14F iSLEEVE Introducer Set: The 14F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the ACURATE TF Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.5 mm.

15F iSLEEVE Introducer Set: The 15F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the LOTUS Edge Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.9 mm.

Device Description

The iSLEEVE™ Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction and removal of compatible valve systems and ancillary devices into the vascular system. The iSLEEVE Introducer Set is composed of a dilator and an introducer sheath with a three-way stopcock. The distal end of the introducer sheath is expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. This reduces the time the access vessel is expanded. There is a hydrophilic coating on the introducer sheath which increases the lubricity of the surface to aid in delivery when activated.

The iSLEEVE Introducer Set is available in two sizes; 14F and 15F. The 14F iSLEEVE Introducer Set is for use with the ACURATE TF Valve System only and the 15F iSLEEVE Introducer Set is for use with the LOTUS Edge™ Valve System only. A product mandrel and flushing tube are also supplied with the iSLEEVE Introducer Set.

AI/ML Overview

This document describes the performance testing for the iSLEEVE™ Introducer Set, but it does not present acceptance criteria or detailed results in a way that allows for a direct comparison as requested. The document states that the iSLEEVE Introducer Set conforms to certain standards and underwent various performance tests, but it does not provide specific numerical acceptance criteria or the reported device performance values for each criterion. It concludes that "No new safety or performance issues were raised during the testing" and "this device may be considered substantially equivalent to the predicate device."

Therefore, I cannot populate the table or provide detailed answers to most of the specific questions as the information is not present in the provided text.

Here's what can be extracted and what cannot:

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

This information is not provided in the document. The document lists the types of tests performed (e.g., Dimensional Verification, Device Deployment and Retraction, Catheter Bond Strength, etc.) and states that the device conforms to relevant sections of EN ISO 10555-1:2013 and EN ISO 11070:2014, and underwent biocompatibility testing in accordance with EN ISO 10993-1. However, it does not specify the numerical acceptance criteria for these tests nor does it report the specific performance values achieved by the device against these criteria.

2. Sample size used for the test set and the data provenance

The document mentions "a preclinical study was executed to support a determination of substantial equivalence. The study evaluated the performance of the iSLEEVE device through an acute animal assessment in a simulated use environment and bench testing under simulated use conditions." However, the sample sizes for these tests are not specified, nor is the exact data provenance (e.g., country of origin, retrospective/prospective). It only states it was an "acute animal assessment."

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

This information is not applicable to the type of performance testing described for a Class II medical device like an introducer set. The testing is primarily engineering and material performance-based, not reliant on expert medical interpretation of images or patient data to establish "ground truth."

4. Adjudication method for the test set

This information is not applicable for the same reasons as #3.

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

This information is not applicable. The device is an introducer set, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable. The device is an introducer set, not an algorithm.

7. The type of ground truth used

For the engineering and biocompatibility tests, the "ground truth" would be established by the specifications in the referenced ISO standards and internal design requirements. For the acute animal assessment, the "ground truth" would be the direct observation of device performance in the simulated use environment. However, this is not "expert consensus, pathology, outcomes data" in the typical sense for AI/diagnostic devices.

8. The sample size for the training set

This information is not applicable. The device is an introducer set, not an algorithm that requires a training set.

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

This information is not applicable. The device is an introducer set, not an algorithm that requires a training set.

In summary, the provided text from the 510(k) summary focuses on demonstrating substantial equivalence through standard device performance and biocompatibility testing, rather than studies involving ground truth establishment by experts, AI performance metrics, or clinical trial data with acceptance criteria for such metrics.

Summary

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Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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.

June 22, 2018

Boston Scientific Corporation Toni Guidarelli Sr. Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55446

Re: K180785

Trade/Device Name: iSLEEVE™ Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 23, 2018 Received: March 26, 2018

Dear Ms. Guidarelli:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jaime Raben -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) K180785

Device Name iSLEEVE Introducer Set

Indications for Use (Describe)

14F iSLEEVE Introducer Set:

The 14F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the ACURATE TF Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.5 mm.

15F iSLEEVE Introducer Set:

The 15F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the LOTUS Edge Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.9 mm.

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

per 21 CFR §807.92

Sponsor	Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA
Contact Name andInformation	Toni GuidarelliThree Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-2870Fax: 763-494-2222e-mail: Toni.Guidarelli@bsci.com
Prepared	March 23, 2018
Proprietary Name	iSLEEVE TM Introducer Set
Common Name	Catheter introducer
Product Code	DYB
Classification	Class II, 21 CFR Part 870.1340
Primary PredicateDevice	Creganna-TactxLotusTM Introducer Set	K140338	27 August 2014
ReferenceDevice(s)	Edwards eSheathIntroducer Set	K152225	24 November 2015

Device Description

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Indications for Use / Intended Use Guide Wire

14F iSLEEVE Introducer Set:

INTENDED USE:

The iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system.

INDICATIONS FOR USE:

15F iSLEEVE Introducer Set:

INTENDED USE:

The iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system.

INDICATIONS FOR USE:

The 15F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the LOTUS Edge™ Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.9 mm.

Comparison of Technological Characteristics

The iSLEEVE™ Introducer Set incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate, Creganna-Tactx Lotus™ Introducer Set K140338.

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Performance Data

The iSLEEVE Introducer Set was subjected to testing to support a determination of substantial equivalence according to Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010. The iSLEEVE Introducer Set also conforms to relevant sections of EN ISO 10555-1: 2013, Sterile, single-use intravascular catheters; Part 1: General Requirements and EN ISO 11070:2014 Sterile single-use intravascular introducers, dilators and quidewires. In addition biocompatibility testing was performed in accordance with EN ISO 10993-1 Biological evaluation of medical devices. A summary of testing completed is provided below;

Dimensional Verification ●
Device Deployment and Retraction ●
Catheter Bond Strength ●
Flexibility and Kink Test
Torque Strength
. Radiopacity
. Coating Integrity
Particulate Evaluation ●
Catheter Body Burst Pressure ●
System Insertion Force ●
Valve Leakage
Visual Appearance
Package Integrity
Sterility and EO Residuals .
Biocompatibility ●
Endotoxin ●

In addition to the aforementioned testing, a preclinical study was executed to support a determination of substantial equivalence. The study evaluated the performance of the iSLEEVE device through an acute animal assessment in a simulated use environment and bench testing under simulated use conditions. As part of the acute animal assessment Tip and Dilator radiopacity performance was assessed.

The results of the tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing; therefore this device may be considered substantially equivalent to the predicate device.

Clinical Testing

Performance testing from clinical studies is not required to demonstrate substantial equivalence of the iSLEEVE Introducer Set.

Conclusion

Based on the indications for use, technological characteristics, and performance testing the iSLEEVE™ Introducer Set has been shown to be appropriate for its' intended use and is considered to be substantially equivalent to the Creganna-Tactx Lotus™ Introducer Set K140338.

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).