(78 days)
Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.
The Hi-Torque Connect guidewire range are disposable medical devices designed for single use only. They consist of a PTFE coated 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 is varied to produce 3 unique levels of support. Each of these 3 levels of support are provided in 3 different length options (145cm - 300cm)
This document is a 510(k) summary for the Hi Torque Connect Guidewire. It describes the device, its intended use, and the performance testing conducted to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance Tests | Implicitly, the device must perform comparably to predicate devices and meet established product specifications for safe and effective use in its intended application. | The results demonstrated that the Hi-Torque Connect Guidewire range met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).Specific tests included: - Tensile Strength - Torque Strength - Outer Diameter measurement - Torque Response - Catheter Compatibility - Coating Adherence/Coating Integrity - Particulate Testing - Tip Flexibility |
| Biocompatibility Tests | No specific numerical acceptance criteria are given, but the device must demonstrate biological safety based on ISO 10993-1. | The device's biological safety has been established through biocompatibility testing carried out in compliance with ISO 10993-1. Specific tests performed: - Cytotoxicity Study (Qualitative and Quantitative) - Irritation Test (Intracutaneous Injection, ISO 10993-10) - Sensitisation Test (Kligman Maximisation, ISO 10993-10) - Acute Systemic Toxicity Test (Systemic Injection, ISO 10993-11; ISO-Rabbit-Pyrogen) - Haemocompatibility Test (Haematology: Haemolysis, In-vitro Haemocompatiblity Assay; Coagulation: Prothrombin Time Assay (PT), Unactivated Partial Thromboplastin Time Assay (UPTT); Thrombosis: In Vivo Thrombogenicity in Dogs; Complement Activation; Lee & White Coagulation Assay) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the mechanical or biocompatibility testing. The data provenance is not specified beyond indicating "in vitro bench tests" and reference to FDA guidance. Given the nature of a 510(k) submission for a medical device of this type, the testing would generally be conducted in a controlled laboratory environment. This would be considered prospective testing for the purpose of regulatory submission. The country of origin for the testing itself is not stated, but the submitter is Lake Region Medical Limited, Ireland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a medical device (guidewire) premarket notification (510(k)) that focuses on engineering performance and biocompatibility rather than diagnostic accuracy or clinical outcomes that typically involve expert consensus on ground truth. The "ground truth" for these tests are the established scientific and engineering principles, and regulatory standards.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. Test results are compared against predefined specifications and regulatory standards, not expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic imaging device or an AI algorithm intended for interpretation, so MRMC studies are not relevant. This submission focuses on the safety and performance of a physical medical device.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical guidewire, not a standalone algorithm.
7. Type of Ground Truth Used
For the performance testing, the "ground truth" is based on:
- Established engineering specifications and standards: These define acceptable ranges for tensile strength, torque strength, dimensions, etc.
- Predicate device performance: The new device must perform "comparably" to legally marketed predicate devices.
- Regulatory guidance: Specifically, "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995" for mechanical tests, and ISO 10993-1 for biocompatibility.
8. Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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K112381 P. 10f3 NOV - 3 2011
Hi Torque Connect Guidewire - 510(k)
510(k) Summary – Hi Torque Connect Guidewires Traditional 510(k)
| Device Name | Hi Torque Guidewire | ||
|---|---|---|---|
| Submitters name | Lake Region Medical Limited,Butlersland,New Ross,Co. Wexford,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 | 12th August 2011 | ||
| Device Name &Classification | Trade Name: | Hi Torque Connect Guidewire | |
| Common Name: | Guidewire | ||
| Classification Name: | Catheter, Guidewire | ||
| Device Classification: | Class II, 21 CFR §870.1330 | ||
| Product Code: | DQX | ||
| Intended Use | Intended Use:Hi-Torque guide wires are indicated to facilitate the placement of percutaneousdevices during Percutaneous Transluminal Angioplasty (PTA) in peripheralarteries such as femoral, popliteal and infra-popliteal arteries. This guide wiremay also be used with compatible stent devices during therapeutic procedures.Contraindications:Hi-Torque wires are not intended for use in the coronary and cerebralvasculature or in patients judged not acceptable for percutaneous intervention. | ||
| Device Description | The Hi-Torque Connect guidewire range are disposable medical devices designedfor single use only. They consist of a PTFE coated 0.018" diameter stainless steelcore wire, one end of which is reduced in diameter in a progressive fashionthrough a centreless grinding operation. The profile of this reduced sectionaffords the product a reduced area of stiffness and is varied to produce 3 uniquelevels of support. Each of these 3 levels of support are provided in 3 differentlength options (145cm - 300cm) | ||
| Predicate Devices | Manufacturer | 510k | Date |
| Boston Scientific, V-18 | K033742 | 12th Jan 2004 | |
| Asahi, Treasure | K061984 | 05th Oct 2006 | |
| Asahi, Astato 30 | K071721 | 13th July 2007 | |
| Principle ofOperation | The Hi-Torque Connect guidewire is operated manually by a manual process |
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| Hi Torque Connect Guidewire - 510(k) | ||
|---|---|---|
| Comparison ofTechnologicalCharacteristics | The technological characteristics are substantially equivalent to the predicatedevices. These performance properties include:- Same length range provided- Same diameter (0.018")- All devices are constructed with a stainless steel core which is reduced indiameter at the distal end to provide flexibility- The proposed 3 models have equivalent tip stiffness characteristics tothe 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 | |
| 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 measurement- Torque Response- Catheter Compatibility- Coating Adherence/Coating Integrity- Particulate Testing- Tip FlexibilityThe results from these performance evaluations demonstrated that the Hi-Torque Connect Guidewire range met the acceptance criteria defined in theproduct specification and performed comparably to the predicate device(s).Biological Safety of the device has been established through biocompatibilitytesting carried out in compliance with ISO 10993-1. | |
| The following biocompatibility tests were performed | ||
| Test Description | Test Method | |
| Cytotoxicity Study | Qualitative Evaluation - Dye Exclusion &Microscopial Evaluation | |
| Cytotoxicity Study | Quantitative Evaluation - MTT or XTT Assay | |
| Irritation Test | Intracutaneous Injection (ISO10993-10) | |
| Sensitisation Test | Kligman Maximisation (ISO10993-10) | |
| Acute Systemic Toxicity Test | Systemic InjectionISO10993-11 | |
| Acute Systemic Toxicity Test | ISO-Rabbit-Pyrogen | |
| Haemocompatibility Test | Haematology: Haemolysis – rabbit blood- Direct(Complete ASTM Method) | |
| Haemocompatibility Test | Haematology:In-vitro Haemocompatiblity Assay | |
| Haemocompatibility Test | Coagulation: The Prothrombin Time Assay (PT) | |
| Haemocompatibility Test | Coagulation: The Unactivated PartialThromboplastin Time Assay (UPTT) | |
| Haemocompatibility Test | Thrombosis: In Vivo Thrombogenicity in Dogs | |
| Haemocompatibility Test | Complement Activation | |
| Haemocompatibility Test | Lee& White Coagulation Assay | |
| Conclusions | Based on safety and performance testing, technological characteristics and theindications for use for the device, the Hi-Torque Connect Guidewire has beendemonstrated to be appropriate for its intended use and is considered to besubstantially equivalent to the predicate devices. |
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Hi Torque Connect Guidewire - 510(k)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 3 2011
Lake Region Medical Limited c/o Kenneth Walsh Senior QA/RA Engineer Brivant Limited Lake Region Medical International R&D Center Parkmore West Business Galway, Ireland
Re: K112381
Trade/Device Name: Hi Torque Connect Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: July 21, 2011 Received: August 17, 2011
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. However, we remind you 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 - Mr. Kenneth Walsh
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 devicerelated 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Hi Torque Connect Guidewire - 510(k)
Image /page/5/Picture/1 description: The image contains the text "Indications for Use Statement". The text is in a bold, sans-serif font. The words are underlined with a solid black line. The background of the image is white.
HI TORQUE GUIDEWIRE
510(k) Number (if known):
Device Name:
11238
Hi-Torque guide wires are indicated to facilitate the Indications for Use: placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures. Hi-Torque wires are not intended for use in the coronary Contraindications:
and cerebral vasculature or in patients judged not acceptable for percutaneous intervention.
(Division Sig/-C
Division of Carc...e Devices
510(k) Number K11238|
§ 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.