(88 days)
No
The device description and performance studies focus on the mechanical and material properties of a vascular introducer set, with no mention of AI or ML.
No.
The device, an Introducer Set, facilitates the access and introduction/removal of other compatible valve systems and ancillary devices. It does not provide any treatment or therapy itself.
No
This device is an introducer set, intended to facilitate access for other devices into the vascular system. Its function is to create a pathway, not to diagnose a condition.
No
The device description clearly states it is a sterile, single-use introducer catheter composed of physical components like a dilator, introducer sheath, and stopcock. It also mentions physical properties like hydrophilic coating and expandable distal end. The performance studies focus on physical characteristics and mechanical testing.
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 used to "facilitate femoral access to the vascular system for introduction and removal of the ACURATE TF Valve System and ancillary devices" and the "LOTUS Edge Valve System and ancillary devices." This describes a device used in vivo (within the body) for a surgical or interventional procedure.
- Device Description: The description details a "sterile, single-use introducer catheter" that provides "percutaneous access to the femoral artery." This further confirms its use within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, while this device is used to access the body itself for a medical procedure.
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.
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 (comma separated list FDA assigned to the subject device)
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 valve systems and ancillary devices into the vascular system. The 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 expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. This reduces the time the access vessel is expanded. There is a hydrophilic coating on the introducer sheath which increases the lubricity of the surface to aid in delivery when activated.
The iSLEEVE Introducer Set is available in two sizes; 14F and 15F. The 14F iSLEEVE Introducer Set is for use with the ACURATE TF Valve System only and the 15F iSLEEVE Introducer Set is for use with the LOTUS Edge™ Valve System only. 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The iSLEEVE Introducer Set was subjected to testing to support a determination of substantial equivalence according to Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010. The iSLEEVE Introducer Set also conforms to relevant sections of EN ISO 10555-1: 2013, Sterile, single-use intravascular catheters; Part 1: General Requirements and EN ISO 11070:2014 Sterile single-use intravascular introducers, dilators and quidewires. In addition biocompatibility testing was performed in accordance with EN ISO 10993-1 Biological evaluation of medical devices. A summary of testing completed is provided below;
- Dimensional Verification
- Device Deployment and Retraction
- Catheter Bond Strength
- Flexibility and Kink Test
- Torque Strength
- Radiopacity
- Coating Integrity
- Particulate Evaluation
- Catheter Body Burst Pressure
- System Insertion Force
- Valve Leakage
- Visual Appearance
- Package Integrity
- Sterility and EO Residuals
- Biocompatibility
- Endotoxin
In addition to the aforementioned testing, a preclinical study was executed to support a determination of substantial equivalence. The study evaluated the performance of the iSLEEVE device through an acute animal assessment in a simulated use environment and bench testing under simulated use conditions. As part of the acute animal assessment Tip and Dilator radiopacity performance was assessed.
The results of the tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing; therefore this device may be considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 and 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.
June 22, 2018
Boston Scientific Corporation Toni Guidarelli Sr. Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55446
Re: K180785
Trade/Device Name: iSLEEVE™ Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 23, 2018 Received: March 26, 2018
Dear Ms. Guidarelli:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jaime Raben -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180785
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.
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 | Toni Guidarelli
Three Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-2870
Fax: 763-494-2222
e-mail: Toni.Guidarelli@bsci.com | | |
| Prepared | March 23, 2018 | | |
| Proprietary Name | iSLEEVE TM Introducer Set | | |
| Common Name | Catheter introducer | | |
| Product Code | DYB | | |
| Classification | Class II, 21 CFR Part 870.1340 | | |
| Primary Predicate
Device | Creganna-Tactx
LotusTM Introducer Set | K140338 | 27 August 2014 |
| Reference
Device(s) | Edwards eSheath
Introducer Set | K152225 | 24 November 2015 |
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 valve systems and ancillary devices into the vascular system. The 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 expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. This reduces the time the access vessel is expanded. There is a hydrophilic coating on the introducer sheath which increases the lubricity of the surface to aid in delivery when activated.
The iSLEEVE Introducer Set is available in two sizes; 14F and 15F. The 14F iSLEEVE Introducer Set is for use with the ACURATE TF Valve System only and the 15F iSLEEVE Introducer Set is for use with the LOTUS Edge™ Valve System only. A product mandrel and flushing tube are also supplied with the iSLEEVE Introducer Set.
4
Indications for Use / Intended Use Guide Wire
14F iSLEEVE Introducer Set:
INTENDED USE:
The iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system.
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, Creganna-Tactx Lotus™ Introducer Set K140338.
5
Performance Data
The iSLEEVE Introducer Set was subjected to testing to support a determination of substantial equivalence according to Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010. The iSLEEVE Introducer Set also conforms to relevant sections of EN ISO 10555-1: 2013, Sterile, single-use intravascular catheters; Part 1: General Requirements and EN ISO 11070:2014 Sterile single-use intravascular introducers, dilators and quidewires. In addition biocompatibility testing was performed in accordance with EN ISO 10993-1 Biological evaluation of medical devices. A summary of testing completed is provided below;
- Dimensional Verification ●
- Device Deployment and Retraction ●
- Catheter Bond Strength ●
- Flexibility and Kink Test
- Torque Strength
- . Radiopacity
- . Coating Integrity
- Particulate Evaluation ●
- Catheter Body Burst Pressure ●
- System Insertion Force ●
- Valve Leakage
- Visual Appearance
- Package Integrity
- Sterility and EO Residuals .
- Biocompatibility ●
- Endotoxin ●
In addition to the aforementioned testing, a preclinical study was executed to support a determination of substantial equivalence. The study evaluated the performance of the iSLEEVE device through an acute animal assessment in a simulated use environment and bench testing under simulated use conditions. As part of the acute animal assessment Tip and Dilator radiopacity performance was assessed.
The results of the tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing; therefore this device may be considered substantially equivalent to the predicate device.
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 Creganna-Tactx Lotus™ Introducer Set K140338.