(80 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon dilation catheter, with no mention of AI or ML capabilities.
Yes
The device is indicated for "dilation of the urinary tract," which is a direct treatment aimed at improving health, therefore qualifying it as a therapeutic device.
No
The device is indicated for dilation of the urinary tract, which is a therapeutic function, not a diagnostic one. While it can be used for "monitoring of pressure" or "infusion of medication and/or contrast medium", its primary and stated purpose is dilation.
No
The device description clearly describes a physical catheter with a balloon and lumens, indicating it is a hardware device, not software-only.
Based on the provided information, the Bard® UroForce™ Balloon Dilation Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "dilation of the urinary tract." This is a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a catheter with a balloon for physical dilation, a guidewire lumen, and lumens for pressure monitoring or infusion. This is consistent with a medical device used for intervention within the body.
- 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.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Bard UroForce Balloon Dilation Catheter is a therapeutic device used for a physical intervention.
N/A
Intended Use / Indications for Use
The Bard® UroForce™ Balloon Dilation Catheter is indicated for dilation of the urinary tract.
Product codes
78 EZN
Device Description
The Bard UroForce Balloon Dilation Catheter is a dual-lumen catheter with a Nydex® two-layer nylon balloon mounted on its distal tip and with two radiopaque markers beneath the balloon that define the working length. The lumen labeled "balloon" is for balloon inflation. The additional lumen allows the catheter to track over a 0.038"(.97mm) guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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
Bench testing was conducted for the following characteristics: balloon burst strength, balloon distensibility, balloon inflation time and balloon diameter and profile. The test results indicate that the Bard UroForce Balloon Dilation Catheter is substantially equivalent to the stated predicate device, that there are no new safety or effectiveness issues, and that the device can be utilized for its stated indication.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).
0
Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
K993840 0. 1083
BARD
SECTION VI
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
A. Submitter Information:
Submitter's Name: Address:
Contact Person: Contact Person's Phone: Contact Person's Fax: Date of Preparation:
C. R. Bard, Inc., Urological Division 8195 Industrial Blvd., Covington, GA 30014 Angela L. Bunn 770-784-6135 770-784-6419 November 10, 1999
- B. Device Name:
Trade Name: Common/Usual Name: Classification Name:
Bard® UroForce™ Balloon Dilation Catheter Balloon Dilation Catheter Dilator, Catheter, Ureteral
-
C. Predicate Device Name(s):
Trade Name: Trade Name: Opti-Plast® Centurion™ 5.5F PTA Catheter Bard® A-Trac Urological Balloon Dilation Catheter -
D. Device Description:
The Bard UroForce Balloon Dilation Catheter is a dual-lumen catheter with a Nydex® two-layer nylon balloon mounted on its distal tip and with two radiopaque markers beneath the balloon that define the working length. The lumen labeled "balloon" is for balloon inflation. The additional lumen allows the catheter to track over a 0.038"(.97mm) guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium. -
E. Intended Use:
180-06
The Bard UroForce Balloon Dilation Catheter is indicated for dilation of the urinary tract.
- F. Technological Characteristics Summary:
Table VI-1 provides a comparison summary of the technological characteristics of the Bard UroForce Balloon Dilation Catheter versus the predicate devices.
1
K 993840
గ్రా. 263 3
Table VI-1 Bard® UroForce™ Balloon Dilation Catheter of the
Bard® UroForce™ Balloon Dilation Catheter to Predicate Devices
| Characteristics | UroForce Balloon
Dilation Catheter | Opti-Plast Centurion
PTA Catheter | A-Trac Urological
Catheter |
|-------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | The Bard UroForce
Balloon Dilation Catheter
is indicated for dilation of
the urinary tract. | The Opti-Plast Centurion
5.5F PTA Catheter is
recommended for use in the
Percutaneous Transluminal
Angioplasty (PTA) of the
Iliac, Femoral and Renal
arteries and for the
treatment of obstructive
lesions of native or
synthetic arteriovenous
dialysis fistulae. The
catheter is not for use in the
Coronary arteries. | The Bard A-Trac
Urological Balloon
Dilation Catheter is
indicated for use in the
dilation of the ureter or
urethra through the
working channel of an
endoscope. |
| Reuse Status | Disposable. For single
patient use only. | Disposable. For single
patient use only. | Disposable. For single
patient use only. |
| Sterile | Yes | Yes | Yes |
| Catheter Balloon Material | Nylon, 2 layers | Nylon, 2 layers | PET, Single layer |
| X-Ray Opaque | yes | yes | yes |
| Fr. Size | 6 | 5.5 | 5 |
| Balloon Lengths | 4, 6, 10 cm | 2, 4 cm | 4, 8, 10 cm |
| Balloon Diameters | 4, 5, 6, 7, 8 mm | 4, 5, 6, 7, 8, 9, 10 mm | 4, 5, 6, 7, 8 mm |
| Operating Pressure | 10 atm | 10 atm | 10 atm |
| Rated Burst Pressures | 25 atm (max.) | 17-20 atm | 12-15 atm |
| Overall Catheter Length | 89.5 cm | 86 cm** | 96 cm |
| Guidewire Lumen Length | 85.5 cm | 84.5 cm** | 95.5 cm |
| Active Shaft Length | 75 cm* | 75 cm** | 75 cm* |
| Guidewire Compatibility | 0.038" | 0.035" | 0.035" |
| Shaft/Tip Design
(under balloon) | one piece with drawn
down tip | two piece with bonded tip | two piece with bonded
tip |
| Stopcock Attached | Yes | No | No |
| Stylet | Yes | Yes | Yes |
| Balloon Sheath | Yes | Yes | Yes |
- Excludes strain relief
** Shorter and longer shaft lengths are available
2
p. 3 of 3
G. Performance Data:
Performance and functional testing standards are based on the FDA "Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters," dated January 24, 1992. Bench testing was conducted for the following characteristics: balloon burst strength, balloon distensibility, balloon inflation time and balloon diameter and profile. The test results indicate that the Bard UroForce Balloon Dilation Catheter is substantially equivalent to the stated predicate device, that there are no new safety or effectiveness issues, and that the device can be utilized for its stated indication.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 31 2000
Ms. Angela L. Bunn Regulatory Affairs Associate C. R. Bard, Inc. 8195 Industrial Boulevard Covington, GA 30014
Re: K993840 Bard® UroForce™ Balloon Dilation Catheter Dated: November 10, 1999 Received: November 12, 1999 Regulatory Class: II 21 CFR §876.5470/Procode: 78 EZN
Dear Ms. Bunn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compilance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION I - D
INDICATIONS FOR USE STATEMENT
x993840 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ___ Bard® UroForce™ Balloon Dilation Catheter
Indications for Use:
The Bard® UroForce™ Balloon Dilation Catheter is indicated for dilation of the urinary tract.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Prescription Use V (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR
(Optional Format 1/2/96)
Stat
(Division Sign-Off) (Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number