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

The Sherpa NX Balanced Guide Catheter design is fundamentally the same for both sizes of the device. The guide catheter is designed to provide a pathway for diagnostic and therapeutic devices in the coronary and peripheral vasculature. The basic design of Sherpa Guide Catheters is a cylindrical tube with a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end of the catheter is towards the tip and the proximal end is towards the hub and strain relief. The catheter shaft has side holes present towards the distal end depending on the model. The Sherpa NX Balanced product line has two French sizes available, 6F and 7F. Sherpa is available in a range of lengths from 47 cm to 110 com.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Medtronic 6F Sherpa NX Balanced Guide Catheter and 7F Sherpa NX Balanced Guide Catheter. It outlines the regulatory review and the company's summary of performance/non-clinical testing to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about studies involving acceptance criteria related to a device with AI/algorithm performance.

The acceptance criteria mentioned are for the physical and biological properties of a medical catheter, not for an AI model's performance metrics (like accuracy, sensitivity, specificity, etc., with human-in-the-loop or standalone performance, MRMC studies, or ground truth establishment relevant to AI).

Therefore, based only on the provided text, I cannot complete a table or provide details for most of the requested points related to AI/algorithm acceptance criteria and performance studies.

Here's what can be extracted and what is missing:

Acceptance Criteria and Study for an AI-Powered Device (Information MISSING from provided text)

Since the provided document is for a physical medical device (a guide catheter) and not an AI/algorithm, the following sections will indicate "Not Applicable" or "Information Not Found" as the requested information pertains specifically to AI/algorithm performance studies.

1. Table of Acceptance Criteria and Reported Device Performance (for AI/Algorithm)

Acceptance Criteria (for AI/Algorithm)	Reported Device Performance (for AI/Algorithm)
Specific AI performance metrics (e.g., Sensitivity, Specificity, AUC for disease detection, or improvement in human reader performance)	Information Not Found in the provided text, as this is for a physical medical catheter.
Pre-defined thresholds for these metrics.	Information Not Found.

Note: The provided document details acceptance criteria for the physical properties and biocompatibility of the catheter (e.g., inner/outer diameters, leak resistance, tensile load, cytotoxicity). These are not AI/algorithm performance metrics.

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

Test Set Sample Size: Information Not Found (Not applicable for a physical catheter).
Data Provenance: Information Not Found (Not applicable for a physical catheter). The document only states that "no clinical testing data was required for this special 510k submission."

3. Number of Experts Used to Establish Ground Truth and Qualifications

Information Not Found (Not applicable for a physical catheter, as ground truth in the context of AI relates to diagnostic accuracy, not physical device integrity).

4. Adjudication Method for the Test Set

Information Not Found (Not applicable for a physical catheter).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done?: No, an MRMC study was not done, as this submission is for a physical medical device, not an AI/algorithm. The document states "No clinical testing data was required for this special 510k submission."
Effect size of human reader improvement with AI vs. without AI assistance: Not Applicable (No AI component).

6. Standalone (Algorithm Only) Performance Study

Was it done?: No, a standalone algorithm performance study was not done. The submission is for a physical medical device.

7. Type of Ground Truth Used

Information Not Found (Not applicable for a physical catheter, which doesn't involve "ground truth" in the AI diagnostic sense).

8. Sample Size for the Training Set

Information Not Found (Not applicable, as this is a physical device, not an AI model requiring a training set).

9. How Ground Truth for the Training Set Was Established

Information Not Found (Not applicable for a physical device).

Summary of what was actually performed and reported in the document:

The provided 510(k) summary describes non-clinical performance testing and biocompatibility assessment for the catheter:

Biocompatibility Assessment:
- Conducted according to ISO 10993-1.
- Evaluated: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Material-Mediated Pyrogenicity, Hemocompatibility, Acute Systemic Toxicity.
Product Performance Evaluation (Dimensional & Performance):
- Tests included: Inner/Outer Diameters, Total/Effective/Exposed Tip Length, Luer Connector Performance, Leak Resistance, Draw-through stiffness, Shaft/Arch bending stiffness & kink resistance, Crush resistance, Torsional Stiffness, Rotational Kink Angle, Rotations to Separation, Curve retention, Soft tip stiffness, Peak shaft/segment/soft tip/hub-shaft tensile load, Internal lubricity.
- Specific standards cited for some tests: 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).
Conclusion: "The necessary tests performed met the acceptance criteria and demonstrated that there are not safety or effectiveness concerns." and "The performance testing along with biocompatibility testing demonstrated that the subject device Sherpa Guide Catheter is substantially equivalent to the predicate device."
Clinical Data: "No clinical testing data was required for this special 510k submission."

Summary

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August 22, 2023

Image /page/0/Picture/1 description: The image shows 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 a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medtronic Vascular Colleen Gentile Senior Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, Massachusetts 01923

Re: K232190

Trade/Device Name: 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 21, 2023 Received: July 24, 2023

Dear Colleen Gentile:

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).

Sincerely,

Samuel G. Raben -S

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) K232190

Device Name

6F Sherpa NX Balanced 7F Sherpa NX Balanced

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Medtronic

Coronary & Renal Denervation

Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923 USA

Tel: 1.234.567.8900 Ext 000 Fax: 1.234.567.8900

www.medtronic.com

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

Submitter: Medtronic Vascular 37A Cherry Hill Drive Danvers, Massachusetts 01923, USA

1.) Name: Colleen Gentile Contact Person(s): Designation: Senior Regulatory Affairs Specialist Email: Colleen.Gentile(@medtronic.com Phone: (508)-843-6178

2.) Name: Elaine O'Connor Designation: Senior Regulatory Affairs Manager Email: elaine.oconnor@medtronic.com Phone: +35391708990

July 17th, 2023 Date Prepared:

Trade Names: 1. 6F Sherpa NX Balanced Guide Catheter 2.7F Sherpa NX Balanced Guide Catheter

Common Name: Percutaneous Guide Catheter

Classification Name: Percutaneous, Catheter Class II per 21 CFR §870.1250 Product Code: DQY

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Predicate Device:

510(k) Number	Device Name	Manufacturer	Product Code
K051846 (2005)	7F Sherpa NXBalanced GuideCatheter	Medtronic Vascular	DQY
This predicate has not been subject to a design-related recall.

Reference Device:

510(k) Number	Device Name	Manufacturer	Product Code
K042489 (2004)	6F Sherpa NXBalanced GuideCatheter	Medtronic Vascular	DQY
This predicate has not been subject to a design-related recall.

Device Description:

Intended Use/Indications for Use:

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.

Comparison to the predicate devices:

The subject devices and predicate device are substantially equivalent. The 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.

Summary of Performance/Non-Clinical Testing

The following tests were performed to evaluate and demonstrate substantial equivalence. The necessary tests performed met the acceptance criteria and demonstrated that there are not safety or effectiveness concerns. The following tests were performed:

Biocompatibility Assessment:

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The biocompatibility evaluation for Sherpa NX Balanced Guide Catheters 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 in 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*)
1. Outer Diameters (shaft, segment, soft tip sleeve, & segment/shaft overlap)
1. Total Segment Length
Effective Length* 4)
ર) Exposed Tip Length
Luer Connector Performance* 6)
1. Leak Resistance*
Draw-through stiffness of primary and secondary curve 8)
Shaft bending stiffness & bending kink resistance (Body temperature and room temperature) 9)
Arch bending stiffness & bending kink resistance (Body temperature and room temperature) 10)
1. Shaft & distal segment crush resistance
Torsional Stiffness, Rotational Kink Angle, and Rotations to Separation 12)
1. Curve retention after simulated seating
1. Soft tip stiffness
ાર) Peak shaft & segment tensile load
1. Peak soft tip tensile load
1. Peak hub/shaft tensile load*
Internal lubricity* 18)

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:

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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 Sherpa Guide Catheter is substantially equivalent to the predicate device.

Summary of Clinical Data:

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

Conclusion from Testing Data:

The differences between subject devices and predicate devices have been 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.

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).