The NeuroEdge™ Infusion Catheter is a single use, 1.4 Fr device designed to fit within a standard microcatheter for advancement to, and navigation of a lesion site. A nitinol mandrel within the NeuroEdge™ Infusion Catheter lumen facilitates axial movement and stability during navigation. The catheter is designed to infuse liquid agents (such as contrast media and liquid embolic glues) through the end hole at select sites in the neurovasculature for the diagnosis, visualization, and treatment of arterio-venous malformations/fistulas (AVM/AVF's), lesions, or embolisms. The catheter is also designed to penetrate an embolism if it is determined to be a soft thrombus and navigate through the thrombus to assess the circulation distal to the thrombus.

The NeuroEdge™ Infusion Catheter is contained in a plastic hoop assembly and sealed in a Tyvek / polyester pouch. The sealed pouch assembly is labeled and placed in a shelf carton along with the instructions for use, and then sterilized via gamma radiation sterilization process.

AI/ML Overview

The provided document describes a 510(k) submission for the NeuroEdge™ Infusion Catheter, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria as you might see for a novel device.

Therefore, the document does not contain specific acceptance criteria, performance metrics, or details about a study designed to prove the device meets those criteria in the way a clinical trial report would. Instead, it focuses on demonstrating that the new device is "substantially equivalent" to existing devices.

Here's an analysis based on the information provided, explaining why certain sections of your request cannot be fully answered by this document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of quantitative metrics or clinical endpoints. The primary "acceptance" for a 510(k) is demonstrating substantial equivalence to predicate devices in terms of intended use, design, materials, and construction.	"Performance testing was completed to verify the design specifications necessary for the open-ended modification and to support the compatibility of the catheter to deliver embolic / therapeutic agents. Test results support the safety and performance of the NeuroEdge™ Infusion Catheter for its intended use." (K011646, p.1, Section 6)

Explanation: The document states that performance testing was done, but does not provide specific numerical acceptance criteria (e.g., minimum flow rate, maximum burst pressure, specific clinical success rates) or the quantitative results from those tests. The "reported device performance" is a general statement that the tests support safety and performance.

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

Sample Size: Not specified. The document mentions "performance testing" but does not detail the number of units tested or the number of cases/patients involved in any clinical or simulated use tests.
Data Provenance: Not specified. Given the nature of a 510(k) for a device like this, the performance testing would typically involve bench testing (in-vitro) and potentially some animal studies, rather than human patient data, unless specifically required based on the predicate device or unique risks. The document does not indicate if any human data was used, retrospectively or prospectively.

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

Number of Experts: Not applicable/not mentioned. "Ground truth" in the context of expert review for medical imaging or diagnostic devices is not relevant here. The performance testing would be engineering or laboratory-based, assessing physical properties and functional aspects of the catheter against design specifications, not expert interpretation of clinical data.
Qualifications of Experts: Not applicable/not mentioned.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/not mentioned. Adjudication methods (like 2+1, 3+1 consensus) are used when multiple human readers interpret ambiguous clinical data to establish a ground truth. This is not the type of study described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. These studies are typically conducted for diagnostic imaging devices to assess the impact of AI on human reader performance. The NeuroEdge™ Infusion Catheter is a delivery device (catheter) for diagnostic, embolic, and therapeutic agents.
Effect Size of Human Readers with vs. without AI Assistance: Not applicable. This device does not incorporate AI for diagnostic assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study: Not applicable. This device is a physical catheter, not an algorithm. Therefore, no standalone algorithm performance study was performed.

7. Type of Ground Truth Used:

Type of Ground Truth: For the "performance testing," the "ground truth" would be the engineering specifications and validated test methods. For example, if testing catheter flexibility, the ground truth would be a defined acceptable range of flexibility. If testing flow rate, the ground truth would be a specified flow rate under certain conditions. The document does not provide details on these specific ground truths or specifications.

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set."

9. How Ground Truth for the Training Set Was Established:

Ground Truth for Training Set: Not applicable, as there is no training set for a physical device.

In summary: The provided document is a 510(k) submission, which focuses on demonstrating "substantial equivalence" of the NeuroEdge™ Infusion Catheter to legally marketed predicate devices. It mentions "performance testing" was conducted to verify design specifications and support safety and performance, but it does not provide the specific details (acceptance criteria, methodologies, sample sizes, or results) of these tests that would be required to answer most of your questions in the context of a detailed study report for a novel medical device or AI system.

Summary

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011646 1/2

AUG 2 7 2001

Section 2 - 510(k) Summary and Certification

[As required by 21 CFR 807.92(c)]

1. Submitter's Name / Contact Person

Jack Slovick	Tel: (763) 315-0013
Director, Quality and Regulatory Affairs	Fax: (763) 315-0966

NeuroVasx, Inc. 7351 Kirkwood Lane, Suite 112 Maple Grove, MN 55369

2. General Information

Trade Name:	NeuroEdge™ Infusion Catheter
Classification Name:	Continuous Flush Catheter
Classification:	This device is classified by the Circulatory Systems DevicePanel into Class II, (21 CFR 870.1210)

3. Device Description

4. Intended Use

The NeuroEdge™ Infusion Catheter is intended for the infusion of various diagnostic, embolic and therapeutic agents into the neurovasculature.

CONFIDENTIAL

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5. Substantial Equivalence Comparison

The NeuroEdge Infusion Catheter is substantially equivalent to the following devices with respect to intended use, design, materials and construction:

NeuroVasx Sub-MicroInfusion Catheter, NeuroVasx Inc. (K984258) o
Prowler™-10 Infusion Catheter, Cordis Endovascular Systems Inc. (K003925) o
LTD Torque Device, B. Braun Medical, (K964352) o

6. Summary of Studies

Performance testing was completed to verify the design specifications necessary for the open-ended modification and to support the compatibility of the catheter to deliver embolic / therapeutic agents. Test results support the safety and performance of the NeuroEdge™ Infusion Catheter for its intended use.

7. Conclusion (statement of equivalence)

The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the NeuroEdge™ Infusion Catheter.

CONFIDENTIAL

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

AUG 2 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jack Slovick Director, Regulatory Affairs/Quality Assurance NeuroVasx, Inc. 7351 Kirkwood Lane, Suite 112 Maple Grove, Minnesota 55369

Re: K011646

R011040
Trade/Device Name: NeuroEdge™ Infusion Catheter Regulation Number: 870.1210 Regulatory Class: II Product Code: KRA Dated: May 25, 2001 Received: May 29, 2001

Dear Mr. Slovick:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becaon - I oxil iteminally equivalent (for the indications for use above and we nave determined the actives is eadicate devices marketed in interstate commerce stated in the encrosule) to legally manated problem Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and flave been reclassified in accordance thre device, subject to the general controls Cosment Act (Act). Tou may, morelors, marcols, marcoisions of the Act include requirements for annual provisions of the Act. "The general oversions practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 children rippt vary, it the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspotions, the Food and may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Juan Carlos Rivera

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607110 for questions on the promotion and advertising of your device, (201) 594-1659. Practicenary), and (301) 594-4639. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or 11allanderal or attitutionet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N. Milkins

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K011646

Indications for Use Statement

Page 1 of 1

The NeuroEdge™ Infusion Catheter is intended for the infusion of various diagnostic, embolic and therapeutic agents into the neurovasculature.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign -Off) Division of General, Restorative and Neurological Devices

510(k) Number K011646

MAY 25, 2001

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).