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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Boston Scientific iSLEEVE Introducer Set. It focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. Since this is a medical device, the acceptance criteria and study that proves the device meets the acceptance criteria are based on non-clinical performance (bench testing), as explicitly stated in the document.

The document does not describe:

A table of acceptance criteria and reported device performance with specific numerical values beyond meeting general criteria for physical integrity, functionality, and performance.
Sample sizes used for a "test set" in the context of an AI/human reader study.
Data provenance, number of experts, adjudication methods, or MRMC studies, as these relate to AI/image-based diagnostic devices, not a catheter introducer.
Standalone algorithm performance or details about training sets for an AI.
Types of ground truth in a clinical sense (e.g., pathology), as the device's performance is assessed through bench tests.

Based on the provided text, here is the information that can be extracted, and where applicable, why certain information (relevant to an AI or diagnostic device) is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a quantitative table of acceptance criteria with specific numerical performance values. Instead, it broadly states the categories of performance assessed through bench testing.

Acceptance Criteria Category	Reported Device Performance
Physical Integrity	Demonstrated through bench testing.
Functionality	Demonstrated through bench testing.
Performance	Demonstrated through bench testing.
Dimensional Requirements	Met through bench testing.
Visibility under Fluoroscopy	Met through bench testing.
Interface with Compatible Devices	Met through bench testing.
Enhance advancement and withdrawal of LOTUS Edge Valve System	Modified distal tip designed to achieve this, confirmed through bench testing.

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

Sample Size: Not specified in terms of a "test set" as would be relevant for an AI or diagnostic study. Performance was evaluated via bench testing, which typically involves a specified number of physical units, but this specific number is not provided in this 510(k) summary.
Data Provenance: Not applicable in the context of clinical data for a "test set" as this is bench testing of a physical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth for a physical catheter introducer is established by engineering specifications, material properties, and physical testing protocols, not by expert clinical review of images or data.

4. Adjudication Method for the Test Set

Not applicable, as this refers to a process for resolving discrepancies in expert labeling or diagnoses for clinical data, which is not relevant for bench testing of this device.

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

No, an MRMC study was not done. The document explicitly states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the iSLEEVE Introducer Set." MRMC studies are typically performed for diagnostic devices (e.g., AI in radiology) to assess changes in human reader performance with and without AI assistance.

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

Not applicable. This device is a physical catheter introducer, not an algorithm. Standalone performance refers to the performance of an AI algorithm on its own, which is irrelevant here.

7. The Type of Ground Truth Used

Engineering Specifications and Benchmarking: The ground truth for this device's performance is established by pre-defined engineering specifications, functional requirements, and comparison to the performance of the predicate device (K191871) under controlled bench test conditions. For example, "dimensional requirements" means the device must meet specific size tolerances, which is a quantitative ground truth. "Visibility under fluoroscopy" would be assessed against a defined standard or observation.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" applies to machine learning algorithms. This document describes a physical medical device submitted for 510(k) clearance based on substantial equivalence to a predicate, primarily through non-clinical bench testing.

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

Not applicable. As there is no training set for an algorithm, there is no "ground truth" to establish for it in this context. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory standards for medical devices.

Summary

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October 6, 2020

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

Re: K202584

Trade/Device Name: iSleeve Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 4, 2020 Received: September 8, 2020

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Jaime Raben Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K202584

Device Name iSLEEVE™ Introducer Set

Indications for Use (Describe)

15F iSLEEVE Introducer Set:

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: 763-494-1654Fax: 763-494-2222e-mail: Kripa.Pandya@bsci.com
Prepared by	Kripa Pandya04 September 2020
Proprietary Name	iSLEEVE™ Introducer Set
Common Name	Catheter Introducer
Product Code	DYB
Classification	Class II, 21 CFR Part 870.1340
Predicate Device	iSLEEVE™ Introducer SetK191871 07 August 2019

Device Description

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Indications for Use / Intended 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 svstem 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, iSLEEVE Introducer Set, K191871.

Device Modifications:

The 15F iSLEEVE Introducer Set has a modified distal tip designed to enhance advancement and withdrawal of the LOTUS Edge Valve System compared to the predicate (K191871).

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 identified predicate.

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).