(113 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guide sheath, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an introducer sheath and guide catheter for the introduction of interventional and diagnostic devices, not as a device that directly performs a therapeutic action.
No
This device, the Vessix™ Guide Sheath, is described as an introducer sheath and guide catheter for the introduction of other interventional and diagnostic devices, not a diagnostic device itself.
No
The device description clearly details a physical medical device (guide sheath) made of materials like polycarbonate and featuring components like a braided shaft, pre-formed tip, valve, and sidearm. It also mentions physical testing like tensile strength and burst pressure. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed for the "introduction of interventional and diagnostic devices through the vasculature to the renal arteries." This describes a device used within the body for accessing a specific anatomical site, not a device used to test samples outside the body.
- Device Description: The description details a physical device (a guide sheath) with features like a braided shaft, pre-formed tip, valve, sidearm, and dilator. These are all components of a medical device used for accessing and navigating within the circulatory system.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis. The device's function is purely procedural – to facilitate the delivery of other devices.
In summary, the Vessix™ Guide Sheath is an invasive medical device used for accessing the renal arteries, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vessix™ Guide Sheath is designed to be used for the introduction of interventional and diagnostic devices through the vasculature to the renal arteries.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
Vessix™ Guide Sheath is a 7F guide sheath designed to perform as an introducer sheath and guide catheter for the introduction of interventional and diagnostic devices through the vasculature to the renal arteries. The Vessix Guide Sheath has been optimized for torque to allow access to both renal arteries during procedures. The guide sheath has an effective length of 45 cm and is available in two curve shapes: RDC (renal double curve) and LIMA (left internal mammary artery).
The guide sheath has a braided shaft design to maximize torque response, and a pre-formed tip shape (either RDC or LIMA) to enable access. It is equipped with a Tuohy-Borst valve (hemostatic valve) to prevent bleeding and a sidearm with a three-way stopcock to allow for flushing and introduction of contrast media. It is also packaged with a dilator to help with delivery over a guidewire. The guide sheath can accommodate guidewires with diameters less than or equal to 0.038 in (0.97 mm). The distal 15 cm of the outer surface of the guide sheath has a hydrophilic coating (Bioslide™). The distal tip is radiopaque to help with placement.
A polycarbonate hub is adhesively bonded to the proximal section of the guide sheath. It incorporates a luer fitting which serves as a junction to the hemostatic valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal arteries
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 Vessix™ Guide Sheath was subjected to testing according to the requirements of Guidance for Industry and FDA Staff - Class il Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010. Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these 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 and, therefore, this device may be considered substantially equivalent to the predicate device.
The following biocompatibility and chemical characterization tests were completed on the Vessix™ Guide Sheath and its accessories:
Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, Hemolysis (Direct Contact), Hemolysis (Extract Method), Partial Thromboplastin Time, In Vitro Hemocompatibility, Complement Activation, In Vivo Thromboresistance* (*This test was performed only on the Ditator accessory.), USP Physicochemical.
The following in-vitro performance tests were completed on the Vessix™ Guide Sheath:
Sheath Effective Length, Sheath Inner and Outer Diameter, Dilator Inner Diameter, Dilator Length, Dilator to Sheath Compatibility (OD), Sheath Tensile, Sheath to Hub Tensile, Dilator to Hub Tensile, Tuohy-Borst Valve Leakage, Dye Flow Rate, Sheath Burst Pressure, Device Visual Appearance, Radiopacity, Sheath Kink Resistance, Particulates, Torque Strength, Coating Integrity.
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.
Not Found
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
、「
K140641 p. 1 of 3
ﺎ
ﺮ
ン
510(k) Summary
per 21 CFR §807.92
:
·
)
l
(
· ।
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
Phone: 763-494-1700
Fax: 763-494-2222 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and
Information | Kurtis Hunsberger
Senior Regulatory Affairs Specialist
Phone: 763-255-0303
Fax: 763-494-2222
e-mail: kurtis.hunsberger@bsci.com |
| Date Prepared | June 26, 2014 |
| Proprietary
Name | Vessix™ Guide Sheath |
| Common Name | Guide Sheath |
| Product Code | DYB |
| Classification | Class II, 21 CFR Part 870.1340 |
| Predicate
Device | Terumo Destination Renal Guiding
Sheath K081045 May 28, 2008 |
| Device
Description | Vessix™ Guide Sheath is a 7F guide sheath designed to perform as an
introducer sheath and guide catheter for the introduction of interventional
and diagnostic devices through the vasculature to the renal arteries. The
Vessix Guide Sheath has been optimized for torque to allow access to
both renal arteries during procedures. The guide sheath has an effective
length of 45 cm and is available in two curve shapes: RDC (renal double
curve) and LIMA (left internal mammary artery).
The guide sheath has a braided shaft design to maximize torque
response, and a pre-formed tip shape (either RDC or LIMA) to enable
access. It is equipped with a Tuohy-Borst valve (hemostatic valve) to
prevent bleeding and a sidearm with a three-way stopcock to allow for
flushing and introduction of contrast media. It is also packaged with a
dilator to help with delivery over a guidewire. The guide sheath can
accommodate guidewires with diameters less than or equal to 0.038 in
(0.97 mm). The distal 15 cm of the outer surface of the guide sheath has a
hydrophilic coating (Bioslide™). The distal tip is radiopaque to help with
placement.
A polycarbonate hub is adhesively bonded to the proximal section of the
guide sheath. It incorporates a luer fitting which serves as a junction to the
hemostatic valve. |
1
1
Comparison of Technological Characteristics
The Vessix ™ Guide Sheath incorporates substantially equivalent device materials and design, packaging materials and design, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Terumo Destination Renal Guiding Sheath K081045 cleared May 28, 2008. Similarities and differences in technological characteristics between the predicate and subject device are listed below.
Similarities:
- Polymer material construction .
- PTFE inner liner material .
- Hydrophilic coating .
- Sheath dimensions and shapes t
- Dilator and Tuohy-Borst valve accessories ●
- Ethylene Oxide sterilization .
- Packaging design with same function .
Differences:
- Radiopaque extrusion (Vessix) versus radiopaque marker . (predicate) for visibility
- Stainless steel braid (Vessix) versus stainless steel coil . (predicate) to provide wall support
Performance Data
The Vessix™ Guide Sheath was subjected to testing according to the requirements of Guidance for Industry and FDA Staff - Class il Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010. Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these 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 and, therefore, this device may be considered substantially equivalent to the predicate device.
The following biocompatibility and chemical characterization tests were completed on the Vessix™ Guide Sheath and its accessories:
| Cytotoxicity | Hemolysis (Extract Method) |
|---|---|
| Sensitization | Partial Thromboplastin Time |
| Intracutaneous Reactivity | In Vitro Hemocompatibility |
| Acute Systemic Toxicity | Complement Activation |
| Materials Mediated Pyrogenicity | In Vivo Thromboresistance* |
| Hemolysis (Direct Contact) | USP Physicochemical |
*This test was performed only on the Ditator accessory.
2
ﻣﻌﺴﺴﺴﺴﺴ
The following in-vitro performance tests were completed on the Vessix™ Guide Sheath:
| Sheath Effective Length | Dye Flow Rate |
|---|---|
| Sheath Inner and Outer Diameter | Sheath Burst Pressure |
| Dilator Inner Diameter | Device Visual Appearance |
| Dilator Length | Radiopacity |
| Dilator to Sheath Compatibility (OD) | Sheath Kink Resistance |
| Sheath Tensile | Particulates |
| Sheath to Hub Tensile | Torque Strength |
| Dilator to Hub Tensile | Coating Integrity |
Tuohy-Borst Valve Leakage
Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Vessix™ Guide Sheath has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Terumo Destination Renal Guiding Sheath.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird.
July 3, 2014
Boston Scientific Corporation Attention: Mr. Kurtis Hunsberger Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K140641
Trade/Device Name: Vessix™ Guide Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 5, 2014 Received: June 6, 2014
Dear Mr. Hunsberger:
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
4
Page 2 - Mr. Kurtis Hunsberger
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillemann
for Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Vessix™ Guide Sheath
Indications for Use:
The Vessix™ Guide Sheath is designed to be used for the introduction of interventional and diagnostic devices through the vasculature to the renal arteries.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hillemann