Search Results

SPS-1TM is intended for the flushing and cold storage of kidney, liver, and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.

SPS-1 TM is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolality of 320 mOsm, a sodium concentration of 29 mEq/L, a potassium concentration of 125 mEq/L, and a pH of approximately 7.4 at 20°C.

The provided document (K091656) does not contain information about a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for a "Static Preservation Solution" that establishes substantial equivalence to predicate devices based on shared manufacturing processes, chemical composition, and intended use.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in this document.

Here's a breakdown of what can be extracted and what is missing:

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

   • Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "functional and safety testing" mentions verifying device design met its requirements through biocompatibility, sterility, chemical identification, and particle enumeration in accordance with standards. However, the specific acceptance criteria (e.g., maximum allowable particle count, sterility pass/fail definition) and the results against these are not detailed.
   • Reported Device Performance: Not provided in terms of outcome statistics from a study (e.g., organ viability rates, post-transplant function). The document states the primary evidence for equivalence is that the device and predicate devices "are manufactured by the same process, with exactly the same chemical composition and have the same intended use." This implies performance is assumed to be equivalent due to these factors, rather than directly measured in a comparative study.

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: Not applicable. No clinical or comparative study data is presented. The "testing" mentioned refers to laboratory tests (biocompatibility, sterility, etc.), not a test set of patient or organ data.
   • Data Provenance: Not applicable.

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 ground truth establishment for a test set is described.

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

   • Not applicable. No test set requiring adjudication is described.

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 static preservation solution, not an AI-assisted diagnostic tool or system that involves human readers.

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

   • Not applicable. This device is a medical solution, not a software algorithm.

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

   • Not applicable in the context of a performance study. For the laboratory testing (biocompatibility, sterility, chemical ID, particle enumeration), the "ground truth" would be the established industry standards and validated test methods for these specific properties.

8. The sample size for the training set:

   • Not applicable. This device is a medical solution, not a machine learning model requiring a training set.

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

   • Not applicable.

Summary of Device Acceptance Rationale from the Document:

The acceptance of the SPS-1™ Static Preservation Solution (K091656) by the FDA is based on demonstrating substantial equivalence to existing legally marketed predicate devices (CoStorSol® K083453, K073693, and ViaSpan® K944866).

The key arguments for substantial equivalence are:

• The SPS-1™ is manufactured by the same process as the predicate devices.
• It has exactly the same chemical composition as the predicate devices.
• It has the same intended use (flushing and cold storage of kidney, liver, and pancreas organs for transplantation).

Functional and safety testing mentioned includes biocompatibility, sterility, chemical identification, and particle enumeration, all performed "in accordance with applicable industry standards and/or FDA guidance documents." However, specific results or acceptance criteria for these tests are not detailed in this summary. The primary evidence presented for equivalence relies on the identical nature of the product to already approved devices.

Ask a specific question about this device

Custodiol HTK Solution is indicated for perfusion and flushing 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 (not for continuous perfusion) to the recipient.

The 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. 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 allows the organ to be quickly cooled.

Here's a breakdown of the acceptance criteria and study information for the Custodiol® HTK Solution, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than defining specific performance acceptance criteria like often seen for novel AI/medical imaging devices. For drug or solution products like Custodiol HTK Solution, "performance" is typically measured by clinical outcomes related to organ preservation effectiveness.

Therefore, the "acceptance criteria" here are implicitly tied to the performance of the legally marketed predicate devices, and the "reported device performance" is the demonstration that Custodiol HTK Solution performs similarly.

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

• Test Set Sample Size: The document states that "a small number of independent clinical studies" were used to demonstrate equivalence. It does not specify the exact sample sizes for these studies.
• Data Provenance: The studies are described as "independent clinical studies," suggesting real-world data, likely prospective or retrospective clinical trials comparing outcomes. The country of origin is not specified.

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

This type of information (number and qualifications of experts) is typically relevant for studies involving subjective assessment (e.g., image interpretation). For a solution like Custodiol HTK, the "ground truth" for its effectiveness is generally established by objective clinical outcomes (e.g., organ survival rates, transplant success) rather than expert consensus on a subjective measure. Therefore, this question is not applicable in the traditional sense for this device.

4. Adjudication Method for the Test Set

As the "ground truth" is based on objective clinical outcomes, an adjudication method for subjective assessments is not applicable. Clinical studies generally have established protocols for data collection and outcome assessment, but not a "2+1" or "3+1" adjudication model for interpreting performance.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic devices or AI algorithms that assist human readers in interpreting images or data.
• The Custodiol HTK Solution is an organ preservation solution, not an AI-powered diagnostic tool. Therefore, this question is not applicable.

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

• No, a standalone (algorithm-only) performance study was not done.
• The Custodiol HTK Solution is a medical product (chemical solution), not an algorithm or AI. Therefore, this question is not applicable.

7. The Type of Ground Truth Used

The ground truth used was primarily clinical outcomes data, specifically:

• "Survival rates"
• "Other outcome measures" (likely related to organ function post-transplant, rejection rates, etc.)

8. The Sample Size for the Training Set

• Not applicable. As this is a medical solution and not a machine learning algorithm, there is no "training set" in the context of AI development. The "training" or development of the solution would involve pharmaceutical research and chemical formulation, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. There is no "training set" or corresponding "ground truth" as defined for AI/ML devices. The "ground truth" for the overall effectiveness of the solution is established through clinical studies (as mentioned in point 7).

Ask a specific question about this device

Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys 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 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 HCl, 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.

Here's an analysis of the provided 510(k) summary regarding the Custodiol® HTK Solution, focusing on acceptance criteria and the study that proves its equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicitly derived from the performance of the predicate device (Viaspan Belzer UW Cold Storage Solution), as the study aims to demonstrate "as well as" performance.

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

• Sample Size: "Over a thousand kidneys" were included in the study.
• Data Provenance: The study was a "47-center randomized clinical study carried out under the guidance of the Eurotransplant organization of Leiden, The Netherlands." This indicates prospective data from multiple European centers.

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

This information is not provided in the document. The study focuses on "overall kidney survival rates" as outcome measures, which are clinical outcomes rather than expert-established ground truth in an imaging or diagnostic sense. The determination of kidney survival likely relies on standardized clinical criteria and medical records, rather than expert interpretation of a specific artifact.

4. Adjudication Method for the Test Set

This information is not explicitly provided. Given the nature of kidney survival rates as the primary outcome, it's unlikely that the "adjudication method" in the context of expert review (e.g., 2+1, 3+1) is directly applicable. Outcomes like kidney survival are typically determined by clinical follow-up and documented medical facts.

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 comparison of two organ preservation solutions, not an AI-assisted diagnostic device. Therefore, a MRMC study with human readers and AI assistance is not relevant to this submission.

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 or AI device.

7. The Type of Ground Truth Used

The ground truth used was outcomes data, specifically "overall kidney survival rates." These rates are clinical outcomes reflecting the functional status of the transplanted kidneys over time.

8. The Sample Size for the Training Set

Not Applicable. This is not a machine learning or AI device that requires a distinct training set. The clinical study described served as the primary performance evaluation.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set in the context of an AI/ML device, this question is not relevant. The "ground truth" for the performance evaluation (kidney survival) was established through clinical follow-up and medical documentation within the multi-center study.

Ask a specific question about this device