CloudCath Peritoneal Dialysis Drain Set Monitoring System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". February 9, 2022 CloudCath Brian Fisher Chief Operating Officer 665 3rd Street, Suite 250 San Francisco, California 94107 Re: K212658 > Trade/Device Name: CloudCath Peritoneal Dialysis Drain Set Monitoring System Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FKX Dated: January 4, 2022 Received: January 10, 2022 Dear Brian Fisher: 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. You must comply with all the Act's {1}------------------------------------------------ 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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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, Glenn B. Bell, Ph.D. Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant 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) K212658 Device Name CloudCath Peritoneal Dialysis Drain Set Monitoring System (also known as the CloudCath System) Indications for Use (Describe) The CloudCath System is intended for patients undergoing acute and chronic peritoneal dialysis. The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent as a supplement to visual examination of cloudiness in dialysate drain is indicated for use by patients undergoing continuous cycling peritoneal dialysis (CCPD) in a healthcare facility or at home. The optical sensor has associated hardware and software components to allow for data transmission to a healthcare professional. This system is not intended to provide diagnostic information and is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Section 5: 510(k) Summary This summary is being submitted in accordance with the requirements of 21 CFR 807.92. ### 510(k) Owner Information: CloudCath 665 3rd St, Suite 250 San Francisco CA 94107 (415) 484-4896 Submission Correspondent: Brian Fisher Chief Operating Officer (415) 651-3393 Brian@CloudCath.com ### Device Information: | Trade Name: | CloudCath Peritoneal Dialysis Drain Set Monitoring System | |-----------------------|-----------------------------------------------------------| | Common Name: | Peritoneal dialysis drain set monitoring device | | Regulation: | 21 CFR 876.5630 | | Classification Panel: | Gastroenterology and Urology | | Device Type: | Peritoneal dialysis system and accessories | | Device Class: | II | | Product Code: | FKX | ### Predicate Device: Trade/Device Name: Liberty Cycler and Disposable Cycler Set Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC Regulation Number: 21 CFR§ 876.5630 Regulation Description: Peritoneal Dialysis System and Accessories Device Class: II Product Code: FKX 510(k) Number: K043363 510(k) Clearance date: March 31, 2005 ### Date Prepared: August 18, 2021 Section 5: 510(k) Summary {4}------------------------------------------------ ### Device Description: The CloudCath Peritoneal Dialysis Drain Set Monitoring System (CloudCath System) is a tabletop passive drainage system used as an attachment during a peritoneal dialysis (PD) treatment and indicated for use by patients with acute and chronic end-stage renal disease undergoing PD. The CloudCath System connects directly to the end of the cycler tubing set drain line in order to enable draining and contains an optical sensor that measures turbidity, reported as a turbidity score, in peritoneal dialysate effluent as a supplement to visual examination of cloudiness in dialysate drain lines. The system is indicated for use with validated peritoneal dialysis cyclers in healthcare facilities or home use environments. The optical sensor has associated hardware and software components to allow for remote data transmission by healthcare providers. The CloudCath System is comprised of three main components: Sensor, Drain Set and Patient Monitoring Software. The Drain Set and the Sensor are components used by the patient. The Patient Monitoring Software is a cloud-based system used by a healthcare professional to view the results from the patient's use of the CloudCath System. ## Intended Use / Indications for Use: The CloudCath System is intended for patients undergoing acute and chronic peritoneal dialysis. The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent as a supplement to visual examination of cloudiness in dialysate drain lines. The system is indicated for use by patients undergoing continuous cycling peritoneal dialysis (CCPD) in a healthcare facility or at home. The optical sensor has associated hardware and software components to allow for data transmission to a healthcare professional. This system is not intended to provide diagnostic information and is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways. # Comparison of Intended Use, Indications for Use and Technological Characteristics with the Predicate Devices: Similar to the Liberty Cycler and Disposable Cycler Set (the predicate device), the CloudCath System is intended for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis in a healthcare facility or at home. Results of testing demonstrated that the differences in the design, materials and function of the subject device do not raise different questions of safety and effectiveness and; therefore, the subject device is substantially equivalent to the predicate device. {5}------------------------------------------------ | | Subject Device<br>CloudCath System | Predicate Device<br>Liberty Cycler and<br>Disposable Cycler Set<br>K043363 | Equivalence | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Classification /<br>Product Code | 21 CFR §876.5630<br>Peritoneal Dialysis System and<br>Accessories / FKX | 21 CFR §876.5630<br>Peritoneal Dialysis System<br>and Accessories / FKX | SAME | | Indications for Use | The CloudCath System is<br>intended for patients<br>undergoing acute and chronic<br>peritoneal dialysis.<br><br>The CloudCath System enables<br>drainage and measures<br>turbidity, reported as a numeric<br>score, in peritoneal dialysate<br>effluent as a supplement to<br>visual examination of<br>cloudiness in dialysate drain<br>lines. The system is indicated<br>for use by patients undergoing<br>continuous cycling peritoneal<br>dialysis (CCPD) in a healthcare<br>facility or at home. The optical<br>sensor has associated hardware<br>and software components to<br>allow for data transmission to a<br>healthcare professional.<br><br>This system is not intended to<br>provide diagnostic information<br>and is not intended to be a<br>substitute for good clinical<br>management practices, nor does<br>its operation create decisions or<br>treatment pathways. | ...is indicated for acute and<br>chronic peritoneal dialysis. | SAME – Both devices are<br>indicated for use by patients<br>undergoing acute and chronic<br>peritoneal dialysis. | | Rx or OTC | Rx | Rx | SAME | | Use Environment | Table-top unit in healthcare and<br>home environments | Table-top unit in healthcare<br>and home environments | SAME | | Patient Population | Patients with acute and chronic<br>end-stage renal disease<br>undergoing peritoneal dialysis<br>(PD) | Patients with acute and<br>chronic end-stage renal<br>disease undergoing<br>peritoneal dialysis (PD) | SAME | | Usability | Sensor: Multi-use<br>Drain Set: Single Use | Cycler: Multi-use<br>Cycler Set: Single Use | SAME | | Sterilization | Sensor: Not provided sterile<br>Drain Set: Provided sterile | Cycler: Not provided sterile<br>Cycler Set: Provided sterile | SAME | | Power Source | Grounded AC Wall Outlet | Grounded AC Wall Outlet | SAME | | Mechanism of Action:<br>Treatment | None, accessory device | Administration of dialysate | Does not raise different<br>questions of safety or<br>effectiveness, as no treatment is<br>being performed by subject<br>device. | | | Subject Device<br>CloudCath System | Predicate Device<br>Liberty Cycler and Disposable Cycler Set<br>K043363 | Equivalence | | Mechanism of Action: Sensing<br>and Monitoring | Turbidity Monitoring through<br>Optical Sensing | Ultrafiltration Volume and<br>Overfill Monitoring through<br>Pressure Sensing | Both devices use a sensing<br>technology to measure a<br>parameter of relevance during<br>dialysis for the same patient<br>population; therefore, they do<br>not raise new questions of<br>safety and effectiveness. | | Wireless Data Transfer | Turbidity data to the HCP | Ultrafiltration and Overfill<br>(including patient entered<br>vitals) data to the HCP | SAME – Sensors provide data to<br>the HCP | | Electrical Safety<br>Testing | IEC 60601-1 and IEC 60601-1-<br>11 Testing | Assume Electrical Safety<br>Testing Completed | Presumably SAME, per FDA<br>Recognized Standard | | EMC Testing | IEC 60601-1-2 Testing | Assume EMC Testing<br>completed | Presumably SAME, per FDA<br>Recognized Standard | | Software V/V Testing | Testing in conformance with<br>IEC 62304 | Assume Software V/V<br>completed | Presumably SAME, per FDA<br>Recognized Standard | | Usability Testing | Testing in conformance with<br>IEC 62366-1 | Assume Usability Testing<br>completed | Presumably SAME, per FDA<br>Recognized Standard | | Cybersecurity<br>(Data Transmission) | Design/testing utilizing FDA<br>Cybersecurity Guidance (2014) | Unknown | Presumably SAME, per FDA<br>Guidance | | Performance Testing<br>(Mechanism of Action) | Optical Sensor Testing and<br>System Validation Testing | Functional, System<br>Validation and release<br>testing completed | Differences supported by<br>Performance Testing - Bench<br>(see Section 18) | | Fluid Contacting Material | Polyvinyl Chloride (PVC)<br>Co-polyester | Materials similar to other<br>peritoneal dialysis systems | Similar | | Biocompatibility | Not applicable - “non-contact”<br>ISO 10993-1 Classification | Assume Biocompatibility<br>testing complete | Not required per 10993-1<br>classification for the CloudCath<br>System as the device is not<br>patient contacting, but<br>mitigation testing was<br>performed to confirm no drain<br>fluid backflow. Subject device<br>use is limited to cyclers with<br>backflow mitigation measures. | | Principal of Operation | ...is used to enable effluent<br>drainage as needed during the<br>drain phase of an Automated<br>Peritoneal Dialysis (APD)<br>treatment. | ...is used to enable effluent<br>drainage as needed during<br>the drain phase of an<br>Automated Peritoneal<br>Dialysis (APD) treatment. | SAME | | Connections | ...connects to the cycler set<br>drain line and drainage<br>receptacle. | Disposable Cycler Set<br>connects to cycler, patient<br>catheter and drainage<br>receptacle | SAME | # Substantial Equivalence Table {6}------------------------------------------------ # Traditional 510(k) Premarket Notification Page 4 of 5 Peritoneal Dialysis Drain Set Monitoring System #### CloudCath K212658 {7}------------------------------------------------ ## Non-Clinical Performance Testing Non-clinical performance testing demonstrated that the CloudCath System is safe and effective in monitoring the peritoneal dialysis fluid during a peritoneal dialysis treatment. The determination of substantial equivalence was based on an assessment of the results from this testing. The table below is a summary of the non-clinical performance testing which was performed. All tests were successfully completed and did not raise any different questions of safety or effectiveness. | Type of Testing Performed | Methods / Standards Used | Results / Conclusions | |----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Packaging performance and aging testing<br>(Drain Set, Sensor) | ASTM D4332, ASTM D4169, ASTM F1980 | Pass / Did not raise any different<br>questions of safety or effectiveness | | Functional performance testing<br>(mechanical characteristics and structural<br>integrity testing) | Visual inspection, clamp test, leak test, tensile test, kink<br>test, pressure test | Pass / Did not raise any different<br>questions of safety or effectiveness | | Maintenance of sterile fluid path (sterility)<br>testing (Drain Set) | Microbial aerosol challenge test per ISO 11607-1 | Pass / Did not raise any different<br>questions of safety or effectiveness | | Dimensional verification testing<br>(Engineering Analysis and Type Testing) | Verification of device features including inner diameter,<br>outer diameter and durometer | Pass / Did not raise any different<br>questions of safety or effectiveness | | Complete system performance validation | End-to-end performance testing of complete CloudCath<br>System in simulated-use environment | Pass / Did not raise any different<br>questions of safety or effectiveness | | Cycler compatibility testing of CloudCath<br>System | Compatibility testing of CloudCath System with<br>compatible cyclers (Force-to-connect test, compatibility<br>testing with and without CloudCath System, backflow,<br>and variety of flow settings test) | Pass / Did not raise any different<br>questions of safety or effectiveness | | Hardware fatigue/aging testing | Fatigue testing of Sensor and Drain Set | Pass / Did not raise any different<br>questions of safety or effectiveness | | Electrical safety and EMC testing | Compliance testing per IEC 60601-1, IEC 60601-1-2, IEC<br>60601-1-11 | Pass / Did not raise any different<br>questions of safety or effectiveness | | Analytical Performance testing of turbidity<br>measurements | Testing to verify turbidity measurements to ensure<br>limits of detection, bias, and precision. Also included<br>static and dynamic flow testing | Pass / Did not raise any different<br>questions of safety or effectiveness | | Method Comparison testing using clinical<br>samples | Testing to verify turbidity measurements by<br>comparability to a comparative method using clinical<br>samples | Pass / Did not raise any different<br>questions of safety or effectiveness | | Reference Intervals/Ranges (Expected<br>Values) testing | Establishing reference intervals/ranges of the<br>CloudCath System Turbidity Score with clinical samples | Pass / Did not raise any different<br>questions of safety or effectiveness | | Electrical aging testing | Evaluation of aging of the measurement systems of the<br>Sensor | Pass / Did not raise any different<br>questions of safety or effectiveness | | Human factors / usability testing | Formative and summative evaluations of CloudCath<br>System in accordance with ISO 62366 and FDA<br>Guidance | Pass / Did not raise any different<br>questions of safety or effectiveness | ### Conclusion The CloudCath System is a Peritoneal Dialysis Drain Set Monitoring Device per 21 CFR 876.5630 and Product Code FKX. It has the same intended use and similar technological characteristics as the predicate device, the Liberty Cycler and Disposable Cycler Set (K043363). The differences between the CloudCath System and the predicate were determined to not raise different questions of safety and effectiveness and testing demonstrated that the CloudCath System is as safe and effective as the predicate device. Therefore, the CloudCath System is concluded to be substantially equivalent to the predicate device.