(129 days)
The Chariot™ Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the peripheral vasculature.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Chariot Guiding Sheath:
This document is a 510(k) summary for a medical device called the "Chariot Guiding Sheath." The summary outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device, as required for FDA clearance.
Important Note: The provided document describes physical and functional performance tests for a medical device (guiding sheath), not a diagnostic or AI-driven device. Therefore, many of the requested categories (like "Number of experts used to establish ground truth," "Adjudication method," "MRMC study," "Standalone AI performance," "Ground truth type," and "Training set ground truth") are not applicable to this type of device and study. The criteria and studies are focused on physical properties, biocompatibility, and functional performance.
Acceptance Criteria and Reported Device Performance
The provided text does not present a formal table of acceptance criteria with specific numerical targets and corresponding device performance values. Instead, it describes various tests performed and states that the results "provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." It also notes: "No new safety or performance issues were raised during the testing."
However, based on the listing of "in-vitro performance tests," we can infer the tested parameters, which implicitly represent the performance areas that needed to meet acceptable standards.
| Acceptance Criteria Area (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Dilator Entry Profile | Conforms to requirements |
| Sheath Length | Conforms to requirements |
| Sheath Inner and Outer Diameter | Conforms to requirements |
| Dilator Inner and Outer Diameter | Conforms to requirements |
| Dilator Length | Conforms to requirements |
| Sheath Tensile | Conforms to requirements |
| Sheath to Hub Tensile | Conforms to requirements |
| Dilator to Hub Tensile | Conforms to requirements |
| Sheath Tip Tensile | Conforms to requirements |
| Hub Function and Luer Compatibility | Conforms to requirements |
| Valve Leakage | Conforms to requirements |
| Dye Flow Rate | Conforms to requirements |
| Sheath Burst Pressure | Conforms to requirements |
| Device Visual Appearance | Conforms to requirements |
| Radiopacity | Conforms to requirements |
| Sheath Kink Resistance | Conforms to requirements |
| Torque Strength | Conforms to requirements |
| Particulates | Conforms to requirements |
| Coating Integrity | Conforms to requirements |
| Cytotoxicity | No adverse findings (biocompatible) |
| Hemolysis (Extract Method) | No adverse findings (biocompatible) |
| Sensitization | No adverse findings (biocompatible) |
| Intracutaneous Reactivity | No adverse findings (biocompatible) |
| Acute Systemic Toxicity | No adverse findings (biocompatible) |
| Materials Mediated Pyrogenicity | No adverse findings (biocompatible) |
| Hemolysis (Direct Contact) | No adverse findings (biocompatible) |
| Partial Thromboplastin Time | No adverse findings (biocompatible) |
| In Vitro Hemocompatibility | No adverse findings (biocompatible) |
| Complement Activation | No adverse findings (biocompatible) |
| In Vivo Thromboresistance | No adverse findings (biocompatible) |
| USP <661> Physicochemical | Conforms to requirements |
Study Details
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify the exact sample sizes used for each performance test. It only states that "bench testing" and "biocompatibility testing" were performed.
- Data Provenance: The studies are "bench testing" (in-vitro performance) and "biocompatibility testing." These are laboratory tests conducted on the physical device itself, not on patient data. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" do not apply.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- N/A. This device is a physical medical instrument (a guiding sheath). Ground truth in the context of expert opinion for diagnostic accuracy is not relevant here. The "ground truth" for these tests would be established by validated test methods and physical measurements in a laboratory setting against engineering specifications and regulatory standards.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically for resolving discrepancies in expert opinion for diagnostic tasks. For physical device testing, results are typically objective measurements or observations against predefined pass/fail criteria.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs. without AI assistance:
- N/A. This is not an AI-assisted diagnostic device.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance tests consists of validated physical measurements and observations against established engineering specifications and regulatory standards (e.g., ISO, ASTM standards, and FDA guidance documents like "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"). Biocompatibility results are compared against established biological safety criteria.
-
The sample size for the training set:
- N/A. This is not an AI/machine learning device; therefore, there is no "training set."
-
How the ground truth for the training set was established:
- N/A. See point 7.
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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
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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
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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)
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510(k) Summary
per 21 CFR §807.92
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311Phone: 763-494-1700Fax: 763-494-2222 | ||
|---|---|---|---|
| Contact NameandInformation | Kurtis HunsbergerPrincipal Regulatory Affairs SpecialistPhone: 763-494-1204Fax: 763-494-2222e-mail: kurtis.hunsberger@bsci.com | ||
| Date Prepared | April 23, 2015 | ||
| ProprietaryName | Chariot™ Guiding Sheath | ||
| Common Name | Guiding Sheath | ||
| Product Code | DYB | ||
| Classification | Class II, 21 CFR Part 870.1340 | ||
| PredicateDevice | Terumo Pinnacle® Destination®Peripheral Guiding Sheath | K091329 | May 29, 2009 |
| DeviceDescription | The Chariot™ Guiding Sheath is designed to perform as an introducersheath for delivering interventional and diagnostic devices into theperipheral vasculature. The guiding sheath has a coiled shaft design andcomes with a straight (ST) or preformed multipurpose (MP) tip shape. It isequipped with a cross-cut hemostatic valve or Tuohy-Borst adapter toprevent bleeding and a sidearm with a three-way stopcock to allow forflushing and introduction of contrast medium. It is also packaged with adilator to facilitate delivery over a guidewire. The guiding sheath canaccommodate guidewires with diameters less than or equal to 0.038 in(0.97 mm). The outer surface of the guiding sheath has a hydrophiliccoating from the distal tip to approximately 9 cm from the hub. The distaltip has a radiopaque marker band approximately 6 mm from the distaledge, to help with guiding sheath placement.A copolyester elastomer hub is over molded onto the proximal section ofthe guiding sheath. It incorporates a luer fitting which serves as a junction | ||
| Intended Use /Indications forUse | to the hemostatic valve.The Chariot™ Guiding Sheath is intended for the introduction ofinterventional and diagnostic devices into the peripheral vasculature. |
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| Comparison ofTechnologicalCharacteristics | The Chariot™ Guiding Sheath incorporates substantially equivalentdevice materials and design, packaging materials and design,fundamental technology, manufacturing processes, sterilization processand 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 thepredicate 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 functionDifferences:• Shaft color: Blue (Chariot); Green (predicate)• Radiopaque marker material: Tantalum (Chariot); Gold (predicate)• Maximum infusion pressure: 309 psi (Chariot); not labeled (predicate) | |
|---|---|---|
| PerformanceData | The Chariot™ Guiding Sheath was subjected to testing according to therequirements of Guidance for Industry and FDA Staff – Class II SpecialControls for Certain Percutaneous Transluminal Coronary Angioplasty(PTCA) Catheters, September 8, 2010. Bench testing andbiocompatibility testing were performed to support a determination ofsubstantial equivalence. The results of these tests provide reasonableassurance that the proposed device has been designed and tested toassure conformance to the requirements for its intended use. No newsafety or performance issues were raised during the testing; therefore,this device may be considered substantially equivalent to the predicatedevice.The following biocompatibility and chemical characterization tests werecompleted on the Chariot™ Guiding 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 | |
| The following in-vitro performance tests were completed on the Chariot™ Guiding Sheath: | ||
| Dilator Entry Profile | Valve Leakage | |
| Sheath Length | Dye Flow Rate | |
| Sheath Inner and Outer Diameter | Sheath Burst Pressure | |
| Dilator Inner and Outer Diameter | Device Visual Appearance | |
| Dilator Length | Radiopacity | |
| Sheath Tensile | Sheath Kink Resistance | |
| Sheath to Hub Tensile | Torque Strength | |
| Dilator to Hub Tensile | Particulates | |
| Sheath Tip Tensile | Coating Integrity | |
| Hub Function and Luer Compatibility | ||
| Conclusion | Based on the indications for use, technological characteristics, and safety and performance testing, the Chariot™ Guiding Sheath has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Terumo Pinnacle Destination Peripheral Guiding Sheath. |
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§ 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).