(78 days)
Not Found
No
The description focuses on the physical characteristics and mechanical performance of a guidewire, with no mention of AI or ML.
No
The Intended Use / Indications for Use section states that the device is "indicated to facilitate the placement of percutaneous devices" and "may also be used with compatible stent devices during therapeutic procedures," but it is not a therapeutic device itself. It is an accessory to therapeutic procedures.
No
Explanation: The device is a guidewire used to facilitate the placement of other percutaneous devices during therapeutic procedures like PTA and stent placement. Its intended use is to guide other devices, not to diagnose a condition.
No
The device description clearly states it is a physical guidewire made of stainless steel with a PTFE coating, indicating it is a hardware device, not software only.
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 in vivo (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 the body.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
Therefore, this device is a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for 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.
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 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 measurement
- Torque Response
- Catheter Compatibility
- Coating Adherence/Coating Integrity
- Particulate Testing
- Tip Flexibility
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 biocompatibility testing carried out in compliance with ISO 10993-1. The following biocompatibility tests were performed:
- 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 Injection ISO10993-11
- 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 Partial Thromboplastin Time Assay (UPTT)
- Haemocompatibility Test - Thrombosis: In Vivo Thrombogenicity in Dogs
- Haemocompatibility Test - Complement Activation
- Haemocompatibility Test - Lee& White Coagulation Assay
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.
0
Image /page/0/Picture/0 description: The image shows a logo with the letters "LSRC" stacked on top of each other. Below the letters, the words "The Resource Center" are written in a smaller font. The logo is black and white and appears to be a simple design. The image is slightly blurry.
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. | |||
| 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 | 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 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 |
| | Boston Scientific, V-18 | K033742 | 12th Jan 2004 |
| | Asahi, Treasure | K061984 | 05th Oct 2006 |
| | Asahi, Astato 30 | K071721 | 13th July 2007 |
| Principle of
Operation | The Hi-Torque Connect guidewire is operated manually by a manual process | | |
1
、イ
·
| Hi Torque Connect Guidewire - 510(k) | ||
|---|---|---|
| Comparison of | ||
| Technological | ||
| Characteristics | The technological characteristics are substantially equivalent to the predicate | |
| devices. These performance properties include: |
- Same length range provided
- Same diameter (0.018")
- All devices are constructed with a stainless steel core which is reduced in
diameter at the distal end to provide flexibility - The proposed 3 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 measurement
- Torque Response
- Catheter Compatibility
- Coating Adherence/Coating Integrity
- Particulate Testing
- Tip Flexibility
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 biocompatibility
testing 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 Injection
ISO10993-11 | |
| 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 Partial
Thromboplastin 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 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. | |
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Hi Torque Connect Guidewire - 510(k)
·
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle.
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.
4
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
5
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|