(32 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a steerable guidewire, with no mention of AI or ML.
No.
The device is described as a guidewire intended for selective placement of microcatheters and other devices, acting as a monorail for catheters, not directly providing therapy.
No
The device description and intended use clearly state that the guidewires are used for the mechanical purpose of guiding other devices (catheters) within the vasculature, not for diagnosing medical conditions.
No
The device description clearly states it is a physical guidewire made of stainless steel and platinum/tungsten, intended for placement within the vasculature. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfusions, or to monitor therapeutic measures.
- Device Description and Intended Use: The NEUROSCOUTTM Steerable Guidewires are described as devices intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature. This is an in vivo (within the living body) procedure, not an in vitro examination of specimens.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological samples, diagnostic testing, or providing information about a physiological or pathological state based on sample analysis.
The NEUROSCOUTTM Steerable Guidewires are a type of interventional medical device used to facilitate procedures within the body's vascular system.
N/A
Intended Use / Indications for Use
The NEUROSCOUT™ Steerable Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.
Product codes
DQX
Device Description
The hydrophilically coated NEUROSCOUT 0.014 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 of 0.014 inch and nominal overall length of up to 300 cm.
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
Preclinical testing data to demonstrate that the device performs according to its description and intended use were used to establish the performance characteristics of the modifications to this device. Clinical testing was not required to establish substantial equivalence. Testing was conducted in accordance with FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995 and included Tensile, Torque Strength, Torqueability, Tip Flexibility/Linear Stiffness, Kink Radius, Lubricity and Catheter Compatibility, Coating Integrity and Simulated Use. Biocompatibility screening was conducted to confirm that modifications did not affect the biocompatibility of the device. Animal studies were conducted to ensure that the user needs were adequately addressed.
Key Metrics
Not Found
Predicate Device(s)
AGILITY® Steerable Guidewire (K991646), AGILITY® Steerable Guidewire (K001033), AGILITY® Steerable Guidewire (K010511)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
A. Submitter Information
MAR 1 6 2010
| Submitter's name: | Codman & Shurtleff, Inc. |
|---|---|
| Address: | 325 Paramount Drive |
| Raynham, MA 02767 | |
| Telephone: | 508-828-2840 |
| Fax: | 508-828-2777 |
| Contact Person: | Joan Bartle |
| Date of Submission: | February 5, 2010 |
| B. Trade/Device Name: | NEUROSCOUT™ Steerable Guidewire |
| Common Name: | Catheter Guidewire |
| Classification Name: | Wire, Guide, Catheter |
| Regulation Number: | 870.1330 |
| C. Predicate Device: | AGILITY® Steerable Guidewire (K991646) (.012) |
| AGILITY® Steerable Guidewire (K001033) (.014) | |
| AGILITY® Steerable Guidewire (K010511) (.016) | |
| D. Device Description: | The hydrophilically coated NEUROSCOUT 0.014 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 of 0.014 inch and nominal | |
| overall length of up to 300 cm. | |
| E. Intended Use: | The NEUROSCOUT Steerable Guidewires are intended for |
| selective placement of microcatheters and other devices within the | |
| neuro and peripheral vasculature. |
F. Summary of technological characteristics of the proposed to the predicate device:
No new technological characteristics are being introduced with the proposed device. A comparison of the technological characteristics of the proposed device to the predicate device show the proposed device has the following same or similar technological characteristics to the device which received 510(k) clearance:
- . Same intended use;
- Same operating principle; .
- Same materials; .
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- Similar device dimensional specifications; .
- Same shelf life and sterilization process; .
- Similar manufacturing process. .
G. Performance Data:
Preclinical testing data to demonstrate that the device performs according to its description and intended use were used to establish the performance characteristics of the modifications to this device. Clinical testing was not required to establish substantial equivalence. Testing was conducted in accordance with FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995 and included Tensile, Torque Strength, Torqueability, Tip Flexibility/Linear Stiffness, Kink Radius, Lubricity and Catheter Compatibility, Coating Integrity and Simulated Use. Biocompatibility screening was conducted to confirm that modifications did not affect the biocompatibility of the device. Animal studies were conducted to ensure that the user needs were adequately addressed.
2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, resembling a bird in flight. The figure is composed of three curved lines that create a sense of movement and dynamism.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
MAR 1 6 2010
Codman & Shurtleff, Inc. c/o Joan Q. Bartle Project Manager, Regulatory Affairs 325 Paramount Drive Raynham, MA 02767
Re: K100351
Trade/Device Name: NEUROSCOUT Steerable Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: Class II Product Code: DQX Dated: February 8, 2010 Received: February 12, 2010
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.
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Page 2 - Ms. Joan Q. Bartle.
、
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 yours,
una R. Viher
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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Indications for Use
510(k) Number (if known): K joo 35 1
Device Name: NEUROSCOUT™ Steerable Guidewire
Indications for Use:
The NEUROSCOUTTM Steerable Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Vchmer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k)0035 |