(103 days)
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is indicated for the in vitro flushing and continuous hypothermic machine perfusion of explanted abdominal organs.
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is a clear to straw-colored, sterile, non-pyrogenic solution for the in-vitro flushing and continuous perfusion of explanted abdominal organs. The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) has the same composition and indication for use as MaPerSol® Organ Preservation Solution.
The solution is consistent with an extracellular solution, based on its sodium/potassium ratio and has a calculated potassium concentration of 25 mEq/L, a sodium concentration of 100 mEq/L, an osmolarity of 300 mosmol/kg, and a pH of approximately 7.4 at 20°C.
The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is supplied in single use 1000mL solution bags, made from flexible PVC free material (e.g., laminated EVA film) with at least two integrated ports including ports for delivery and component addition. Each individual bag is enclosed in a protective outer overwrap bag. The solution is sterile and is intended for one single use.
The provided text describes a 510(k) premarket notification for a medical device called Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001). This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (MaPerSol® Solution, K080432), rather than providing detailed acceptance criteria and performance study data typically associated with de novo clearances or PMAs for novel devices or software.
Therefore, much of the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in terms of algorithm performance for an AI/ML device is not applicable in this specific document. The "acceptance criteria" in this context are for demonstrating substantial equivalence of a solution composition and function, not algorithmic performance.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria (for Substantial Equivalence to Predicate): The core acceptance criterion is that Belzer MPS® (BMPS-001) is "substantially equivalent in composition, safety and efficacy" to the predicate device, MaPerSol® Solution. This is primarily demonstrated by:
- Same Indications for Use: Flushing and continuous hypothermic machine perfusion of explanted abdominal organs.
- Same Composition: The exact chemical composition (components and g/L) is identical to the predicate.
- Same Technological Characteristics: pH, Osmolality, Product State (liquid), Single Use, Storage Temperature, Pre-cooling requirements, Internal cooling mechanism, Product Bag materials, Pyrogenicity, Sterility methods, Biocompatibility (as per ISO standards), Fluid Volume.
- Reported Device Performance: The document states that the device is "safe and effective as predicate and reference devices" and that "The non-clinical data supports and demonstrates the safety of the device." No specific quantitative performance metrics (e.g., organ viability rates, post-transplant outcomes) are provided for the Belzer MPS® itself, as its equivalence is established based on its identical composition and intended use to a proven predicate. The "performance" is implicitly deemed equivalent to that of the predicate.
| Criteria Category | Acceptance Criteria (for Substantial Equivalence) | Reported Performance (for Belzer MPS®) |
|---|---|---|
| Intended Use | Must be the same as or very similar to the predicate device. | Belzer MPS®: Indicated for "in-vitro flushing and continuous hypothermic machine perfusion of explanted abdominal organs." Predicate (MaPerSol®): Indicated for "in vitro flushing and continuous hypothermic machine perfusion of explanted kidneys." Comparison: The subject device is similar to the predicate, with a slightly broader indication ("abdominal organs" vs. "kidneys"). This is a key point where the manufacturer argues "similarity" based on other shared characteristics. |
| Composition | Must be identical to the predicate device. | Belzer MPS®: Identical chemical composition (Adenine, Calcium Chloride, Dextrose, Glutathione, HEPES, Hydroxyethyl Starch, Magnesium Gluconate, Mannitol, Potassium Phosphate, Ribose, Sodium Gluconate, Sodium Hydroxide, Sterile Water) and concentrations (g/L, mmol/L) as the predicate. Comparison: Same Chemical Composition. |
| Technological Characteristics | pH, Osmolality, Product State, Single Use, Storage Temperature, Pre-cooling, Internal cooling mechanism, Product Bag materials, Pyrogenicity, Sterility methods, Biocompatibility, Fluid Volume, Container type. Must be same or demonstrate equivalent safety/efficacy. | pH: Approx. 7.4 at 20°C (Same as predicate). Osmolality: 300 mOsmol/kg (Same as predicate). Product State: Liquid – Solution (Same as predicate). Single Use Only: Yes (Same as predicate). Storage Temperature: 2°-25°C (Same as predicate). Pre-Cooling: 2°-8°C (Same as predicate). In-Situ Organ Cooling: Internal cooling from perfusion of cold solution (Same as predicate). Maintain Cold Organ Temperature: Directly cools external/internal surfaces (Same as predicate). Primary Container: PVC-Free Bag (Equivalent to predicate). Pyrogenicity: Non-Pyrogenic (Same as predicate). Sterility: Aseptic processing and sterile filtration (Same as predicate). Biocompatibility: In accordance with ISO 10993 (Equivalent to predicate). Fluid Volume: 1000 mL (Same as predicate). |
| Safety and Efficacy | Must be demonstrated to be equally safe and effective as the predicate device, typically through non-clinical testing and comparative analysis. | "The non-clinical data supports and demonstrates the safety of the device." "The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is safe and effective as predicate and reference devices." "Substantially equivalent in biocompatibility to the predicate device via testing and biological risk assessment." |
| Shelf Life | Must be established and justified. | 6 Months (Currently, with an on-going study to meet 24 months, matching the predicate). |
2. Sample sized used for the test set and the data provenance:
- This document does not describe a clinical study in the form typically seen for AI device validation with test sets of patient data. The "test set" here refers to the parameters/characteristics of the solution itself and its manufacturing process, not patient data.
- Data Provenance: Not applicable in the context of patient data. The data provenance relates to the chemical composition, physical properties, manufacturing processes, sterilization, and biocompatibility studies conducted on the solution and its packaging materials. These are typically generated through laboratory testing of the product itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/ML device that generates diagnoses or interpretations requiring expert ground truth in the radiological sense. The "ground truth" for this device relates to its chemical and physical properties meeting specified standards, and its safety/efficacy being equivalent to a known predicate. This is established through standard laboratory testing, chemical analysis, and biocompatibility assessments by qualified personnel in those fields, not expert radiologists creating consensus labels.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This methodology is for clinical image interpretation or similar tasks requiring human consensus or adjudication, which is not relevant to a medical solution like Belzer MPS®.
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-assisted interpretation device. No MRMC study was conducted or is applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm. Therefore, no standalone performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on analytical chemistry, physical property measurements, biocompatibility testing (in vitro and in vivo animal models often), and sterility testing to confirm the product's specifications and safety. The ultimate "ground truth" for "substantial equivalence" rests on the established safety and efficacy of the predicate device, MaPerSol® Solution, which presumably underwent its own validation studies years prior (K080432).
8. The sample size for the training set:
- Not applicable. This is a chemical solution, not an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set or ground truth in the AI/ML context.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 26, 2025
Bridge to Life Mark Harper Compliance Manager 707 Skokie Boulevard, Suite 340 Northbrook, Illinois 60062
Re: K243840
Trade/Device Name: Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion And Transport System And Accessories Regulatory Class: Class II Product Code: KDN. KDL Dated: December 13, 2024 Received: February 24, 2025
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,
Image /page/2/Picture/3 description: The image shows the name "Maura Rooney" followed by "-S". The text is written in a clear, sans-serif font and is prominently displayed against a white background. The letters are large and easily readable.
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) K243840
Device Name
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
Indications for Use (Describe)
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is indicated for the in vitro flushing and continuous hypothermic machine perfusion of explanted abdominal organs.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K243840: 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 | : | December 13th 2024 |
2.0 DEVICE
| Proprietary Name : | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) |
|---|---|
| Classification Name : | Isolated kidney perfusion and transport system and accessories |
| Device Classification : | Class II, 876.5880 |
| Product Code : | KDN, KDL |
3.0 PREDICATE DEVICE
| Company | Device | K Number | Date Cleared |
|---|---|---|---|
| Preservation Solutions, Inc | MaPerSol® Solution | K080432 | August 8, 2008 |
4.0 DEVICE DESCRIPTION
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is a clear to straw-colored, sterile, non-pyrogenic solution for the in-vitro flushing and continuous perfusion of explanted abdominal organs. The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) has the same composition and indication for use as MaPerSol® Organ Preservation Solution.
The solution is consistent with an extracellular solution, based on its sodium/potassium ratio and has a calculated potassium concentration of 25 mEq/L, a sodium concentration of 100 mEq/L, an osmolarity of 300 mosmol/kg, and a pH of approximately 7.4 at 20°C.
The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is supplied in single use 1000mL solution bags, made from flexible PVC free material (e.g., laminated EVA film) with at least two integrated ports including ports for delivery and component addition. Each individual bag is enclosed in a protective outer overwrap bag. The solution is sterile and is intended for one single use.
The solution should be used only by medical healthcare staff, adequately trained according to established operating protocols.
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The solution should be stored indoors at temperatures controlled between 2° and 25°C (36° and 77°F) until use. Excessive heat and freezing should be avoided. Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) should not be used if discolored or if obvious particulate matter, precipitates, or contamination are evident in the solution.
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is substantially equivalent in composition, safety and efficacy to currently marketed MaPerSol® Solution, which was cleared by the US FDA in prior 510(k) submission K080432.
Table 1 provides information about the composition of Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001).
| Component | g/L | Mmol/L |
|---|---|---|
| Adenine (free base) | 0.68g | 5 |
| Calcium Chloride (dihydrate) | 0.068g | 0.5 |
| Dextrose (+) | 1.80g | 10 |
| Glutathione (reduced) | 0.92g | 3 |
| HEPES (free acid) | 2.38 g | 10 |
| Hydroxyethyl Starch | 50.0g | N/A |
| Magnesium Gluconate | 1.13 g | 5 |
| Mannitol | 5.4 g | 30 |
| Potassium Phosphate (monobasic) | 3.4 g | 25 |
| Ribose, D(-) | 0.75g | 5 |
| Sodium Gluconate | 17.45 g | 80 |
| Sodium Hydroxide | 0.70g | N/A |
| Sterile Water | To 1000 ml Volume |
Table 1: Composition of Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
5.0 INDICATION FOR USE
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is indicated for the in-vitro flushing and continuous hypothermic machine perfusion of explanted abdominal organs.
6.0 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following table provides a comparison of attributes between the subject, predicate and reference devices:
| Subject Device | Predicate Device | Reference Device | Comparison | |
|---|---|---|---|---|
| Device | Belzer MPS® (UW Machine Perfusion Solution (BMPS-001)) | MaPerSol® Organ Preservation Solution (UW Machine Perfusion Solution) | EasiSlush® Cold Storage Solution | |
| 510k Number | K243840 | K080432 | K191006 | |
| Manufacturer | Bridge to Life707 Skokie BoulevardSuite 340, Northbrook,IL 60062 | Preservation Solutions, Inc., 980 Proctor Drive, Elkhorn, Wisconsin 53121 | Bridge to Life707 Skokie Boulevard Suite340, Northbrook, IL 60062 | |
| Classification &Product Code | 876.5880; KDN | 876.5880; KDN | 876.5880; KDN | Same |
| Device RegulationDescription | Isolated kidneyperfusion and transportsystem and accessories | Isolated kidneyperfusion and transportsystem and accessories | Isolated kidney perfusionand transport system andaccessories | Same |
| Common Name | Organ PreservationSolution | Organ PreservationSolution | 0.9% Saline Slush Solution | Same |
| DESCRIPTION,INDICATIONS,& INTENDEDUSE | ||||
| Device Description | BTL's Belzer MPS®(UW MachinePerfusion Solution)(BMPS-001) is a clearto straw-coloredsolution for the in-vitro flushing andcontinuous machineperfusion of explantedabdominal organs.This solution isconsistent with anextracellular solution,based on itssodium/potassiumratio. This solution hasa calculated potassiumconcentration of 25mEq/L, a sodiumconcentration of 100mEq/L, an osmolarityof 300 mosmol/kg, anda pH of approximately7.4 at 20°C.The solution ispackaged in 1-L bags. | MaPerSol® OrganPreservation Solution isa clear to straw-coloredsolution for the in-vitroflushing and temporarycontinuous perfusionpreservation ofexplanted kidneys. Thissolution is consistentwith an extracellularsolution, based on itssodium/potassium ratio.This solution has acalculated potassiumconcentration of 25mEq/L, a sodiumconcentration of 100mEq/L, an osmolarity of300 mosmol/kg, and apH of approximately 7.4at 20°C.The solution ispackaged in 1-Literbags | EasiSlush® is a clear,colorless 0.9% SodiumChloride solution forpreparation of slushedsolution to providehypothermia during therecovery, storage, andtransport of donor organsfor transplantation. Thesolution is sterile, non-pyrogenic, isotonic and iscontained in a 2L sterile,flexible, non- PVC bag. | SameSubject, predicate andreference devices are allused as organ preservationsolutions. Devices are usedin the organ procurementand transplant process perstandard organpreservation practices. |
| Indications for Use | Belzer MPS® (UWMachine PerfusionSolution) (BMPS-001) is indicated forthe in-vitro flushingand continuoushypothermicmachine perfusion ofexplanted abdominalorgans. | MaPerSol® OrganPreservation Solution isindicated for in vitroflushing and continuoushypothermic machineperfusion of explantedkidneys. | EasiSlush slushed solutionis intended for topicalcooling of in-situ,abdominal donor organsduring intraoperativerecovery from the donor. Itis also intended to maintainorgan hypothermia duringstorage and transport to thetransplant recipient.EasiSlush™ slushedsolution is used to establish,and maintain hypothermiaof donor organs during | SameSubject, predicate andreference devices are allused as organ preservationsolutions. All devices areused at cold hypothermictemperatures, to slowbiological deterioration inorgans removed from theirphysiological environmentper standard organpreservation practices.Specifically: |
| Intended Use | Belzer MPS® (UWMachine PerfusionSolution) (BMPS-001) is intended forin-vitro flushing andcontinuoushypothermicmachine perfusion ofexplanted abdominalorgans. | MaPerSol® OrganPreservation Solution isintended for the in-vitroflushing and continuoushypothermic machineperfusion preservationof explanted kidneys. | EasiSlush™ slushedsolution is intended fortopical cooling of in-situ ,abdominal donor organsduring intraoperativerecovery from the donor. Itis also intended to maintainorgan hypothermia duringstorage and transport to thetransplant recipient. | Subject device is similar tothe predicate device inwhich they are bothintended to flush, perfuse,or be left in the abdominalorgan.Use #2 - SimilarDuring organ perfusion,subject and predicatedevice create hypothermia,by cooling of organ.Use #3 - SimilarSubject device is similar tothe reference device inwhich both are used fororgan preservation solutionby maintaining organhypothermia, by coolingthe organ duringpreservation.SimilarSubject device is anaccessory to organpreservation solutions. Alldevices are intended for useat cold hypothermia, toslow biologicaldeterioration in organsremoved from theirphysiological environmentper standard organpreservation practices. |
| TECNOLOGICALCHARACTERISTICS | ||||
| StorageTemperature | 2° to 25° C | 2° to 25° C | 2° to 25° C | Same |
| Pre-Cooling | Pre-cool solution priorto use(2° to 8° C) | Pre-cool solution priorto use(2° to 8° C) | Pre-cool solution prior touse (-4° to -15° C) | SimilarSubject, predicate andreference solutions are allpre-cooled to hypothermictemperature ranges |
| In-Situ OrganCooling | Internal cooling oforgan from perfusionof cold solutionthrough organ bloodvessels | Internal cooling oforgan from perfusion ofcold solution throughorgan blood vessels | External and internalcooling of organ | SameSubject, predicate andreference device are all forinternal cooling of organfrom perfusion of coldsolution through organblood vessels. |
| Maintain ColdOrgan TemperatureDuring Storage andTransport | Directly cools organexternal and internalsurfaces via contactwith cold solution. | Directly cools organexternal and internalsurfaces via contact withcold solution. | Directly cools the organvasculature duringhypothermic storage andtransportation (not forcontinuous perfusion) tothe patient. | SameOverall systemperformance bycooling/maintaininghypothermic temperature |
| of organs are similar forall devices. | ||||
| Product State | Liquid – Solution | Liquid - Solution | Liquid - Solution | Same |
| Composition | Adenine (freebase) 0.68 g/LCalcium Chloride(dihydrate)0.068 g/LDextrose (+)1.80 g/LGlutathione (reduced)0.92 g/LHEPES (free acid)2.38 g/LHydroxyethyl Starch50.0 g/LMagnesium Gluconate1.13 g/LMannitol5.4 g/LPotassium Phosphate(monobasic)3.4 g/LRibose, D(-)0.75 g/LSodium Gluconate17.45 g/LSodium Hydroxide0.70 g/LSterile Water forInjectionTo 1000 mL Volume | Adenine (free base)0.68 g/LCalcium Chloride(dihydrate)0.068 g/LDextrose (+)1.80 g/LGlutathione (reduced)0.92 g/LHEPES (free acid)2.38 g/LHydroxyethyl Starch50.0 g/LMagnesium Gluconate1.13 g/LMannitol5.4 g/LPotassium Phosphate(monobasic)3.4 g/LRibose, D(-)0.75 g/LSodium Gluconate17.45 g/LSodium Hydroxide0.70 g/LSterile Water forInjectionTo 1000 mLVolume | Buffered saline solution.0.9% Sodium ChlorideIrrigation USP | SameSubject and predicatedevices are of the sameexact chemical composition |
| Osmolality | 300 mOsmol/kg | 300 mOsmol/kg | 300 mOsmol/kg | Same |
| pH | Approximately 7.4 at20°C | Approximately 7.4 at20°C | 4.5-7.0 (per USPmonograph for 0.9%Sodium ChlorideIrrigation) | SameSubject and predicatedevices have the same pHspecifications |
| Fluid Volume | 1,000 ml | 1,000 ml | 1,250ml | SameSubject device is availablein same volume as thepredicate device. |
| Single Use Only | Yes | Yes | Yes | Same |
| Primary Container | PVC-Free Bag | PVC-Free Bag | PVC-Free Bag | Equivalent |
| ProtectingOverwrap Bag | Yes | Yes | Yes | Same |
| Shelf Life | 6 Months | 24 Months | 24 Months | Same. Shelf life stabilitystudy is on-going to meet 24months shelf life. |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | Non-Pyrogenic | Same |
| Sterility | Sterility assured via0.2 μ and two 0.1 μmembrane filtrations | Sterility assured via 0.1μ membrane filtration | Terminally sterilized | Same |
| Sterilization | Asepticprocessing andsterile filtration | Aseptic processing andsterile filtration | Terminal gamma irradiation | SameAll devices are sterile. |
| Biocompatibility | Biocompatible inaccordance with ISO10993-1/2/5/10/12. | Biocompatible inaccordance with ISO10993-1/2/5/10/12. | Biocompatible inaccordance with ISO10993-1/2/5/10/12. | Equivalent |
| SterileDispensing/Administration | Fluid is dispensed viasterile port on bag. | Fluid is dispensed viasterile port on bag. | Sterile bag is cut with sterileinstrument and contentsdispensed to desiredlocation. | Similar |
| Bag Connections | Fluid port provided fororgan flushing | Fluid port providedfor organ flushing | None | SameSubject and predicate deviceare same.DifferentReference device is notintended for organ flushing,so no port is provided. |
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NON-CLINICAL PERFORMANCE DATA 7.0
7.1. Biocompatibility
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) 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 Sterilitv
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is aseptically filled and sterility assured via 0.2 µ and two 0.1 µ membrane filtration.
7.3 Shelf Life
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) has a shelf life claim of 6 months.
8.0 DESIGN CONTROL SUMMARY
All procedural Design Controls were followed, and all design control elements were satisfied.
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9.0 SUMMARY OF VERIFICATION & VALIDATION
Verification and validation testing was done on the Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001). The subject device is substantially equivalent to the predicate and reference 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 Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) indicated in the Instructions for Use. It is appropriate to conclude that Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is substantially equivalent to the predicate device K080432.
10.0 CONCLUSION
The subject and predicate devices have the same intended use and are substantially equivalent in technological characteristics and performance (same composition). The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is safe and effective as predicate and reference devices. The non-clinical data supports and demonstrates the safety of the device.
The conclusion is that Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is substantially equivalent to the legally marketed MaPerSol® Solution and therefore should have clearance for premarket activities in the United States.
§ 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).