(135 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Baxter Homechoice Claria APD System and Sharesource Connectivity Platform:
It's important to note that the provided text is a 510(k) summary and not a detailed clinical study report. Therefore, some information, especially detailed performance metrics, sample sizes for specific tests, and expert qualifications, is either summarized at a high level or not explicitly stated in the document.
Acceptance Criteria and Study for Baxter Homechoice Claria APD System & Sharesource Connectivity Platform
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics. Instead, it describes a high-level approach to demonstrating substantial equivalence. The "acceptance criteria" are implied to be achieving equivalence to the predicate devices through successful performance testing and risk mitigation.
| Acceptance Criteria (Implied from Summary) | Reported Device Performance (Summary) |
|---|---|
| Meets user needs and intended use | Design validation confirms user needs and intended use are met, and the device is substantially equivalent to the predicate. |
| Electrical safety | Electrical safety testing was successfully completed for Claria. |
| Electromagnetic compatibility (EMC) | Electromagnetic compatibility testing was successfully completed for Claria. |
| AIM testing (unspecified) | AIM testing was successfully completed for Claria. |
| Risk assessment and control | Hazard analyses confirm that Claria and Sharesource do not perform in an unexpected or unsafe manner; all potential risks were deemed acceptable after mitigation. |
| Labeling requirements | Labeling has been successfully implemented. |
| Software (including cybersecurity) | Software including cybersecurity has been successfully implemented. |
| Human Factors | Human Factors have been successfully implemented. |
| Functional performance equivalent to predicate devices | 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. The differences do not affect intended use, fundamental technology, or operating principles, nor do they raise safety/effectiveness issues. |
2. Sample Sizes and Data Provenance (Test Set)
- Sample Size Used for the Test Set: Not explicitly stated in the provided summary. The summary refers to "performance testing" but does not give specific numbers of cases, cycles, or patient data points used for these tests.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. The document refers to "design validation" and "performance testing," which typically involve internal testing and potentially external validation, but specific details about the type or origin of data used for these tests are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the summary. The nature of this device (a peritoneal dialysis system and connectivity platform) makes "ground truth" establishment less about expert interpretation of images or clinical findings, and more about functional verification and validation against requirements and predicate performance. Therefore, "experts" would likely be engineers, clinicians (involved in setting requirements), and quality assurance personnel, rather than ground truth adjudicators in the typical sense of diagnostic AI.
4. Adjudication Method for the Test Set:
This information is not provided and is generally not applicable in the context of device functional performance testing for a 510(k) submission. Adjudication methods like 2+1 or 3+1 are typically used in studies where clinical diagnosis or interpretation of data (e.g., images) requires independent expert review to establish a "ground truth" that a device's output is compared against. For a physical device and software platform, the assessment would be against pre-defined functional specifications, safety standards, and equivalence to a predicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is relevant for diagnostic AI tools that assist human readers in tasks like image interpretation. The Baxter Homechoice Claria APD System and Sharesource Connectivity Platform are for managing peritoneal dialysis and remote monitoring/programming, not for diagnostic interpretation by human readers. The "AI" (Sharesource) here functions as a data transfer and remote programming tool, not as a diagnostic aid that enhances human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, in spirit, but not in the diagnostic AI sense. The performance testing described suggests that the system's functionalities (e.g., automatic solution exchanges, data transfer, remote programming capabilities) were validated as standalone functions according to their specifications. The safety and effectiveness claims are based on the device operating independently (the cycler itself) and the Sharesource platform facilitating data/program exchange, rather than its performance in conjunction with a human diagnostic interpreter. The Sharesource explicitly states it "is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways," emphasizing that human clinical judgment remains central.
7. The Type of Ground Truth Used:
The "ground truth" for this type of device is established through:
- Engineering specifications and requirements: The device functions according to its design.
- Predicate device performance: The new device performs equivalently to the legally marketed predicate devices.
- Risk analysis and mitigation: All identified risks are addressed, and the device operates safely.
- Compliance with standards: Adherence to electrical safety, EMC, software, and human factors standards.
- Verification and Validation (V&V) testing: Demonstrating that the device meets its design inputs and user needs.
This is a functional and safety "ground truth" derived from design control processes, rather than a clinical ground truth like pathology or outcome data typically used for diagnostic or predictive AI.
8. The Sample Size for the Training Set:
This information is not provided and is not applicable in the typical sense. This device is a medical device system (hardware and software) and a connectivity platform, not a machine learning or AI model that undergoes a "training phase" with a specific dataset. The "software" mentioned would likely be traditional embedded software and web-based applications, developed through standard software engineering practices (coding, testing, debugging), rather than being "trained" on a dataset like a deep learning model.
9. How the Ground Truth for the Training Set was Established:
This information is not provided and is not applicable for the reasons stated above (not an AI model with a training set). The "ground truth" for developing the software and hardware would be the design requirements, functional specifications, and relevant regulatory standards.
§ 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.