(26 days)
The Bard® AquaGuide™ Ureteral Access Sheath is indicated for use in endoscopic 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.
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.
The submitted text is a 510(k) summary for the Bard® AquaGuide™ Ureteral Access Sheath. It describes the device, its intended use, and states that performance data was submitted, but does not provide details on specific acceptance criteria or the results of a study demonstrating the device meets those criteria.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | The document states, "The Bard® AquaGuide™ Ureteral Access Sheath is constructed of biocompatible materials. The additional lumen reduces the potential for hypervolemia (excess fluid build-up)." This is a general statement about material and a benefit, not a performance metric against a specific criterion. |
Missing Information: Comprehensive acceptance criteria (e.g., specific dimensions, tensile strength, flow rates, biocompatibility test results, etc.) and quantitative or qualitative results against these criteria are not included.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, the performance data would typically be generated from internal testing, possibly in vitro or bench testing. There is no mention of human clinical data or animal studies as a "test set" in the context of device performance testing. The document states it's "constructed of biocompatible materials," implying relevant testing was done, but details are absent.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: Not applicable/Not specified. The performance data mentioned (biocompatibility, reduced hypervolemia) typically doesn't rely on expert ground truth in the same way an AI diagnostic device would. It's based on objective measurements and scientific principles.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/Not specified. As mentioned above, the type of "test set" for this device's performance data likely doesn't involve expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This device is a medical instrument (ureteral access sheath), not an AI diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For biocompatibility, the ground truth would be established through standardized in vitro and in vivo biocompatibility testing (e.g., ISO 10993 series). For "reducing the potential for hypervolemia," the ground truth would likely be established through fluid dynamics testing and potentially animal models demonstrating the efficacy of the additional lumen for fluid aspiration. The document does not provide details on these.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. As this is a physical medical device and not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable.
In summary, the provided document is a 510(k) summary for a physical medical device and lacks the kind of detailed performance study information typically requested for AI/ML-based devices. It confirms the device's identity, intended use, and regulatory classification, but it does not present acceptance criteria or detailed study results in the format requested. The "Performance Data Summary" section is very brief and high-level.
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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 Division8195 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.
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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).
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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.
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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
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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.
§ 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.