The ReTrace Ureteral Access Sheath is used 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 comprised of the following components: 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 and orange clip is fitted on the proximal end of the sheath. 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 exit holes for fluid delivery are located at the distal end of the introducer. This submission expands the product line to include 28 cm long and 55 cm long sheaths with inner diameters of 10 and 12 Fr.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the ReTrace Ureteral Access Sheath. This specific submission is for an expansion of the product line, including new lengths and diameters of the existing device.

Based on the information provided, this document does not contain the details of a study that proves the device meets specific acceptance criteria in the manner requested by the prompt. The submission is a "Special 510(k) Summary" which aims to demonstrate substantial equivalence to previously cleared predicate devices (K140523 and K123675) for new sizes of the ReTrace Ureteral Access Sheath, rather than presenting a de novo clinical study with specific acceptance criteria related to accuracy, sensitivity, or specificity.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to the content of this document.

However, I can extract the information related to the device's mechanical and sterilization testing which serves as "performance data" in the context of this 510(k) submission for demonstrating substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the format of a clinical trial (e.g., sensitivity > X%, specificity > Y%). Instead, it lists mechanical tests performed to ensure the new device variations maintain equivalence to the predicate devices. The "reported device performance" is essentially that these tests were completed successfully and support substantial equivalence.

Test Category	Specific Test / Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Testing	Visual	Conformance to visual specifications	Completed (implies conformance)
	Dimensional verification	Conformance to specified dimensions (10/12 Fr ID, 28/55 cm L)	Completed (implies conformance)
	Guidewire pullout force	Maintain appropriate force for safe use	Completed (implies satisfactory performance)
	Device integrity and functionality	Device remains intact and functions as intended	Completed (implies satisfactory performance)
	Simulated use	Performs as expected in simulated surgical environment	Completed (implies satisfactory performance)
	Viscous fluid	Maintains patency and allows passage of viscous fluid	Completed (implies satisfactory performance)
	Kink resistance	Resists kinking during use	Completed (implies satisfactory performance)
	Shelf life testing to support 5 years	Maintains mechanical and functional properties for 5 years	Completed (supports 5 years shelf life)
Biocompatibility	Biocompatibility	Device materials are biocompatible (no additional testing needed due to predicate)	No additional testing provided, relies on predicate's data
Sterilization	Sterilization (Ethylene Oxide - Microbial Assurance)	Sterility Assurance Level (SAL) of 10⁻⁶	Demonstrated SAL of 10⁻⁶ in a validated cycle

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify sample sizes for the mechanical or sterilization testing. These types of tests typically involve a defined number of units per batch or configuration, but the specific numbers are not disclosed.
Data Provenance: The tests are conducted internally by the manufacturer (Coloplast A/S, based in Denmark, with a US contact in Minneapolis) as part of their design control and quality system. It is laboratory-based testing, not clinical data from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This is not applicable as the document describes mechanical and sterilization testing, not studies requiring expert review of patient data to establish "ground truth." The "ground truth" for these tests are objective measurements against engineering specifications.

4. Adjudication Method for the Test Set:

This is not applicable for mechanical and sterilization testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This is a regulatory pathway (510(k)) that, for this specific device and modification, relies on non-clinical data to demonstrate substantial equivalence, not comparative effectiveness.

6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done:

This is not applicable. The device is a physical medical instrument (ureteral access sheath), not an algorithm or AI software. Therefore, there's no "standalone algorithm" performance to assess.

7. The Type of Ground Truth Used:

The "ground truth" for the mechanical and sterilization testing referenced is based on engineering specifications, international standards, and validated methods for device performance and sterility. For example, a "guidewire pullout force" test would have an engineering specification for the minimum acceptable force, and the test result confirms it meets that specification.

8. The Sample Size for the Training Set:

This is not applicable as there is no "training set" in the context of an AI/algorithm. The device is a physical medical instrument.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable as there is no "training set."

Summary of Key Findings from the Document:

The document is a regulatory submission demonstrating substantial equivalence for new sizes of an existing medical device. It relies on non-clinical (mechanical and sterilization) testing to show that the new sizes perform similarly to the predicate devices and do not raise new questions of safety or effectiveness. It explicitly states that no animal or clinical studies were conducted for this specific submission to support substantial equivalence.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 7, 2018

Coloplast A/S Cori L. Ragan Regulatory Affairs Manager 1601 West River Road North Minneapolis, MN 55411

Re: K181811

Trade/Device Name: ReTrace Ureteral Access Sheath Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: August 7. 2018 Received: August 8, 2018

Dear Cori L. Ragan:

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. 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 located 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.

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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)

K181811

Device Name ReTrace 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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Confidential

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7. SPECIAL 510(k) SUMMARY

SUBMITTER I.

510(K) Owner's Name:	Coloplast A/S
Legal Manufacturer Address:	Holtedam 13050 Humlebaek, Denmark
Phone/Fax/Email:	Phone: (612) 597-5106Email: usclr@coloplast.com
Name of Contact Person:	Cori L. RaganRegulatory Affairs Manager
Address/Contact:	1601 West River RoadMinneapolis, MN 55411
Date Prepared:	June 28, 2018
II. DEVICE
Trade or Proprietary Name:	ReTrace® Ureteral Access Sheath
Common or Usual Name:	Endoscopic Access Overtube, Gastroenterology-Urology
Classification Name:	Endoscope and Accessories(21 CFR section 876.1500)Product Code: FEDDevice Class: 2
Classification Panel:	Gastroenterology-Urology

PREDICATE DEVICE III.

The proposed additional lengths of the ReTrace Ureteral Access Sheath are substantially equivalent in performance, indication, design, and materials to the Coloplast's own predicate device, ReTrace Ureteral Access Sheaths cleared under 510(k) K140523 and K123675.

These predicates have not been subject to a design-related recall. No reference devices were used in this submission.

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IV. DEVICE DESCRIPTION

The ReTrace Ureteral Access Sheath is comprised of the following components:

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 and orange clip is fitted on the proximal end of the sheath.

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 exit holes for fluid delivery are located at the distal end of the introducer.

This submission expands the product line to include 28 cm long and 55 cm long sheaths with inner diameters of 10 and 12 Fr.

V. INDICATIONS FOR USE

The modified ReTrace Ureteral Access Sheaths have the same intended use as the previously cleared models which is as follows:

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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 (K140523 and K123675).

TechnologicalCharacteristic	ReTrace Ureteral AccessSheath(Subject Device)	Retrace Ureteral AccessSheath - K140523(Predicate Device)	Retrace Ureteral AccessSheath - K123675(Predicate Device)
Design	Access Sheath withintroducer	Same	Same
Sizes	10 FR Inner Diameter (ID) /12 FR Outer Diameter (OD)and 12 FR ID / 14 FR OD	12 FR ID / 14 FR OD	10 FR ID / 12 FR OD and12 FR ID / 14 FR OD
Length	28cm and 55cm	35 and 45cm	35 and 45cm
Length of dilator outof sheath	5 cm	5 cm	5 cm2 cm
Insertion Technique	Insertion over a guidewire	Same	Same
Device Materials	PEBA, PTFE, stainless steel,PVC, polycarbonate, Nitinol	Same	Same
Coating	Hydrophilic coating	Same	Same
Single use	Yes	Same	Same
Sterility	Ethylene Oxide Sterilized	Same	Same
Shelf Life	5 years	Same	2 years

PERFORMANCE DATA VII.

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

Biocompatibility Testing

No additional biocompatibility testing was provided.

Mechanical Testing

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

Visual ●
Dimensional verification ●
Guidewire pullout force
Device integrity and functionality ●
. Simulated use
Viscous fluid
Kink resistance
Shelf life testing to support 5 years ●

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Sterilization

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

Packaging and Distribution

No additional packaging or distribution testing was provided.

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

VIII. CONCLUSIONS

The additional lengths of the ReTrace Ureteral Access Sheath have been demonstrated to be substantially equivalent to the predicate, ReTrace Ureteral Access Sheath, based on the nonclinical data provided. The test results demonstrate that the additional models do not raise new questions of safety or effectiveness and are substantially similar to the ureteral access sheaths cleared as ReTrace Ureteral Access Sheaths in K140523 and K123675.

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.