The NEUROSCOUT® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

Device Description

The hydrophilically coated AGILITY® and NEUROSCOUT® Steerable 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 range of 0.012 to 0.016 inches and overall length of up to 350 cm. Guidewire length, diameter, and distal tip configuration are indicated on the product label. A steering/torquing device and a guidewire introducer are packaged with the guidewires.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary:

This 510(k) summary describes a modification to existing AGILITY® and NEUROSCOUT® Steerable Guidewires, specifically material changes and related manufacturing process changes. The submission asserts substantial equivalence to predicate devices, meaning that clinical testing was not required. Therefore, the acceptance criteria and studies are focused on non-clinical (bench and biocompatibility) performance rather than clinical outcomes or human reader performance.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes various tests conducted to verify the modified design. The acceptance criteria for these tests are generally implied to be meeting the performance of the predicate devices or established engineering specifications, but explicit numerical acceptance criteria are not provided in this summary. The reported device performance is stated as "performed according to their description, intended use and the established performance characteristics" and "meet all the same biocompatibility requirements as the predicate devices."

Acceptance Criteria Category	Specific Test	Reported Device Performance
Physical/Mechanical	Visual Inspection	Performed according to their description, intended use, and established performance characteristics (implied to meet visual quality standards).
	Dimensional Inspection	Performed according to their description, intended use, and established performance characteristics (implied to meet dimensional specifications).
	Linear Tip Stiffness	Performed according to their description, intended use, and established performance characteristics.
	Torque Response	Performed according to their description, intended use, and established performance characteristics.
	Tensile Strength (Distal Tip)	Performed according to their description, intended use, and established performance characteristics.
	Tensile Strength (Middle Joint)	Performed according to their description, intended use, and established performance characteristics.
	Tensile Strength (Proximal Joint)	Performed according to their description, intended use, and established performance characteristics.
	Coating Adherence/Integrity (Particulates)	Performed according to their description, intended use, and established performance characteristics.
	Lubricity Testing	Performed according to their description, intended use, and established performance characteristics.
	Torque Strength (Rotations to Failure)	Performed according to their description, intended use, and established performance characteristics.
Biocompatibility	In Vitro Cytotoxicity MEM Elution	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	Sensitization Guinea Pig Maximization	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	Intracutaneous/Irritation Reactivity	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	Acute Systemic Toxicity	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	Material Mediated Rabbit Pyrogenicity	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	In Vitro Bacterial Mutagenicity - Ames Assay	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	In Vitro Mouse Lymphoma Mutagenicity Assay	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	In Vivo Mouse Bone Marrow Micronucleus Assay	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	In Vitro Hemolysis (Direct Contact & Extract)	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	Complement Activation (C3a Assay)	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	Complement Activation (SC5b-9 Assay)	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	Partial Thromboplastin Time (PTT)	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	In Vivo Dog Thrombogenicity	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	USP Physicochemical Tests (Aqueous)	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).
	Physicochemical Tests (Non-Aqueous)	Meet all the same biocompatibility requirements as the predicate devices as specified by ISO 10993 Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices (implied to pass).

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

The document does not specify the exact sample sizes used for each individual bench test (e.g., number of guidewires tested for tensile strength, number of samples for coating adherence). It indicates "Design Verification testing" was conducted.

The data provenance is internal laboratory testing conducted by Codman & Shurtleff, Inc. "Bench testing data demonstrated..." and "Full biocompatibility testing... was conducted." This is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

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

Not applicable. This submission is for a medical device (guidewire) and relies on objective, quantifiable engineering and biological tests rather than expert interpretation of medical images or records. The "ground truth" for the bench tests is defined by the established test methods and specifications, often derived from industry standards (FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995 and ISO 11070:1998, ISO 10993-1). No human experts are involved in establishing ground truth for these types of device performance tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting data (e.g., medical images) to establish a consensus ground truth. For the bench and biocompatibility tests conducted here, the "adjudication" is inherent in the test method itself – a pass/fail criterion based on objective measurements or observations.

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 product is a physical medical device (guidewire), not an AI-powered diagnostic or assistive tool. Clinical studies involving human reader performance or AI assistance are not relevant to its regulatory pathway or the provided testing summary.

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

Not applicable. This product is a physical guidewire, not an algorithm or software. "Standalone performance" in this context refers to the device's inherent physical and biological properties. The bench and biocompatibility tests assess this standalone performance against predefined standards.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the bench tests, the "ground truth" refers to the established performance specifications (e.g., minimum tensile strength, acceptable coating integrity, specific torque response values) that the guidewire must meet. These specifications are derived from:

FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995
ISO 11070:1998 Sterile Single-Use Intravascular Catheter Introducers (though the device is a guidewire, this standard was cited, likely for relevant general requirements for intravascular devices)
Internal engineering specifications designed to ensure the device performs as intended and is equivalent to the predicate.

For biocompatibility tests, the "ground truth" is defined by international standards and regulatory guidance:

ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)
General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices

The device is deemed to meet these "ground truths" if it passes the tests within the defined acceptable parameters.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "training set" concept does not apply to the regulatory submission for this physical medical device.

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

Not applicable. As explained above, there is no training set for this device.

Summary

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510(k) Summary (As Required By 21 CFR 807.92(a))

AUG 1 4 2012

K121776

A. Submitter Information

Codman & Shurtleff, Inc. Submitter's name: Address: 325 Paramount Drive Raynham, MA 02767 Telephone: 508.828.2840 Fax: 508.977.7979 Contact Person: Joan Bartle

Date of Submission June 15, 2012

B. Trade/Device Name:

Common Name: Classification Name: Regulation Number:

AGILITY® Steerable Guidewire NEUROSCOUT® Steerable Guidewire Guidewire Catheter, Guidewire Class II per 21 CFR 870.1330

C. Predicate Devices:
Device . . . . . Company 510(k) Product Predicate For: : Number Code AGILITY Standard Codman & K991646 Intended Use DQX and Soft .010 Shurtleff, Inc. Design Materials Manufacturing Sterilization AGILITY Standard Codman & K001033 Intended Use DQX and Soft .014 Shurtleff, Inc. Design Materials Manufacturing Sterilization AGILITY Standard Codman & K010511 DQX Intended Use and Soft .016 Shurtleff, Inc. Design Materials Manufacturing Sterilization NEUROSCOUT Codman & K100351 DQX Intended Use Standard and Soft Shurtleff, Inc. Design .014 Materials Manufacturing Sterilization

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D. Device Description:

K121776 page

E. Intended Use:

The AGILITY® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

The NEUROSCOUT® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

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

The proposed AGILITY® Steerable Guidewires and NEUROSCOUT® Steerable Guidewires are the same as the currently cleared AGILITY® Steerable Guidewires and NEUROSCOUT® Steerable Guidewires with regard to intended use, function, design, manufacturing and sterilization processes. The proposed device modifications include material changes and the related manufacturing process changes. No new technological characteristics are being introduced with the proposed device.

A summary table including specifications of the proposed device compared with those of the predicate devices follows.

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Comparative Information
Characteristics	AGILITY 10, 14, 16	NEUROSCOUT 14	ProposedDevice
Classification	Class II	Class II	Class II
Intended Use	Selective placement ofmicrocatheters and otherdevices in the neuro andperipheral vasculature	Selective placement ofmicrocatheters andother devices in theneuro and peripheralvasculature	Selective placement ofmicrocatheters andother devices in theneuro and peripheralvasculature
OperatingPrinciple	The basic principle of theguidewires is to act as amonorail that catheterscan track over to reach aparticular area of theneuro and peripheralvasculature.	The basic principle of theguidewires is to act as amonorail that catheterscan track over to reach aparticular area of theneuro and peripheralvasculature.	The basic principle of theguidewires is to act as amonorail that catheterscan track over to reach aparticular area of theneuro and peripheralvasculature.
Shelf Life	2 years	2 years	2 years
Sterilization	EtO	EtO	EtO
GuidewireLength (cm)	100 - 350	100-300	Same as current
GuidewireProximal ShaftMaximumDiameter(inches)	0.0110 - 0.0164	0.0144	Same as current
GuidewireDistal CoilMaximum OuterDiameter(inches)	0.0105 - 0.0155	0.0135	Same as current
CorewireNominalDiameter(inches)	0.009 - 0.015	0.0133	Same as current
CorewireMaterial	Stainless Steel	Stainless Steel	Stainless Steel
CorewireCoating	Hydrophilic	Hydrophilic	Hydrophilic
Tip Style	Straight	Straight	Straight
Tip Shape	Flattened core	Flattened core	Flattened core
Shapeable TipLength (cm)	2 - 5	2	Same as current
Tip Coil Length(Distal Length(cm)	5 - 45	10	Same as current
Coil wire size(inches)	0.0015 - 0.0025	0.002	Same as current
Coil material	Pt/W	Pt/W	Pt/W
Distal TipCoating	Hydrophilic	Hydrophilic	Hydrophilic
RadiopaqueLength (cm)	5 — 45	10	Same as current
Number ofJoints	3	3	3
Joint Type(proximal todistal)	UV x 3	UV x 3	UV x 3

3df 5

K121776 page

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K121776 page 4 of 5

G. Testing Summary:

Design Verification testing was conducted according to FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995 and ISO 11070:1998 Sterile Single-Use Intravascular Catheter Introducers. Bench testing data demonstrated that the AGILITY® Steerable Guidewires and NEUROSCOUT® Steerable Guidewires performed according to their description, intended use and the established performance characteristics. The testing, in conjunction with the similarities to the predicate devices, demonstrates the safety and effectiveness of the modified device for its intended use and determination of substantial equivalence. Clinical testing was not required to establish substantial equivalence.

The following tests were conducted to verify the modified design:

Visual Inspection .
◆ Dimensional Inspection
Linear Tip Stiffness .
Torque Response .
Tensile Strength (Distal Tip) .
Tensile Strength (Middle Joint) .
. Tensile Strength (Proximal Joint)
Coating Adherence/Integrity (Particulates) .
Lubricity Testing ◆
Torque Strength (Rotations to Failure) .

Full biocompatibility testing in accordance with ISO 10993-1 was conducted. demonstrated that the proposed devices meet all Results the same biocompatibility requirements as the predicate devices as specified by ISO 10993

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Part 1 and the General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices.

In Vitro Cytotoxicity MEM Elution .
Sensitization Guinea Pig Maximization .
Intracutaneous/Irritation Reactivity .
. Acute Systemic Toxicity
Material Mediated Rabbit Pyrogenicity .
. In Vitro Bacterial Mutagenicity - Ames Assay
. In Vitro Mouse Lymphoma Mutagenicity Assay
. In Vivo Mouse Bone Marrow Micronucleus Assay
. In Vitro Hemolysis (Direct Contact and Extract)
Complement Activation (C3a Assay)
. Complement Activation (SC5b-9 Assay)
Partial Thromboplastin Time (PTT) .
In Vivo Dog Thrombogenicity .
USP Physicochemical Tests (Aqueous)
Physicochemical Tests (Non-Aqueous) .

The packaging and sterilization for the proposed devices is identical to the packaging and sterilization for the current devices.

Based upon the design, materials, function and intended use comparison with currently marketed devices, and the non-clinical testing performed by Codman & Shurtleff, Inc., it is concluded that the AGILITY® Steerable Guidewires and NEUROSCOUT® Steerable Guidewires are substantially equivalent to the predicate AGILITY® Steerable Guidewires and NEUROSCOUT® Steerable Guidewires.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Codman & Shurtleff. Inc. % Joan Bartle 325 Paramount Dr. Raynham, MA 02767-0350 US

AUG 1 4 2012

Re: K121776

Trade/Device Name: Agility steerable guidewire and NeuroScout steerable guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Guidewire Regulatory Class: Class II Product Code: DQX Dated: June 15, 2012 Received: June 18, 2012

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.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Joan Bartle

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 vours.

CMgKllbe

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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INDICATION FOR USE STATEMENT

510(k) Number (if known): K121776

Device Name:

AGILITY® Steerable Guidewire NEUROSCOUT® Steerable Guidewire

Indications for Use:

The AGILITY® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

The NEUROSCOUT® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

M. Skilleben

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K121776

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.