(266 days)
Not Found
No
The description focuses on the chemical composition and intended use of a preservation solution, with no mention of AI or ML technologies.
No.
The device is used for organ preservation and perfusion, not for treating a disease or condition in a patient.
No
The device description indicates it is a solution used for organ perfusion and preservation during transplantation, not for diagnosing medical conditions.
No
The device description clearly states it is a "solution," which is a physical substance, not software.
Based on the provided information, the OrganProtex™ HTK Solution is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the perfusion, flushing, and preservation of donor organs (kidneys, liver, pancreas, and heart) prior to transplantation. This is a direct intervention on the organ itself, not a test performed on a sample taken from a patient to diagnose a condition or monitor health.
- Device Description: The description details a solution used to maintain the viability of organs outside the body. It's a preservation medium, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis or monitoring of a patient's health status.
- Anatomical Site: The anatomical sites listed are the organs themselves, which are being preserved, not the source of a diagnostic sample.
IVDs are typically used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The OrganProtex™ HTK Solution's function is to maintain the viability of organs for transplantation, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KDL, MSB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidneys, liver, pancreas and heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical healthcare staff
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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)
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.
| 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 |
| : | 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 Chemie | |||
| GmBH (Germany) | Custodiol® HTK Solution | K192408 | April 24, 2020 |
4.0 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.
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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
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.
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™ HTK | ||
| Solution | Custodiol® HTK Solution | ||
| 510k Number | K241239 | K192408 | |
| Manufacturer | Rusoma Laboratories Pvt. | ||
| Ltd. | |||
| 149 Bhamori, Rusoma | |||
| Chauraha, AB Road, Indore | |||
| (MP) -452010 | Dr. Franz Kohler Chemie | ||
| GmBH Postfach 1117 D- | |||
| 64659Alsbach-Hahnlein, | |||
| Germany | - | ||
| 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 |
| DESCRIPTION, | |||
| INDICATIONS, | |||
| & INTENDED | |||
| USE | |||
| Device | |||
| Description | Clear, colourless to pale | ||
| yellow coloured solution, | |||
| sterile, non-pyrogenic | |||
| electrolyte and amino acid | |||
| aqueous solution for organ | |||
| perfusion and preservation. | |||
| Available in 1000ml bag. | |||
| The solution is sterile and | |||
| is intended for one single | |||
| and continuous | |||
| administration. | Clear, colourless to pale | ||
| yellow coloured solution, | |||
| sterile, non-pyrogenic | |||
| electrolyte and amino acid | |||
| aqueous solution for organ | |||
| perfusion and preservation. | |||
| Available in 1000mL, | |||
| 2000mL and 5000ml bags. | |||
| The solution is sterile and is | |||
| intended for one single and | |||
| continuous administration. | Same | ||
| Subject and predicate devices | |||
| are both used as organ | |||
| preservation solutions. Devices | |||
| are used in the organ | |||
| procurement and transplant | |||
| process per standard organ | |||
| preservation practices. | |||
| Indications for | |||
| Use | 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. OrganProtexTM | |||
| HTK solution is not | |||
| indicated for continuous | |||
| machine perfusion of | |||
| donor organs. | 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. | Same | ||
| Subject and predicate devices | |||
| are both used as organ | |||
| preservation solutions. All | |||
| devices are used at cold | |||
| temperatures, to slow biological | |||
| deterioration in organs removed | |||
| from their physiological | |||
| environment per standard organ | |||
| preservation practices. | |||
| Intended Use | OrganProtex™ HTK | ||
| Solution is intended for | |||
| the perfusion and flushing | |||
| of donor kidney, 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. | Intended for the perfusion | ||
| and flushing of donor liver, | |||
| kidney, heart, and pancreas | |||
| prior to removal from the | |||
| donor and for preserving | |||
| these organs during | |||
| hypothermic storage and | |||
| transport to the recipient. | Same | ||
| Subject and predicate devices | |||
| are both used as organ | |||
| preservation solutions. All | |||
| devices are used at cold | |||
| temperatures, to slow biological | |||
| deterioration in organs removed | |||
| from their physiological | |||
| environment per standard organ | |||
| preservation practices. | |||
| TECNOLOGI- | |||
| CAL | |||
| CHARATERIS | |||
| TICS | |||
| 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) to the | |||
| patient. | Directly cools the organ | ||
| vasculature during | |||
| hypothermic storage and | |||
| transportation (not for | |||
| continuous perfusion) to the | |||
| patient. | Same | ||
| Product State | Liquid - Solution | Liquid - Solution | Same |
| Composition | 1000 mL OrganProtex™ | ||
| HTK Solution contains: | |||
| 0.8766 g Sodium | |||
| chloride | |||
| 0.6710 g Potassium | |||
| chloride | |||
| 0.1842 g Potassium | |||
| hydrogen 2- | |||
| Oxopentandioate | |||
| 0.8132 g Magnesium | |||
| chloride·6H2O | |||
| 3.7733 g Histidine | |||
| HCl·H2O | |||
| 27.9289 g Histidine | |||
| 0.4085 g Tryptophan | |||
| 5.4651 g Mannitol | |||
| 0.0022 g Calcium | |||
| chloride·2H2O | |||
| Water for Injection | 1000 mL Custodiol® | ||
| HTK Solution | |||
| contains: | |||
| 0.8766 g Sodium chloride | |||
| 0.6710 g Potassium | |||
| chloride 0.1842 g | |||
| Potassium hydrogen 2- | |||
| Oxopentandioate | |||
| 0.8132 g Magnesium | |||
| chloride·6H2O | |||
| 3.7733 g | |||
| Histidine · HCl · H2O | |||
| 27.9289 g Histidine | |||
| 0.4085 g Tryptophan | |||
| 5.4651 g Mannitol | |||
| 0.0022 g Calcium | |||
| chloride | |||
| Water for Injection | Same | ||
| Osmolality | 310 mOsmol/kg | 310 mOsmol/kg | Same |
| 6.5-7.5 | 7.02-7.20 at 25degC | ||
| 7.4-7.45 at 4degC | Equivalent. | ||
| Both devices are within set | |||
| specifications. | |||
| The pH specification for | |||
| OrganProtex™ HTK Solution | |||
| was set at 6.5-7.5 during the | |||
| stability study. The difference | |||
| in pH range does not impact the | |||
| safety and efficacy of the | |||
| OrganProtex™ HTK Solution | |||
| as the components | |||
| of HTK itself, histidine serves | |||
| as the buffer and retards the | |||
| tissue pH decline during cold | |||
| ischemic conditions. | |||
| pH | |||
| Fluid Volume | 1,000 ml | 1,000 ml | |
| 2,000 ml | |||
| 5,000 ml | Equivalent | ||
| Subject device is available in a | |||
| subset of the 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 |
| SAFETY | |||
| 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 |
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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.