The NeuroVasx Sub-Microinfusion 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 NeuroVasx catheter lumen facilitates axial movement and stability during navigation. The catheter is designed to infuse liquid diagnostic agents radially through side holes in the wall of the catheter to improve the diffusion and mixing of the infused agent with the blood flow.

The NeuroVasx 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 in a gamma radiation sterilization process.

AI/ML Overview

The provided document is a 510(k) summary for the NeuroVasx Sub-Microinfusion Catheter, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test and training sets, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/algorithm performance, is not present.

However, based on the available text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or detailed performance metrics in the format of a table as typically seen for AI device evaluations. Instead, it states that "Design verification testing was performed to verify that the NeuroVasx catheter met the design specifications and performance requirements." It then reports a high-level outcome: "The results of the comparative and design verification testing confirmed that the NeuroVasx catheter performs as well or better than the predicate devices tested and is suitable for use; no new questions of safety and effectiveness were raised."

Implicit acceptance criteria would likely be related to the design specifications and performance requirements for safe and effective delivery of diagnostic agents into the neurovasculature, including:

Mechanical Integrity: Ability to withstand forces during navigation and infusion without failure.
Dimensions: Adherence to specified dimensions (e.g., 1.4 Fr) to fit within standard microcatheters.
Infusion Capability: Effective and controlled radial infusion of liquid diagnostic agents.
Biocompatibility: Materials used must be safe for contact with human tissue and blood.
Sterility: Ability to be sterilized via gamma radiation.
Ease of Use: Facilitation of axial movement and stability during navigation.

Reported Device Performance:

Performs "as well or better than the predicate devices tested."
"Suitable for use."
"No new questions of safety and effectiveness were raised."
"All materials passed biocompatibility testing and are suitable for this application."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Design verification testing" and "comparative and design verification testing" but does not specify any sample sizes for these tests. It also does not mention any human data or clinical study in terms of data provenance (e.g., country of origin, retrospective or prospective). The testing described appears to be primarily bench testing and material compatibility.

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 as the submission describes a physical medical device and its bench testing, not an AI or diagnostic algorithm requiring expert-established ground truth from clinical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there is no expert adjudication process described for establishing ground truth in this device's evaluation.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI systems on human reader performance, which is not the subject of this 510(k) submission for a physical infusion catheter.

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 submission is for a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as typically understood in AI/diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. The "truth" or reference standard for this device's performance would be against established engineering design specifications, material standards, and performance characteristics consistent with its intended function and predicate devices. For biocompatibility, the ground truth would be established scientific standards and tests.

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable/not provided. There is no "training set" for this physical device.

Summary

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2/11/99
CONFIDENTIAL

Section 2 - 510(k) Summary and Certification

[As required by 21 CFR 807.92(c)]

1. Submitter's Name / Contact Person

Jeffrey A. Lee President and CEO NeuroVasx. Inc. 2355 Polaris Lane No. Suite 116 Plymouth. MN 55447

Tel: (612) 476-8106 (612) 476-8176 Fax:

2. General Information

Trade Name	NeuroVasx Sub-Microinfusion Catheter
Classification Name	Diagnostic Intravascular Catheter
Classification:	This device has been classified by the Circulatory Systems DevicePanel into Class II, (21 CFR 870.1200).
Identification ofEquivalentDevice	In-Time™ Intravascular Infusion Catheter; Boston ScientificCorporation / SciMed Life Systems (K963988) Segue™ Infusion Catheter; Interventional InnovationsCorporation (K964154) Mach-16 Nitinol Guidewire; Target Therapeutics (K862983)

3. Device Description

4. Intended Use

The NeuroVasx Sub-Microinfusion Catheter is intended for the delivery of diagnostic agents into the neurovasculature.

5. Technological Characteristic Comparisons

The NeuroVasx Sub-Microinfusion Catheter is substantially equivalent to the Boston Scientific Corporation / Target Therapeutics In-Time™ Intravascular

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Infusion Catheter (K963988), the Interventional Innovations Corporation Seque™ Infusion Catheter (K964154) and the Mach-16 Nitinol Guidewire: Target Therapeutics (K862983). Compared to these predicate devices, the NeuroVasx catheter has similar intended use (delivery of liquid agents into the vascular system) and is constructed of the same or substantially equivalent materials (high density polyethylene, nitinol wire, polycarbonate hub). The NeuroVasx catheter sizes are comparable as are the infusion pressures.

6. Summary of Studies

Design verification testing was performed to verify that the NeuroVasx catheter met the design specifications and performance requirements. The results of the comparative and design verification testing confirmed that the NeuroVasx catheter performs as well or better than the predicate devices tested and is suitable for use; no new questions of safety and effectiveness were raised. Confirmatory biocompatibility testing was performed on the materials used in the construction of the NeuroVasx catheter. All materials passed biocompatibility testing and are suitable for this application.

7. Substantial Equivalence Comparison

The NeuroVasx Sub-Microinfusion Catheter is substantially equivalent to the following products:

In-Time™ IntravascularInfusion Catheter	Segue™ InfusionCatheter	Mach-16 Nitinol Guidewire
Boston Scientific Corp /SciMed Life Systems6655 Wedgewood RoadMaple Grove, MN 55311	InterventionalInnovations Corp.2670 Patton RoadSt. Paul, MN 55113	Target Therapeutics2100 South Sepulveda BlvdLos Angeles, CA 90025
Premarket NotificationNumber: K963988	Premarket NotificationNumber: K964154	Premarket NotificationNumber: K862983

8. 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 NeuroVasx Sub-Microinfusion Catheter.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 1999

Mr. Jeffrey A. Lee President/Chief Executive Officer NeuroVasx, Inc. 2355 Polaris Lane North, Suite 116 Plymouth, Minnesota 55447

Re: K984258

Trade Name: Neuro Vasx Sub-Microinfusion Catheter Regulatory Class: II Product Code: JCY Dated: November 25, 1998 Received: November 30, 1998

Dear Mr. Lee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 comply with the GMP regulation 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. Jeffrey A. Lee

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Sincerely yours,

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

Enclosure

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CONFIDENTIAL

Indications for Use

The NeuroVasx Sub-Microinfusion Catheter is intended for the delivery of diagnostic agents into the neurovasculature.

K98425

Pacollo

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).