(114 days)
Not Found
No
The device description and summary do not mention any AI or ML components or functionalities. The device is a standard medical catheter.
No
This device is primarily for drainage and irrigation, which are supportive functions, not directly treating a disease or condition in a therapeutic manner.
No
The device is described as a 3 Way Silicone Foley Balloon Catheter used for continuous bladder irrigation and drainage of urine, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines a physical medical device (catheter) made of silicone and polyvinylchloride, with lumens, a balloon, and a valve. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is a catheter used for draining urine from and irrigating the bladder. This is a direct intervention within the body (in vivo) for therapeutic and management purposes, not for analyzing a sample to diagnose a condition.
- Lack of Diagnostic Purpose: The intended use and device description focus on the physical process of fluid management within the urinary tract, not on analyzing the urine itself for diagnostic information.
Therefore, based on the provided information, the 3 Way Silicone Foley Balloon Catheter is a medical device used for patient care, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or by Nephrostomy.
Product codes
EZL
Device Description
The 3 Way Silicone Foley Balloon Catheter is composed of a silicone tube with an imbedded radiopaque blue stripe, a silicone balloon and polyvinylchloride valve. The tube has three lumens, one lumen for urinary drainage which is to be connected to urine collection container, one lumen with two-way valve for inflation/deflation of Foley balloon and one lumen for irrigation of bladder. Catheter is available in 16, 18, 20, 22, 24, 26 French with 30 cc balloon. Catheter is available in open or closed end. Open end allows for use of wire quide available separate). The 3 Way Silcone Foley Balloon Catheter is intended to be used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or Nephrostomy.
The devices are provided sterile and are intended for one time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urinary tract, urethra
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidances and recognized international standards. Testing data and information is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K951106, K002868, K082815, K013276, K981612, K070558
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
K091767
Page 1 of 2
510(k) SUMMARY
Submitted by:
Brenda Davis Regulatory Affairs Specialist Cook Urological. Incorporated 1100 West Morgan Street Spencer, IN 47460 June 15, 2009
Device: .
Trade Name:
3 Way Silicone Foley Balloon Catheter
Proposed Classification Name:
Urological catheter and accessories 21 CFR Part 876.5130
Product Code and Class:
EZL. Class II
Predicate Devices:
The 3 Way Silicone Foley Balloon Catheter is intended to be used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or Nephrostomy. The 3 Way Silicone Foley Balloon Catheter is similar with respect to indications for use and technology to existing predicate devices: COOK- Silicone Foley Catheter (510(k) No. 951106), C.R. Bard - Bardex® All Silicone 3-Way Foley (510(k) No. 002868), Well Lead - All Silicone Foley Catheters (510(k) No. 082815), Sewoon Medical Co., LTD - All-Silicone Foley Balloon Catheter (510(k) No. 013276), Rochester Medical Corp.- Two-Way Radiopaque Foley Catheter (510(k) No. 981612), C.R. Bard - Bardex® Lubri-Sil® 3-Way Foley Catheter (510(k) No. 070558). Please refer to Attachment C for marketing and FDA information regarding the predicate devices.
Device Description:
The 3 Way Silicone Foley Balloon Catheter is composed of a silicone tube with an imbedded radiopaque blue stripe, a silicone balloon and polyvinylchloride valve. The tube has three lumens, one lumen for urinary drainage which is to be connected to urine collection container, one lumen with two-way valve for inflation/deflation of Foley balloon and one lumen for irrigation of bladder. Catheter is available in 16, 18, 20, 22, 24, 26 French with 30 cc balloon. Catheter is available in open or closed end. Open end allows for use of wire quide available separate). The 3 Way Silcone Foley Balloon Catheter is intended to be used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or Nephrostomy.
The devices are provided sterile and are intended for one time use.
OCT - 9 2009
1
K091767
Page 2 of 2
Indications for Use:
Used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or by Nephrostomy.
Substantial Equivalence:
The 3 Way Silicone Foley Balloon Catheter is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.
Test Data:
Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidances and recognized international standards. Testing data and information is included in this submission.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
OCT - 9 2009
Ms. Brenda Davis Regulatory Affairs Specialist Cook Urological. Incorporated 1100 West Morgan Street SPENCER IN 47460
Re: K091767
Trade Name: 3 Way Silicone Foley Balloon Catheter Regulation Number: 21 CFR8876,5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: September 22, 2009 Received: September 24, 2009
Dear Ms. Davis:
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 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 (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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical
3
Page 2 -
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K091767 |
Device Name:
3 Way Silicone Foley Balloon Catheter
Indications for Use:
Used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or by Nephrostomy.
Prescription Use? × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number .