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

K242173 · Coloplast Corp. · FED · Nov 12, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K242173
• Device Name: Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
• Applicant: Coloplast Corp.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Nov 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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.

Device Story

ReTrace Ureteral Access Sheath is a sterile, single-use device used in hospital settings during ureteroscopic procedures. It consists of a reinforced polymeric sheath, introducer/dilator, connector, and clip. The device is inserted over a guidewire into the urinary tract; the dilator facilitates gradual passage enlargement and trackability. Once positioned, the dilator is removed, leaving a hollow conduit for the passage of endoscopes and instruments. The sheath features a hydrophilic coating for lubricity, kink-resistant reinforcement, and a radiopaque distal tip. It is operated by physicians to provide access to the upper and lower urinary tract, potentially improving procedural efficiency and patient outcomes by protecting the ureter during repeated instrument exchanges.

Clinical Evidence

No clinical data or animal studies were provided. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), dimensional inspection, simulated use, tensile strength, kink resistance, friction testing, and shelf-life validation.

Technological Characteristics

Materials: PEBA, PTFE, stainless steel, PVC, polycarbonate, Nitinol. Features: Hydrophilic coating, radiopaque distal ring, kink-resistant reinforced tube. Dimensions: 10/12 Fr and 12/14 Fr diameters; 28-55 cm lengths. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring ureteroscopic procedures in a hospital environment to establish a conduit for endoscopes and instruments in the upper and lower urinary tract.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ReTrace Ureteral Access Sheath (K181811)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 1<br>3050 Humlebaek, Denmark |
| Phone/Fax/Email: | Phone: [phone]<br>Email: [e-mail] |
| Name of Contact Person: | Jennifer Tvrdik<br>Sr. Regulatory Specialist |
| Address/Contact: | 1601 West River Road North<br>Minneapolis, 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<br>(21 CFR section 876.1500)<br>Product Code: FED<br>Device 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

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.

#### 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/<br>Component | ReTrace Ureteral Access Sheath<br>(Subject Device) | ReTrace Ureteral Access Sheath<br>K181811<br>(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 |
| Classification<br>product code | FED | FED |
| Classification | II | II |
| Prescription device | Yes | Yes |
| Intended Use | To establish a continuous conduit<br>during urological endoscopic<br>procedures facilitating the in and out<br>passage of endoscopes and other<br>instruments into the urinary tract. | Used to establish a continuous conduit<br>during urological endoscopic procedures<br>facilitating the in and out passage of<br>endoscopes and other instruments into the<br>urinary tract. |
| Duration of Use | During procedure <24 hrs | During procedure <24 hrs |
| Target Patient<br>Population | Patients requiring ureteroscopic<br>procedures. | Patients requiring ureteroscopic<br>procedures. |
| Anatomical sites | Upper and lower urinary tract | Upper and lower urinary tract |
| Where used<br>(hospital, home,<br>ambulance, etc.) | Hospital | Hospital |
| Components | The ReTrace UAS is comprised of<br>four components:<br>● Reinforced tube/sheath<br>● Introducer/dilator<br>● Connector<br>● Clip | The ReTrace UAS is comprised of four<br>components:<br>● Reinforced tube/sheath<br>● Introducer/dilator<br>● Connector<br>● Clip |
| Sizes | 10 FR ID / 12 FR OD<br>12 FR ID / 14 FR OD | 10 FR ID / 12 FR OD<br>12 FR ID / 14 FR OD |
| Length | 28 cm through 55 cm | 28 cm through 55 cm |
| Performance | Testing of dimensions, device<br>integrity, device functionality,<br>simulated use, guidewire pullout<br>force, kink resistance, injection<br>testing, and shelf-life testing to<br>support 5 years | Testing of dimensions, device integrity,<br>device functionality, simulated use,<br>guidewire pullout force, kink resistance,<br>injection testing, and shelf-life testing to<br>support 5 years |
| Insertion<br>Technique | Insertion over a guidewire | Insertion over a guidewire |
| Device Materials | PEBA, PTFE, stainless steel, PVC,<br>polycarbonate, Nitinol | PEBA, PTFE, stainless steel, PVC,<br>polycarbonate, Nitinol |
| Coating | Hydrophilic coating | Hydrophilic coating |
| Single use | Yes | Yes |
| Biocompatibility<br>per ISO 10993 | Meets Standard | Meets Standard |
| Sterilization<br>method | Ethylene Oxide | Ethylene Oxide |
| Device Feature/<br>Component | ReTrace Ureteral Access Sheath<br>(Subject Device) | ReTrace Ureteral Access Sheath<br>K181811<br>(Primary Predicate) |
| Sterility Assurance<br>Level | $10^{-6}$ | $10^{-6}$ |
| 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.