(192 days)
Folysil catheters are intended for use up to 30 days in adult and pediatric populations for:
-
Bladder drainage by urethral catheterization,
-
Bladder drainage by suprapubic catheter replacement only (for non-grooved, straight 2-way Folysil catheters with a maximum balloon volume of 15mL).
-
Bladder instillation of physiological saline solution.
Folysil catheters are thin, hollow tubes equipped with a balloon, funnel and valve, to be inserted into the bladder by the urethral or supra-pubic approach to drain urine into a urine collection bag. Folysil catheters are held in place within the bladder by the balloon, which is filled with sterile water or with aqua-glycerin solution.
The provided text describes a medical device, the Folysil® Silicone Catheter, seeking 510(k) clearance from the FDA. The submission focuses on demonstrating substantial equivalence to predicate devices through biocompatibility and bench testing. However, it does not include information about clinical studies involving human patients, multi-reader multi-case (MRMC) studies, or the use of AI. Therefore, most of the requested information regarding human-in-the-loop performance, expert consensus, and training/test set details cannot be extracted from this document.
Here's the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that "All pre-determined acceptance criteria were met for 14-24 Fr. catheters" for the bench tests conducted according to FDA recognized standards and guidance. For catheter sizes 6-12 Fr., "the protocol and acceptance criteria for these tests were scientifically adequate and clinically relevant, and the acceptance criteria were met for these tests as well."
The text lists the following bench tests performed:
| Acceptance Criteria (Test) | Reported Device Performance (Met/Not Met) |
|---|---|
| Visual tests | Met |
| Catheter integrity test | Met |
| Balloon size and shaft size | Met |
| Flow rate through drainage lumen | Met |
| Balloon integrity (resistance to rupture) | Met |
| Inflated balloon response to traction | Met |
| Balloon volume maintenance | Met |
| Deflation reliability test (failure to deflate) | Met |
| Funnel security of fit test | Met |
| Tensile test on funnel junction | Met |
| Tensile test on tip | Met |
| Simulation of use test | Met |
| Kink resistance test | Met |
| Radiopacity test | Met |
| Tensile test on valve junction | Met |
Additionally, for biocompatibility testing:
| Acceptance Criteria (Test) | Reported Device Performance (Met/Not Met) |
|---|---|
| Cytotoxicity | Met (demonstrates biocompatibility) |
| Irritation | Met (demonstrates biocompatibility) |
| Sensitization | Met (demonstrates biocompatibility) |
| Acute Systemic Toxicity | Met (demonstrates biocompatibility) |
| Material-mediated Pyrogenicity | Met (demonstrates biocompatibility) |
| Genotoxicity Ames and Mouse Lymphoma | Met (demonstrates biocompatibility) |
| Implantation 4 and 13 weeks | Met (demonstrates biocompatibility) |
| Systemic toxicity 13 weeks | Met (demonstrates biocompatibility) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (number of devices) used for each individual test or for the overall test set. It refers to "14-24 Fr. catheters" and "6-12 Fr. catheter sizes."
- Data Provenance: The testing was presented by Coloplast, an international company with its legal manufacturer address in Humlebaek, Denmark. The testing appears to be internal company testing based on recognized standards and guidance documents. The data is retrospective in the sense that it's data collected from internal testing for the purpose of this submission, not a prospective clinical trial.
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):
This information is not applicable as the evaluation mentioned is based on objective bench tests and biocompatibility testing, not on human interpretation or clinical data requiring expert ground truth in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for objective bench and biocompatibility testing. The "ground truth" for these tests is defined by the physical or biological measurement outcomes against pre-defined quantitative or qualitative acceptance limits.
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 present in the document. The submission pertains to a physical medical device (catheter) and its substantial equivalence, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present in the document. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
The "ground truth" for this submission is established by:
- Physical measurements and performance criteria defined in recognized standards (ASTM F623-19, ISO 20696:2018) and FDA guidance documents for bench testing.
- Biological responses and cytotoxicity assessments defined in recognized standards (ISO 10993-1 and relevant sub-standards) for biocompatibility testing.
8. The sample size for the training set:
This information is not applicable. This is a submission for a physical medical device (catheter) based on bench and biocompatibility testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a stylized image. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
April 15, 2024
Coloplast Corp % Kristen Swanson Regulatory Consultant Kompass Regulatory Consulting 1583 Northrop St. Falcon Heights, Minnesota 55108
Re: K233411
Trade/Device Name: Folysil® Silicone Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: II Product Code: EZL Dated: October 6, 2023 Received: October 6, 2023
Dear Kristen Swanson:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
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the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -S
for Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K233411
Device Name Folysil® Silicone Catheter
Indications for Use (Describe)
Folysil catheters are intended for use up to 30 days in adult and pediatric populations for:
-
Bladder drainage by urethral catheterization,
-
Bladder drainage by suprapubic catheter replacement only (for non-grooved, straight 2-way Folysil catheters with a maximum balloon volume of 15mL).
-
Bladder instillation of physiological saline solution.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K233411 Page 1 of 5 Coloplast 1601 West River Road North Minneapolis, MN 55411
TRADITIONAL 510(k) SUMMARY
SUBMITTER INFORMATION I.
| Applicant | Coloplast A/S |
|---|---|
| Legal Manufacturer Address: | Holtedam 13050 Humlebaek, Denmark |
| Official Correspondent: | Kristen SwansonRegulatory Consultant1583 Northrop St.Falcon Heights, MN 55108Phone: 651-245-2678Email: uskrs@coloplast.com) |
| Date Prepared: | April 12, 2024 |
II. DEVICE NAME
| Trade or Proprietary Name: | Folysil® Silicone Catheter |
|---|---|
| Common or Usual Name: | Foley Catheter |
| Classification Regulation: | 21 CFR 876.5130 |
| Device Class: | II |
| Product Code: | EZL (Catheter, Retention Type, Balloon) |
| Panel: | Gastroenterology/Urology |
III. PREDICATE DEVICES IDENTIFICATION
| Primary Predicate device: | Folysil® Silicone Catheter (K013174) |
|---|---|
| Secondary Predicate device: | Modified Pediatric Silicone Foley Catheter (K900031) |
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IV. DEVICE DESCRIPTION
Folysil catheters are thin, hollow tubes equipped with a balloon, funnel and valve, to be inserted into the bladder by the urethral or supra-pubic approach to drain urine into a urine collection bag. Folysil catheters are held in place within the bladder by the balloon, which is filled with sterile water or with aqua-glycerin solution.
Folysil Silicone catheters are provided in a variety of configurations as shown in Table 1.
| Pediatric Use | Adult Use | |
|---|---|---|
| 2-way | 2-way | 2-way |
| Size, Fr | 6 Fr - 10 Fr | 12 Fr - 24 Fr |
| Tip Shapes | Straight round, Tiemann, Straight | Straight round, Tiemann, Straight |
| Open | Open | |
| Balloon Volume, mL | 1.5mL - 3.0mL | 10 mL - 30 mL |
| Drainage eyes | 2 | 1-6 |
| Catheter Total Length, cm | 26 cm - 32 cm | 25 cm - 41 cm |
| Tube Surface | Smooth | Smooth and grooved |
Table 1: Folysil Silicone Catheter Range
INDICATIONS FOR USE V.
Folysil catheters are intended for use up to 30 days in adult and pediatric populations for: Bladder drainage by urethral catheterization, -
- Bladder drainage by suprapubic catheterization for catheter replacement only (for non-grooved, straight 2-way Folysil catheters with a maximum balloon volume of 15mL).
- -Bladder instillation of physiological saline solution.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| ComparisonElement | DeviceFolysil® Silicone Catheters | Primary Predicate DevicePorges Folysil Silicone FoleyCathetersK013174 | Secondary PredicateDeviceModified PediatricSilicone Foley CathetersK900031 |
|---|---|---|---|
| Indications forUse | Folysil catheters are intendedfor use up to 30 days in adultand pediatric populations for:- Bladder drainage byurethral catheterization,- Bladder drainage bysuprapubic catheterizationfor catheter replacementonly (for non-grooved,straight 2-way Folysilcatheters with a maximumballoon volume of 15mL). | The 2-way PORGES Folysilsilicone Foley catheter is usedfor urethral urinarycatheterization for short-termdrainage of vesical urines.Only straight 2-way PORGESFolysil silicone Foley catheterwith a maximum 15 mlballoon volume may be usedin a supra-pubic way (exceptthe grooved catheters). | The PORGES paediatricsilicone Foley catheter isused to pass fluids or fromthe urinary tract forchildren. |
Table 2: Comparison between Subject Device and Predicate Device
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Image /page/6/Picture/1 description: The image shows the logo for Coloplast. The logo consists of a blue circle with horizontal lines on the left side and the word "Coloplast" in blue on the right side. The font of the word "Coloplast" is bold and sans-serif.
1601 West River Road North
| Minneapolis, MN 55411 | |||
|---|---|---|---|
| ComparisonElement | DeviceFolysil® Silicone Catheters | Primary Predicate DevicePorges Folysil Silicone FoleyCathetersK013174 | Secondary PredicateDeviceModified PediatricSilicone Foley CathetersK900031 |
| Bladder instillation ofphysiological salinesolution. | The 3-way PORGES Folysilsilicone Foley catheter is usedfor urethral urinarycatheterization to allow shortterm drainage of the vesicalurines, irrigation/injectionfollowing surgery. | ||
| TargetPopulation | Pediatric and Adult, male andfemale | Pediatric and Adult, male andfemale | Pediatric patients. |
| DurationofUse/Indwell time | Up to 30 days. | Up to 30 days. | Up to 30 days. |
| Common Name | Catheter, Retention Type,Balloon | Catheter, Retention Type,Balloon | Catheter, Retention Type,Balloon |
| French Size | 6 - 24 Fr | 12 - 24 Fr | 6-10 Fr |
| Length | 25 - 41 cm | 25 - 41 cm | 30 — 35 cm |
| Lumen | 2-way | 2-way or 3-way | 2-way |
| Balloon | Yes | Yes | Yes |
| Balloon Size | 1.5mL-30mL | 10mL-30mL | 1.5 - 3mL |
| Single Use | Yes | Yes | Yes |
| Sterile | Yes, via EO | Yes, via EO | Yes, via EO |
| MainShaftMaterial | Silicone | Silicone | Silicone |
| Shelf Life | 5 years | 5 years | 5 years |
| Radiopaque line | Yes | Yes, (only for neobladdercatheters) | - |
| Eyes | Up to 6 | Up to 6 | up to 6 |
| Tip Shapes | Tiemann (coude tip), straightcylindrical," Over the guide"(straight open), straight round | Tiemann (coude tip), straightcylindrical, "Over the guide"(straight open), straight round | Tiemann (coude tip),straight cylindrical," Overthe guide" (straight open),straight round |
| Stylet/Introducer | Yes (for pediatric sizes),Looped stylet | Not for adult sizes | Yes (for pediatric sizes),Straight stylet |
As evidenced by the above table, both the subject and the predicate devices have same intended use, but the subject and predicate devices have different technological characteristics. The differences in technological characteristics between the subject and the predicate does not raise different questions of safety or effectiveness.
VII. PERFORMANCE DATA
Device performance data was provided in support of the substantial equivalence determination.
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Biocompatibility Testing
Biocompatibility testing was conducted based upon ISO 10993-1 (2018): Biological evaluation of medical devices - Part 1: "Evaluation and testing within a risk management process" and FDA Guidance document (2023). "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" | FDA". The subject device is an externally communicating device in contact with mucosal tissue for 30 days or more and following tests were conducted in accordance with the relevant ISO 10993 standards:
- Cytotoxicity
- Irritation ●
- Sensitization ●
- Acute Systemic Toxicity ●
- Material-mediated Pyrogenicity ●
- Genotoxicity Ames and Mouse Lymphoma ●
- Implantation 4 and 13 weeks ●
- Systemic toxicity 13 weeks ●
The results of these tests demonstrate that the subject device is biocompatible.
Bench Testing
The following tests were performed per FDA recognized standard ASTM F623-19, ISO 20696:2018 and FDA guidance document (2020), "Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway | FDA".
- Visual tests ●
- Catheter integrity test
- Balloon size and shaft size ●
- Flow rate through drainage lumen ●
- Balloon integrity (resistance to rupture)
- Inflated balloon response to traction
- . Balloon volume maintenance
- Deflation reliability test (failure to deflate) ●
- Funnel security of fit test
- Tensile test on funnel junction ●
- Tensile test on tip
- Simulation of use test
- Kink resistance test
- Radiopacity test
- Tensile test on valve junction .
All pre-determined acceptance criteria were met for 14-24 Fr. catheters. The performance testing on the catheter sizes 6-12 Fr. was conducted according to the sponsor's internal test protocols as these catheter sizes are not covered under the above referenced standards. The protocol and acceptance criteria for these tests were scientifically adequate and clinically relevant, and the acceptance criteria were met for these tests as well.
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Image /page/8/Picture/0 description: The image shows the Coloplast logo and address. The logo is a blue circle with white lines inside. The text above the logo says "K233411 Page 5 of 5". The address is "1601 West River Road North Minneapolis, MN 55411".
Sterility, Packaging and Distribution
The Folysil® Silicone Catheters were validated to be sterilized using ethylene oxide in accordance with ANSVAAMI/ISO 11135:2014. To support the claimed shelf life, the Folysil Silicone Catheters were subjected to bench performance testing, transportation testing and package integrity testing to demonstrate that the product and package would be undamaged throughout the product life and maintain device sterility.
VIII. CONCLUSIONS
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicates.
§ 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.