(30 days)
Not Found
No
The document describes a mechanical introducer set with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device (introducer set) facilitates access for other cardiovascular devices and is not itself intended to treat a disease or condition.
No
The device is an introducer set designed to facilitate access to the vascular system for the introduction and removal of other cardiovascular devices, not for diagnosing medical conditions.
No
The device description clearly outlines physical components such as a dilator, introducer sheath, stopcock, product mandrel, and flushing tube, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate femoral access to the vascular system for introduction and removal of cardiovascular devices." This describes a device used in vivo (within the body) for a procedural purpose.
- Device Description: The description details a catheter, dilator, sheath, and stopcock, all components used for accessing blood vessels and introducing other devices. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is clearly designed for use in vivo to facilitate a medical procedure.
N/A
Intended Use / Indications for 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.
Product codes
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral access to the vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical testing was successfully completed on the modified device, specifically "Sheath to Hub Tensile Testing". The 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(K) SUMMARY (K233503)
| Sponsor | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA | | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------|---------|--------------------|
| Contact Name and
Information | Alyssa Manno
One Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-2602
e-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
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.
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.