous introduction of pacing or defibrillation leads.
The modified Delivery Catheter (SSPC NXT Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads. The modified Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.
The FDA 510(k) summary for the SSPC NXT Delivery Catheter (K243180) outlines performance testing to ensure substantial equivalence to its predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Complies with ISO 10993-1 | SSPC NXT Delivery Catheter passed biocompatibility testing. |
| Sterilization Validation | Complies with ISO 11137 (SAL 10-6) | SSPC NXT Delivery Catheter passed sterilization validation (E-Beam Sterilization, SAL 10-6). |
| Packaging Validation | Complies with ANSI/AAMI/ISO 11607-1 | SSPC NXT Delivery Catheter passed packaging validation. |
| Visual Inspection | Device meets specified visual requirements | SSPC NXT Delivery Catheter passed visual inspection. |
| Simulated Use Testing (with ancillary devices) | Device performs as intended during simulated use and is compatible with ancillary devices. | SSPC NXT Delivery Catheter passed simulated use testing, including use/compatibility with ancillary devices. |
| Valve Liquid Leak Test | Valve prevents liquid leakage | SSPC NXT Delivery Catheter passed valve liquid leak test. |
| Tensile Tests | Device components withstand specified tensile forces | SSPC NXT Delivery Catheter passed tensile tests. |
| Sheath and Dilator Dimensional Verification (OD/ID, working length) | Dimensions conform to specifications | SSPC NXT Delivery Catheter passed sheath and dilator dimensional verification. |
| Flush Test | Device allows proper flushing | SSPC NXT Delivery Catheter passed flush test. |
| Intended Use | "For the venous introduction of pacing or defibrillation leads" | Same as predicate; device is for venous introduction of pacing or defibrillation leads. |
| Technological Characteristics | Substantially equivalent to predicate (K190475) | Proposed device is "substantially equivalent" to predicate given minor differences do not raise different questions of safety/effectiveness. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the numerical sample size for each specific test set. It mentions tests were performed on "test units representative of finished devices."
The provenance of the data is internal to the manufacturer (CenterPoint Systems LLC), as these are performance data generated to support the 510(k) submission. The type of study is a pre-market performance validation study for regulatory clearance. It is retrospective in the sense that the data is collected prior to the submission, but it's a prospective testing program for the purpose of demonstrating device safety and effectiveness.
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 information is not provided in the document. The document describes engineering and biological performance tests, not clinical studies involving human experts to establish ground truth in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable to the type of performance testing described (engineering, mechanical, biocompatibility). These tests usually have objective pass/fail criteria based on standards and specifications, rather than requiring expert adjudication.
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:
No, an MRMC comparative effectiveness study was not done. This device is a delivery catheter, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This device is a physical medical device (catheter), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests described (biocompatibility, sterilization, mechanical, dimensional) are the established industry standards (e.g., ISO 10993-1, ISO 11137, ANSI/AAMI/ISO 11607-1) and internal design specifications for the device. For example, for tensile tests, the ground truth is the specified tensile strength the device must meet according to its design requirements.
8. The sample size for the training set:
Training set information is not applicable as this is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
§ 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).