(28 days)
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.
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.
The provided document is a 510(k) summary for the Victory Guidewire. It describes the device, its intended use, and the non-clinical performance testing conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance against those criteria. Instead, it describes:
- Acceptance Criteria and Reported Device Performance: This section outlines the in-vitro bench tests performed and states that the results met the defined acceptance criteria and performed comparably to predicate devices. The acceptance criteria themselves are not explicitly detailed with specific numerical thresholds but are implied to be part of the "product specification."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Defined in product specification based on FDA guidance | Met the acceptance criteria defined in the product specification |
| Performed comparably to predicate devices in specified tests | Performed comparably to the predicate device(s) in specified tests |
| Biological safety established through biological risk assessment | Biological safety established through biological risk assessment |
| Biocompatibility testing in compliance with ISO 10993-1 | Biocompatibility testing carried out in compliance with ISO 10993-1 |
- Sample size used for the test set and the data provenance: The document details "In vitro bench tests" for the device, which are performed on physical samples of the guidewire. It does not refer to a "test set" in the context of data for an AI/ML model. The sample sizes for these bench tests are not explicitly stated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the study involves physical product testing, not human-interpreted data for establishing ground truth for an AI/ML model.
- Adjudication method: Not applicable for this type of device testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML device, and no MRMC study was performed.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: The "ground truth" for the bench tests would be the established engineering specifications and performance characteristics of the predicate devices and the industry standards (e.g., FDA guidance, ISO 10993-1).
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Study Description:
The study described is a series of in vitro bench tests conducted to demonstrate the substantial equivalence of the Victory Guidewire to predicate devices. The tests were performed with reference to the FDA's guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995".
The specific bench tests performed include:
- Tensile Strength
- Torque Strength
- Outer Diameter & Length Measurement
- Torque Response
- Catheter Compatibility
- Coating Adherence/Coating Integrity
- Particulate Testing
- Tip Flexibility
In addition to these mechanical and physical tests, biological safety was established through biological risk assessment, chemical characterization, and biocompatibility testing in compliance with ISO 10993-1.
The conclusion of the study was that the Victory Guidewire met the predefined acceptance criteria and performed comparably to its predicate devices, thus demonstrating substantial equivalence.
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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 |
| ApplicationCorrespondent | Kenneth WalshSenior QA/RA EngineerBrivant Ltd, t/a Lake Region Medical International R&D CentreTel: +353 91 385037Fax: +353 91 766598 |
| SummaryPreparation Date | 20th December 2011 |
| Device Name &Classification | Trade Name: Victory GuidewireCommon Name: GuidewireClassification Name: Catheter, GuidewireDevice Classification: Class II, 21 CFR §870.1330Product Code: DQX |
| Intended Use | Indications for Use:The guidewires are intended to facilitate the placement and exchange of ballooncatheters or other interventional devices within the peripheral vasculatureduring Percutaneous Transluminal Angioplasty (PTA) or other intravascularinterventional procedures.Contraindications:The Guidewires are not intended for use in the coronary or cerebral vasculaturesor in patients judged not acceptable for percutaneous intervention. |
| Device Description | The Victory Guidewire range are a disposable medical device designed for singleuse only. The device is intended to facilitate the placement of percutaneousdevices during Percutaneous Transluminal Angioplasty (PTA) in the peripheralvasculature. The family consists of a PTFE coated 195cm or 300cm, 0.014" or0.018" diameter stainless steel core wire, one end of which is reduced indiameter in a progressive fashion through a centreless grinding operation. Theprofile of this reduced section affords the product a reduced area of stiffness andcan be varied to produce 6 various levels of support. |
| Predicate Devices | Manufacturer 510k DateBrivant Ltd K102211 03rd Sept 2010 |
| Principle ofOperation | The Victory guidewire is operated manually by a manual process. |
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| Comparison ofTechnologicalCharacteristics | The technological characteristics are substantially equivalent to the predicatedevices. These performance properties include:- Same length range provided- All devices are constructed with a stainless steel core which is reduced indiameter at the distal end to provide flexibility- The proposed models have equivalent tip stiffness characteristics to thepredicate 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 |
|---|---|
| PerformanceTesting (non-clinical) | In vitro bench tests were carried out to demonstrate equivalence with referenceto the FDAs guidance document "Coronary and Cerebrovascular GuidewireGuidance, 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 FlexibilityThe results from these performance evaluations demonstrated that the Victoryrange met the acceptance criteria defined in the product specification andperformed comparably to the predicate device(s).Biological Safety of the device has been established through biological riskassessment, chemical characterisation and biocompatibility testing carried out incompliance with ISO 10993-1. |
| Conclusions | Based on safety and performance testing, technological characteristics and theindications for use for the device, the Victory Guidewire has been demonstratedto be appropriate for its intended use and is considered to be substantiallyequivalent to the predicate devices. |
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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
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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
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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 |
|---|---|
| --------------- | --------- |
Page 1 of ____
§ 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.