Search Results

CUSTODIOL® HTK solution is indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the patient. CUSTODIOL® HTK solution is not indicated for continuous machine perfusion of donor organs.

The CUSTODIOL® HTK solution is intended for perfusion and flushing donor kidney, liver, heart, and pancreas prior to removal from the donor and for preserving these organs during hypothermic storage and transport to the recipient. CUSTODIOL® HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCI, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the CUSTODIOL® HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the CUSTODIOL® HTK solution occur naturally in the body. The CUSTODIOL® HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in orqans that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The CUSTODIOL® HTK solution has a low viscosity, even at low temperatures. This characteristic assures rapid flow rates during initial perfusion, allowing the organ to be quickly cooled.

This document is a 510(k) premarket notification for the CUSTODIOL® HTK Solution, an organ preservation solution. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K043461), rather than outlining specific performance criteria and a study to prove they are met in a traditional sense for a new AI/diagnostic device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The document primarily focuses on comparing the new device to a predicate based on existing data and prior clearances.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not present "acceptance criteria" and "reported device performance" in the typical format of a diagnostic or AI device where specific metrics (e.g., sensitivity, specificity, AUC) are measured against predefined thresholds. Instead, the "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate device.

The "reported device performance" is essentially the demonstrated similarity across various characteristics, supported by existing data and non-clinical testing.

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

This information is not provided in this 510(k) submission. The document relies on existing data, standards, and non-clinical testing to demonstrate substantial equivalence, rather than a specific new clinical "test set" with a defined sample size for performance evaluation. The "non-clinical testing" mentioned for packaging differences likely involved laboratory tests, not a patient-based test set.

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 applicable/not provided. This is a device for organ preservation, not an AI/diagnostic device that generates an output requiring expert interpretation or "ground truth" establishment in the context of a diagnostic study.

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

This information is not applicable/not provided. See point 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

This information is not applicable/not provided. This is not an AI-assisted diagnostic device.

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

This information is not applicable/not provided. This is an organ preservation solution, not an algorithm.

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

This information is not applicable/not provided in the context of a new study to establish "ground truth" for a performance evaluation. The "ground truth" here is the established safety and efficacy of the predicate device, and the substantial equivalence of the current device to that predicate based on physico-chemical properties, biological characteristics, and non-clinical testing.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable/not provided. There is no "training set" for this type of device submission.

Ask a specific question about this device

Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys and liver prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.

The HTK solution is intended for perfusion and flushing donor kidneys and liver prior to removal from the donor and for preserving the kidney during hypothermic storage and transport to the recipient. HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCI, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the HTK solution occur naturally in the body. The HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The HTK solution has a low viscosity, even at low temperatures. This characteristic assures rapid flow rates during initial perfusion, allowing the organ to be quickly cooled.

The provided text describes the performance of Custodiol® HTK Solution in comparison to a predicate device (Viaspan Belzer UW Cold Storage Solution) for liver preservation. However, it does not outline explicit "acceptance criteria" in the format of defined thresholds that the device must meet. Instead, the study aims to demonstrate "substantial equivalence" based on clinical outcomes, particularly patient and graft survival rates.

Here's an analysis based on the information provided, framed around the concepts requested:

1. Table of Acceptance Criteria and Reported Device Performance:

As explicit acceptance criteria were not stated as numerical thresholds (e.g., "must achieve X% survival"), the table below reflects the comparative performance of the Custodiol HTK Solution against the predicate (UW solution) and general outcomes when using HTK, which served as the basis for demonstrating equivalence. The "Acceptance Criteria" here are inferred to be "survival rates at least as good as, and not significantly different from, the predicate device (Viaspan Belzer UW Cold Storage Solution) or generally accepted outcomes for liver transplantation using similar preservation methods."

2. Sample Size Used for the Test Set and Data Provenance:

• Four-Center Prospective Clinical Study (Eurotransplant):
  • Sample Size: 228 livers
  • Data Provenance: Prospective, from four centers located at Essen, Innsbruck, Göttingen, and Vienna (Europe, specifically Germany and Austria).
• Randomized Prospective Study (Essen):
  • Sample Size: 60 livers (30 preserved with HTK, 30 preserved with UW solution).
  • Data Provenance: Prospective, from Essen (Germany).
• Retrospective Study (Hanover):
  • Sample Size: 747 liver transplants (515 using UW solution, 232 using HTK solution). These involved 416 patients (UW) and 197 patients (HTK), with some re-transplants.
  • Data Provenance: Retrospective, from Medizinische Hochschule Hanover, Clinic for Abdominal and Transplantation Surgery (Germany).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

The document describes clinical studies measuring patient and graft survival rates, which are direct clinical outcomes. It does not mention the use of experts to establish a "ground truth" for the test set in the sense of independent adjudication or labeling of images/data, as would be typical for diagnostic AI devices. The outcomes (survival rates) are objectively measured clinical events.

4. Adjudication Method for the Test Set:

Not applicable in the context of this device. The studies directly measured clinical outcomes (patient and graft survival), which are not typically subject to an adjudication process in the way a diagnostic interpretation would be.

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 medical solution (organ preservation fluid), not a diagnostic device that assists human readers.

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

Not applicable. This is a medical solution, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" used in these studies was outcomes data, specifically:

• Patient survival (mortality)
• Graft survival (failure of the transplanted organ)

These are direct, objective clinical endpoints.

8. The Sample Size for the Training Set:

Not applicable. This is a medical solution, not a machine learning algorithm requiring a training set. The clinical studies described are for validation/comparison, not for training a model.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device