Search Results

Indications For Use of the System 1000®:

• The intended use of the device is to provide hemodialysis treatments in the acute and chronic setting, including high flux hemodialysis.
• The device is intended to be used by trained operators when prescribed by a physician.
• The device is intended to be use in conjunction with a hollow fiber or parallel plate dialyzer.

Indications for Use of the Hematocrit and Blood Volume Monitor Option:
The intended use of this device is to monitor Hematocrit. Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation.

• The device is intended to be used as an integrated option of the System 1000 Dialysis Delivery System.
• The device is intended to be used by trained operators when prescribed by a physician.
• The device is intended to be used in conjunction with the Crit-Line disposable Blood Chamber. The Blood Chamber is a non reusable device.
• To provide the medical professional with a means of monitoring Hematocrit. Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation during hemodialysis treatment.

The System 1000® and AltraTouch™ 1000 devices are Single Patient Dialysis Delivery Systems for hemodialysis. The systems fulfill the following functions:

• Mixes concentrate with water in the appropriate proportions to produce dialysate .
• Delivers dialysate at the appropriate temperature and ionic concentration to the . dialyzer,
• Removes the appropriate amount of liquid from the patient's blood .
• . Along with the dialyzer and blood pump acts as a total artificial kidney.
• The following option is the subject of this submission that will be implemented Note: with FDA approval.

The System 1000® and AltraTouch™ 1000 Dialysis Delivery System with HCT/BV Monitor, integrates two 510(k) approved devices into one device. [System 1000%/ AltraTouch™ 1000 Dialysis Delivery System: K910215, K954987 and K955384; andCrit-Line Instrument: K924167, K950842 and K953875] This device provides the care giver with the option to monitor hematocrit, percent blood volume change, oxygen saturation value and access recirculation. The HCT/BV Monitor uses a light emitter/light detector sensor connected to a sterile disposable Blood Chamber (Crit-Line™ Blood Chamber: K924167 and K935958) in the extracorporeal blood circuit. The sensor detects various absorption and scattering characteristics exhibited by the blood. Data from the intergraded HCT/BV Monitor are communicated to the host System 1000@/AltraTouch™ 1000 machine via the serial communication port (RS232) and displayed on CRT/LCD screen of the System 1000@/AltraTouch™ 1000 machine.

The HCT/BV Monitor option alerts the operator with audible and visual alarms if the patient's hematocrit is equal or exceeds the operator set hematocrit alarm limit or if the patient's blood volume is equal or lower than the operator set blood volume alarm limit.

The provided text is a 510(k) summary for the Drake Willock® System 1000® AltraTouch™ 1000 Dialysis Delivery System with a Hematocrit and Blood Volume Monitor Option.

This document does not contain the acceptance criteria or a detailed study report with specific performance metrics, sample sizes, expert qualifications, or ground truth establishment methods for a device's performance. Instead, it describes a modification to an existing device, integrating a previously 510(k) cleared monitoring technology (Crit-Line™ II) into a dialysis delivery system. The primary claim for regulatory approval is substantial equivalence to the predicate devices.

Therefore, I cannot populate the requested table and answer the study-related questions directly from the provided text. The document focuses on the technological characteristics of the integrated device and its intended use in comparison to the predicate devices, rather than presenting a de novo performance study against defined acceptance criteria.

Key points from the document regarding the HCT/BV Monitor Option:

• Modification: The HCT/BV Monitor feature is an integration of the stand-alone Crit-Line™ II Instrument into the System 1000®/AltraTouch™ 1000 dialysis delivery system.
• Identical Circuit Design: The HCT/BV Monitor printed circuit board (PCB) has the identical circuit design as the Crit-Line II™ Instrument PCB.
• Identical Blood Chamber: The Blood Chamber is the same as the Crit-Line™ Blood Chamber.
• Substantial Equivalence: Althin Medical, Inc. asserts that the design and testing of this modified system demonstrate it is safe and effective, implying substantial equivalence based on the predicate devices and the identical nature of the integrated components' core technology.

Absence of requested information:

• Acceptance Criteria/Reported Performance Table: No such table is present. The document focuses on the equivalence of the integrated components to previously cleared devices.
• Sample Size (Test Set) & Data Provenance: Not specified for a de novo performance study. The approval is based on substantial equivalence to predicate devices, which would have had their own performance data.
• Number of Experts & Qualifications: Not applicable as no new ground truth establishment study is described.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not mentioned.
• Standalone Performance Study: Covered by the predicate Crit-Line™ II Instrument's original 510(k) clearances, which are referenced. The current submission focuses on the integration not a new standalone performance of the core monitoring technology.
• Type of Ground Truth: Not specified in this document for the integrated component, but would have been part of the predicate device's clearance.
• Sample Size (Training Set): Not applicable for this type of 510(k) a new algorithm training is not descriebd.
• Ground Truth (Training Set) Establishment: Not applicable.

In summary, the provided document is a 510(k) summary for a device modification based on the principle of substantial equivalence. It leverages the prior clearances of its components rather than presenting new, detailed performance study data against specific acceptance criteria.

Ask a specific question about this device