Servator B SALF Solution

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 21, 2019 S.A.L.F. S.p.A. % Joyce St. Germain Regulatory Dept. Manager The 510k Consulting, LLC 1449 Springleaf Dr. Ormond Beach, FL 32174 Re: K180481 Trade/Device Name: Servator B SALF Solution Regulation Number: 21 CFR& 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDN Dated: May 25, 2018 Received: May 31, 2018 Dear Joyce St. Germain: This letter corrects our substantially equivalent letter of June 29, 2018. 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 (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 located 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Gema Gonzalez -S for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K180481 Device Name Servator B SALF Solution #### Indications for Use (Describe) Servator B SALF Solution is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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S.p.A Via Marconi, 2, Cenate Sotto, BG, Italy Phone: +39-035-940097 Contact: Dr. Carmelo Gagliano (Quality Manager) carmelo.gagliano@salfspa.it Date Prepared: June 28, 2018 #### Preparer/Consultant The 510k Consulting, LLC 1449 Springleaf Dr. Ormond Beach, FL 32174 904-477-3203 Phone: Contact: Joyce St. Germain, Regulatory Consultant (joyce510kfda(@gmail.com) ### Device Classification | Trade/Model Names: | Servator B SALF Solution | |--------------------|-------------------------------------------------------------------| | Common Name: | Organ perfusion and preservation solution | | Regulation Name: | Isolated kidney perfusion and transport system and<br>accessories | | Regulation Number: | 21 CFR 876.5880 | | Product Code: | KDN | | Regulatory Class: | II | | Medical Specialty: | Gastroenterology/Urology Panel | #### Predicate Device The subject device claims equivalence to the following legally marketed predicate: | 510(k) Number: | K091245 | |----------------|-------------------------------------------| | Date Cleared | July 17, 2009 | | Trade Name: | CoStorSol / Brand Name: Belzer UW | | Common Name: | Organ perfusion and preservation solution | {4}------------------------------------------------ | Classification Name: | System, Perfusion, Kidney | |----------------------|----------------------------------------------------| | Regulation Name: | Isolated kidney perfusion and transport system and | | | accessories | | Regulation Number: | 21 CFR 876.5880 | | Product Code: | KDN | | Regulatory Class: | II | | Medical Specialty: | Gastroenterology/Urology Panel | #### Indications for Use Servator B SALF Solution is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. #### Intended Use Organ storage and preservation for transplantation. #### Device Description Servator B SALF Solution is a clear to light yellow, single use only, sterile (by steam sterilization) and non-pyrogenic for hypothermic flushing and preservation of organs. The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP). The primary containers used for the device are PVC free bags 1000ml and 2000ml; therefore, they are free of phthalates. The bags must be chilled to between 2° and 6° C (36° to 43° F) prior to use. The solution may be used without any point of use filtration. The Servator B SALF Solution is intended for perfusion and flushing donor kidneys, liver and pancreas immediately before or immediately after removal from a dead donor or immediately after removal from a living donor. The solution remains in the organ vessels during hypothermic storage and transportation. Servator B SALF Solution is meant for the cold storage of the organ and is not indicated for hypothermic preservation with continuous mechanical perfusion. ### Comparison of Technological Characteristics with Predicate The indications for use and intended use of the subject and predicate devices are identical. The technologies are substantially equivalent as the composition of both solutions are identical. {5}------------------------------------------------ The subject and predicate devices are both supplied in bags with overbags for single use. The subject and predicate devices are both supplied sterile. Tests were performed in order to confirm the equivalence between the subject and predicate devices. The following table compares technological and other characteristics of the subject and predicate device. ## Table of Comparison | | Subject Device | Predicate Device | Comparison | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Device | Servator B SALF | CoStorSol® | NA | | 510k Number | K180481 | K091245 | NA | | Manufacturer | S.A.L.F. S.p.A.<br>(Italy) | Preservation Solutions, Inc.,<br>WI, USA | NA | | Classification & Product Code | 876.5880; KDN | 876.5880; KDN | Same | | Device Classification Name | Isolated kidney perfusion and transport system and accessories | Isolated kidney perfusion and transport system and accessories | Same | | Device Description | System, Perfusion, Kidney | System, Perfusion, Kidney | Same | | Common Name | Organ perfusion and preservation solution | Organ perfusion and preservation solution | Same | | Indications for Use | Servator B SALF Solution is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. | CoStorSol® is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. | Same | ## Table B.1 -- Technological Comparison {6}------------------------------------------------ | Intended for Use | Organ storage and<br>preservation for<br>transplantation | Organ storage and<br>preservation for<br>transplantation | Same | |----------------------------------|----------------------------------------------------------|----------------------------------------------------------|------| | Meets UNOS Policy | YES | YES | Same | | Material<br>Container/Bag | PVC Free / Bags | PVC Free / Bags | Same | | Protecting<br>Overwrap Bag | YES | YES | Same | | Single Use Only | YES | YES | Same | | Bag Connections | 1 flip off, 1 needle<br>point | 1 flip off, 1 needle<br>point | Same | | Used for Organ<br>Transplants of | Used for kidneys,<br>liver and pancreas | Used for kidneys,<br>liver and pancreas | NA | | Product State | Liquid - Solution | Liquid - Solution | Same | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------| | Model Numbers | Bag1000ml /<br>SERVB10DMA<br>Bag 2000ml /<br>SERVB20DM | Bag 1000ml /<br>Model # unknown | Different Model<br>Numbers - due to<br>different<br>manufacturers | | Configurations | Box containing 10<br>bags of 1000ml<br>PVC free.<br>Box containing 5<br>bags of 2000ml<br>PVC free. | Bags 1000 ml,<br>and carton of 10 | Same,<br>Subject device<br>has additional<br>packaging<br>available | | Sterilization<br>Method | Steam -<br>Sterilization<br>processes validated | Solution is<br>aseptically<br>processed and the<br>tubing used for the | Different;<br>however both<br>passed according<br>to ISO standards | | | according to ISO<br>17665-1 | aseptic filling is<br>steam sterilized.<br>The bags are<br>gamma sterilized.<br>Sterilization<br>processes were<br>validated according<br>to ISO 17665-1 or<br>USP Section<br><1211>, as<br>appropriate. | | | Sodium<br>Concentration | 29 mEq/L | 29 mEq/L | Equivalent | | Potassium<br>Concentration | 125 mEq/L | 125 mEq/L | Equivalent | | pH | 7.4 at 20°C | 7.4 at 20°C | Equivalent | | Osmolality | 320 mOsm/Kg | 320 mOsm/Kg | Equivalent | | Manufacture<br>Standards of<br>Conformity | ISO 9001:2008<br>ISO 13485:2003<br>GMP Certification | Unknown | Subject meets<br>current standards | | Shelf Life | 24 Months | 24 Months | Same | | Device Standards of<br>Conformity | Subject device<br>passed according<br>to ISO standards | Unknown | Subject device<br>passed according<br>to ISO standards | | ISO Standards | ISO 10993-1<br>10993-2<br>10993-4<br>10993-5<br>10993-10<br>10993-11<br>10993-12<br>10993-18<br>ISO 11607-1<br>11607-2<br>ISO 11737-1<br>ISO 14001<br>ISO 14971<br>ISO15189 | ISO 10993 series<br>ISO 17665<br>USP <788><br>USP <1211> | Subject and<br>Predicate passed<br>standardized tests | {7}------------------------------------------------ {8}------------------------------------------------ | ISO15223-1 | |---------------| | ISO 17025 | | ISO 17665-1 | | ASTM F1980-16 | | USP <71> | | USP <85> | | USP <39> | | USP <1225> | The above comparison shows the subject and predicate devices are substantially equivalent in technology characteristics. The differences are highlighted and those differences do not make the subject device any less safe and effective as the predicate device. The differences are due to different manufacturers with different model numbers and the subject device has additional configuration of packaging that the predicate doesn't have. ### Non-Clinical Performance Data The following performance data is provided in support of the substantial equivalence determination. All tests performed are included in this submission. Biocompatibility... is required for this device. The Cytotoxicity, Irritation, System Toxicity and Haemocompatibility tests were all performed of the ISO 10993 series and all are listed above in the Table of Comparison. The subject device passed all biocompatibility test standards. Sterilization and Shelf Life . . . is required for the subject device. The Validation of Sterility was performed and the results passed according to ISO 17655-1 and ASTM F1980-16. Shelf life for the subject and predicate device is the same at 24 months. Electrical Safety and EMC . . . testing was not applicable for this device. Software ... was not applicable for this device. Performance Testing...was completed as a direct comparison between the subject and predicate device. The chemical comparisons and leachables performance testing demonstrated the substantial equivalence of this device to the predicate. #### Conclusion The subject and predicate devices have the same indications for use and the same intended use. Both devices are substantially equivalent in design, materials, packaging and other technological characteristics and performance (since they have, in fact, the same chemical composition). The Servator B SALF Solution does not raise any questions regarding safety and effectiveness and is equivalent to the predicate device. The non-clinical data supports and demonstrates the safety of the device. {9}------------------------------------------------ The conclusion is that Servator B SALF Solution warrants a finding of substantial equivalence to the legally marketed CoStorSol® by Preservations Solutions, Inc., and therefore, should have clearance for premarket activities in the United States.