The SIDEKICK® and USHER® Support Catheters are single lumen catheters with a standard luer fitting hub and separate attachable hemostatic valve to support the CROSSER® CTO Recanalization Catheters 14S and S6. 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 working 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.

The SIDEKICK® Catheter is available in straight, angled, tapered and non-tapered configurations in 70cm and 110cm working lengths. The USHER® Catheter is tapered and is available in straight and angled configurations in 83cm and 130cm working lengths. The SIDEKICK® and straight USHER® Catheters have a single radiopaque marker 1mm from the distal tip. The angled USHER® Catheter configurations have three radiopaque markers at the distal tip for enhanced visualization of the catheter tip and angle under fluoroscopy. The third proximal radiopaque marker is located 15mm from the distal tip.

The GEOALIGN® Marking System has been added to the device. The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GEOALIGN® Markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GEOALIGN® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GEOALIGN® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GEOALIGN® Marking System.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SIDEKICK® and USHER® Support Catheters, focusing on the addition of the GEOALIGN® Marking System. This is a medical device submission, and the "acceptance criteria" and "device performance" mentioned in the request refer to the performance testing of the device for regulatory approval, not typically the performance of an AI algorithm or a clinical study in the traditional sense.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table with acceptance criteria thresholds and discrete performance values in the way one might expect for an AI algorithm. Instead, it describes general performance testing and concludes that the device is "comparable" and "substantially equivalent" to the predicate device.

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
GEOALIGN® Marking Legibility	Markings are legible.	Evaluated and found satisfactory to ensure visibility. The results demonstrate that the technological characteristics and performance criteria... are comparable to the predicate device and that it performs substantially equivalent to the legally marketed predicate device.
Dimensional Analysis:	Markings are within specified tolerances for location and spacing.	GEOALIGN® Marking Location (Distal Position): Within ±1mm accuracy for 1cm increment bands. GEOALIGN® Marking Location (Proximal Position): Within ±1mm accuracy for 1cm increment bands. GEOALIGN® Marking Spacing: Within ±1mm accuracy for 1cm increment bands.
Catheter Outer Diameter (OD)	Within specified tolerances.	Evaluated and found satisfactory. The results demonstrate that the technological characteristics and performance criteria... are comparable to the predicate device and that it performs substantially equivalent to the legally marketed predicate device.
GEOALIGN® Marking durability with Introducer Sheaths	Markings maintain integrity after interaction with introducer sheaths.	Evaluated and found satisfactory. The results demonstrate that the technological characteristics and performance criteria... are comparable to the predicate device and that it performs substantially equivalent to the legally marketed predicate device.
GEOALIGN® Marking compatibility with Introducer Sheaths	Markings function correctly and safely with introducer sheaths.	Evaluated and found satisfactory. The results demonstrate that the technological characteristics and performance criteria... are comparable to the predicate device and that it performs substantially equivalent to the legally marketed predicate device.
Biocompatibility and Chemical Characterization	Device is biocompatible and does not elicit substances at concerning levels.	Per ISO 10993-1:2009 CORR 1, biocompatibility and chemical characterization demonstrate the subject device is biocompatible and does not elicit any substances at levels of concern as result of this change.

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes used for each of the performance tests (e.g., how many catheters were tested for marking legibility, durability, or dimensions). It refers generally to "nonclinical tests." The data provenance is internal testing performed by the manufacturer, Bard Peripheral Vascular, Inc., in the USA (Tempe, Arizona). These are laboratory and engineering tests, not clinical data from patients. The study is not a clinical study; it's a non-clinical, benchtop performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to the type of testing described in the document. The "ground truth" here is defined by engineering specifications, measurement standards, and regulatory requirements (e.g., ISO 10993 for biocompatibility), not by expert consensus on clinical data. No "experts" were used in the sense of clinical reviewers to establish ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable. The tests performed are objective, measurable non-clinical tests (e.g., dimensional measurements, durability tests, biocompatibility assays). There is no "adjudication" in the sense of conflicting expert opinions on a clinical outcome.

5. 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:

Not applicable. This document is for a physical medical device (support catheters), not an AI algorithm. Therefore, no MRMC study or assessment of human readers with/without AI assistance was performed or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This document is for a physical medical device (support catheters), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

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

Engineering specifications and design requirements: For dimensional accuracy, legibility, and durability.
Established scientific and regulatory standards: Such as ISO 10993-1:2009 CORR 1 for biocompatibility.

8. The sample size for the training set:

Not applicable. This document describes the testing of a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no AI algorithm training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.

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

August 4, 2016

Bard Peripheral Vascular, Inc. Ms. Melanie Hadlock Regulatory Affairs Specialist 1625 West 3rd Street Tempe, AZ 85281

Re: K161986

Trade/Device Name: Sidekick and Usher Support Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 18, 2016 Received: July 19, 2016

Dear Ms. Hadlock:

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 devicerelated 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.

{1}------------------------------------------------

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.

Sincerelv

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161986

Device Name

SIDEKICK® and USHER® Support Catheters

Indications for Use (Describe)

The SIDEKICK® and USHER® Support Catheters are single lumen catheters intended to create a pathway for other devices in 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

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."

{4}------------------------------------------------

510(k) Summary

[As required by 21 CFR 807.92(c)]

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 summary of the information upon which substantial equivalence determination is based is as follows:

1. Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc.1625 West 3rd StreetTempe, Arizona 85281
Phone:	480.350.6083
Fax:	480.449.2546
Contact:	Melanie Hadlock, Regulatory Affairs Specialist
Date:	July 18, 2016

2. Subject Device:

Device Trade Name:	SIDEKICK® and USHER® Support Catheters
Common Name:	Percutaneous Catheter
Device Classification	Class II
Classification Name:	Percutaneous Catheter
Classification ProductCode:	DQY
Regulation Number:	21 CFR 870.1250
Review Panel:	Cardiovascular

3. Predicate Device:

SIDEKICK® and USHER® Support Catheters (K131493)

Reference devices: ULTRAVERSE® 035 PTA Dilatation Catheter (K142261, cleared September 24, 2014); CROSSER® CTO Recanalization Catheter (K161208, cleared May 24, 2016).

{5}------------------------------------------------

4. Summary of Change:

The GEOALIGN® Marking System has been added to the device. The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip.

5. Device Description:

The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GEOALIGN® Markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GEOALIGN® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GEOALIGN® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GEOALIGN® Marking System.

6. 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® Support Catheters are contraindicated for use with cutting/scoring balloons, pediatrics, neonatal and neurovascular patients.

7. Technological Comparison to Predicate Devices:

The technological characteristics of the subject device are substantially equivalent to those of the predicate device because the two have the following similarities:

{6}------------------------------------------------

. Same intended use
Same indications for use ●
Same patient population o
Same sheath compatibility .
. Same fundamental scientific technology
Same operating principal and mechanism of action
Same packaqing configuration ●
Same sterility assurance level and method of sterilization .

The subject device is a modification to the predicate device and is different as follows:

The GEOALIGN® Marking System has been added to the device. The GEOALIGN® . Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The markings have the same intended purpose, use the same ink formulation, and ink application process as the previously cleared reference devices of the same requlation number, the ULTRAVERSE® 035 PTA Balloon Dilatation Catheter (K142261, cleared September 24, 2014, Requlation Number 870.1250) and the CROSSER® CTO Recanalization (K161208, cleared May 24, 2016, Regulation Number 870.1250).

8. Performance Testing Summary:

To demonstrate substantial equivalence of the subject device to the predicate device. the technological characteristics and performance criteria were evaluated. Using the FDA guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessment procedures, the following nonclinical tests were performed:

GEOALIGN® Marking Legibility ●
Dimensional Analysis: ●
- o GEOALIGN® Marking Location (Distal Position)
- o GEOALIGN® Marking Location (Proximal Position)
- o GEOALIGN® Marking Spacing
- Catheter Outer Diameter (OD) о
GEOALIGN® Marking durability with Introducer Sheaths ●
GEOALIGN® Marking compatibility with Introducer Sheaths .

The results demonstrate that the technological characteristics and performance criteria of the SIDEKICK® and USHER® Support Catheters are comparable to the predicate device and that it performs substantially equivalent to the legally marketed predicate device.

Per ISO 10993-1:2009 CORR 1, biocompatibility and chemical characterization demonstrate the subject device is biocompatible and does not elicit any substances at levels of concern as result of this change.

{7}------------------------------------------------

9. Conclusion:

The SIDEKICK® and USHER® Support Catheters are substantially equivalent to the legally marketed predicate devices, the SIDEKICK® and USHER® Support Catheters (K131493, cleared August 2, 2013).

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).