The Sidekick® and Usher® Support Catheters are single lumen catheters with a standard luer fitting hub and separate attachable hemostatic valve. The catheters are recommended to support the Crosser® CTO Recanalization Catheters 14S/14P and S6.

The Sidekick® Support Catheter is available in straight, angled, tapered and non-tapered configurations in 70cm and 110cm effective lengths. The Usher® Catheter is tapered and is available in straight and angled configurations in 83cm effective lengths. The Sidekick® and straight Usher® Catheters have a single radiopaque marker 1mm from the distal tip. The angled Usher® Support Catheter configurations have three radiopaque markers at the distal tip for enhanced visualization of the catheter tip and angle under fluoroscopy. The most proximal radiopaque marker is located 15mm from the distal tip.

The product hub identifies SD for Sidekick® Catheter, USH for Usher® Catheter, A for Angled and T for Tapered; in addition to the sheath profile and effective length in centimeters. A guidewire introducer is provided to facilitate the guidewire passage through the optional hemostatic valve. The guidewire introducer shaft color matches the shaft color of the recommended support catheter.

AI/ML Overview

The provided text describes the Sidekick® and Usher® Support Catheters and their 510(k) submission for substantial equivalence. It outlines various performance tests conducted to demonstrate their safety and effectiveness compared to predicate devices. However, the document does NOT contain information related to an AI/ML powered device, therefore no information about acceptance criteria or studies based on AI model performance are relevant.

Table of Acceptance Criteria and Reported Device Performance

The document describes several in vitro tests and biocompatibility tests conducted, and it generally states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Sidekick® and Usher® Support Catheters are comparable to the predicate devices and performs at least as safely and effectively as the legally marketed device." and that the devices "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum leak rate) and the reported device performance values against these criteria are not detailed in the provided 510(k) summary. The document simply lists the types of tests performed.

The study proving the device meets acceptance criteria appears to be a series of in vitro performance and biocompatibility tests, as well as shelf-life stability testing. The document states that these tests were performed "Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures" and "in accordance with ISO 10993-1:2009".

Regarding the specific questions about AI/ML device testing criteria:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not applicable as the document describes a traditional medical device (catheter), not an AI/ML powered device that would use a test set of data. The "test set" in this context refers to the physical units of the catheters and packaging tested in the various in vitro and biocompatibility studies. The specific number of units tested for each in vitro test is not provided. The provenance of the data is that it was generated from "in vitro" testing and "in-vivo" biocompatibility testing (referring to animal studies, typically).
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):
- This information is not applicable as the device is not an AI/ML powered diagnostic or image analysis tool. Ground truth is not established by human experts in this context. The "ground truth" for catheter performance is defined by engineering specifications, regulatory standards, and established test methods.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert panel reviews for AI/ML models to resolve discrepancies or establish ground truth. For physical device testing, the outcome is typically pass/fail based on objective measurements against pre-defined engineering specifications.
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:
- This information is not applicable. MRMC studies are designed to evaluate the impact of AI on human reader performance for diagnostic tasks. This device is a catheter, not an AI system for clinicians.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This device is a physical catheter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this traditional device, the "ground truth" is based on engineering specifications, established regulatory standards (e.g., ISO, ASTM), and internal test protocols designed to ensure the device performs as intended and is safe. The comparison is made against the performance of predicate devices.
The sample size for the training set:
- This information is not applicable. As this is not an AI/ML device, there is no "training set."
How the ground truth for the training set was established:
- This information is not applicable, as there is no training set for a device of this nature.

Summary

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Sidekick® and Usher® Support Catheters

510(k) Summary 21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc1625 West 3rd StreetTempe, Arizona 85281
Phone:	480-638-2939	AUG 02 2013
Fax:	480-449-2546
Contact:	Timothy Wade, Regulatory Affairs Associate
Date	March 19, 2013

Subject Device Name:

Device Trade Name:	Sidekick® and Usher® Support Catheters
Common or Usual Name:	Percutaneous Catheter (21 CFR 870.1250,Product Code DQY)
Classification:	Class II
Classification Panel:	Cardiovascular

Predicate Devices:

MicroSheath XL Support Catheter (K073289; cleared January 11, 2008) .
MicroSheath LP Support Catheter (K080849; cleared July 25, 2008) .

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Device Description:

Indications for Use of Device:

The Sidekick® and Usher® Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.

Contraindications:

The Sidekick® and Usher® Catheters are contraindicated for use with cutting/scoring balloons, pediatrics, neonatal and neurovascular patients.

Technological Comparison to Predicate Devices:

The Sidekick® and Usher® Support Catheters have the following similarities to the predicate devices:

. Same intended use (MicroSheath® XL Predicate)
. Same indications for use (MicroSheath® XL Predicate)
. Same target population (MicroSheath® XL Predicate)
Same fundamental scientific technology (both predicates) .
. Same operating principle (both predicates)
. Same sterility assurance level and method of sterilization (both predicates)

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The Sidekick® and Usher® Support Catheters differ from the predicate devices in dimensional characteristics, tapered catheter configurations, modifications in the shaft design, and new materials including the new hemostasis valve and guidewire introducer components. Additionally, as compared to the MicroSheath® LP Support Catheter predicate, the subject Usher® Support Catheter is not indicated for use in the coronary vasculature. The use of the Usher® Support Catheter in the peripheral vasculature is fully within the scope of both predicate devices and therefore does not affect the safety or effectiveness when used as indicated.

Performance Data:

To demonstrate substantial equivalence of the subject devices, the Sidekick® and Usher® Support Catheters, to the predicate devices, the technological characteristics and performance criterion were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed:

. Ablation Efficiency
. Catheter Burst
. Catheter Leak
. Catheter Inner Diameter
. Catheter Outside Diameter
Catheter Effective Length .
Catheter Hub Testing .
Hub Leak Testing .
Hub Luer Taper .
. Kink Resistance
Track Without Damage .
. Tensile Strength
Delivery of Recommended Devices .
. Tracking Force
Catheter Tip Visualization .
. Ease of Guidewire Loading
. Particulate Evaluation
. Coating Integrity
. Pouch Visual Inspection
. Dye Penetration

Bard Peripheral Vascular, Inc.

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Pouch Tensile .

Product will have a viable shelf life based upon successful completion of testing performed in accordance with ASTM F1980-07, "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices", FDA Guidance, "Shelf Life of Medical Devices", issued April 1991, and the Bard internal stability program. Additionally, biocompatibility tests were performed in accordance with ISO 10993-1:2009, "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process." Testing conducted includes Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Testing, Hemolysis, Complement Activation, and in-vivo Thrombogenicity.

The results from these tests demonstrate that the technological characteristics and performance criteria of the Sidekick® and Usher® Support Catheters are comparable to the predicate devices and performs at least as safely and effectively as the legally marketed device.

Conclusions:

The Sidekick® and Usher® Support Catheters, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Sidekick® and Usher® Support Catheters are substantially equivalent to the legally marketed predicate devices, the MicroSheath® XL and MicroSheath® LP Support Catheters.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

August 2, 2013

Bard Peripheral Vascular, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

Re: K131493

Trade/Device Name: Sidekick® and Usher® Support Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DOY Dated: July 18, 2013 Received: July 19, 2013

Dear Mr. Job:

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

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Page 2 - Mr. Job

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

Kenneth J. Cavanaugh -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

Device Name: Sidekick® and Usher® Support Catheter

Indications for Use: The Sidekick® and Usher® Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.

Prescription Use X (Part21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Bard Peripheral Vascular, Inc.

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Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Test Category	Specific Test	Acceptance Criteria (Not Detailed in Document)	Reported Device Performance (Not Detailed in Document)
Mechanical/Physical	Ablation Efficiency	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Catheter Burst	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Catheter Leak	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Catheter Inner Diameter	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Catheter Outside Diameter	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Catheter Effective Length	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Catheter Hub Testing	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Hub Leak Testing	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Hub Luer Taper	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Kink Resistance	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Track Without Damage	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Tensile Strength	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Delivery of Recommended Devices	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Tracking Force	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Catheter Tip Visualization	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Ease of Guidewire Loading	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Particulate Evaluation	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
	Coating Integrity	(Implicit: comparable to predicate)	(Implicit: comparable to predicate)
Packaging	Pouch Visual Inspection	(Implicit: per internal stability program)	(Implicit: per internal stability program)
	Dye Penetration	(Implicit: per internal stability program)	(Implicit: per internal stability program)
	Pouch Tensile	(Implicit: per internal stability program)	(Implicit: per internal stability program)
Biocompatibility	Cytotoxicity	(Implicit: compliant with ISO 10993-1)	(Implicit: compliant with ISO 10993-1)
	Sensitization	(Implicit: compliant with ISO 10993-1)	(Implicit: compliant with ISO 10993-1)
	Intracutaneous Reactivity	(Implicit: compliant with ISO 10993-1)	(Implicit: compliant with ISO 10993-1)
	Acute Systemic Toxicity	(Implicit: compliant with ISO 10993-1)	(Implicit: compliant with ISO 10993-1)
	Pyrogen Testing	(Implicit: compliant with ISO 10993-1)	(Implicit: compliant with ISO 10993-1)
	Hemolysis	(Implicit: compliant with ISO 10993-1)	(Implicit: compliant with ISO 10993-1)
	Complement Activation	(Implicit: compliant with ISO 10993-1)	(Implicit: compliant with ISO 10993-1)
	In-vivo Thrombogenicity	(Implicit: compliant with ISO 10993-1)	(Implicit: compliant with ISO 10993-1)
Shelf Life	Accelerated Aging	(Implicit: compliant with ASTM F1980-07)	(Implicit: compliant with ASTM F1980-07)