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

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 transcatheter heart valve systems and ancillary devices into the vascular system. The iSLEEVE Introducer Set is composed of a dilator and an introducer sheath with a threeway stopcock.

The distal end of the introducer sheath is passively expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. Once expanded, this region of the introducer sheath is radially compliant, which allows it to expand and collapse as needed during device delivery and removal. This reduces the time the access vessel is expanded. A hydrophilic coating is applied to the entire iSLEEVE introducer sheath which increases the lubricity to aid in delivery when activated.

A product mandrel and flushing tube are also supplied with the iSLEEVE Introducer Set.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding the "iSLEEVE™ Introducer Set". It's a regulatory clearance document, not a study report detailing acceptance criteria for an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this document. The document describes a medical device (catheter introducer), not an AI system.

However, I can extract the information that is present about the device's technical specifications and the testing performed, acknowledging that it's "non-clinical performance data" for a physical device, not an AI model.

Here's an analysis based on the provided text, explicitly stating where the requested AI/ML-related details are not available or not applicable:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (General)	Reported Device Performance (General)
Physical integrity	Bench testing was performed to evaluate physical integrity, functionality, and performance.
Functionality	Bench testing was performed to evaluate physical integrity, functionality, and performance. The distal end of the introducer sheath is passively expandable, radially compliant, expands and collapses as needed, and has a hydrophilic coating to increase lubricity.
Performance	Bench testing was performed to evaluate physical integrity, functionality, and performance. Performance criteria includes dimensional requirements, visibility under fluoroscopy, and interface with compatible devices. The proposed 14F iSLEEVE Introducer Set has a modified distal tip design to enhance robustness and ease of vessel insertion compared to the predicate.
Usability (ease of use)	The modified distal tip design enhances robustness and ease of vessel insertion.
Compatibility (interface with other devices)	Evaluated interface with compatible devices. Intended to facilitate introduction and removal of the ACURATE TF Valve System and ancillary devices.
Radiographic visibility	Evaluated visibility under fluoroscopy.
Dimensional requirements	Evaluated dimensional requirements. Suitable for use in vessels ≥ 5.5 mm diameter.
Substantial Equivalence to Predicate K180785	The device incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as the predicate. Based on indications for use, technological characteristics, and performance testing, the iSLEEVE Introducer Set is considered substantially equivalent to the iSLEEVE Introducer Set, K180785. The 14F iSLEEVE Introducer Set has a modified distal tip design compared to the predicate.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any specific test. The document generally refers to "bench testing."
- Data Provenance: The testing appears to be "non-clinical performance bench testing" conducted by Boston Scientific Corporation. This is likely internal testing, not patient data (retrospective or prospective). Country of origin is not specified, but the applicant (Boston Scientific) is based in the USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a physical medical device, not an AI/ML system requiring expert-established ground truth from medical images or data. The "ground truth" for a physical device would typically be its adherence to engineering specifications and performance standards established through bench testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not applicable to a physical medical device's bench testing.
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:
- N/A. This device is a catheter introducer, not an AI imaging or diagnostic tool. No MRMC study was conducted or is relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a physical device, the "ground truth" for performance would be its adherence to established engineering specifications and performance standards as measured by various bench tests (e.g., dimensional accuracy, material properties, functional movements, compatibility with other devices). No medical "ground truth" types like pathology or expert consensus on clinical findings are applicable here.
The sample size for the training set:
- N/A. This is a physical medical device, not an AI/ML system that uses training data.
How the ground truth for the training set was established:
- N/A. Not applicable.

Summary

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March 7, 2019

Boston Scientific Kripa Pandya Regulatory Affairs Specialist I Three Scimed Place Maple Grove, Minnesota 55311

Re: K190184

Trade/Device Name: iSLEEVE™ Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 31, 2019 Received: February 1, 2019

Dear Kripa Pandya:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

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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) K190184

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 diameter.

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)

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510(k) Summary

per 21 CFR §807.92

Sponsor	Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA
Contact Name andInformation	Kripa PandyaThree Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-2870Fax: 763-494-2222e-mail: Kripa.Pandya@bsci.com
Prepared by	Kripa Pandya31 January 2019
Proprietary Name	iSLEEVE™ Introducer Set
Common Name	Catheter Introducer
Product Code	DYB
Classification	Class II, 21 CFR Part 870.1340
Predicate Device	iSLEEVE™ Introducer Set K180785 22 June 2018

Device Description

A product mandrel and flushing tube are also supplied with the iSLEEVE Introducer Set.

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Indications for Use / Intended Use

14F iSLEEVE Introducer Set:

INTENDED USE:

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

INDICATIONS FOR USE:

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, iSLEEVE Introducer Set, K180785.

The proposed 14F iSLEEVE Introducer Set has a modified distal tip design to enhance robustness and ease of vessel insertion compared to the predicate 14F iSLEEVE Introducer Set.

Non-clinical Performance Data

Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing data.

Bench Testing:

Bench testing was performed to evaluate physical integrity, functionality, and performance of the iSLEEVE Introducer Sheath Set. Performance criteria includes dimensional requirements, visibility under fluoroscopy, and interface with compatible devices.

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 iSLEEVE Introducer Set, K180785.

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).