(266 days)
The OrganProtex™ 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. OrganProtex™ HTK Solution is not indicated for continuous machine perfusion of donor organs.
OrganProtex™ HTK Solution is a clear, colorless to pale yellow colored solution, sterile, nonpyrogenic electrolyte and amino acid aqueous solution for organ perfusion and preservation. OrganProtex™ 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. OrganProtex™ HTK Solution is not indicated for continuous machine perfusion of donor organs.
Histidine-tryptophan-ketoglutarate or HTK solution is a high-flow, low-potassium preservation solution used for organ transplantation. The solution was initially developed by Hans-Jurgen Bretschneider.
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 hydrochloride, so as to prolong the period during which the organs will tolerate interruption of oxygenated blood. The composition of HTK is similar to that of extracellular fluid. All of the components of HTK, with the exception of mannitol, occur naturally in the body. The solution should be used only by medical healthcare staff, adequately trained according to established operating protocols.
The document describes the OrganProtex™ HTK Solution, which is an organ preservation solution. This device is applying for 510(k) clearance based on substantial equivalence to a predicate device, Custodiol® HTK Solution (K192408).
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a medical solution, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating equivalence in composition, function, and safety to a legally marketed predicate device, rather than a quantifiable performance metric against a specific clinical outcome.
The main acceptance criterion for a 510(k) is demonstrating substantial equivalence to an existing predicate device. This is achieved by showing that the new device has the same intended use, and either the same technological characteristics or, if different, that these differences do not raise new questions of safety and effectiveness.
The document provides a detailed comparison table (Table 6.0 in the original document, reproduced below as "Comparison of Technological Characteristics") that serves as the reported device performance against the predicate.
Comparison of Technological Characteristics
| Characteristic | Subject Device (OrganProtex™ HTK Solution) | Predicate Device (Custodiol® HTK Solution) | Comparison / Reported Performance |
|---|---|---|---|
| Device Manufacturer | Rusoma Laboratories Pvt. Ltd. (India) | Dr. Franz Kohler Chemie GmBH (Germany) | - |
| 510(k) Number | K241239 | K192408 | - |
| Classification & Product Code | 876.5880; KDL, MSB | 876.5880; KDL, MSB | Same |
| Device Regulation Description | Isolated kidney perfusion and transport system and accessories | Isolated kidney perfusion and transport system and accessories | Same |
| Common Name | HTK Solution | HTK Solution | Same |
| Device Description | Clear, colorless to pale yellow colored solution, sterile, non-pyrogenic electrolyte and amino acid aqueous solution for organ perfusion and preservation. Available in 1000ml bag. Sterile and intended for one single and continuous administration. | Clear, colorless to pale yellow colored solution, sterile, non-pyrogenic electrolyte and amino acid aqueous solution for organ perfusion and preservation. Available in 1000mL, 2000mL and 5000ml bags. Sterile and intended for one single and continuous administration. | Same. Used as organ preservation solutions in the procurement and transplant process. |
| Indications for Use | Indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal or immediately after removal. Solution left in organ vasculature during hypothermic storage and transportation. Not for continuous machine perfusion. | Indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal or immediately after removal. Solution left in organ vasculature during hypothermic storage and transportation. Not for continuous machine perfusion. | Same. Used at cold temperatures to slow biological deterioration. |
| Intended Use | Perfusion and flushing of donor kidney, liver, pancreas and heart prior to removal or immediately after removal. Solution left in organ vasculature during hypothermic storage and transportation. | Perfusion and flushing of donor liver, kidney, heart, and pancreas prior to removal and for preserving these organs during hypothermic storage and transport. | Same. Used at cold temperatures to slow biological deterioration. |
| Storage Temperature | 2° to 8° C | 2° to 8° C | Same |
| Pre-Cooling | Pre-cool solution prior to use (2° to 4° C) | Pre-cool solution prior to use (2° to 4° C) | Same |
| In-Situ Organ Cooling | Surface cooling of organs (heart, kidney, liver, pancreas). | Surface cooling of organs (heart, kidney, liver, pancreas). | Same |
| Maintain Cold Organ Temperature During Storage and Transport | Directly cools the organ vasculature during hypothermic storage and transportation (not for continuous perfusion). | Directly cools the organ vasculature during hypothermic storage and transportation (not for continuous perfusion). | Same |
| Product State | Liquid - Solution | Liquid - Solution | Same |
| Composition | Identical quantitative composition of Sodium chloride, Potassium chloride, Potassium hydrogen 2-Oxopentandioate, Magnesium chloride·6H2O, Histidine HCl·H2O, Histidine, Tryptophan, Mannitol, Calcium chloride·2H2O, Water for Injection. | Identical quantitative composition of Sodium chloride, Potassium chloride, Potassium hydrogen 2-Oxopentandioate, Magnesium chloride·6H2O, Histidine HCl·H2O, Histidine, Tryptophan, Mannitol, Calcium chloride·2H2O, Water for Injection. | Same |
| Osmolality | 310 mOsmol/kg | 310 mOsmol/kg | Same |
| pH | 6.5-7.5 | 7.02-7.20 at 25°C, 7.4-7.45 at 4°C | Equivalent. Both within set specifications. The difference in pH range (6.5-7.5 vs. 7.02-7.20) does not impact safety and efficacy as histidine buffers tissue pH. |
| Fluid Volume | 1,000 ml | 1,000 ml, 2,000 ml, 5,000 ml | Equivalent. Subject device in a subset of available volumes of the predicate. |
| Single Use Only | Yes | Yes | Same |
| Primary Container | Polypropylene PVC-Free Bag | Polypropylene PVC-Free Bag | Equivalent |
| Protecting Overwrap Bag | Yes | Yes | Same |
| Shelf Life | 12 Months | 12 Months | Same |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | Same |
| Sterility | Sterile solution | Sterile solution | Same |
| Sterilization | Terminal steam sterilization | Terminal steam sterilization | Same |
| Biocompatibility | Biocompatible in accordance with ISO 10993-1/2/5/10/12. | Biocompatible in accordance with ISO 10993-1/2/5/10/12. | Equivalent. |
| Sterile Dispensing | Fluid is dispensed via sterile port on bag. | Fluid is dispensed via sterile port on bag. | Same |
| Bag Connections | Fluid delivery and drug administration ports | Fluid delivery and drug administration ports | Same |
2. Sample Size Used for the Test Set and Data Provenance
This is a submission for a medical solution, not typically a device that undergoes "test set" evaluation in the same way an AI/software device would. The "test set" here refers to the data and testing used to demonstrate the solution's properties (sterility, pH, osmolality, shelf life, biocompatibility).
- Sample Size for Test Set: The document doesn't specify a numerical "sample size" in terms of how many units of
OrganProtex™ HTK Solutionwere tested for each non-clinical performance category (biocompatibility, sterilization, shelf-life). These are standard laboratory tests typically performed on a statistically relevant batch size for manufacturing quality control and regulatory submission. - Data Provenance: The manufacturing entity is Rusoma Laboratories Pvt. Ltd. in India. The studies performed (biocompatibility, sterilization, shelf-life) were conducted to demonstrate the properties necessary for substantial equivalence. The document doesn't specify if the underlying data/tests were conducted retrospectively or prospectively, but typically, these are prospectively planned tests to support the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information (number of experts, qualifications, and ground truth establishment) is typically relevant for studies involving human interpretation, such as image analysis for diagnosis. For a medical solution like OrganProtex™ HTK Solution, there isn't a "ground truth" established by human experts in the same way. The ground truth for its properties (like sterility, pH, composition) is established through analytical chemistry, microbiology, and physical property testing performed by qualified laboratory personnel following validated methods.
4. Adjudication Method for the Test Set
Not applicable for this type of device. Adjudication methods (e.g., 2+1, 3+1) are common in clinical trials or human performance studies where multiple experts evaluate cases and discrepancies are reconciled. The non-clinical performance data for OrganProtex™ HTK Solution relies on objective laboratory measurements.
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 medical solution (a liquid for organ preservation), not an AI-powered diagnostic or assistive device. Therefore, MRMC studies and the concept of "human readers" or "AI assistance" are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical solution and does not involve any algorithms or software for standalone performance.
7. The Type of Ground Truth Used
The ground truth for the non-clinical performance data is based on:
- Analytical Chemistry: For composition, pH, osmolality.
- Microbiology Testing: For sterility and pyrogenicity.
- Biocompatibility Testing: In accordance with ISO 10993 standards.
- Stability Studies: To determine shelf life.
8. The Sample Size for the Training Set
Not applicable. This product is a medical solution, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 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).