The St Jude Medical Nanostim Introducer Kit is designed to perform as a quiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm.

The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the current design to improve the manufacturability and to increase the product shelf life. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.

AI/ML Overview

The provided text is a 510(k) summary for the Nanostim Introducer Kit, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance criteria for accuracy or diagnostic efficacy in the way an AI or diagnostic imaging device would.

Therefore, many of the requested categories for AI/diagnostic studies (e.g., sample size of test set, ground truth experts, MRMC studies, standalone performance) are not applicable here. This document primarily describes engineering verification and biocompatibility testing.

Here's the information extracted from the document that is relevant to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Reported Device Performance
Visual test	Not explicitly stated (implied to meet visual standards)	All pre-determined acceptance criteria were met.
Dimensional measurement test	Not explicitly stated (implied to meet specifications)	All pre-determined acceptance criteria were met.
Tensile Strength	Not explicitly stated (implied to meet specifications)	All pre-determined acceptance criteria were met.
Torsional Strength	Not explicitly stated (implied to meet specifications)	All pre-determined acceptance criteria were met.
Liquid Leak	Not explicitly stated (implied to prevent leaks)	All pre-determined acceptance criteria were met.
Simulated Use	Not explicitly stated (implied to function as intended)	All pre-determined acceptance criteria were met.
Biocompatibility: Cytotoxicity	In accordance with ISO 10993-1:2009 for an external communicating device with limited exposure (<24 hours contact with circulating blood)	Completed in accordance with the standard.
Biocompatibility: Chemical Characterization	In accordance with ISO 10993-1:2009 for an external communicating device with limited exposure (<24 hours contact with circulating blood)	Completed in accordance with the standard.

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

The document does not specify the sample sizes for the non-clinical (design verification) tests. These are typically engineering tests performed on a limited number of devices, not clinical subject data.
The data provenance is from internal testing conducted by St. Jude Medical, Inc. It is non-clinical/engineering test data, not patient data (retrospective or prospective).

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

Not applicable. Ground truth as typically defined for diagnostic device performance (e.g., expert consensus on images, pathology results) is not relevant for these engineering verification tests. The "ground truth" here is the adherence to design specifications and performance standards as determined by engineers and laboratory testing.

4. Adjudication Method for the Test Set

Not applicable. As these are engineering verification tests, "adjudication" in the sense of resolving discrepancies between expert readings is not relevant. The results of the tests were compared against pre-determined acceptance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done, and is not applicable for this type of device (an introducer kit) seeking 510(k) clearance based on substantial equivalence to a predicate, especially when focused on engineering design changes. This device is not an AI or diagnostic imaging device; it's an interventional accessory.

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

Not applicable. This device is an introducer kit, not an algorithm.

7. The type of ground truth used

For the non-clinical (engineering) testing, the "ground truth" would be the established engineering specifications and performance standards for the device. For biocompatibility, the ground truth is adherence to the ISO 10993-1:2009 standard.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no training set. The "ground truth" for the non-clinical tests was established by predefined engineering specifications and international standards (ISO 10993-1:2009).

Summary

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

April 14, 2016

St. Jude Medical, Inc. Mr. Hassan Labay Regulatory Affairs Manager 645 Almanor Avenue Sunnyvale, CA 94085

Re: K160716

Trade/Device Name: Nanostim Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 14, 2016 Received: March 15, 2016

Dear Mr. Labay:

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.

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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 yours,

Kenneth J. Cavanaugh -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K160716

Device Name The Nanostim™ Introducer Kit

Indications for Use (Describe)

The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

This summary of 510(k) substantial equivalence information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number:

Applicant Information:

Owner Name:	St. Jude Medical, Inc.
Address:	645 Almanor AvenueSunnyvale, CA. 94085Office: 408 522 6622
Contact Person:	Hassan Labay
Phone Number:	408 522 6622

4/13/2016 Date Prepared:

Device Information:

Classification:	Class II
Trade Name:	St. Jude Medical NanostimTM Introducer Kit
Common name:	Introducer, Catheter
Classification name:	Catheter Introducer (21 CFR 870.1340/DYB)

Predicate Devices:

The modified Nanostim Introducer Kit is substantially equivalent in intended use and method of operation to the predicate Nanostim Introducer Kit (K140793).

Device Description:

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Indications For Use:

The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

Summary of Technological Characteristics in Comparison to Predicate Device:

The modified device and the predicate device (K140793) have the same indication for use, technological characteristics and performance. Both the subject device and predicate device are intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices. The minor differences in design to improve manufacturability and to increase the product shelf life do not alter the intended patient or clinical effect, and, therefore, the subject device is substantially equivalent to the predicate Nanostim Introducer Kit (K140793) with respect to indications, design, and function. There are no technological characteristics that raise new issues of safety or effectiveness.

Summary of Non-Clinical Testing:

Design verification testing was performed to verify the modified device remains substantially equivalent to the predicate device. Testing performed on the modified device included the following:

Visual test; ●
. Dimensional measurement test;
Tensile Strength: ●
Torsional Strength:
. Liquid Leak;
Simulated Use; ●
Torsional Strength; ●

All of the pre-determined acceptance criteria were met.

Biocompatibility Testing:

Biocompatibility testing for the subject device has been completed in accordance with the International Standard ISO 10993-1:2009 "Biological Evaluation of Medical devices- Part 1: Evaluation and testing within a risk management process" for an external communicating device with limited exposure (contact with circulating blood is <24 hours). Testing included the following:

Cytotoxicity ●
. Chemical Characterization

Summary of Clinical Testing:

Clinical evaluation is not required for this device.

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Substantial equivalence:

The subject device has the following similarities to the predicate device cleared under K140793:

. the same indication for use:
the same fundamental scientific technology; ●
the same technological characteristics; ●
the same principles of operation; .
incorporates the same basic introducer design and has the same sterilization process:

The minor differences in design to improve manufacturability and to increase the product shelf life between the subject device and the predicate device do not affect the intended use of the device or clinical effect and scientific technology of the device, therefore, the subject device is substantially equivalent to currently cleared Nanostim Introducer Kit (K140793).

Summary:

In summary, the modified device that is subject to this submission is substantial|" Á equivalent to the predicate device. It has the same indication for use, the same technological characteristics, and the same principles of operation as the predicate device. The differences between the modified device and the predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the subject device performs as the predicate device and is therefore 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).