(177 days)
The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
The HomeChoice/HomeChoice PRO Automated Personal Cycler is used for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis therapy. The HomeChoice/HomeChoice PRO cycler automates peritoneal dialysis by heating the dialysis solution, pumping the solution to and from the patient, controlling dwell times, accounting for volumes of the solution according to a physician prescribed therapy and recording the ultrafiltration volume produced by the therapy.
The provided document, K102936, describes the Baxter Healthcare Corporation's HomeChoice/HomeChoice PRO Automated Personal Cycler. This submission is for a modified device with Version 10.4 software, and the evaluation is primarily based on non-clinical data to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Software Validation & Verification | Modifications function as intended. | Testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria. |
| System Compatibility | Device is compatible with communicating devices. | Verified for system compatibility with the devices with which it communicates. |
| Hardware Safety | Certified to applicable safety standards. | Device hardware is certified to applicable safety standards. |
| Electromagnetic Compatibility (EMC) | Meets IEC 60601-1-2 requirements. | EMC testing conducted according to IEC 60601-1-2. The modified device meets the requirements. |
| Electrical Safety | Meets IEC 60601-1 requirements. | Electrical safety testing conducted according to IEC 60601-1. The modified device meets the requirements. |
| Human Factors | Not explicitly stated beyond "Human Factors Testing". | Human Factors Testing was performed, and results "demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical data for algorithmic performance. The testing described is primarily for system validation, software verification, and adherence to safety standards. These tests would involve specific units of the device and pre-defined test cases, but the sample size for individual software tests or hardware tests is not enumerated.
- Data Provenance: The data provenance is non-clinical, originating from internal testing and verification performed by Baxter Healthcare Corporation. There is no mention of country of origin for any data beyond the company's address in McGaw Park, IL, USA. The studies are internal validation and verification processes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
As this is a non-clinical submission, there is no mention of experts establishing a "ground truth" for a test set in the traditional sense of medical image analysis or patient outcome studies. The "ground truth" for non-clinical testing refers to predefined design specifications, industry standards, and expected functional behavior, which would be established by the device's engineering and quality assurance teams.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring expert adjudication. The "adjudication" for non-clinical tests would involve confirming whether the device's performance matches the predetermined acceptance criteria, likely performed by a quality assurance team.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. The document explicitly states "ASSESSMENT OF CLINICAL DATA: Not Applicable." Therefore, no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence, the "testing performed" for software validation and verification, EMC, and electrical safety can be considered standalone performance evaluation of the device and its software (the "algorithm" in this context). The device's operation, the software's execution, and adherence to safety standards were tested without human intervention influencing the device's core functions. However, this is not "standalone" in the typical AI/ML sense of an algorithm making diagnostic decisions. It's evaluating the functional integrity of the device itself.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on:
- Design Specifications: The device was evaluated for "conformance to its design specifications."
- Applicable Industry Standards: Compliance with standards like IEC 60601-1-2 (EMC) and IEC 60601-1 (Electrical Safety).
- Predicate Device Performance: The primary claim is "substantial equivalence" to predicate devices, implying that the modified device should perform as safely and effectively as the previously cleared versions.
- Pre-determined Acceptance Criteria: For all the listed tests, the results "met pre-determined acceptance criteria."
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that is "trained" on a dataset in the typical sense. It is a medical device with embedded software. The software's development likely involved iterative testing and debugging, but not "training" on a specific dataset to learn patterns or make predictions.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The ground truth for the device's development would be its functional requirements, safety requirements, and performance specifications, established by engineering and regulatory teams during the design and development phases.
§ 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.