(57 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of the guidewires, with no mention of AI or ML.
No
The device, guidewires, are intended for selective placement of microcatheters and other devices, acting as a monorail for other devices to reach a particular area. They do not directly provide therapeutic effect.
No
Explanation: The device, a Steerable Guidewire, is intended for the selective placement of microcatheters and other devices. Its function is to facilitate the delivery of other tools, not to provide diagnostic information about a patient's condition.
No
The device description clearly outlines physical components like a stainless steel wire core, platinum/tungsten coil, and packaging with a steering/torquing device and introducer, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the AGILITY® and NEUROSCOUT® Steerable Guidewires are intended for "selective placement of microcatheters and other devices in the neuro and peripheral vasculature." This is an invasive medical procedure performed directly within the patient's body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens or providing diagnostic information based on such analysis.
The device is a tool used during a medical procedure, not a device used to analyze samples outside the body for diagnostic purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQX
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.
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)
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 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.
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.
K991646, K001033, K010511, K100351
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
510(k) Summary (As Required By 21 CFR 807.92(a))
AUG 1 4 2012
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
1
D. 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.
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.
2
| Comparative Information | |||
|---|---|---|---|
| Characteristics | AGILITY 10, 14, 16 | NEUROSCOUT 14 | Proposed |
| Device | |||
| Classification | Class II | Class II | Class II |
| Intended Use | Selective placement of | ||
| microcatheters and other | |||
| devices in the neuro and | |||
| peripheral vasculature | Selective placement of | ||
| microcatheters and | |||
| other devices in the | |||
| neuro and peripheral | |||
| vasculature | Selective placement of | ||
| microcatheters and | |||
| other devices in the | |||
| neuro and peripheral | |||
| vasculature | |||
| Operating | |||
| Principle | 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. | 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. | 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. | |||
| Shelf Life | 2 years | 2 years | 2 years |
| Sterilization | EtO | EtO | EtO |
| Guidewire | |||
| Length (cm) | 100 - 350 | 100-300 | Same as current |
| Guidewire | |||
| Proximal Shaft | |||
| Maximum | |||
| Diameter | |||
| (inches) | 0.0110 - 0.0164 | 0.0144 | Same as current |
| Guidewire | |||
| Distal Coil | |||
| Maximum Outer | |||
| Diameter | |||
| (inches) | 0.0105 - 0.0155 | 0.0135 | Same as current |
| Corewire | |||
| Nominal | |||
| Diameter | |||
| (inches) | 0.009 - 0.015 | 0.0133 | Same as current |
| Corewire | |||
| Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Corewire | |||
| Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| Tip Style | Straight | Straight | Straight |
| Tip Shape | Flattened core | Flattened core | Flattened core |
| Shapeable Tip | |||
| Length (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 Tip | |||
| Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| Radiopaque | |||
| Length (cm) | 5 — 45 | 10 | Same as current |
| Number of | |||
| Joints | 3 | 3 | 3 |
| Joint Type | |||
| (proximal to | |||
| distal) | UV x 3 | UV x 3 | UV x 3 |
3df 5
K121776 page
3
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
4
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.
5
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
6
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
7
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