Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guiding sheath, with no mention of AI or ML.

Therapeutic

No.
The device is an introducer sheath intended for delivering interventional and diagnostic devices, not for therapeutic action itself.

Diagnostic

No

The device is described as a "Guiding Sheath" and its stated purpose is for the "introduction of interventional and diagnostic devices" into the peripheral vasculature. It is not itself a diagnostic device, but rather a tool used to facilitate the delivery of other devices, some of which may be diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical medical device (guiding sheath) with various hardware components and features, not a software-only product.

IVD (In Vitro Diagnostic)

Based on the provided information, the Chariot™ Guiding Sheath is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the "introduction of interventional and diagnostic devices into the peripheral vasculature." This describes a device used within the body to facilitate other procedures, not a device used to test samples outside the body.
Device Description: The description details a physical sheath with features for insertion into blood vessels, preventing bleeding, and allowing for flushing and contrast introduction. This aligns with an invasive medical device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro testing.
Performance Studies: The performance studies focus on physical properties (tensile strength, burst pressure, kink resistance), biocompatibility, and hemocompatibility, which are relevant to devices used within the body. They do not describe studies related to diagnostic accuracy or analytical performance on biological samples.

In summary, the Chariot™ Guiding Sheath is a medical device used for accessing and navigating within the peripheral vasculature, which is an in vivo application, not an in vitro diagnostic application.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Chariot™ Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the peripheral vasculature.

Product codes

DYB

Device Description

The Chariot™ Guiding Sheath is designed to perform as an introducer sheath for delivering interventional and diagnostic devices into the peripheral vasculature. The guiding sheath has a coiled shaft design and comes with a straight (ST) or preformed multipurpose (MP) tip shape. It is equipped with a cross-cut hemostatic valve or Tuohy-Borst adapter to prevent bleeding and a sidearm with a three-way stopcock to allow for flushing and introduction of contrast medium. It is also packaged with a dilator to facilitate delivery over a guidewire. The guiding sheath can accommodate guidewires with diameters less than or equal to 0.038 in (0.97 mm). The outer surface of the guiding sheath has a hydrophilic coating from the distal tip to approximately 9 cm from the hub. The distal tip has a radiopaque marker band approximately 6 mm from the distal edge, to help with guiding sheath placement. A copolyester elastomer hub is over molded onto the proximal section of the guiding 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

peripheral vasculature

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

The Chariot™ Guiding Sheath was subjected to testing according to the requirements of Guidance for Industry and FDA Staff – Class II 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; therefore, this device may be considered substantially equivalent to the predicate device.

The following biocompatibility and chemical characterization tests were completed on the Chariot™ Guiding 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
USP Physicochemical

The following in-vitro performance tests were completed on the Chariot™ Guiding Sheath:
Dilator Entry Profile
Sheath Length
Sheath Inner and Outer Diameter
Dilator Inner and Outer Diameter
Dilator Length
Sheath Tensile
Sheath to Hub Tensile
Dilator to Hub Tensile
Sheath Tip Tensile
Hub Function and Luer Compatibility
Valve Leakage
Dye Flow Rate
Sheath Burst Pressure
Device Visual Appearance
Radiopacity
Sheath Kink Resistance
Torque Strength
Particulates
Coating Integrity

Key Metrics

Not Found

Predicate Device(s)

K091329

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 5, 2015

Boston Scientific Corp. Kurtis Hunsberger Principal Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311

Re: K150186

Trade/Device Name: Chariot Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 6, 2015 Received: May 7, 2015

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

1

Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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" (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 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. Hilleman

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) K150186

Device Name Chariot™ Guiding Sheath

Indications for Use (Describe)

The Chariot™ Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the peripheral vasculature.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Summary

per 21 CFR §807.92

| 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
Principal Regulatory Affairs Specialist
Phone: 763-494-1204
Fax: 763-494-2222
e-mail: kurtis.hunsberger@bsci.com | | |
| Date Prepared | April 23, 2015 | | |
| Proprietary
Name | Chariot™ Guiding Sheath | | |
| Common Name | Guiding Sheath | | |
| Product Code | DYB | | |
| Classification | Class II, 21 CFR Part 870.1340 | | |
| Predicate
Device | Terumo Pinnacle® Destination®
Peripheral Guiding Sheath | K091329 | May 29, 2009 |
| Device
Description | The Chariot™ Guiding Sheath is designed to perform as an introducer
sheath for delivering interventional and diagnostic devices into the
peripheral vasculature. The guiding sheath has a coiled shaft design and
comes with a straight (ST) or preformed multipurpose (MP) tip shape. It is
equipped with a cross-cut hemostatic valve or Tuohy-Borst adapter to
prevent bleeding and a sidearm with a three-way stopcock to allow for
flushing and introduction of contrast medium. It is also packaged with a
dilator to facilitate delivery over a guidewire. The guiding sheath can
accommodate guidewires with diameters less than or equal to 0.038 in
(0.97 mm). The outer surface of the guiding sheath has a hydrophilic
coating from the distal tip to approximately 9 cm from the hub. The distal
tip has a radiopaque marker band approximately 6 mm from the distal
edge, to help with guiding sheath placement.
A copolyester elastomer hub is over molded onto the proximal section of
the guiding sheath. It incorporates a luer fitting which serves as a junction | | |
| Intended Use /
Indications for
Use | to the hemostatic valve.
The Chariot™ Guiding Sheath is intended for the introduction of
interventional and diagnostic devices into the peripheral vasculature. | | |

4

| Comparison of
Technological
Characteristics | The Chariot™ Guiding 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 Pinnacle®
Destination® Peripheral Guiding Sheath K091329 cleared May 29, 2009.
Similarities and differences in technological characteristics between the
predicate and subject device are listed below.
Similarities:
• Polymer material construction
• Stainless steel coil
• PTFE inner liner material
• Hydrophilic coating
• Radiopaque marker
• Sheath dimensions
• Dilator, Tuohy-Borst Valve, and Cross-Cut Valve accessories
• Ethylene Oxide sterilization
• Packaging design with same function
Differences:
• Shaft color: Blue (Chariot); Green (predicate)
• Radiopaque marker material: Tantalum (Chariot); Gold (predicate)
• Maximum infusion pressure: 309 psi (Chariot); not labeled (predicate) | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Performance
Data | The Chariot™ Guiding Sheath was subjected to testing according to the
requirements of Guidance for Industry and FDA Staff – Class II 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; therefore,
this device may be considered substantially equivalent to the predicate
device.

5