(28 days)
Not Found
No
The document describes a physical guidewire and its mechanical properties and performance, with no mention of software, algorithms, or AI/ML technologies.
No
The device is a guidewire intended to facilitate the placement and exchange of other interventional devices, rather than directly treating a condition itself.
No
The device description states its intended use is to "facilitate the placement and exchange of balloon catheters or other interventional devices" during medical procedures. This describes an interventional or therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical guidewire made of stainless steel with a PTFE coating, designed for single use in medical procedures. It is a tangible 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 that the guidewires are used to "facilitate the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures." This describes a device used in vivo (within the body) for a medical procedure.
- Device Description: The description details a physical medical device (guidewire) used for navigating within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This guidewire is used in vivo to assist in medical procedures.
N/A
Intended Use / Indications for Use
Indications for Use: The guidewires are intended to facilitate the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures.
Contraindications: The Guidewires are not intended for use in the coronary or cerebral vasculatures or in patients judged not acceptable for percutaneous intervention.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Victory Guidewire range are a disposable medical device designed for single use only. The device is intended to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. The family consists of a PTFE coated 195cm or 300cm, 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and can be varied to produce 6 various levels of support.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
In vitro bench tests were carried out to demonstrate equivalence with reference to the FDAs guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995". The following bench tests were performed: - Tensile Strength - Torque Strength - Outer Diameter & Length Measurement - Torque Response - Catheter Compatibility - Coating Adherence/Coating Integrity - Particulate Testing - Tip Flexibility The results from these performance evaluations demonstrated that the Victory range met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s). Biological Safety of the device has been established through biological risk assessment, chemical characterisation and biocompatibility testing carried out in compliance with ISO 10993-1.
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.
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Image /page/0/Picture/0 description: The image shows a black background with many small white dots scattered across it. The dots are not uniformly distributed, but rather appear to be clustered in certain areas. The overall impression is that of a night sky with many stars, or perhaps a grainy or noisy image.
K120137
FEB 1 4 2012
Victory Guidewire - 510(k)
510(k) Summary – Victory Guidewires Special 510(k)
| Device Name | Victory Guidewire |
|---|---|
| Submitters name | Brivant Ltd, |
| Parkmore West Business Park, | |
| Galway, | |
| Ireland | |
| Application | |
| Correspondent | Kenneth Walsh |
| Senior QA/RA Engineer | |
| Brivant Ltd, t/a Lake Region Medical International R&D Centre | |
| Tel: +353 91 385037 | |
| Fax: +353 91 766598 | |
| Summary | |
| Preparation Date | 20th December 2011 |
| Device Name & | |
| Classification | Trade Name: Victory Guidewire |
| Common Name: Guidewire | |
| Classification Name: Catheter, Guidewire | |
| Device Classification: Class II, 21 CFR §870.1330 | |
| Product Code: DQX | |
| Intended Use | Indications for Use: |
| The guidewires are intended to facilitate the placement and exchange of balloon | |
| catheters or other interventional devices within the peripheral vasculature | |
| during Percutaneous Transluminal Angioplasty (PTA) or other intravascular | |
| interventional procedures. |
Contraindications:
The Guidewires are not intended for use in the coronary or cerebral vasculatures
or in patients judged not acceptable for percutaneous intervention. |
| Device Description | The Victory Guidewire range are a disposable medical device designed for single
use only. The device is intended to facilitate the placement of percutaneous
devices during Percutaneous Transluminal Angioplasty (PTA) in the peripheral
vasculature. The family consists of a PTFE coated 195cm or 300cm, 0.014" or
0.018" diameter stainless steel core wire, one end of which is reduced in
diameter in a progressive fashion through a centreless grinding operation. The
profile of this reduced section affords the product a reduced area of stiffness and
can be varied to produce 6 various levels of support. |
| Predicate Devices | Manufacturer 510k Date
Brivant Ltd K102211 03rd Sept 2010 |
| Principle of
Operation | The Victory guidewire is operated manually by a manual process. |
1
:
.
| Image: [illegible text] | Image: [illegible text] |
|---|---|
| Image: [illegible text] | Image: [illegible text] |
| Image: [illegible text] | Image: [illegible text] |
.
| Comparison of
Technological
Characteristics | The technological characteristics are substantially equivalent to the predicate
devices. These performance properties include:
- Same length range provided
- All devices are constructed with a stainless steel core which is reduced in
diameter at the distal end to provide flexibility - The proposed models have equivalent tip stiffness characteristics to the
predicate devices. - All devices have a hydrophilic coating at the distal tip
- All devices have a PTFE coating on the guidewire shaft
- All devices are sterilized using ETO gas |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Testing (non-
clinical) | In vitro bench tests were carried out to demonstrate equivalence with reference
to the FDAs guidance document "Coronary and Cerebrovascular Guidewire
Guidance, Jan 1995".
The following bench tests were performed: - Tensile Strength
- Torque Strength
- Outer Diameter & Length Measurement
- Torque Response
- Catheter Compatibility
- Coating Adherence/Coating Integrity
- Particulate Testing
- Tip Flexibility
The results from these performance evaluations demonstrated that the Victory
range met the acceptance criteria defined in the product specification and
performed comparably to the predicate device(s).
Biological Safety of the device has been established through biological risk
assessment, chemical characterisation and biocompatibility testing carried out in
compliance with ISO 10993-1. |
| Conclusions | Based on safety and performance testing, technological characteristics and the
indications for use for the device, the Victory Guidewire has been demonstrated
to be appropriate for its intended use and is considered to be substantially
equivalent to the predicate devices. |
- September 2017 11:40
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of 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
FEB 1 4 2012
Brivant, LTD. c/o Mr. Kenneth Walsh Senior OA/RA Engineer Parkmore West Business Park Galway Ireland
Re: K120137
Trade/Device Name: Victory Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Guidewire Regulatory Class: Class II Product Code: DOX Dated: January 9, 2012 Received: January 17, 2012
Dear Mr. Walsh:
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
3
Page 2 - Mr. Kenneth Walsh
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 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 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.
M. J. Zilleben
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if known): | K120137 |
|---|---|
| Device Name: | Victory Guidewire |
| Indications For Use: | The guidewires are intended to facilitate the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures. |
| Contraindications: | The Guidewires are not intended for use in the coronary or cerebral vasculatures or in patients judged not acceptable for percutaneous intervention. |
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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cm A. Willelverne
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K120137 |
|---|---|
| --------------- | --------- |
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