(58 days)
The Bardex I. C. Pediatric Foley Catheter is intended 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.
The Bardex I. C. Pediatric Foley Catheter is a two-way latex Foley catheter with silver and hydrogel coatings.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Bardex I.C. Pediatric Foley Catheter), which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies with acceptance criteria.
The "Performance Data Summary" section explicitly states: "The Bardex I.C. Pediatric Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those Foley catheters currently manufactured. Performance and functional testing standards are based on the FDA draft 'Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters'' dated September 12, 1994."
This indicates that the submission relies on adherence to existing standards and specifications, implying that specific, new performance studies with acceptance criteria were not part of this 510(k) filing for demonstrating equivalence to predicate devices. Therefore, I cannot provide the requested information from the given text.
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K993464 Euge 1of2
Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209-2695
DEC I 0 1999
BARID
SECTION VI
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.
A. Submitter's Information:
| Submitter's Name: | C. R. Bard, Inc., Medical Division |
|---|---|
| Address: | 8195 Industrial Blvd.Covington, Georgia 30014 |
| Contact Person: | Georgia C. Abernathy |
| Contact Person's Phone: | (770) 784-6454 |
| Contact Person's Fax: | (770) 784-6419 |
| Date of Preparation: | October 8, 1999 |
B. Device Name:
| Trade Name: | Bardex® I. C. Pediatric Foley Catheter |
|---|---|
| Common / Usual Name: | Latex Pediatric Foley Catheter with lubricious and silver coating |
| Classification Name: | Urological catheter (antimicrobial) and accessories |
C. Predicate Device Names:
| Trade Name: | Bard Hydrogel/Silver-Coated Foley Catheter |
|---|---|
| Trade Name: | Bard Latex Urinary Catheters |
| Trade Name: | Bard Hydrogel-Coated Foley Catheters |
D. Device Description:
The Bardex I. C. Pediatric Foley Catheter is a two-way latex Foley catheter with silver and hydrogel coatings.
E. Intended Use:
The Bardex I. C. Pediatric Foley Catheter is intended 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.
F. Technological Characteristics Summary:
Table VI-1 provides a tabulated comparison summary of the technological characteristics of the Bardex I.C. Pediatric Foley Catheter versus the predicate devices.
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K993464 Page Zixi
| Component/Characteristic | Bardex I. C.Pediatric Foley Catheter(Hydrogel Impregnated) | Bard Hydrogel/Silver-Coated FoleyCatheter | Bard Catheters | Bard Hydrogel-CoatedFoley Catheters | Ultragen |
|---|---|---|---|---|---|
| Indications orIntended Use | The Bardex I. C.Pediatric Foley Catheteris intended for use inthe drainage and/orcollection and/ormeasurement of urine.Generally, drainage isaccomplished byinserting the catheterthrough the urethra andinto the bladder.However, drainage issometimesaccomplished bysuprapubic or otherplacement of thecatheter, such as anephrostomy tract. | The Bard Hydrogel/Silver-Coated FoleyCatheter is intended foruse in the drainageand/or collection and/ormeasurement of urine.Generally, drainage isaccomplished byinserting the catheterthrough the urethra andinto the bladder.However, drainage issometimesaccomplished bysuprapubic or otherplacement of thecatheter, such as anephrostomy tract. | Bard catheters areintended for use in thedrainage and/orcollection and/ormeasurement of urine.Generally, drainage isaccomplished byinserting thecatheter/drain throughthe urethra and into thebladder. However,drainage is sometimesaccomplished bysuprapubic or otherplacement of thecatheter/drain, such as anephrostomy tract. | Bard Hydrogel-CoatedFoley catheters areintended for use indrainage of urine.Generally, drainage isaccomplished byinserting the catheterthrough the urethra andinto the bladder.However, drainage issometimesaccomplished bysuprapubic or otherplacement of thecatheter, such as anephrostomy tract. | Nosubstantialdifference |
| Disposable | Yes | Yes | Yes | Yes | None |
| Sterile | Yes | Yes | Yes | Yes | None |
| Catheter BaseMaterial | latex | latex | latex | latex | None |
| French sizesAvailable** | 8 and 10 Fr. | 12-30 Fr. | Includes 8 and 10 Fr. | Includes 8 and 10 Fr. | Pediatricsizes addedto hydrogel/silver-coatedcatheter line |
| Balloon sizes | 3cc | Smallest is 5cc | Includes 3cc | Includes 3cc | #1 identicalto #3 and #4 |
| Silver CoatingForm | Metallic | Metallic | N/A | N/A | #1 and #2identical |
| LubriciousCoating | Hydrogel hydrophilicpolymer | Hydrogel hydrophilicpolymer | Hydrogel hydrophilicpolymer | Hydrogel hydrophilicpolymer | None |
| CatheterSurfaceHydrogelCoated | From bifurcation to tip,internal and externalincluding balloon | From bifurcation to tip,internal and externalincluding balloon | From bifurcation to tip,internal and externalincluding balloon | From bifurcation to tip,internal and externalincluding balloon | None |
| CatheterSurface SilverCoated | From bifurcation to tip,internal and externalincluding balloon | From bifurcation to tip,internal and externalincluding balloon | N/A | N/A | #1 and #2identical |
Table VI-1
** New feature(s) or a change in this 510(k)
Performance Data Summary: G.
The Bardex I.C. Pediatric Folcy Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those Foley catheters currently manufactured. Performance and functional testing standards are based on the FDA draft "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters'' dated September 12, 1994.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple, using only black and white, which gives it a clean and official appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC I 0 1999
Ms. Georgia C. Abernathy Regulatory Affairs Associate Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
Re: K993464 Bardex® I. C. Pediatric Foley Catheter Dated: October 8, 1999 Received: October 13, 1999 Regulatory Class: II 21 CFR 876.5130/Procode: 78 KOD and MJC
Dear Ms. Abernathy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have have have have have have have have have have have headly vve have reviewed your section 310(i) notifications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactings of the marketed predicate devices marketing in merse phor to high as with the provisions of the provisions of the Medical Device Antendhens, or to device that have both realer market the device, subject to the general control Federal FOOD, DTQ, and Cosment Act (Act (Act include requirements for annual reguirements for annual registration, listing of provisions of the Act. The general obtitled provibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may if your device is classlited (Sec above) into entrel sides in (Special on affecting your device can be found in the Code of be subject to such additional oonly in John Ally equivalent determination assumes compliance with r ederal Regulations, Thic Pr, This 600 to Society System Regulation (GS) for the Current Good Manufacturing Practions) as a that, through periodic QS inspections, the Food and Medical Devices: "Ocheral rogulation" (2) Stssumptions. Failure to comply with the GMP regulation may result in Drug Action (1 DA) will ron) Seen blish further announcements concerning your device in the Federal register. In addition, von may pour 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.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA r ma reter will and you to bogin 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 809.10 for ஸ் with diagnostic devices), please contact the Office of Complance 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, the promotion and advertising 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. 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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SECTION I - D
INDICATIONS FOR USE STATEMENT
5993444 and the same of the same of the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________
Device Name: Bardex® I. C. Pediatric Foley Catheter
Indications for Use:
The Bardex I. C. Pediatric Foley Catheter is intended for use in the drainage is I he Bardex T. C. Pediativ Poloy Catholor and of urine. Generally, drainage is and/or collection and/or measurement of the urethra and into the bladder.
accomplished by inserting the catheter through the or other placement accomplished by inserting the catherer through the around.
However, drainage is sometimes accomplished by suprapubic or other placement frowover, ateming
of the catheter, such as a 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)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K993464 |
|---|---|
| --------------- | --------- |
§ 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.