(72 days)
The FLUME catheter is intended for bladder drainage via urethral or suprapubic route.
The FLUME catheter is intended for the drainage of urine from the bladder. The FLUME catheter is a sterile indwelling urinary catheter intended for single use. The FLUME catheter is made using polyurethanebased polymers. The catheter has an inflatable retention balloon attached to the catheter shaft. The catheter has a dual lumen tube. The larger lumen is for urine drainage. The smaller lumen is used to inflate and deflate the balloon with sterile water. The distal end has two opposite eye holes, which are used for drainage. The product is available in standard sizes. The catheter may be placed following the institutions' standard practice for either urethral bladder drainage or via percutaneous suprapubic access to the bladder.
This document is a 510(k) summary for the FLUME catheter, which seeks to expand its indications for use to include suprapubic drainage. This is a special 510(k) submission, meaning it relies heavily on the predicate device (FLUME catheter K212151) as the current device has no changes in design, materials, or manufacturing processes.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against specific criteria for the expanded indication of suprapubic use. Instead, it relies on the predicate device's established performance and extensive non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (Biocompatibility): The device should not cause adverse biological reactions when in contact with the body. | Biocompatibility testing from the predicate device (FLUME catheter K212151) was leveraged. The performed tests include: • Cytotoxicity • Sensitization • Irritation • Acute Systemic Toxicity • Subacute Systemic Toxicity • Material Mediated Pyrogenicity • Subcutaneous Implantation • Genotoxicity All tests align with ISO 10993-1. Conclusion: Biocompatibility evaluation expectations for suprapubic use are met. |
| Pyrogenicity: The device should be free of pyrogens to prevent fever. | Bacterial Endotoxin Testing (BET) was conducted and confirmed the device meets pyrogen limit specifications. |
| Functional Equivalence: The FLUME catheter, when used for suprapubic drainage, should function equivalently to its previously cleared urethral use and to the predicate device. | The submission states: "There are no changes or differences made to the FLUME catheter to extend the indication for use to include suprapubic drainage. The only change in this Special 510(k) is to the current indication for use and instructions for use." And "According to the risk assessment, there is no difference to the patient when the FLUME catheter is placed suprapubic." This implies that the existing performance (drainage, retention, material integrity) is considered adequate for the new route of administration due to the lack of device changes. The device maintains the following features of the predicate: • Sterile indwelling urinary catheter for single use. • Made of polyurethane-based polymers. • Inflatable retention balloon. • Dual lumen (larger for urine drainage, smaller for balloon inflation/deflation). • Two opposite eye holes for drainage. • Available in standard sizes. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a new "test set" in the traditional sense of a clinical or ex-vivo study with a defined sample size for the expanded indication.
- Sample Size: Not applicable/not provided for a specific test set related to the suprapubic indication as it's a Special 510(k) leveraging prior data.
- Data Provenance: The biocompatibility data is "leveraged from the predicate device." This suggests the data was generated previously for the predicate device, but its original provenance (e.g., country, retrospective/prospective) is not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert-established ground truth for a test set. The submission relies on non-clinical data and risk assessment.
4. Adjudication Method for the Test Set
Not applicable. There is no described test set requiring adjudication in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states "SUMMARY of NON-CLINICAL TESTING." There is no mention of an MRMC comparative effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical urological catheter, not an algorithm or AI-based device.
7. The Type of Ground Truth Used
The "ground truth" for the safety aspects (biocompatibility, pyrogenicity) is based on standardized testing protocols (e.g., ISO 10993-1 for biocompatibility, bacterial endotoxin testing for pyrogenicity) and internal risk assessments concluding equivalence. For functional equivalence, the ground truth is the established performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device that requires a training set.
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June 29, 2023
Flume Catheter Company, Ltd. % Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082
Re: K231101
Trade/Device Name: FLUME catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL, KOB Dated: Mav 26, 2023 Received: May 30, 2023
Dear Elaine Duncan:
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. 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 located 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.
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.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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,
Jessica K. Nguyen -S
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)
Device Name FLUME catheter
Indications for Use (Describe)
The FLUME catheter is intended for bladder drainage via urethral or suprapubic route.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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SPECIAL 510(k)
SUMMARY
| Submitted on behalf of: | The Flume Catheter Company Ltd.Company Contact Name: Roger Holmes |
|---|---|
| Address: | The Granary, Mill House Frensham,Farnham, GU10 3EE, United Kingdom |
| Telephone: | 44(0) 207 808 9125 |
| by: | Paladin Medical, Inc.PO Box 560Stillwater, MN 55082 |
| Telephone: | 715-549-6035 |
| SUBMISSION CONTACT PERSON: | Elaine Duncan, MSME, RAC, FAIMBEPresident, Paladin Medical, Inc. |
| DATE PREPARED: | June 28, 2023 |
| TRADE NAME: | FLUME catheter |
| COMMON NAME: | Catheter, Retention Type, Balloon & Suprapubic |
| REGULATION NAME: | Urological Catheter and Accessories |
| REGULATION NUMBER: | 876.5130 |
| REGULATORY CLASS: | II |
| PRODUCT CODE: | EZL, KOB |
PREDICATE DEVICE:
FLUME catheter K212151. The predicate device has not been subject to a design-related recall.
DESCRIPTION of the DEVICE:
The FLUME catheter is intended for the drainage of urine from the bladder. The FLUME catheter is a sterile indwelling urinary catheter intended for single use. The FLUME catheter is made using polyurethanebased polymers. The catheter has an inflatable retention balloon attached to the catheter shaft. The catheter has a dual lumen tube. The larger lumen is for urine drainage. The smaller lumen is used to inflate and deflate the balloon with sterile water. The distal end has two opposite eye holes, which are used for drainage. The product is available in standard sizes. The catheter may be placed following the institutions' standard practice for either urethral bladder drainage or via percutaneous suprapubic access to the bladder.
INDICATIONS FOR USE:
The FLUME catheter is intended for bladder drainage via urethral or suprapubic route.
SUBSTANTIALLY EQUIVALENT TO:
The FLUME catheter is substantially equivalent to FLUME catheter, K212151. There are no changes or differences made to the FLUME catheter to extend the indication for use to include suprapubic drainage. The only change in this Special 510(k) is to the current indication for use and instructions for use. According to the risk assessment, there is no difference to the patient when the FLUME catheter is placed suprapubic.
SUMMARY of NON_CLINICAL TESTING:
- . Biocompatibility testing from the predicate device was leveraged for the subject device since the materials and method of manufacture are identical. The biocompatibility testing endpoints completed for the predicate device align with the biocompatibility evaluation expectations to support suprapubic use. Biocompatibility was conducted per International Standard ISO 10993-1. "Biological Evaluation of medical devices – Part 1: Evaluation and Testing within a risk management process:
- Cytotoxicity, o
- Sensitization, O
- Irritation, O
- Acute Systemic Toxicity, o
- Subacute Systemic Toxicity, O
- Material Mediated Pyrogenicity O
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- Subcutaneous Implantation, о
- O Genotoxicity.
- Bacterial endotoxin testing (BET) was conducted to ensure the device meets pyrogen limit • specifications.
CONCLUSION: The FLUME catheter is substantially equivalent to the predicate device.
§ 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.