Medtronic 6F Taiga Guiding Catheter

K192296 · Medtronic Vascular · DQY · Sep 20, 2019 · Cardiovascular

Device Facts

• Record ID: K192296
• Device Name: Medtronic 6F Taiga Guiding Catheter
• Applicant: Medtronic Vascular
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 20, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

Device Story

Intravascular guiding catheter; provides pathway for therapeutic devices in coronary or peripheral vasculature. Operated by physicians in clinical settings. Device features 6F outer diameter; available in various curves/lengths to accommodate patient anatomy. Modification involves soft tip component specification. Bench testing confirms performance and biocompatibility equivalence to predicate.

Clinical Evidence

No clinical investigation performed. Substantial equivalence demonstrated via bench testing and biocompatibility evaluation.

Technological Characteristics

6F (0.082") outer diameter; 30-130 cm length. Construction: Luer hub, strain relief, shaft (inner liner, braid wire, outer jacket, intermediate layer), soft tip, distal segments, sleeve. Single-use, sterile. No software or electronic components.

Indications for Use

Indicated for patients requiring a pathway for the introduction of therapeutic devices into the coronary or peripheral vascular system.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Medtronic 6F Taiga Guiding Catheter (K083422)

Submission Summary (Full Text)

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September 20, 2019

Medtronic Vascular Colleen Mullins, MSRA, RAC Principal Regulatory Affairs Specialist 37a Cherry Hill Drive Danvers, Massachusetts 01923

Re: K192296

Trade/Device Name: Medtronic 6F Taiga Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 22, 2019 Received: August 23, 2019

Dear Colleen Mullins:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/ training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K192296

Device Name Medtronic 6F Taiga Guiding Catheter

Indications for Use (Describe)

The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> |

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## K192296 Special 510(k) Summary

| Submitter: | Medtronic Vascular<br>37A Cherry Hill Drive<br>Danvers, MA 01923,<br>USA |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Colleen Mullins<br>Principal Regulatory Affairs Specialist<br>37A Cherry Hill Drive<br>Danvers, MA 01923<br>USA<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | September 20, 2019 |
| Trade Name: | Medtronic 6F Taiga™ Guiding Catheter |
| Common Name: | Guiding Catheter |
| Classification<br>Name: | Percutaneous Catheter<br>Product Code DQY. |
| Predicate Device: | Medtronic 6F Taiga™ Guiding Catheter - K083422 |
| Device<br>Description: | Medtronic 6F Taiga Guiding Catheter is an intravascular<br>catheter that is supplied sterile and intended for single use<br>only. The primary function of the 6F Taiga Guiding Catheter<br>is to provide a pathway through which therapeutic devices are<br>introduced. Medtronic 6F Taiga Guiding Catheter has a 6F<br>outer diameter (0.082") and is be available in variety of<br>curves and lengths, identical to the predicate Medtronic Taiga<br>Guide Catheter. The various curves and lengths available, will<br>allow the catheter to accommodate the varying patient<br>vascular system anatomies |
| Statement of<br>Intended Use: | The Medtronic Guiding Catheter is designed to provide a<br>pathway through which therapeutic devices are introduced.<br>The guiding catheter is intended to be used in the coronary or<br>peripheral vascular system. |

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| Summary of Technological Characteristics: | The 6F Taiga Guiding Catheter consists of the following technical characteristics: <ul><li>Catheter length: 30-130 cm</li><li>Catheter size: 6 French</li><li>Design Components/ Construction: <ul><li>Luer Hub</li><li>Strain Relief</li><li>Shaft comprising of: <ul><li>Inner liner</li><li>Braid wire</li><li>Outer jacket</li><li>Intermediate layer</li></ul></li><li>Soft tip</li><li>Distal Segments</li><li>Sleeve</li></ul></li></ul> |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Compared to the predicate device, the subject device was modified to include a specification related to the soft tip component. |
| Summary of Non-clinical Data: | The device performance/ bench tests and biocompatibility tests were conducted in accordance to the relevant FDA guidance to demonstrate substantial equivalence to the legally marketed predicate devices. |
| | Performance/ Bench Testing: The following bench tests were performed on the predicate Taiga Guide Catheters: <ol><li>Shaft Inner Diameter</li><li>Shaft Outer Diameter</li><li>Segments Outer Diameter</li><li>Sleeve Outer Diameter</li><li>Overlap Segment/Shaft OD</li><li>Usable Length</li><li>Soft Tip Exposed Length</li><li>Shaft Stiffness @ Room Temp</li><li>Shaft Kink @ Room Temp</li><li>Shaft Stiffness @ Body Temp</li><li>Shaft Kink @ Body Temp</li><li>Shaft Torque</li><li>Shaft Kink</li><li>Shaft Torque to separation</li><li>Shaft Crush</li><li>Shaft Tensile</li><li>Primary Stiffness</li></ol> |

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| | 20) Arch Kink @ Room Temp |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 21) Arch Stiffness @ Body Temp |
| | 22) Arch Kink @ Body Temp |
| | 23) Segment Crush |
| | 24) Ostial Engagement |
| | 25) Secondary Curve Retention |
| | 26) Primary Curve Retention |
| | 27) Segment Tensile |
| | 28) Soft Tip Tensile* |
| | 29) Soft Tip Compression* |
| | 30) Hub Tensile |
| | 31) Pressure and Leak Resistance |
| | 32) Inner Lubricity |
| | *These tests, Soft Tip Tensile and Soft Tip Compression, |
| | were performed on the subject device to demonstrate<br>substantial equivalence to the predicate Taiga device for the |
| | modification in this premarket notification. |
| | |
| | Biocompatibility Testing: Pursuant to the ISO 10993-1<br>Biological evaluation of medical devices- Part 1: Evaluation<br>and testing within a risk management process; the<br>biocompatibility testing for the predicate Taiga Guide<br>Catheter represents the modified Taiga Guide Catheter has<br>met all requirements. |
| | The performance testing along with biocompatibility testing<br>demonstrated that the modified Taiga Guide Catheters are<br>substantially equivalent to the predicate device. |
| Summary of<br>Clinical Data: | No clinical investigation has been performed on the modified<br>device. |
| Conclusion from<br>Data: | Medtronic Vascular has demonstrated that the modified Taiga<br>Guide Catheters are substantially equivalent to the legally<br>marketed predicate devices based on its intended use and<br>technological characteristics. |

18) Secondary Stiffness

19) Arch Stiffness @ Room Temp