(117 days)
Not Found
No
The description focuses on the physical components and function of a standard urinary catheter, with no mention of AI or ML capabilities.
No
The device is described as aiding in the drainage of urine, which is a supportive function, not a therapeutic treatment for a disease or condition.
No
The device is described as a catheter "intended for the drainage of the urinary tract," which is a therapeutic function, not a diagnostic one. There is no mention of it being used to detect or identify a medical condition.
No
The device description clearly states it is a physical catheter made of polyurethane-based polymers with a balloon and lumens, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "drainage of the urinary tract." This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a physical device (catheter) used for drainage, not for analyzing samples from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like urine itself for diagnostic markers), image processing, AI/ML, or any other technology typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on the physical and functional aspects of the catheter (biocompatibility, sterilization, performance testing), not on the accuracy of a diagnostic result.
In vitro diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The FLUME catheter is a medical device used within the body for a therapeutic purpose (drainage).
N/A
Intended Use / Indications for Use
The FLUME catheter is intended for the drainage of the urinary tract.
Product codes (comma separated list FDA assigned to the subject device)
EZL
Device Description
The FLUME catheter is intended for the drainage of the urinary tract. The FLUME catheter is a sterile indwelling urinary catheter intended for single use. The FLUME catheter is made using polyurethane-based polymers. The catheter has an inflatable retention balloon attached to the catheter has a dual lumen tube. The larger lumen is for draining urine from the urinary tract. 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 size 14 Fr with a smooth shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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)
Non-clinical testing was performed.
- 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.
- Sterilization validation was conducted per the following FDA-recognized standards: ●
- ISO 11137-1:2006/(R)2015, Sterilization of health care products Radiation Part 1: . Requirements for development, validation and routine control of a sterilization process for medical devices.
- . ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- . Transportation simulation, package integrity and shelf-life were conducted to demonstrate that the subject device packaging materials can withstand the rigors of shipping and distribution and maintain the integrity of the sterile barrier during transportation and its proposed shelf life. Accelerated aging was performed in conformance with ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- . Performance/Functional testing was conducted per ASTM F623-19 Standard Performance Specification for Foley Catheter.
CONCLUSION: The non-clinical testing provided support that the FLUME catheter is substantially equivalent to the predicate device.
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 3, 2021
The Flume Catheter Company, Ltd. % Elaine Duncan, MS.ME, RAC, FAIMBE President Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082
Re: K212151
Trade/Device Name: FLUME catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: September 29, 2021 Received: September 30, 2021
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
Page 2
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, 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 the drainage of the urinary tract.
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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3
510(K) SUMMARY FLUME catheter
Submitted on behalf of:
| Company Name:
Contact Name: | The Flume Catheter Company Ltd.
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 |
| CONTACT PERSON: | Elaine Duncan, MSME, RAC, FAIMBE
President, Paladin Medical, Inc. |
| DATE PREPARED: | November 3, 2021 |
| TRADE NAME: | FLUME catheter |
| COMMON NAME: | Catheter, Retention Type, Balloon |
| REGULATION NAME: | Urological Catheter and Accessories |
| REGULATION NUMBER: | 876.5130 |
| REGULATORY CLASS: | II |
| PRODUCT CODE: | EZL |
PREDICATE DEVICE:
Teleflex Rusch All-Silicone Foley Catheter (K980870)
DESCRIPTION of the DEVICE:
The FLUME catheter is intended for the drainage of the urinary tract. The FLUME catheter is a sterile indwelling urinary catheter intended for single use. The FLUME catheter is made using polyurethane-based polymers. The catheter has an inflatable retention balloon attached to the catheter has a dual lumen tube. The larger lumen is for draining urine from the urinary tract. 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 size 14 Fr with a smooth shaft.
INDICATIONS FOR USE:
The FLUME catheter is intended for the drainage of the urinary tract.
SUBSTANTIALLY EQUIVALENT TO:
The FLUME catheter is substantially equivalent to Teleflex Rusch All-Silicone Foley Catheter K980870.
4
Comparison of Technological Characteristics with Predicate Device
| Attribute | Rusch Silicone Foley
Catheter | FLUME catheter | Similarities and
Differences |
|----------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Catheter, Retention
Type, Balloon | Catheter,
RetentionType,
Balloon | SAME |
| Produce Code | EZL | EZL | SAME |
| Regulation Number | 876.5130 | 876.5130 | SAME |
| Class | 2 | 2 | SAME |
| Indication for Use | The Rusch Silicone
Foley is used to drain
fluids to and from the
urinary tract | The FLUME catheter
is intended for the
drainage of the
urinary tract | FLUME catheter is
only offered as a
two-lumen catheter,
drainage only |
| Intended Population | Male or female | Male or female | SAME |
| Lumen | Two-way: lumen to
fill balloon, lumen to
drain bladder. | Two-way: lumen to fill
balloon, lumen to
drain bladder | SAME |
| Indwelling Time | Maximum indwell
time of 29 days | Maximum indwell
time of 29 days | SAME |
| Single use or reusable | Single use | Single use | SAME |
| Size Ranges | Shaft sizes 8Fr to
26Fr, Net effective
length 285mm for the
standard Teleflex
Rusch. | Shaft size 14Fr,
i.e.,outer diameter
of 4.7mm. Net
effective length of
315mm. | The difference in
length does not affect
the safety and
effectiveness
compared to the
predicate device. |
| Balloon Volume | 5cm3 | 5cm3 | SAME |
| Balloon positioning | Below/proximal of the
catheter tip and drain
holes | Envelops catheter
tip and positioned
lateral to drain
holes. | The FLUME balloon
is positioned so that
it envelops the tip at
the time of inflation,
cushioning the
bladder wall on
emptying and aids
full drainage of the
bladder. |
| Balloon attachment | Bonded to catheter
shaft, around full
circumference of
both ends of the
balloon component | Bonded to
cathetershaft for
half the
circumference of
both ends of the
balloon component | Testing shows
differences do not
affect safety and
effectiveness
compared to the
predicate device. |
| Sold Sterile and Method | Ethylene Oxide 10-6
SAL | Gamma; ISO 11137-
2; 10-6 SAL | Met requirements |
| Biocompatibility/materials | Silicone | ISO 10993;
polyurethanes | Materials differences
do not introduce new
risks, meets ISO
10993 |
| Tip shape | Rounded, tapered | Rounded, tapered | SAME |
| Drain holes | Two opposite
eyeholes at distal
end | Two opposite
eyeholes at distal end | SAME |
| Drainage connector | Funnel | Funnel | SAME |
| Check valve | Luer activated
valve | Luer activated
valve | SAME |
5
SUMMARY of NON CLINICAL TESTING:
- 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.
- Sterilization validation was conducted per the following FDA-recognized standards: ●
- ISO 11137-1:2006/(R)2015, Sterilization of health care products Radiation Part 1: . Requirements for development, validation and routine control of a sterilization process for medical devices.
- . ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- . Transportation simulation, package integrity and shelf-life were conducted to demonstrate that the subject device packaging materials can withstand the rigors of shipping and distribution and maintain the integrity of the sterile barrier during transportation and its proposed shelf life. Accelerated aging was performed in conformance with ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- . Performance/Functional testing was conducted per ASTM F623-19 Standard Performance Specification for Foley Catheter.
CONCLUSION: The non-clinical testing provided support that the FLUME catheter is substantially equivalent to the predicate device.