← Product Code [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY) · K192296 # Medtronic 6F Taiga Guiding Catheter (K192296) _Medtronic Vascular · DQY · Sep 20, 2019 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K192296 ## Device Facts - **Applicant:** Medtronic Vascular - **Product Code:** [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY.md) - **Decision Date:** Sep 20, 2019 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1250 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for 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. ## Regulatory 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](/device/K083422.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ ## 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) | Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## K192296 Special 510(k) Summary | Submitter: | Medtronic Vascular
37A Cherry Hill Drive
Danvers, MA 01923,
USA | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Colleen Mullins
Principal Regulatory Affairs Specialist
37A Cherry Hill Drive
Danvers, MA 01923
USA
Phone: (978)-739-3267
Email: colleen.mullins@medtronic.com | | Date Prepared: | September 20, 2019 | | Trade Name: | Medtronic 6F Taiga™ Guiding Catheter | | Common Name: | Guiding Catheter | | Classification
Name: | Percutaneous Catheter
Product Code DQY. | | Predicate Device: | Medtronic 6F Taiga™ Guiding Catheter - K083422 | | Device
Description: | Medtronic 6F Taiga Guiding Catheter is an intravascular
catheter that is supplied sterile and intended for single use
only. The primary function of the 6F Taiga Guiding Catheter
is to provide a pathway through which therapeutic devices are
introduced. Medtronic 6F Taiga Guiding Catheter has a 6F
outer diameter (0.082") and is be available in variety of
curves and lengths, identical to the predicate Medtronic Taiga
Guide Catheter. The various curves and lengths available, will
allow the catheter to accommodate the varying patient
vascular system anatomies | | Statement of
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. | {4}------------------------------------------------ | Summary of Technological Characteristics: | The 6F Taiga Guiding Catheter consists of the following technical characteristics: | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 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:
  1. Shaft Inner Diameter
  2. Shaft Outer Diameter
  3. Segments Outer Diameter
  4. Sleeve Outer Diameter
  5. Overlap Segment/Shaft OD
  6. Usable Length
  7. Soft Tip Exposed Length
  8. Shaft Stiffness @ Room Temp
  9. Shaft Kink @ Room Temp
  10. Shaft Stiffness @ Body Temp
  11. Shaft Kink @ Body Temp
  12. Shaft Torque
  13. Shaft Kink
  14. Shaft Torque to separation
  15. Shaft Crush
  16. Shaft Tensile
  17. Primary Stiffness
| {5}------------------------------------------------ | | 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
substantial equivalence to the predicate Taiga device for the | | | modification in this premarket notification. | | | | | | Biocompatibility Testing: Pursuant to the ISO 10993-1
Biological evaluation of medical devices- Part 1: Evaluation
and testing within a risk management process; the
biocompatibility testing for the predicate Taiga Guide
Catheter represents the modified Taiga Guide Catheter has
met all requirements. | | | The performance testing along with biocompatibility testing
demonstrated that the modified Taiga Guide Catheters are
substantially equivalent to the predicate device. | | Summary of
Clinical Data: | No clinical investigation has been performed on the modified
device. | | Conclusion from
Data: | Medtronic Vascular has demonstrated that the modified Taiga
Guide Catheters are substantially equivalent to the legally
marketed predicate devices based on its intended use and
technological characteristics. | 18) Secondary Stiffness 19) Arch Stiffness @ Room Temp --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K192296](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K192296) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com