(132 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a standard Foley catheter, with no mention of AI or ML.
No.
The device is intended for the drainage and measurement of urine, which is a diagnostic and supportive function rather than a therapeutic one aiming to treat a disease or condition.
No
The device is described as being used for the drainage and/or measurement of urine, which are functions related to treatment or monitoring, not diagnosis.
No
The device description clearly outlines a physical medical device (Foley catheter) with hardware components (shaft, eyelets, balloon, lumens, valve, cap). It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Bard LubriGuard Foley Catheter is used for the drainage and/or measurement of urine directly from the bladder. It is inserted into the body and its function is to physically remove urine, not to analyze it for diagnostic purposes.
- Intended Use: The intended use clearly states "drainage and/or measurement of urine," which is a therapeutic and monitoring function, not a diagnostic one.
- Device Description: The description focuses on the physical components and how they facilitate drainage and retention within the bladder. There is no mention of analyzing the urine itself.
Therefore, based on the provided information, the Bard LubriGuard Foley Catheter is a medical device used for drainage and measurement, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Bard LubriGuard Foley Catheter is intended for use in the drainage and/or measurement of urine. Drainage is accomplished by inserting the catheter through the urethra and into the bladder.
The Bard LubriGuard Foley Catheter is intended for use in the drainage and/or collection and/or measurement of urine. Drainage is accomplished by inserting the catheter through the urethra and into the bladder.
Product codes (comma separated list FDA assigned to the subject device)
EZL
Device Description
The LubriGuard Foley Catheter is a biocompatible, hydrogel-coated, synthetic polyisoprene Foley catheter used in the drainage of urine. The catheter consists of a shaft with eyelets near the tip, balloon, drainage funnel and inflation arm with cap and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. The balloon once inflated retains the catheter within the bladder. There are two lumens: one for urine drainage and the second for balloon inflation. The two-way valve, upon activation, permits flow in either direction and allows for inflation and deflation of the balloon. The cap retains the valve and provides identification for the catheter.
The catheter will be offered in multiple French sizes to accommodate differing patient anatomies. The product is ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products – ethylene oxide – Requirements for development, validation and routine control of a sterilized process for medical devices). The catheter is for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra and into the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical functional performance testing was performed per ASTM F623-99 (2006), Standard Performance Specification for Foley Catheter and Coefficient of Friction testing. Nonclinical biocompatibility testing was conducted in accordance with ISO 10993-1:2009/(R)2013, Bioloqical evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing.".
The subject device is substantially equivalent to the predicate device and nonclinical test data demonstrates that the subject device is safe and effective.
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.
Bard Hydrogel-Coated Foley Catheters, K910195
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol representing the human form, composed of three abstract figures facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2015
C.R. Bard, Inc. Michele Davis Regulatory Affairs Project Manager Bard Medical Division 8195 Industrial Blvd Covington, GA 30014
Re: K150699
Trade/Device Name: Bard LubriGuard Foley Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: June 19, 2015 Received: June 22, 2015
Dear Michele Davis,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Bard LubriGuard Foley Catheter
Indications for Use (Describe)
The Bard LubriGuard Foley Catheter is intended for use in the drainage and/or measurement of urine. Drainage is accomplished by inserting the catheter through the urethra and into the bladder.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ( Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
Bard Medical Division C.R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
Image /page/3/Picture/3 description: The image shows the logo for Bard Medical. The logo is in green and consists of the word "BARD" in a bold, sans-serif font, followed by a vertical line and the word "MEDICAL" in a similar font. The logo is simple and modern, and the green color suggests a connection to health and nature.
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Bard LubriGuard Foley Catheter 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | BARD Medical Division
C. R. BARD, Inc.
8195 Industrial Blvd.
Covington, GA 30014
Establishment Registration Number: 1018233 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michele Davis, RAC
Regulatory Affairs Project Manager
Bard Medical Division
Tel: 770-784-6274
Fax: 770-385-4706 |
| Date: | March 17, 2015 |
| Subject Device: | Trade Name: Bard® LubriGuard™ Foley Catheter
Common Name: Urological Catheter
Classification Name: Urological catheter and accessories
Regulation: 21 CFR 876.5130
Classification: II
Product Code: EZL |
Legally marketed device to which substantial equivalence is claimed:
- Bard Hydrogel-Coated Foley Catheters, K910195
Device Description
The LubriGuard Foley Catheter is a biocompatible, hydrogel-coated, synthetic polyisoprene Foley catheter used in the drainage of urine. The catheter consists of a shaft with eyelets near the tip, balloon, drainage funnel and inflation arm with cap and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. The balloon once inflated retains the catheter within the bladder. There are two lumens: one for urine drainage and the second for balloon inflation. The two-way valve, upon activation, permits flow in either direction and allows for inflation and deflation of the balloon. The cap retains the valve and provides identification for the catheter.
4
The catheter will be offered in multiple French sizes to accommodate differing patient anatomies. The product is ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products – ethylene oxide – Requirements for development, validation and routine control of a sterilized process for medical devices). The catheter is for single use.
Indications for Use
The Bard LubriGuard Foley Catheter is intended for use in the drainage and/or collection and/or measurement of urine. Drainage is accomplished by inserting the catheter through the urethra and into the bladder.
Technological Characteristics
The Bard LubriGuard Foley Catheter has similar technological characteristics as the predicate device. The subject device is manufactured from synthetic polyisoprene which has similar properties as the predicate device that is manufactured from natural rubber latex. Both the subject and predicate device are hydrogel-coated.
Performance Data
Nonclinical functional performance testing was performed per ASTM F623-99 (2006), Standard Performance Specification for Foley Catheter and Coefficient of Friction testing. Nonclinical biocompatibility testing was conducted in accordance with ISO 10993-1:2009/(R)2013, Bioloqical evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing.".
Substantial Equivalence
The Bard LubriGuard Foley Catheter has similar design features and indications for use as the predicate device, Bard Hydrogel-Coated Foley Catheters, K910195. The subject device is substantially equivalent to the predicate device and nonclinical test data demonstrates that the subject device is safe and effective.