The introducer sheath is used to facing a catheter through the skin and into a vein or artery, including, but not limited to, the radial artery. The micropuncture needle or IV catheter is used to gain access to a vein or artery, including, but not limited to, the radial artery, for placement of the mini-guidewire is used for placement of the sheath into a vein or artery, including, but not limited to, the radial artery.

Device Description

Medtronic's InTRAkit™ device is a Catheter Introducer (PCI) which is intended to facilitate percutaneous vascular access into a vein or artery, performed as part of the Cardiac catheterization procedure. The InTRAkit™ Catheter Introducers are designed to facilitate access into the vasculature from different access sites including but not limited to the radial arteries. InTRAkit™ Catheter Introducers are single-use use devices sold in a sterile condition. The InTRAkit™ Access Kit includes four main type of components required for percutaneous vascular access procedure: 1) Needles 2) Mini-Guidewires 3) Introducer Sheath 4) Dilator

AI/ML Overview

The provided text describes a 510(k) premarket notification for the InTRAkit™ Access Kit, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study typically associated with AI/ML-based devices.

Therefore, the requested information elements (acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable in the context of this 510(k) submission as it is presented. This submission relies on non-clinical (bench) testing and biocompatibility testing to show that engineering differences do not raise new safety or effectiveness concerns compared to a legally marketed predicate device.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Not applicable. This document does not present quantitative performance metrics against pre-defined acceptance criteria in the manner one would expect for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it states that "Design Verification (DV) testing was completed on the InTRAkit™ device in accordance with the requirements of the ISO 11070: 2014" and that "bench testing qualification and biocompatibility testing demonstrated that InTRAkit™ is substantially equivalent to the predicate device." The "performance" is implicitly tied to meeting the standards of ISO 11070:2014 and the biocompatibility requirements, which are typically pass/fail for specific tests rather than reported as continuous performance metrics.

2. Sample sized used for the test set and the data provenance:

Not applicable. No test set (in the context of AI/ML evaluation) is mentioned. "Non-clinical testing" was performed, which refers to bench testing and biocompatibility testing. The sample sizes for these types of engineering and biological tests are not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no "ground truth" establishment in the AI/ML sense mentioned. The evaluation is based on engineering standards and biological safety tests.

4. Adjudication method for the test set:

Not applicable. No test set or related adjudication process is described.

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. The document explicitly states: "No clinical investigation was performed on the subject device (InTRAkit™)." Therefore, no MRMC study, AI assistance, or human reader improvement data is present.

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

Not applicable. This device is a physical medical instrument (catheter introducer) and does not involve an algorithm or AI component.

7. The type of ground truth used:

Not applicable. For this type of physical device, "ground truth" would relate to meeting engineering specifications (e.g., dimensional accuracy, material strength, fluid flow rates) and biological safety standards. The document states that testing was done in accordance with ISO 11070:2014 and ISO 10993-1:2009. These standards define the "truth" or acceptance criteria for the respective tests.

8. The sample size for the training set:

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. There is no training set mentioned.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 17, 2016

Medtronic Vascular Nisarg Shah Senior Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, Massachusetts 01923

Re: K162097

Trade/Device Name: InTRAkit Access Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 18, 2016 Received: October 19, 2016

Dear Nisarg Shah:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Image /page/1/Picture/7 description: The image shows the name "Brian D. Pullin -S" in a clear, sans-serif font. The text is horizontally oriented and appears to be part of a larger document or label. The background is a light color, providing good contrast for the dark text.

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K162097

Device Name InTRAkit™ Access Kit

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)

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}------------------------------------------------

510(k) Summary - K162097

Submitter:	Medtronic Vascular37A Cherry Hill Drive,Danvers, Massachusetts 01923, USA
Contact Person:	Nisarg ShahSenior Regulatory Affairs Specialist37A Cherry Hill DriveDanvers, MA 01923, USAPhone: (978) 739-6632Fax: (978) 750-8204Email: nisarg.g.shah@medtronic.com
Date Prepared:	November 16, 2016
Trade Name(s):	InTRAkit™ Access Kit
Common Name:	Catheter Introducer
Classification Name:	Catheter IntroducerClass II per 21 CFR §870.1340Product Code: DYB
Predicate Device:	Device Name	Manufacturer	510(k)clearance #
	Glidesheath® CatheterIntroducer	Terumo MedicalCorporation	K082644

Medtronic's InTRAkit™ device is a Catheter Introducer (PCI) Device Description: which is intended to facilitate percutaneous vascular access into a vein or artery, performed as part of the Cardiac catheterization procedure. The InTRAkit™ Catheter Introducers are designed to facilitate access into the vasculature from different access sites including but not limited to the radial arteries. InTRAkit™ Catheter Introducers are single-use use devices sold in a sterile condition. The InTRAkit™ Access Kit includes four main type of components required for percutaneous vascular access procedure:

{4}------------------------------------------------

	1) Needles2) Mini-Guidewires3) Introducer Sheath4) Dilator
Statement ofIntended Use:	The introducer sheath is used to facilitate placing a catheterthrough the skin and into a vein or artery, including, but notlimited to, the radial artery. The micropuncture needle or IVcatheter is used to gain access to a vein or artery, including,but not limited to, the radial artery, for placement of the mini-guidewire. The mini-guidewire is used for placement of thesheath into a vein or artery, including, but not limited to, theradial artery.
Summary ofTechnologicalCharacteristics:	Medtronic's InTRAkit™ device components comprise offollowing technological characteristics:
	Introducer Sheath and Dilator: Sheath size: 4French to 6French Sheath length: 7 to 23cm Needles: Micropuncture Needles Gauge size: 18 to 21G IV Catheter Needles Gauge size: 20 to 22G Mini-Guidewires Diameter size: 0.021" Length: 45- 80cm
Comparison to thepredicate devices:	The following information outlines the differences andsimilarities between the subject device and the predicatedevice: Similar Intended Use/ Indication for Use Similar Device Design Component/ Construction Different device materials
	Medtronic's InTRAkit™ Access Kit is substantially

equivalent to the predicate device based on similarities in intended use and technological characteristics. The testing

{5}------------------------------------------------

on the InTRAkit™ Catheter performed Introducers demonstrates that the technological differences do not raise any new concerns or risks relevant to the intended use of the device.

The following non-clinical testing was performed on Summary of Non-Medtronic's InTRAkit™ device: clinical Data:

1. Design Verification Testing/ In-vitro bench testing:

Design Verification (DV) testing was completed on the InTRAkit™ device in accordance with the requirements of the ISO 11070: 2014 - Sterile single-use intravascular introducers, dilators and guidewires.

2. Biocompatibility Testing:

The following Biocompatibility Testing was completed on InTRAkit™ device in compliance with the the requirements of ISO 10993-1: 2009/ Cor 1: 2010-Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

Cytotoxicity testing ●
Sensitization testing ●
Intracutaneous reactivity testing ●
Acute systemic toxicity testing ●
Pyrogenicity testing
Genotoxicity testing ●
Hemolysis testing
C3a and SC5b-9 Complement Activation study ●
Partial Thromboplastin Time study ●
In-vivo Thromboresistance testing ●

No new risks or concerns relevant to the device's intended use were raised during the testing. The bench testing qualification and biocompatibility testing demonstrated that InTRAkit™ is substantially equivalent to the predicate device.

Summary of No clinical investigation was performed on the subject device Clinical Data: (InTRAkit™).

{6}------------------------------------------------

Conclusion from	The data provided in this 510(k) premarket notification
Data:	demonstrated that the subject device is substantially
	equivalent to the predicate device.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).