(135 days)
Not Found
No
The description focuses on automated control and remote communication of treatment parameters, with no mention of AI/ML for analysis, decision-making, or learning from data. The Sharesource platform explicitly states it is not intended to be a substitute for clinical judgment or create treatment pathways.
Yes
The device is described as "intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis", which clearly indicates a therapeutic purpose.
No
The device is described as an "APD System" intended for "automatic control of dialysis solution exchanges" and not for diagnosing medical conditions. While it allows for the transfer and review of historical treatment data, this is for evaluation of treatment results, not for diagnosis.
No
The device description clearly states the system includes the "Homechoice Claria APD System," which is a cycler (a hardware device for automated peritoneal dialysis), in addition to the "Sharesource Connectivity Platform" software.
Based on the provided information, the Homechoice Claria APD System and the Sharesource Connectivity Platform are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly states that the system is for "automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis." This describes a therapeutic treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the mechanical and software functions of the system for delivering peritoneal dialysis and managing treatment data. It does not mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition based on sample analysis.
The Sharesource platform facilitates the communication and management of treatment parameters and historical data, which supports the clinical management of the patient's dialysis treatment. This is a supporting function for a therapeutic device, not a diagnostic function.
N/A
Intended Use / Indications for Use
Homechoice Claria APD System:
Baxter's Homechoice Claria APD system is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis in the HOME HEALTHCARE ENVIRONMENT including comparable use in professional healthcare facilities.
Sharesource Connectivity Platform for use with the Homechoice Claria APD System:
The Sharesource portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment database to aid in the review, analysis, and evaluation of patients' historical treatment results. This system is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.
Product codes (comma separated list FDA assigned to the subject device)
FKX, 5C6M40, 5CGM01
Device Description
The Homechoice Claria APD System (Claria) is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. The system automatically cycles peritoneal dialysis solution in the amounts and at the times prescribed by a clinician familiar with and well informed about peritoneal dialysis. The clinician may use the Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (Sharesource) to remotely communicate with the Claria cycler. Sharesource allows the transfer of treatment data originating from the treatment device to the clinician for review of historical treatment results. It also allows the clinician to adjust the device settings of the Claria cycler remotely. Changes to the device program by the clinician require the patient to review and accept the changes prior to the implementation of those changes. If the patient does not accept the changes, the Claria cycler will not accept the modified program. Sharesource does not include any real-time monitoring or real-time programming capabilities.
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
pediatric and adult
Intended User / Care Setting
HOME HEALTHCARE ENVIRONMENT including comparable use in professional healthcare facilities.
healthcare professionals
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)
Performance testing was conducted on the Homechoice Claria APD System with Sharesource to evaluate the functional performance of the device. The performance testing confirms that Homechoice Claria is as safe and effective as the HomeChoice/HomeChoice PRO cycler, and that the Sharesource Platform for Claria is as safe and effective as the Sharesource Platform for Amia.
In summary, Claria and Sharesource have successfully implemented performance requirements and subsequent outputs verifying and validating:
- . The design validation meets the user needs and intended use and is substantially equivalent to the predicate.
- . Electrical safety, electromagnetic compatibility, and AIM testing was successfully completed for Claria.
- Risk assessment and risk control measures. Hazard analyses confirm that Claria and Sharesource do not perform in an unexpected or unsafe manner.
- . Labeling, software including cybersecurity, and Human Factors have been successfully implemented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5630 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.
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November 19, 2020
Baxter Healthcare Corporation Brad Roynon Sr. Manager, Regulatory Affairs 25212 W. Illinois Route 120 Round Lake, IL 60073
Re: K201867
Trade/Device Name: Homechoice Claria Automated Peritoneal Dialysis (APD) System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: Class II Product Code: FKX Dated: October 8, 2020 Received: October 19, 2020
Dear Brad Roynon:
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
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statutes and regulations administered by other Federal agencies. 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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,
Carolyn Y. Neuland, Ph.D. Assistant 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201867
Device Name Homechoice Claria APD System &
Sharesource Connectivity Platform for use with the Homechoice Claria APD System
Indications for Use (Describe)
Homechoice Claria APD System:
Baxter's Homechoice Claria APD system is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis in the HOME HEALTHCARE ENVIRONMENT including comparable use in professional healthcare facilities.
Sharesource Connectivity Platform for use with the Homechoice Claria APD System:
The Sharesource portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment database to aid in the review, analysis, and evaluation of patients' historical treatment results. This system 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) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| and the comments of the comments of the comments of the first of the first of |
× | 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
DATE:
October 14, 2020
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Brad Roynon Sr. Manager, Global Regulatory Affairs 25212 W. Illinois Route 120 Round Lake, IL 60073 Telephone: (262) 581-7157 Fax: (224) 270-4119
IDENTIFICATION OF THE DEVICE:
Common Name: Automated Peritoneal Dialysis System Trade/Device Name: Homechoice Claria Automated Peritoneal Dialysis (APD) SystemClassification Panel: 78 Gastroenterology and Urology Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis sytem and accessories Regulatory Class: Class II Product Code: FKX
Common Name: Peritoneal Dialysis Software Trade/Device Name: Sharesource Connectivity Platform for Use with Homechoice Claria APD SystemClassification Panel: 78 Gastroenterology and Urology Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis sytem and accessories Regulatory Class: Class II Product Code: FKX
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| Product Code | Name |
|---|---|
| 5C6M40 | Homechoice Claria APD System |
| 5CGM01 | Sharesource Connectivity Platform for Use with |
| the Homechoice Claria APD System |
Table 1. Product Codes in this Submission
PREDICATE DEVICE:
The Homechoice Claria APD System is substantially equivalent to the HomeChoice/HomeChoice PRO Automated Peritoneal Dialysis personal cyclers, which were previously cleared under 510(k) premarket notification K102936. The Sharesource Connectivity Platform for Use with the Homechoice Claria APD System is substantially equivalent to the Sharesource Connectivity Platform for Use with the AMIA APD System, which was previously cleared under 510(k) premarket notification K151525.
DESCRIPTION OF THE DEVICE:
The Homechoice Claria APD System (Claria) is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. The system automatically cycles peritoneal dialysis solution in the amounts and at the times prescribed by a clinician familiar with and well informed about peritoneal dialysis. The clinician may use the Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (Sharesource) to remotely communicate with the Claria cycler. Sharesource allows the transfer of treatment data originating from the treatment device to the clinician for review of historical treatment results. It also allows the clinician to adjust the device settings of the Claria cycler remotely. Changes to the device program by the clinician require the patient to review and accept the changes prior to the implementation of those changes. If the patient does not accept the changes, the Claria cycler will not accept the modified program. Sharesource does not include any real-time monitoring or real-time programming capabilities. A more detailed device description is included in Section 10 of this submission.
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INDICATIONS FOR USE: Homechoice Claria APD System
Baxter's Homechoice Claria APD System is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis in the HOME HEALTHCARE ENVIRONMENT including comparable use in professional healthcare facilities.
Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
The Sharesource portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment data to a central database to aid in the review, analysis, and evaluation of patients' historical treatment results. This system is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.
TECHNOLOGICAL CHARACTERISTICS
The Homechoice Claria APD System has similar technological characteristics as compared to its' predicate device. The Sharesource Connectivity Platform for Use with the Homechoice Claria APD System has similar technological characteristics as compared to its' predicate device. Risk analysis has been completed and potential hazards associated with the differences in the proposed devices from their predicates have been identified and mitigated. All potential risks were deemed acceptable after mitigation.
DISCUSSION OF NONCLINICAL TESTS:
Performance testing was conducted on the Homechoice Claria APD System with Sharesource to evaluate the functional performance of the device. The performance testing confirms that Homechoice Claria is as safe and effective as the HomeChoice/HomeChoice PRO cycler, and that the Sharesource Platform for Claria is as safe and effective as the Sharesource Platform for Amia.
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In summary, Claria and Sharesource have successfully implemented performance requirements and subsequent outputs verifying and validating:
- . The design validation meets the user needs and intended use and is substantially equivalent to the predicate.
- . Electrical safety, electromagnetic compatibility, and AIM testing was successfully completed for Claria.
- Risk assessment and risk control measures. Hazard analyses confirm that Claria and Sharesource do not perform in an unexpected or unsafe manner.
- . Labeling, software including cybersecurity, and Human Factors have been successfully implemented.
CONCLUSION:
Based on demonstrable evidence, the differences between the proposed devices and their predicates described within this submission do not affect the intended use, the fundamental technology or the operating principles of the device, nor do any changes raise safety or effectiveness issues with regard to the Homechoice Claria APD System and the Sharesource Connectivity Platform for Use with the Homechoice Claria APD System.