(266 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a wire guide, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to facilitate the placement of other devices during procedures and is not itself providing therapy.
No
The device, Double Flexible Tipped Wire Guides, is used to "facilitate the placement of devices during diagnostic and interventional procedures." It acts as a guide for other devices, rather than performing a diagnostic function itself.
No
The device description clearly states it is a physical wire guide made of stainless steel, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The text clearly states the device is a "Wire Guide" used to "facilitate the placement of devices during diagnostic and interventional procedures." This describes a tool used within the body to guide other instruments, not a device that analyzes specimens outside the body.
- Classification: The device is classified under 21 CFR §870.1330, which is for "Wire, Guide, Catheter." This classification is for devices used in the cardiovascular system, not for in vitro diagnostic tests.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Double Flexible Tipped Wire Guides are medical devices used for interventional procedures, not IVDs.
N/A
Intended Use / Indications for Use
The Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Double Flexible Tipped Wire Guides are Class II devices according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The Double Flexible Tipped Wire Guides are wire guides with a flexible distal and proximal end. Double Flexible Tipped Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.
The Double Flexible Tipped Wire Guides, subject of this submission, have been modified from the predicate device, Heavy Double Flexible Tipped Wire Guide (K150802), to include additional lengths ranging from 30 to 260 centimeters, additional outside diameters ranging from 0.018 to 0.038 inches, and additional curve radii ranging from 0 to 3 millimeters.
The Double Flexible Tipped Wire Guides are manufactured using a stainless steel core wire, and stainless steel coils. Some configurations include an exterior coating on the coils.
The modifications to the Double Flexible Tipped Wire Guides have been created to provide additional options for physicians in selecting the appropriate wire guide during diagnostic and interventional procedures.
The Double Flexible Tipped Wire Guides are packaged, sterile devices intended for single use.
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 Double Flexible Tipped Wire Guides met applicable design and performance requirements and support a determination of substantial equivalence:
- Fracture Testing – Testing was performed in accordance with Annex F of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- Tensile Testing - Testing was performed in accordance with Annex H of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- Flexing Test – Testing was performed in accordance with Annex G of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- Evaluation of Coating Integrity - The device coating was evaluated in accordance with BS EN ISO 11070:2014, Section 8.5, and Sub-section d. The device was evaluated for flaking of the coating using magnification to 40X.
- Torque Strength Testing - Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
- Tip Flexibility (Tip Deflection) Testing - Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
- Corrosion Testing - Testing demonstrated, when tested in accordance with Annex B of BS EN ISO 11070:2014, the device revealed no signs of corrosion that would affect functional performance. The pre-determined acceptance criteria were met.
- Catheter Compatibility Testing - Testing was performed in accordance with BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- Biocompatibility Testing – Testing was performed in accordance with BS EN ISO 10993-1:2009, the materials and methods used to manufacture the subject device are non-toxic and met the pre-determined acceptance criteria for their intended use.
- Performance Testing on Aged Devices Performance testing was repeated on aged devices in accordance with BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- Acute Performance Evaluation - Evaluation of device performance in an animal model under conditions intended to simulate clinical use. All test articles evaluated met the predetermined acceptance criteria for all of the performance parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, and then the word "ADMINISTRATION" in a smaller font size below that.
March 19, 2018
Cook Incorporated Ms. Jennifer Allman, RAC Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47402
Re: K171912
Trade/Device Name: Double Flexible Tip Wire Guides Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: February 20, 2018 Received: February 20, 2018
Dear Ms. Allman:
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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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,
for
Kenneth J. Cavanaugh -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171912
Device Name
Double Flexible Tipped Wire Guides
Indications for Use (Describe)
The Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, smaller block letters on a red background. The red background is shaped like a rectangle with a notch cut out of the upper right corner.
510(k) SUMMARY
510(k) Number:
Submitted By:
Jennifer L. Allman Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (812) 335-3575 x104280 Fax: (812) 332-0281 Date Prepared: March 19, 2018
Traditional 510(k) Premarket Notification
Device:
| Trade Name: | Double Flexible Tipped Wire Guides |
|---|---|
| Common Name: | Catheter Wire Guide |
| Classification Name: | Wire, Guide, Catheter |
| DQX (21 CFR §870.1330) |
Indications for Use:
The Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.
Predicate Device:
The predicate device manufactured by Cook Incorporated, the Heavy Double Flexible Tip Wire Guide, was cleared for commercial distribution under 510(k) number K150802, on May 28, 2015.
Comparison to Predicate Device:
It has been demonstrated that the Double Flexible Tipped Wire Guides are identical to the predicate device (K150802) in terms of intended use, principles of operation, basic technological characteristics, sterilization method, packaging, and shelf life. The subject device is similar in materials of construction to the predicate device. Additional wire guide lengths, diameters, curve radii, PTFE coating, and a connection point have been included for the subject device as compared to the predicate device. The substantial equivalence of the subject device modifications are supported by performance and biocompatibility testing.
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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, sans-serif font, stacked on top of the word "MEDICAL" in white, sans-serif font. The words are set against a red background. The word "COOK" is in a larger font size than the word "MEDICAL". The registered trademark symbol is next to the word "COOK".
Reference Devices:
- . K140485, Mandrel Guidewires or M-Wires
- K142393, Predicate III Guidewire
- K081337, Approach CTO Wire Guide ●
Device Description:
The Double Flexible Tipped Wire Guides are Class II devices according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The Double Flexible Tipped Wire Guides are wire guides with a flexible distal and proximal end. Double Flexible Tipped Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.
The Double Flexible Tipped Wire Guides, subject of this submission, have been modified from the predicate device, Heavy Double Flexible Tipped Wire Guide (K150802), to include additional lengths ranging from 30 to 260 centimeters, additional outside diameters ranging from 0.018 to 0.038 inches, and additional curve radii ranging from 0 to 3 millimeters.
The Double Flexible Tipped Wire Guides are manufactured using a stainless steel core wire, and stainless steel coils. Some configurations include an exterior coating on the coils.
The modifications to the Double Flexible Tipped Wire Guides have been created to provide additional options for physicians in selecting the appropriate wire guide during diagnostic and interventional procedures.
The Double Flexible Tipped Wire Guides are packaged, sterile devices intended for single use.
There are no prior submissions for the subject device.
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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif letters on a slightly darker red background. The word "MEDICAL" is smaller than the word "COOK".
Test Data:
The following tests were performed to demonstrate that the Double Flexible Tipped Wire Guides met applicable design and performance requirements and support a determination of substantial equivalence:
- . Fracture Testing – Testing was performed in accordance with Annex F of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- . Tensile Testing - Testing was performed in accordance with Annex H of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- . Flexing Test – Testing was performed in accordance with Annex G of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- . Evaluation of Coating Integrity - The device coating was evaluated in accordance with BS EN ISO 11070:2014, Section 8.5, and Sub-section d. The device was evaluated for flaking of the coating using magnification to 40X.
- . Torque Strength Testing - Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
- . Tip Flexibility (Tip Deflection) Testing - Characterization testing was performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
- I Corrosion Testing - Testing demonstrated, when tested in accordance with Annex B of BS EN ISO 11070:2014, the device revealed no signs of corrosion that would affect functional performance. The pre-determined acceptance criteria were met.
- . Catheter Compatibility Testing - Testing was performed in accordance with BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- . Biocompatibility Testing – Testing was performed in accordance with BS EN ISO 10993-1:2009, the materials and methods used to manufacture the subject device are non-toxic and met the pre-determined acceptance criteria for their intended use.
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Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, set against a red square. Below the square, the word "MEDICAL" is written in white on a red trapezoid. The trapezoid is positioned so that its top edge aligns with the bottom edge of the square, creating a visually cohesive design.
- Performance Testing on Aged Devices Performance testing was repeated on . aged devices in accordance with BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- . Acute Performance Evaluation - Evaluation of device performance in an animal model under conditions intended to simulate clinical use. All test articles evaluated met the predetermined acceptance criteria for all of the performance parameters.
Conclusion
In conclusion, the results of these tests support a determination that the Double Flexible Tipped Wire Guides met the design input requirements based on the intended use and support the conclusion that the modifications to the device do not raise new issues of safety or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device, the Heavy Double Flexible Tip Wire Guide (K150802).