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POLYFLUX LR is intended for use in hemodialysis for the treatment of acute and chronic renal failure. The POLYFLUX LR may be reprocessed for reuse on the same patient.

The Gambro POLYFLUX 6 LR, 8 LR, and 10 LR, Capillary Dialyzers labeled for multiple use / reuse are identical in design, materials, function and intended use to the Gambro POLYFLUX 6L, 8L, and 10L Capillary Dialyzers/ Filters labeled for single use which have been previously cleared by the FDA under a 510(k) Notification for single use (510(k) Notification K010985). These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure and for certain types of intoxications. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylethersulfone (PES) which is identical to the membrane utilized in the Gambro POLYFLUX 6L, 8L, and 10L Capillary Dialyzers/ Filters labeled for single use which have been previously cleared for marketing in the United States under 510K Notifications (K010985). Blood enters a blood inlet port where it is distributed to the hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of hollow fibers in each hemodialyzer / filter is 10,00 for the POLYFLUX 6 LR, 10,000 for the POLYFLUX 8 LR, and 12,500 for the POLYFLUX 10 LR. This effective membrane length is 210 mm for the POLYFLUX 6 LR, and 250 mm for the POLYFLUX 8 LR and 10 LR. The effective membrane surface area is 1.4 square meters for the POLYFLUX 6 LR, 1.7 square meters for the 8 LR and 2.1 square meters for the 10 LR. The housing and end caps of this hemodialyzer / filter are made of polycarbonate. The fibers used in the Gambro POLYFLUX 6 LR, 8 LR, and 10 LR are of the same composition as those previously approved for the Gambro POLYFLUX L 6L, 8L, and 10L Capillary Dialyzers/ Filters labeled for single use and multiple use (K010985). The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the membrane, plasma water along with certain lower molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets these criteria in the format requested for AI/software-based devices. Instead, this document is a 510(k) summary for a medical device (hemodialyzer/filter) under the traditional regulatory pathway (K023615).

The core of this submission is to demonstrate "substantial equivalence" to a predicate device, not necessarily to meet pre-defined performance acceptance criteria through independent studies as would be typical for novel AI/software devices.

However, I can extract information related to the device's performance based on the provided text, interpreting "acceptance criteria" in the context of substantial equivalence to the predicate device.

Here's an attempt to answer using the provided information, noting where the requested details are not applicable or unavailable:

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

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

The document mentions "In vitro data" and "Clinical data" were collected, but it does not specify the sample size for either. The data provenance (country of origin, retrospective/prospective) is not 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 is not applicable to this type of device and submission. The "ground truth" for a hemodialyzer's performance is typically established through direct measurement of physical and chemical parameters (clearance, ultrafiltration, etc.) in mechanical or biological models, rather than expert interpretation of data points.

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

This is not applicable as the evaluation of a hemodialyzer does not involve subjective expert adjudication in the way AI model performance is often assessed.

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 is not applicable. This submission is for a physical medical device (hemodialyzer/filter), not an AI algorithm. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.

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

This is not applicable. This is not an AI algorithm.

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

The "ground truth" for a hemodialyzer's performance typically comes from:

• In vitro measurements: Direct quantitative measurements of device parameters such as urea clearance, creatinine clearance, ultrafiltration rate, sieving coefficients, etc., using standardized test solutions and conditions.
• Clinical outcomes: Observations of patient physiological parameters (e.g., reduction in uremic toxins) during actual use, compared to expected performance or to the predicate device.
  The document states "In vitro data was collected" and "Clinical data was collected."

8. The sample size for the training set

This is not applicable as this is not an AI algorithm requiring a training set.

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

This is not applicable for the same reason as above.

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POLYFLUX R is indicated for use in hemodialysis for the treatment of chronic or acute renal failure. The choice of the filter is the responsibility of the physician. Special attention must be paid in connection with pediatric use. CAUTION! If POLYFLUX R is reused, the procedure and disinfection specified in the RENATRON INSTRUCTION MANUAL must be followed. The POLYFLUX R may be reprocessed for reuse on the same patient.

The Gambro Polyflux 17R and 21R, Capillary Dialyzers/Filters labeled for multiple use (reuse) are identical in construction in function to Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters labeled for single use which are currently marketed in the United States and have been previously cleared by the FDA under 510(k) Notification K981414. Only the product designation "R" has been changed from "S" to designate that they are labeled for multiple use (reuse). These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure and for certain types of intoxications for both single when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies undertaken by Gambro and presented in the labeling for this device. It may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in these devices is polyethersulfone (PES) which is identical to the membrane utilized in the Gambro Polyflux 17S and 21S Hemodialyzers / Hemofitters for labeled for single use which have been previously approved for marketing in the United States under a 510K Notification (K982414). Blood enters a blood inlet port where it is distributed to polyethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyethersulfone hollow fibers in each hemodialyzer / hemofilter is 10,000 for the Polyflux 17R and 12,500 for the 21R. These dialyzers have an effective membrane length of 250 mm. The effective membrane surface area is 1.7 square meters for the 17R and 2.1 square meters for the 21R. The housing and end caps of these hemodialyzers / hemofiters are made of polycarbonate. The fibers used in the Gambro Polyflux 17R and 21R are identical in design and materials to the previously approved Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters for labeled for single use (K982414). The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the polyethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through polyethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

This document describes the 510(k) Notification for the Gambro Polyflux 17R & 21R Capillary Dialyzers/Filters, labeled for multiple use. This submission seeks clearance for the multiple-use labeling of these devices, which are identical in construction and function to the previously cleared single-use Gambro Polyflux 17S & 21S Hemodialyzers/Hemofilters (K981414).

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the proposed devices (Polyflux 17R & 21R for multiple use) are identical in construction and function to the predicate devices (Polyflux 17S & 21S for single use), with the only difference being the labeling for multiple use. Therefore, the acceptance criteria are implicitly linked to demonstrating that the reprocessing for reuse does not compromise the device's original performance, safety, and effectiveness.

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

• Sample Size for Test Set: The document simply states that "Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling," and refers to "confirmatory clinical studies undertaken by Gambro." However, no specific sample sizes (number of devices or patients) for the clinical test set are provided within the excerpt.
• Data Provenance: The country of origin of the data is not explicitly stated. The nature of the studies ("confirmatory clinical studies undertaken by Gambro") suggests they were prospective studies, as they were conducted to support the multiple-use claim.

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 provided in the given excerpts. For medical devices like dialyzers, ground truth often relates to measurable clinical and laboratory parameters (e.g., solute clearance, ultrafiltration rates, patient outcomes), rather than interpretation by a panel of experts in the same way an imaging study would.

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

This information is not applicable/provided for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where subjective interpretation is involved. For a hemodialyzer, the performance is assessed through objective measurements.

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:

Not applicable. This excerpt describes a 510(k) submission for a medical device (hemodialyzer) for multiple use, not an AI or imaging diagnostic device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is entirely irrelevant to this submission.

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

Not applicable. This is a hardware medical device, not an algorithm or AI system.

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

Based on the nature of the device (hemodialyzer), the ground truth for performance and safety would have been established through a combination of:

• In vitro performance criteria: Objective measurements of device function (e.g., solvent removal, solute clearance, fiber integrity, pressure drop, biocompatibility measures like membrane integrity after reprocessing challenges).
• Clinical outcomes data: Patient safety data and clinical effectiveness parameters (e.g., maintaining patient electrolyte balance, fluid removal, absence of adverse events related to reprocessing) over the course of multiple reuse cycles. The document refers to "in vitro and confirmatory clinical studies."

8. The sample size for the training set:

Not applicable. As this is a medical device, not an AI algorithm, there is no "training set" in the computational learning sense. The "training" for the device's design and manufacturing would come from extensive engineering design, material science, and manufacturing process validation, which are not detailed in this excerpt.

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

Not applicable. As there is no "training set" for an AI algorithm, this question does not apply. The "ground truth" for the device's initial design and subsequent multiple-use validation is based on established engineering principles, regulatory standards (like the FDA Guidance for Hemodialyzer Reuse Labeling), and clinical guidelines for hemodialysis treatment.

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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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Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs. These dialyzers are indicated for single use or reuse. If the dialyzer is reused on the same patient, the reuse procedure and disinfectant specified in the Direction Insert must be followed. No other reuse procedure or disinfectant has been evaluated for clinical acceptability.

Models CAHP-110, CAHP-130, CAHP-150, CAHP-170, CAHP-210 Hemodialyzers

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for a hemodialyzer, primarily discussing its regulatory classification, intended use, and substantial equivalence to a predicate device. It mentions "Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling" and "In Vivo and In Vitro performance data, and directions for reuse have been included in the labeling," but does not provide details of any specific study, acceptance criteria, sample sizes, ground truth establishment methods, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided text.

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Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs. This dialyzer is indicated for single use or reuse. If the dialyzer is reused on the same patient, the reuse procedure and disinfectant specified in the Direction Insert must be followed. No other reuse procedure or disinfectant has been evaluated for clinical acceptability.

Models CA-170, and CA-210 Hemodialyzers

The provided text describes a 510(k) premarket notification for a medical device, the CA® Cellulose Acetate Hollow Fiber Dialyzer. However, it does not describe the acceptance criteria and the study that proves the device meets those criteria in the typical format you've requested for AI/algorithm performance.

This document is from 1997, and the concept of AI/algorithm performance evaluation in the way you've outlined (sample size, data provenance, ground truth experts, MRMC studies, standalone performance, training set details) is not applicable to a physical hemodialyzer submitting for 510(k) clearance at that time. The "device" in this context is a physical medical device, not a software algorithm or AI.

Instead, the document details the performance of the physical dialyzer through various tests and comparisons to a predicate device. I will extract the information available, interpreting "acceptance criteria" and "device performance" in the context of this physical device.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Applicable or Not Provided for an AI/Algorithm Study:

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

• This is not an AI/algorithm study. "Clinical data" was collected for reuse labeling, but specific sample sizes, geographic origin, or retrospective/prospective nature are not detailed in this summary for the physical device.

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)

• Not applicable to this type of device and submission.

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

• Not applicable to this type of device and submission.

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

• Not applicable; this is a physical medical device, not an AI-assisted diagnostic tool.

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

• Not applicable; this is a physical medical device.

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

• For the physical device, "ground truth" would be established by validated test methods (e.g., chemical analysis for residues, biological assays for pyrogens, mechanical tests for integrity, and in vivo performance data from clinical studies aligning with FDA guidance). Outcomes data and clinical data for reuse were part of the submission.

8. The sample size for the training set

• Not applicable, as this is not an AI/algorithm.

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

• Not applicable, as this is not an AI/algorithm.

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The Primus® Hollow Fiber Dialyzer is indicated for hemodialysis of patients with acute or chronic renal insufficiency. The Primus Dialyzer is intended for reuse.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Primus® Hollow Fiber Dialyzer," intended for hemodialysis and reuse. It does not contain information regarding detailed acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment methods for an AI/ML powered medical device. The document is a regulatory approval, not a technical performance report.

Therefore, I cannot provide the requested information based on the provided text.

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