(242 days)
The EnligHTN™ Renal Guiding Catheter system is indicated for percutaneous use through an introducer sheath to facilitate a pathway to introduce interventional and diagnostic devices into the renal arterial vasculature.
The EnligHTN Renal Guiding Catheter consists of two primary components, the guiding catheter assembly and the dilator. The guide catheter assembly is the renal access device and has a usable length of 55cm. The outside diameter (OD) of the catheter shaft is 8F (2.7mm) with a distal tip inner diameter (ID) of 0.089 inches. The device is single use and packaged sterile via Ethylene oxide (EO) sterilization. The dilator fits inside the guiding catheter providing support during advancement through the vasculature and placement near the renal ostia. At the proximal end of the guiding catheter is a molded hub equipped with a hemostasis valve that is secured by an ultrasonically welded cap. The hub has a side port feature with an extension tubing and stopcock assembly attached. The distal end of the guiding catheter is formed to match the RDC-1 curve common to the industry and incorporates a radiopaque marker band. The dilator lumen is designed to accommodate a guidewire with an outside diameter of 0.035" or less.
The EnligHTN Renal Guiding Catheter system includes the following design aspects:
- 55cm Usable Length
- Renal double curve (RDC-1) at the distal end to assist in engagement of renal ostium
- Radiopaque marker band at the distal tip to aid in visualization under fluoroscopy
- Hub with hemostasis valve
- Extension tube with 3-way stopcock
- Compatible Dilator
Here's an analysis of the provided text regarding the acceptance criteria and study for the EnligHTN Renal Guiding Catheter:
Summary of Acceptance Criteria and Device Performance (Assumed from Testing Summary)
The document describes various performance tests conducted to demonstrate that the EnligHTN Renal Guiding Catheter meets product specifications and intended uses, and is as safe and effective as the predicate device (Cordis Guide Catheter). While explicit "acceptance criteria" are not listed with quantitative thresholds, the successful completion of these tests implies that the device met the required performance standards.
| Item | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Device Performance | Meets product specifications for: Dimensions, Kink Resistance, Torque Manipulation and Strength, Air Leak, Seal Manipulation, Hemostasis Performance, Renal Double Curve Maintenance, Tensile Strength, Corrosion Resistance. | Testing demonstrated that the guide catheter's design meets product specifications and intended uses. |
| Biocompatibility | Meets biological safety standards for: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Partial Thromboplastin Time, Complement Activation, In Vivo Thromboresistance, and Chemical Characterization (GC/MS, ICP, FTIR, NVR). | All biocompatibility tests were successfully conducted. |
| Sterilization/Microbiology | Meets standards for: Sterilization, Ethylene Oxide Residuals, Bioburden, LAL Endotoxin. | All sterilization and microbiology tests were successfully conducted. |
| Packaging | Meets standards for: Bubble Leak Test, Visual Inspection, Pouch Seal Strength. | All packaging tests were successfully conducted. |
| Shelf Life | Maintains performance over the specified shelf life of 13 months (accelerated and real-time). | 13-month accelerated aging and 13-month real-time aging (in-process) were conducted. (Implicitly met criteria). |
| Animal Testing (In-Vivo Performance) | Demonstrates satisfactory performance for: Fit of the Dilator and Catheter, Visualization, Engagement, Seal Performance, and Withdrawal Performance. | Performed a study to assess fit, visualization, engagement, seal, and withdrawal. (Implicitly met criteria). |
1. A table of acceptance criteria and the reported device performance:
(See table above)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: The document does not explicitly state the numerical sample sizes for each specific test (e.g., how many catheters were used for kink resistance, how many animals for animal testing). It lists the types of tests performed.
- Data Provenance: Not specified. Standard practice for medical device testing implies that these tests are performed in a controlled laboratory environment. The country of origin of the data is not mentioned and is typically not a requirement for this type of 510(k) submission unless specific clinical trial data from diverse populations is being used. This would be considered prospective bench and animal testing.
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. For bench and animal testing of this nature, "experts" in the traditional sense of medical specialists establishing ground truth for diagnostic accuracy are not typically involved. The "ground truth" would be defined by engineering specifications and expected physiological responses, assessed by engineers, technicians, and veterinarians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable to the non-clinical (bench and animal) testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly those involving human interpretation of medical images, to resolve discrepancies among expert readers.
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 physical medical device (catheter), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant.
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 medical catheter and does not involve any algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests (bench, biocompatibility, sterilization, packaging, shelf life): The "ground truth" is based on engineering specifications, recognized industry standards, and regulatory requirements (e.g., ISO standards for biocompatibility, sterility assurance levels).
- For the animal testing: The "ground truth" for performance aspects like fit, visualization, engagement, seal, and withdrawal performance would be based on direct observation and assessment by trained personnel (e.g., veterinarians, researchers) in accordance with study protocols, confirming the device performs as intended within the physiological model.
8. The sample size for the training set:
- Not applicable. This document describes the testing of a physical medical device. There is no "training set" in the context of machine learning or AI algorithm development. The device's design is refined through engineering and iterative testing, not through training on a dataset.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply here.
§ 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).