RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR

K123675 · Coloplast A/S · FED · Mar 1, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K123675
• Device Name: RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
• Applicant: Coloplast A/S
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Mar 1, 2013
• 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

The Re-Trace Ureteral Access Sheath and Ureteral Access Sheath are medical devices used to create a continuous conduit in the urinary tract during endoscopic procedures. The device consists of a reinforced tube/sheath, an introducer/dilator, a connector, and a clip. The 10/12 Ch/Fr model includes a stainless steel ring at the distal tip for reinforcement. The introducer/dilator features a guidewire entry eye. The device is used by urologists in a clinical setting to facilitate the insertion and withdrawal of endoscopes and other surgical instruments. By providing a stable pathway, the sheath protects the ureter and simplifies instrument exchange, potentially reducing procedural time and trauma to the urinary tract.

Clinical Evidence

Bench testing only. Performance testing included sheath/introducer/component break force, friction, kink resistance, injection, and guidewire pullout force testing. Biocompatibility testing was conducted in accordance with ISO 10993.

Technological Characteristics

Reinforced tube/sheath, introducer/dilator, connector, and clip. 10/12 Ch/Fr model features a stainless steel ring at the distal tip. Biocompatibility per ISO 10993. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing urological endoscopic procedures requiring a conduit for the passage of endoscopes and instruments into the 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

• Re-Trace Ureteral Access Sheath 12/14 Ch/Fr (K102485)

Reference Devices

• Cook Flexor® Access Sheath (K043418)

Submission Summary (Full Text)

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K123675

#### 1. 510(k) SUMMARY

#### MAR 1 2013

510(K) Owner's Name:

Address:

Phone/Fax/Email:

3050 Humlebaek, Denmark [phone] Office: Mobile: [phone] [phone] Fax: Email: [e-mail]

Coloplast A/S

Brian E. Schmidt

January 3, 2013

Regulatory Affairs Manager 1601 West River Road N

Re-Trace Ureteral Access Sheath

Minneapolis, MN 55411

Ureteral Access Sheath

Ureteral Access Sheath

Endoscope and Accessories

21CFR section 876.1500 Gastroenterology-Urology Devices

. Holtedam 1

Name of Contact Person:

Address/Contact:

Date Prepared:

Trade Name:

Common Name:

ﻢ

Classification Name:

Product code:

FED

Class II

## Legally Marketed Device To Which Your Firm Is Claiming Equivalence:

The Re-Trace Ureteral Access Sheath 10/12 Ch/Fr & Ureteral Access Sheath are substantially equivalent in performance, indication, design and materials to Re-Trace Ureteral Access Sheath 12/14 Ch/Fr from Coloplast A/S, cleared under Premarket notification # K 102485.

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## Description of the Device:

The Re-Trace Ureteral Access Sheath 10/12 Ch/Fr & Ureteral Access Sheath are line extensions of the Re-Trace Ureteral Access Sheath 12/14 Ch/Fr. All these devices comprise the following components:

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

The only design addition to the 10/12 Ch/Fr reinforced tube/sheath compared to the 12/14 Cly/Fr sheath is the presence of a reinforcing Stainless Steel ring at the distal tip.

For the Ureteral Access Sheath, the introducer/dilator also only has a guidewire entry eye at the distal tip compared with guidewire entry and exit eyes and three exit holes for fluid delivery on the Re-Trace Ureteral Access Sheath introducer/dilator.

Apart from these modifications, all the Re-Trace Ureteral Access Sheath & Ureteral Access Sheath range is very similar in design.

### Intended Use of the Device:

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

### Predicate Device:

The Re-Trace Ureteral Access Sheath 10/12 Ch/Fr & Ureteral Access Sheath are substantially equivalent in performance, indication, design and materials to Re-Trace Ureteral Access Sheath 12/14 Ch/Fr from Coloplast A/S, cleared under Premarket notification # K102485.

### Reference Device:

Regarding the proposed size range for Re-Trace Access Sheath & Ureteral Access Sheath, the Cook Flexor® Access Sheath from Cook Urological, Inc., cleared under Premarket notification #K043418, will be used as a reference device.

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## Summary and Conclusions from the Nonclinical Tests Submitted:

Product Performance testing comparing the subject device to the predicate device included the following tests/analysis: Sheath/ introducer/component break force testing, friction testing, kink resistance testing, injection testing, guidewire pullout force testing, packaging testing.

Biocompatibility testing was performed according to ISO 10993 on the Re-Trace Ureteral Access Sheath.

#### Conclusion

Substantial equivalence is supported by successful completion of the performance testing comparing Re-Trace Ureteral Access Sheath 10/12 Ch/Fr & Ureteral Access Sheath to the predicate device and the biocompatibility testing conducted on the Re-Trace Ureteral Access Sheath.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centrally aligned. To the left of the text is a graphic element that appears to be a stylized representation of a human figure or symbol, possibly related to health or human services. The overall impression is that of an official heading or title, likely from a document or publication associated with the Department of Health & Human Services.

Public Health Service

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

March 01. 2013

Coloplast A/S Coloplast Corp. % Mr. Brian E. Schmidt Regulatory Affairs Manager 1601 West River Road North MINNEAPOLIS MN 55411

Re: K123675

Trade/Device Name: Re-Trace Ureteral Access Sheath (Models ACXL10 and AXXL10) and Ureteral Access Sheath (Models ACXS12, AXXS12, ACXS10 AXXS10) Regulation Number: 21 CFR& 876.1500

Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: November 27, 2012 Received: December 4, 2012

Dear Mr. 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 misb randing 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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Page 2 - Mr. Brian E. Schmidt

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -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):

K 123675

Device Name:

Re-Trace Ureteral Access Sheath 10/12 Ch/Fr & Ureteral Access Sheath

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.

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)

Benjami 2013.03

oductive, Gastro-P

no 20 of 265