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The PS 150 Hemodialyzer is intended for hemodialysis in patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate.

The PS 158 Hemodialyzer consists of approximately 13,000 polysulfone hollow fibers encapsulated in polyurethane resin with an outer housing and headers made of Polycarbonate. The device is packaged in a blister package composed of Glycol modified Polyethylene Terephtalate for the bottom web, and a foil laminater for the top web. The PS 15® Hemodialyzer has two compartments, the blood compartment and the dialysate compartment, separated by the polysulfone permeable membrane and and flows from the patient access site through the tubing of the extracorporeal. system and accessories to the blood compartment of the dialyzer. From the blood compartment, undesirable substances in the blood pass through the membrane into the dialysate compartment of the dialyzer. Circulation and monitoring of dialysate into flow through the dialysate compartment is controlled by the dialysate delivery system, while the ultrafiltration controller prevents excessive loss of yeater from the patient's blood.

This document describes the acceptance criteria and study that proves the PS 15® Hemodialyzer meets these criteria. The device is intended for hemodialysis in patients with acute or chronic renal failure.

1. Acceptance Criteria and Reported Device Performance

The PS 15® Hemodialyzer was evaluated against a predicate device, the Altrex 170 Hemodialyzer, and in some functional tests, also against the Fresenius F60 Polysulfone Dialyzer. The acceptance criteria are implicitly defined by demonstrating substantial equivalence to these legally marketed predicate devices through comparable functional and biocompatibility test results.

Table: Acceptance Criteria (as demonstrated by predicate device performance) and PS 15® Hemodialyzer Performance

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Altra Fluxed 200 Heinodialyzers are intended for acule or chronic Hemodialysis. Hemodiatysis is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. The Altra Flux 200 Hemodialyzer is indicated for single use or multiple use with the same patient.

The Altra Flux® 200 multiple use hemodialyzer is the Altra Flux® 200 single use device with reuse labeling. Like the Altra Flux® 200 single use device, it is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.

The provided text describes the Altra Flux® 200 Hemodialyzer with multiple use labeling, focusing on its substantial equivalence to an already marketed single-use device and its validation for reuse. However, it does not explicitly detail specific quantitative acceptance criteria or the full study design with all the requested information for a device performance study.

Based on the information provided, here's what can be extracted and what is not available:

1. A table of acceptance criteria and the reported device performance

The document states that "Testing performed on reprocessed devices demonstrate that the Altra Nova® 200 multiple use hemodialyzer is as safe and effective as the currently marketed Altra Nova® 200 single use hemodialyzer." This implies the acceptance criterion was "as safe and effective as the predicate device" after reprocessing.

However, specific quantitative metrics (e.g., clearance rates, ultrafiltration rates, fiber bundle volume integrity) and their acceptable ranges are not provided in this summary. Therefore, a table cannot be fully completed.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the "testing performed on reprocessed devices." It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and hence not provided, as the study described is a performance validation of a medical device, not an AI or diagnostic tool requiring ground truth established by experts. The "ground truth" for a hemodialyzer's performance would be objective measurements of its function.

4. Adjudication method for the test set

This information is not applicable and hence not provided, as the study described is a performance validation of a medical device, not an AI or diagnostic tool requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices or AI tools evaluated by multiple human readers. The Altra Flux® 200 Hemodialyzer is a therapeutic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept is not applicable to a hemodialyzer. The device itself performs its function (filtration), and its performance is measured directly, not through an algorithm or human interpretation.

7. The type of ground truth used

The "ground truth" for the performance of a hemodialyzer would be direct measurements of its functional parameters (e.g., clearance of waste products, ultrafiltration rates, integrity of the membrane). While not explicitly stated, these are typically measured in laboratory settings or in simulated clinical conditions. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in this context.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for a physical medical device.

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Altra Nova® 200 Hemodialyzers are intended for acute or chronic Hemodialysis. Hemodialysis is indicated for patients with acute or chronic result failure when conservative therapy is judged to be inadequate.
The Altra Nova 200 Hemodialyzer is indicated for single use or multiple use with the same patient.

The Altra Nova® 200 multiple use hemodialyzer is the Altra Nova® 200 single use device with reuse labeling. Like the Altra Nova® 200 single use device, it is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the The hemodialyzer has semipermeable hollow fibers which divide the patient. device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer.

A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.

The provided text describes a 510(k) summary for the Altra Nova® 200 Hemodialyzer with multiple-use labeling. It focuses on demonstrating equivalence to an existing single-use device rather than performing a typical clinical study with acceptance criteria and reported device performance in the way a new diagnostic or AI-driven device would.

Therefore, many of the requested categories (e.g., AI integration, expert consensus, MRMC studies, training set details) are not applicable to this type of submission. The document is a regulatory submission for a medical device (hemodialyzer) seeking clearance for reuse, not a study evaluating software performance or diagnostic accuracy.

Here's a breakdown based on the information available, highlighting what is applicable and what isn't:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with performance metrics like sensitivity or specificity. Instead, the acceptance criteria for this device (a reusable hemodialyzer) revolve around demonstrating that the reprocessed device is as safe and effective as the single-use predicate device. The "performance" is implicitly tied to maintaining the original device's characteristics after reprocessing.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated in this 510(k) summary. The summary refers to "Testing performed on reprocessed devices," but the number of devices or cycles tested is not disclosed.
• Data Provenance: Not specified, but likely proprietary internal testing conducted by Althin Medical, Inc. (the manufacturer) in the USA. It would be retrospective in the sense that the testing was performed on devices that were then reprocessed according to a defined protocol.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is Not Applicable (N/A). This submission is for a physical medical device (hemodialyzer), not an AI-driven or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set:

• This is Not Applicable (N/A). No adjudication method is described because the testing doesn't involve subjective interpretations or expert consensus. It likely involved objective measurements of device performance parameters (e.g., clearance rates, ultrafiltration rates, material integrity) after reprocessing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• This is Not Applicable (N/A). This is a physical medical device, not an AI or diagnostic tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This is Not Applicable (N/A). This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth," in this context, is the original performance specifications and safety profile of the single-use Altra Nova® 200 Hemodialyzer. The study's goal was to demonstrate that the reprocessed device met these same predefined engineering and functional standards. This would involve objective measurements (e.g., chemical analysis, physical integrity tests, performance characteristics like solute clearance and ultrafiltration coefficient) against established benchmarks for the fresh device.

8. The sample size for the training set:

• This is Not Applicable (N/A). There is no AI or machine learning model involved, therefore no training set.

9. How the ground truth for the training set was established:

• This is Not Applicable (N/A). There is no AI or machine learning model involved, therefore no training set or ground truth establishment relevant to AI.

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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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To provide hemodialysis treatment to patients with acute or chronic renal failure.

A hemodialysis delivery system which will provide dialysate at the prescribed temperature and ionic concentration to be used for hemodialysis treatment. It has the ability to monitor machine, dialysate, and blood circuit functions during dialysis. The machine treatment parameters are displayed on a Liquid Crystal Display monitor screen. The operator controls is done through a interactive touch screen.

This 510(k) summary does not contain the level of detail required to fulfill all aspects of your request. It's a summary for clearance, not a comprehensive study report. Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided text. The document states that the AltraTouch™ 1000 is a modification of a predicate device and that "Althin Medical, Inc. believes that the design and testing of this modified System1000® machine demonstrates that it is safe and effective." However, it does not specify any quantitative acceptance criteria or present performance data against them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text. No details about specific testing or data are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text. No mention of experts or ground truth establishment is made.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided text. No mention of adjudication or test methods is made.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not available in the provided text. The device described is a hemodialysis delivery system, not an AI diagnostic tool that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not available in the provided text. The device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available in the provided text. No ground truth is mentioned.

8. The sample size for the training set

This information is not available in the provided text. No mention of a training set is made.

9. How the ground truth for the training set was established

This information is not available in the provided text. No mention of a training set or its ground truth establishment is made.

Summary of available information regarding the device and its compliance:

The document describes the AltraTouch™ 1000 Single Patient Hemodialysis Delivery System as a modification of the Drake Willock® System 1000. The key modifications are:

• Replacing a 12-inch CRT with a 9.5-inch LCD, reducing height and weight.
• Reducing maximum dialysate flow rate by 20%.
• Increasing the minimum temperature requirement for incoming water.
• Making some standard features from the predicate optional.

The document emphasizes that "Except for the parts associated with the change to the LCD screen, the AltraTouch™1000 machine is built from the same parts as the predicate device. The only software changes are those that control the display color pallet. All machine/patient safety systems are identical to the predicate device."

This reliance on the predicate device's established safety and effectiveness, along with the assertion that "All machine/patient safety systems are identical to the predicate device," is the primary argument for the device meeting safety and effectiveness criteria in this 510(k) summary. It suggests that the "study" proving the device meets criteria is largely a comparison to and demonstration of equivalence with the previously cleared predicate device, rather than a de novo clinical trial or extensive independent performance study reported here.

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