(77 days)
Bardex® All-Silicone Foley Catheter, Lubri-Sil® All-Silicone Foley Catheter, Lubri-Sil® All-Silicone I.C. Foley Catheter
Not Found
No
The device description and intended use clearly describe a physical medical device (Foley catheter) for urine drainage. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is used for the drainage, collection, and measurement of urine, which are therapeutic functions (e.g., relieving urinary retention).
No
The device is a Foley catheter used for the drainage, collection, and measurement of urine. While it can measure urine, its primary function described is mechanical drainage and collection, not the diagnosis of a disease or condition.
No
The device description clearly describes a physical catheter with a balloon, which is a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "drainage and/or collection and/or measurement of urine." This describes a physical process of removing and collecting a bodily fluid.
- Device Description: The description details a physical catheter inserted into the body to facilitate drainage.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze the urine for diagnostic purposes (e.g., detecting substances, identifying pathogens, measuring levels of biomarkers). IVDs are specifically designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening.
This device is a medical device used for a therapeutic or management purpose (urine drainage), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Bardex®, Lubri-Sil® and Lubri-Sil® I.C. All-Silicone Foley Catheters are indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.
Product codes
78 EZL
Device Description
The Bard® all-silicone Foley catheter is a two-way all silicone Foley catheter which is placed in the bladder through the urethra. The balloon on the distal end of the catheter is inflated with sterile water after insertion and used to secure the catheter in place and ensure that the opening in the distal tip of the catheter is positioned correctly to allow for urine drainage. The urine drains out through the catheter into a collection device attached to the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder through the urethra, suprapubic, nephrostomy 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
Bardex®, Lubri-Sil® and Lubri-Sil® IC All-Silicone Foley Catheters were tested in accordance with the relevant standards for function and biocompatibility.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Bardex®, Lubri-Sil® and Lubri-Sil® IC All-Silicone Foley Catheters were tested in accordance with the relevant standards for function and biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bardex® All-Silicone Foley Catheter, Lubri-Sil® All-Silicone Foley Catheter, Lubri-Sil® All-Silicone I.C. Foley Catheter
Reference Device(s)
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
MAY 1 4 2004
K040501
Page 1 of 2
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., Medical Division |
|---|---|
| Address: | 8195 Industrial Blvd. |
| Covington, GA 30014 |
| Contact Person: | John C. Knorpp |
|---|---|
| Contact Person's Telephone Number: | 770-784-6451 |
| Contact Person's Fax: | 770-784-6419 |
| Date of Preparation: | February 24, 2004 |
B. DEVICE NAME:
Trade Names:
Bardex® All-Silicone Foley Catheter Lubri-Sil® All-Silicone Foley Catheter Lubri-Sil® 1.C. All-Silicone Foley Catheter Foley Catheter Catheter, Retention Type, Balloon Catheter, Urological (Antimicrobial) and Accessories 21 CFR 876.5130
PREDICATE DEVICE NAME: C.
Common / Usual Name:
Classification Names:
Bardex® All-Silicone Foley Catheter Trade Names: Lubri-Sil® All-Silicone Foley Catheter Lubri-Sil® All-Silicone I.C. Foley Catheter
D. Device Description:
The Bard® all-silicone Foley catheter is a two-way all silicone Foley catheter which is placed in the bladder through the urethra. The balloon on the distal end of the catheter is inflated with sterile water after insertion and used to secure the catheter in place and ensure that the opening in the distal tip of the catheter is positioned correctly to allow for urine drainage. The urine drains out through the catheter into a collection device attached to the catheter.
1
Image /page/1/Picture/0 description: The image contains a handwritten text that appears to be a signature. The text is written in a cursive style, with some letters connected and others separated. The writing is somewhat illegible, but it seems to contain a combination of uppercase and lowercase letters, possibly forming a name or a word. The overall impression is that of a quick, informal signature.
ட். INTENDED USE:
The Bardex®, Lubri-Sil® and Lubri-Sil® IC Ail-Silicone Foley Catheters are intended for use in the drainage and/or collection and/or measurement of urine.
TECHNOLOGICAL CHARACTERISTICS SUMMARY: F.
The Bardex®, Lubri-Sil® and Lubri-Sil® IC All-Silicone Foley Catheters are constructed of healthcare grade silicone. They have the same intended use, general design and fundamental scientific technology as the predicate devices.
PERFORMANCE DATA SUMMARY: G.
The Bardex®, Lubri-Sil® and Lubri-Sil® IC All-Silicone Foley Catheters were tested in accordance with the relevant standards for function and biocompatibility.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2004
Mr. John C. Knorpp Sr. Regulatory Affairs Specialist Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30209-2695
Re: K040504
Trade/Device Name: Bardex®, Lubri-Sil® and Lubri-Sil® I.C. All-Silicone Foley Catheters Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL Dated: February 24, 2004 Received: February 27, 2004
Dear Mr. Knorpp:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined 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 encrease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . devices that have been reclassified in accordance with the provisions of the Federal Food, Dryg, de noon mat move ocen that do not require approval of a premarket approval application (PMA). and oosmeter for , roy teet 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 geneful bonuroly proficitive, 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 r that FDA has made a determination that your device complies with other requirements of the Act enany 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)
10 Jegally This letter will allow you to ocgin marketing for antial equivalence of your device to a legally premarket notification. The FDA inding of sabbanna e of the more of this, 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 If you desire specific advice for your device on our learned 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, for questions on the promotion in the regulation entitled, "Misoranding
Office of Compliance at (301) 594-4639. Also, por on Othce of Compliance at (301) 574-1057. Fass, prices 807.97) you may obtain. Other general by reference to premarket nouncation (210) Act use of an election the Division of Strati information on your responsibilities under the researce at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance Assissance (democrain h Manufacturers, International and Collidants +18.000
(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
Enclosure
4
Bard Medical Division, C.R. Bard, Inc. All-Silicone Foley Catheter Premarket Notification [510(k)]
Indications for Use Statement 1.3
510(k) Number (if known): _ K040504
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Bardex®, Lubri-Sil® and Lubri-Sil® I.C. All-Silicone Foley Catheters are indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.
(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)
David R. Lynn
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number