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 consists of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. 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 AGILITY® and NEUROSCOUT® Guidewires.

AI/ML Overview

The provided text describes a 510(k) submission (K133625) for a packaging change to the AGILITY® and NEUROSCOUT® Steerable Guidewires. It largely focuses on demonstrating that the packaging changes only do not alter the fundamental technology or intended use of the previously cleared predicate devices (K121776).

Therefore, the study described is not for the performance of the guidewires themselves in their intended clinical use, but rather for the integrity and safety of the new packaging. The acceptance criteria and "device performance" consequently pertain to packaging validation, sterilization validation, and biocompatibility, not to the clinical efficacy or accuracy of an AI or medical device for which such metrics usually apply.

Given this context, the request cannot be fully answered as it typically would for a device demonstrating clinical performance or AI algorithm performance. Many of the requested fields (e.g., multi-reader multi-case study, effect size of human readers with AI, training set size, ground truth for training set) are not applicable to this type of submission focused on packaging changes for a steerable guidewire.

However, I will extract the information that is present concerning the validation of the packaging changes.

Acceptance Criteria and Study for Packaging Modifications of AGILITY® and NEUROSCOUT® Steerable Guidewires (K133625)

The study described in this 510(k) submission (K133625) is not for the device's functional performance in a clinical setting, but rather for the packaging modifications to the AGILITY® and NEUROSCOUT® Steerable Guidewires, demonstrating substantial equivalence to the predicate device. The primary objective was to ensure that the new packaging maintained sterility, integrity, and safety.

1. Table of Acceptance Criteria and Reported Device Performance (Packaging)

Category	Acceptance Criteria	Reported Device Performance (Based on "Bench Testing" and "Sterilization Validation" sections for packaging)
Packaging Validation	Visual Inspection: (Implied: No defects, damage, or compromise to sterile barrier)Dye Leak: (Implied: No leaks to indicate compromise of sterile barrier)Seal Strength: (Implied: Seals meet predefined strength requirements to maintain package integrity)	"Verification and validation activities were focused on demonstrating package integrity of the proposed pouches... all testing was performed on final sterile product." (Implied: All tests passed, as package was deemed substantially equivalent and cleared.)
Sterilization Validation	EO/ECH Residuals: (Implied: Residuals of Ethylene Oxide (EO) and its byproducts (e.g., Ethylene Chlorohydrin - ECH) must be below acceptable limits according to ISO 11135-1:2007 and ISO 10993-7:2008 standards to ensure patient safety and product biocompatibility.)	"EO/ECH Residuals" testing was conducted. (Implied: Results met the acceptance criteria, as the submission states, "does not raise any new questions of safety and effectiveness.")
Sterile Pouch Shelf-Life Stability Validation	Visual Inspection: (Implied: No degradation, damage, or compromise to sterile barrier over time)Dye Leak: (Implied: No leaks over time)Seal Strength: (Implied: Seals maintain required strength over the stated shelf-life)(Stated Shelf-Life: Two (2) years)	Testing conducted for two (2) years shelf-life. (Implied: All stability tests passed for the two-year shelf-life, as the device was cleared without new safety or effectiveness concerns.)
Biocompatibility Testing	In vitro Cytotoxicity: (Implied: Absence of cytotoxic effects, meeting ISO 10993-5:2009 standards for any leachable substances from the new packaging interacting with the device or patient.)	"In vitro Cytotoxicity" testing was conducted. (Implied: Results met the acceptance criteria, as the submission states that the device is "substantially equivalent" and raises "no new questions of safety and effectiveness.")

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

Sample Size for Test Set: Not explicitly stated in the document. The text indicates "appropriate testing was identified" and "all testing was performed on final sterile product" for packaging validation, sterilization validation, and shelf-life stability. Specific numbers of units tested are not provided.
Data Provenance: The studies were prospective bench tests performed by the manufacturer, Codman & Shurtleff, Inc. The country of origin for the data is not specified but is presumably where the manufacturing and testing facilities of Codman & Shurtleff, Inc. are located (e.g., USA, as the company is based in Raynham, MA).

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

This information is not applicable to this submission concerning packaging modifications. "Ground truth" in the requested sense (e.g., expert consensus on medical images or diagnoses) is not relevant for testing packaging integrity, sterilization residuals, or biocompatibility.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for clinical endpoints or image interpretations where multiple experts assess a case. The tests performed here (e.g., dye leak, seal strength, chemical residuals) are objective, quantitative measurements that do not require expert adjudication in that manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC study was not done. This type of study is for evaluating the clinical performance of a diagnostic or therapeutic device by comparing human reader performance with and without AI assistance. This submission is for packaging changes to a guidewire, not an AI-enabled diagnostic device.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable. The device is a steerable guidewire; it does not involve an algorithm or AI.

7. Type of Ground Truth Used

For the packaging validation, the "ground truth" would be established by objective technical standards and specifications (e.g., dye penetration not exceeding a certain limit, seal strength within a defined range, chemical residuals below a specified ppm). These are based on recognized industry standards (listed in Table 4) and regulatory requirements for medical device packaging and sterilization.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable.

Summary

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K133625

FEB 2 4 2014

510(k) Summary

[As Required By 21 CFR 807.92(a)]

A. Sponsor
Submitter's Name:	Codman & Shurtleff, Inc.
Address:	325 Paramount Drive
	Raynham, MA 02767
Primary Contact:	Hannah Foley
Telephone:	(305) 265-6810
Fax:	(305) 265-6889
Secondary Contact:	Amarilys Machado
Telephone:	(305) 265-6869
Fax:	(305) 265-6889
B. Date Prepared:	November 25, 2013

C. Device Name and Classification:

Proprietary Name:	AGILITY® Steerable Guidewire andNEUROSCOUT® Steerable Guidewire
Common/Usual Name:	Wire, Guide, CatheterNeurovascular
Classification Name:	Catheter Guide Wire (21 CFR 870.1330), Class II
Product Code:	MOF, DQX

D. Predicate Devices

This 510(k) submission provides pre-market notification of the AGILITY® and NEUROSCOUT® Steerable Guidewires' packaging change. The proposed packaging changes have not altered the fundamental technology of the predicate devices or the devices' intended use.

Table 1: Prior 510(k) Clearances
510(k)Number	DateCleared	Name	Manufacturer
PredicateK121776	08/14/2012	AGILITY® Steerable Guidewiresand NEUROSCOUT® SteerableGuidewires	Codman &Shurtleff, Inc.

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E. Device Description

F. Indications for Use

The Codman AGILITY® and NEUROSCOUT® Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.

G. Summary of Technological Characteristics of the Proposed Device to the Predicate Device

The proposed AGILITY and NEUROSCOUT Steerable Guidewires are identical to the predicate AGILITY and NEUROSCOUT Steerable Guidewires with regard to intended use, design, material, function, mechanism of action, clinical utility, manufacturing and sterilization process.

The AGILITY® and NEUROSCOUT® Steerable Guidewires were shown to be substantially equivalent to the predicate devices through comparison of indications for use, function, operating principle, bench testing, biocompatibility, and materials. A summary table including characteristics of the proposed device compared with those of the predicate device is provided in Table 2.

Table 2: Predicate Comparison Profile
	Predicate Device:AGILITY® &NEUROSCOUT® SteerableGuidewires	This Submission:Device w/ ProposedPackaging Change:AGILITY® SteerableGuidewire	This Submission:Device w/ ProposedPackaging Change:NEUROSCOUT®Steerable Guidewire
Description	(K121776)
Intended Use	The Codman AGILITY® andNEUROSCOUT® Guidewiresare intended for selectiveplacement of microcathetersand other devices within theneuro and peripheralvasculature.	Same	Same
Product Code	DQX	Same	Same
Classification	21 CFR 870.1330,Class II	Same	Same
Guidewire Length (cm)	AGILITY®:175cm, 195cm, 205cm, &350cmNEUROSCOUT®:	Same	Same

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Table 2: Predicate Comparison Profile
Description	Predicate Device:AGILITY® &NEUROSCOUT® SteerableGuidewires(K121776)205cm & 300cm	This Submission:Device w/ ProposedPackaging Change:AGILITY® SteerableGuidewire	This Submission:Device w/ ProposedPackaging Change:NEUROSCOUT®Steerable Guidewire
Guidewire Proximal ShaftMaximum Diameter(Inches)	AGILITY®:0.0110"(10), 0.0144"(14), &0.0164" (16)NEUROSCOUT®:0.0144" (14)	Same	Same
Shapeable Tip Length(cm)	2cm-5cm	Same	Same
Radiopaque Length(cm)	AGILITY®:5cm-45cmNEUROSCOUT®:10cm	Same	Same
Corewire Material	Stainless Steel	Same	Same
Coil Material	Platinum/ Tungsten	Same	Same
Corewire & Distal Tip Coating	Hydrophilic	Same	Same
Tip Style	Straight	Same	Same
Sterilization Method	Ethylene Oxide	Same	Same
Product Shelf-Life	Two (2) years	Same	Same

There are no new technological characteristic being introduced with the proposed packaging changes to the AGILITY® and NEUROSCOUT® Guidewires. The only differences are the packaging. modifications identified for both products, which are summarized in Table 3.

Table 3: AGILITY® and NEUROSCOUT® Steerable Guidewires Packaging Modifications
Description	ProposedAGILITY® Steerable Guidewire	Proposed NEUROSCOUT®Steerable Guidewire
Sterile Pouch Dimensions	X	X
Sterile Pouch Material:(Uncoated Tyvek 1073B)	X	X
Sterile Pouch Material:(Nylon/Polyethylene Film)	X	No Change
Sterile Pouch Vendor	X	No Change
Carton Dimensions	X	X
Carton Vendor	X	X
Hoop DispenserConfiguration	X*	No Change

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H. Summary of Nonclinical testing:

The AGILITY® and NEUROSCOUT® Steerable Guidewires were evaluated and have been found to be substantially equivalent to the predicate devices in terms of intended use, design, material, function, mechanism of action, clinical utility, manufacturing and sterilizationprocess. The testing conducted to assess the packaging modifications includes performance assessment per the following recognized standards:

Table 4: Performance Standards
Standard	Description
ISO 11135-1:2007	Sterilization of health care products Ethylene Oxide Part 1
ISO 10993-1:2009	Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing
ISO 10993-7:2008	Biological Evaluation of Medical Devices Part 7: Ethylene oxide sterilization residuals
ISO 14971: 2012	Medical Device - Application of Risk Management to Medical Devices
HE75 : 2009	Human Factors Engineering - Design of Medical Devices
ISO 11607-1: 2009	Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials.sterile barrier systems and packaging systems
ISO 10993-5:2009	Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity

Bench Testing

There were no changes made that affect the AGILITY and NEUROSCOUT steerable guidewires' intended use, operational principle, design principle, manufacturing or sterilization processes. The modifications proposed in this submission are for the packaging only. Therefore, design verification and validation of the devices was not warranted.

Verification and validation activities were focused on demonstrating package integrity of the proposed pouches. Appropriate testing was identified based on a review of the products' risk analyses and previous use of the new pouch materials. Testing was conducted as appropriate for the inclusion of the proposed pouches based on current standards, and all testing was performed on final sterile product.

The following testing was conducted:

Packaging Validation

o Visual Inspection
O Dye Leak
o Seal Strength

Sterilization Validation

o EO/ECH Residuals

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Sterile Pouch Shelf-Life Stability Validation

Visual Inspection o
o Dye Leak
Seal Strength o

Biocompatibility Testing

o In vitro Cytotoxicity

I. Animal Testing

No animal studies were required as appropriate verification and validation of the packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.

J. Summary of Clinical testing:

No clinical studies were required as appropriate verification and validation of the packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.

Conclusion:

Based upon the design, materials, function, intended use, and the non-clinical testing performed by Codman it is concluded that the proposed packaging for the AGILITY® and NEUROSCOUT® Steerable Guidewire is substantially equivalent to the current AGILITY® and NEUROSCOUT® Steerable Guidewire (K121776), and therefore, does not raise any new questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

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

February 24, 2014

Codman & Shurtleff, Inc. % Ms. Hannah Foley Regulatory Affairs Specialist II Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767

Re: K133625

Trade/Device Name: AGILITY and NEUROSCOUT Steerable Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Neurovascular Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Additional Procode: DQX Dated: January 28, 2014 Received: January 29, 2014

Dear Ms. Foley,

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

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Page 2 - Ms. Hannah Foley

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133625

Device Name

AGILITY® Steerable Guidewire, NEUROSCOUT® Steerable Guidewire

Indications for Use (Describe)

The AGILITY® Steerable Guidewires are intended for selective placement of microcathers 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.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena -S

FORM FDA 3881 (1/14)

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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.