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510(k) Data Aggregation
(156 days)
074 Zenith Flex System
The Zenith Flex System, including the Zetheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
The InNeuroCo 074 Zenith Flex Catheter is a variable stiffness catheter that has a catheter shaft reinforced with Stainless-Steel and Nitinol to provide support. The Stainless-Steel is wound as a double coil in the proximal section and the Nitinol is a single coil in the distal section. It has a radiopaque Platinum/lridium marker band on the distal 25 cm of the 074 Zenith Flex Catheter has a hydrophilic coating. The 074 Zenith Flex Catheter is available with an internal diameter of 0.074 inches. The outer diameter is of 0.089 inches along its proximal shaft, and 0.083 inches along its distal shaft. The 074 Zenith Flex Catheter is available in three workinq lengths: 115 cm, 125 cm, and 132 cm. The 074 Zenith Flex Catheter has a PTFE lined lumen. Accessories included with the device are a Tuohy-Borst Hemostasis Valve, two peel-away Introducers, and a Scout introducer. The Scout may be used to introduce the 074 Zenith Flex Catheter into distal vasculature, thereby helping the device reach the target anatomy.
The provided text describes the Zenith Flex System (074 Zenith Flex Catheter) and its non-clinical data for demonstrating substantial equivalence. It does not describe a study involving an AI/Machine Learning device or algorithm. Therefore, I cannot provide details regarding acceptance criteria, sample size, ground truth, or adjudication methods in the context of an AI study.
However, I can extract the acceptance criteria and observed performance described for the non-clinical (bench and animal) testing of the Zenith Flex Catheter.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Zenith Flex Catheter & its accessories Biocompatibility | ||
| Material Mediated Pyrogen | The test article extracts must not cause a febrile reaction greater than 0.5°C in any individual subject. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Cytotoxicity MEM Elution | The cultures treated with the test article must not have a reactivity grade greater than 2. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Hemolysis (ASTM Method, extract human blood) | The hemolytic index above the negative control article must be less than 5%. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Unactivated Partial Thromboplastin Time (UPTT) | There must be no statistical decrease between the UPTT of plasma exposed to the test article and to the negative or untreated control. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| 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. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Dog Thromboresistance | The test articles must receive a thrombus formation score less than or equal to that of the control. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Maximization Sensitization | The test article must elicit a positive response in less than 10% of the test animals. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Intracutaneous Toxicity/Reactivity | The test article extracts must not induce a significantly greater biological reaction than the control. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Acute Systemic Toxicity Test | The test article extracts must not induce a significantly greater biological reaction than the control. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Chemical Compatibility | Product shall withstand exposure to chemicals without degradation. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Zenith Flex Catheter Performance Testing | ||
| Working Length | Test samples should be within existing working length specification. | Zenith Flex Catheter test samples met the acceptance criteria. |
| Hub compatibility | Hub shall meet existing Luer specifications. | Test articles met the acceptance criteria (leveraged from K171672, materials and manufacturing processes equivalent). |
| Outside diameter | Test samples should be within existing outside diameter specification. | Zenith Flex Catheter test samples met the acceptance criteria. |
| Leak - Air | Test samples should be within existing Air - Leak specifications. | Zenith Flex Catheter test samples met the acceptance criteria. |
| Leak - Liquid | Test samples should be within existing Leak - Liquid specifications. | Zenith Flex Catheter test samples met the acceptance criteria. |
| Particulates | Test samples should be within existing Particulate specifications. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Simulated Use - Bench | Test samples must meet predetermined user needs. | Zenith Flex Catheter test samples met the acceptance criteria. |
| Catheter Burst | Test sample burst pressures must meet or exceed existing minimum burst pressure specification. | Zenith Flex Catheter test samples met the acceptance criteria. |
| Tensile | Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications. | Zenith Flex Catheter test samples met the acceptance criteria. |
| Corrosion | Test samples shall exhibit no evidence of corrosion. | Test articles met the acceptance criteria (leveraged from K152202, materials and manufacturing processes equivalent). |
| PTFE Liner inspection | Test sample liner adhesion must meet or exceed existing PTFE Liner inspection specifications. | Zenith Flex Catheter test samples met the acceptance criteria. |
| Hydrophilic Coating Integrity | Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Simulated Use Testing (Aspiration) | Successfully removed the thrombi. | Zenith Flex System test samples met the acceptance criteria. |
| Labeling Legibility | Test samples shall demonstrate text legibility. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Barcode | Test samples shall demonstrate readily readable barcodes. | Test articles met the acceptance criteria (leveraged from K172167, materials and manufacturing processes equivalent). |
| Sterilization (Catheter & Aspiration Tubing Set) | Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads. | Sterilization loads met the acceptance criteria. |
| Shelf Life (Catheter & Aspiration Tubing Set) | Aged test samples must meet or exceed existing specifications. | Zenith Flex Catheter & Aspiration Tubing Set test samples met the acceptance criteria. |
| Torque Strength | Test sample results must meet or exceed existing torque specifications. | Zenith Flex Catheter test samples met the acceptance criteria. |
| Kink Resistance | Test sample results must meet or exceed existing kink resistance specifications. | Zenith Flex Catheter test samples met the acceptance criteria. |
| Lumen Patency | Test sample results must meet or exceed existing lumen patency specifications. | Zenith Flex Catheter test samples met the acceptance criteria. |
| Tip Flexibility | Zenith Flex tip flexibility results were compared to predicate device results. | Zenith Flex Catheter test samples performed comparatively against the predicate device. |
| Friction Force | Zenith Flex friction force results were compared to predicate device results. | Zenith Flex Catheter test samples performed comparatively against the predicate device. |
| Simulated Use Testing - Usability | Test samples must meet predetermined user needs. | Zenith Flex System test samples met the acceptance criteria. |
| Aspiration Tubing Set Performance Testing | ||
| Visual Inspection | Test samples should meet visual inspection specifications. | Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same). |
| Tensile | Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications. | Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same). |
| Leak - Liquid | Test samples should be within existing Leak - Liquid specifications. | Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same). |
| Leak - Air, Tubing and Control Switch | Test samples should be within existing Air - Leak specifications. | Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same). |
| Luer Compatibility | Hub shall meet existing Luer specifications. | Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same). |
| Suction Connector Separation Force | Test sample results must meet or exceed existing force specifications. | Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same). |
| Vacuum Drop / Suction Connector Secure Attachment | Test sample results must meet or exceed existing pressure specifications. | Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same). |
| Lumen Patency | Test sample results must meet or exceed existing lumen patency specifications. | Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same). |
| Dimensions | Test samples should be within existing dimensional specifications. | Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same). |
| Packaging (Catheter and Aspiration Tubing Set) Testing | ||
| Packaging - Dye Leak | Test sample shall not exhibit any visual leaks or channels. | Test articles met the acceptance criteria (leveraged from K172167, packaging is the same). |
| Packaging - Peel | Test sample tensile strength must meet or exceed existing tensile strength specifications. | Test articles met the acceptance criteria (leveraged from K172167, packaging is the same). |
| Aspiration Tubing Set Biocompatibility | ||
| Cytotoxicity MEM Elution | The cultures treated with the test article must not have a reactivity grade greater than 2. | Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same). |
| Maximization Sensitization | The test article must elicit a positive response in less than 10% of the test animals. | Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same). |
| Intracutaneous Toxicity/Reactivity | The test article extracts must not induce a significantly greater biological reaction than the control. | Test articles met the acceptance criteria (leveraged from K172167, aspiration tubing is the same). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each benchtop or animal test. It refers to "test samples" for bench testing and does not provide numerical counts.
For animal testing: "Clot was used to create occlusions within several arteries of swine. One side of each swine was treated with the subject Zenith Flex system and the contralateral side was treated with the reference device." The exact number of swine used is not provided.
Data provenance: The non-clinical data is generated from laboratory (bench) and animal (swine) studies. The country of origin for the studies is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in this context. The non-clinical studies rely on objective measurements and observations in laboratory and animal settings, not on expert ground truth for interpretation of images or clinical outcomes. For 'Simulated Use - Bench' and 'Simulated Use Testing - Usability', a physician's assessment was used, but details on the number or qualifications of these physicians are not provided.
4. Adjudication Method for the Test Set
Not applicable, as the tests involve objective measurements and direct observation rather than subjective interpretations requiring 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
Not applicable. This is a medical device (catheter), not an AI/ML device for diagnostic interpretation. There was no MRMC study involving human readers and AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Not applicable. This is a medical device (catheter), not an AI/ML device.
7. The Type of Ground Truth Used
For bench testing, the ground truth is based on physical and chemical properties measured against established specifications (e.g., ISO, ASTM standards).
For animal testing, the ground truth for effectiveness was "angiographic assessment of revascularization," and for safety, "angiographic assessment and histopathological assessment."
8. The Sample Size for the Training Set
Not applicable. This is a medical device (catheter); there is no "training set" in the context of an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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