FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The InNeuroCo, Inc. 091 Long Sheath is a variable stiffness catheter that has a catheter shaft reinforced with a stainless steel double coil. It has a radiopaque Platinum/lridium marker band on the distal end. The distal 10 cm of the 091 Long Sheath Catheter has a hydrophilic coating. The catheter has a nominal outer diameter of 0.109 inches and a nominal inner diameter of 0.091 inches. It is available in three working lengths: 70 cm, and 90 cm. The 091 Long Sheath has a PTFE-lined lumen. The 091 Long Sheath is inserted at a vascular access point to provide 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 and a Vessel Dilator. The 091 Long Sheath is supplied sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

The provided text is a 510(k) summary for the InNeuroCo 091 Long Sheath peripheral, coronary, and neuro vasculature catheter. It outlines the device's characteristics and its comparison to a predicate device, along with the results of performance testing to demonstrate substantial equivalence.

Based on the provided document, here's a description of the acceptance criteria and the study proving the device meets these criteria:

This document describes the validation of a medical device, the InNeuroCo 091 Long Sheath, for regulatory approval. It is not an AI/ML device, and therefore several of the requested sections (e.g., number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable as they relate to the validation of AI/ML algorithms, not traditional medical devices like catheters.

Acceptance Criteria and Device Performance Study for the InNeuroCo 091 Long Sheath

The InNeuroCo 091 Long Sheath is a percutaneous catheter intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The study conducted was a series of non-clinical (bench and animal) tests to demonstrate substantial equivalence to a legally marketed predicate device (Stryker AXS Infinity LS, K152876).

1. Table of Acceptance Criteria and Reported Device Performance

Test	Test Method Summary	Acceptance Criteria	Reported Device Performance (Conclusions)
Biocompatibility-Material Mediated Pyrogen Testing	Completed per ISO 10993-11	The test article extracts must not cause a febrile reaction greater than 0.5°C in any individual subject.	Test results for the InNeuroCo Super Distal Access (K161262) and the Zenith Catheter (K171672) were leveraged as materials and manufacturing processes are equivalent. Met acceptance criteria.
Biocompatibility-Cytotoxicity MEM Elution	Completed per ISO 10993-5	The cultures treated with the test article must not have a reactivity grade greater than 2.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Hemolysis ASTM Method, extract human blood	Completed per ISO 10993-4	The hemolytic index above the negative control article must be less than 5%.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Hemolysis, ASTM method, direct contact (human blood)	Completed per ISO 10993-4	The hemolytic index above the negative control article must be less than 5%.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Unactivated Partial Thromboplastin Time	Completed per ISO 10993-4	There must be no statistical decrease between the UPTT of plasma exposed to the test article and to the negative or untreated control.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Complement Activation	Completed per ISO 10993-4	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.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Dog Thrombogenicity	Completed per ISO 10993-4	The test articles must receive a thrombus formation score less than or equal to that of the control.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Maximization Sensitization	Completed per ISO 10993-10	The test article must elicit a positive response in less than 10% of the test animals.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Intracutaneous Toxicity/Reactivity	Completed per ISO 10993-10	The test article extracts must not induce a significantly greater biological reaction than the control.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Biocompatibility-Acute Systemic Toxicity Test	Completed per ISO 10993-11	The test article extracts must not induce a significantly greater biological reaction than the control.	Leveraged results from InNeuroCo Super Distal Access (K161262) and Zenith Catheter (K171672). Met acceptance criteria.
Animal Testing-Angiographic Evaluation	Product evaluated within a porcine model for clinically significant injury.	No units tested can cause vessel injury.	Test article met the acceptance criteria for Animal Testing.
Bench Testing - Chemical Compatibility	Catheter exposed to chemicals readily available in a clinical setting.	Chemicals have no negative effect on the catheter or accessories.	Leveraged results from InNeuroCo Super Distal Access (K161262). Met acceptance criteria.
Bench Testing - Visual Inspection	Completed per ISO 10555-1	Catheter shall appear free from damage, including a rounded tip and smooth transition points.	091 Long Sheath test samples met the acceptance criteria.
Bench Testing - Dimensions	Completed per ISO 10555-1	Test samples should be within existing dimensional specifications.	091 Long Sheath test samples met the acceptance criteria. Leveraged results for Hemostasis Valve from InNeuroCo Super Distal Access (K161262), which also met the criteria.
Bench Testing - Hub compatibility	Completed per ISO 594-1 and ISO 594-2	Hub shall meet existing Luer specifications.	Leveraged results for the 091 Long Sheath and Dilator from InNeuroCo Intermediate Catheter (K152202) and for the Hemostasis Valve from Super Distal Access (K161262). All tested samples met the acceptance criteria.
Bench Testing - Leak - Air	Completed per ISO 10555-1	Test samples should be within existing Air – Leak specifications.	091 Long Sheath test samples met the acceptance criteria.
Bench Testing - Leak - Liquid	Completed per ISO 10555-1	Test samples should be within existing Leak - Liquid specifications.	091 Long Sheath test samples met the acceptance criteria.
Bench Testing - Particulates	Completed per USP 788	Test samples should be within existing Particulate specifications.	091 Long Sheath test samples met the acceptance criteria.
Bench Testing - Simulated Use	LS underwent simulated use testing by a physician in a benchtop model.	Test samples must meet predetermined user needs.	091 Long Sheath test samples met the acceptance criteria.
Bench Testing - Catheter Burst	Completed per ISO 10555-1	Test sample burst pressures must meet or exceed existing minimum burst pressure specification.	091 Long Sheath test samples met the acceptance criteria. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Tensile	Completed per ISO 10555-1	Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications.	091 Long Sheath test samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Corrosion	Completed per ISO 10555-1	Test samples shall exhibit no evidence of corrosion.	Leveraged results from InNeuroCo Intermediate Catheter (K152202). All samples met the acceptance criteria. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Packaging - Dye Leak	Completed per ASTM F1929-12	Test sample shall not exhibit any visual leaks or channels.	091 Long Sheath test samples met the acceptance criteria. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Packaging - Peel	Completed per ASTM F88-09	Test sample tensile strength must meet or exceed existing tensile strength specifications.	091 Long Sheath test samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Kink Resistance	Samples are subjected to different diameters until kink is observed.	Test sample kink resistance must meet or exceed existing Kink Resistance specifications.	091 Long Sheath test samples met the acceptance criteria. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Torque	Conditioned samples are torqued to failure.	Test sample torque results must meet or exceed existing torque specifications.	091 Long Sheath test samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - PTFE Liner inspection	LS was challenged to demonstrate liner adherence.	Test sample liner adhesion must meet or exceed existing PTFE Liner inspection specifications.	091 Long Sheath test samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Hydrophilic Coating Integrity	Conditioned samples were repeatedly exposed to friction to demonstrate that the hydrophilic coating is not affected.	Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications.	091 Long Sheath test samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Labeling Legibility	Label is legible after printing.	Test samples shall demonstrate text legibility.	091 Long Sheath test samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bench Testing - Barcode	Barcode is readable with a standard barcode reader.	Test samples shall demonstrate readily readable barcodes.	091 Long Sheath test samples met the acceptance criteria. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sterilization	ISO 11135 and AAMI TIR 28	Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads.	091 Long Sheath sterilization load met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bacterial Endotoxin	AAMIST72	Test samples must meet the bacterial endotoxin acceptance criteria.	The 091 Long Sheath samples met the acceptance criteria. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Shelf Life	ASTM F1980	Aged test samples must meet or exceed existing specifications.	091 Long Sheath test samples met the acceptance criteria. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The exact sample sizes for each specific test are not explicitly enumerated in the provided summary table. The statements typically indicate "Test samples" or "All samples," implying that a sufficient number were tested according to the referenced ISO or ASTM standards.
Data Provenance: The data is a mix of:
- Direct testing: For many bench tests (e.g., Visual Inspection, Leaks, Particulates, Simulated Use, Catheter Burst, Tensile, Kink Resistance, Torque, PTFE Liner inspection, Hydrophilic Coating Integrity, Labeling Legibility, Barcode, Sterilization, Bacterial Endotoxin, Shelf Life). These tests were conducted on the 091 Long Sheath.
- Leveraged data: For all biocompatibility tests, Chemical Compatibility, Hub compatibility, and Corrosion, data was leveraged from previously approved InNeuroCo devices (Super Distal Access K161262, Zenith Catheter K171672, and Intermediate Catheter K152202). This leveraging is justified by stating that the materials and manufacturing processes are equivalent.
- Animal Testing: Product evaluated within a porcine model for angiographic evaluation.
Retrospective/Prospective: All described testing appears to be prospective (new tests conducted for this device and leveraged results from other devices), not retrospective analysis of existing clinical data.
Country of Origin: Not specified in the document, but given the FDA 510(k) submission, it would be expected to follow US or internationally recognized standards. The company address is in Florida, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not Applicable. This is a traditional medical device (catheter) validation, not an AI/ML algorithm. Ground truth for device performance is established through standardized physical, chemical, biological, and animal testing, not human expert interpretation of data.
For "Simulated Use" testing, it mentions "by a physician," indicating one or more physicians were involved in that specific assessment, but their number and specific qualifications are not detailed beyond "physician."

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/ML study, there is no need for adjudication of conflicting expert opinions on a dataset. Test results are objective measurements against defined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for the validation of a physical medical device like a catheter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. There is no AI algorithm being validated in this submission. The "device" is a physical catheter.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:
- Standardized Test Methods: Adherence to established international (ISO, ASTM, USP) and industry standards for material properties, mechanical performance, biocompatibility, and sterility.
- Physical Measurements: Objective measurements of dimensions, burst pressure, tensile strength, etc.
- Chemical/Biological Assays: Results from biocompatibility tests (e.g., cytotoxicity, hemolysis, pyrogenicity, sensitization) and bacterial endotoxin tests.
- Functional Demonstrations: Successful performance in simulated use environments and in an animal model (porcine model for angiographic evaluation, showing no vessel injury).
- Predetermined Specifications: Comparison against established product specifications and the performance of the predicate device.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no AI/ML training set, this question is not relevant.

Summary

Regulation Number and Section

§ 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).