(128 days)
cyberREN is a clinical data management system, designed specifically for nephrology, to replace the paper medical chart. Full chart replacement, i.e. a conversion from a paper medical record to an electronic medical record is at the option of the client. The cyberREN electronic chart essentially provides the functions of a data repository and data query / reporting system.
cyberREN is a clinical data management system designed for nephrology. It functions as a data repository and data query/reporting system, intended to replace paper medical charts. It is a multiuser, multidisciplinary system accessible via standard Windows 95 based computers. It saves, calculates, displays, and reports clinical information. Data is primarily entered manually by caregivers, but can also be received from networked systems like laboratory computers and dialysis machines (specifically the Fresenius 2008H). It calculates values such as weight gain, protein catabolic rate, percent urea reduction, KT/V dialysis efficacy index, and nutrition parameters. It supports general charting functions like patient demographics, problem lists, orders, medications, progress notes, consultations, and laboratory results reporting. It also supports charting for hemodialysis (treatment orders, session charting, access charting, scheduling) and peritoneal dialysis (orders, session charting, peritonitis charting, access charting). It can also be used to document transplant status and workup activities. cyberREN does not alter entered information, make treatment recommendations, influence dialysis machine operation, or provide diagnoses.
The provided text describes the "cyberREN" device, a clinical data management system for nephrology. However, the document is a 510(k) clearance letter from the FDA, and it primarily focuses on the device's "Indications for Use" and its substantial equivalence to previously marketed devices. It does NOT contain the details required to answer your specific questions about acceptance criteria, device performance study details, sample sizes, expert qualifications, or ground truth establishment.
The document states that cyberREN is intended to:
- Replace paper medical charts in nephrology.
- Function as a data repository and data query/reporting system.
- Save and display clinical information (manually entered, from labs, or directly from Fresenius 2008H dialysis machines).
- Calculate a limited number of values (weight gain, protein catabolic rate, urea reduction, KT/V dialysis efficacy index, nutrition parameters).
- Report clinical information.
- Support general charting functions (patient demographics, problem lists, orders, medications, progress notes, consultations, laboratory results reporting, billable services, nutrition).
- Support hemodialysis management (treatment orders, session charting, access charting, schedule).
- Support peritoneal dialysis management (orders, session charting, peritonitis charting, access charting).
- Support transplant management (status, workup).
It explicitly states what cyberREN does not do:
- Logically alter information entered or imported.
- Make recommendations for treatment.
- Influence the operation of the Fresenius 2008H dialysis machine.
- Provide a diagnosis or selection of possible diagnoses.
Since the document is a regulatory clearance letter, it assumes the device manufacturer has performed these studies, but the details of those studies are not typically included in the public FDA 510(k) summary or this type of letter.
Therefore, I cannot provide the requested information based on the given text.
§ 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.