To establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

Device Description

The ReTrace Ureteral Access Sheath is a sterile, single use device that is inserted over a guidewire into the upper or lower urinary tract of patients requiring ureteroscopic procedure sin a hospital environment. The ReTrace Ureteral Access Sheath consists of:

Reinforced tube/sheath
Introducer/dilator
Connector
Clip

The reinforced polymeric introducer sheath includes a hydrophilic coating on the exterior and a lubricious inner surface. The sheath is reinforced to provide kink resistance. The distal tip of the sheath is fitted with a radiopaque ring. A white connector is fitted on the proximal end of the sheath and an orange connector is on the proximal end of the introducer to allow the two components to be attached.

The dilator 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 exit holes for fluid delivery are located at the distal end of the introducer. The dilator protrudes out the distal end and allows for a gradual enlargement of the passage if needed and improves trackability along the guidewire. Once in the desired location, the dilator is removed to establish a hollow conduit for insertion of endoscopes and other instruments into and out of the urinary tract.

The ReTrace Ureteral Access Sheaths are available in two diameters 10/12 Fr and 12/14 Fr. Lengths range between 28 and 55 cm.

This submission is for modifications to device materials, labeling, packaging, and connector design.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based solely on the provided text.

Crucial Note: The provided document is a 510(k) summary for a medical device (Ureteral Access Sheath) that underwent modifications. This means the primary argument for clearance is substantial equivalence to a previously cleared predicate device, rather than proving efficacy from scratch with a new device. Therefore, the details requested in your prompt regarding AI/ML models (e.g., training/test sets, human reader studies, ground truth establishment by experts) are generally not applicable to this type of device clearance. The performance data focuses on demonstrating that the modifications do not negatively impact the device's basic safety and function compared to the original cleared version.

Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for a modified device, the "acceptance criteria" are implicitly that the modified device performs comparably to the predicate device in relevant mechanical, biocompatibility, and sterilization tests, and the modifications do not raise new questions of safety or effectiveness. The reported performance is that the device met these criteria.

Acceptance Criteria (Implied for Device Modification)	Reported Device Performance (Summary)
Biocompatibility: Meets established standards (ISO 10993-1).	"Biocompatibility testing was conducted based upon ISO 10993-1 (2018)... Meets Standard."
Mechanical Performance: Maintains integrity and functionality as per design specifications.	"Mechanical testing was completed in support of the substantial equivalence determination and changes to the product line." This includes: Visual Inspection, Dimensional Inspection, Viscous fluid test, Simulated use test, Compatibility with accessories, Compatibility with Solutions, Peelability test, Tensile strength on introducer, Tensile strength between introducer and luer, Tensile strength between connector and sheath, Folding resistance on sheath, Radiopacity test on introducer, Friction test on sheath, Friction test on introducer tip, No perforation test, Tip flexibility, Nitinol tube compression / position.
Sterilization Efficacy: Achieves a Sterility Assurance Level (SAL) of 10⁻⁶.	"The ReTrace Ureteral Sheaths are sterilized using ethylene oxide in a validated cycle demonstrating a microbial assurance level of 10⁻⁶."
Packaging Integrity: Maintains sterility and product integrity through shelf life.	"Packaging testing included dye penetration testing, peel strength, peelability and visual inspection including through five year simulated accelerated aging."
Shelf Life: Supports a 5-year shelf life.	"Shelf life testing to support 5 years." (Across various tests)

Study Details (Based on Provided Text)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices for each test. The document lists types of mechanical tests performed (e.g., tensile strength, friction tests) which implicitly involve testing multiple samples, but the exact quantity is not given.
- Data Provenance: Not specified regarding country of origin. The studies are non-clinical testing (mechanical, biocompatibility, sterilization, packaging) and not human subject data. Thus, the concept of "retrospective or prospective" human data does not apply here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes the clearance of a physical medical device (Ureteral Access Sheath) through non-clinical performance testing for substantial equivalence after modifications. It is not an AI/ML device that requires expert-established ground truth for a test set. The "ground truth" for these tests is defined by the technical specifications, standards (like ISO 10993-1), and acceptable performance parameters for the device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Again, this pertains to expert review of data, typically in AI/ML performance studies. Here, the "adjudication" is whether the device passed specific engineering and performance tests, which would be determined by laboratory results and quality system procedures, not expert consensus on ambiguous data.
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:
- No. This type of study (MRMC, human readers with/without AI) is specifically for AI-powered diagnostic/interpretive devices. The Retrace Ureteral Access Sheath is a physical, mechanical medical 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.):
- The "ground truth" for this device's performance testing is defined by engineering specifications, industry standards (e.g., ISO 10993-1), and established test methodologies to ensure the device's physical and functional properties meet design requirements and maintain equivalency to the predicate device.
The sample size for the training set:
- Not Applicable. This is not an AI/ML device with a training set.
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML model.

Summary of why AI/ML related questions are not addressed:

The provided text is a 510(k) summary for a physical, mechanical medical device (a Ureteral Access Sheath) that underwent modifications. The FDA clearance pathway for such devices, especially when arguing substantial equivalence, relies heavily on non-clinical performance testing (biocompatibility, mechanical integrity, sterilization validation, packaging) to demonstrate that the device is as safe and effective as a legally marketed predicate device. It does not involve AI/ML components, diagnostic interpretation, or human reader studies. Therefore, many of the questions asked in your prompt are not relevant to the content of this specific FDA submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 12, 2024

Coloplast Corp. Jennifer Tvrdik Senior Regulatory Affairs Specialist 1601 West River Road North Minneapolis, Minnesota 55411

Re: K242173

Trade/Device Name: Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: July 24, 2024 Received: October 7, 2024

Dear Jennifer Tvrdik:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark R. Kreitz -S

for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242173

Device Name

Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)

Indications for Use (Describe)

To establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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2.03 510(k) SUMMARY

I. SUBMITTER

510(K) Owner's Name:	Coloplast A/S
Legal Manufacturer Address:	Holtedam 13050 Humlebaek, Denmark
Phone/Fax/Email:	Phone: (612) 998-4517Email: usjtvr@coloplast.com
Name of Contact Person:	Jennifer TvrdikSr. Regulatory Specialist
Address/Contact:	1601 West River Road NorthMinneapolis, MN 55411
Date Prepared:	July 12, 2024
II. DEVICE
Trade or Proprietary Name:	ReTrace® Ureteral Access Sheath
Common or Usual Name:	Endoscopic Access Overtube, Gastroenterology-Urology
Classification Name:	Endoscope Access Overtube(21 CFR section 876.1500)Product Code: FEDDevice Class: 2
Classification Panel:	Gastroenterology-Urology

III. PREDICATE DEVICE

Primary Predicate:	ReTrace Ureteral Access Sheath
510(k) Holder:	Coloplast A/S
510(k) Number:	K181811

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

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IV. DEVICE DESCRIPTION

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

The ReTrace Ureteral Access Sheaths are available in two diameters 10/12 Fr and 12/14 Fr. Lengths range between 28 and 55 cm.

This submission is for modifications to device materials, labeling, packaging, and connector design.

V. INDICATIONS FOR USE

To establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The modified ReTrace Ureteral Access Sheath is substantially equivalent in performance, indication, design, and materials to the previously cleared, ReTrace Ureteral Access Sheath (K181811) as shown in Table 1.

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Device Feature/Component	ReTrace Ureteral Access Sheath(Subject Device)	ReTrace Ureteral Access SheathK181811(Primary Predicate)
Manufacturer	Coloplast A/S	Coloplast A/S
510 (k) number	510(k) Pending	K181811
Regulation name	Endoscopic Access Overtube	Endoscopic Access Overtube
Regulation number	21 CFR 876.1500	21 CFR 876.1500
Classificationproduct code	FED	FED
Classification	II	II
Prescription device	Yes	Yes
Intended Use	To establish a continuous conduitduring urological endoscopicprocedures facilitating the in and outpassage of endoscopes and otherinstruments into the urinary tract.	Used to establish a continuous conduitduring urological endoscopic proceduresfacilitating the in and out passage ofendoscopes and other instruments into theurinary tract.
Duration of Use	During procedure <24 hrs	During procedure <24 hrs
Target PatientPopulation	Patients requiring ureteroscopicprocedures.	Patients requiring ureteroscopicprocedures.
Anatomical sites	Upper and lower urinary tract	Upper and lower urinary tract
Where used(hospital, home,ambulance, etc.)	Hospital	Hospital
Components	The ReTrace UAS is comprised offour components:● Reinforced tube/sheath● Introducer/dilator● Connector● Clip	The ReTrace UAS is comprised of fourcomponents:● Reinforced tube/sheath● Introducer/dilator● Connector● Clip
Sizes	10 FR ID / 12 FR OD12 FR ID / 14 FR OD	10 FR ID / 12 FR OD12 FR ID / 14 FR OD
Length	28 cm through 55 cm	28 cm through 55 cm
Performance	Testing of dimensions, deviceintegrity, device functionality,simulated use, guidewire pulloutforce, kink resistance, injectiontesting, and shelf-life testing tosupport 5 years	Testing of dimensions, device integrity,device functionality, simulated use,guidewire pullout force, kink resistance,injection testing, and shelf-life testing tosupport 5 years
InsertionTechnique	Insertion over a guidewire	Insertion over a guidewire
Device Materials	PEBA, PTFE, stainless steel, PVC,polycarbonate, Nitinol	PEBA, PTFE, stainless steel, PVC,polycarbonate, Nitinol
Coating	Hydrophilic coating	Hydrophilic coating
Single use	Yes	Yes
Biocompatibilityper ISO 10993	Meets Standard	Meets Standard
Sterilizationmethod	Ethylene Oxide	Ethylene Oxide
Device Feature/Component	ReTrace Ureteral Access Sheath(Subject Device)	ReTrace Ureteral Access SheathK181811(Primary Predicate)
Sterility AssuranceLevel	$10^{-6}$	$10^{-6}$
Shelf Life	5 years	5 years

Table 1: Comparison of Technological Characteristics

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VII. PERFORMANCE DATA

The following testing data was provided in support of the substantial equivalence determination and changes to the product line.

Biocompatibility Testing

Biocompatibility testing was conducted based upon ISO 10993-1 (2018): Biological evaluation of medical devices – Part 1: "Evaluation and testing within a risk management process" and FDA Guidance for Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff - September 2020.

Mechanical Testing

Mechanical testing was completed in support of the substantial equivalence determination and changes to the product line.

Visual Inspection ●
Dimensional Inspection ●
Viscous fluid test ●
Simulated use test
Compatibility with accessories ●
Compatibility with Solutions ●
Peelability test
Tensile strength on introducer
Tensile strength between introducer and luer
Tensile strength between connector and sheath ●
Folding resistance on sheath
Radiopacity test on introducer
Friction test on sheath
Friction test on introducer tip ●
No perforation test
Tip flexibility ●
Nitinol tube compression / position ●
Shelf life testing to support 5 years ●

Sterilization

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The ReTrace Ureteral Sheaths are sterilized using ethylene oxide in a validated cycle demonstrating a microbial assurance level of 10-6.

Packaging and Distribution

Packaging testing included dye penetration testing, peel strength, peelability and visual inspection including through five year simulated accelerated aging.

No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate device.

VIII. CONCLUSIONS

The modifications to the ReTrace Ureteral Access Sheath have been demonstrated to be substantially equivalent to the primary predicate, ReTrace Ureteral Access Sheath, based on the non-clinical data provided. The test results demonstrate that the design and labeling changes do not raise new questions of safety or effectiveness and are substantially similar to the predicate.

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.