The Re-Trace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

Device Description

The Re-Trace Ureteral Access Sheath is comprised of the following components: Reinforced tube/sheath, Introducer/dilator, Connector, Clip. The reinforced introducer sheath is composed of a polyether block amide (PEBA) outer surface with a hydrophilic coating. The inner surface of the sheath is polytetralluoroethylene (PTFF). The sheath is reinforced with a stainless steel coil between the PEBA and PTFE materials. The distal tip of the sheath is fitted with a radiopaque ring. A white connector and orange clip is fitted on the proximal end of the sheath. The introducer/dilator is a radiopaque polyvinyl chloride (PVC). The introducer is fitted with a luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and three exit holes for fluid delivery are located at the distal end of the introducer. A 4cm length Nitinol tube is inserted in the injection channel of the introducer to stiffen the guide wire exit eye section of this introducer.

AI/ML Overview

The request concerns a 510(k) submission for the "Re-Trace Ureteral Access Sheath," focusing on modifications made to a previously cleared device. The provided text, however, details nonclinical (bench) testing and biocompatibility assessments, not a study evaluating device performance with human interaction or AI assistance. Therefore, many of the requested details about acceptance criteria, human study design, and AI elements are not present in the provided document.

Here's a breakdown of the information that can be extracted or inferred, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states that biocompatibility and performance testing were conducted, and the conclusions state that the modified device "is as safe and effective and performs as well as the predicate device." However, specific quantitative acceptance criteria or reported performance values for each test are not provided in the given text. The tests performed are listed as:

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility:
Cytotoxicity-MEM Elution	Met (Implied by conclusion)
Irritation-Intracutaneous Reactivity	Met (Implied by conclusion)
Sensitization-Guinea Pig Maximization	Met (Implied by conclusion)
Performance Testing:
Break force/Tensile	Met (Implied by conclusion)
Fluid Delivery	Met (Implied by conclusion)
Coefficient of Friction	Met (Implied by conclusion)
Kink force/Folding Resistance	Met (Implied by conclusion)
Tip Flexibility	Met (Implied by conclusion)
Sterile Barrier/Dye Penetration	Met (Implied by conclusion)

2. 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 provided in the document, as the tests described are nonclinical (bench testing) and biocompatibility studies, not human clinical trials.

3. 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 document describes nonclinical testing, not studies requiring expert interpretation or ground truth establishment.

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

This information is not applicable as the document describes nonclinical testing.

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

This information is not applicable. The device is a ureteral access sheath, a physical medical device, not an AI-powered diagnostic tool or system that would involve human readers or AI assistance.

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

This information is not applicable as the device is not an algorithm.

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

For the nonclinical tests described, the "ground truth" would be established by objective physical and chemical measurements and standard protocols for biocompatibility testing, rather than expert consensus, pathology, or outcomes data typically associated with clinical studies of diagnostic or prognostic devices.

8. The sample size for the training set

This information is not applicable as the device is not an AI algorithm requiring a training set.

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

This information is not applicable as the device is not an AI algorithm requiring a training set.

In summary, the provided document details a 510(k) submission for a modified physical medical device (Ureteral Access Sheath). The "study" referenced is a series of nonclinical bench tests and biocompatibility tests designed to demonstrate substantial equivalence to a predicate device. It does not involve human subjects, AI, or expert adjudication in the context of the requested questions.

Summary

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3. 510(K) SUMMARY

510(K) Owner's Name:	Coloplast A/S
Address:	Holtedam l3050 Humlebaek, Denmark
Phone/Fax/Email:	Office: (612) 302-4987Mobile: (612) 968-9567Fax: (612) 287-4138e-mail: usbes@coloplast.com
Name of Contact Person:	Brian E. SchmidtRegulatory Affairs Manager
Address/Contact:	1601 West River RoadMinneapolis, MN 55411
Date Prepared:	July 24, 2014
Trade Name:	Re-Trace Ureteral Access Sheath
Common Name:	Ureteral Access Sheath
Classification Name:	Endoscope and Accessories21 CFR 876.1500 Gastroenterology-Urology DevicesClass II
Product Code:	FED

Legally Marketed Devices to Which Your Firm Is Claiming Equivalence:

The Re-Trace Ureteral Access Sheath is substantially equivalent in performance, indication, design and materials to Re-Trace Ureteral Access Sheath, cleared under Premarket notification # K102485.

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Description of the Modified Device:

The Re-Trace Ureteral Access Sheath is comprised of the following components:

. Reinforced tube/sheath
Introducer/dilator .
Connector .
. Clip

The reinforced introducer sheath is composed of a polyether block amide (PEBA) outer surface with a hydrophilic coating. The inner surface of the sheath is polytetralluoroethylene (PTFF). The sheath is reinforced with a stainless steel coil between the PEBA and PTFE materials. The distal tip of the sheath is fitted with a radiopaque ring. A white connector and orange clip is fitted on the proximal end of the sheath.

The introducer/dilator is a radiopaque polyvinyl chloride (PVC). The introducer is fitted with a luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and three exit holes for fluid delivery are located at the distal end of the introducer.

Comparison to the Predicate Device

A 4cm length Nitinol tube is inserted in the injection channel of the introducer to stiffen the guide wire exit eye section of this introducer.

Intended Use Of The Device:

The intended use of the modified device, as described in its labeling, has not changed as a results of the modification.

Technological Characteristics Compared To Predicate Device:

The Re-Trace Ureteral Access Sheath is substantially equivalent in performance, indication, design and materials to Re-Trace Ureteral Access Sheath., cleared under Premarket notification # K102485. The only difference is that the Re-Trace Ureteral Access Sheath subject to this 510k contains a 4cm length Nitinol tube in the injection channel of the introducer to stiffen the guide wire exit eve section of the introducer compared to the predicate.

The modification has not altered the fundamental scientific technology of the predicate Re-Trace Ureteral Access Sheath.

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Summary of Nonclinical Tests Submitted:

The following biocompatibility testing and bench testing comparing the modified device to the predicate device was conducted.

Biocompatibility

. Cytotoxicity-MEM Elution
Irritation-Intracutancous Reactivity .
Sensitization-Guinca Pig Maximization .

Performance Testing

Break force/Tensilc .
Fluid Delivery .
Coefficient of Friction .
Kink force/Folding Resistance .
Tip Flexibility .
Sterile Barrier/Dye Penetration .

Conclusions

The performance and biocompatibility testing provided in this submission demonstrates that the modified Re-Trace Ureteral Access Sheath is as safe and effective and performs as well as the predicate device and therefore supports the determination of substantial equivalence.

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Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font. The text is black and the background is white.

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

July 24, 2014

COLOPLAST A/S Brian Schmidt Regulatory Affairs Manager 1601 West River Road N Minneapolis MN 5541 I

Re: K140523

Trade/Device Name: Re-trace Ureteral Access Sheath Regulation Number: 21 CFRS 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FED Dated: June 25, 2014 Received: June 26, 2014

Dear Brian Schmidt,

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

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Page 2 - Brian Schmidt

(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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin RASher -S

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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2. STATEMENT OF INDICATIONS FOR USE

Indications for Use

510(k) Number (if known): K140523

Re-Trace Ureteral Access Sheath Device Name:

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2014.07.24 14:55:15 -04'00'

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.