(117 days)
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.
The provided text is a 510(k) summary for the FLUME catheter, which is a urological catheter. It discusses the device's indications for use, its comparison to a predicate device (Teleflex Rusch All-Silicone Foley Catheter K980870), and the non-clinical testing performed to demonstrate substantial equivalence.
However, the document does not contain any information about acceptance criteria and the study that proves the device meets those criteria for an AI/ML-driven medical device. Specifically, there is no mention of:
- AI/ML performance metrics (e.g., sensitivity, specificity, AUC)
- Sample sizes for test or training sets for an AI model
- Data provenance for AI/ML data
- Expert ground truth establishment for AI/ML models
- Adjudication methods for AI/ML ground truth
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies
- Standalone AI algorithm performance
- Types of ground truth for AI/ML (e.g., pathology, outcomes data)
- How ground truth for a training set was established for an AI model
The FLUME catheter is a physical medical device, and the testing described (Biocompatibility, Sterilization Validation, Transportation simulation/package integrity/shelf-life, and Performance/Functional testing per ASTM F623-19) are standard non-clinical tests for such devices to demonstrate physical and biological safety and performance, not AI/ML algorithm performance.
Therefore, I cannot extract the requested information based on the provided input. The document does not describe a study involving an AI/ML component.
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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.
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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
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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 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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510(K) SUMMARY FLUME catheter
Submitted on behalf of:
| Company Name:Contact Name: | The Flume Catheter Company Ltd.Roger Holmes |
|---|---|
| Address: | The Granary, Mill HouseFrensham, Farnham, GU10 3EE,United Kingdom |
| Telephone: | 44(0) 207 808 9125 |
| by: | Paladin Medical, Inc.PO Box 560Stillwater, MN 55082 |
| Telephone: | 715-549-6035 |
| CONTACT PERSON: | Elaine Duncan, MSME, RAC, FAIMBEPresident, 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.
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Comparison of Technological Characteristics with Predicate Device
| Attribute | Rusch Silicone FoleyCatheter | FLUME catheter | Similarities andDifferences |
|---|---|---|---|
| Classification Name | Catheter, RetentionType, 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 SiliconeFoley is used to drainfluids to and from theurinary tract | The FLUME catheteris intended for thedrainage of theurinary tract | FLUME catheter isonly offered as atwo-lumen catheter,drainage only |
| Intended Population | Male or female | Male or female | SAME |
| Lumen | Two-way: lumen tofill balloon, lumen todrain bladder. | Two-way: lumen to fillballoon, lumen todrain bladder | SAME |
| Indwelling Time | Maximum indwelltime of 29 days | Maximum indwelltime of 29 days | SAME |
| Single use or reusable | Single use | Single use | SAME |
| Size Ranges | Shaft sizes 8Fr to26Fr, Net effectivelength 285mm for thestandard TeleflexRusch. | Shaft size 14Fr,i.e.,outer diameterof 4.7mm. Neteffective length of315mm. | The difference inlength does not affectthe safety andeffectivenesscompared to thepredicate device. |
| Balloon Volume | 5cm3 | 5cm3 | SAME |
| Balloon positioning | Below/proximal of thecatheter tip and drainholes | Envelops cathetertip and positionedlateral to drainholes. | The FLUME balloonis positioned so thatit envelops the tip atthe time of inflation,cushioning thebladder wall onemptying and aidsfull drainage of thebladder. |
| Balloon attachment | Bonded to cathetershaft, around fullcircumference ofboth ends of theballoon component | Bonded tocathetershaft forhalf thecircumference ofboth ends of theballoon component | Testing showsdifferences do notaffect safety andeffectivenesscompared to thepredicate device. |
| Sold Sterile and Method | Ethylene Oxide 10-6SAL | Gamma; ISO 11137-2; 10-6 SAL | Met requirements |
| Biocompatibility/materials | Silicone | ISO 10993;polyurethanes | Materials differencesdo not introduce newrisks, meets ISO10993 |
| Tip shape | Rounded, tapered | Rounded, tapered | SAME |
| Drain holes | Two oppositeeyeholes at distalend | Two oppositeeyeholes at distal end | SAME |
| Drainage connector | Funnel | Funnel | SAME |
| Check valve | Luer activatedvalve | Luer activatedvalve | SAME |
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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.
§ 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.