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

Device Description

Launcher Guide Catheters are comprised of a cylindrical catheter having a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end is the section of the catheter towards the tip and the proximal end is towards the hub and strain relief. The guide catheter is comprised of a luer hub, strain relief, shaft, segments, tungsten marker band, sleeve, and soft tip. The catheter shaft is made of three distinct layers. The guide catheter is available in various lengths ranging from 45 cm to 130 cm and four French sizes [5F, 6F, 7F, and 8F]. Launcher Guide Catheters have a lubricious inner lumen that runs from the proximal to the distal end of the catheter via a lubricious liner material or coating on the inner lumen.

AI/ML Overview

The provided document is a 510(k) summary for the Medtronic Launcher Guide Catheter. It outlines the product's description, intended use, and substantial equivalence to a predicate device based on non-clinical performance and biocompatibility testing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance/Conclusion |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility Assessment | 1) Cytotoxicity2) Sensitization3) Intracutaneous Reactivity4) Material-Mediated Pyrogenicity5) Hemocompatibility6) Acute Systemic Toxicity | Performed in accordance with FDA Guidance "Use of International Standard ISO 10993-1" and demonstrated no safety or effectiveness concerns. |
| Product Performance Evaluation (Dimensional & Performance) | 1) Inner Diameters (shaft, tip, & hub)2) Outer Diameters (shaft, segment, soft tip sleeve, & segment/shaft overlap)3) Total Segment Length4) Effective Length5) Exposed Tip Length6) Luer Connector Performance*7) Leak Resistance*8) Draw-through stiffness of primary and secondary curve9) Shaft bending stiffness & bending kink resistance (Body temperature and room temperature)10) Arch bending stiffness & bending kink resistance (Body temperature and room temperature)11) Shaft & distal segment crush resistance12) Torsional Stiffness, Rotational Kink Angle, and Rotations to Separation13) Curve retention after simulated seating14) Peak shaft & segment tensile load15) Peak soft tip tensile load16) Soft tip stiffness17) Peak hub/shaft tensile load*18) Internal lubricity | Necessary tests performed met the acceptance criteria and demonstrated that there are no safety or effectiveness concerns. The performance testing, along with biocompatibility testing, demonstrated substantial equivalence to the predicate device. Specific standards used for some tests are noted: ISO 594-1, ISO 594-2, EN ISO 80369-7 for Luer Connector Performance; ISO 10555-1 for Leak Resistance and Peak Hub/Shaft Tensile Load. |

Note: Tests marked with an asterisk () were specifically highlighted as being performed on the subject device to demonstrate substantial equivalence for modifications in this premarket notification.*

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

The document does not explicitly state the sample sizes used for the non-clinical and biocompatibility tests. It broadly mentions "Summary of Nonclinical Data/Performance Testing" and "Product Performance Evaluation". Given the nature of these tests for medical devices, they would typically involve a statistically relevant number of samples to ensure robust results, but the exact numbers are not provided in this summary.

The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer, Medtronic Vascular. No information regarding country of origin of the data or whether it was retrospective or prospective is mentioned (as these terms usually apply to clinical studies).

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

This information is not applicable to this submission. The "ground truth" concept usually applies to clinical studies where expert consensus or pathological findings are used to establish a definitive diagnosis or outcome. For non-clinical performance and biocompatibility testing, the "ground truth" is established by adherence to recognized international standards and engineering principles, with results evaluated against predefined acceptance criteria derived from these standards or predicate device performance. Experts involved would be engineers, scientists, and toxicologists specializing in medical device testing and regulatory compliance, but their specific numbers or detailed qualifications are not typically included in a 510(k) summary (beyond general statements about adherence to guidance documents like ISO 10993-1).

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials where multiple experts assess cases and their disagreements need to be resolved to establish a ground truth. For the non-clinical tests described, the "adjudication" is inherent in the test methodology and adherence to international standards and acceptance criteria. Any deviations or failures would be investigated and resolved according to quality system procedures.

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

No MRMC comparative effectiveness study was done. This device is a physical medical device (catheter), not an AI-powered diagnostic or imaging tool that would involve human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance and biocompatibility testing is established by:

Adherence to International/Recognized Standards: Such as ISO 594-1, ISO 594-2, EN ISO 80369-7, ISO 10555-1, and FDA Guidance "Use of International Standard ISO 10993-1".
Predicate Device Performance: The subject device's performance is compared to the predicate device, aiming to demonstrate substantial equivalence by showing that any differences in characteristics do not raise different questions of safety and effectiveness.
Engineering Specifications and Design Requirements: The tests verify that the device meets its own engineering specifications for parameters like dimensions, strength, flexibility, and resistance to various stresses.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this device. Training sets are used in machine learning and AI model development.

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

Not Applicable. As there is no training set for this physical medical device, there is no ground truth to be established for it.

Summary

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June 30, 2023

Medtronic Vascular Shalin Parikh Senior Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers. Massachusetts 01923

Re: K230156

Trade/Device Name: 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 2, 2023 Received: June 2, 2023

Dear Shalin Parikh:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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-regulatoryassistance/contact-us-division-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).

Sincerelv.

Lydia S. Glaw -

Digitally signed by Lydia S. Glaw -S Date: 2023.06.30 11:55:45 -04'00'

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) K230156

Device Name

5F Launcher Guide Catheter

6F Launcher Guide Catheter

7F Launcher Guide Catheter & 8F Launcher Guide 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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Image /page/3/Picture/0 description: The image shows the word "Medtronic" in blue font. The font is sans-serif and appears to be bolded. The word is horizontally oriented and centered in the image.

Medtronic Vascular 37A Cherry Hill Dr Danvers MA 01923 www.medtronic.com

510(k) Summary (As required by 21 CFR 807.92)

510(k) Number:	K230156
510(k) Type:	Special 510(k)
Submitter:	Medtronic Vascular
	37A Cherry Hill Drive,
	Danvers, Massachusetts 01923, USA
Contact Person:	Name: Shalin Parikh
	Designation: Senior Regulatory Affairs Specialist
	Email : shalin.a.parikh@medtronic.com
	Phone: (978) 739-3047
Date Prepared:	June 2, 2023
Trade Name(s):	1. 5F Launcher™ Guide Catheter2. 6F Launcher™ Guide Catheter3. 7F Launcher™ Guide Catheter4. 8F Launcher™ Guide Catheter
Common Name:	Percutaneous Guide Catheter
ClassificationName:	Percutaneous, CatheterClass II per 21 CFR §870.1250Product Code: DQY
Predicate Device:	510(k) Number	Device Name	Manufacturer	Product Code
	K022764 (2002)	7F Launcher Guide Catheter	Medtronic Vascular	DQY

This predicate has not been subject to a design-related recall.

Launcher Guide Catheter Special 510(k) Summary

Page 1 of 4

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Image /page/4/Picture/0 description: The image shows the word "Medtronic" in a bold, blue font. The word is written in a sans-serif typeface. The letters are evenly spaced and the word is horizontally aligned. The background is white.

Medtronic Vascular

37A Cherry Hill Dr Danvers MA 01923 www.medtronic.com

Reference Devices:

510(k) Number	Device Name	Manufacturer	Product Code
K132673 (2013)	5F Launcher GuideCatheter	MedtronicVascular	DQY
K132673 (2013)	6F Launcher GuideCatheter	MedtronicVascular	DQY
K103386 (2010)	8F Launcher GuideCatheter	MedtronicVascular	DQY

Device Description: Launcher Guide Catheters are comprised of a cylindrical catheter having a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end is the section of the catheter towards the tip and the proximal end is towards the hub and strain relief. The guide catheter is comprised of a luer hub, strain relief, shaft, segments, tungsten marker band, sleeve, and soft tip. The catheter shaft is made of three distinct layers. The guide catheter is available in various lengths ranging from 45 cm to 130 cm and four French sizes [5F, 6F, 7F, and 8F]. Launcher Guide Catheters have a lubricious inner lumen that runs from the proximal to the distal end of the catheter via a lubricious liner material or coating on the inner lumen.

Intended The Medtronic Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guide catheter is intended to be used Use/Indications for in the coronary or peripheral vascular system. Use:

Comparison to the The subject devices and predicate device are substantially equivalent. The predicate devices: predicate device is Medtronic Vascular's own legally marketed device. The indications for use/intended use of the subject device and predicate device is same. The catheter shaft design of subject devices is identical to that of predicate device. The components of catheter shaft, distal end and proximal end are the same and the devices have same fundamental operating principle. There are no changes to the sterilization method, sterility assurance level, packaging process, packaging materials, packaging configuration and shelf life of the subject devices in comparison to the predicate devices. The differences in catheter's dimensional, performance and materials related technological characteristics identified between the subject (modified) devices and the predicate (previously cleared) device do not raise different questions of safety and effectiveness.

Launcher Guide Catheter Special 510(k) Summary

Page 2 of 4

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Medtronic

Medtronic Vascular 37A Cherry Hill Dr Danvers MA 01923 www.medtronic.com

Summary of Nonclinical Data/Performance Testing:

The following tests were performed to evaluate and demonstrate substantial equivalence. The necessary test performed met the acceptance criteria and demonstrated that there are no safety or effectiveness concerns. The following tests were performed:

Biocompatibility Assessment

The biocompatibility evaluation for Launcher Guide Catheter was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1,"Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" dated September 04, 2020. The biological evaluation included the following:

1. Cytotoxicity
1. Sensitization
1. Intracutaneous Reactivity
1. Material-Mediated Pyrogenicity
1. Hemocompatibility
1. Acute Systemic Toxicity

Product Performance Evaluation [Dimensional & Performance]

1. Inner Diameters (shaft, tip, & hub*)
Outer Diameters (shaft, segment, soft tip sleeve, & segment/shaft overlap) 2)
1. Total Segment Length
1. Effective Length*
1. Exposed Tip Length
1. Luer Connector Performance*
1. Leak Resistance*
1. Draw-through stiffness of primary and secondary curve
1. Shaft bending stiffness & bending kink resistance (Body temperature and room temperature)
1. Arch bending stiffness & bending kink resistance (Body temperature and room temperature)
1. Shaft & distal segment crush resistance
1. Torsional Stiffness, Rotational Kink Angle, and Rotations to Separation
1. Curve retention after simulated seating
1. Peak shaft & segment tensile load

Launcher Guide Catheter Special 510(k) Summary

Page 3 of 4

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Medtroni

Medtronic Vascular 37A Cherry Hill Dr Danvers MA 01923

www.medtronic.com

1. Peak soft tip tensile load
1. Soft tip stiffness
1. Peak hub/shaft tensile load*
1. Internal lubricity

*These tests were performed on the subject device to demonstrate substantial equivalence to the predicate device for the modifications in this premarket notification. Relevant standards for these tests detailed below.

Luer Connector Performance testing conducted in accordance with the following standards:

. ISO 594-1 First edition 1986-06-15 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
EN ISO 80369-7 Second edition 2021-05 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

Leak Resistance and Peak Hub/Shaft Tensile Load testing conducted in accordance with the following standard:

ISO 10555-1 Second Edition 2013+A1:2017 Intravascular Catheters -. Sterile and Single-Use Catheters - Part 1: General Requirements -Amendment 1
The performance testing along with biocompatibility testing demonstrated that the subject device Launcher Guide Catheter is substantially equivalent to the predicate device.

Summary of Clinical No clinical testing data was required for this special 510k submission.

Data:

Conclusion from The differences between subject devices and predicate devices have been Testing Data: evaluated through non-clinical testing. Based on the results of the testing performed, the subject devices are demonstrated as substantially equivalent to the predicate device.

Page 4 of 4

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).