(126 days)
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.
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.
The provided text describes the "Servator B SALF Solution," an organ preservation solution, and its substantial equivalence to a predicate device, CoStorSol® (Belzer UW). The document is a 510(k) summary for FDA clearance.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance criteria are implicitly the demonstration of substantial equivalence to the predicate device, CoStorSol®, across various technological characteristics and non-clinical performance aspects. The "reported device performance" is the result of tests confirming this equivalence.
Here's a table based on the provided "Table of Comparison" and "Non-Clinical Performance Data" section, framed as a comparison to achieve substantial equivalence:
| Characteristic/Test | Acceptance Criterion (Implicit: Substantial Equivalence to Predicate) | Reported Servator B SALF Solution Performance |
|---|---|---|
| Indications for Use | Same as predicate | Same as predicate (flushing and cold storage of kidney, liver and pancreas) |
| Intended Use | Same as predicate | Same as predicate (Organ storage and preservation for transplantation) |
| Composition (Key Chemicals) | Identical to predicate formulation | Same chemical composition as predicate |
| Material Container/Bag | PVC Free / Bags | PVC Free / Bags |
| Protecting Overwrap Bag | Yes | Yes |
| Single Use Only | Yes | Yes |
| Bag Connections | 1 flip off, 1 needle point | 1 flip off, 1 needle point |
| Sodium Concentration | 29 mEq/L | 29 mEq/L |
| Potassium Concentration | 125 mEq/L | 125 mEq/L |
| pH | 7.4 at 20°C | 7.4 at 20°C |
| Osmolality | 320 mOsm/Kg | 320 mOsm/Kg |
| Sterilization Method | Validated according to ISO standards | Steam (ISO 17665-1 compliant) |
| Shelf Life | 24 Months | 24 Months |
| Biocompatibility | Meet ISO 10993 series standards | Passed Cytotoxicity, Irritation, System Toxicity, and Haemocompatibility (ISO 10993 series) |
| Sterility Validation | Meet ISO 17665-1 and ASTM F1980-16 | Passed according to ISO 17655-1 and ASTM F1980-16 |
| Chemical Comparisons | Demonstrate equivalence to predicate | Demonstrated substantial equivalence |
| Leachables Performance | Demonstrate equivalence to predicate | Demonstrated substantial equivalence |
2. Sample size used for the test set and the data provenance
The document explicitly states: "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."
However, it does not specify the sample size for these tests (e.g., how many batches were tested for chemical composition, how many samples for leachables) nor the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of the device (a solution), the "test set" would refer to specific batches or formulations tested in a laboratory setting, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a 510(k) submission concerning a medical solution, ground truth is typically established through analytical chemical testing and standardized biological assays, not human expert consensus on interpretations of complex data like medical images.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers interpreting data, especially in diagnostic imaging. For a chemical solution, the assessment relies on objective measurements and established scientific protocols.
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
No MRMC study was done or is relevant for this device. This is a medical solution for organ preservation, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a solution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for demonstrating substantial equivalence for this device relies on:
- Analytical Chemistry and Physicochemical Properties: Direct measurement of concentrations (Na+, K+), pH, osmolality, and confirmation of chemical composition.
- Sterility Testing: Conformance to ISO and ASTM standards.
- Biocompatibility Testing: Conformance to ISO 10993 series standards.
- Leachables Testing: To ensure no harmful substances migrate from the packaging into the solution.
- Functional Equivalence: Implicitly, the solution's performance in preserving organs is assumed to be equivalent to the predicate due to identical composition and physical properties.
8. The sample size for the training set
Not applicable. This device is a medical solution, not based on an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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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.
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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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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The 510k Consulting, LLC
1449 Springleaf Dr., Ormond Beach, FL 32174
Key to success in obtaining your medical device clearance
510(k) Summary
Submitter/Applicant
S.A.L.F. 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 andaccessories |
| 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 |
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| 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.
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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.(Italy) | Preservation Solutions, Inc.,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
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| Intended for Use | Organ storage andpreservation fortransplantation | Organ storage andpreservation fortransplantation | Same |
|---|---|---|---|
| Meets UNOS Policy | YES | YES | Same |
| MaterialContainer/Bag | PVC Free / Bags | PVC Free / Bags | Same |
| ProtectingOverwrap Bag | YES | YES | Same |
| Single Use Only | YES | YES | Same |
| Bag Connections | 1 flip off, 1 needlepoint | 1 flip off, 1 needlepoint | Same |
| Used for OrganTransplants of | Used for kidneys,liver and pancreas | Used for kidneys,liver and pancreas | NA |
| Product State | Liquid - Solution | Liquid - Solution | Same |
|---|---|---|---|
| Model Numbers | Bag1000ml /SERVB10DMABag 2000ml /SERVB20DM | Bag 1000ml /Model # unknown | Different ModelNumbers - due todifferentmanufacturers |
| Configurations | Box containing 10bags of 1000mlPVC free.Box containing 5bags of 2000mlPVC free. | Bags 1000 ml,and carton of 10 | Same,Subject devicehas additionalpackagingavailable |
| SterilizationMethod | Steam -Sterilizationprocesses validated | Solution isasepticallyprocessed and thetubing used for the | Different;however bothpassed accordingto ISO standards |
| according to ISO17665-1 | aseptic filling issteam sterilized.The bags aregamma sterilized.Sterilizationprocesses werevalidated accordingto ISO 17665-1 orUSP Section<1211>, asappropriate. | ||
| SodiumConcentration | 29 mEq/L | 29 mEq/L | Equivalent |
| PotassiumConcentration | 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 |
| ManufactureStandards ofConformity | ISO 9001:2008ISO 13485:2003GMP Certification | Unknown | Subject meetscurrent standards |
| Shelf Life | 24 Months | 24 Months | Same |
| Device Standards ofConformity | Subject devicepassed accordingto ISO standards | Unknown | Subject devicepassed accordingto ISO standards |
| ISO Standards | ISO 10993-110993-210993-410993-510993-1010993-1110993-1210993-18ISO 11607-111607-2ISO 11737-1ISO 14001ISO 14971ISO15189 | ISO 10993 seriesISO 17665USP <788>USP <1211> | Subject andPredicate passedstandardized tests |
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| 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.
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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.
§ 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).