(210 days)
Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys, livers, and hearts 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 hearts prior to removal from the donor and for preserving the heart 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 is a 510(k) summary for the Custodiol HTK Solution, which is a medical device for organ preservation. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the generalized sense of a diagnostic, imaging, or AI-powered device. Instead, it describes clinical studies comparing the performance of the Custodiol HTK Solution with predicate devices to demonstrate its substantial equivalence for organ preservation.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary does not define explicit "acceptance criteria" in a quantitative sense as might be seen for a diagnostic or imaging device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices in terms of performance and safety for organ preservation. The reported device performance is related to survival rates and other outcome measures of transplanted organs.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in effectiveness. | "Custodiol performs as well as the predicate device." |
| Similar indications for use as predicate devices. | Indications for Use statement is clearly the same. |
| Similar technological characteristics as predicate devices. | Solutions contain electrolytes, buffering agents, etc. |
| Equivalent survival rates and outcome measures of preserved organs. | Compared survival rates and other outcome measures in clinical studies. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: "a small randomized clinical study" and "extensive experience of the largest heart transplant center in the world." Specific numbers are not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin), but reference to "the largest heart transplant center in the world" suggests a clinical setting. The studies are clinical in nature. The term "retrospective or prospective" is not used, but "clinical studies have been reported" implies real-world data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" here would relate to organ viability and patient outcomes, which are objective clinical measures rather than expert interpretations of data (like radiology reads).
4. Adjudication method for the test set:
Not applicable for this type of device and study.
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 or diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a chemical solution, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" largely refers to clinical outcomes data, specifically "survival rates and other outcome measures" of transplanted organs.
8. The sample size for the training set:
Not applicable. This is not a machine learning device with a training set. The clinical studies mentioned serve as the basis for demonstrating equivalence.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).