(2 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a ureteral access sheath and dilator, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats a disease or condition. This device is an access sheath intended to facilitate procedures, not to treat a condition itself.
No
The device is described as an access sheath and dilator used for inserting and removing endoscopes and instruments, and for fluid injection, which are interventional procedures rather than diagnostic ones.
No
The device description clearly outlines physical components (sheath, dilator, hub, luer connector) made of polymers and other materials, and describes manufacturing processes like sterilization. This indicates a hardware medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a medical procedure (endoscopic urology) to facilitate access and passage of instruments. It is a tool used in vivo (within the body).
- Device Description: The description details a physical device (sheath and dilator) designed for mechanical manipulation and access within the ureter. It does not describe a device that analyzes biological samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic results. The device's function is purely procedural.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Proxis™ ureteral access sheath does not fit this definition.
N/A
Intended Use / Indications for Use
The Proxis™ ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.
Product codes
FED
Device Description
Proxis™ Ureteral Access Sheath is a two component ureteral dilation system which contains 1) a sheath with a lumen for passage of endoscopes and related instruments and 2) a dilator with a lumen for passage over a guidewire and injection of fluids.
Proxis™ Ureteral Access Sheath is a hydrophilic-coated sheath tube comprised of a coil reinforced polymer with a PTFE liner and marker band near the distal end. On the proximal end of the sheath is a plastic hub which provides identification for the device and acts as an interface for introducing endoscopes and related instruments through the sheath. The dilator is comprised of a hydrophiliccoated polymer tube with a tapered distal end and a female luer connector with a lock mechanism on the proximal end to attach and lock to the hub on the sheath. The device will be offered in multiple sizes to accommodate different patient anatomies. The product is ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products – ethylene oxide – Requirements for development, validation and routine control of a sterilized process for medical device is for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteral
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
Nonclinical performance testing (bench) of the proposed device was conducted per the applicable requirements of:
- BS EN 1616:1997 + A1:1999 Sterile urethral catheters for single use
- ISO 594-2 Second Edition: 1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- JIS T 3260:2012 Dilators
Additional testing was completed to compare additional performance characteristics of the subject and predicate devices.
Nonclinical biocompatibility testing was conducted in accordance with ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing".
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of a human figure in profile, with three overlapping faces representing the department's focus on health and human well-being. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2016
C.R. Bard, Inc. % Dave Yungvirt Official Correspondent Third Party Review Group, LLC 45 Rockefeller Plaza, Suite 2000 New York, NY 1011
Re: K160861
Trade/Device Name: Proxis™ Ureteral Access Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FED Dated: December 16, 2015 Received: March 29, 2016
Dear Dave Yungvirt,
This letter corrects our substantially equivalent letter of March 31, 2016.
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.
1
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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert P. Lerner -S
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
2
Indications for Use
510(k) Number (if known)
Device Name
ProxisTM Ureteral Access Sheath
Indications for Use (Describe)
The Proxis™ ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
Image /page/3/Picture/3 description: The image shows the word "BARD" in a stylized, sans-serif font. The letters are thick and outlined in green, giving them a bold appearance. The overall design is simple and clean, with a focus on readability.
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Proxis™ Ureteral Access Sheath 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Bard Medical Division
C. R. Bard, Inc.
8195 Industrial Blvd.
Covington, GA 30014 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Beatrice Wan
Regulatory Affairs Specialist II
Bard Medical Division
Ph: 770-784-6414
Fax: 770-385-4706 |
| Submission Date: | March 24, 2016 |
| Subject Device: | Trade Name: Proxis ™ Ureteral Access Sheath
Common Name: Ureteral Access Sheath
Classification Name: Endoscopic Overtube
Regulation: 21 CFR §876.1500
Regulatory Classification: II
Product Code: FED |
| Predicate Device: | Legally marketed device to which substantial equivalence is claimed Boston Scientific Navigator™ HD Ureteral Access Sheath Set, K122649 |
Device Description
Proxis™ Ureteral Access Sheath is a two component ureteral dilation system which contains 1) a sheath with a lumen for passage of endoscopes and related instruments and 2) a dilator with a lumen for passage over a guidewire and injection of fluids.
Proxis™ Ureteral Access Sheath is a hydrophilic-coated sheath tube comprised of a coil reinforced polymer with a PTFE liner and marker band near the distal end. On the proximal end of the sheath is a plastic hub which provides identification for the device and acts as an interface for introducing
4
endoscopes and related instruments through the sheath. The dilator is comprised of a hydrophiliccoated polymer tube with a tapered distal end and a female luer connector with a lock mechanism on the proximal end to attach and lock to the hub on the sheath. The device will be offered in multiple sizes to accommodate different patient anatomies. The product is ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products – ethylene oxide – Requirements for development, validation and routine control of a sterilized process for medical device is for single use.
Indications for Use
The Proxis™ ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.
Technological Characteristics
The Proxis™ Ureteral Access Sheath has similar technological characteristics as the predicate device, Navigator ™ HD Ureteral Access Sheath Set. The subject and predicate devices are based on the following technological elements:
- Similar indications for use י
- -Similar design features
- -Provided sterile for single-use
- -Composed of biocompatible materials
Performance Data
Nonclinical performance testing (bench) of the proposed device was conducted per the applicable requirements of:
- . BS EN 1616:1997 + A1:1999 Sterile urethral catheters for single use
- . ISO 594-2 Second Edition: 1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- . JIS T 3260:2012 Dilators
Additional testing was completed to compare additional performance characteristics of the subject and predicate devices.
Nonclinical biocompatibility testing was conducted in accordance with ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing".
Conclusion
The Bard Proxis™ Ureteral Access Sheath is substantially equivalent to the legally marketed predicate device as demonstrated by similar indications for use and similar design features, and nonclinical test data demonstrates that the subject device is safe and effective.