The 14F iSLEEVE™ Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of cardiovascular devices. The iSLEEVE™ Introducer Set is suitable for use in vessels > 5.5 mm diameter.

Device Description

The 14F iSLEEVE Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction and removal of cardiovascular devices into the vascular system. The 14F 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 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 coatinq is applied to the working end of the 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 is a submission for a medical device (14F iSLEEVE™ Introducer Set) and therefore doesn't involve AI/ML. The provided text describes a 510(k) submission for a non-AI medical device, focusing on its substantial equivalence to a predicate device based on physical and mechanical properties. Therefore, most of your requested information (acceptance criteria for AI performance, sample size for test/training sets, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types) is not applicable to this document.

However, I can extract information related to the device's performance testing given the provided text:

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

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Mechanical Performance	Sheath to Hub Tensile Testing	Met previously established acceptance criteria (specific values not detailed)	"Testing demonstrated that the modified 14F iSLEEVE Introducer Set met the previously established acceptance criteria."

The rest of the requested information is not applicable to this 510(k) submission as it is for a physical medical device, not an AI/ML algorithm.

Here's why the other points are not applicable:

2. Sample size used for the test set and the data provenance: This relates to data for AI/ML validation, not physical device testing. The "test set" here refers to physical devices, not data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical device. Ground truth is usually established through engineering specifications and physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: MRMC studies are for AI-assisted image interpretation, not physical devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: "Standalone" in this context refers to the device itself, which performs its function physically, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical devices, ground truth often comes from engineering specifications, material properties, and in vitro/in vivo measurements that are compared against predefined performance limits. For this specific submission, the "ground truth" for the tensile strength test would be the engineering specification for how much force the sheath-to-hub connection must withstand.
8. The sample size for the training set: Not applicable as there is no AI/ML algorithm to train.
9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA clearance document pertains to a physical introducer set, and the "study that proves the device meets the acceptance criteria" refers to non-clinical performance data, specifically mechanical testing, rather than studies involving AI/ML performance metrics.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 30, 2023

Boston Scientific Corporation Alyssa Manno Regulatory Affairs Specialist III Two Scimed Place Maple Grove, Minnesota 55311

Re: K233503

Trade/Device Name: 14F iSLEEVE™ Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 31, 2023 Received: October 31, 2023

Dear Alyssa Manno:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

{1}------------------------------------------------

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.

Julie B. M.

For

Jennifer Bastijanic Acting Assistant Director DHT2B: Division of Circulatory Support,

{2}------------------------------------------------

Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K233503

Device Name 14F iSLEEVE™ Introducer Set

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(K) SUMMARY (K233503)

Sponsor	Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA
Contact Name andInformation	Alyssa MannoOne Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-2602e-mail: Alyssa.Manno@bsci.com
Date Prepared by	October 31st, 2023
Proprietary Name	14F iSLEEVE™ Introducer Set
Common Name	Catheter Introducer
Product Code	DYB
Classification	Class II, 21 CFR Part 870.1340
Predicate Device	iSLEEVE™ Introducer Set	K230051	February 3rd, 2023

Device Description

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

Indications for Use / Intended Use

The 14F iSLEEVE™ Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of cardiovascular devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.5 mm diameter.

{5}------------------------------------------------

Comparison of Technological Characteristics

The modified device includes an enhanced transition point between the sheath and hub components. There are no other design changes associated with this 510(k).

Comparison of the new design and the currently marketed predicate device show that the technological characteristics such as performance, materials, design, sterilization, biocompatibility, and packaging are equivalent. The subject 14F iSLEEVE Introducer Set intended purpose and principles of operation also remain unchanged.

Non-clinical Performance Data

Modifications to the predicate device were assessed according to risk-based failure mode effects analysis. The following non-clinical testing was successfully completed on the modified device.

. Sheath to Hub Tensile
Testing demonstrated that the modified 14F iSLEEVE Introducer Set met the previously established acceptance criteria. No new safety or effectiveness issues were raised during verification activities, thereby supporting a determination of substantial equivalence.

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).