(77 days)
The Bardex® Lubri-Sil™ Foley Catheter 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 a nephrostomy tract.
Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostasis following surgery such as transurethral resection of the prostate.
The Bardex® Lubri-Sil™ Foley Catheter is a two-way all-silicone Foley catheter with a lubricious hydrophilic coating.
The Bard Lubri-Sil Foley Catheter is constructed of high grade extruded clear silicone rubber with a molded tip and funnel. It is a two-lumen catheter with a drainage lumen and an inflation lumen with two-way valve. A hydrophilic polymeric coating is applied to the finished catheter. This coating becomes very slippery when wet. The Lubri-Sil Foley Catheter is available in shaft sizes 8 and 10 Fr. with a 3cc balloon, in even shaft sizes 12-24 Fr. with a 5cc balloon and in even shaft sizes 16-24 Fr. with a 30cc balloon.
The provided text describes the Bardex® Lubri-Sil™ Foley Catheter, its intended use, and performance data, but it does not describe a study involving an AI device or software. Therefore, many of the requested sections about AI-specific criteria, sample sizes for AI models, expert adjudication, or MRMC studies cannot be answered from the provided document as they are not applicable.
The document focuses on the physical and biocompatibility performance of a medical device (a Foley catheter) against established standards and internal criteria.
Here's a breakdown of the information that can be extracted from the provided text, adapted to the questions where possible:
Acceptance Criteria and Device Performance for Bardex® Lubri-Sil™ Foley Catheter
The Bardex® Lubri-Sil™ Foley Catheter is a medical device, not an AI or software device. The acceptance criteria and performance data pertain to its physical and biological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Bard Lubri-Sil Foley Catheter "meets the following performance requirements per testing conducted according to ASTM F 623-89, when appropriate, and/or Bard testing/acceptance criteria." Specific numerical performance results or explicit acceptance thresholds are not provided in the document for each criterion, only that the device "meets" them.
| Acceptance Criterion (Based on ASTM F 623-89 and/or Bard criteria) | Reported Device Performance |
|---|---|
| Flow rate through the drainage lumen | Meets requirements |
| Resistance of the balloon to rupture (7 days at claimed volume) | Meets requirements |
| Resistance of inflated balloon to distortion/pull-through | Meets requirements |
| Maintenance of balloon inflation over extended time | Meets requirements |
| Manufacturing tolerances (tip, balloon, shaft diameters) | Meets requirements |
| Ability of inflated catheter to deflate reliably (within 4 Fr. sizes, incl. deflation time) after 7 days | Meets requirements |
| Coefficient of friction | Meets requirements |
| Shaft tensile strength and tip adherence | Meets requirements |
| Balloon burst | Meets requirements |
| Application of coating has no adverse effect on base material (shaft/balloon) after aging | Meets requirements |
| Biocompatibility per ISO 10993-1 (cytotoxicity, systemic toxicity, mucosal irritation, sensitization, implantation) | Passes testing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for each test conducted for the catheter's physical performance or biocompatibility. The tests are described as "Bard testing/acceptance criteria" and "testing conducted according to ASTM F 623-89" and "biocompatibility testing per ISO 10993-1." The provenance of the data is implicitly internal testing conducted by C. R. Bard, Inc. (USA). The data would be prospective in the sense that the tests were performed to evaluate the manufactured device against specified criteria.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical medical device, not an AI or diagnostic tool requiring expert ground truth for its performance evaluation in the context described. Its performance is evaluated through engineering and biocompatibility tests.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI or diagnostic study, an adjudication method in the sense of resolving conflicting expert opinions is not relevant. Performance is determined by meeting objective engineering and biological test specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic systems where human readers interpret medical images or data. This document describes a physical medical device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For the physical and performance tests (e.g., flow rate, balloon integrity, tensile strength), the "ground truth" would be the objective measurement against established engineering standards (ASTM F 623-89) and internal Bard specifications. For biocompatibility, the "ground truth" is determined by established biological safety standards (ISO 10993-1) for cytotoxicity, systemic toxicity, etc. There is no "expert consensus" or "pathology" in the typical sense for these types of device performance evaluations.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI or machine learning model.
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12/2
C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
FEB 1 1999
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
-
A. Submitter Information:
Submitter's Name: C. R. Bard, Inc., Medical Division Submitter's Address: 8195 Industrial Blvd., Covington, GA 30014 Contact Person's Telephone Number: 770-784-6135 Contact Person's FAX Number 770-784-6419 Date of Preparation: November 12, 1998 -
B. Device Name:
Bardex® Lubri-Sil™ Foley Catheter -
C. Predicate Device Name:
Bardex® All-Silicone Foley Catheter Bardex® Lubricath® Foley Catheter -
D. Device Description
The Bardex® Lubri-Sil™ Foley Catheter is a two-way all-silicone Foley catheter with a lubricious hydrophilic coating. -
E. Intended Use:
The Bardex® Lubri-Sil™ Foley Catheter 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 a nephrostomy tract.
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984084
212
Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostasis following surgery such as transurethral resection of the prostate.
-
F. Technological Characteristics Summary:
The Bard Lubri-Sil Foley Catheter is constructed of high grade extruded clear silicone rubber with a molded tip and funnel. It is a two-lumen catheter with a drainage lumen and an inflation lumen with two-way valve. A hydrophilic polymeric coating is applied to the finished catheter. This coating becomes very slippery when wet. The Lubri-Sil Foley Catheter is available in shaft sizes 8 and 10 Fr. with a 3cc balloon, in even shaft sizes 12-24 Fr. with a 5cc balloon and in even shaft sizes 16-24 Fr. with a 30cc balloon. -
G. Performance Data:
The Bard Lubri-Sil Foley Catheter meets the following performance requirements per testing conducted according to ASTM F 623-89, when appropriate, and/or Bard testing/acceptance criteria: -
flow rate through the drainage lumen;
-
resistance of the balloon to rupture when inflated to the claimed ● balloon volume and held under conditions approximating the usage environment for a period of seven days;
-
resistance of the inflated balloon to being distorted and pulled through the bladder outlet;
-
maintenance of balloon inflation to fill volume over an extended time;
-
manufacturing tolerances for catheter tip, balloon and shaft diameters;
-
ability of an inflated catheter that has been submerged for seven ● days to deflate reliably to within 4 Fr. sizes of the labeled shaft size, as applicable, including the time for such deflation;
-
coefficient of friction;
-
. shaft tensile strength and tip adherence;
-
balloon burst.
Testing on aged product indicates that application of the coating has no adverse effect on the base material of the shaft or balloon.
The Lubri-Sil Foley Catheter passes biocompatibility testing per ISO 10993-1 (cytotoxicity, systemic toxicity, mucosal irritation, sensitization and implantation.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right, suggesting a sense of community and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1999 FEB
Ms. Donna J. Wilson Director, Regulatory Affairs C. R. Bard, Inc. 8195 Industrial Blvd. Covington, Georgia 30209
Re: K984084
Bardex® Lubri-Sil™ (2-way Silicone) Foley Catheter (with hydrogel) and Tray Regulatory Class: II 21 CFR 876.5130/Product Code: 78 EZL Dated: November 12, 1998 Received: November 16, 1998
Dear Ms. Wilson:
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 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the tray have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Donna J. Wilson
In addition, we have determined that your device kit contains Povidone-Iodine which is subject to regulation as a drug.
Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D.
CAPT. Daniel G. Schultz, M.D. Acting Director Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Bardex® Lubri-Sil™ Foley Catheter
Indications For Use: The Bardex® Lubri-Sil™ Foley Catheter 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 a nephrostomy tract.
Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostasis 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 (Per 21 CFR 801.109)
Over-The Counter Use_
(Optional Format 1-2-96)
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
§ 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.