(87 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a silicone catheter, with no mention of AI or ML.
No
The device is a prostatectomy catheter used for drainage, irrigation, and hemostasis, which are largely procedural or supportive functions rather than direct therapeutic actions to treat a disease or condition. While it aids in recovery post-surgery, it's primarily a surgical/post-surgical tool rather than a therapeutic device in itself.
No
This device is a catheter used for drainage, irrigation, injection, and hemostasis following prostatectomy surgery. These are therapeutic and support functions, not diagnostic.
No
The device description clearly describes a physical catheter made of silicone elastomer with lumens, a balloon, and other physical components. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for drainage, irrigation, and hemostasis within the body (specifically the urinary tract and prostate area). IVDs are used to examine specimens from the body (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health.
- Device Description: The description details a physical catheter with lumens, a balloon, and connectors designed for insertion into the body. This is consistent with a medical device used for treatment or diagnosis in vivo, not for testing samples in vitro.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological samples, or any other components or processes typically associated with in vitro diagnostics.
Therefore, the PORGES™ Silicone prostatectomy catheter is a medical device used for procedures performed on the patient, not for testing samples from the patient in a laboratory setting.
N/A
Intended Use / Indications for Use
The PORGES™ Silicone prostatectomy catheter is used for :
- short term drainage of the vesical urines,
- irrigation/injection and drainage following surgery,
- after prostate surgery : hemostasis of the prostate area.
Product codes
78 EZL
Device Description
The PORGES™ Silicone prostatectorny catheter is a balloon catheter of the retention type, commonly called Foley catheter. This Foley catheter is a single use, disposable, sterile, cream-transparent silicone elastomer with a radiopaque tip and 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 a third lumen, it is used in conjunction with the first lumen for the irrigation/injection and drainage. Water is used for inflation and deflation of the balloon. The distal end has opposite eye holes, which are used for drainage.
Nominal balloon inflation volumes are 15 to 30 cm³ or 30 to 50 cm³ with the 15 to 30 cm³ balloon being used for normal usage, and 30 to 50 cm³ when a larger balloon is indicated.
To hold the catheter in place there are on the shaft, are an connecting funnel and a Luer activated valve of which the colour varies according to the size of the catheter.
This product is available in sizes 18 Fr to 24 Fr, with DUFOUR, DELINOTTE, COUVELAIRE or standard tip. Total length of all catheters : 42 cm. One catheter has an open tip to fit over a guide wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate area, vesical urines
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™ Silicone prostatectorny catheter referenced in this submission is held to the same design, performance manulaciure, and performanon and the FDA "Guidance for the content of premarket notifications for conventional and anti-inftional Foley catheters" dated September 12, 1994.
THE FONGES - Silleone prosidioson's baller Provinte, 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 Note: ASTMT - 020 00 - nower, the test methods described therein will also be utilised to test tri-lumen (3-way) catheters, balloon catheters equal to or larger than 30 cm³.
- Flow rate through the drainage lumen .
- r low taxe and 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;
- ditions approximating the 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; .
Malitationing theration 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™ Silicone prostatectorny catheter passes biocompatibility testing per ISO 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
the modified paediatric silicone The POTGES and to the Bardex® All-silicone 3-way Foley 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
DEC 2 0 2001
(
ection J: 510(k) Sur
ORGES™ Silicone prostatectomy catheter 510(k) submission Origin : Regulatory Affairs
Image /page/0/Picture/3 description: The image is a black and white logo for "PORGES". The logo consists of the word "PORGES" in a bold, sans-serif font, with a horizontal line above and below the word. Above the word is a symbol that resembles a key or a stylized letter "P". The symbol consists of a circle with a dot in the center, connected to a vertical line that splits into two lines at the bottom.
Ref. US1AB60A.DOC
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
| Classification name: | Urological Catheter, Retention type, Balloon (78 EZ |
|---|---|
| Common / Usual name: | Prostatectomy catheter |
| Proprietary name: | PORGES™ Silicone prostatectomy catheter |
J.3. Predicate devices
The PORGES™ Silicone prostatectorny catheter is substantially equivalent to the modified paediatric silicone The POTGES and to the Bardex® All-silicone 3-way Foley catheter from BARD.
J.4. Description of the Device
The PORGES™ Silicone prostatectorny catheter is a balloon catheter of the retention type, commonly called THE FORGES " Silkone prosidioning outhere is a banetransparent silicone elastomer with a radiopaque a Toley datable 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 Shall. One laimer is for araning halas to anyth a third lumen, it is used in conjunction with the first lumen for the ballow with other water in used for inflation and deflation of the balloon. The distal end has opposite eye holes, which are used for drainage.
opposite eye nores, which are used for than ago.
Nominal balloon inflation volumes are 15 to 30 cm³ or 30 to 50 cm³ with the 15 to 30 cm³ balloon being used Nominal banoon innation for normal usage, and 30 to 50 cm³ when a larger balloon is indicated.
to head of outher in place rehaft, are an connecting funnel and a Luer activated valve of which the colour varies according to the size of the catheter.
varies according to the Sizes of the outloter.
This product is available in sizes 18 Fr to 24 Fr, with DUFOUR, DELINOTTE, COUVELAIRE or standard tip. Total length of all catheters : 42 cm. One catheter has an open tip to fit over a guide wire.
J.5. Intended use of the Device
The PORGES™ Silicone prostatectomy catheter is used for :
- short term drainage of the vesical urines,
- irrigation/injection and drainage following surgery,
- after prostate surgery : hemostasis of the prostate area.
J.6. Technological characteristics
The PORGES™ Silicone prostatectory catheter has similar technological and performance characteristics to the predicate devices. The catheter is manufactured entirely from silicone elastomer as for the predicate to the producer to the eather is supplied in French sizes ranging from 18 to 24 and balloon capacities 15-30 cm to devices: The battletter to oupplied in French sizes from 6 to 26 balloon capacities from 1.5 cm 1.5 cm 1.5 cm 1.5 cm 1.5 cm 1.5 cm 1.5 cm 30 cm . The device is supplied in male length only. The predicate device is supplied in male and female lengths. All of the devices are supplied sterile for single use.
1
Section J: 510(k) Sum
PORGES™ Silicone prostatectomy catheter 510(k) submission Origin : Regulatory Affairs
Image /page/1/Picture/2 description: The image is a logo for Porges. The logo consists of a stylized symbol above the word "PORGES". The symbol features a circle with a vertical line extending downwards from its center, ending in two parallel lines. The logo is black and white and is contained within a rectangular border.
Ref. US1AB60A.DOC
J.7. Testing and results
The PORGES™ Silicone prostatectorny catheter referenced in this submission is held to the same design, THE PORGES -- SMOUNE prostateority battleters currently manufactured. Performance performance manulaciure, and performanon and the FDA "Guidance for the content of premarket notifications and functional tooking otariaal old Foley catheters" dated September 12, 1994.
for conventional and antinitional Poly vatheter meets the following performance requirements per testing THE FONGES - Silleone prosidioson's baller Provinte, 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 Note: ASTMT - 020 00 - nower, the test methods described therein will also be utilised to test tri-lumen (3-way) catheters, balloon catheters equal to or larger than 30 cm³.
- Flow rate through the drainage lumen .
- r low taxe and 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;
- ditions approximating the 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; .
Malitationing theration 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™ Silicone prostatectorny catheter passes biocompatibility testing per ISO 10993-1.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2001
Mr. Bernard Ismael Regulatory Affairs Manager PORGÈS-C.A. La Boursidière 92357 Le Plessis Robinson CEDEX FRANCE
Re: K013172
Trade/Device Name: Porges Silicone Prostatectomy Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessor: Regulatory Class: II Product Code: 78 EZL Dated: September 21, 2001 Received: September 24, 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 for associor 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 r ou may , increase 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 0011) war an an an 110 revel 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 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), 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/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Croghan
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 Stater
PORGES™ Silicone prostatectomy catheter 510(k) submission
Image /page/4/Picture/2 description: The image shows a close-up of a document with the words "Statement" and "Origin : Regulatory Affairs" printed on it. The text is in a clear, sans-serif font and appears to be part of a larger document. There is also a partial logo or symbol visible in the upper right corner of the image.
Ref. US1AB60A.DOC
Page 1 of 1
KO13172 510(k) Number (if known):
Device Name: PORGES™ Silicone prostatectomy catheter
Indications for use:
The PORGES™ Silicone prostatectomy catheter is used for :
- short term drainage of the vesical urines, -
- irrigation/injection and drainage following surgery,
- infigurer.hijformate surgery : hemostasis of the prostate area.
(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)
Prescription Use
David A. Segerson
(Division Sign-OR
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013172