(71 days)
Not Found
Not Found
No
The document describes a guidewire and its physical properties and modifications. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies. The performance studies focus on biocompatibility and bench testing of the physical device.
Yes
The "Intended Use / Indications for Use" section states that the guidewires are used "to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures." This indicates the device is used in therapeutic contexts.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the guidewires are indicated for use "during diagnostic and/or therapeutic procedures." This indicates that aiding in diagnostic procedures is one of its intended functions.
No
The device description clearly describes a physical guidewire made of stainless steel with a platinum coil and hydrophilic coating, indicating it is a hardware device.
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 guidewires are for "general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures." This describes a device used within the body to facilitate a medical procedure, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description details the physical components of the guidewire (stainless steel, platinum coil, hydrophilic coating, PTFE coating). This aligns with a medical device used for navigation within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This guidewire does not fit that description.
N/A
Intended Use / Indications for Use
The SilverSpeed™, Mirage™, X-celerator™ Exchange , and X-pedion™ Hydrophilic Guidewires are indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
MOF, DQX
Device Description
The Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated on the distal portion. For the Xcelerator ™ Hydrophilic Guidewire labeled as an "Exchange" quidewire, the proximal portion is coated with polytetrafluoroethylene (PTFE). The Exchange guidewire facilitates the exchange of one interventional device for another, while maintaining guidewire position in the anatomy.
The following modifications have been made to the device:
- Change in the degree of polymerization with the base coat . material.
- . Elimination of Brown Oxide pigment from base coat material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, visceral and cerebral 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)
Non-Clinical Performance Data
Biocompatibility Testing
- USP Physiochemical Extraction .
- Cytotoxicity: ISO MEM Elution Using L-929 Mouse Fibroblast Cells
- Sensitization: ISO Guinea Pig Maximization Sensitization . Test
- ISO Intracutaneous Reactivity Test .
- ISO Acute Systemic Injection Test .
- Material Mediated Rabbit Pyrogen Test .
- ASTM Hemolysis Assay Direct Contact Method .
- Complement Activation C3a and SC5b-9 Assay .
Four Hour Thromboresistance Evaluation in Dogs . Bench Testing
- Visual Inspection .
- Tip Buckling (Flexibility) .
- Tip Shapeability .
- Tip Retention .
- . Coating Adherence.
- Friction Test .
- Torque Response
Shelf-life Testing
- 36-month Accelerated Aging .
In addition, no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device.
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.
Not Found
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
1
Device Description:
The Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated on the distal portion. For the Xcelerator ™ Hydrophilic Guidewire labeled as an "Exchange" quidewire, the proximal portion is coated with polytetrafluoroethylene (PTFE). The Exchange guidewire facilitates the exchange of one interventional device for another, while maintaining guidewire position in the anatomy.
The following modifications have been made to the device:
- Change in the degree of polymerization with the base coat . material.
- . Elimination of Brown Oxide pigment from base coat material.
Intended Use:
Non-Clinical Performance Data:
The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
The following tests were performed to support the changes to the Hydrophilic Guidewires:
Biocompatibility Testing
- USP Physiochemical Extraction .
- Cytotoxicity: ISO MEM Elution Using L-929 Mouse Fibroblast Cells
- Sensitization: ISO Guinea Pig Maximization Sensitization . Test
- ISO Intracutaneous Reactivity Test .
- ISO Acute Systemic Injection Test .
- Material Mediated Rabbit Pyrogen Test .
- ASTM Hemolysis Assay Direct Contact Method .
- Complement Activation C3a and SC5b-9 Assay .
Four Hour Thromboresistance Evaluation in Dogs . Bench Testing
- Visual Inspection .
- Tip Buckling (Flexibility) .
- Tip Shapeability .
- Tip Retention .
- . Coating Adherence.
- Friction Test .
- Torque Response
Shelf-life Testing
- 36-month Accelerated Aging .
In addition, no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device.
2
Substantial Equivalence Determination
The information presented in the 510(k) shows that the Hydrophilic Guidewires are substantially equivalent to the predicate devices previously in regards to the identical indications for use, device design, similar device materials, device dimensions, and materials comprising its accessories and final packaging, and design specifications.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread.
March 7,2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Analia Staubly Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K124007
Trade/Device Name: SilverSpeed™, Mirage™, X-celerator™ Exchange, and X-pedion™ Hydrophilic Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: December 21, 2012 Received: December 26, 2012
Dear Ms. Staubly:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Analia Staubly
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K124007
SilverSpeed™, Mirage™, X-celerator™ Exchange, and Device Name: X-pedion™ Hydrophilic Guidewires
Indications For Use:
The SilverSpeed™, Mirage™, X-celerator™ Exchange , and X-pedion™ Hydrophilic Guidewires are indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Victor Krauthamer -S 2013.03.05 18:38:20 -05'00'
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number _ K124007
Page 1 of 1