(91 days)
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Not Found
No
The summary describes a physical catheter for drainage and navigation, with no mention of software, algorithms, or any AI/ML related terms.
No.
The primary intended use of the device is for drainage and retrograde pyelogram, which are diagnostic and facilitative procedures, not directly therapeutic.
No
The device is intended to facilitate drainage and retrograde pyelogram, which are procedures related to accessing and imaging the urinary tract, but it is not described as interpreting or diagnosing conditions from the images or data it helps collect.
No
The device description clearly outlines a physical catheter with lumens, luer lock fittings, and specific dimensions (Fr. size, length), indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate drainage and retrograde pyelogram of the upper urinary tract" and "allow access to and navigation of a torturous ureter using standard endoscopic techniques." This describes a device used within the body for a medical procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a catheter with lumens for guidewire passage and fluid injection/drainage, designed for insertion into the urinary tract. This aligns with a surgical or interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Bard® Dual Lumen Ureteral Catheter is intended to facilitate drainage and retrograde pyelogram of the upper urinary tract. This catheter will allow access to and navigation of a torturous ureter using standard endoscopic techniques.
Product codes (comma separated list FDA assigned to the subject device)
78 EYB
Device Description
The Dual Lumen Ureteral Catheter is a bifurcated catheter with one lumen used for the passage of a quidewire and the other lumen used to inject or drain fluids. Each "Y" extension employs a female luer lock fitting used for connection to a syringe. The Dual Lumen is available in 10 Fr. with the catheter tip tapered to approximately 6 Fr. The working length of the catheter is 50 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper urinary tract
Indicated Patient Age Range
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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® Dual Lumen Ureteral Catheter is constructed with biocompatible materials and has been tested for performance and found equivalent to the predicate device.
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.
Not Found
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.
Not Found
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
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/2 description: The image shows handwritten text that appears to be a combination of a code and a page number. The code reads 'K032521' and is positioned at the top of the image. Below the code, the text 'Page 1 of 2' is written in cursive, indicating that this is the first page of a two-page document. The handwriting is clear, although the style is informal.
Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be outlined in black. The font is simple and modern, and the word is easy to read.
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 INFORMATION:
C. R. Bard, Inc., Urological Division Submitter's Name: Address: 8195 Industrial Blvd. Covington, GA 30014
Contact Person: Contact Person's Telephone Number: Contact Person's Fax: Date of Preparation:
Frances E. Harrison, RAC 770-784-6257 770-784-6419 August 7. 2003
B. Device Name:
| Trade Name: | Bard® Dual Lumen Ureteral Catheter |
|---|---|
| Common / Usual Name: | Ureteral Catheter |
| Classification Name: | Ureteral Catheter (21 CFR 876.5130) |
C. PREDICATE DEVICE NAME:
Bard® Dual Lumen Ureteral Catheter Trade Name:
D. DEVICE DESCRIPTION:
The Dual Lumen Ureteral Catheter is a bifurcated catheter with one lumen used for the passage of a quidewire and the other lumen used to inject or drain fluids. Each "Y" extension employs a female luer lock fitting used for connection to a syringe. The Dual Lumen is available in 10 Fr. with the catheter tip tapered to approximately 6 Fr. The working length of the catheter is 50 cm.
1
K032521
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Intended Use: ய்
The Bard® Dual Lumen Ureteral Catheter is intended to facilitate drainage and retrograde pyelogram of the upper urinary tract. This catheter will allow access to and navigation of a torturous ureter using standard endoscopic techniques.
F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:
The Bard® Dual Lumen Ureteral Catheter is constructed of polyurethane. It has the same intended use, general design and is manufactured from the same biocompatible materials as the predicate devices.
Performance Data Summary: G.
The Bard® Dual Lumen Ureteral Catheter is constructed with biocompatible materials and has been tested for performance and found equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles a stylized caduceus, featuring a staff with a snake winding around it, though it is not a traditional caduceus. The emblem is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Frances E. Harrison, RAC Director, Regulatory Affairs C.R.Bard, Incorporated 8195 Industrial Boulevard COVINGTON GA 30014
NOV 1 4 2003
Re: K032521
Trade/Device Name: Bard® Dual Lumen Ureteral Catheter Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II
Product Code: 78 EYB Dated: August 7, 2003 Received: August 18, 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 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.
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 (21 CFR Part 807); labeling (21 CFR Part 801); 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.
3
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
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
K0.3 2521
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K032521 |
|---|---|
| --------------------------- | --------- |
Device Name:
Indications for Use:
The Bard® Dual Lumen Ureteral Catheter is intended to facilitate drainage and retrograde pyelogram of the upper urinary tract. This catheter will allow access to and navigation of a torturous ureter using standard endoscopic techniques.
(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) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
| (Division Sign-Off) | (Optional Format 1/2/96) | |
|---|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | ||
| 510(k) Number | K032521 |