The Proxis™ ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.

Device Description

Proxis™ Ureteral Access Sheath is a two component ureteral dilation system which contains 1) a sheath with a lumen for passage of endoscopes and related instruments and 2) a dilator with a lumen for passage over a guidewire and injection of fluids.

Proxis™ Ureteral Access Sheath is a hydrophilic-coated sheath tube comprised of a coil reinforced polymer with a PTFE liner and marker band near the distal end. On the proximal end of the sheath is a plastic hub which provides identification for the device and acts as an interface for introducing endoscopes and related instruments through the sheath. The dilator is comprised of a hydrophiliccoated polymer tube with a tapered distal end and a female luer connector with a lock mechanism on the proximal end to attach and lock to the hub on the sheath. The device will be offered in multiple sizes to accommodate different patient anatomies. The product is ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products – ethylene oxide – Requirements for development, validation and routine control of a sterilized process for medical device is for single use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Proxis™ Ureteral Access Sheath. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting acceptance criteria and a study proving those criteria are met in the way a clinical performance study for an AI/ML device would.

Therefore, many of the requested categories are not applicable to this document. The document details non-clinical performance testing and biocompatibility testing to show the device is safe and effective in comparison to a predicate device.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

Table of acceptance criteria and the reported device performance

The document does not explicitly list acceptance criteria in a quantitative manner for a clinical study comparing the device's diagnostic or predictive performance against a ground truth. Instead, it refers to compliance with established international and national standards for medical devices and comparison to a predicate device.

Acceptance Criteria	Reported Device Performance
Compliance with BS EN 1616:1997 + A1:1999 (Sterile urethral catheters for single use)	Achieved (implied by "Nonclinical performance testing (bench) of the proposed device was conducted per the applicable requirements")
Compliance with ISO 594-2:1998 (Conical fittings with a 6% (Luer) taper)	Achieved (implied by "Nonclinical performance testing (bench) of the proposed device was conducted per the applicable requirements")
Compliance with JIS T 3260:2012 (Dilators)	Achieved (implied by "Nonclinical performance testing (bench) of the proposed device was conducted per the applicable requirements")
Biocompatibility in accordance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1	Achieved (implied by "Nonclinical biocompatibility testing was conducted...")
Similar performance characteristics to predicate device (Boston Scientific Navigator™ HD Ureteral Access Sheath Set)	Demonstrated by "Additional testing was completed to compare additional performance characteristics of the subject and predicate devices."

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes non-clinical bench testing and biocompatibility testing for the physical device, not a test set of data for an AI/ML algorithm. Therefore, there is no "test set" in the context of diagnostic performance data.
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)

Not applicable. Ground truth as typically defined for AI/ML device performance (e.g., expert consensus on image interpretation) is not relevant to this type of device and study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No "test set" in the context of diagnostic performance data requiring adjudication.
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 is a physical medical device (ureteral access sheath), not an AI/ML diagnostic or assistive device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the referenced standards (e.g., BS EN 1616, ISO 594-2, JIS T 3260, ISO 10993-1). For the comparative performance, the "ground truth" would be the established performance characteristics of the predicate device.
The sample size for the training set

Not applicable. This is a physical medical device; there is no "training set" of data.
How the ground truth for the training set was established

Not applicable.

Summary

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

May 5, 2016

C.R. Bard, Inc. % Dave Yungvirt Official Correspondent Third Party Review Group, LLC 45 Rockefeller Plaza, Suite 2000 New York, NY 1011

Re: K160861

Trade/Device Name: Proxis™ Ureteral Access Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FED Dated: December 16, 2015 Received: March 29, 2016

Dear Dave Yungvirt,

This letter corrects our substantially equivalent letter of March 31, 2016.

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.

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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.

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 vours.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological 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

ProxisTM Ureteral Access Sheath

Indications for Use (Describe)

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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Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014

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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Proxis™ Ureteral Access Sheath 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Bard Medical DivisionC. R. Bard, Inc.8195 Industrial Blvd.Covington, GA 30014
Contact:	Beatrice WanRegulatory Affairs Specialist IIBard Medical DivisionPh: 770-784-6414Fax: 770-385-4706
Submission Date:	March 24, 2016
Subject Device:	Trade Name: Proxis ™ Ureteral Access SheathCommon Name: Ureteral Access SheathClassification Name: Endoscopic OvertubeRegulation: 21 CFR §876.1500Regulatory Classification: IIProduct Code: FED
Predicate Device:	Legally marketed device to which substantial equivalence is claimed Boston Scientific Navigator™ HD Ureteral Access Sheath Set, K122649

Device Description

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endoscopes and related instruments through the sheath. The dilator is comprised of a hydrophiliccoated polymer tube with a tapered distal end and a female luer connector with a lock mechanism on the proximal end to attach and lock to the hub on the sheath. The device will be offered in multiple sizes to accommodate different patient anatomies. The product is ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products – ethylene oxide – Requirements for development, validation and routine control of a sterilized process for medical device is for single use.

Indications for Use

Technological Characteristics

The Proxis™ Ureteral Access Sheath has similar technological characteristics as the predicate device, Navigator ™ HD Ureteral Access Sheath Set. The subject and predicate devices are based on the following technological elements:

Similar indications for use י
-Similar design features
-Provided sterile for single-use
-Composed of biocompatible materials

Performance Data

Nonclinical performance testing (bench) of the proposed device was conducted per the applicable requirements of:

. BS EN 1616:1997 + A1:1999 Sterile urethral catheters for single use
. ISO 594-2 Second Edition: 1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
. JIS T 3260:2012 Dilators

Additional testing was completed to compare additional performance characteristics of the subject and predicate devices.

Nonclinical biocompatibility testing was conducted in accordance with ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing".

Conclusion

The Bard Proxis™ Ureteral Access Sheath is substantially equivalent to the legally marketed predicate device as demonstrated by similar indications for use and similar design features, and nonclinical test data demonstrates that the subject device is safe and effective.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.