The NEUROSCOUTTM Steerable Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.

Device Description

The hydrophilically coated NEUROSCOUT 0.014 guidewires consist of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. The basic principle of the guidewires is to act as a monorail that catheters can track over to reach a particular area of the neuro and peripheral vasculature. They have a nominal outside diameter of 0.014 inch and nominal overall length of up to 300 cm.

AI/ML Overview

The provided text describes the 510(k) summary for the NEUROSCOUT™ Steerable Guidewire. This is a medical device submission, and the content focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria in the typical sense of AI/ML performance evaluation (e.g., sensitivity, specificity, AUC).

Instead, the "acceptance criteria" here refer to meeting engineering performance standards and demonstrating safety and effectiveness comparable to existing devices. The "study" refers to a series of preclinical tests validating these physical and functional properties.

Here's an analysis based on the provided text, addressing your questions where applicable and indicating when information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the conformance to FDA Guidance and the performance of the predicate devices. The reported device performance is that it met these criteria through preclinical testing.

Acceptance Criterion (Implied)	Reported Device Performance
Mechanical Performance:
Tensile Strength	Testing conducted; device performs according to description.
Torque Strength	Testing conducted; device performs according to description.
Torqueability	Testing conducted; device performs according to description.
Tip Flexibility/Linear Stiffness	Testing conducted; device performs according to description.
Kink Radius	Testing conducted; device performs according to description.
Lubricity and Catheter Compatibility	Testing conducted; device performs according to description.
Material/Coating Integrity:
Coating Integrity	Testing conducted; device performs according to description.
Biocompatibility	Screening confirmed modifications did not affect biocompatibility.
Functionality:
Simulated Use	Testing conducted; device performs according to description.
Adequately address user needs (via animal studies)	Animal studies conducted to ensure user needs addressed.
Overall Equivalence:
Same intended use as predicate device	Confirmed.
Same operating principle as predicate device	Confirmed.
Same materials as predicate device	Confirmed.
Similar device dimensional specifications as predicate device	Confirmed.
Same shelf life and sterilization process as predicate device	Confirmed.
Similar manufacturing process as predicate device	Confirmed.

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

This document does not describe an "AI/ML test set" in the conventional sense. The "test set" here refers to the guidewire samples used for various preclinical tests.

Sample Size for Test Set: Not specified in the document. The tests like tensile, torque, lubricity, etc., would have involved a sufficient number of device samples per test to generate statistically sound data, but the exact numbers are not provided.
Data Provenance: The preclinical testing was conducted by Codman & Shurtleff, Inc. This is prospective testing of the device itself, not data from patients or a specific country. Animal studies were also conducted, implying live subject data (animals), but specific information on the type of animal or location is not given.

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

This information is not applicable and not provided. The "ground truth" for this medical device submission involves objective physical and mechanical measurements, and direct observation of performance in simulated and animal use. It does not rely on expert interpretation of data like images for AI/ML models.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are relevant for resolving discrepancies in expert interpretations (e.g., radiologists reading images). The preclinical tests described here yield objective measurements or observations of physical performance.

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

This information is not applicable and not provided. An MRMC study is relevant for evaluating the impact of AI on human reader performance, particularly in diagnostic imaging. The NEUROSCOUT Steerable Guidewire is a physical medical device, not an AI/ML product designed to assist human interpretation.

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

This information is not applicable and not provided. This device is a physical guidewire, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation refers to:

Engineering Specifications/Standards: Performance measured against predefined acceptable ranges derived from regulatory guidance (FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995) and the performance characteristics of the predicate devices.
Objective Measurements: Results from tests for tensile strength, torque strength, flexibility, kink radius, lubricity, coating integrity.
Observed Functional Performance: During simulated use and in animal studies to ensure user needs are met.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no mention of a "training set" as this is not an AI/ML device. The device itself is manufactured based on design specifications; it is not "trained" on data.

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

This question is not applicable and not provided for the same reason as point 8.

Summary

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510(k) Summary

A. Submitter Information

MAR 1 6 2010

Submitter's name:	Codman & Shurtleff, Inc.
Address:	325 Paramount DriveRaynham, MA 02767
Telephone:	508-828-2840
Fax:	508-828-2777
Contact Person:	Joan Bartle
Date of Submission:	February 5, 2010
B. Trade/Device Name:	NEUROSCOUT™ Steerable Guidewire
Common Name:	Catheter Guidewire
Classification Name:	Wire, Guide, Catheter
Regulation Number:	870.1330
C. Predicate Device:	AGILITY® Steerable Guidewire (K991646) (.012)AGILITY® Steerable Guidewire (K001033) (.014)AGILITY® Steerable Guidewire (K010511) (.016)
D. Device Description:	The hydrophilically coated NEUROSCOUT 0.014 guidewiresconsist of a stainless steel wire core and a radiopaqueplatinum/tungsten coil on the distal tip. The basic principle of theguidewires is to act as a monorail that catheters can track over toreach a particular area of the neuro and peripheral vasculature.They have a nominal outside diameter of 0.014 inch and nominaloverall length of up to 300 cm.
E. Intended Use:	The NEUROSCOUT Steerable Guidewires are intended forselective placement of microcatheters and other devices within theneuro and peripheral vasculature.

F. Summary of technological characteristics of the proposed to the predicate device:

No new technological characteristics are being introduced with the proposed device. A comparison of the technological characteristics of the proposed device to the predicate device show the proposed device has the following same or similar technological characteristics to the device which received 510(k) clearance:

. Same intended use;
Same operating principle; .
Same materials; .

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Similar device dimensional specifications; .
Same shelf life and sterilization process; .
Similar manufacturing process. .

G. Performance Data:

Preclinical testing data to demonstrate that the device performs according to its description and intended use were used to establish the performance characteristics of the modifications to this device. Clinical testing was not required to establish substantial equivalence. Testing was conducted in accordance with FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995 and included Tensile, Torque Strength, Torqueability, Tip Flexibility/Linear Stiffness, Kink Radius, Lubricity and Catheter Compatibility, Coating Integrity and Simulated Use. Biocompatibility screening was conducted to confirm that modifications did not affect the biocompatibility of the device. Animal studies were conducted to ensure that the user needs were adequately addressed.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MAR 1 6 2010

Codman & Shurtleff, Inc. c/o Joan Q. Bartle Project Manager, Regulatory Affairs 325 Paramount Drive Raynham, MA 02767

Re: K100351

Trade/Device Name: NEUROSCOUT Steerable Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: Class II Product Code: DQX Dated: February 8, 2010 Received: February 12, 2010

Dear Ms. Bartle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Joan Q. Bartle.

、

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

una R. Viher

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K joo 35 1

Device Name: NEUROSCOUT™ Steerable Guidewire

Indications for Use:

The NEUROSCOUTTM Steerable Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Vchmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k)0035 |

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.