(223 days)
Not Found
No
The device description and performance studies focus on the physical and functional characteristics of a urological catheter, with no mention of AI or ML technologies.
No.
The device is a catheter for urine drainage and irrigation, which manages a condition rather than treating or curing it.
No
The device is described as a urological catheter designed to provide transurethral access for irrigation and urine drainage, which are therapeutic and management functions, not diagnostic ones.
No
The device description clearly states it is a physical catheter made of natural rubber latex with a balloon, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "transurethral access to the obstructed bladder in the male patient for irrigation and urine drainage." This is a direct intervention on the patient's body for therapeutic purposes (drainage and irrigation).
- Device Description: The description confirms it's a "urological catheter" used for "irrigation and urine drainage."
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to analyze blood, urine, tissue, etc., outside of the body.
This device is a therapeutic medical device, specifically a catheter, used for a procedural purpose within the body.
N/A
Intended Use / Indications for Use
The Kendall Coude Foley catherer is a urological catherer designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and uring drainage.
Product codes (comma separated list FDA assigned to the subject device)
78 EZL
Device Description
The Kendall Ultraner Coude Foley Catheter is a sterile, single use unological catheter composed of natural rubber latex with a 5 cc or 30cc balloon and designed with a beat tip to provide transurethral access to an obstructed bladder, for purposes of irrigation and urine drainage. The Coude catheter is exclusively used in the male patient, typically in a hospital secting. The Kendall Ultramer Coude Foley Catheters will be marketed in 12-24 French sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
typically in a hospital secting.
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 resting: Biocompatibility resting was performed on the Kendall cather, following ISO-10993 Biological Evaluation of Medical Devices. The testing found that the Materials used in the Kendall Coude Foley Catheter are biocompatible. Fun. tional/mechanical testing was performed to determine flow rates, balloon integrity, inflated balloon response to traction, balloon volume maintenance, balloon size and shaft size, and deflation reliability. The testing found the Kendall Coude catheter to meet ASTM F623-89 Standard Performance Specifications for Foley Catheters. The testing also verified equivalence to the predicate device.
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.
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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SEP 2 8 1999
P 1 of 2
II. 510(k) SUMMARY
| Submitted by: | The Kendall Company
15 Hampshire Street
Mansfield, MA 02048 |
|----------------------|-------------------------------------------------------------------|
| Contact Person: | Paul W. Evans
(508) 261-8203 |
| Date Prepared: | January 31, 1999 |
| Proprietary Name: | Kendall Ultramer Coude Foley Catheter |
| Common Name: | Coude Foley Catheter |
| Classification Name: | Urological Catheter and accessories (21 CFR §876.5130(h)) |
| Predicate Device: | Bardex Lubricath Coude Foley Catheter
510(k) #K910195 |
Description of the Device:
The Kendall Ultraner Coude Foley Catheter is a sterile, single use unological catheter composed of natural rubber latex with a 5 cc or 30cc balloon and designed with a beat tip to provide transurethral access to an obstructed bladder, for purposes of irrigation and urine drainage. The Coude catheter is exclusively used in the male patient, typically in a hospital secting. The Kendall Ultramer Coude Foley Catheters will be marketed in 12-24 French sizes.
Intended Use of the Device:
The Kendall Coude Foley catherer is a urological catherer designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and uring drainage.
Technological Characteristics:
The Kendall Ultramer Coude Foley Catherer is equivalent to the referenced predicate device in that they are fabricated from similar materials, have the same function, equivalent indications for use, and similar overall design.
Nonclinical resting:
Biocompatibility resting was performed on the Kendall cather, following ISO-10993 Biological Evaluation of Medical Devices. The testing found that the Materials used in the Kendall Coude Foley Catheter are biocompatible.
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K990500
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Fur. tional/mechanical testing was performed to determine flow rates, balloon integrity, inflated balloon response to traction, balloon volume maintenance, balloon size and shaft size, and deflation reliability. The testing found the Kendall Coude catheter to meet ASTM F623-89 Standard Performance Specifications for Foley Catheters. The testing also verified equivalence to the predicate device.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 1999
Mr. Paul W. Evans Director, Regulatory Affairs The Kendall Company 15 Hampshire Street Mansfield, MA 02048
Re: K990500 Kendall Ultramer Coude Foley Catheter Dated: September 9, 1999 Received: September 10, 1999 Regulatory Class: II 21 CFR §876.5130/Procode: 78 EZL
Dear Mr. Evans:
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 (Act). 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, isting 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 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, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in regulatory action. In addition, 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.
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 809,10 for in vitto diagnosic devices), piease 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,
CART Daniel J. Scheidt, 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
3
VII. INDICATIONS FOR USE STATEMENT
K 990500 510(k) Number: Kendall Coude Foley Catheter Device Name: _
Indications for Use: The Kendall Coude Foley Catheter is a urological catheter designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and urine drainage.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRD, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR §801.109) | ✓ |
|---|---|
| OR Over-The Counter Use |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K990500 |
|---|---|
| --------------- | --------- |