(90 days)
Not Found
No
The document describes a physical medical device (guidewires) and its packaging modifications. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on packaging integrity and biocompatibility, not algorithmic performance.
No.
The device is a guidewire intended for selective placement of microcatheters and other devices, not for directly treating a medical condition.
No
The device is described as guidewires intended for selective placement of microcatheters and other devices in the vasculature, which is an interventional function, not a diagnostic one.
No
The device description clearly states it consists of a stainless steel wire core and a radiopaque platinum/tungsten coil, which are physical hardware components. The submission focuses on packaging modifications for these physical guidewires.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for "selective placement of microcatheters and other devices in the neuro and peripheral vasculature." This describes a surgical or interventional procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical guidewire used for navigation within blood vessels. This is consistent with a medical device used in a procedure, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MOF, DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
ISO 11135-1:2007
ISO 10993-1:2009
ISO 10993-7:2008
ISO 14971: 2012
HE75 : 2009
ISO 11607-1: 2009
ISO 10993-5:2009
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
Sterile Pouch Shelf-Life Stability Validation
Visual Inspection o
o Dye Leak
Seal Strength o
Biocompatibility Testing
o In vitro Cytotoxicity
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
NEUROSCOUT® Steerable Guidewire |
|----------------------|---------------------------------------------------------------------|
| Common/Usual Name: | Wire, Guide, Catheter
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) | |||
| Number | Date | ||
| Cleared | Name | Manufacturer | |
| Predicate | |||
| K121776 | 08/14/2012 | AGILITY® Steerable Guidewires | |
| and NEUROSCOUT® Steerable | |||
| Guidewires | Codman & | ||
| Shurtleff, Inc. |
1
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: | |||
| AGILITY® & | |||
| NEUROSCOUT® Steerable | |||
| Guidewires | This Submission: | ||
| Device w/ Proposed | |||
| Packaging Change: | |||
| AGILITY® Steerable | |||
| Guidewire | This Submission: | ||
| Device w/ Proposed | |||
| Packaging Change: | |||
| NEUROSCOUT® | |||
| Steerable Guidewire | |||
| Description | (K121776) | ||
| Intended Use | The Codman AGILITY® and | ||
| NEUROSCOUT® Guidewires | |||
| are intended for selective | |||
| placement of microcatheters | |||
| and other devices within the | |||
| neuro and peripheral | |||
| vasculature. | Same | Same | |
| Product Code | DQX | Same | Same |
| Classification | 21 CFR 870.1330, | ||
| Class II | Same | Same | |
| Guidewire Length (cm) | AGILITY®: | ||
| 175cm, 195cm, 205cm, & | |||
| 350cm | |||
| NEUROSCOUT®: | Same | Same |
2
| Table 2: Predicate Comparison Profile | |||
|---|---|---|---|
| Description | Predicate Device: | ||
| AGILITY® & | |||
| NEUROSCOUT® Steerable | |||
| Guidewires | |||
| (K121776) | |||
| 205cm & 300cm | This Submission: | ||
| Device w/ Proposed | |||
| Packaging Change: | |||
| AGILITY® Steerable | |||
| Guidewire | This Submission: | ||
| Device w/ Proposed | |||
| Packaging Change: | |||
| NEUROSCOUT® | |||
| Steerable Guidewire | |||
| Guidewire Proximal Shaft | |||
| Maximum 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-45cm | |||
| NEUROSCOUT®: | |||
| 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 | |
| AGILITY® 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 Dispenser | ||
| Configuration | X* | No Change |
3
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
4
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.
5
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
6
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
7
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)
8
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