(213 days)
The Delivery Catheter is indicated for the introduction of pacing and defibrillation leads to the right heart, inclusive of the Left Bundle Branch Area.
The subject Delivery Catheter (CPS Locator 3D Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads.
The subject Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the subject Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The subject 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.
This FDA 510(k) clearance letter pertains to a medical device, not an AI/ML software. Therefore, the detailed acceptance criteria and study information requested, which are typical for AI/ML device evaluations, are not applicable in this context.
The document discusses the CPS Locator 3D Delivery Catheter, a physical medical device. The 510(k) process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance testing (bench testing, biocompatibility, sterilization, etc.) and, in this case, some real-world usage data. It does not involve AI/ML performance metrics like sensitivity, specificity, or ground truth established by expert consensus for diagnostic accuracy.
Here's a breakdown of why many of your requested points are not applicable, followed by the information that can be extracted:
- Acceptance Criteria Table & Reported Performance: Not available in an AI/ML context. The document focuses on demonstrating the device's functional integrity and equivalence to a predicate.
- Sample Size (Test Set) & Data Provenance: Not applicable for an AI/ML test set. The clinical data mentioned is retrospective/real-world observational data on the previously cleared device.
- Number of Experts & Qualifications (Ground Truth): Not applicable as there's no diagnostic AI/ML algorithm requiring ground truth establishment by experts.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable.
- Standalone Performance: Not applicable as it's a physical catheter, not an AI/ML algorithm.
- Type of Ground Truth: Not applicable. The "ground truth" for a physical device is its functional performance and safety during use.
- Sample Size (Training Set): Not applicable as there's no AI/ML model to train.
- How Ground Truth for Training Set was Established: Not applicable.
Information that can be extracted from the provided document regarding the CPS Locator 3D Delivery Catheter:
The document describes the acceptance criteria and study to demonstrate substantial equivalence for a physical medical device, not an AI/ML system. Therefore, many of the requested fields related to AI/ML software evaluation are not directly applicable.
Here's a summary of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Tests/Performance Evaluated | Reported Device Performance (Summary) |
|---|---|---|
| Material & Biocompatibility | Biocompatibility testing (per ISO 10993-1) | Device passed all required biocompatibility tests. |
| Sterilization | Sterilization validation (per ISO 11137) | Device passed sterilization validation. |
| Packaging Integrity | Packaging validation (per ANSI/AAMI/ISO 11607-1) | Device passed packaging validation. |
| Manufacturing Quality | Visual Inspection | Not explicitly stated "passed," but implied by clearance. |
| Functional Performance (Simulated) | Simulated use testing (including use/compatibility with ancillary devices) | Device performed as intended in simulated use. |
| Leakage | Valve liquid leak test | Not explicitly stated "passed," but implied by clearance. |
| Mechanical Strength | Tensile tests | Not explicitly stated "passed," but implied by clearance. |
| Dimensional Accuracy | Sheath and Dilator Dimensional verification (OD/ID, working length) | Dimensions verified (similar to predicate, 9.0F OD, 7F ID). |
| Fluid Flow | Flush test | Not explicitly stated "passed," but implied by clearance. |
| Clinical Performance (Real-World Observational Data on K230363) | Post-market study (physician surveys) | 100% successful delivery of ancillary device to target location. |
| 31/44 cases specifically targeted LBB/LBBA. | ||
| Minor blood loss reported by 5 of 42 physicians. No adverse events or unexpected complications. | ||
| Retrospective observational study 1 (US centers, LBBAP implant procedures) | LBBAP successfully achieved in 95% of patients using the device. No reported complications or adverse events. | |
| Retrospective observational study 2 (US centers, LBBAP implant procedures) | Out of 66 patients undergoing successful lead implantation, 49 achieved LBBAP with device aid. No reported complications or adverse events. | |
| Publication in HeartRhythm (defibrillator lead at LBBAP) | Defibrillator lead successfully deployed in 7 of 8 patients targeting LBBA. One failure due to patient anatomy. No reported adverse events or complications. |
2. Sample size used for the test set and the data provenance
- Test Set (Bench/Performance Testing): Not explicitly stated as a separate "test set" for the new submission, but the document mentions "All testing was performed on test units representative of finished devices." The specific number of units for each bench test is not provided in this summary.
- Clinical Data (Real-World Evidence):
- Post-market study: Data collected from 42 physicians at multiple US centers.
- Retrospective Observational Study 1: Not explicitly stated sample size, but mentioned "patients."
- Retrospective Observational Study 2: 66 patients.
- HeartRhythm Publication: 8 patients.
- Data Provenance: Primarily United States (US) centers. The data is described as post-market, real-world observational, and retrospective from the previously cleared predicate device (K230363).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical medical device clearance, not an AI/ML diagnostic device requiring expert-established ground truth for performance metrics like sensitivity/specificity. The "ground truth" for the clinical data related to lead delivery success was based on actual surgical outcomes reported by physicians.
4. Adjudication method for the test set
- Not Applicable. No expert adjudication for an AI/ML algorithm's output was performed.
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 a physical medical device, not an AI/ML system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device.
7. The type of ground truth used
- For the clinical data, the "ground truth" was based on observed clinical outcomes (e.g., successful lead delivery, achievement of LBBAP, reported complications/adverse events) as documented and reported by treating physicians and study investigators. This is akin to patient outcomes data in real-world settings.
8. The sample size for the training set
- Not Applicable. There is no AI/ML algorithm with a training set.
9. How the ground truth for the training set was established
- Not Applicable. There is no AI/ML algorithm with a training set.
§ 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).