(63 days)
No
The document describes a standard Foley catheter and its variations. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is a catheter used for bladder drainage and irrigation, which are procedures for managing physiological functions rather than active treatment of a disease or condition in a therapeutic sense.
No
The device is described as a two-way or three-way catheter for bladder drainage and irrigation, with an optional radiopaque substance for radiographic visualization to aid in placement. Its intended use is described for urological use only. None of these functions involve diagnosing a condition or disease.
No
The device description clearly details a physical catheter with lumens, eyes, and balloon capacities, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Urethral catheterization for bladder drainage" and "bladder irrigation." These are direct interventions on the body for therapeutic or diagnostic purposes (in the case of drainage for analysis, but the device itself isn't performing the analysis).
- Device Description: The description details a physical catheter designed to be inserted into the body.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such analysis on specimens.
The device is a medical device, specifically a catheter, used for direct patient care.
N/A
Intended Use / Indications for Use
Two-Way Catheter: Urethral catheterization for bladder drainage.
Three -Way Catheter: Urethral catheterization for bladder drainage and bladder irrigation.
Radiopaque Catheter:
Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization.
INTENDED USE For urological use only.
Product codes
78 EZL
Device Description
The catherer consists of a double or triple lumen drainage eye on the proximal tip. The threeway cather has an additional eye for irrigation purposes. The two-way catheter is available with a radiopaque option. The catherer is available in a combination of French sizes, balloon capacties and lengths to accommodate pediative and adult male and female applications. Available catheter lengths range from 10.6 to 15.8, French sizes from 6 to 26 and balloon sizes 1.5cc to 30cc.
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
pediative and adult
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
Test results indicate that the Rochester Medical Corocration All Silicone Foley catherers meet the requirements of ASTM F 623-89 Standard Specifications for Foley Catheters with the exception of requirements 5.3 and 5.5 regarding catheter tip and shaft diameters. These exceptions are due to the proprietary manufacturing process that allows Rochester Medical to manufacture catheters with balloons that are incorporated into the cather than being applied during a secondary operation, the tip diameter is equivalent to the balloon diameter which complies with therefore is not considered clinically significant. Biocompatibility testing was completed on catherer samples including tests for: CCytotoxicity, Systemic Toxicity, Intractaneous Reactivity, Muscle Implantation with Histopathology, Sensitization and Irlritation. Results were acceptable for all tests.
Key Metrics
Not Found
Predicate Device(s)
K896053, Rusch Foley Catheters, Bard Urological Inc. Foley Catheters
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
Image /page/0/Picture/0 description: The image shows the logo for Rochester Medical. The logo includes a circle with a check mark through it, and the words "Rochester" and "MEDICAL" in bold letters. The image also includes the date "JUL - 8 1998" at the top. The logo is black and white.
K481612
P171
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION 14.0
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92,
| Submitter and Contact Person: | Mary M. Wilen
Rochester Medical Corporation |
|-------------------------------|-----------------------------------------------------------------------------|
| Name of the Device: | Classification Name: Urological Catheter |
| | Common/Usual Name: All Silicone Foley Catheter |
| | Proprietary Name: Rochester Medical Corporation All Silicone Foley Catheter |
| | ➤ Two-Way Foley Catheter |
| | ➤ Three-Way Foley Catheter |
| | ➤ Two-Way Radiopaque Foley Catheter |
Predicate Device
The predicate device for purposes of substantial equivalence is the Rochester Medical Corporation All Silicone Folcy Catheter which receive matketing approval under K896053, Rusch Foley Catheters, and Bard Urological Inc. Foley Catheters.
Intended Use of the Device
For urological use only.
Device Description
The catherer consists of a double or triple lumen drainage eye on the proximal tip. The threeway cather has an additional eye for irrigation purposes. The two-way catheter is available with a radiopaque option. The catherer is available in a combination of French sizes, balloon capacties and lengths to accommodate pediative and adult male and female applications. Available catheter lengths range from 10.6 to 15.8, French sizes from 6 to 26 and balloon sizes 1.5cc to 30cc.
Technological Characteristics
The catheter described in the 510(k) has similar technological and performance characteristics to the predicate devices. The cather is manufactured entirely from silicone elassomer. The predicate devices are manufactured from silicone elastomer, latex, rubber and red rubber. The device is supplied in French sizes ranging from 6 to 26 and balloon capacities 1.5cc to 30cc. The predicate devices are available in French sizes from 6 to 26 and balloon capacities 1.5cc to 75cc. The device is supplied in pediatric, male and female lengths. The predicate devices are supplied in pediative, male and female lengths. All of the devices are supplied sterile for single use.
Testing and Results
Test results indicate that the Rochester Medical Corocration All Silicone Foley catherers meet the requirements of ASTM F 623-89 Standard Specifications for Foley Catheters with the exception of requirements 5.3 and 5.5 regarding catheter tip and shaft diameters. These exceptions are due to the proprietary manufacturing process that allows Rochester Medical to manufacture catheters with balloons that are incorporated into the cather than being applied during a secondary operation, the tip diameter is equivalent to the balloon diameter which complies with therefore is not considered clinically significant. Biocompatibility testing was completed on catherer samples including tests for: CCytotoxicity, Systemic Toxicity, Intractaneous Reactivity, Muscle Implantation with Histopathology, Sensitization and Irlritation. Results were acceptable for all tests.
Rochester Medical Corporation All Silicone Foley Catheter Section 510(k) Notification 07/07/98
One Rochester Medical Drive Stewartville, MN 55976
Image /page/0/Picture/17 description: The image shows a logo with the text "ISO 9001 CERTIFIED". The text "ISO 9001" is in bold and is placed in the center of the logo. The word "CERTIFIED" is placed below "ISO 9001". The logo is surrounded by a globe-like design.
Tel: (507) 533-9600
Fax: (507) 533-9726
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 1998
Ms. Mary M. Wilen Director of Clinical and Regulatory Affairs Rochester Medical One Rochester Medical Drive Stewartville, Minnesota 55976
Re: K981612
Rochester Medical Corporation All Silicone Foley Catheter Dated: May 1, 1998 Received: May 6, 1998 Regulatory Class: II 21 CFR 876.5130/Procode: 78 EZL
Dear Ms. Wilen:
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 Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (2) 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 regulation may result 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 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) 594-4613. 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/dsmaldsmam.html".
Sincerely yours
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
Page 1 of 1
510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________
Device Name: __All Silicone Two-Way Catheter, All Silicone Three-Way Foley Catheter, & Radiopaque Silicone Foley Catheter Rochester Medical Corporation
Indications for Use:
Two-Way Catheter: Urethral catheterization for bladder drainage.
Three -Way Catheter: Urethral catheterization for bladder drainage and bladder irrigation.
Radiopaque Catheter:
Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization.
INTENDED USE For urological use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Doler R Sathing/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 98 16 510(k) Number _
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter-Use ____________
(Optional Format 1-2-96)