(72 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a standard urinary catheter, with no mention of AI or ML capabilities.
No.
A urinary catheter, though it performs a bodily function, does not typically 'treat' a disease or condition in the way a therapeutic device would. It is used for drainage, which is a supportive function rather than a curative or therapeutic one.
No
The FLUME catheter is intended for bladder drainage, which is a therapeutic function, not a diagnostic one. The provided text indicates its purpose is to drain urine, not to identify or monitor a medical condition.
No
The device description clearly outlines a physical catheter made of polyurethane-based polymers with a dual lumen tube and an inflatable balloon. This is a hardware device, not software.
Based on the provided information, the FLUME catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "bladder drainage via urethral or suprapubic route." This is a direct therapeutic or management function, not a diagnostic one.
- Device Description: The description details a physical device for draining urine, not for analyzing biological samples to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing urine or any other biological sample for diagnostic purposes. The device's function is purely mechanical drainage.
- Performance Studies: The performance studies focus on biocompatibility and bacterial endotoxin testing, which are relevant to the safety and function of a physical medical device, not the performance of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The FLUME catheter does not perform this function.
N/A
Intended Use / Indications for Use
The FLUME catheter is intended for bladder drainage via urethral or suprapubic route.
Product codes (comma separated list FDA assigned to the subject device)
EZL, KOB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder
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)
- 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,
- Sensitization,
- Irritation,
- Acute Systemic Toxicity,
- Subacute Systemic Toxicity,
- Material Mediated Pyrogenicity
- Subcutaneous Implantation,
- Genotoxicity.
- Bacterial endotoxin testing (BET) was conducted to ensure the device meets pyrogen limit specifications.
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.
FLUME catheter K212151
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
§ 876.5130 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The Department of Health & Human Services seal is a stylized representation of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square.
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.
1
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
2
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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3
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 560
Stillwater, MN 55082 |
| Telephone: | 715-549-6035 |
| SUBMISSION CONTACT PERSON: | Elaine Duncan, MSME, RAC, FAIMBE
President, 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
4
- 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.