(26 days)
Not Found
No
The summary describes a mechanical device for accessing the ureter and does not mention any AI or ML components or functions.
No
The device is a ureteral access sheath designed to facilitate other procedures; it does not directly treat a disease or condition.
No
Explanation: The device is a ureteral access sheath designed for mechanical access and fluid management during endoscopic urology procedures, not for identifying or diagnosing a medical condition.
No
The device description clearly states it is a "two-component ureteral dilation system" with physical components like an introducer and a sheath, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for surgical procedures (endoscopic urology procedures, ureteral dilation, access for instruments and fluids). IVDs are used to examine specimens outside the body (in vitro) to diagnose or monitor conditions.
- Device Description: The description details a physical device designed for insertion into the ureter, with lumens for fluid and instrument passage. This is consistent with a surgical access device, not a diagnostic test performed on a sample.
- Anatomical Site: The anatomical site is "ureteral," indicating use within the body.
- No mention of samples, reagents, or laboratory testing: The description and intended use do not mention any activities related to collecting or analyzing biological samples, which are core to IVDs.
This device is a surgical instrument used for access and manipulation within the urinary tract.
N/A
Intended Use / Indications for Use
The Bard® AquaGuide™ Ureteral Access Sheath is indicated for use in indoscopic urology procedures where ureteral dilation and continued ureteral access is desired for injection and aspiration of fluids and insertion and removal of endoscopes and related instruments.
Product codes
78 FED
Device Description
The Bard® AquaGuide™ Ureteral Access Sheath is a twocomponent ureteral dilation system which contains multiple lumens for injection and aspiration of fluids as well as passage of endoscopes and related instruments. The auptram consists of a hydrophilic-coated introducer with female luer connector and a hydrophilic-coated dual-lumen sheath with multi-function access hub. The system is available in Introducer sizes 10-13, Sheath sizes 12-16 and lengths: 25 - 55cm.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Bard® AquaGuide™ Ureteral Access Sheath is r onstructed of biocompatible materials. The additional lumen reduces the potential for hypervolemia (excess fluid build-up).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bard® AquaGuide™ Ureteral Conduit
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
DEC 3 0 2003
Image /page/0/Picture/1 description: The image shows the text "C. R. Bard, Inc." on the first line, followed by the address "8195 Industrial Blvd." on the second line. The third line contains the city, state, and zip code: "Covington, GA 30014". The text is in a simple, sans-serif font and is left-aligned.
Image /page/0/Picture/2 description: The image shows a handwritten text that appears to be a combination of alphanumeric characters and words. The text includes 'K033778' on the top line, followed by 'page 1 of 2' on the second line. The handwriting is cursive and slightly stylized, with some characters more legible than others.
Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and connected, giving the word a solid, block-like appearance. The overall impression is one of strength and stability.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
| Submitter's Name:
Address: | C. R. Bard, Inc., Urological Division
8195 Industrial Blvd.
Covington, Georgia 30014 |
|-------------------------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Frances E. Harrison, RAC |
| Contact Person's Phone: | (770) 784-6257 |
| Contact Person's Fax: | (770) 784-6419 |
| Date of Preparation: | November 26, 2003 |
- B. Device Name:
Trade Name: | Bard® AquaGuide™ Ureteral Access Sheath |
---|---|
Common / Usual Name: | Ureteral Conduit |
Classification Name: | Endoscope and Accessories |
- C. Predicate Device Name: Bard® AquaGuide™ Ureteral Conduit Trade Name: Same as above
- D. Device Description: The Bard® AquaGuide™ Ureteral Access Sheath is a twocomponent ureteral dilation system which contains multiple lumens for injection and aspiration of fluids as well as passage of endoscopes and related instruments. The auptram consists of a hydrophilic-coated introducer with female luer connector and a hydrophilic-coated dual-lumen sheath with multi-function access hub. The system is available in Introducer sizes 10-13, Sheath sizes 12-16 and lengths: 25 - 55cm.
- E. Intended Use: The Bard® AquaGuide™ Ureteral Access Sheath is indicated for use in indoscopic urology procedures where ureteral dilation and continued ureteral access is desired for injection and aspiration of fluids and insertion and removal of endoscopes and related instruments.
1
K033778
Page 2 of 2
- F. Technological Characteristics Summary: The Bard® AquaGuide™ Ureteral Access r connological onaracted online coating and is constructed of materials that soften at Oncan has a labholoud hydrophilis comfort. The device can be placed over a 0.038" buidewire, allows for passage of endoscopes and related instruments, allows for injection and aspiration of fluids and provides for continuous flow.
- G. Performance Data Summary: The Bard® AquaGuide™ Ureteral Access Sheath is r onstructed of biocompatible materials. The additional lumen reduces the potential for hypervolemia (excess fluid build-up).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2003
Frances E. Harrison, RAC Director, Regulatory Affairs Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014
Re: K033778
Trade/Device Name: Bard® AquaGuide™ Ureteral Access Sheath Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FED Dated: November 26, 2003 Received: December 5, 2003
Dear Ms. Harrison:
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 for use stated in the encreated.1976, the enactment date of the Medical Device Amendments, or to connices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees that have been rout 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 r ou may, thereferer, missus of the Act include requirements for annual registration, listing of Echolar volurole provinstvring practice, labeling, and prohibitions against misbranding and adulteration.
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 r that FDA has made a determination that your device complies with other requirements of the Act that x 1971 here interes and regulations administered by other Federal agencies. You must or any I varrate the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CI R Part 007), acoming (2) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality of the provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin harketing of substantial equivalence of your device to a legally prematication. The PDF mailing to and group device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), plcase If you desire specific advice for your dones an one of the following numbers, based on the regulation number at the top of the letter:
8xx. 1xxx | (301) 594-4591 |
---|---|
876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions of the premier A. .
Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Compliance at (301) 37 1 105 Part 807.97) you may obtain. Other general by reletence to premarked nombation (er the Act may be obtained from the Division of Strall information on your responsionalism and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Solless http://www.fda.gov/cdrf/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
033778 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Bard® AquaGuide™ Ureteral Access Sheath Device Name: ________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Bard® AquaGuide™ Ureteral Access Sheath is indicated for use in endoscopic urology procedures where ureteral dilation and continued ureteral endoscopic arology procession and aspiration of fluids and insertion and removal of endoscopes and related instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
-Prescription Use _ (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR
(Optional Format 1/2/96)
Nancy C. Brogdon
(Division Sign Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.