(26 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical function of the introducer set, with no mention of AI or ML.
No
The device is an introducer set designed to facilitate access for other devices (transcatheter heart valve systems), not to directly treat a medical condition.
No
The device is an introducer set designed to facilitate access to the vascular system for other medical devices, not to diagnose a condition.
No
The device description clearly states it is a "sterile, single-use introducer catheter" and is composed of physical components like a dilator, introducer sheath, stopcock, mandrel, and flushing tube. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for facilitating femoral access to the vascular system for the introduction and removal of other medical devices (heart valve systems and ancillary devices). This is a procedural device used in vivo (within the body).
- Device Description: The description details a physical introducer catheter, dilator, and sheath used for accessing blood vessels. This aligns with a surgical or interventional device, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and procedural for accessing the vascular system.
N/A
Intended Use / Indications for Use
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.
15F iSLEEVE™ Introducer Set: 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.
Product codes
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery, vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 7, 2019
Boston Scientific Corporation Kripa Pandya Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311
Re: K191871
Trade/Device Name: 15F iSLEEVE™ Introducer Set, 14F iSLEEVE™ Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 11, 2019 Received: July 12, 2019
Dear Ms. 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
1
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 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,
for Nicole G. Ibrahim, Ph.D. 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
Enclosure
2
Indications for Use
510(k) Number (if known) K191871
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.
15F iSLEEVE Introducer Set:
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
per 21 CFR §807.92
| Sponsor | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Kripa Pandya
Three Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-1654
Fax: 763-494-2222
e-mail: Kripa.Pandya@bsci.com |
| Prepared by | Kripa Pandya
11 July 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
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.
4
Indications for Use / Intended Use
14F iSLEEVE Introducer Set:
INTENDED USE:
The iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular svstem.
INDICATIONS FOR USE:
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.
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 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.
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.
15F Changes:
The 15F iSLEEVE Introducer Set has a modified distal tip design to enhance robustness and ease of vessel insertion compared to the predicate iSLEEVE Introducer Set (K180785).
14F and 15F Changes:
The iSLEEVE Introducer Set, compared to the predicate (K180785), incorporates an increase in radiopaque tip wall thickness intended to strengthen the distal tip. In addition, the subject device includes a modified tip perforation intended to optimize consistency of sheath expansion.
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.
5
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.