(163 days)
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
| Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Custodiol HTK Solution) | Metric |
|---|---|---|
| 91% kidney survival at 1 month | 91% kidney survival at 1 month | Kidney Survival Rate |
| 82% kidney survival at 12 months | 83% kidney survival at 12 months | Kidney Survival Rate |
| 74% kidney survival at 24 months | 77% kidney survival at 24 months | Kidney Survival Rate |
| 68% kidney survival at 36 months | 74% kidney survival at 36 months | Kidney Survival Rate |
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.
§ 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).