Search Results

The Baxter AK 98 dialysis machine is intended to be used for intermittant haemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or Home use.

The U9000 Ultrafilter is indication of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Ultrafilter is intended to be used in conjunction with a water treatment system.

C-705 Accessory Expansion Chamber is a single use sterile medical device intended to be used during the delivery of Hemodialysis treatment in Single Needle mode, on patients affected by chronic renal failure. The C-705 Accessory Expansion Chamber is an ancillary device used to allow the conversion from Double Needle to Single Needle administration mode of treatments, after connection to proper Blood Tubing System intended for Haemodialysis treatment in Double Needle mode and to a Dialyzer filter. C-705 Accessory Expansion Chamber shall be used in combination with Blood Tubing System suitable for AK 98 haemodialysis delivery system only. The total extracorporeal blood volume for the extracorporeal circuit including the set, dialyzer and accessories should represent less than 10% of the patient's blood volume.

The proposed device AK 98 Hemodialysis system, which is subject for this Traditional 510(k) premarket notification, consists of the following:

• AK 98 dialysis machine
• U9000 (Ultrafilter)
• C-705 (Accessory Expansion chamber)

AK 98 is a standalone, software controlled hemodialysis machine intended to be used in a chronic care dialysis or hospital care environment for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload.

The Ultrafilter product family (U9000, and its predicate device Diaclear) are ultrafilters intended for water filtration (removal of pyrogens and microorganisms), and filtration of dialysis fluid.

The C-705 Accessory Expansion Chamber is a single use sterile medical device for hemodialysis intended to be connected to compatible bloodlines for hemodialysis that allow the channeling of blood from the body through its circuits into another device that carries out the hemodialysis effect of the treatment.

This document is an FDA 510(k) premarket notification for a medical device. It does not describe an AI medical device or a study involving human experts to establish ground truth or assess AI performance. Instead, it details the substantial equivalence of new hemodialysis equipment (AK 98 Dialysis Machine, U9000 Ultrafilter, and C-705 Accessory Expansion Chamber) to previously cleared predicate devices.

Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria, involving items like sample size, expert adjudication, MRMC studies, standalone performance, and ground truth establishment, cannot be extracted from this document because it pertains to conventional medical devices, not AI/ML-based ones.

The document primarily focuses on:

• Device Identification and Intended Use: Clearly defines what the devices are and what they are used for.
• Predicate Device Comparison: Detailed tables (Table 3, Table 4, Table 5) compare the features, specifications, and performance of the proposed devices to their respective predicate devices. This is the core of a 510(k) submission, demonstrating "substantial equivalence."
• Nonclinical Testing: Summarizes the performance testing conducted to confirm the functional performance, electrical safety, electromagnetic compatibility, risk assessment, and biocompatibility of the devices, all in accordance with relevant FDA guidance and international standards (e.g., IEC 60601 series, ISO 10993-1).

No information related to AI/ML acceptance criteria, expert adjudication, or MRMC studies is present.

Ask a specific question about this device