(64 days)
Not Found
Not Found
No
The description focuses on the mechanical components and materials of a catheter and its accessories, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a medical device intended for placement of a Foley catheter for drainage in the bladder, which is a therapeutic intervention.
No
The device description clearly states its purpose is for "placement of the Foley catheter in the bladder for drainage," which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly describes a physical catheter made of PVC and its accessories, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the placement of a Foley catheter in the bladder for drainage. This is a procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a catheter and accessories used for insertion into the body. It does not involve the analysis of biological samples.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, this device falls under the category of a medical device used for a therapeutic or procedural purpose, not an in vitro diagnostic purpose.
N/A
Intended Use / Indications for Use
The Device is intended for placement of the Foley catheter in the bladder for drainage when there is difficulty in negotiating the urethra
Product codes
78 EZL
Device Description
The Rusch Inc. Simplastic Councill Tip Catheter may be supplied as a stand alone device or may be accompanied with accessories including a filiform and follower. The Simplastic Councill Tip Catheter consists of a 2-way PVC Foley catheter with a 5 ml balloon and an open tip to fit over a guide. The catheter can be supplied with a lubricious coating to facilitate insertion. The guide will be a flexible PVC shaft with standard threaded male Philips connector for attachment of a detachable filiform. The filiform also consists of a PVC shaft with a standard threaded female Philips connector. The catheter and accessories are supplied sterile. Sterility is by Ethylene Oxide Sterilization.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Porges Graham® Catheter
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
JAN 27 1998
PIGL Attachment E
Substantial Equivalence 510(k)Summary
Rusch Inc. Simplastic Councill Tip Catheter
To Whom it may concern
Date: November 20, 1997
Submitter/ Contact - Name and Address
Ronald J. Young Director QA/RA Rusch Inc. 2450 Meadowbrook Parkway Duluth, GA 30096
Telephone: (770) 623-0816 (770) 623-1829 Fax:
Device Details:
Trade Name: Rusch Inc. Simplastic Councill Tip Catheter
Common Name: Simplastic Councill Tip Catheter
Classification Name: Urological Catheter and Accessories
Predicate Legally Marketed Device: Porges Graham® Catheter
Page 1 of 2
1
K974419 12012
Description of Device
The Rusch Inc. Simplastic Councill Tip Catheter may be supplied as a stand alone device or may be accompanied with accessories including a filiform and follower. The Simplastic Councill Tip Catheter consists of a 2-way PVC Foley catheter with a 5 ml balloon and an open tip to fit over a guide. The catheter can be supplied with a lubricious coating to facilitate insertion. The guide will be a flexible PVC shaft with standard threaded male Philips connector for attachment of a detachable filiform. The filiform also consists of a PVC shaft with a standard threaded female Philips connector. The catheter and accessories are supplied sterile. Sterility is by Ethylene Oxide Sterilization.
Device Intended Use
The device design is intended for placement of the Foley catheter in the bladder, for deainage, when there is difficulty in negotiating the urethra.
Technological Characteristics of the Device
The device is equivalent is design and construction to the Porges Graham® Catheter. It comes in a range of sizes from 12 to 26FR.
Page 2 of 2
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 1998
Ronald J. Young Director, Quality Assurance and Regulatory Affairs RUSCH, Inc. 2450 Meadowbrook Parkway Duluth, GA 30136
Re: K974419
RUSCH Simplastic Councill Tip Catheter Dated: December 18, 1997 Received: December 23, 1997 Regulatory Class: II 21 CFR 8876.5130/Procode: 78 EZL
Dear Mr. Young:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 requirement, as set forth in the Quality System Regulation (OS) 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 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 531 through 542 of the Act for devices under 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) prematiet notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 question 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.
H. William Yin
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Rysch simplastic Council Tip Catheter
Indications For Use:
The Device is intended for placement of the Foley catheter in the bladder for drainage when there is difficulty in negotiating the urethra
Signed:
Title: Director QA/RA
Date: 1/26/98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Athing
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974419
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)