(197 days)
No
The summary describes a physical wire guide and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "wire guide" used for "complex diagnostic and interventional procedures," indicating its direct involvement in medical interventions, which is characteristic of a therapeutic device.
No
The device description indicates it is a "PTFE-coated 0.035 inch stainless steel wire" used in "interventional procedures" to "control large diameter, stiff devices." This describes a tool used during procedures, not a device that provides diagnostic information.
No
The device description clearly states it is a physical wire guide made of stainless steel with a PTFE coating and gold coil, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for "complex diagnostic and interventional procedures" where it acts as a guide wire. This is a tool used during a procedure, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical wire guide used to navigate within the body. This is consistent with an interventional device, not an IVD.
- Performance Studies: The performance studies focus on the physical properties and performance of the wire guide itself (biocompatibility, surface tests, friction, flexing, tensile force, etc.). These are typical tests for a medical device used within the body, not for an IVD which would focus on analytical performance (sensitivity, specificity, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the device described is a medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide is needed.
Product codes
DOX
Device Description
The subject device, the Lunderquist Extra Stiff DC Wire Guide with an extended double curved tip, is considered a line extension of the predicate Lunderquist Extra Stiff DC Wire Guides. The subject device is a PTFE-coated 0.035 inch stainless steel wire with a 4 cm flexible tip that includes an inner gold coil for enhanced visibility. The length of the device is either 260 cm or 300 cm and the J-curve radius is 15 mm. The devices have the body and stiffness required to control large diameter, stiff devices without causing damage to the patient's anatomy or the lumen of the delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The following tests were performed to demonstrate that the Lunderquist Extra Stiff DC Wire Guide - Extended Double Curved met applicable design and performance requirements and support a determination of substantial equivalence.
- Biocompatibility Testing - Tested in accordance with ISO 10993-1:2009. The pre-determined acceptance criteria were met.
- Surface test - Tested in accordance with EN ISO 11070. The predetermined acceptance criteria were met.
- Tape adhesion test - Evaluation of PTFE coating adhesion. The pre-determined acceptance criteria were met.
- Friction test - Evaluation of device performance. The predetermined acceptance criteria were met.
- Flexing test - Tested in accordance with EN ISO 11070. The predetermined acceptance criteria were met.
- Peak tensile force - Tested in accordance with EN ISO 11070. The pre-determined acceptance criteria were met.
- Ultrasound test - Evaluation of PTFE coating adhesion. The predetermined acceptance criteria were met.
- Simulated Use Test – Evaluation of device performance in a bench top model under conditions intended to simulate use. The predetermined acceptance criteria were met.
- Torque test - Evaluation of device performance. The predetermined acceptance criteria were met.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
December 7, 2017
William Cook Europe ApS Henriette Christiansen Director of Regulatory Affairs Sandet 6 DK-4632 Bjaeverskov, Denmark
Re: K171513
Trade/Device Name: Lunderquist Extra Stiff Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: November 3, 2017 Received: November 7, 2017
Dear Henriette Christiansen:
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. Iisting 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 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 and Part 809); medical device 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.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
M.A. Willemen
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) K171513
Device Name Lunderquist Extra Stiff Wire Guide
Indications for Use (Describe)
The device is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide is needed.
| 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)
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5.0 510(k) SUMMARY
Lunderquist Extra Stiff Wire Guide 21 CFR § 870.1330 Date Prepared: May 23, 2017
Submitted By:
| Applicant: | William Cook Europe ApS |
|---|---|
| Contact: | Lene Vittrup Foged |
| Applicant Address: | William Cook Europe ApS |
| Sandet 6 | |
| DK-4632 Bjaeverskov, Denmark | |
| Contact Phone Number: | +45 56 86 88 59 |
| Contact Fax Number: | +45 56 86 86 96 |
Device Information:
| Trade Name: | Lunderquist® Extra Stiff Wire Guide |
|---|---|
| Common Name: | Catheter Guide Wire / Wire, Guide, Cathete |
| Classification Name: | Catheter Guide Wire |
| Proposed Classification: | 870.1330 DQX Class II, Cardiovascular |
Predicate Devices:
The Lunderquist Extra Stiff Wire Guide and Lunderquist Extra Stiff DC Wire Guide (William Cook Europe ApS, K061670) were cleared for market on January 19, 2007. The predicate devices are PTFE-coated stainless steel wire guides with an outer diameter of 0.035 inches and lengths of 90 cm to 300 cm. For lengths 260-300 cm, a radiopaque gold coil is present on the flexible distal tip. The Lunderquist Extra Stiff DC Wire Guide features a double curved tip design. The predicate devices are intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide is needed.
Description of the Subject Device:
The subject device, the Lunderquist Extra Stiff DC Wire Guide with an extended double curved tip, is considered a line extension of the predicate Lunderquist Extra
4
Stiff DC Wire Guides. The subject device is a PTFE-coated 0.035 inch stainless steel wire with a 4 cm flexible tip that includes an inner gold coil for enhanced visibility. The length of the device is either 260 cm or 300 cm and the J-curve radius is 15 mm. The devices have the body and stiffness required to control large diameter, stiff devices without causing damage to the patient's anatomy or the lumen of the delivery system.
Indications for Use:
The device is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide is needed.
Comparison to Predicate Devices:
The Lunderquist Extra Stiff DC Wire Guide - Extended Double Curved, subject of this submission, is substantially equivalent to the predicate devices, the Lunderquist Extra Stiff Wire Guide and the Lunderquist Extra Stiff DC Wire Guide (K061670) in that these devices all belong to the same product family. As such, the Lunderquist Extra Stiff DC Wire Guide – Extended Double Curved is similar in design, technological characteristics, materials, and intended use to the cleared Lunderquist Extra Stiff Wire Guides. The characteristic differences between the subject device and the predicate devices include a modified double curved configuration and a PTFE coating reformulation.
Performance data:
The following tests were performed to demonstrate that the Lunderquist Extra Stiff DC Wire Guide - Extended Double Curved met applicable design and performance requirements and support a determination of substantial equivalence.
- . Biocompatibility Testing - Tested in accordance with ISO 10993-1:2009. The pre-determined acceptance criteria were met.
- . Surface test - Tested in accordance with EN ISO 11070. The predetermined acceptance criteria were met.
- . Tape adhesion test - Evaluation of PTFE coating adhesion. The pre-determined acceptance criteria were met.
- . Friction test - Evaluation of device performance. The predetermined acceptance criteria were met.
- . Flexing test - Tested in accordance with EN ISO 11070. The predetermined acceptance criteria were met.
5
- . Peak tensile force - Tested in accordance with EN ISO 11070. The pre-determined acceptance criteria were met.
- . Ultrasound test - Evaluation of PTFE coating adhesion. The predetermined acceptance criteria were met.
- . Simulated Use Test – Evaluation of device performance in a bench top model under conditions intended to simulate use. The predetermined acceptance criteria were met.
- . Torque test - Evaluation of device performance. The predetermined acceptance criteria were met.
Conclusion:
In summary, the Lunderquist Extra Stiff DC Wire Guide - Extended Double Curved, described in this submission, met the design input requirements based on the intended use and supports the conclusion that this device does not raise new questions of safety and effectiveness. The results of these tests support a determination of substantial equivalence to the predicate devices, the Lunderquist Extra Stiff Wire Guide and Lunderquist Extra Stiff DC Wire Guide (K061670).