(91 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI/ML or related concepts.
No
The device facilitates the passage of instruments into the urinary tract but does not claim to directly treat any medical condition.
No
The intended use of the device is to facilitate the passage of endoscopes and instruments, which is an interventional/access function, not a diagnostic one.
No
The device description explicitly lists physical components (reinforced tube/sheath, introducer/dilator, connector, clip) and describes material (Stainless Steel ring). The performance studies also involve physical testing of these components. There is no mention of software as a component or function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract." This describes a device used within the body for a surgical or procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a physical device with components like a reinforced tube/sheath, introducer/dilator, connector, and clip. These are all components of a surgical access device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on physical properties and functionality of the device (break force, friction, kink resistance, etc.), not on the accuracy or reliability of a diagnostic test.
In vitro diagnostics are devices used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly falls outside of that definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FED
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
1. 510(k) SUMMARY
MAR 1 2013
510(K) Owner's Name:
Address:
Phone/Fax/Email:
3050 Humlebaek, Denmark (612) 302-4987 Office: Mobile: (612) 968-9567 (612) 287-4138 Fax: Email: usbes@coloplast.com
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.
1
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.
2
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.
3
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.
4
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 (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 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
5
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