(53 days)
The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
The InNeuroCo Zenith Support product consists of a catheter, a hemostasis valve, and a split sheath introducer. The Zenith Support catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith Support catheter has a radiopaque Platinum/Iridium marker band on the distal end. The Zenith Support is available with an internal diameter of 0.074 inches and a nominal outer diameter of 0.086 inches. There are three working lengths available: 95 cm, 105 cm, and 115 cm in either diameter. The Zenith Support catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith Support catheter is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The Zenith product line is supplied sterile, non-pyrogenic, and intended for single use only.
This request concerns the InNeuroCo Zenith Support Catheter, a percutaneous catheter used for introducing interventional devices into the peripheral and neuro vasculature. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study for novel device acceptance criteria.
The information primarily revolves around non-clinical data and justifications for not re-testing certain parameters due to the device's similarity to its predicate. Therefore, detailed information on ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available as this type of submission typically relies on a comparison to an already approved device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a "SUMMARY OF NON-CLINICAL DATA" (page 8, "Table 1: Non-Clinical Testing Analysis") which serves this purpose. Many tests were not re-tested for the Zenith Support Catheter because no material changes were made from the predicate device (Zenith 074) and manufacturing processes were identical or within the predicate's tolerance.
| Test | Acceptance Criteria | Reported Device Performance (Analysis/Outcome) |
|---|---|---|
| Biocompatibility | No re-testing for Zenith Support Catheter: "There are no material changes from the predicate device. Manufacturing process is identical to the predicate. Only the segment lengths were changed and pitch adjustments were within the predicate device's tolerance." This applies to all biocompatibility tests below. | |
| - Material Mediated Pyrogen | The test article extracts must not cause a febrile reaction greater than 0.5°C in any individual subject. | Not re-tested. |
| - Cytotoxicity MEM Elution | The cultures treated with the test article must not have a reactivity grade greater than 2. | Not re-tested. |
| - Hemolysis (ASTM Method, extract human blood) | The hemolytic index above the negative control article must be less than 5%. | Not re-tested. |
| - Hemolysis (ASTM method, direct contact human blood) | The hemolytic index above the negative control article must be less than 5%. | Not re-tested. |
| - Unactivated Partial Thromboplastin Time | There must be no statistical decrease between the UPTT of plasma exposed to the test article and to the negative or untreated control. | Not re-tested. |
| - Complement Activation | There must be no statistical increase between either the C3a or SC5b-9 concentrations in plasma exposed to the test article as compared to the negative and untreated controls. | Not re-tested. |
| - Dog Thromboresistance | The test articles must receive a thrombus formation score less than or equal to that of the control. | Not re-tested. |
| - Maximization Sensitization | The test article must elicit a positive response in less than 10% of the test animals. | Not re-tested. |
| - Intracutaneous Toxicity/Reactivity | The test article extracts must not induce a significantly greater biological reaction than the control. | Not re-tested. |
| - Acute Systemic Toxicity Test | The test article extracts must not induce a significantly greater biological reaction than the control. | Not re-tested. |
| Animal Testing - Angiographic Evaluation | No units tested can cause vessel injury. | Not re-tested. "The tips, materials, and transitions are identical to the predicate, and the initial evaluation for the predicate included the use of the device without the Scout Introducer." |
| Chemical Compatibility | Chemicals have no negative effect on the catheter or accessories. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Radiographic Detectability | Product shall be visible under fluoro imaging. | Not re-tested. "The marker bands are identical to the predicate." |
| Visual Inspection | Catheter shall appear free from damage, including a rounded tip and smooth transition points. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Working Length | Test samples should be within existing working length specification. | Not re-tested. "The segment lengths do not impact the cut to length step in addition the working length test compares the output to the target length." |
| Hub compatibility | Hub shall meet existing Luer specifications. | Not re-tested. "The hub is identical to the predicate device." |
| Outside Diameter | Test samples should be within existing outside diameter specifications. | Not re-tested. "OD is unaffected by the working length change." |
| Leak – Air | Test samples should be within existing Air - Leak specifications. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Leak – Liquid | Test samples should be within existing Leak - Liquid specifications. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Particulates | Test samples should be within existing Particulate specifications. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Simulated Use - Bench | Test samples must meet predetermined user needs. | Re-tested Yes. "Zenith Support Catheter test samples met the acceptance criteria for Simulated Use-Bench to demonstrate that it is substantially equivalent to the predicate device." |
| Catheter Burst | Test sample burst pressures must meet or exceed existing minimum burst pressure specification. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Tensile | Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications. | Not re-tested. "The bonds and joints are the same as the predicate Zenith 074 device. Any pitch adjustments are within the tolerance of the predicate device." |
| Corrosion | Test samples shall exhibit no evidence of corrosion. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Packaging - Dye Leak | Test sample shall not exhibit any visual leaks or channels. | Not re-tested. "The packaging is identical to the cleared reference SDA device." (Note: The reference here is to an "SDA device," not the Zenith 074 predicate, indicating identical packaging to another cleared device.) |
| Packaging - Peel | Test sample tensile strength must meet or exceed existing tensile strength specifications. | Not re-tested. "The packaging is identical to the cleared reference SDA device." (Again, referring to SDA device for packaging.) |
| Kink Resistance | Test sample kink resistance must meet or exceed existing Kink Resistance specifications. | Not re-tested. "All transitions are the same, only the location of the transition changes, in addition, the pitch adjustments are within the Zenith 074 tolerance." |
| Torque | Test sample torque results must meet or exceed existing torque specifications. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| PTFE Liner Inspection | Test sample liner adhesion must meet or exceed existing PTFE Liner inspection specifications. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Hydrophilic Coating Integrity | Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Labeling Legibility | Test samples shall demonstrate text legibility. | Not re-tested. "The label is almost identical to the predicate device, except that the Scout Introducer is removed from the labeling." |
| Barcode | Test samples shall demonstrate readily readable barcodes. | Not re-tested. "Barcodes are similar to the predicate." |
| Sterilization | Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads. | Not re-tested. "The Zenith Support Catheter was adopted into the Zenith Family Sterilization Cycle." |
| Shelf Life | Aged test samples must meet or exceed existing specifications. | Not re-tested. "There are no material changes from the predicate device, therefore shelf life testing conducted for the Zenith 074 still applies." |
2. Sample Size Used for the Test Set and the Data Provenance
Due to the nature of a 510(k) summary relying on substantial equivalence, specific sample sizes for re-tested parameters (like Simulated Use - Bench) are not explicitly stated. For most tests, the data provenance is essentially inherited from the predicate device (Zenith 074) and another reference device (InNeuroCo SDA) because the new device's materials and manufacturing are identical or within tolerance. The document indicates these are non-clinical studies (benchtop and animal models for predicate devices). The geographical origin of the data is not specified beyond the manufacturer being based in Florida, USA. All studies are retrospective in relation to the current device's testing, as they refer to data from predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. For non-clinical tests, "ground truth" is typically established by laboratory procedures and measurements against defined standards (e.g., ISO, ASTM). For the "Simulated Use - Bench" test, it states it was conducted "by a physician," implying at least one expert, but qualifications and number are not detailed.
4. Adjudication Method for the Test Set
Not applicable/not provided. This type of detail (e.g., 2+1, 3+1 consensus) is typical for clinical studies, especially those involving expert interpretation of medical images, which is not the focus of this non-clinical submission.
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 medical device (catheter), not an AI/Software as a Medical Device (SaMD) product. Therefore, MRMC studies and AI-assisted performance metrics are not relevant or performed for this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used
For the majority of the non-clinical tests not re-performed, the "ground truth" (or accepted performance) is based on:
- Established performance of the predicate device (Zenith 074): This implies that the predicate device previously met these standards.
- International Standards (ISO 10993, ISO 10555-1, ISO 594-1, ISO 594-2, ISO 11135) and ASTM standards (ASTM F1929-12, ASTM F88-09, ASTM F1980): These standards define methodologies and acceptable ranges for material properties, biocompatibility, and device functionality.
- USP 788: For particulates.
For the re-tested "Simulated Use - Bench" test, the ground truth was "predetermined user needs," likely established through design validation or clinical input.
8. The Sample Size for the Training Set
Not applicable. The Zenith Support Catheter is a physical medical device. The concept of "training set" is relevant for AI/machine learning models, which this device is not.
9. How the Ground Truth for the Training Set was Established
Not applicable as there is no "training set" for this physical 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).