The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™M 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 one size (18F) and two lengths (30cm and 50cm).

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 length and packaging of the current device. 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 describes a 510(k) premarket notification for a medical device called the Nanostim Introducer Kit. This document is a submission to the FDA seeking to demonstrate that the modified device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Mechanical/Physical	Visual test	All pre-determined acceptance criteria were met.
	Dimensional measurement test	All pre-determined acceptance criteria were met.
	Torsional Strength	All pre-determined acceptance criteria were met.
	Simulated use/kink test	All pre-determined acceptance criteria were met.
Functional Equivalence	Same indication for use as predicate	Yes
	Same fundamental scientific technology as predicate	Yes
	Same technological characteristics as predicate	Yes
	Same materials as predicate	Yes
	Same principles of operation as predicate	Yes
	Same basic introducer design and sterilization process	Yes
Safety and Effectiveness	Changes do not affect intended use or clinical effect	Yes
	Differences raise no new issues of safety or effectiveness.	Yes

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

The document does not explicitly state the specific sample sizes for each non-clinical test (visual, dimensional, torsional, simulated use/kink). It generally refers to "Design verification testing."

Test Set Sample Size: Not specified for individual tests.
Data Provenance: The study is reported as "Design verification testing," which implies it was conducted by the manufacturer (St. Jude Medical, Inc.) to verify their modified product. The origin of the data (e.g., country) is not specified beyond being generated by the applicant. It is a retrospective study in the sense that the testing was performed on the manufactured device, not as part of a prospective clinical trial.

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

This information is not applicable to this submission. The tests conducted are non-clinical, design verification tests, not clinical evaluations relying on expert interpretation of medical data (like imaging or pathology). The "ground truth" for these engineering tests would be established by objective measurements and defined specifications, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are non-clinical, objective measurements against pre-defined specifications determine success or failure. There is no human variability in interpreting results that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical evaluation is not required for this device." This type of study is typically performed for AI/image analysis devices where human reader performance is a key metric.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical instrument (an introducer kit), not an AI algorithm or software device.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests would be based on engineering specifications and industry standards for medical device performance. For example:

Visual test: Conformance to manufacturing standards, absence of defects.
Dimensional measurement test: Conformance to specified dimensions (e.g., diameter, length).
Torsional Strength: Ability to withstand a specified torsional force without breaking or deforming.
Simulated use/kink test: Ability to perform as intended under simulated use conditions without kinking or failure.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning or AI models. The device's design is based on engineering principles and prior iterations, not trained on a dataset.

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

This information is not applicable for the same reason as point 8. There is no training set for this device.

Summary

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

May 19, 2016

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

Re: K161102

Trade/Device Name: Nanostim Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 18, 2016 Received: April 19, 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) K161102

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
Date Prepared:	4/18/2016

Device Information:

Classification:	Class II
Trade Name:	St. Jude Medical Nanostim™ 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 (K160716).

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 (K160716) 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 modified device is identical to the existing Nanostim Introducer Kit, with the exception of the device length. The predicate device is 30cm while the modified device is 50cm. The modification described herein do not affect the intended use of the device or alter the fundamental scientific technology associated with the device, and, therefore, the subject device is substantially equivalent to the predicate device with respect to indications, design, and function.

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; ●
Torsional Strength; ●
Simulated use/kink test

All of the pre-determined acceptance criteria were met.

Summary of Clinical Testing:

Clinical evaluation is not required for this device.

Substantial equivalence:

The subject device has the following similarities to the predicate device cleared under K160716:

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

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The changes made to the device do not affect the intended use of the device or clinical effect and scientific technology of the device, the subject device is substantially equivalent to currently cleared Nanostim Introducer Kit 30cm (K160716).

Summary:

In summary, the modified device that is subject to this submission is substantial equivalent to the predicate device. It has the same indication for use, the same technological characteristics, the same materials, the same sterilization process 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).