(283 days)
Not Found
No
The device description and intended use describe a standard mechanical Foley catheter for drainage and irrigation, with no mention of AI or ML capabilities. The performance studies reference established standards for conventional catheters.
Yes
The device is indicated for drainage/collection/measurement of urine and assisting in hemostasis, which are medical treatments or procedures.
No
This device, a Foley catheter, is indicated for the drainage, collection, and measurement of urine, and for assisting in hemostasis. These are therapeutic and measurement functions, not diagnostic ones. There is no mention of it being used to identify or analyze a medical condition.
No
The device description clearly outlines physical components like a silicone tube, balloon, and valve, indicating it is a hardware device.
Based on the provided text, 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 is a direct interaction with the patient's body for a physiological purpose (removing fluid).
- Device Description: The description details a physical catheter designed for insertion into the body to facilitate drainage and irrigation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. This device does not perform any analysis or testing of the urine itself; it simply collects and drains it.
Therefore, the Bardex® Lubri-Sil® All-Silicone Foley Catheter is a medical device used for patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bardex® Lubri-Sil® 3-Way Foley Catheter, and the Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter 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 a nephrostomy tract.
Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostatis following surgery such as transurethral resection of the prostate.
Product codes (comma separated list FDA assigned to the subject device)
EZL, MJC
Device Description
The subject device three-way Foley catheter is composed of a trifurcated silicone tube, a silicone balloon and a two-way valve (a valve that upon activation permits flow in either of two directions, i.e., for inflation of the balloon). The three-way designation of the catheter refers to the number of lumens in the catheter tubing. The tube has three lumens, one lumen for urinary drainage which is to be connected to a urine collection container (drainage bag or urine meter), one lumen with a two-way valve for inflation/deflation of the Foley balloon, and one lumen for irrigation of the bladder. Catheters with either a 5cc or 30cc balloon will be available with 16 through 24 Fr. shafts (i.e., 16, 18, 20, 22, and 24).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Bardex® Lubri-Sil® 3-Way Foley Catheter and Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter referenced in this submission are held to the same design, manufacture, and performance specifications as the predicate (#K002868). Performance and functional testing standards are based on the FDA "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" dated September 12, 1994. ISO 10993-1, "Biological Evaluation of Medical Devices," and ASTM F623-99, "Standard Performance Specification for Foley Catheter."
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.
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
SECTION 5 BARDEX® LUBRI-SIL® 3-WAY FOLEY CATHETER AND BARDEX® LUBRI-SIL® I.C. 3-WAY FOLEY CATHETER 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.
JEC 77 2007
| Submitter's Name | C.R. Bard, Inc.
Bard Medical Division
8195 Industrial Blvd.
Covington, GA 30014 |
|------------------------------------|------------------------------------------------------------------------------------------|
| Contact Person: | Skip Rimer |
| Contact Person's Telephone Number: | 770-784-6160 |
B. DEVICE NAME:
Contact Person's Fax: Date of Preparation:
| Trade Name(s): | Bardex® Lubri-Sil® 3-Way Foley Catheter,
Bardex® Lubri-Sil® I.C. Foley Catheter |
|------------------------------|------------------------------------------------------------------------------------|
| Common/Usual Name: | Urological Foley catheter |
| Classification Product Code: | EZL - Catheter, Retention Type, Balloon
21 CFR 876.5130 |
| Subsequent Product Code: | MJC - Catheter, Urological (Antimicrobial) and
Accessories
21 CFR 876.5130 |
770-784-6419
August 16, 2007
C. PREDICATE DEVICE NAME:
Trade Name(s): Bard® Lubri-Sil™ 3-Way Foley Catheter, Bard® Lubri-Sil™ I.C. 3-Way Foley Catheter
D. DEVICE DESCRIPTION:
The subject device three-way Foley catheter is composed of a trifurcated silicone tube, a silicone balloon and a two-way valve (a valve that upon activation permits flow in either of two directions, i.e., for inflation of the balloon). The three-way designation of the catheter refers to the number of lumens in the catheter tubing. The tube has three lumens, one lumen for urinary drainage which is to be connected to a urine collection container (drainage bag or urine meter), one lumen with a two-way valve for inflation/deflation of the Foley balloon, and one lumen for irrigation of the bladder. Catheters with either a 5cc or 30cc balloon will be available with 16 through 24 Fr. shafts (i.e., 16, 18, 20, 22, and 24).
1
SECTION 5 BARDEX® LUBRI-SIL® 3-WAY FOLEY CATHETER AND BARDEX® LUBRI-SIL® I.C. 3-WAY FOLEY CATHETER 510(K) SUMMARY OF SAFETY AND EFFECTIVENSS INFORMATION
E. INTENDED USE:
Bardex® Lubri-Sil® 3-Way Foley Catheter, and the Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter 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 a nephrostomy tract.
Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostatis following surgery such as transurethral resection of the prostate.
F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:
The subject devices, Bardex® Lubri-Sil® 3-Way Foley Catheter and Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter, have the same intended use, design and fundamental scientific technology as the predicate devices.
F. PERFORMANCE DATA SUMMARY:
The Bardex® Lubri-Sil® 3-Way Foley Catheter and Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter referenced in this submission are held to the same design, manufacture, and performance specifications as the predicate (#K002868). Performance and functional testing standards are based on the FDA "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" dated September 12, 1994. ISO 10993-1, "Biological Evaluation of Medical Devices," and ASTM F623-99, "Standard Performance Specification for Foley Catheter."
,上海
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized graphic of three human figures in profile, with flowing lines representing movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC -7 2007
C.R. Bard, Inc. % Mr. Robert Mosenkis President Citech 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K070558
Trade/Device Name: Bardex® Lubri-Sil® 3-wav Foley Catheter, Bardex® Lubri-Sil® I.C. Foley Catheter
Regulation Number: 21 CFR 876.5130
Regulation Name: Urological catheter and accessories
Regulatory Class: II
Product Code: EZL
Dated: November 20, 2007
Received: November 21, 2007
Dear Mr. Mosenkis:
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 (MA), 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, isting 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 such 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 Registed.
3
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
SECTION 4 BARDEX® ALL-SILICONE 3-WAY IRRIGATON FOLEY CATHETER INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K070558
Device Name: Bardex® Lubri-Sil® All-Silicone Foley Catheter, and Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter
Indications for Use:
The Bardex® Lubri-Sil® All-Silicone Foley Catheter, and the Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 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 a nephrostomy tract.
Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostatis following surgery 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)
OR
Prescription Use ﮯ۔ (Per 21 CFR 801.109) Over-The-Counter Use __
Nancy C brogdon
(Division (Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
(Optional Format 1/2/96)
Page 4-1