(61 days)
Not Found
No
The summary describes a physical medical device (a catheter) with design modifications and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage, which are therapeutic interventions.
No
The device is indicated for drainage and irrigation, which are therapeutic and management functions, not diagnostic.
No
The device description clearly states it is a catheter, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage". This describes a device used within the body for therapeutic or drainage purposes, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a catheter with lumens and drainage eyes, consistent with a device used for internal drainage.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and related to drainage and irrigation within the urinary tract.
N/A
Intended Use / Indications for Use
The Bardex I. C. 4-Way Foley Catheter is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage following procedures such as transurethral resection of the prostate.
Product codes
78 MJC
Device Description
The Bardex I. C. 4-Way Foley Catheter is a new catheter design incorporating the addition of a fourth lumen for prostatic drainage and the addition of several prostatic drainage eyes proximal to the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder/urinary tract, prostate
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
The Bardex I. C. 4-Way Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those catheters currently manufactured. Performance and functional testing standards are based on the "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" dated September 12, 1994.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K9831.01
NOV C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209
SECTION VI
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:
Contact Person: Contact Person's Phone: Contact Person's Fax: Date of Preparation:
C. R. Bard, Inc., Urological Division 8195 Industrial Blvd. Covington, Georgia 30014 Georgia C. Abernathy (770) 784-6454 રન્ડ જુ (770) 784-6419 8-31-98
-
B. Device Name:
Bardex I. C. 4-Way Foley Catheter Trade Name: Common / Usual Name: Antimicrobial Catheter Catheter, Urological (Antimicrobial) and Accessories Classification Name: -
C. Predicate Device Names:
| Trade Name: | Bard Latex Urinary Catheters |
|---|---|
| Trade Name: | Bard Hydrogel/Silver-Coated Foley Catheter |
D. Device Description:
The Bardex I. C. 4-Way Foley Catheter is a new catheter design incorporating the addition of a fourth lumen for prostatic drainage and the addition of several prostatic drainage eyes proximal to the balloon.
E. Intended Use:
The Bardex I. C. 4-Way Foley Catheter is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage following procedures such as transurethral resection of the prostate.
F. Technological Characteristics Summary:
Table VI-1 provides a tabulated comparison summary of the technological characteristics of the Bardex I. C. 4-Way Foley Catheter versus the predicate device.
1
| Table VI-1 | ||||
|---|---|---|---|---|
| Comparison Summary of Technological Characteristics |
| Product
Characteristic | Bard 4-Way Catheter
(this 510(k)) | Bard Latex Urinary
Catheters
(Predicate device)
(#K922431) | Bard Hydrogel/Silver-
Coated Foley Catheter
(Predicate device)
(#K910318) |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications or
Intended Use | The Bardex I.C. 4-Way Foley
Catheter is indicated for use
in bladder/urinary tract
drainage/irrigation and to
assist in hemostasis and
surgical site drainage
following procedures such as
transurethral resection of the
prostate.* | Bard Catheters are intended
for use in the drainage and/or
collection and/or
measurement of urine and in
bladder/urinary tract irrigation
and to assist in hemostasis
following surgery such as
transurethral resection of the
prostate. | The Bard Hydrogel/Silver-
Coated Foley Catheter is
intended for use in the
drainage and/or collection
and/or measurement of urine
and in bladder/urinary tract
irrigation and to assist in
hemostasis following surgery
such as transurethral resection
of the prostate. |
| Disposable | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| Catheter Base
Material | Red Latex | Red Latex | Red Latex |
| X-Ray Opaque | Yes | Yes | Yes |
| Coating | Silver/Hydrogel | Hydrogel | Silver/Hydrogel |
| Drainage Eyes
Proximal to
Balloon | 5 Drainage Eyes * | None | None |
| Tip Type –
Drainage Eyes
Distal to
Balloon | Open Concave Tip
(Couvelaire) and 3 additional
eyes | Single Eye | Open Concave Tip
(Couvelaire) and 2 opposed
eyes |
| Fr. Sizes
Available | 18-24 Fr. | 22-24 Fr. | 18-24 Fr. |
| Foley Balloon
Size | 30cc | 30cc | 30cc |
| Available
Packaged
Singly | Yes | Yes | Yes |
| Tip Shape | Coude | Coude | Coude |
| Number of
Lumens | 4 lumens* | 3 lumens | 3 lumens |
| Catalog # of
example | 1865SIXX** | 6003LXX** | 1859SIXX** |
- New feature(s) this 510(k)
** XX = French size (e.g., 1865SIXX = 1865SI18, 1865SI20, 1865SI22, 1865SI24)
Performance Data Summary: G.
The Bardex I. C. 4-Way Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those catheters currently manufactured. Performance and functional testing standards are based on the "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" dated September 12, 1994.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/3 description: The image shows the date November 3, 1998. The month is abbreviated as NOV. The number 3 is written in a simple, sans-serif font. The year 1998 is also written in a similar font.
Ms. Georgia Abernathy Regulatory Affairs Associate C.R. Bard, Incorporated Medical Division 8195 Industrial Blvd. Covington, Georgia 30209
Re: K983101 Bardex I.C. 4-Way Foley Catheter Dated: October 22, 1998 Received: October 26, 1998 Regulatory Class: II 21 CFR §876.5130/Product Codes: 78 MJC
Dear Ms. Abernathy:
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 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, 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 (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 requirement, 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 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 Compliance 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/dsmamain.html".
Sincerely yours
William Yin
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 1 - D
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ----------------------------------------------------------------------------------------------------------------------------------------------------
Device Name:
Indications for Use:
The Bardex I. C. 4-Way Foley Catheter is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage following procedures such as transurethral resection of the prostate.
(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 |
(Optional Format 1/2/96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
K983101