Medtronic 6F Taiga Guiding Catheter by Medtronic Vascular

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 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

AI/ML Overview

The Medtronic 6F Taiga Guiding Catheter is a physical medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific aspects such as human readers, AI assistance, training sets, and ground truth for AI algorithms are not applicable.

Based on the provided text, the acceptance criteria and the study that proves the device meets them are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a modified version of a legally marketed predicate device (Medtronic 6F Taiga™ Guiding Catheter - K083422). The modification involves a specification related to the soft tip component. Therefore, the acceptance criteria are generally based on demonstrating substantial equivalence to the predicate device through performance/bench testing and biocompatibility testing. The specific acceptance criteria for each test are not explicitly detailed in the provided summaries (e.g., specific thresholds for tensile strength or kink resistance). Instead, the document states that tests were conducted "in accordance to the relevant FDA guidance to demonstrate substantial equivalence."

For the modified soft tip component, two specific tests were performed on the subject device to demonstrate substantial equivalence to the predicate:

Acceptance Criteria	Reported Device Performance
Demonstrate substantial equivalence to predicate device for Modified Soft Tip Component:	Tests were performed on the subject device to demonstrate substantial equivalence to the predicate Taiga device for the modification in this premarket notification.
* Soft Tip Tensile Strength*	Performance met criteria for substantial equivalence to the predicate.
* Soft Tip Compression*	Performance met criteria for substantial equivalence to the predicate.
Overall Device Performance: (Based on 32 bench tests performed on the predicate, and through inference, the subject device is expected to meet these as well for substantial equivalence)	The performance testing along with biocompatibility testing demonstrated that the modified Taiga Guide Catheters are substantially equivalent to the predicate device.
Examples of bench tests listed (acceptance criteria not detailed in document):
Shaft Inner Diameter	Performance met criteria for substantial equivalence.
Shaft Outer Diameter	Performance met criteria for substantial equivalence.
Segments Outer Diameter	Performance met criteria for substantial equivalence.
Pressure and Leak Resistance	Performance met criteria for substantial equivalence.
Inner Lubricity	Performance met criteria for substantial equivalence.
Biocompatibility:	Met all requirements as per ISO 10993-1.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size (number of units) used for each specific bench test. It mentions that "Performance/Bench Testing" was conducted, and "biocompatibility tests were conducted." The testing is described as non-clinical data. The provenance of the data is from Medtronic Vascular, the manufacturer. The data is retrospective in the sense that it's reported after the tests were conducted for the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable as the device is a physical medical device and its performance is evaluated through objective bench testing and biocompatibility assessments, not through expert-driven ground truth establishment for an AI/ML algorithm.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. Bench tests have objective measurements and pass/fail criteria, not subjective adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable as the device is a physical medical device and not an AI/ML-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical medical device and not an AI/ML algorithm.

7. The Type of Ground Truth Used

For a physical device, the "ground truth" for performance is typically defined by:

Engineering Specifications/Standards: Each bench test will have predefined acceptance limits or ranges derived from engineering design specifications and relevant industry standards (e.g., ISO, ASTM) and FDA guidance for catheters.
Predicate Device Performance: For substantial equivalence, the performance of the subject device is compared against the established performance characteristics of the predicate device.
Biocompatibility Standards: Ground truth for biocompatibility is established by international standards like ISO 10993-1, which outlines the requirements for biological evaluation of medical devices.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device and does not involve AI/ML requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is a physical medical device and does not involve AI/ML requiring a training set or its associated ground truth establishment.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K192296

Device Name Medtronic 6F Taiga Guiding Catheter

Indications for Use (Describe)

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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K192296 Special 510(k) Summary

Submitter:	Medtronic Vascular37A Cherry Hill DriveDanvers, MA 01923,USA
Contact Person:	Colleen MullinsPrincipal Regulatory Affairs Specialist37A Cherry Hill DriveDanvers, MA 01923USAPhone: (978)-739-3267Email: colleen.mullins@medtronic.com
Date Prepared:	September 20, 2019
Trade Name:	Medtronic 6F Taiga™ Guiding Catheter
Common Name:	Guiding Catheter
ClassificationName:	Percutaneous CatheterProduct Code DQY.
Predicate Device:	Medtronic 6F Taiga™ Guiding Catheter - K083422
DeviceDescription:	Medtronic 6F Taiga Guiding Catheter is an intravascularcatheter that is supplied sterile and intended for single useonly. The primary function of the 6F Taiga Guiding Catheteris to provide a pathway through which therapeutic devices areintroduced. Medtronic 6F Taiga Guiding Catheter has a 6Fouter diameter (0.082") and is be available in variety ofcurves and lengths, identical to the predicate Medtronic TaigaGuide Catheter. The various curves and lengths available, willallow the catheter to accommodate the varying patientvascular system anatomies
Statement ofIntended Use:	The Medtronic Guiding Catheter is designed to provide apathway through which therapeutic devices are introduced.The guiding catheter is intended to be used in the coronary orperipheral vascular system.

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Summary of Technological Characteristics:	The 6F Taiga Guiding Catheter consists of the following technical characteristics: Catheter length: 30-130 cmCatheter size: 6 FrenchDesign Components/ Construction: Luer HubStrain ReliefShaft comprising of: Inner linerBraid wireOuter jacketIntermediate layerSoft tipDistal SegmentsSleeve
	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: Shaft Inner DiameterShaft Outer DiameterSegments Outer DiameterSleeve Outer DiameterOverlap Segment/Shaft ODUsable LengthSoft Tip Exposed LengthShaft Stiffness @ Room TempShaft Kink @ Room TempShaft Stiffness @ Body TempShaft Kink @ Body TempShaft TorqueShaft KinkShaft Torque to separationShaft CrushShaft TensilePrimary Stiffness

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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 demonstratesubstantial equivalence to the predicate Taiga device for the
	modification in this premarket notification.

	Biocompatibility Testing: Pursuant to the ISO 10993-1Biological evaluation of medical devices- Part 1: Evaluationand testing within a risk management process; thebiocompatibility testing for the predicate Taiga GuideCatheter represents the modified Taiga Guide Catheter hasmet all requirements.
	The performance testing along with biocompatibility testingdemonstrated that the modified Taiga Guide Catheters aresubstantially equivalent to the predicate device.
Summary ofClinical Data:	No clinical investigation has been performed on the modifieddevice.
Conclusion fromData:	Medtronic Vascular has demonstrated that the modified TaigaGuide Catheters are substantially equivalent to the legallymarketed predicate devices based on its intended use andtechnological characteristics.

Secondary Stiffness
Arch Stiffness @ Room Temp

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).