(233 days)
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.
| Characteristic | Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (as demonstrated) |
|---|---|---|
| Indications for Use | Substantially Equivalent to Predicate | Deemed "Substantially Equivalent" without differences. |
| Biological Characteristics (Body Contact Type/Duration) | Substantially Equivalent to Predicate | Deemed "Substantially Equivalent" without differences. |
| Design/Technical Characteristics (Material) | Substantially Equivalent to Predicate | Deemed "Substantially Equivalent." |
| Design/Technical Characteristics (Packaging) | Differences evaluated through non-clinical testing | "Different; Substantial Equivalence demonstrated through non-clinical testing." |
| Biocompatibility | Satisfactorily demonstrated | Satisfactorily demonstrated by available data (USP, EU.Ph, ISO 10993 standards). |
| Sterilization | STERILE via steam sterilization | Supplied in STERILE via steam sterilization. |
| Shelf-Life | Validated up to 12 months | Validated up to 12 months through stability studies, biocompatibility testing, and packaging validation. |
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.
§ 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).