(133 days)
The PORGES™ Ureteral catheters are used for ureteral catheterisation:
- drainage catheters: straight catheters with bevel, olive or cylindrical tip, elbowed catheter with olive tip
- catheters for retrograde ureteropyelography (R.U.P.): Chevassu, cone or Braasch -
- interventional catheters: flush, open straight, open elbowed. The appropriate quide-wire size for each catheter is shown on the box.
The PORGES™ Ureteral catheters consist of a single lumen catheter in medical grade radiopaque polymer, graduated every cm along 50 cm, and fitted with either a metal or a polymer removable stylet or no stylet. The stylet allows straightening of the catheter for easier insertion. A wax knob is added on the external end of the stylet for easy retreat of the coudé tip catheters are fitted with a silicone stop ring on the stylet between the catheter and the wax knob to hold the renal tip of the stylet away from the catheter's renal tip.
The ureteral catheters are available with different types of renal tips and in sizes ranging from 03 FR to 12 FR.
The preamendment devices have been designed for R.U.P. (retrograde ureteropyelography).
PORGES has validated the following uses for the new range of ureteral catheters :
- . drainage
- R.U.P. (= retrograde uretero pyelography) .
- interventional ("per operating") use with a Seldinger guide wire (not supplied)
The PORGES™ Ureteral catheters are supplied sterile and for single use only.
The provided text is a 510(k) summary for the PORGES™ Ureteral catheters. It does not describe an AI/ML powered device, but rather a traditional medical device (catheters). Therefore, many of the requested details, such as those pertaining to AI model performance, multi-reader multi-case studies, and ground truth establishment for AI training sets, are not applicable and cannot be extracted from this document.
However, I can provide the relevant information regarding the device's acceptance criteria and the study that proves it meets them, based on the provided text.
Acceptance Criteria and Device Performance for PORGES™ Ureteral Catheters
The PORGES™ Ureteral catheters are traditional medical devices, and their acceptance criteria and proof of compliance are based on demonstrating substantial equivalence to predicate devices through technical characteristics and performance testing, rather than AI/ML model performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Specifications) | Reported Device Performance (Test Results) |
|---|---|
| Functional Performance: | |
| - Flow rate | Successfully passed, demonstrating substantial equivalence to predicate devices. |
| - Tensile strength | Successfully passed, demonstrating substantial equivalence to predicate devices. |
| - Tear strength of bulbs (for Chevassu and cone-tip catheters) | Successfully passed, demonstrating substantial equivalence to predicate devices. |
| - Passage of contrast medium | Successfully passed, demonstrating substantial equivalence to predicate devices. |
| Biocompatibility: | Successfully passed biocompatibility testing per ISO 10993-1. |
| Material Equivalence: | Similar materials (medical grade thermoplastic like polyvinyl chloride, polyamide, polyurethane, PEBA) to predicate devices. The choice of material provides a slight difference in stiffness but "does not affect clinical properties." |
| Tip Performance: | The straight open tip of interventional ureters allows placement over a guide-wire, performing similarly to the "straight whistle tip of both Porges' and Bard's currently marketed catheters." |
| Design and Manufacturing: | Held to the same design, manufacture, and performance specifications as the predicate devices. |
| Safety and Effectiveness: | Confirmed by biocompatibility and mechanical/physical tests; device performs "as well as or better than the predicate devices." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify exact sample sizes for the mechanical/physical and biocompatibility tests. It broadly states that "The PORGES™ Ureteral catheters referenced in this submission are held to the same design, manufacture, and performance specifications as the predicate devices." Testing was performed on the PORGES™ Ureteral catheters to demonstrate substantial equivalence.
- Sample Size: Not explicitly stated for specific tests.
- Data Provenance: The tests were conducted on the PORGES™ Ureteral catheters themselves, manufactured by PORGES S.A. in France. The study is prospective in the sense that the new device was tested against established standards and predicates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a physical medical device, not an AI/ML algorithm. "Ground truth" in this context refers to established engineering and biocompatibility standards, not expert consensus on image interpretation or similar AI-related tasks.
4. Adjudication Method for the Test Set
This information is not applicable as the device is a physical medical device. Test results for mechanical, physical, and biocompatibility properties are typically objective measurements against defined thresholds, not subjective evaluations requiring adjudication.
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
This information is not applicable as the device is a physical medical device, not an AI/ML system, and therefore, an MRMC study related to AI assistance would not have been conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical medical device, not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" (or basis for evaluation) for this device is based on established engineering and material science standards and pre-clinical laboratory tests. This includes:
- Objective measurements: for flow rate, tensile strength, tear strength, and passage of contrast medium. These are quantitative assessments against predefined specifications for the device's functional performance.
- Biocompatibility standards: specifically ISO 10993-1.
- Comparison to predicate devices: The "ground truth" for substantial equivalence often means demonstrating performance "as well as or better than" legally marketed predicate devices, which have a known history of safe and effective use.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical device, not an AI/ML system. There is no "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical medical device, not an AI/ML system.
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OCT 1 7 2002
Section J: 510(k) Sum
Ref. US021A41.DOC
Origin : Regulatory Affairs
Image /page/0/Picture/4 description: The image is a logo for Porges. The logo consists of a stylized symbol above the word "PORGES". The symbol is a circle with a line extending down from the center, ending in a small circle. The word "PORGES" is in a bold, sans-serif font.
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 Boursidière92357 Le Plessis Robinson - France |
| Contact person: | Mr Bernard ISMAELRegulatory 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: | February, 2002 |
J.2. Device name
| Classification name: | Catheter, ureteral, gastro-urolog |
|---|---|
| Common / Usual name: | Ureteral catheters |
| Proprietary name: | PORGES™ Ureteral catheters |
J.3. Predicate devices
The PORGES™ Ureteral catheters are substantially equivalent to the PORGES™ pre-amendment range of ureteral catheters, C.R. Bard Inc. Urological Division's currently marketed ureteral catheter line and Bard Flexible Tip Ureteral catheter (K950300). PORGES S.A., is not aware of any information suggesting that C.R. Bard Inc. ureteral catheters are not legally marketed. Ureteral catheters may also be referic catheters, both denominations being equally used within the medical profession.
J.4. Description of the Device
The PORGES™ Ureteral catheters consist of a single lumen catheter in medical grade radiopaque polymer, graduated every cm along 50 cm, and fitted with either a metal or a polymer removable stylet or no stylet. The stylet allows straightening of the catheter for easier insertion. A wax knob is added on the external end of the stylet for easy retreat of the coudé tip catheters are fitted with a silicone stop ring on the stylet between the catheter and the wax knob to hold the renal tip of the stylet away from the catheter's renal tip.
The ureteral catheters are available with different types of renal tips and in sizes ranging from 03 FR to 12 FR.
The preamendment devices have been designed for R.U.P. (retrograde ureteropyelography).
PORGES has validated the following uses for the new range of ureteral catheters :
- . drainage
- R.U.P. (= retrograde uretero pyelography) .
- interventional ("per operating") use with a Seldinger guide wire (not supplied)
The predicate devices Bard® Flexible Tip ureteral catheters (K950300) and C.R. Bard's currently marketed devices are designed for the same intended use.
The PORGES™ Ureteral catheters are supplied sterile and for single use only.
J.5. Intended use of the Device
The PORGES™ Ureteral catheters are used for ureteral catheterisation:
- drainage catheters: straight catheters with bevel, olive or cylindrical tip, elbowed catheter with olive tip ●
- . catheters for retrograde ureteropyelography (R.U.P.): Chevassu, cone or Braasch
interventional catheters: flush, open straight, open elbowed. The appropriate guide-wire size for each catheter is shown on the box.
{1}------------------------------------------------
Section J: 510(k) Summa PORGES™ Ureteral catheters 510(k) submission
Ref. US021A41.DOC
Origin : Regulatory Affairs
Image /page/1/Picture/3 description: The image shows a logo with the word "PORGES" written in bold, block letters at the bottom. Above the word is a symbol that resembles a stylized key or a tuning fork. The symbol consists of a circle with a vertical line extending downwards from its center, ending in a small circle. The logo is enclosed in a rectangular border.
J.6. Technological characteristics
The PORGES™ Ureteral catheters have similar technological and performance characteristics to the predicate devices. The PORGES™ Ureteral catheters are similar as it concerns its materials to PORGES and C.R. Bard's currently marketed ureteral catheters and to the Bard Flexible tip ureteral catheter (K950300). All are made of medical grade thermoplastic material. The choice of either a polyvinyl chloride, polyamide, polyurethane or PEBA (polyether block amide) catheter or metal or polymer stylet may provide a slight difference in stiffness, which does not affect clinical properties, but may be preferred by practioners according to the method of use.
The polyvinyl chloride and polyamide mixtures which are used for the manufacturing of most PORGES Ureteral catheters are the same as those used since 1971 for the manufacturing of the PORGES preamendment devices.
The straight open tip of the interventional ureters allows placement over a quide-wire. The straight open tip is similar in performance as the straight whistle tip of both Porges' and Bard's currently marketed catheters.
J.7. Test Summary
The PORGES™ Ureteral catheters referenced in this submission are held to the same design, manufacture, and performance specifications as the predicate devices. Substantial equivalence of the devices with respect to functional performance has been demonstrated by mechanical/physical testing. The following tests have been performed :
- Flow rate
- Tensile strength .
- Tear strength of bulbs (Chevassu and cone-tip catheters)
- Passage of contrast medium
The PORGES™ Ureteral catheters have successfully passed biocompatibility testing per ISO 10993-1.
J.8. Conclusion.
The biocompatibility and mechanical/physical tests confirm the safety and effectiveness for these devices is assured and these devices perform as well as or better than the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the caduceus symbol.
OCT 1 7 2002
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Re: K021856
Trade/Device Name: PORGES™ Ureteral Catheters Models ACN6xx, ACN5xx, AC5B, AC5C07, ACP5xx, ACP2xx, ACP3xx, ACP4xx, and ACP6xx Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EYB Dated: September 24, 2002 Received: October 7, 2002
Dear Mr. ISMAEL:
Mr. Bernard ISMAEL
PORGES S.A.
FRANCE
Regulatory Affairs Manager
Centre d'Affaires La Boursidière 92357 Le Plessis-Robinson Cedex
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}------------------------------------------------
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. Croydon.
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™ Ureteral catheters 510(k) submission
Ref. US021A41.DOC
Origin : Requlatory Affairs
Image /page/4/Picture/4 description: The image is a logo for Porges. The logo features a stylized image of a key with a circular head. The word "PORGES" is written in bold, sans-serif letters below the key image. The logo is black and white and has a simple, modern design.
Page 1 of 1
510(k) Number (if known): K1021856
Device Name: PORGES™ Ureteral catheters
Indications for use:
The PORGES™ Ureteral catheters are used for ureteral catheterisation:
- drainage catheters: straight catheters with bevel, olive or cylindrical tip, elbowed catheter with olive tip
- catheters for retrograde ureteropyelography (R.U.P.): Chevassu, cone or Braasch -
- interventional catheters: flush, open straight, open elbowed. The appropriate quide-wire size for each catheter is shown on the box.
(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
IDivision Sign-Off) Division of Seproductive, Abdominal, and Padiciogical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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.