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.

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.

AI/ML Overview

The CloudCath Peritoneal Dialysis Drain Set Monitoring System (CloudCath System) measures turbidity, reported as a numeric score, in peritoneal dialysate effluent as a supplement to visual examination of cloudiness in dialysate drain lines for patients undergoing continuous cycling peritoneal dialysis (CCPD). While this document does not contain an "acceptance criteria" table in the traditional sense for specific performance metrics (e.g., sensitivity, specificity), it outlines the non-clinical performance testing conducted to demonstrate the device's safety and effectiveness and its substantial equivalence to a predicate device.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria (Interpreted from "Results / Conclusions") and Reported Device Performance

The document states that all tests were successfully completed and did not raise any different questions of safety or effectiveness. This implies that the acceptance criteria for each test type were met. The "Results / Conclusions" column effectively serves as the reported device performance against implicitly set acceptance criteria for each non-clinical test.

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

2. Sample Sizes Used for the Test Set and Data Provenance

The document mentions "clinical samples" for Method Comparison testing and Reference Intervals/Ranges testing. However, it does not specify the sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective nature). The focus is on non-clinical performance and comparability.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not provided in the document. The ground truth for the analytical and clinical sample testing would likely be based on established laboratory methods for turbidity measurement, rather than expert interpretation in the same way an imaging AI model would use expert readers.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of turbidity measurement, it's unlikely that an adjudication method for human interpretation would be primarily used for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted or described. The device measures turbidity as a supplement to visual examination, and the testing focuses on the instrumental performance and comparability of the turbidity measurements rather than a human-in-the-loop diagnostic improvement.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

The "Analytical Performance testing of turbidity measurements" and "Method Comparison testing using clinical samples" represent evaluations of the device's standalone performance in measuring turbidity. The "algorithm" here refers to the optical sensor's ability to accurately quantify turbidity. The results indicate that the device "Pass[ed]" these tests, implying its standalone performance met the internal criteria for limits of detection, bias, precision, and comparability to a comparative method.

7. Type of Ground Truth Used

The ground truth for the performance testing related to turbidity measurements would be based on:

Reference laboratory methods: For "Method Comparison testing using clinical samples," the ground truth would be the results from a highly accurate and precise comparative method for measuring turbidity in dialysate effluent.
Defined solutions/standards: For "Analytical Performance testing," the ground truth would be precise, known turbidity values in control solutions or standards used for calibration and validation.
Engineering specifications/measurements: For mechanical, electrical, and dimensional testing, the ground truth would be the defined engineering specifications the device is designed to meet, validated by precise measurement tools.

8. Sample Size for the Training Set

This information is not applicable/not provided in the document for the turbidity measurement aspect. The CloudCath System is an optical sensor measuring a physical property (turbidity), not a machine learning model that requires a "training set" in the conventional sense of AI for image interpretation or diagnosis. Its "learning" is based on its optical and electronic design for accurate physical measurement.

9. How the Ground Truth for the Training Set Was Established

As above, this is not applicable for this device in the context of an AI/ML training set. The device's operation is based on established optical measurement principles rather than a trained AI algorithm in the typical machine learning sense. The "ground truth" for its development would be based on physics, engineering, and chemistry principles for accurate turbidity sensing.

Summary

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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

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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

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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.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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

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Device Description:

Intended Use / Indications for Use:

The CloudCath System is intended for patients undergoing acute and chronic peritoneal dialysis.

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.

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	Subject DeviceCloudCath System	Predicate DeviceLiberty Cycler andDisposable Cycler SetK043363	Equivalence
Regulatory Classification /Product Code	21 CFR §876.5630Peritoneal Dialysis System andAccessories / FKX	21 CFR §876.5630Peritoneal Dialysis Systemand Accessories / FKX	SAME
Indications for Use	The CloudCath System isintended for patientsundergoing acute and chronicperitoneal dialysis.The CloudCath System enablesdrainage and measuresturbidity, reported as a numericscore, in peritoneal dialysateeffluent as a supplement tovisual examination ofcloudiness in dialysate drainlines. The system is indicatedfor use by patients undergoingcontinuous cycling peritonealdialysis (CCPD) in a healthcarefacility or at home. The opticalsensor has associated hardwareand software components toallow for data transmission to ahealthcare professional.This system is not intended toprovide diagnostic informationand is not intended to be asubstitute for good clinicalmanagement practices, nor doesits operation create decisions ortreatment pathways.	...is indicated for acute andchronic peritoneal dialysis.	SAME – Both devices areindicated for use by patientsundergoing acute and chronicperitoneal dialysis.
Rx or OTC	Rx	Rx	SAME
Use Environment	Table-top unit in healthcare andhome environments	Table-top unit in healthcareand home environments	SAME
Patient Population	Patients with acute and chronicend-stage renal diseaseundergoing peritoneal dialysis(PD)	Patients with acute andchronic end-stage renaldisease undergoingperitoneal dialysis (PD)	SAME
Usability	Sensor: Multi-useDrain Set: Single Use	Cycler: Multi-useCycler Set: Single Use	SAME
Sterilization	Sensor: Not provided sterileDrain Set: Provided sterile	Cycler: Not provided sterileCycler 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 differentquestions of safety oreffectiveness, as no treatment isbeing performed by subjectdevice.
	Subject DeviceCloudCath System	Predicate DeviceLiberty Cycler and Disposable Cycler SetK043363	Equivalence
Mechanism of Action: Sensingand Monitoring	Turbidity Monitoring throughOptical Sensing	Ultrafiltration Volume andOverfill Monitoring throughPressure Sensing	Both devices use a sensingtechnology to measure aparameter of relevance duringdialysis for the same patientpopulation; therefore, they donot raise new questions ofsafety and effectiveness.
Wireless Data Transfer	Turbidity data to the HCP	Ultrafiltration and Overfill(including patient enteredvitals) data to the HCP	SAME – Sensors provide data tothe HCP
Electrical SafetyTesting	IEC 60601-1 and IEC 60601-1-11 Testing	Assume Electrical SafetyTesting Completed	Presumably SAME, per FDARecognized Standard
EMC Testing	IEC 60601-1-2 Testing	Assume EMC Testingcompleted	Presumably SAME, per FDARecognized Standard
Software V/V Testing	Testing in conformance withIEC 62304	Assume Software V/Vcompleted	Presumably SAME, per FDARecognized Standard
Usability Testing	Testing in conformance withIEC 62366-1	Assume Usability Testingcompleted	Presumably SAME, per FDARecognized Standard
Cybersecurity(Data Transmission)	Design/testing utilizing FDACybersecurity Guidance (2014)	Unknown	Presumably SAME, per FDAGuidance
Performance Testing(Mechanism of Action)	Optical Sensor Testing andSystem Validation Testing	Functional, SystemValidation and releasetesting completed	Differences supported byPerformance Testing - Bench(see Section 18)
Fluid Contacting Material	Polyvinyl Chloride (PVC)Co-polyester	Materials similar to otherperitoneal dialysis systems	Similar
Biocompatibility	Not applicable - “non-contact”ISO 10993-1 Classification	Assume Biocompatibilitytesting complete	Not required per 10993-1classification for the CloudCathSystem as the device is notpatient contacting, butmitigation testing wasperformed to confirm no drainfluid backflow. Subject deviceuse is limited to cyclers withbackflow mitigation measures.
Principal of Operation	...is used to enable effluentdrainage as needed during thedrain phase of an AutomatedPeritoneal Dialysis (APD)treatment.	...is used to enable effluentdrainage as needed duringthe drain phase of anAutomated PeritonealDialysis (APD) treatment.	SAME
Connections	...connects to the cycler setdrain line and drainagereceptacle.	Disposable Cycler Setconnects to cycler, patientcatheter and drainagereceptacle	SAME

Substantial Equivalence Table

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Traditional 510(k) Premarket Notification Page 4 of 5 Peritoneal Dialysis Drain Set Monitoring System

CloudCath

K212658

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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 differentquestions of safety or effectiveness
Functional performance testing(mechanical characteristics and structuralintegrity testing)	Visual inspection, clamp test, leak test, tensile test, kinktest, pressure test	Pass / Did not raise any differentquestions 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 differentquestions 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 differentquestions of safety or effectiveness
Complete system performance validation	End-to-end performance testing of complete CloudCathSystem in simulated-use environment	Pass / Did not raise any differentquestions of safety or effectiveness
Cycler compatibility testing of CloudCathSystem	Compatibility testing of CloudCath System withcompatible cyclers (Force-to-connect test, compatibilitytesting with and without CloudCath System, backflow,and variety of flow settings test)	Pass / Did not raise any differentquestions of safety or effectiveness
Hardware fatigue/aging testing	Fatigue testing of Sensor and Drain Set	Pass / Did not raise any differentquestions of safety or effectiveness
Electrical safety and EMC testing	Compliance testing per IEC 60601-1, IEC 60601-1-2, IEC60601-1-11	Pass / Did not raise any differentquestions of safety or effectiveness
Analytical Performance testing of turbiditymeasurements	Testing to verify turbidity measurements to ensurelimits of detection, bias, and precision. Also includedstatic and dynamic flow testing	Pass / Did not raise any differentquestions of safety or effectiveness
Method Comparison testing using clinicalsamples	Testing to verify turbidity measurements bycomparability to a comparative method using clinicalsamples	Pass / Did not raise any differentquestions of safety or effectiveness
Reference Intervals/Ranges (ExpectedValues) testing	Establishing reference intervals/ranges of theCloudCath System Turbidity Score with clinical samples	Pass / Did not raise any differentquestions of safety or effectiveness
Electrical aging testing	Evaluation of aging of the measurement systems of theSensor	Pass / Did not raise any differentquestions of safety or effectiveness
Human factors / usability testing	Formative and summative evaluations of CloudCathSystem in accordance with ISO 62366 and FDAGuidance	Pass / Did not raise any differentquestions 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.

Regulation Number and Section

§ 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.