(288 days)
No
The description focuses on the physical characteristics and mechanical performance of a guidewire, with no mention of AI or ML.
No.
The guide wire is used to facilitate the placement of devices; it does not directly provide therapy. It may be used during therapeutic procedures, but it is not a therapeutic device itself.
No.
Explanation: The device is a guidewire used to facilitate the placement of other percutaneous devices during therapeutic procedures. Its purpose is to aid in the delivery of treatment, not to diagnose a condition.
No
The device description clearly states it is a physical guidewire made of stainless steel with a PTFE coating, which is a hardware component.
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 device is used to "facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries" and "with compatible stent devices during therapeutic procedures." This describes a device used within the body for a therapeutic or interventional procedure.
- Device Description: The description details a physical guidewire made of stainless steel with a PTFE coating, designed to be inserted into blood vessels. This is consistent with an invasive medical device used for navigation and support during procedures.
- 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 compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body to assist with medical procedures.
N/A
Intended Use / Indications for Use
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.
Contraindications:
Hi-Torque wires are not intended for use in the coronary and cerebral vasculature or in patients judged not acceptable for percutaneous intervention.
Product codes
DQX
Device Description
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries such as femoral, popliteal and infra-popliteal arteries.
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 of the existing design to the modified design with reference to the FDAs guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995".
This testing demonstrates improved coating adhesion properties of the new PTFE coating and that the new process for application of the PTFE coating does not adversely affect other performance characteristics of the wire.
The following bench tests were performed:
- Tensile Strength
- Torque Strength
- Dimensional Verification
- Torque Response
- Catheter Compatibility
- Coating Adherence/Coating Integrity
- Particulate Testing
- Tip Flexibility
- PTFE Coating Adhesion
- PTFE Coating Durability
The results from these performance evaluations 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2014
Lake Region Medical Mr. Kenneth Walsh Quality Manager Parkmore West Business Park Galway, Ireland
Re: K140536
Trade/Device Name: Hi Torque Connect Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: October 28, 2014 Received: November 3, 2014
Dear Mr. Walsh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to
1
proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K140536
Device Name
Hi Torque Connect Guidewire
Indications for Use (Describe)
Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, poplited anteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Product: Hi Torque Connect Guidewire Submission Type: Traditional 510(k) Submission Date: March 28, 2014
510(k) Summary
| Device Name | Hi Torque Connect Guidewire | ||
|---|---|---|---|
| Submitters name | Lake Region Medical Limited, | ||
| Butlersland, | |||
| New Ross, | |||
| Co. Wexford, | |||
| Ireland. | |||
| Application | Kenneth Walsh | ||
| Correspondent | Regulatory Affairs Group Leader | ||
| Lake Region Medical Limited | |||
| Tel: +353 91 385037 | |||
| Fax: +353 91 766598 | |||
| Summary Preparation | 28th March 2014 | ||
| Date | |||
| Device Name & | Trade Name: | Hi Torque Connect Guidewire | |
| Classification | 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 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. | |||
| Contraindications: | |||
| Hi-Torque wires are not intended for use in the coronary and cerebral vasculature or in | |||
| patients judged not acceptable for percutaneous intervention. | |||
| Device Description | 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) | |||
| Predicate Devices | Manufacturer | 510k | Date |
| Hi Torque Connect Guidewire | K112381 | 03rd Nov 2011 | |
| Principle of Operation | The Hi-Torque Connect guidewire is operated manually by a manual process | ||
| Comparison of | This design change involves a change in the PTFE coating formulation applied to the | ||
| Technological | proximal shaft of the guidewire. No other changes are proposed to the device. | ||
| Characteristics | |||
| Performance Testing | In vitro bench tests were carried out to demonstrate equivalence of the existing design | ||
| (non-clinical) | to the modified design with reference to the FDAs guidance document "Coronary and | ||
| Cerebrovascular Guidewire Guidance, Jan 1995". | |||
| This testing demonstrates improved coating adhesion properties of the new PTFE coating | |||
| and that the new process for application of the PTFE coating does not adversely affect | |||
| other performance characteristics of the wire. | |||
| The following bench tests were performed: | |||
| - Tensile Strength |
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ි Lake Regi Medical®
Product: Hi Torque Connect Guidewire Submission Type: Traditional 510(k) Submission Date: March 28, 2014
| - | Torque Strength |
|---|---|
| - | Dimensional Verification |
| - | Torque Response |
| - | Catheter Compatibility |
| - | Coating Adherence/Coating Integrity |
| - | Particulate Testing |
| - | Tip Flexibility |
| - | PTFE Coating Adhesion |
| - | PTFE Coating Durability |
| The results from these performance evaluations 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). | |
| Biological Safety of the device has been established through successful use of the same | |
| materials and manufacturing process in current 510(k) approved Lake Region Medical | |
| product. | |
| Conclusions | Based on safety and performance testing, technological characteristics and the |
| indications for use for the device, the Hi-Torque Connect Guidewire has been | |
| demonstrated to be appropriate for its intended use and is considered to be substantially | |
| equivalent to the predicate devices. |