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.

Device Description

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.

AI/ML Overview

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 Solution were 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

January 24, 2025

Bridge to Life Ltd Mark Harper Compliance Manager 707 Skokie Blvd. Ste.340 Northbrook, Illinois 60062

Re: K241239

Trade/Device Name: OrganProtex HTK Solution Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion And Transport System And Accessories Regulatory Class: Class II Product Code: KDL, MSB Dated: December 20, 2024 Received: December 23, 2024

Dear Mark Harper:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Maura Rooney -S

Maura Rooney Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241239

Device Name OrganProtex™ HTK Solution

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K241239: 510(k) Summary

1.0 SUBMITTER

Bridge to Life Ltd

707 Skokie Blvd, Ste. 340 Northbrook, IL 60062

Contact Person	:	Mark Harper
Phone	:	847-796-3070
Fax	:	803-753-9798
Email	:	m.harper@b2ll.com
Date Prepared	:	April 30th 2024

2.0 DEVICE

Proprietary Name :	OrganProtex TM HTK Solution
Classification Name :	Isolated kidney perfusion and transport system and accessories
Device Classification :	Class II, 876.5880
Product Code :	KDL, MSB

3.0 PREDICATE DEVICE

Company	Device	K Number	Date Cleared
Dr. Franz Kohler ChemieGmBH (Germany)	Custodiol® HTK Solution	K192408	April 24, 2020

4.0 DEVICE DESCRIPTION

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OrganProtexTM HTK Solution is substantially equivalent in composition, safety and efficacy to currently marketed Custodiol® HTK solution, which was cleared by the US FDA in prior 510(k) submission K192408.

Table 1 provides information about the composition of OrganProtex™ HTK Solution.

Component	g/L	Mmol/L
Sodium chloride	0.8766	15.0
Potassium chloride	0.6710	9.0
Magnesium chloride. 6H2O	0.8132	4.0
Histidine Hydrochloride.H2O	3.7733	18.0
Histidine	27.9289	180.0
Tryptophan	0.4085	2.0
Mannitol	5.4651	30.0
Calcium Chloride.2H2O	0.0022	0.015
Potassium Hydrogen 2-Oxopentandioate (Ketoglutarate)	0.1842	1.0
Sterile Water for Injection	qs to 1000 mL Volume

Table 1: Composition of OrganProtex™ HTK Solution

5.0 INDICATION FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6.0 PREDICATE DEVICE

The following table provides a comparison of attributes between the proposed device and the predicate and reference devices:

	Subject Device	Predicate Device	Comparison
Device	OrganProtex™ HTKSolution	Custodiol® HTK Solution
510k Number	K241239	K192408
Manufacturer	Rusoma Laboratories Pvt.Ltd.149 Bhamori, RusomaChauraha, AB Road, Indore(MP) -452010	Dr. Franz Kohler ChemieGmBH Postfach 1117 D-64659Alsbach-Hahnlein,Germany	-
Classification &Product Code	876.5880; KDL, MSB	876.5880; KDL, MSB	Same

DeviceRegulationDescription	Isolated kidney perfusionand transport system andaccessories	Isolated kidney perfusion andtransport system andaccessories	Same
Common Name	HTK Solution	HTK Solution	Same
DESCRIPTION,INDICATIONS,& INTENDEDUSE
DeviceDescription	Clear, colourless to paleyellow coloured solution,sterile, non-pyrogenicelectrolyte and amino acidaqueous solution for organperfusion and preservation.Available in 1000ml bag.The solution is sterile andis intended for one singleand continuousadministration.	Clear, colourless to paleyellow coloured solution,sterile, non-pyrogenicelectrolyte and amino acidaqueous solution for organperfusion and preservation.Available in 1000mL,2000mL and 5000ml bags.The solution is sterile and isintended for one single andcontinuous administration.	SameSubject and predicate devicesare both used as organpreservation solutions. Devicesare used in the organprocurement and transplantprocess per standard organpreservation practices.
Indications forUse	OrganProtex™ HTKsolution is indicated forperfusion and flushing ofdonor kidneys, liver,pancreas and heart priorto removal from the donoror immediately afterremoval from the donor.The solution is left in theorgan vasculature duringhypothermic storage andtransportation to thepatient. OrganProtexTMHTK solution is notindicated for continuousmachine perfusion ofdonor organs.	Custodiol ® HTKsolution is indicated forperfusion and flushing ofdonor kidneys, liver,pancreas and heart prior toremoval from the donor orimmediately after removalfrom the donor. The solutionis left in the organvasculature duringhypothermic storage andtransportation to the patient.Custodiol ® HTKsolution is not indicated forcontinuous machineperfusion of donor organs.	SameSubject and predicate devicesare both used as organpreservation solutions. Alldevices are used at coldtemperatures, to slow biologicaldeterioration in organs removedfrom their physiologicalenvironment per standard organpreservation practices.
Intended Use	OrganProtex™ HTKSolution is intended forthe perfusion and flushingof donor kidney, liver,pancreas and heart prior toremoval from the donor orimmediately after removalfrom the donor. Thesolution is left in theorgan vasculature duringhypothermic storage andtransportation to thepatient.	Intended for the perfusionand flushing of donor liver,kidney, heart, and pancreasprior to removal from thedonor and for preservingthese organs duringhypothermic storage andtransport to the recipient.	SameSubject and predicate devicesare both used as organpreservation solutions. Alldevices are used at coldtemperatures, to slow biologicaldeterioration in organs removedfrom their physiologicalenvironment per standard organpreservation practices.
TECNOLOGI-CALCHARATERISTICS
StorageTemperature	2° to 8° C	2° to 8° C	Same
Pre-Cooling	Pre-cool solution prior touse(2° to 4° C)	Pre-cool solution prior to use(2° to 4° C)	Same
In-SituOrganCooling	Surface cooling of organs(heart, kidney, liver,pancreas).	Surface cooling of organs(heart, kidney, liver,pancreas).	Same
Maintain ColdOrganTemperatureDuring Storageand Transport	Directly cools the organvasculature duringhypothermic storage andtransportation (not forcontinuous perfusion) to thepatient.	Directly cools the organvasculature duringhypothermic storage andtransportation (not forcontinuous perfusion) to thepatient.	Same
Product State	Liquid - Solution	Liquid - Solution	Same
Composition	1000 mL OrganProtex™HTK Solution contains:0.8766 g Sodiumchloride0.6710 g Potassiumchloride0.1842 g Potassiumhydrogen 2-Oxopentandioate0.8132 g Magnesiumchloride·6H2O3.7733 g HistidineHCl·H2O27.9289 g Histidine0.4085 g Tryptophan5.4651 g Mannitol0.0022 g Calciumchloride·2H2OWater for Injection	1000 mL Custodiol®HTK Solutioncontains:0.8766 g Sodium chloride0.6710 g Potassiumchloride 0.1842 gPotassium hydrogen 2-Oxopentandioate0.8132 g Magnesiumchloride·6H2O3.7733 gHistidine · HCl · H2O27.9289 g Histidine0.4085 g Tryptophan5.4651 g Mannitol0.0022 g CalciumchlorideWater for Injection	Same
Osmolality	310 mOsmol/kg	310 mOsmol/kg	Same
	6.5-7.5	7.02-7.20 at 25degC7.4-7.45 at 4degC	Equivalent.Both devices are within setspecifications.The pH specification forOrganProtex™ HTK Solutionwas set at 6.5-7.5 during thestability study. The differencein pH range does not impact thesafety and efficacy of theOrganProtex™ HTK Solutionas the componentsof HTK itself, histidine servesas the buffer and retards thetissue pH decline during coldischemic conditions.
pH
Fluid Volume	1,000 ml	1,000 ml2,000 ml5,000 ml	EquivalentSubject device is available in asubset of the available volumesof the predicate.
Single Use Only	Yes	Yes	Same
PrimaryContainer	Polypropylene PVC-FreeBag	Polypropylene PVC-FreeBag	Equivalent
ProtectingOverwrap Bag	Yes	Yes	Same
Shelf Life	12 Months	12 Months	Same
SAFETY
Pyrogenicity	Non-Pyrogenic	Non-Pyrogenic	Same
Sterility	Sterile solution	Sterile solution	Same
Sterilization	Terminal steamsterilization	Terminal steamsterilization	Same
Biocompatibility	Biocompatible inaccordance with ISO10993-1/2/5/10/12.	Biocompatible in accordancewith ISO 10993-1/2/5/10/12.	Equivalent.
SterileDispensing	Fluid is dispensed viasterile port on bag.	Fluid is dispensed via sterileport on bag.	Same
BagConnections	Fluid delivery and drugadministration ports	Fluid delivery and drugadministration ports	Same

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7.0 NON-CLINICAL PERFORMANCE DATA

Performance data is provided in support of the substantial equivalence determination. All tests performed are included in this submission.

7.1. Biocompatibility

OrganProtex™ HTK Solution has been demonstrated as substantially equivalent in biocompatibility to the predicate device via testing and biological risk assessment, such that it is safe for its intended use.

7.2 Sterilization

OrganProtex TM HTK Solution is supplied STERILE via steam sterilization.

7.3 Shelf Life

OrganProtex™ HTK Solution shelf life has been validated up to 12 months through stability studies.

8.0 DESIGN CONTROL SUMMARY

All procedural Design Controls were followed, and all design control elements were satisfied.

9.0 SUMMARY OF VERIFICATION & VALIDATION

Verification and validation testing was done on the OrganProtexTM HTK Solution. The subject device is substantially equivalent to the predicate device. Any risks to the overall system were addressed in the Risk Analysis. Concerns or risks identified were mitigated by the actual proper use and function OrganProtex™ HTK Solution indicated in the Instructions for Use. It is appropriate to conclude that OrganProtex "M HTK Solution is substantially equivalent to the predicate device (K192408).

CONCLUSION 10.0

The subject and predicate devices have the same intended use and are substantially equivalent in technological characteristics and performance (same composition). The OrganProtex 110 TTK Solution is safe and effective as the predicate device. The non-clinical data supports and demonstrates the safety of the device.

The conclusion is that OrganProtex™ HTK Solution is substantially equivalent to the legally marketed Custodiol® HTK Solution and therefore should have clearance for premarket activities in the United States.

Regulation Number and Section

§ 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).