(70 days)
Not Found
Not Found
No
The summary describes a physical catheter for drainage and navigation, with no mention of software, image processing, or AI/ML terms.
No
The device is used to facilitate drainage and retrograde pyelogram, which are diagnostic and facilitative procedures, not therapeutic treatments for a disease or condition.
No
The device is described as facilitating drainage and retrograde pyelogram, which are procedures, not diagnostic functions of the device itself. It also allows access and navigation, which are assistive functions during a procedure, not diagnostic.
No
The device description clearly states it is a physical catheter comprised of a shaft and flexible tip, indicating it is a hardware medical device.
Based on the provided information, the Bard® TigerTail™ Ureteral Catheter 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 test performed on samples taken from the body.
- Device Description: The description details a physical catheter used for insertion into the urinary tract.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic tests.
Therefore, the Bard® TigerTail™ Ureteral Catheter is a medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bard® TigerTail™ 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 KOD
Device Description
The Bard® TigerTail™ Ureteral Catheter is a single lumen catheter comprised of a shaft and flexible tip. The device is offered with or without side holes and both configurations are available in 4,5 and 6 Fr. sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper urinary tract, ureter
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® TigerTail™ 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.
Bard® TigerTail™ Ureteral Catheter
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 a handwritten document with the text "K033719" at the top. Below this, the text "page 1 of 2" is written in cursive. The handwriting appears somewhat rough, and the image quality is slightly grainy.
BARD
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.
SUBMITTER INFORMATION: A.
| Submitter's Name: | C. R. Bard, Inc., Urological Division |
|---|---|
| Address: | 8195 Industrial Blvd. |
| Covington, GA 30014 | |
| Contact Person: | Frances E. Harrison, RAC |
| Contact Person's Telephone Number: | 770-784-6257 |
| Contact Person's Fax: | 770-784-6419 |
| Date of Preparation: | November 13, 2003 |
B. DEVICE NAME:
| Trade Name: | Bard® TigerTail™ Ureteral Catheter |
|---|---|
| Common / Usual Name: | Ureteral Catheter |
| Classification Name: | Ureteral Catheter (21 CFR 876 5130) |
PREDICATE DEVICE NAME: C.
Bard® TigerTail™ Ureteral Catheter Trade Name:
Device Description: D.
The Bard® TigerTail™ Ureteral Catheter is a single lumen catheter comprised of a shaft and flexible tip. The device is offered with or without side holes and both configurations are available in 4,5 and 6 Fr. sizes.
Intended Use: E.
The Bard® TigerTail™ 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.
1
K033719
Page 2 of 2
Technological Characteristics Summary: F.
The Bard® TigerTail™ 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® TigerTail™ 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 "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three wavy lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 4 2004
Frances E. Harrison, RAC Director, Regulatory Affairs C. R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014
Re: K033719
Trade/Device Name: Bard® TigerTail™ Ureteral Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KOD Dated: November 13, 2003 Received: November 26, 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 adultcration.
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
This letter will allow you to begin marketing your device as described in your Section 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 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 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
Finclosure
4
INDICATIONS FOR USE STATEMENT
(033719
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Bard® TigerTail™ Ureteral Catheter is intended to facilitate drainage and retrograde pyclogram 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)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K033719 | (Optional Format 1/2/96) |
|---|---|---|
| --------------- | --------- | -------------------------- |