(15 days)
No
The device description and performance studies focus on the physical properties and function of a Foley catheter, with no mention of AI or ML.
No
A therapeutic device is one that treats a disease or condition. This device is for drainage and collection of urine, which is a supportive function, not a treatment.
No
The device is a Foley catheter used for the drainage, collection, or measurement of urine, which are therapeutic and monitoring functions, not diagnostic ones.
No
The device description clearly identifies the product as a physical Foley catheter, which is a hardware medical device. There is no mention of software as the primary or sole component.
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 is a direct interaction with the patient's body for a physiological purpose (drainage and collection), not for testing a sample in vitro (outside the body).
- Device Description: The description details a catheter, which is a device inserted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to collect the specimen from the body, not to analyze it.
N/A
Intended Use / Indications for Use
The Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr is 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
EZL
Device Description
The Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr is a single use, sterile, 2-way, latex-free, hydrogel-coated Foley catheter and represents a product line extension to the current Bard Medical Division product line range of silicone Foley catheters found substantially equivalent in K984084 and K002868.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder
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 new device was tested to meet C.R. Bard Inc. dimensional requirements, coefficient of friction test and ASTM F623-99 Standard Performance Specification for Foley Catheter for flow rate, balloon integrity, inflated balloon response to pull out, balloon volume maintenance, balloon and shaft size, and balloon deflation reliability. Biocompatibility testing has also been performed successfully. Additional testing established by C.R. Bard Inc. for a silicone-coated pediatric catheter are also provided within this 510(k).
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.
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5.0 510(k) Summary of Safety and Effectiveness
MAR 0 9 2007
| Product : | Bardex® Lubri-Sil® All-Silicone Lubricious
Coated Foley Catheter 6 Fr |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparer/Contact | Michelle Gudith
Senior Regulatory Affairs Manager
Bard Medical Division
C.R. Bard Inc.
8195 Industrial Blvd.
Covington, Georgia 30014 USA
Phone (770) 784-6722, Fax (770) 784-6722
E-mail michelle.gudith(@crbard.com |
| Manufacturer | C.R. Bard Inc. |
| Date summary was prepared: | January 03, 2007 |
| Name(s) of the device: | Bardex® Lubri-Sil® All-Silicone Lubricious
Coated Foley Catheter 6 Fr |
| Identification of predicate device(s): | Rochester Medical Silicone Hydrophilic Coated
Foley Catheter
Bardex® All-Silicone Lubri-Sil® Lubricious
Coated Foley Catheter, 2 and 3-way.
Bardex® Lubri-Sil® I.C. All-Silicone Lubricious
Coated Foley Catheter, 3-way. |
5.1 ESTABLISHMENT REGISTRATION NUMBER
Owner/Operator: C.R. Bard Inc.
C.R. Bard Manufacturing Locations:
The device will be lubricious-coated at Moncks Corner, South Carolina, USA, Establishment Registration Number, 1030583.
Device packaging will occur at the Nogales, Sonora, Mexico, Establishment Registration Number, 9611950.
The device will be sterilized/distributed Covington, Georgia, USA, Establishment Registration Number, 1018223.
1
Qualified Suppliers/Contract Manufacturers:
Uncoated catheters will be extruded and assembled at Degania Silicone, Ltd. in Tel Aviv, Israel. Registration Number, 8030107.
5.2 OFFICIAL CORRESPONDENT
Michelle Gudith Senior Manager, Regulatory Affairs Bard Medical Division C.R. Bard Inc. 8195 Industrial Blvd. Covington, Georgia 30014 USA Phone (770) 784-6722, E-mail michelle.gudith(@crbard.com
5.3 CLASSIFICATION
21 CFR 876.5130 Regulation Name: Urological Catheter Regulatory Class: Class II Product Code: EZL
5.4 CLASSIFICATION NAME
Urological Catheter/Catheter, Retention Type, Balloon
5.5 COMMON OR USUAL NAMES
Urological Foley Catheter
5.6 PROPRIETARY NAME
Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr
5.7 INTENDED USE
The Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr is 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.
Confidential
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NOLLOHS
BOTCHIS
BOTON
ECTON
5.8 PREDICATE DEVICES
| K000723 - | Rochester Medical Silicone Hydrophilic coated Foley catheters |
|---|---|
| K984084 - | Bardex® All-Silicone Lubri-Sil® Lubricious coated Foley catheter, 2- |
| way. | |
| K002868 - | Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley catheter, 3- |
| way. | |
| Bardex® Lubri-Sil® I.C. All-Silicone Lubricious Coated Foley cathete | |
| 3-way. |
5.9 DESCRIPTION OF THE DEVICE:
Intended Use:
The Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr is 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.
Device Description
The Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr is a single use, sterile, 2-way, latex-free, hydrogel-coated Foley catheter and represents a product line extension to the current Bard Medical Division product line range of silicone Foley catheters found substantially equivalent in K984084 and K002868.
Technological Characteristics
The catheters described in this 510(k) have similar technological and performance characteristics to the predicate devices. The catheters are manufactured from silicone and have a lubricious/hydrophilic coating, just as the predicate devices from C.R. Bard Inc. and Rochester Medical.
3
Evaluation of Substantial Equivalence:
The device is a line extension of the C.R. Bard Foley Catheter product line of lubricious-coated silicone catheters. The 6 Fr size adds another pediatric size in addition to the 8 and 10 Fr sizes currently commercially available. In addition, Rochester Medical's 510(k) includes a 6 Fr size made of silicone with a hydrophilic coating.
The new device was tested to meet C.R. Bard Inc. dimensional requirements, coefficient of friction test and ASTM F623-99 Standard Performance Specification for Foley Catheter for flow rate, balloon integrity, inflated balloon response to pull out, balloon volume maintenance, balloon and shaft size, and balloon deflation reliability. Biocompatibility testing has also been performed successfully. Additional testing established by C.R. Bard Inc. for a silicone-coated pediatric catheter are also provided within this 510(k).
Conclusion
The proposed Barde - Lubri-Sil® All-Silicone Lubricious coated Foley Catheter 6 Fr is substantially equivalent to commercially available devices.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its head, body, and feet. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR 0 9 2007
C. R. Bard, Inc. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K070508
Trade/Device Name: Bardex® Lubri-Sile All-Silicone Lubricious Coated Foley Catherer 6 Fr Regulation Number: 21 CFRT §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: February 21, 2007 Received: February 22, 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 (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 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/4/Picture/10 description: The image shows a logo with the text "1906-2006 FDA Centennial" in a circular design. There are three stars below the word Centennial. The text "Protecting and Promoting Public Health" is written in a decorative font below the logo.
5
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 (OS) 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 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) | 240-276-011 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-011 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-012 |
| Other | 240-276-010 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
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
6
Indications for Use Statement
510(k) Number (if known): Unknown K070508
Device Name: Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr
Indications for Use: The Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr is 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.
AND/OR Prescription Use: (21 CFR 801 Subpart D)
Over-the-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Segarra
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070508
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C.R. Bard, Inc.
Confidential
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