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.

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. 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 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.

AI/ML Overview

The provided text is a 510(k) summary for the PORGES™ Silicone double loop ureteral stent. It confirms substantial equivalence to predicate devices based on design, manufacturing, and performance specifications, and biocompatibility testing. However, it does not provide detailed acceptance criteria and a study that proves the device meets those criteria in the format requested.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Functional Performance: Conforms to FDA "Guidance for the content of premarket notifications for ureteral stents" (Feb 10, 1993)	"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... has been demonstrated in conformity with the FDA 'Guidance for the content of premarket notifications for ureteral stents'..." Specific tests performed include: - Flow rate through the stent - Elongation and tensile strength of the stent after an 18-month soaking period in different buffer solutions. - Loop strength
Biocompatibility: Conforms to ISO 10993-1	"The PORGES™ Silicone double loop ureteral stent passes biocompatibility testing per ISO 10993-1."
Implantation Period: Suitability for extended use	"The data currently available for the silicone stents enables them to be validated for an implantation period of up to 12 months."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The document refers to "testing and results" but does not provide details on the number of stents tested for each performance metric.
Data Provenance: Not explicitly stated. The submitter is PORGES S.A. from France, suggesting the testing likely occurred in Europe or was overseen by a European entity, but this isn't confirmed for the data itself. The document does not specify whether the data is retrospective or prospective; it describes in vitro performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for performance testing of a medical device like a ureteral stent is typically objective measurements from laboratory or simulated-use tests, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving expert interpretation (e.g., radiology reads), not for the in vitro performance testing described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/software device, and therefore, no MRMC comparative effectiveness study involving human readers and AI assistance would be conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/software device. The performance tests are for the physical properties of the stent itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance tests (flow rate, elongation/tensile strength, loop strength, biocompatibility) is based on objective laboratory measurements against established engineering standards and regulatory guidance (e.g., ISO 10993-1, FDA guidance for ureteral stents).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As this is not a machine learning or AI device, there is no training set or ground truth in that context.

Summary

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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

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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.

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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.

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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

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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

Regulation Number and Section

§ 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).