Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a standard guiding catheter and its physical properties and performance tests. There is no mention of AI, ML, image processing, or any data-driven algorithms.

Therapeutic

No
The device is described as providing a pathway for other therapeutic devices, rather than being therapeutic itself.

Diagnostic

No

The device is described as providing a "pathway through which therapeutic devices are introduced," indicating its function as an access tool for treatment, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "intravascular catheter" and describes physical characteristics like outer diameter, curves, and lengths. The performance studies also detail bench tests related to the physical properties of the catheter. This indicates it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "provide a pathway through which therapeutic devices are introduced" within the coronary or peripheral vascular system. This describes a device used in vivo (within the body) to facilitate a medical procedure, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
Device Description: The description reinforces its use as an intravascular catheter, designed to be inserted into blood vessels.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing specimens.

Therefore, the Medtronic Guiding Catheter is a medical device used for interventional procedures, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DQY

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary or peripheral vascular system

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)

Performance/ Bench Testing: The following bench tests were performed on the predicate Taiga Guide Catheters:

Shaft Inner Diameter
Shaft Outer Diameter
Segments Outer Diameter
Sleeve Outer Diameter
Overlap Segment/Shaft OD
Usable Length
Soft Tip Exposed Length
Shaft Stiffness @ Room Temp
Shaft Kink @ Room Temp
Shaft Stiffness @ Body Temp
Shaft Kink @ Body Temp
Shaft Torque
Shaft Torque to separation
Shaft Crush
Shaft Tensile
Primary Stiffness
Secondary Stiffness
Arch Stiffness @ Room Temp
Arch Kink @ Room Temp
Arch Stiffness @ Body Temp
Arch Kink @ Body Temp
Segment Crush
Ostial Engagement
Secondary Curve Retention
Primary Curve Retention
Segment Tensile
Soft Tip Tensile*
Soft Tip Compression*
Hub Tensile
Pressure and Leak Resistance
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.

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.

Medtronic 6F Taiga™ Guiding Catheter - K083422

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.

Not Found

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

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).

Summary

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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

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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)

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)

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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. |

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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 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.

Secondary Stiffness
Arch Stiffness @ Room Temp