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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.

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The indications for use of the device are 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 used in conjunction with a hollow fiber or parallel plate dialyzer.
• The auto start option is intended to allow up to a three day . delayed start of the fluid path heat clean or rinse cycle.

The Drake Willock® System 1000® Single Patient Dialysate Delivery System is a dialysate proportioning system for hemodialysis. The system fulfills 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 with FDA approval.
  The fundamental modification is to provide the patient care provider with a means to delay the start of fluid path rinse or heat clean up to 3 calendar days.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is a 510(k) summary for a modification to a dialysate delivery system, focusing on its substantial equivalence to a predicate device.

Here's why I cannot provide the requested information:

• No Acceptance Criteria or Performance Study: The document primarily discusses the "AutoStart" feature, which is a software change to delay the start of heat clean or fluid path rinse. It explicitly states that "The machine and patient safety systems are the same as the predicate devices" and "The only difference is a software change." It does not mention any specific acceptance criteria or an independently designed study to prove the performance of this new software feature. The focus is on demonstrating that the modification itself is safe and effective through design and testing, rather than a standalone performance study as would be described for a new diagnostic or prognostic AI device.
• Focus on Substantial Equivalence: The entire submission is built around demonstrating "substantial equivalence" to existing predicate devices (K910215 and K954987). This means the manufacturer is arguing that the modified device is as safe and effective as devices already on the market, not necessarily presenting novel performance data against a specific set of criteria as might be expected for an AI-powered diagnostic product.
• No AI Component: The device described is a dialysate delivery system, a piece of medical hardware with a software modification. There is no mention of any Artificial Intelligence (AI) component, machine learning algorithms, or image analysis involved. Therefore, questions related to AI performance, such as MRMC studies, standalone algorithm performance, or ground truth for training sets, are not applicable.
• Information Not Present: The document does not contain information on:
  • Sample sizes for test sets or data provenance.
  • Number of experts or their qualifications for ground truth establishment.
  • Adjudication methods.
  • MRMC comparative effectiveness studies or effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used (pathology, outcomes data, etc.).
  • Sample size for training sets.
  • How ground truth for training sets was established.

In summary, the provided text describes a regulatory submission for a minor software modification to an existing medical device, emphasizing its substantial equivalence to predicate devices. It does not contain the kind of detailed performance study information, particularly in the context of AI, that your request anticipates.

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Single Needle Single Lumen Dialysis is indicated for use when a single venipuncture is chosen for use in chronic or acute hemodialysis treatments.

This application is for adding the option of Single Needle Single Lumen dialysis treatment to the current System 1000® Hemodialysis Machine. Single Needle Single Lumen dialysis is performed by controlling blood flow into and out of the patient with a single needle single lumen blood access, as opposed to dialysis blood access with two needle punctures. Because of the single lumen access, the hemodialysis machine operates cyclically, i.e. part of the time blood is aspirated from the patient (arterial phase), and part of the time blood is infused to the patient (venous phase).

Arterial Phase: During the arterial phase, the venous blood line is clamped, and blood is pumped via the peristaltic blood pump from the patient into the machine's extracorporeal circuit, and into (a) holding chamber(s) until a predetermined volume of blood has been accumulated. When the specified volume has been reached, the blood pump is stopped. The arterial phase is now complete.

Venous Phase: During the venous phase, the venous blood line is unclamped, the arterial blood line is clamped, and the blood in the holding chamber(s) and extracorporeal circuit is returned to the patient. When the venous pressure reaches a predetermined Low Pressure Trip Point, the venous blood line is clamped. At this point, the system returns to the arterial phase, and the cycle starts again.

Single Needle Single Lumen dialysis can be performed using either one peristaltic blood pump or two. (The Arterial and Venous phases described above apply to either system configuration). In systems using two pumps, the second pump returns the blood to the patient (Venous Phase). In systems using one pump, the pressure difference between the venous drip chamber and the patient causes the blood to return to the patient.

Single Needle Single Lumen dialysis (with systems using either one peristaltic pump or two) can be performed using either one line clamp or two. (The Arterial and Venous phases described above apply to either system configuration.) The second (arterial) clamp is required only when a blood line with an arterial drip chamber is used.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is a 510(k) summary for a hemodialysis system, focusing on its description, intended use, and substantial equivalence to predicate devices. It lists technological characteristics and safety systems but does not detail performance metrics, study designs, sample sizes, or ground truth establishment.

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