Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)

{0}------------------------------------------------ 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" {1}------------------------------------------------ (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). {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 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 | | Email | : | 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. {5}------------------------------------------------ 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 Life<br>707 Skokie Boulevard<br>Suite 340, Northbrook,<br>IL 60062 | Preservation Solutions, Inc., 980 Proctor Drive, Elkhorn, Wisconsin 53121 | Bridge to Life<br>707 Skokie Boulevard Suite<br>340, Northbrook, IL 60062 | | | Classification &<br>Product Code | 876.5880; KDN | 876.5880; KDN | 876.5880; KDN | Same | | Device Regulation<br>Description | Isolated kidney<br>perfusion and transport<br>system and accessories | Isolated kidney<br>perfusion and transport<br>system and accessories | Isolated kidney perfusion<br>and transport system and<br>accessories | Same | | Common Name | Organ Preservation<br>Solution | Organ Preservation<br>Solution | 0.9% Saline Slush Solution | Same | | DESCRIPTION,<br>INDICATIONS,<br>& INTENDED<br>USE | | | | | | Device Description | BTL's Belzer MPS®<br>(UW Machine<br>Perfusion Solution)<br>(BMPS-001) is a clear<br>to straw-colored<br>solution for the <i>in-vitro</i> flushing and<br>continuous machine<br>perfusion of explanted<br>abdominal organs.<br>This solution is<br>consistent with an<br>extracellular solution,<br>based on its<br>sodium/potassium<br>ratio. This solution has<br>a calculated potassium<br>concentration of 25<br>mEq/L, a sodium<br>concentration of 100<br>mEq/L, an osmolarity<br>of 300 mosmol/kg, and<br>a pH of approximately<br>7.4 at 20°C.<br>The solution is<br>packaged in 1-L bags. | MaPerSol® Organ<br>Preservation Solution is<br>a clear to straw-colored<br>solution for the <i>in-vitro</i><br>flushing and temporary<br>continuous perfusion<br>preservation of<br>explanted kidneys. This<br>solution is consistent<br>with an extracellular<br>solution, based on its<br>sodium/potassium ratio.<br>This solution has a<br>calculated potassium<br>concentration of 25<br>mEq/L, a sodium<br>concentration of 100<br>mEq/L, an osmolarity of<br>300 mosmol/kg, and a<br>pH of approximately 7.4<br>at 20°C.<br>The solution is<br>packaged in 1-Liter<br>bags | EasiSlush® is a clear,<br>colorless 0.9% Sodium<br>Chloride solution for<br>preparation of slushed<br>solution to provide<br>hypothermia during the<br>recovery, storage, and<br>transport of donor organs<br>for transplantation. The<br>solution is sterile, non-<br>pyrogenic, isotonic and is<br>contained in a 2L sterile,<br>flexible, non- PVC bag. | Same<br>Subject, predicate and<br>reference devices are all<br>used as organ preservation<br>solutions. Devices are used<br>in the organ procurement<br>and transplant process per<br>standard organ<br>preservation practices. | | Indications for Use | Belzer MPS® (UW<br>Machine Perfusion<br>Solution) (BMPS-<br>001) is indicated for<br>the <i>in-vitro</i> flushing<br>and continuous<br>hypothermic<br>machine perfusion of<br>explanted abdominal<br>organs. | MaPerSol® Organ<br>Preservation Solution is<br>indicated for <i>in vitro</i><br>flushing and continuous<br>hypothermic machine<br>perfusion of explanted<br>kidneys. | EasiSlush slushed solution<br>is intended for topical<br>cooling of in-situ,<br>abdominal donor organs<br>during intraoperative<br>recovery from the donor. It<br>is also intended to maintain<br>organ hypothermia during<br>storage and transport to the<br>transplant recipient.<br>EasiSlush™ slushed<br>solution is used to establish,<br>and maintain hypothermia<br>of donor organs during | Same<br>Subject, predicate and<br>reference devices are all<br>used as organ preservation<br>solutions. All devices are<br>used at cold hypothermic<br>temperatures, to slow<br>biological deterioration in<br>organs removed from their<br>physiological environment<br>per standard organ<br>preservation practices.<br>Specifically: | | | | | | | | Intended Use | Belzer MPS® (UW<br>Machine Perfusion<br>Solution) (BMPS-<br>001) is intended for<br><i>in-vitro</i> flushing and<br>continuous<br>hypothermic<br>machine perfusion of<br>explanted abdominal<br>organs. | MaPerSol® Organ<br>Preservation Solution is<br>intended for the <i>in-vitro</i><br>flushing and continuous<br>hypothermic machine<br>perfusion preservation<br>of explanted kidneys. | EasiSlush™ slushed<br>solution is intended for<br>topical cooling of <i>in-situ</i> ,<br>abdominal donor organs<br>during intraoperative<br>recovery from the donor. It<br>is also intended to maintain<br>organ hypothermia during<br>storage and transport to the<br>transplant recipient. | Subject device is similar to<br>the predicate device in<br>which they are both<br>intended to flush, perfuse,<br>or be left in the abdominal<br>organ.<br>Use #2 - Similar<br>During organ perfusion,<br>subject and predicate<br>device create hypothermia,<br>by cooling of organ.<br>Use #3 - Similar<br>Subject device is similar to<br>the reference device in<br>which both are used for<br>organ preservation solution<br>by maintaining organ<br>hypothermia, by cooling<br>the organ during<br>preservation.<br>Similar<br>Subject device is an<br>accessory to organ<br>preservation solutions. All<br>devices are intended for use<br>at cold hypothermia, to<br>slow biological<br>deterioration in organs<br>removed from their<br>physiological environment<br>per standard organ<br>preservation practices. | | TECNOLOGICAL<br>CHARACTERISTI<br>CS | | | | | | Storage<br>Temperature | 2° to 25° C | 2° to 25° C | 2° to 25° C | Same | | Pre-Cooling | Pre-cool solution prior<br>to use<br>(2° to 8° C) | Pre-cool solution prior<br>to use<br>(2° to 8° C) | Pre-cool solution prior to<br>use (-4° to -15° C) | Similar<br>Subject, predicate and<br>reference solutions are all<br>pre-cooled to hypothermic<br>temperature ranges | | In-Situ Organ<br>Cooling | Internal cooling of<br>organ from perfusion<br>of cold solution<br>through organ blood<br>vessels | Internal cooling of<br>organ from perfusion of<br>cold solution through<br>organ blood vessels | External and internal<br>cooling of organ | Same<br>Subject, predicate and<br>reference device are all for<br>internal cooling of organ<br>from perfusion of cold<br>solution through organ<br>blood vessels. | | Maintain Cold<br>Organ Temperature<br>During Storage and<br>Transport | Directly cools organ<br>external and internal<br>surfaces via contact<br>with cold solution. | Directly cools organ<br>external and internal<br>surfaces via contact with<br>cold solution. | Directly cools the organ<br>vasculature during<br>hypothermic storage and<br>transportation (not for<br>continuous perfusion) to<br>the patient. | Same<br>Overall system<br>performance by<br>cooling/maintaining<br>hypothermic temperature | | | | | | of organs are similar for<br>all devices. | | Product State | Liquid – Solution | Liquid - Solution | Liquid - Solution | Same | | Composition | Adenine (free<br>base) 0.68 g/L<br>Calcium Chloride<br>(dihydrate)<br>0.068 g/L<br>Dextrose (+)<br>1.80 g/L<br>Glutathione (reduced)<br>0.92 g/L<br>HEPES (free acid)<br>2.38 g/L<br>Hydroxyethyl Starch<br>50.0 g/L<br>Magnesium Gluconate<br>1.13 g/L<br>Mannitol<br>5.4 g/L<br>Potassium Phosphate<br>(monobasic)<br>3.4 g/L<br>Ribose, D(-)<br>0.75 g/L<br>Sodium Gluconate<br>17.45 g/L<br>Sodium Hydroxide<br>0.70 g/L<br>Sterile Water for<br>Injection<br>To 1000 mL Volume | Adenine (free base)<br>0.68 g/L<br>Calcium Chloride<br>(dihydrate)<br>0.068 g/L<br>Dextrose (+)<br>1.80 g/L<br>Glutathione (reduced)<br>0.92 g/L<br>HEPES (free acid)<br>2.38 g/L<br>Hydroxyethyl Starch<br>50.0 g/L<br>Magnesium Gluconate<br>1.13 g/L<br>Mannitol<br>5.4 g/L<br>Potassium Phosphate<br>(monobasic)<br>3.4 g/L<br>Ribose, D(-)<br>0.75 g/L<br>Sodium Gluconate<br>17.45 g/L<br>Sodium Hydroxide<br>0.70 g/L<br>Sterile Water for<br>Injection<br>To 1000 mL<br>Volume | Buffered saline solution.<br>0.9% Sodium Chloride<br>Irrigation USP | Same<br>Subject and predicate<br>devices are of the same<br>exact chemical composition | | Osmolality | 300 mOsmol/kg | 300 mOsmol/kg | 300 mOsmol/kg | Same | | pH | Approximately 7.4 at<br>20°C | Approximately 7.4 at<br>20°C | 4.5-7.0 (per USP<br>monograph for 0.9%<br>Sodium Chloride<br>Irrigation) | Same<br>Subject and predicate<br>devices have the same pH<br>specifications | | Fluid Volume | 1,000 ml | 1,000 ml | 1,250ml | Same<br>Subject device is available<br>in same volume as the<br>predicate device. | | Single Use Only | Yes | Yes | Yes | Same | | Primary Container | PVC-Free Bag | PVC-Free Bag | PVC-Free Bag | Equivalent | | Protecting<br>Overwrap Bag | Yes | Yes | Yes | Same | | Shelf Life | 6 Months | 24 Months | 24 Months | Same. Shelf life stability<br>study is on-going to meet 24<br>months shelf life.…