(102 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functional performance of a standard Foley catheter, with no mention of AI or ML capabilities.
Yes.
The device is used for a medical purpose (drainage and irrigation) and is intended to be used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
No
Explanation: The device is a Foley catheter, which is used for drainage and irrigation, not for diagnosing medical conditions. Its intended uses involve the physical management of urine and bladder contents, not the detection or identification of diseases or conditions.
No
The device description clearly outlines a physical, single-use, disposable catheter with a retention balloon, lumens, and various physical characteristics and components. The performance studies also focus on physical properties and testing of the hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "urethral urinary catheterisation for short term drainage of vesical urines" and "irrigation/injection following surgery." This describes a procedure performed on the patient to manage bodily fluids, not a test performed on a sample of bodily fluid to diagnose a condition.
- Device Description: The description details a physical device designed to be inserted into the body for drainage and irrigation. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information about a disease or condition
The device is a medical device used for a therapeutic and management purpose (drainage and irrigation), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The 2-way PORGES™ FOLYSIL™ silicone Foley catheter is used for urethral urinary catheterisation for short term drainage of vesical urines. Only straight 2-way PORGES™ FOLYSIL™ silicone Foley catheter with a maximum 15 ml balloon volume may be used in a supra-pubic way (except the grooved catheters).
The 3-way PORGES™ FOLYSIL™ silicone Foley catheter is used for urethral urinary catheterisation to allow short term drainage of the vesical urines, irrigation/injection following surgery.
Product codes
78 EZL
Device Description
The PORGES™ FOLYSIL™ silicone Foley catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation of the balloon. The distal end has opposite eye holes, which are used for drainage. On the Tiemann tip there is one hole. Straight cylindrical, "over the guide wire" and Tiemann tips are available versions of this product. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. This product is available in sizes 12 Fr to 24 Fr, smooth and profile (grooved) shafts. Profile shafts provide drainage channels along the shaft length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethral, vesical, bladder
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)
The PORGES™ FOLYSIL™ silicone Foley catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those Foley catheters currently manufactured. Performance and functional testing standards are based on the FDA "Guidance for the content of premarket notifications for conventional and antimicrobial Foley catheters" dated September 12, 1994.
The PORGES™ FOLYSIL™ silicone Foley catheter meets the following performance requirements per testing conducted according to ASTM F 623-89, when appropriate, and/or PORGES testing/acceptance criteria:
- Flow rate through the drainage lumen.
- Resistance of the balloon to rupture when inflated to the claimed balloon volume and held under conditions approximating the usage environment for a period of seven days;
- Resistance of the inflated balloon to being distorted and pulled through the bladder outlet;
- Maintenance of balloon inflation to fill volume over an extended time;
- Manufacturing tolerances for catheter tip, balloon and shaft diameters;
- Ability of an inflated catheter that has been submerged for seven days to deflate reliability to within 4 Fr. sizes of the labelled shaft size, as applicable, including the time for such deflation;
- Shaft tensile strength and tip adherence;
- Balloon burst.
The PORGES™ FOLYSIL™ silicone Foley catheter passes biocompatibility testing per ISO 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
modified paediatric silicone Foley catheter from PORGES, silicone Foley catheters from ROCHESTER, Inc., Bardex® All-silicone 3-way Folev catheter from BARD and Oligon® Foley Catheter from IMPLEMED.
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 0 4 2002
tion J: 510(k) Summ
PORGES™ FOLYSIL™ silicone Foley catheter 510(k) submission
Ref. US1AA61A.DOC
Origin : Regulatory Affairs
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
J.1. Submitter's information
| Submitter's name: | PORGES S.A. |
|---|---|
| Submitter's address: | Centre d'Affaires La Boursidière |
| 92357 Le Plessis Robinson - France | |
| Contact person: | Mr Bernard ISMAEL |
| Regulatory Affairs Manager | |
| Contact person's phone: | + 33 1 46 01 32 06 |
| Contact person's fax: | + 33 1 46 01 32 56 |
| Contact person's email: | bernard.ismael@porges.com |
| Date of preparation: | July 2001 |
J.2. Device name
Urological Catheter, Retention type, Balloon (78 EZL) Classification name: Foley catheter Common / Usual name: PORGES™ FOLYSIL™ silicone Foley catheter Proprietary name:
J.3. Predicate devices
The PORGES™ FOLYSIL™ silicone Foley catheter is substantially equivalent to the modified paediatric silicone Foley catheter from PORGES, silicone Foley catheters from ROCHESTER, Inc., Bardex® All-silicone 3-way Folev catheter from BARD and Oligon® Foley Catheter from IMPLEMED.
J.4. Description of the Device
The PORGES™ FOLYSIL™ silicone Foley catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation of the balloon. The distal end has opposite eye holes, which are used for drainage. On the Tiemann tip there is one hole. Straight cylindrical, "over the guide wire" and Tiemann tips are available versions of this product. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. This product is available in sizes 12 Fr to 24 Fr, smooth and profile (grooved) shafts. Profile shafts provide drainage channels along the shaft length.
J.5. Intended use of the Device
The 2-way PORGES™ FOLYSIL™ silicone Foley catheter is used for urethral urinary catheterisation for short term drainage of vesical urines. Only straight 2-way PORGES™ FOLYSIL™ silicone Foley catheter with a maximum 15 ml balloon volume may be used in a supra-pubic way (except the grooved catheters). The 3-way PORGES™ FOLYSIL™ silicone Foley catheter is used for urethral urinary catheterisation to allow short term drainage of the vesical urines, irrigation/injection following surgery.
J.6. Technological characteristics
The PORGES™ FOLYSIL™ sillcone Foley catheter has similar technological and performance characteristics to the predicate devices. The catheter is manufactured entirely from silicone elastomer as for the predicate devices. The catheter is supplied in French sizes ranging from 12 to 24 and balloon capacities 5 cm to 30 cm³. The predicate devices are available in French sizes from 6 to 26 balloon capacities from 1.5 cm³ to 30 cm³. The device is supplied in male and female lengths. The predicate devices are supplied in male and female lengths. All of the devices are supplied sterile for single use.
J.7. Testing and results
The PORGES™ FOLYSIL™ silicone Foley catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those Foley catheters currently manufactured. Performance
Image /page/0/Picture/20 description: The image shows the word "MENTOR" in bold, black capital letters. To the left of the word is a black symbol that resembles a four-pointed star or compass rose. There is a horizontal line above the word and symbol.
1
ection J: 510(k) Su
GES™ FOLYSIL™ silicone Foley
Ref. US1AA61A.DOC
Image /page/1/Picture/3 description: The image is a logo with the word "PORGES" written in bold, sans-serif font at the bottom. Above the word is a symbol that resembles a stylized lightbulb or a keyhole. The symbol consists of a circle with a vertical line extending downwards from its center, ending in a small circle. The logo is contained within a rectangular border.
Origin : Regulatory Affairs
and functional testing standards are based on the FDA "Guidance for the content of premarket notifications for conventional and antimicrobial Foley catheters" dated September 12, 1994.
The PORGES™ FOLYSIL™ silicone Foley catheter meets the following performance requirements per testing conducted according to ASTM F 623-89, when appropriate, and/or PORGES testing/acceptance criteria:
Note: ASTM F 623-89 excludes from the scope the catheters that have three lumens, balloons equal to or larger than 30 cm³, or shaft sizes smaller than 12 Fr or larger. Also excluded are catheters for paediatric and nonurethral catheterizations such as suprapubic cystostomy. However, the test methods described therein will also be utilised to test tri-lumen (3-way) catheters equal to or larger than 30 cm , and catheters size equal to or smaller than 12 Fr including paediatric catheters.
- Flow rate through the drainage lumen .
- Resistance of the balloon to rupture when inflated to the claimed balloon volume and held under . conditions approximating the usage environment for a period of seven days;
- Resistance of the inflated balloon to being distorted and pulled through the bladder outlet; .
- Maintenance of balloon inflation to fill volume over an extended time; .
- Manufacturing tolerances for catheter tip, balloon and shaft diameters; .
Ability of an inflated catheter that has been submerged for seven days to deflate reliability to . within 4 Fr. sizes of the labelled shaft size, as applicable, including the time for such deflation;
. Shaft tensile strength and tip adherence;
- Balloon burst. .
The PORGES™ FOLYSIL™ silicone Foley catheter passes biocompatibility testing per ISO 10993-1.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 4 2002
Mr. Bernard Ismael Regulatory Affairs Manager PORGES-C.A. La Boursidière 92357 Le Plessis Robinson CEDEX FRANCE
Re: K013174
Trade/Device Name: PORGESTM FOLYSIL™ Silicone Foley Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL Dated: December 20, 2001 Received: December 27, 2001
Dear Mr. Ismael:
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); 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.
3
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 needicate 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section F: Indications for Use Statem
silicone Foley catheter 510(k) submissio
Origin : Regulatory Affairs
Image /page/4/Picture/3 description: The image is a black and white logo for "PORGES". The logo is inside of a rectangle. Above the word "PORGES" is a symbol that looks like a circle with a line going through the middle of it. The line has a small circle at the top.
Ref. US1AA61A.DOC
Page 1 of 1
013174 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PORGES™ FOLYSIL™ silicone Foley catheter
Indications for use:
The 2-way PORGES™ FOLYSIL™ silicone Foley catheter is used for une matheterisation for short term drainage of vesical urines. Only straight 2-way PORGES™ FOLYSIL™ silicone Foley for short with a maximum 15 ml balloon volume may be used in a supra-pubic way (except the grooved catheters).
grooved batheoloj:
The 3-way PORGES™ FOLYSIL™ silkone Foley catheter is used for urethral urinary catheterisation to allow short term drainage of the vesical urines, irrigation/injection following surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
(Optional Format 3-10-98)
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K013174
Prescription Use