(210 days)
Not Found
No
The description focuses on the mechanical design features of the catheter and its function for continuous urine drainage, with no mention of AI or ML.
Yes
The device is indicated for continuous urine drainage, which is a medical intervention used to manage a health condition (urinary issues).
No
The device is indicated for continuous urine drainage, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an indwelling urinary catheter with physical design features for urine flow and retention, indicating it is a hardware device.
Based on the provided information, the ContiDrain™ Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "continuous urine drainage." This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description clearly states its function is to drain urine from the bladder, similar to a conventional Foley catheter.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze urine or any other biological sample for diagnostic purposes. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The anatomical sites (bladder, urethra, meatus) are involved in the collection and drainage of urine, not in the analysis of a sample.
The ContiDrain™ Catheter is a medical device used for a physiological function (drainage), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ContiDrain™ Catheter is indicated for continuous urine drainage.
Product codes
78 EZL
Device Description
The ContiDrain™ Catheter is an indwelling urinary catheter with the same indication for use and function as a conventional Foley catheter. Like a Foley catheter, the ContiDrain™ Catheter is indicated for continuous urine drainage. Both devices use a tubular catheter to pass urine from the bladder through the urethra and meatus into a urinary drainage bag. Both devices also have a mechanism for retention in the bladder. The ContiDrain™ Catheter has two design features that are different from the conventional Foley catheter. The ContiDrain™ Catheter incorporates two design features found in conventional ureteral stents. These features involve the methods of urine flow and of retention in the bladder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The ContiDrain™ Catheter Feasibility Study protocol has been cleared as a non-significant risk clinical study by the FDA and by three IRB-centers with three investigators. The feasibility study, lasting less than 15 minutes per patient, evaluated how well the healthcare professional can insert and remove the 16 Fr catheter and if the catheter will remain in place during the evaluation period. Nine adult male patients in three centers presenting with either an indwelling Foley catheter or at the urodynamic lab for routine evaluation were enrolled. Data from these centers indicate that retention is adequate when the catheter is properly secured. Furthermore, the healthcare professionals have reported satisfactory insertion and removal, with generally favorable acceptance from the patients. Urine drainage was evaluated in one patient and found to be good.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
K964757 Questions and Responses
June 19, 1997
K964757 1-11
510(k) Summary
SUBMITTER:
ContiMed. Inc. 7680 Golden Triangle Drive Eden Prairie, MN 55344 612-829-4057
JUN 2 5 1997
DATE SUMMARY PREPARED: 06-19-97
| TRADE NAME: | ContiDrain™ Catheter & Accessories |
|---|---|
| COMMON NAME: | Urological catheter |
SUBSTANTIALLY EQUIVALENT TO: The ContiDrain™ Catheter is substantially equivalent to the Folev catheter indications for use. The ContiDrain™ Catheter is substantially equivalent to the technological characteristics for retention to the Bard Figure Four Ureteral Stent and pigtail ureteral stents (K861478). The ContiDrain™ Catheter employs the same type of open-sided flow channels as are found in the Tower peripheral stent. The ContiDrain™ Catheter is substantially equivalent to the materials of the Bard Polyurethane (Flexible tip) Ureteral Catheters (K950300).
DESCRIPTION OF THE DEVICE: The ContiDrain™ Catheter is an indwelling urinary catheter with the same indication for use and function as a conventional Foley catheter. Like a Foley catheter, the ContiDrain™ Catheter is indicated for continuous urine drainage. Both devices use a tubular catheter to pass urine from the bladder through the urethra and meatus into a urinary drainage bag. Both devices also have a mechanism for retention in the bladder. The ContiDrain™ Catheter has two design features that are different from the conventional Foley catheter. The ContiDrain™ Catheter incorporates two design features found in conventional ureteral stents. These features involve the methods of urine flow and of retention in the bladder.
INDICATIONS FOR USE: The ContiDrain™ Catheter is indicated for continuous urine drainage.
SUPPORTING INFORMATION:
BENCH TESTING: Flow and retention bench testing that has been conducted according to (modified) methods and fixtures described in the Foley and stent (draft) ASTM methods.
CLINICAL EVALUATION: The ContiDrain™ Catheter Feasibility Study protocol has been cleared as a non-significant risk clinical study by the FDA and by three IRB-centers with three investigators. The feasibility study, lasting less than 15 minutes per patient, evaluated how well the healthcare professional can insert and remove the 16 Fr catheter and if the catheter will remain in place during the evaluation period. Nine adult male patients in three centers presenting with either an indwelling Foley catheter or at the urodynamic lab for routine evaluation were enrolled. Data from these centers indicate that retention is adequate when the catheter is properly secured. Furthermore, the healthcare professionals have reported satisfactory insertion and removal, with generally favorable acceptance from the patients. Urine drainage was evaluated in one patient and found to be good.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 1997
Claude Tihon, Ph.D. President ContiMed, Inc. 7680 Golden Triangle Drive Eden Prairie, Minnesota 55344 Re: K964757
ContiDrain™ Catheter . . . . . Dated: April 18, 1997 Received: April 21, 1997 Regulatory class: II 21 CFR §876.5130/Product code: 78 EZL
Dear Dr. Tihon:
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 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, 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements conceming 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 53 I 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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/dsmamain.html".
Sincerely yours,
William Yin, Ph.D.
Lillian Yin, Ph.D Director, Division of Reproducti Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) 1464757
Device Name: ContiDrain™ Catheter by ContiMed, Inc
Indications for Use:
The ContiDrain™ Catheter is indicated for continuous urine drainage.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
OR
Over - The-Counter Use
(Oprtional Format 1-2-96)
Robert R. Ratliff
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K9641257
8