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 coating 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

The provided text describes a 510(k) premarket notification for a medical device, the 14F iSLEEVE Introducer Set. It focuses on demonstrating substantial equivalence to a predicate device, specifically after a modification involving an alternative hydrophilic coating.

However, the document does not contain the level of detail typically found in a clinical study report or a robust performance study for an AI/ML medical device, which would include the specific acceptance criteria tables, sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth, and MRMC study details.

The provided information pertains to the acceptance criteria and study that proves the device meets the acceptance criteria for a medical device with a coating change, not an AI/ML algorithm.

Based on the provided text, here is an attempt to address your questions, while highlighting the limitations due to the nature of the document:

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

The document mentions that "Testing demonstrated that the modified 14F iSLEEVE Introducer Set met all previously established acceptance criteria." However, it does not provide a specific table of acceptance criteria with corresponding performance numbers. It lists the types of non-clinical tests performed:

Test Category	Acceptance Criteria (Implied)	Reported Performance (Implied)
Coating Material and Length	Met specifications	Met specifications
Coating Lubricity and Durability (L&D)	Met specifications	Met specifications
Introducer System Advancement Force	Met specifications	Met specifications
Maximum Junction OD	Met specifications	Met specifications
Particulate Evaluation	Met specifications	Met specifications
Coating Integrity	Met specifications	Met specifications
Visual Appearance	Met specifications	Met specifications
Biocompatibility (Cytotoxicity)	Met specifications	Met specifications
Biocompatibility (Irritation)	Met specifications	Met specifications
Biocompatibility (Sensitization)	Met specifications	Met specifications
Biocompatibility (Material Mediated Pyrogenicity)	Met specifications	Met specifications
Biocompatibility (Acute Systemic Toxicity)	Met specifications	Met specifications
Biocompatibility (Hemocompatibility)	Met specifications	Met specifications
Biocompatibility (Genotoxicity)	Met specifications	Met specifications
Animal Study: Performance of Insertion and Removal	Functionally equivalent to predicate	Functionally equivalent to predicate

Note: The "Reported Performance (Implied)" column is based on the statement "Testing demonstrated that the modified 14F iSLEEVE Introducer Set met all previously established acceptance criteria" and "Results confirm that the modified device remains biocompatible for its intended use." Specific quantitative results are not provided in this summary.

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

Test Set Sample Size: Not explicitly stated for each non-clinical test. The document refers to "the modified device" meeting criteria. For the animal study, it mentions a "double-blinded animal study" in the "porcine model," implying a sample size of animals, but the exact number of animals or devices tested is not provided.
Data Provenance:
- Non-clinical testing: Performed internally by the manufacturer (Boston Scientific Corporation). The location of the testing is not specified, but it's presumed to be in a controlled laboratory environment.
- Animal Study: Conducted in a "porcine model." No information on the country of origin or whether it was retrospective or prospective is given, though animal studies for device testing are typically prospective.

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

Non-clinical tests: Ground truth is established by standard engineering and biocompatibility testing methodologies and validated equipment, not typically by human experts in the same way as medical image analysis.
Animal Study: "Physicians were asked to separately evaluate the performance of the insertion and removal of the predicate and alternative hydrophilic coated device."
- Number of experts: Not specified (e.g., "physicians" could be one or multiple).
- Qualifications of experts: Only identified as "Physicians." No details on their specialty, experience level, or specific training are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Non-clinical tests: Not applicable in the context of human expert adjudication.
Animal Study: The phrase "Physicians were asked to separately evaluate" suggests individual assessments, but it does not specify an adjudication method (e.g., consensus, majority vote) if multiple physicians were involved. It implies a comparative evaluation between the modified and predicate device's performance characteristics during insertion and removal.

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

No MRMC study was performed. This document describes the testing for a physical medical device (introducer sheath) with a coating change, not an AI/ML algorithm. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

Not applicable. This relates to a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Non-clinical tests: Ground truth is established through physical measurements, chemical analyses, and standardized biological assays, adhering to relevant standards (e.g., ISO 10993-1 for biocompatibility).
Animal Study: Ground truth was based on the "functional performance" assessed by "physicians" during the insertion and removal of the devices in the porcine model. This would involve qualitative and potentially some quantitative assessment of ease of use, resistance, and other performance characteristics directly observed during the procedure. It's a form of expert observation/assessment in a simulated use environment.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm. It is a manufactured physical good, and as such, there is no "training set" in the context of machine learning. The design and manufacturing process would involve internal development and verification.

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

Not applicable. See point 8.

Summary

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February 3, 2023

Boston Scientific Corporation Kendall Lindenman Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311

Re: K230051

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: January 5, 2023 Received: January 6, 2023

Dear Kendall Lindenman:

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,

Jennifer Bastijanic -S

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

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Indications for Use

510(k) Number (if known) K230051

Device Name iSLEEVE Introducer Set

Indications for Use (Describe)

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.

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 (K230051) per 21 CFR §807.92

Sponsor	Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA
Contact Name andInformation	Kendall LindenmanOne Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-1284e-mail: Kendall.Lindenman@bsci.com
Date Prepared by	January 5th, 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	K191871	August 07, 2019

Device Description

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

Indications for Use / Intended Use

Comparison of Technological Characteristics

The modified device includes an alternative hydrophilic coating, there are no other design changes associated with this 510(k).

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

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Non-clinical Performance Data

Modifications to the predicate device were assessed according to risk-based failure mode effects analysis and with consideration of FDA Guidance, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010. The following non-clinical testing was successfully completed on the modified device.

Coating Material and Length
Coating Lubricity and Durability (L&D)
Introducer System Advancement Force .
Maximum Junction OD ●
. Particulate Evaluation
Coating Integrity .
Visual Appearance ●

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

Biocompatibility testing was also assessed with consideration recommendations per ISO 10993-1. Biological Evaluation of Medical Devices - Part 1: 10993-1 (issued September 2020) for devices categorized as externally communicating with limited (<24 hours) direct circulating blood contact. The following is a list of the biocompatibility tests conducted on the modified 14F iSLEEVE Introducer Set.

. Cytotoxicity
. Irritation
Sensitization .
Material Mediated Pyrogenicity .
Acute Systemic Toxicity ●
Hemocompatibility ●
Genotoxicity ●

Results confirm that the modified device remains biocompatible for its intended use.

Animal Study

A double-blinded animal study was conducted in the porcine model to further support a determination that the modified device with alternative hydrophilic coating is substantially equivalent to that of the predicate. Physicians were asked to separately evaluate the performance of the insertion and removal of the predicate and alternative hydrophilic coated device.

The animal study and simulated use evaluation further supports that the modified iSLEEVE Introducer Set, when coated with the alternate coating, demonstrates functionally equivalent performance as compared to the current coating.

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).