AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &
Device Facts
| Record ID | K133625 |
|---|---|
| Device Name | AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & |
| Applicant | Codman & Shurtleff, Inc. |
| Product Code | MOF · Cardiovascular |
| Decision Date | Feb 24, 2014 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1330 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
AGILITY and NEUROSCOUT steerable guidewires consist of stainless steel wire core with radiopaque platinum/tungsten distal tip coil; hydrophilic coating applied to core and tip. Device used by physicians in clinical settings for selective placement of microcatheters and other interventional devices within neuro and peripheral vasculature. Guidewire provides trackability and steerability to navigate complex vascular anatomy. Packaging change only; no changes to device design, materials, or function.
Clinical Evidence
No clinical data. Bench testing only.
Technological Characteristics
Stainless steel core; platinum/tungsten distal coil; hydrophilic coating. Sterilization via Ethylene Oxide. Standards: ISO 11135-1, ISO 10993-1/5/7, ISO 14971, ISO 11607-1, HE75.
Indications for Use
Indicated for selective placement of microcatheters and other devices within the neuro and peripheral vasculature in patients requiring neurovascular or peripheral vascular intervention.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- AGILITY® Steerable Guidewires and NEUROSCOUT® Steerable Guidewires (K121776)
Submission Summary (Full Text)
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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 and<br>NEUROSCOUT® Steerable Guidewire |
|----------------------|---------------------------------------------------------------------|
| Common/Usual Name: | Wire, Guide, Catheter<br>Neurovascular |
| 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)<br>Number | Date<br>Cleared | Name | Manufacturer |
| Predicate<br>K121776 | 08/14/2012 | AGILITY® Steerable Guidewires<br>and NEUROSCOUT® Steerable<br>Guidewires | Codman &<br>Shurtleff, Inc. |
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# E. 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.
# 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:<br>AGILITY® &<br>NEUROSCOUT® Steerable<br>Guidewires | This Submission:<br>Device w/ Proposed<br>Packaging Change:<br>AGILITY® Steerable<br>Guidewire | This Submission:<br>Device w/ Proposed<br>Packaging Change:<br>NEUROSCOUT®<br>Steerable Guidewire |
| Description | (K121776) | | |
| Intended Use | The Codman AGILITY® and<br>NEUROSCOUT® Guidewires<br>are intended for selective<br>placement of microcatheters<br>and other devices within the<br>neuro and peripheral<br>vasculature. | Same | Same |
| Product Code | DQX | Same | Same |
| Classification | 21 CFR 870.1330,<br>Class II | Same | Same |
| Guidewire Length (cm) | AGILITY®:<br>175cm, 195cm, 205cm, &<br>350cm<br>NEUROSCOUT®: | Same | Same |
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| Table 2: Predicate Comparison Profile | | | |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Description | Predicate Device:<br>AGILITY® &<br>NEUROSCOUT® Steerable<br>Guidewires<br>(K121776)<br>205cm & 300cm | This Submission:<br>Device w/ Proposed<br>Packaging Change:<br>AGILITY® Steerable<br>Guidewire | This Submission:<br>Device w/ Proposed<br>Packaging Change:<br>NEUROSCOUT®<br>Steerable Guidewire |
| Guidewire Proximal Shaft<br>Maximum Diameter<br>(Inches) | AGILITY®:<br>0.0110"(10), 0.0144"(14), &<br>0.0164" (16)<br>NEUROSCOUT®:<br>0.0144" (14) | Same | Same |
| Shapeable Tip Length<br>(cm) | 2cm-5cm | Same | Same |
| Radiopaque Length<br>(cm) | AGILITY®:<br>5cm-45cm<br>NEUROSCOUT®:<br>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 | Proposed<br>AGILITY® Steerable Guidewire | Proposed NEUROSCOUT®<br>Steerable Guidewire |
| Sterile Pouch Dimensions | X | X |
| Sterile Pouch Material:<br>(Uncoated Tyvek 1073B) | X | X |
| Sterile Pouch Material:<br>(Nylon/Polyethylene Film) | X | No Change |
| Sterile Pouch Vendor | X | No Change |
| Carton Dimensions | X | X |
| Carton Vendor | X | X |
| Hoop Dispenser<br>Configuration | 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.<br>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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