(75 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated by studies) |
|---|---|
| Maintain organ viability and function during hypothermic storage and transport comparable to predicate devices (e.g., Belzer UW Cold Storage Solution). | "Several clinical studies have been reported that compared the performance of Custodiol HTK Solution with the UW Solution, and others. These studies have compared survival rates and other outcome measures. The primary evidence for the equivalence in effectiveness of Custodiol to that of UW has come from a small number of independent clinical studies." |
| No significant adverse events or safety concerns compared to predicate devices. | Not explicitly detailed in summary, but implied by substantial equivalence determination. |
| Physiochemical characteristics (e.g., low viscosity, composition) suitable for intended use. | "The Custodiol HTK Solution has the same technological characteristics as the predicate devices...The HTK solution has a low viscosity, even at low temperatures. This allows rapid cooling of the organ during initial perfusion." |
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).
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).