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PrismaSATE solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

PrismaSATE dialysis solutions are ready to use sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialyzable or filterable substances. The solutions are intended to be used with commercially available CRRT systems as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags. The composition of the fluid used in renal therapies mirrors normal plasma water, since normalization of the blood is the objective.

PrismaSATE solutions, like other currently available dialysate solutions, consist of various quantities of the following chemicals: sodium chloride, potassium chloride, magnesium chloride, calcium chloride, dextrose, and a buffer of lactose and/or bicarbonate. The solution is prescribed by a physician; the physician selects the appropriate formulation based on the patient's blood electrolyte level and desired traits. PrismaSATE dialysate solutions are offered in a range of electrolyte concentrations which mirror the range of electrolytes in plasma. The solution may be buffered using lactate, bicarbonate using lactic acid as a pH adjustor, or bicarbonate using hydrochloric acid as a pH-adjusting excipient.

This document is a 510(k) premarket notification for a medical device called "PrismaSATE dialysis solutions" by Baxter Healthcare Corporation.

Based on the provided text, the device is the PrismaSATE dialysis solutions buffered with bicarbonate using hydrochloric acid as a pH-adjusting excipient, packaged in polyolefin primary packaging materials. The purpose of this 510(k) is to expand the existing PrismaSATE solution formulations into a different packaging material.

Here's an analysis of the acceptance criteria and the "study" (design verification in this case) that aims to prove the device meets these criteria:

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

The document states: "Baxter Healthcare Corporation performed design verification for the modification. The result met its acceptance criteria, and supports that the proposed device is appropriately designed for its intended use." However, it does not explicitly list the acceptance criteria or specific numerical performance results of this "design verification".

Instead, it refers to the modification of packaging material. The acceptance criteria would likely relate to the integrity and compatibility of the solution with the new polyolefin packaging, and the maintenance of the solution's properties.

Based on the "Device Comparison Table" (Table 3) and the "Discussion of Nonclinical Tests," the implied performance criteria and the device's reported ability to meet them are:

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 explicitly states: "No performance data is included in this Special 510(k)." This implies that no new testing with a specific test set was conducted or provided in this submission to demonstrate performance with the new packaging. The submission relies on the substantial equivalence to predicate devices, where performance data would have been established for the individual components (solution formulation and packaging material).

Therefore, specific sample sizes, country of origin, or retrospective/prospective nature of the data for this specific submission are not provided. The "design verification" mentioned is described broadly without these details.

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. No new test set data is presented for which ground truth would need to be established by experts for performance evaluation. The "design verification" would likely involve internal company experts in engineering, quality, and manufacturing, but their specific roles or number are not specified for "ground truth" establishment in a performance study context.

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

Not applicable. There is no mention of a performance study involving interpretation or scoring of data that would require an adjudication method.

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 device is a dialysis solution and its packaging, not an AI or imaging diagnostic device that would require an MRMC study.

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

Not applicable. This device is not an algorithm.

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

Not applicable in the conventional sense of a clinical performance study for an AI or diagnostic device. The "ground truth" for this submission is effectively the established performance and safety profiles of the predicate devices. The "design verification" likely relied on manufacturing specifications, chemical analysis, stability testing, and packaging integrity tests, rather than a clinical "ground truth" established by external experts.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that would require a training set.

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

Not applicable.

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Gambro PrismaSate solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

Gambro PrismaSATE solutions are sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialyzable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags.

The provided text is a 510(k) summary for a medical device (PrismaSATE Dialysis Solutions). It describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria in the way typically expected for a diagnostic or machine learning-based device.

The "Testing, and Recognized Standards" section mentions:

• Expiration Dating: Stability studies were performed and results provided.
• Sterilization: Validation methods followed ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 11138-3.
• Biocompatibility: Primary packaging material was tested per Gambro's procedure for physico-chemical and biological evaluation.

These are compliance activities related to manufacturing and material safety, not performance criteria for a diagnostic or AI-driven system. The core of this 510(k) is based on substantial equivalence to predicate devices due to having the same intended use, indication for use, chemical concentration range, and packaging characteristics, with "no significant technological changes."

Therefore, I cannot populate the requested table and study information because the provided text does not contain a performance study with acceptance criteria for a device that would typically involve such metrics (like sensitivity, specificity, AUC, etc.). The "performance" here is demonstrating chemical and physical equivalence and safety.

Here's a breakdown of why the requested information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on chemical composition, packaging, and safety/sterilization standards rather than a quantifiable performance metric (e.g., accuracy for a diagnostic).
2. Sample size used for the test set and the data provenance: Not applicable in the context of this submission. The "tests" mentioned are for stability, sterilization validation, and biocompatibility, not for a "test set" of patient data for a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for an AI/diagnostic device is not discussed.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" here is adherence to specified chemical concentrations, sterility, and biocompatibility standards.
8. The sample size for the training set: Not applicable. There is no "training set" for an AI/ML algorithm mentioned.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a medical device (dialysis solutions) that is a consumable and is cleared based on substantial equivalence to existing products, as well as adherence to manufacturing and safety standards. It is not a diagnostic device or an AI-powered system that would typically undergo the kind of performance study outlined in your request.

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Gambro PrismaSate™ solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

Gambro PrismaSate solutions are sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialysable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags.

This document is a 510(k) summary for a medical device called PrismaSate, which are dialysis solutions. It states that the device is substantially equivalent to predicate devices and describes its intended use. However, it does not contain any information about acceptance criteria, device performance results, sample sizes, ground truth establishment, or clinical study methodologies typically associated with proving a device meets acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance
2. Sample sizes used for the test set and data provenance
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. Comparative effectiveness study results (MRMC)
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This document is primarily for regulatory submission and approval based on substantial equivalence, not a detailed report of a performance study with specific acceptance criteria.

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Gambro PrismaSate™ solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

Gambro PrismaSate solutions are sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialysable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used.

The solutions are perfused through the dialysis fluid compartment of hemofilters/dialyzers. The dialysate is separated from the patient's blood by means of a semi-permeable membrane. Excess waste products, fluids and toxins found in the blood of a patient with acute renal failure pass through the membrane into the dialysate and eventually go to waste. The therapy is aimed at normalizing the blood.

CRRT is used for acute renal failure patients that may be too unstable to tolerate conventional hemodialysis, in which this function occurs much more rapidly (3-4 hours per treatment) and intermittently (3-6 times a week). In CRRT, the balancing is done on a continuous basis, 24 hours a day, in order to mimic kidney function.

The provided text describes a 510(k) premarket notification for a dialysis solution, not a medical device that utilizes AI or requires a study comparing its performance to acceptance criteria in the way a diagnostic algorithm would. Therefore, most of the requested information (sample sizes, experts, adjudication methods, MRMC studies, standalone performance, training sets) is not applicable.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving performance against specific acceptance criteria through a clinical or technical study of the device's diagnostic or predictive capabilities.

Here's the closest interpretation of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (dialysis solution), the "acceptance criteria" are primarily related to its chemical composition, sterility, packaging, and intended use being equivalent to already cleared devices. The "reported device performance" is the statement of its characteristics.

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

• Not Applicable. This is a medical device submission for a dialysis solution, not an AI or diagnostic device that uses a test set of data. The "test" is the comparison of its characteristics and intended use to predicate devices and recognized standards.

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

• Not Applicable. Ground truth, in the context of an AI or diagnostic device, is not relevant here. The "ground truth" for chemical composition would be established by analytical chemistry techniques, and for sterility by microbiological testing, but these are part of standard manufacturing and quality control, not a "test set" in the AI sense.

4. Adjudication method for the test set

• Not Applicable. See reasons for #2 and #3.

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 not an AI-assisted diagnostic device.

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

• Not Applicable. This device does not have an algorithm.

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

• For the chemical composition and sterility, the "ground truth" would be established by analytical chemistry testing (e.g., spectrophotometry, chromatography) and microbiological testing (e.g., sterility tests). For the intended use and technological characteristics, the "ground truth" is established by comparison to regulatory definitions and established predicate devices. The document explicitly states: "Comparing the proposed device to the predicate devices, its ranges of chemical compositions, packaging, and sterility are equivalent to one or more of the predicate devices."

8. The sample size for the training set

• Not Applicable. There is no training set for this type of device.

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

• Not Applicable. There is no training set.

Summary of the Study/Demonstration of Acceptance:

The "study" in this context is a comparative analysis of the device's characteristics against legally marketed predicate devices, as detailed in the "Comparison to Predicate Devices" section of the 510(k) summary. The manufacturer, Gambro Renal Products, asserts that their PrismaSate Dialysis Solutions are substantially equivalent to the following predicate devices:

• Premixed Dialysate for Hemodiafiltration (K910270, Baxter Healthcare Corp.)
• Normocarb Sterile Bicarbonate Renal Dialysis Concentrate (K001059, Dialysis Solutions, Inc. / Novex Pharma)
• Hemodialysis Bath Concentrate Solutions for Hemodialysis (K864265, Dial Medical of Florida, Inc.)
• Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis (K011368, Gambro Renal Products)

The documentation highlights that the PrismaSate solutions' chemical compositions, packaging, and sterility are equivalent to one or more of these predicates. A specific point of comparison was the lactate concentration, where PrismaSate's upper level (40 mEq/L) was higher than the predicate devices but was justified as being within the European Pharmacopoeia Monograph for Solutions for Hemofiltration and Hemodiafiltration (30-60 mEq/L), which is an accepted reference standard. The manufacturer argued that the higher lactate concentration brings the pH closer to physiological plasma pH and has no adverse effect on safety or effectiveness.

Ultimately, the FDA's letter states that they reviewed the 510(k) and "determined the device is substantially equivalent (...) to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" that the device meets the necessary regulatory "acceptance criteria" for market clearance.

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