(170 days)
Not Found
No
The summary describes an optical sensor measuring turbidity and transmitting data, but there is no mention of AI or ML being used for analysis, interpretation, or decision support. The system provides a "turbidity score" as a supplement to visual examination, not an AI-driven diagnosis or prediction.
No
The device is described as a "tabletop passive drainage system" that "enables drainage and measures turbidity," acting as a supplement to visual examination. The intended use explicitly states it "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." It monitors and transmits data for healthcare professionals, rather than directly treating a condition or restoring function.
No
The "Intended Use / Indications for Use" section explicitly states, "This system is not intended to provide diagnostic information."
No
The device description explicitly states the system is comprised of three main components: Sensor, Drain Set, and Patient Monitoring Software. The Sensor and Drain Set are hardware components used by the patient.
Based on the provided information, the CloudCath System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the system "is not intended to provide diagnostic information." It is described as a supplement to visual examination and a tool for monitoring turbidity, not for diagnosing a condition.
- Function: The device measures turbidity in dialysate effluent. While changes in turbidity can be indicative of issues, the device itself doesn't perform a diagnostic test on a biological sample to identify a disease or condition.
- Lack of Diagnostic Claims: The documentation avoids making any claims about diagnosing peritonitis or other complications based on the turbidity score. It emphasizes that it's a supplement to visual examination and not a substitute for clinical judgment.
- Comparison to Predicate: The predicate device listed (Liberty Cycler and Disposable Cycler Set) is a peritoneal dialysis cycler, which is a therapeutic device, not an IVD.
In summary, the CloudCath System is a monitoring device that provides information about the physical characteristics (turbidity) of the dialysate effluent during peritoneal dialysis. It is not designed or intended to diagnose a disease or condition, which is the core function of an IVD.
N/A
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.
Product codes
FKX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility or at home.
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 performance testing demonstrated that the CloudCath System is safe and effective in monitoring the peritoneal dialysis fluid during a peritoneal dialysis treatment. All tests were successfully completed and did not raise any different questions of safety or effectiveness. Testing included: Packaging performance and aging testing, Functional performance testing, Maintenance of sterile fluid path (sterility) testing, Dimensional verification testing, Complete system performance validation, Cycler compatibility testing of CloudCath System, Hardware fatigue/aging testing, Electrical safety and EMC testing, Analytical Performance testing of turbidity measurements, Method Comparison testing using clinical samples, Reference Intervals/Ranges (Expected Values) testing, Electrical aging testing, Human factors / usability testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.
0
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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)
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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
CloudCath System | Predicate Device
Liberty Cycler and
Disposable Cycler Set
K043363 | Equivalence |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Classification /
Product Code | 21 CFR §876.5630
Peritoneal Dialysis System and
Accessories / FKX | 21 CFR §876.5630
Peritoneal Dialysis System
and Accessories / FKX | SAME |
| 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. | ...is indicated for acute and
chronic peritoneal dialysis. | SAME – Both devices are
indicated for use by patients
undergoing acute and chronic
peritoneal dialysis. |
| Rx or OTC | Rx | Rx | SAME |
| Use Environment | Table-top unit in healthcare and
home environments | Table-top unit in healthcare
and home environments | SAME |
| Patient Population | Patients with acute and chronic
end-stage renal disease
undergoing peritoneal dialysis
(PD) | Patients with acute and
chronic end-stage renal
disease undergoing
peritoneal dialysis (PD) | SAME |
| Usability | Sensor: Multi-use
Drain Set: Single Use | Cycler: Multi-use
Cycler Set: Single Use | SAME |
| Sterilization | Sensor: Not provided sterile
Drain Set: Provided sterile | Cycler: Not provided sterile
Cycler Set: Provided sterile | SAME |
| Power Source | Grounded AC Wall Outlet | Grounded AC Wall Outlet | SAME |
| Mechanism of Action:
Treatment | None, accessory device | Administration of dialysate | Does not raise different
questions of safety or
effectiveness, as no treatment is
being performed by subject
device. |
| | Subject Device
CloudCath System | Predicate Device
Liberty Cycler and Disposable Cycler Set
K043363 | Equivalence |
| Mechanism of Action: Sensing
and Monitoring | Turbidity Monitoring through
Optical Sensing | Ultrafiltration Volume and
Overfill Monitoring through
Pressure Sensing | Both devices use a sensing
technology to measure a
parameter of relevance during
dialysis for the same patient
population; therefore, they do
not raise new questions of
safety and effectiveness. |
| Wireless Data Transfer | Turbidity data to the HCP | Ultrafiltration and Overfill
(including patient entered
vitals) data to the HCP | SAME – Sensors provide data to
the HCP |
| Electrical Safety
Testing | IEC 60601-1 and IEC 60601-1-
11 Testing | Assume Electrical Safety
Testing Completed | Presumably SAME, per FDA
Recognized Standard |
| EMC Testing | IEC 60601-1-2 Testing | Assume EMC Testing
completed | Presumably SAME, per FDA
Recognized Standard |
| Software V/V Testing | Testing in conformance with
IEC 62304 | Assume Software V/V
completed | Presumably SAME, per FDA
Recognized Standard |
| Usability Testing | Testing in conformance with
IEC 62366-1 | Assume Usability Testing
completed | Presumably SAME, per FDA
Recognized Standard |
| Cybersecurity
(Data Transmission) | Design/testing utilizing FDA
Cybersecurity Guidance (2014) | Unknown | Presumably SAME, per FDA
Guidance |
| Performance Testing
(Mechanism of Action) | Optical Sensor Testing and
System Validation Testing | Functional, System
Validation and release
testing completed | Differences supported by
Performance Testing - Bench
(see Section 18) |
| Fluid Contacting Material | Polyvinyl Chloride (PVC)
Co-polyester | Materials similar to other
peritoneal dialysis systems | Similar |
| Biocompatibility | Not applicable - “non-contact”
ISO 10993-1 Classification | Assume Biocompatibility
testing complete | Not required per 10993-1
classification for the CloudCath
System as the device is not
patient contacting, but
mitigation testing was
performed to confirm no drain
fluid backflow. Subject device
use is limited to cyclers with
backflow mitigation measures. |
| Principal of Operation | ...is used to enable effluent
drainage as needed during the
drain phase of an Automated
Peritoneal Dialysis (APD)
treatment. | ...is used to enable effluent
drainage as needed during
the drain phase of an
Automated Peritoneal
Dialysis (APD) treatment. | SAME |
| Connections | ...connects to the cycler set
drain line and drainage
receptacle. | Disposable Cycler Set
connects to cycler, patient
catheter and drainage
receptacle | SAME |
Substantial Equivalence Table
6
Traditional 510(k) Premarket Notification Page 4 of 5 Peritoneal Dialysis Drain Set Monitoring System
CloudCath
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 | ||
| (Drain Set, Sensor) | ASTM D4332, ASTM D4169, ASTM F1980 | Pass / Did not raise any different |
| questions of safety or effectiveness | ||
| Functional performance testing | ||
| (mechanical characteristics and structural | ||
| integrity testing) | Visual inspection, clamp test, leak test, tensile test, kink | |
| test, pressure test | Pass / Did not raise any different | |
| questions of safety or effectiveness | ||
| Maintenance of sterile fluid path (sterility) | ||
| testing (Drain Set) | Microbial aerosol challenge test per ISO 11607-1 | Pass / Did not raise any different |
| questions of safety or effectiveness | ||
| Dimensional verification testing | ||
| (Engineering Analysis and Type Testing) | Verification of device features including inner diameter, | |
| outer diameter and durometer | Pass / Did not raise any different | |
| questions of safety or effectiveness | ||
| Complete system performance validation | End-to-end performance testing of complete CloudCath | |
| System in simulated-use environment | Pass / Did not raise any different | |
| questions of safety or effectiveness | ||
| Cycler compatibility testing of CloudCath | ||
| System | Compatibility testing of CloudCath System with | |
| compatible cyclers (Force-to-connect test, compatibility | ||
| testing with and without CloudCath System, backflow, | ||
| and variety of flow settings test) | Pass / Did not raise any different | |
| questions of safety or effectiveness | ||
| Hardware fatigue/aging testing | Fatigue testing of Sensor and Drain Set | Pass / Did not raise any different |
| questions of safety or effectiveness | ||
| Electrical safety and EMC testing | Compliance testing per IEC 60601-1, IEC 60601-1-2, IEC | |
| 60601-1-11 | Pass / Did not raise any different | |
| questions of safety or effectiveness | ||
| Analytical Performance testing of turbidity | ||
| measurements | Testing to verify turbidity measurements to ensure | |
| limits of detection, bias, and precision. Also included | ||
| static and dynamic flow testing | Pass / Did not raise any different | |
| questions of safety or effectiveness | ||
| Method Comparison testing using clinical | ||
| samples | Testing to verify turbidity measurements by | |
| comparability to a comparative method using clinical | ||
| samples | Pass / Did not raise any different | |
| questions of safety or effectiveness | ||
| Reference Intervals/Ranges (Expected | ||
| Values) testing | Establishing reference intervals/ranges of the | |
| CloudCath System Turbidity Score with clinical samples | Pass / Did not raise any different | |
| questions of safety or effectiveness | ||
| Electrical aging testing | Evaluation of aging of the measurement systems of the | |
| Sensor | Pass / Did not raise any different | |
| questions of safety or effectiveness | ||
| Human factors / usability testing | Formative and summative evaluations of CloudCath | |
| System in accordance with ISO 62366 and FDA | ||
| Guidance | Pass / Did not raise any different | |
| 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.