(142 days)
No
The device description and performance studies focus on the physical components and mechanical properties of the ureteral access sheath, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates a procedure but does not directly treat a disease or condition; it creates a conduit for endoscopic instruments.
No
The device is described as an access sheath used to facilitate the passage of endoscopes and other instruments during urological procedures. Its purpose is to provide a conduit, not to diagnose a condition.
No
The device description explicitly details multiple hardware components (reinforced tube/sheath, introducer/dilator, connector, clip) made of various materials (PEBA, PTFE, stainless steel, PVC, Nitinol). The performance studies also focus on physical properties and biocompatibility of these hardware components.
Based on the provided information, 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 passage of endoscopes and other instruments into the urinary tract." This describes a device used within the body for a surgical or interventional procedure.
- Device Description: The description details a physical device (sheath, introducer, etc.) made of various materials, designed to be inserted into the urinary tract.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) in vitro (outside the body) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are specifically designed for testing samples outside the body to diagnose or monitor conditions. This device is clearly intended for direct use within the patient's body during a medical procedure.
N/A
Intended Use / Indications for Use
The Re-Trace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the passage of endoscopes and other instruments into the urinary tract.
Product codes
FED
Device Description
The Re-Trace Ureteral Access Sheath is comprised of the following components:
- . Reinforced tube/sheath
- Introducer/dilator .
- Connector .
- . Clip
The reinforced introducer sheath is composed of a polyether block amide (PEBA) outer surface with a hydrophilic coating. The inner surface of the sheath is polytetralluoroethylene (PTFF). The sheath is reinforced with a stainless steel coil between the PEBA and PTFE materials. 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/dilator is a radiopaque polyvinyl chloride (PVC). 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 three exit holes for fluid delivery are located at the distal end of the introducer. A 4cm length Nitinol tube is inserted in the injection channel of the introducer to stiffen the guide wire exit eye section of this introducer.
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
The following biocompatibility testing and bench testing comparing the modified device to the predicate device was conducted.
Biocompatibility
- . Cytotoxicity-MEM Elution
- Irritation-Intracutancous Reactivity .
- Sensitization-Guinca Pig Maximization .
Performance Testing
- Break force/Tensilc .
- Fluid Delivery .
- Coefficient of Friction .
- Kink force/Folding Resistance .
- Tip Flexibility .
- Sterile Barrier/Dye Penetration .
Conclusions
The performance and biocompatibility testing provided in this submission demonstrates that the modified Re-Trace Ureteral Access Sheath is as safe and effective and performs as well as the predicate device and therefore supports the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
3. 510(K) SUMMARY
:
:
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Address: | Holtedam l |
| 3050 Humlebaek, Denmark | |
| Phone/Fax/Email: | Office: (612) 302-4987 |
| Mobile: (612) 968-9567 | |
| Fax: (612) 287-4138 | |
| e-mail: usbes@coloplast.com | |
| Name of Contact Person: | Brian E. Schmidt |
| Regulatory Affairs Manager | |
| Address/Contact: | 1601 West River Road |
| Minneapolis, MN 55411 | |
| Date Prepared: | July 24, 2014 |
| Trade Name: | Re-Trace Ureteral Access Sheath |
| Common Name: | Ureteral Access Sheath |
| Classification Name: | Endoscope and Accessories |
| 21 CFR 876.1500 Gastroenterology-Urology Devices | |
| Class II | |
| Product Code: | FED |
Legally Marketed Devices to Which Your Firm Is Claiming Equivalence:
The Re-Trace Ureteral Access Sheath is substantially equivalent in performance, indication, design and materials to Re-Trace Ureteral Access Sheath, cleared under Premarket notification # K102485.
1
Description of the Modified Device:
The Re-Trace Ureteral Access Sheath is comprised of the following components:
- . Reinforced tube/sheath
- Introducer/dilator .
- Connector .
- . Clip
The reinforced introducer sheath is composed of a polyether block amide (PEBA) outer surface with a hydrophilic coating. The inner surface of the sheath is polytetralluoroethylene (PTFF). The sheath is reinforced with a stainless steel coil between the PEBA and PTFE materials. 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/dilator is a radiopaque polyvinyl chloride (PVC). 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 three exit holes for fluid delivery are located at the distal end of the introducer.
Comparison to the Predicate Device
A 4cm length Nitinol tube is inserted in the injection channel of the introducer to stiffen the guide wire exit eye section of this introducer.
Intended Use Of The Device:
The Re-Trace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the passage of endoscopes and other instruments into the urinary tract.
The intended use of the modified device, as described in its labeling, has not changed as a results of the modification.
Technological Characteristics Compared To Predicate Device:
The Re-Trace Ureteral Access Sheath is substantially equivalent in performance, indication, design and materials to Re-Trace Ureteral Access Sheath., cleared under Premarket notification # K102485. The only difference is that the Re-Trace Ureteral Access Sheath subject to this 510k contains a 4cm length Nitinol tube in the injection channel of the introducer to stiffen the guide wire exit eve section of the introducer compared to the predicate.
The modification has not altered the fundamental scientific technology of the predicate Re-Trace Ureteral Access Sheath.
2
Summary of Nonclinical Tests Submitted:
The following biocompatibility testing and bench testing comparing the modified device to the predicate device was conducted.
Biocompatibility
- . Cytotoxicity-MEM Elution
- Irritation-Intracutancous Reactivity .
- Sensitization-Guinca Pig Maximization .
Performance Testing
- Break force/Tensilc .
- Fluid Delivery .
- Coefficient of Friction .
- Kink force/Folding Resistance .
- Tip Flexibility .
- Sterile Barrier/Dye Penetration .
Conclusions
The performance and biocompatibility testing provided in this submission demonstrates that the modified Re-Trace Ureteral Access Sheath is as safe and effective and performs as well as the predicate device and therefore supports the determination of substantial equivalence.
3
Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font. The text is black and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2014
COLOPLAST A/S Brian Schmidt Regulatory Affairs Manager 1601 West River Road N Minneapolis MN 5541 I
Re: K140523
Trade/Device Name: Re-trace Ureteral Access Sheath Regulation Number: 21 CFRS 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FED Dated: June 25, 2014 Received: June 26, 2014
Dear Brian 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 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. You must comply with all the Act's requirements. including, but not limited to: registration and listing
4
Page 2 - Brian Schmidt
(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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education 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 RASher -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): K140523
Re-Trace Ureteral Access Sheath Device Name:
Indications for Use:
The Re-Trace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the 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)
Benjamin R. Fisher -S 2014.07.24 14:55:15 -04'00'