The Vessix™ Guide Sheath is designed to be used for the introduction of interventional and diagnostic devices through the vasculature to the renal arteries.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Vessix™ Guide Sheath. It's important to note that the provided text describes a 510(k) submission for a medical device (guide sheath), which involves proving substantial equivalence to a predicate device, not typically a clinical study with human readers or AI.

The information primarily focuses on bench testing and biocompatibility testing, which are common for physical medical devices, especially those that are fundamentally similar to existing technology. Therefore, many of the requested categories related to clinical studies, human readers, and AI assistance will be addressed by stating that such information is not applicable or not provided in this specific document.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" with numerical targets and then report specific "device performance" values against those targets in the format of a table as typically seen in clinical study reports. Instead, it lists the types of tests performed to demonstrate that the device meets requirements for its intended use and is substantially equivalent to the predicate. The "reported device performance" is implied to be "passed" or "conformed" to the requirements for each test.

Test Category	Specific Test	Implied Performance Outcome
Biocompatibility & Chemical Characterization	Cytotoxicity	Conformed
	Sensitization	Conformed
	Intracutaneous Reactivity	Conformed
	Acute Systemic Toxicity	Conformed
	Materials Mediated Pyrogenicity	Conformed
	Hemolysis (Direct Contact)	Conformed
	Hemolysis (Extract Method)	Conformed
	Partial Thromboplastin Time	Conformed
	In Vitro Hemocompatibility	Conformed
	Complement Activation	Conformed
	In Vivo Thromboresistance* (*on Dilator)	Conformed
	USP <661> Physicochemical	Conformed
In-Vitro Performance	Sheath Effective Length	Conformed
	Sheath Inner and Outer Diameter	Conformed
	Dilator Inner Diameter	Conformed
	Dilator Length	Conformed
	Dilator to Sheath Compatibility (OD)	Conformed
	Sheath Tensile	Conformed
	Sheath to Hub Tensile	Conformed
	Dilator to Hub Tensile	Conformed
	Tuohy-Borst Valve Leakage	Conformed
	Dye Flow Rate	Conformed
	Sheath Burst Pressure	Conformed
	Device Visual Appearance	Conformed
	Radiopacity	Conformed
	Sheath Kink Resistance	Conformed
	Particulates	Conformed
	Torque Strength	Conformed
	Coating Integrity	Conformed

The document states: "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."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample sizes for each of the bench or biocompatibility tests. This level of detail is typically found in the full test reports, not usually in the 510(k) summary itself.
Data Provenance: The data comes from bench testing (in-vitro performance) and biocompatibility testing conducted by Boston Scientific Corporation for the Vessix™ Guide Sheath. This is not clinical human data; it's laboratory testing of the device itself.
Country of Origin of Data: Not explicitly stated, but assumed to be performed according to international standards (e.g., ISO, ASTM) within the regulatory framework of the US (FDA).
Retrospective or Prospective: Not applicable as this refers to device testing, not clinical data collection.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of device submission. The "ground truth" for bench testing and biocompatibility is established by engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and validated test methods. It does not involve human expert consensus in the way an imaging study would.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies, often for assessing ambiguous cases or establishing ground truth from multiple expert opinions. This document describes laboratory and physical testing of a medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document does not mention any studies involving human readers, AI assistance, or comparative effectiveness in a clinical setting. The submission focuses on substantial equivalence based on technological characteristics and performance testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm performance study was not done. This device is a physical medical instrument (guide sheath), not a software algorithm or AI-powered system, so this type of study is irrelevant.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on:

Engineering Specifications: Defined dimensions, material properties, and functional performance requirements (e.g., burst pressure, tensile strength, kink resistance).
Biocompatibility Standards: Established criteria from standards like ISO 10993 for biological safety.
Predicate Device Comparison: The predicate device (Terumo Destination Renal Guiding Sheath K081045) serves as a benchmark for substantial equivalence, implying that its performance characteristics (if not explicitly exceeded or matched) were considered acceptable.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for this device.

Summary

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K140641 p. 1 of 3

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510(k) Summary

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Submitter'sName andAddress	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311Phone: 763-494-1700Fax: 763-494-2222
Contact NameandInformation	Kurtis HunsbergerSenior Regulatory Affairs SpecialistPhone: 763-255-0303Fax: 763-494-2222e-mail: kurtis.hunsberger@bsci.com
Date Prepared	June 26, 2014
ProprietaryName	Vessix™ Guide Sheath
Common Name	Guide Sheath
Product Code	DYB
Classification	Class II, 21 CFR Part 870.1340
PredicateDevice	Terumo Destination Renal GuidingSheath K081045 May 28, 2008
DeviceDescription	Vessix™ Guide Sheath is a 7F guide sheath designed to perform as anintroducer sheath and guide catheter for the introduction of interventionaland diagnostic devices through the vasculature to the renal arteries. TheVessix Guide Sheath has been optimized for torque to allow access toboth renal arteries during procedures. The guide sheath has an effectivelength of 45 cm and is available in two curve shapes: RDC (renal doublecurve) and LIMA (left internal mammary artery).The guide sheath has a braided shaft design to maximize torqueresponse, and a pre-formed tip shape (either RDC or LIMA) to enableaccess. It is equipped with a Tuohy-Borst valve (hemostatic valve) toprevent bleeding and a sidearm with a three-way stopcock to allow forflushing and introduction of contrast media. It is also packaged with adilator to help with delivery over a guidewire. The guide sheath canaccommodate 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 ahydrophilic coating (Bioslide™). The distal tip is radiopaque to help withplacement.A polycarbonate hub is adhesively bonded to the proximal section of theguide sheath. It incorporates a luer fitting which serves as a junction to thehemostatic valve.

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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 <661> Physicochemical

*This test was performed only on the Ditator accessory.

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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.

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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

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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

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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

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).