(324 days)
Not Found
No
The description focuses on the physical characteristics, materials, and functional performance of a silicone ureteral stent and its associated components. There is no mention of any computational or algorithmic processing, let alone AI/ML. The performance studies are based on physical testing and biocompatibility, not data analysis or model training.
Yes
The device is used for drainage of the upper urinary tract and management of ureteral stenoses, which are medical treatments for specific conditions.
No
Explanation: The device description and intended use clearly state that this is a ureteral stent used for drainage and management of obstructions/stenoses in the urinary tract. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components such as a double loop ureteral stent, obturator, guide-wire, and pusher, all made of silicone elastomer. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a ureteral stent used for drainage and management of the upper urinary tract. It is an implantable device that is placed within the body.
- Intended Use: The intended use is for drainage and management of physical obstructions and conditions within the urinary tract, not for analyzing biological samples.
- Device Description: The description focuses on the physical characteristics and materials of the stent, not on reagents, analyzers, or other components typically associated with IVDs.
- Performance Studies: The performance studies described relate to the physical properties and functionality of the stent (flow rate, tensile strength, loop strength, biocompatibility), not to the accuracy or precision of diagnostic measurements.
Therefore, this device is a medical device, specifically an implantable device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PORGES™ Silicone double loop ureteral stent is intended for the exact same use as the current PORGES ureteral stent (K881744) and VORTEK™ and BIOSOFT™ ureteral double loop stents (K981591). The PORGES™ Silicone double loop ureteral stent is used for :
- Standard versions
- Drainage of the upper urinary tract over fistulas or ureteral obstructions (e.g. periureteral tumour) ● . Cicatrisation stent
Reinforced versions: Management of ureteral stenoses
- Partial enlargement of the diameter: localised stenoses connected with ureteropelvic junction . syndrome
- Total enlargement of the diameter: stenoses over all or part of the ureter ●
Product codes (comma separated list FDA assigned to the subject device)
FAD
Device Description
The PORGES™ Silicone double loop ureteral stents are supplied in kits, containing the following components:
- A double loop ureteral stent and an obturator ●
- A guide-wire, where applicable ●
- A pusher (where applicable supplied with a clamp)
The catheter is manufactured entirely from silicone elastomer as for the predicate devices. The ureteral stents are made of the same yellow silicone tubing as the predicate silicone ureteral stent. They are steerable or non-steerable, and radiopaque.
Most references are available in 06/07/08 CH/Fr and in different lengths, ranging from 12 to 30 cm.
Renal and vesical loops may be either closed or open. The straight section may be totally or partially reinforced.
The eyes are lateral and staggered and are situated every 2 cm along the entire length of the stent (except for the no eye on the straight section version).
The ureteral stents have either a fixed core guide-wire, a movable core guide-wire or no guide-wire, depending upon the method of use. The steerable ureteral stents have connectable pushers, and the non-steerable stents have simple pushers. The ureteral stent kits are supplied sterile and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper urinary tract, ureteral
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 double loop ureteral stent referenced in this submission is held to the same design, manufacture, and performance specifications as the predicate devices. Substantial equivalence of the devices with the VORTEK™ and BIOSOFT™ ureteral double loop stents (K981591) with respect to functional performance has been demonstrated in conformity with the FDA "Guidance for the content of premarket notifications for ureteral stents" dated February 10th, 1993. Where available, standard specifications are used to establish test methods. Tests are conducted in conditions similar to most unfavorable conditions of medical/surgical practice.
The following tests have been performed:
- Flow rate through the stent
- Elongation and tensile strength of the stent after a 18 month soaking period in different buffer solutions.
- Loop strength
The PORGES™ Silicone double loop ureteral stent passes biocompatibility testing per ISO 10993-1.
The data currently available for the silicone stents enables them to be validated for an implantation period of up to 12 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).
0
OCT 1 7 2002
510(k) Summa
Origin : Regulatory Affairs
Ref. US1AJ41C.DOC
Image /page/0/Picture/35 description: The image is a logo for Porges. The logo features a stylized image of a radio tower with a circular antenna on top. The word "PORGES" is written in a bold, sans-serif font below the image. The logo is black and white and is surrounded by a thin black border.
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: Submitter's address:
Contact person:
Contact person's phone: Contact person's fax: Contact person's email: Date of preparation:
PORGES S.A. Centre d'Affaires La Boursidière 92357 Le Plessis Robinson - France Mr Bernard ISMAEL Regulatory Affairs Manager + 33 1 46 01 32 06 + 33 1 46 01 32 56 bernard.ismael@porges.com November, 2001
J.2. Device name
Classification name: Splint, ureteral (78 FAD) Common / Usual name: Double loop ureteral stent PORGES™ Silicone double loop ureteral stent Proprietary name:
J.3. Predicate devices
The PORGES™ Silicone double loop ureteral stent is substantially equivalent to the PORGES ureteral stent from BIVONA and the VORTEK™ and BIOSOFT™ ureteral double loop stents.
J.4. Description of the Device
The PORGES™ Silicone double loop ureteral stents are supplied in kits, containing the following components:
- A double loop ureteral stent and an obturator ●
- A guide-wire, where applicable ●
- A pusher (where applicable supplied with a clamp)
J.5. Intended use of the Device
The PORGES™ Silicone double loop ureteral stent is intended for the exact same use as the current PORGES ureteral stent (K881744) and VORTEK™ and BIOSOFT™ ureteral double loop stents (K981591). The PORGES™ Silicone double loop ureteral stent is used for :
- Standard versions
- Drainage of the upper urinary tract over fistulas or ureteral obstructions (e.g. periureteral tumour) ● . Cicatrisation stent
Reinforced versions: Management of ureteral stenoses
- Partial enlargement of the diameter: localised stenoses connected with ureteropelvic junction . syndrome
- Total enlargement of the diameter: stenoses over all or part of the ureter ●
J.6. Technological characteristics
The PORGES™ Silicone double loop ureteral stent has similar technological and performance characteristics to the predicate devices. The catheter is manufactured entirely from silicone elastomer as for the predicate devices. The ureteral stents are made of the same yellow silicone tubing as the predicate silicone ureteral stent. They are steerable or non-steerable, and radiopaque.
Most references are available in 06/07/08 CH/Fr and in different lengths, ranging from 12 to 30 cm.
Renal and vesical loops may be either closed or open. The straight section may be totally or partially reinforced.
The eyes are lateral and staggered and are situated every 2 cm along the entire length of the stent (except for the no eye on the straight section version).
- MENTOR
1
Image /page/1/Picture/0 description: The image shows the text "KOI 3921 PAGE 2 OF 2" in a handwritten style. The text is arranged in two lines, with "KOI 3921" on the first line and "PAGE 2 OF 2" on the second line. The handwriting is clear and legible, and the text is likely part of a document or report.
Section J: 510(k) Summar
PORGES™ Silicone double loop ureteral stent 510(k) submiss
Ref. US1AJ41C.DOC
Origin : Regulatory Affairs
The ureteral stents have either a fixed core guide-wire, a movable core guide-wire or no guide-wire, depending upon the method of use.
The steerable ureferal stents have connectable pushers, and the non-steerable stents have simple pushers. The ureteral stent kits are supplied sterile and for single use only.
J.7. Testing and results
The PORGES™ Silicone double loop ureteral stent referenced in this submission is held to the same design, manufacture, and performance specifications as the predicate devices. Substantial equivalence of the devices with the VORTEK™ and BIOSOFT™ ureteral double loop stents (K981591) with respect to functional performance has been demonstrated in conformity with the FDA "Guidance for the content of premarket notifications for ureteral stents" dated February 10th, 1993. Where available, standard specifications are used to establish test methods. Tests are conducted in conditions similar to most unfavorable conditions of medical/surgical practice.
The following tests have been performed :
- Flow rate through the stent ●
- Elongation and tensile strength of the stent after a 18 month soaking period in different buffer solutions.
- . Loop strength
The PORGES™ Silicone double loop ureteral stent passes biocompatibility testing per ISO 10993-1.
The data currently available for the silicone stents enables them to be validated for an implantation period of up to 12 months. The decision to leave the withdrawal wire in place on the stent must be taken in relation to the planned implantation period.
Periodic examinations via radiographic and/or cystoscopic means are recommended to evaluate stent efficiency and to observe for possible complications. The stent must be replaced if encrustation hampers drainage, if there is indication of infection in the area of the stent or in case of migration or rupture.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2002
Re: K013921
Mr. Bernard ISMAEL Regulatory Affairs Manager PORGÈS S.A. . . . . Centre d'Affaires La Boursidière 92 357 Le Plessis-Robinson Cedex FRANCE
Trade/Device Name: PORGES™ Silicone Double Loop Ureteral Stent Regulation Number: 21 CFR §876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: FAD Dated: August 8, 2002 Received: August 15, 2002
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. Iisting 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
Page 2
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/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 Statement
PORGES™ Silicone double loop ureteral stent 510(k) submission Origin : Regulatory Affairs
Image /page/4/Picture/2 description: The image shows the text "Ref. US1AJ41B.DOC". The text is in a sans-serif font and is left-aligned. The text is likely a reference number or document identifier. The letters and numbers are all capitalized.
Page 1 of 1
K013921
Device Name: PORGES™ Silicone double loop ureteral stent
Indications for use:
510(k) Number (if known):
Standard versions
- Drainage of the upper urinary tract over fistulas or ureteral obstructions (e.g. periureteral tumour) ●
- Cicatrisation stent .
Reinforced versions
Management of ureteral stenoses
- Partial enlargement of the diameter: localised stenoses connected with ureteropelvic . junction syndrome
- Total enlargement of the diameter: stenoses over all or part of the ureter ●
(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-Division of and Ra 510(k) No