(201 days)
The Bardex® I.C. latex Foley catheter is indicated for use in the drainage and/or collection, the The Dardes .. Online. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes calleter through the "drethra" and "into" the "bladen" "Hower, such as nephrostomy tract.
The Bard® Bardex® I.C. latex Foley catheter is a two-way Foley catheter which is placed in the bladder through the urethra. The balloon on the distal end of the catheter is inflated with sterile water after insertion and used to secure the catheter in place and ensure that the opening in the distal tip of the catheter is positioned correctly to allow for urine drainage. The urine drains out through the catheter into a collection device attached to the catheter.
The provided 510(k) summary for the Bardex® I.C. Latex Foley Catheter focuses on substantial equivalence to a predicate device based on its intended use, general design, and fundamental scientific technology. It does not present a study with specific acceptance criteria and detailed device performance metrics in the manner typically associated with studies for a medical imaging AI/ML device.
Instead, the submission states:
1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document mentions "The Bardex® IC latex Foley catheter was tested in accordance with the relevant standards for function and biocompatibility." but does not elaborate on these standards, acceptance criteria, or specific performance outcomes.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no such test set or study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no ground truth establishment for a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device for drainage/collection, not an AI/ML imaging device requiring human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) pertains to a physical medical device (Foley catheter) and its clearance is based on demonstrating substantial equivalence to a predicate device through adherence to relevant standards for "function and biocompatibility." It does not involve the type of performance study (with acceptance criteria, test sets, ground truth establishment, etc.) that would be conducted for an AI/ML diagnostic or prognostic device.
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SEP 2 9 2004
Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be outlined in black. The overall impression is a strong, simple, and easily readable logo or wordmark.
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.
| Submitter's Name: | C. R. Bard, Inc., Medical Division |
|---|---|
| Address: | 8195 Industrial Blvd.Covington, GA 30014 |
John C. Knorpp Contact Person: Contact Person's Telephone Number: 770-784-6451 770-784-6419 Contact Person's Fax: March 11, 2004 Date of Preparation:
B. DEVICE NAME:
Trade Names: Common / Usual Name: Classification Names:
Bardex® I.C. Latex Foley Catheter Foley Catheter Catheter, Urological (Antimicrobial) and Accessories 21 CFR 876.5130
C. PREDICATE DEVICE NAME:
Bardex® I.C. Latex Foley Catheter Trade Names:
D. Device Description:
The Bard® Bardex® I.C. latex Foley catheter is a two-way Foley catheter which is placed in the bladder through the urethra. The balloon on the distal end of the catheter is inflated with sterile water after insertion and used to secure the catheter in place and ensure that the opening in the distal tip of the catheter is positioned correctly to allow for urine drainage. The urine drains out through the catheter into a collection device attached to the catheter.
E. INTENDED USE:
The Bardex® I.C. latex Foley catheter is intended for use in the drainage and/or collection and/or measurement of urine.
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TECHNOLOGICAL CHARACTERISTICS SUMMARY: F.
The Bardex® IC latex Foley catheter is constructed of natural latex rubber. It has the same intended use, general design and fundamental scientific technology as the predicate devices.
Performance Data Summary: G.
The Bardex® IC latex Foley catheter was tested in accordance with the relevant standards for function and biocompatibility.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 2004
Mr. John C. Knorpp Sr. Regulatory Affairs Specialist Bard Medical & Urological Divisions C. R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014-2655
Re: K040658
Trade/Device Name: Bardex® I.C. Latex Foley Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 MJC Dated: September 14, 2004 Received: September 16, 2004
Dear Mr. Knorpp:
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 r ou may) dieres very mains 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 (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 or any I 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will allow you to ocgin marteanig your antial equivalence of your device to a legally premarket notification. The PDA mading or case of the mail 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 If you desire specific advice to your dones on the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on also, please note the regulation entitled, "Misbranding Other of Compliance at (301) 37 + 1059. Part 807.97) you may obtain. Other general by reference to premation (Dr. B. B. B. B. B. B. B. Act may be obtained from the Division of Small information on your responsionalities and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Collisanter - Lancerner - Santament - San - San - San - San - San - San - San - San - San -
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
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Bard Medical Division, C.R. Bard, Inc. Bardex® I.C. Latex Foley Catheter Premarket Notification [510(k)]
Indications for Use Statement 1.3
040650 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ____Bardex® 1.C. Latex Foley Catheter
Indications for Use:
The Bardex® I.C. latex Foley catheter is indicated for use in the drainage and/or collection, the The Dardes .. Online. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes calleter through the "drethra" and "into" the "bladen" "Hower, such as 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)
David A. Lizman
510k) Nu
§ 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.