(188 days)
Servator M SALF Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation, and eventual transportation, and eventual transplantation into a recipient.
The Servator M SALF is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion preservation of explained kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 rnEq/L, and a pH of approximately 7.4 at room temperature. The primary containers used for the device are PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration. Servator M SALF is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
The Servator M SALF Solution is intended for flushing and continuous hypothermic machine perfusion of kidneys, and for the preservation of these organs for eventual transplantation. The device is a clear, sterile, non-pyrogenic, non-toxic solution.
Here's a breakdown of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance relies on demonstrating substantial equivalence to a predicate device (PERF-GENQ® Pulsatile Perfusion Solution, K121736). Therefore, the acceptance criteria are based on matching or providing equivalent performance/characteristics to the predicate.
| Acceptance Criteria (Based on Predicate Equivalence) | Reported Device Performance (Servator M SALF Solution) |
|---|---|
| Same Indications for Use | Servator M SALF Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation, and eventual transportation, and eventual transplantation into a recipient. (Identical to predicate) |
| Same Intended Use | Organ perfusion and preservation solution. (Identical to predicate) |
| Identical Chemical Composition | The solution qualitative and quantitative composition is identical to the predicate for all listed constituents (Adenine, Calcium Chloride, Dextrose, Glutathione, HEPES, Hydroxyethyl Starch, Magnesium Gluconate, Mannitol, Potassium Phosphate, Ribose, Sodium Gluconate, Sodium Hydroxide, Sterile Water for injection). |
| Similar Device Description | A clear, sterile, non-pyrogenic, non-toxic solution for in-vitro flushing and temporary continuous perfusion preservation of explained kidneys. Approximate calculated osmolarity of 300 mOsm/kg, sodium concentration of 100 mEq/L, potassium concentration of 25 mEq/L, and pH of approximately 7.4 at room temperature. |
| Similar pH | 6.90-7.50 at 20°C |
| Similar Container/Bag | PVC free bags |
| Meets UNOS Policy | Yes |
| Particulate Matter & Biocompatibility | Particle counts less than limits for Large Volume Injections per USP <788>; Biocompatible per ISO 10993-1 battery of tests for Externally Communicating Blood Path Indirect Contact for prolonged periods >24 hours. (Conforms to standards) |
| Sterilization Method | Steam |
| Nominal Volume | 1000 mL bags |
| Shelf Life | 24 months |
| Storage Temperature | Indoors with temperature at 2°-25°C, without freezing. |
| Protecting Overwrap Bag | Yes |
| Bag Connections | 1 flip off, 1 needle point |
| Single Use Only | Yes |
| Safe Interaction with Other Medical Technology | Labels include warnings regarding expiration date, container damage, and visible particles/precipitates/contaminations. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of a clinical trial with a defined sample size for the Servator M SALF Solution itself. Instead, the evaluation focuses on non-clinical performance data and a direct comparison to a predicate device.
- Non-Clinical Performance Data: The reported data includes:
- Biocompatibility tests (according to ISO 10993 series).
- Sterilization and Shelf Life validation (according to ISO 17655-1).
- Chemical comparisons.
- Leachables performance testing.
The document does not specify the number of samples used for each of these non-clinical tests.
- Data Provenance: The device manufacturer is SALF S.p.A. in Italy, suggesting the non-clinical testing was likely conducted in Italy or by contracted labs. The nature is retrospective in terms of comparing against the established predicate specifications and existing standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the clearance is based on substantial equivalence demonstrated through non-clinical testing and direct comparison to a predicate, rather than a clinical study requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
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
This information is not applicable. The device is a medical solution for organ preservation, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical solution and not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness profile of the predicate device (PERF-GENQ® Pulsatile Perfusion Solution) and the adherence to relevant international standards (ISO 10993, ISO 17665-1, USP <788>, USP <85>) for biocompatibility, sterility, and particulate matter. The core of the submission is to demonstrate that the Servator M SALF Solution is chemically identical and performs equivalently to the predicate, meeting these established safety and performance benchmarks.
8. The Sample Size for the Training Set
This information is not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context refers to the development and manufacturing processes adhering to quality systems (e.g., good manufacturing practice).
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As mentioned above, this device does not utilize a training set in the AI/ML sense.
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December 20, 2021
S.A.L.F. S.p.A. % Joyce St. Germain Owner The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach, Florida 32174
Re: K211842
Trade/Device Name: Servator M SALF Solution Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion And Transport System And Accessories Regulatory Class: II Product Code: KDL Dated: December 10, 2021 Received: December 16, 2021
Dear Joyce St. Germain:
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.
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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).
Sincerely,
Glenn B. Bell. Ph.D. 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) K211842
Device Name Servator M SALF Solution
Indications for Use (Describe)
Servator M SALF Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation, and eventual 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
to success in obtaining your medical device clearance ringleaf Dr., Ormond Beach, FL 32174 da@gmail.com
510(k) Summary K211842
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: May 28,2021
Preparer/Consultant
The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach, FL 32174
| Phone: | 904-477-3203 |
|---|---|
| Contact: | Joyce St. Germain, Regulatory Consultant, joyce510kfda@gmail.com |
Device Classification
| Trade/Model Names: | Servator M SALF Solution |
|---|---|
| Submitter: | SALF, S.p.A., Italy |
| Common Name: | Cold Storage Solution |
| Classification Name: | System, Perfusion, Kidney, Disposable |
| Regulation Name: | Isolated kidney perfusion and transport system and accessories |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | KDL |
| Regulatory Class: | II |
| 510k Review Panel: | Gastroenterology/Urology Panel |
Predicate Device
The subject device claims equivalence to the following legally marketed predicate:
| 510(k) Number: | K121736 |
|---|---|
| Date Cleared | August 16, 2013 |
| Submitter: | Waters Medical Systems, LLC, Rochester, MN |
| Trade Name: | PERF-GENQ® Pulsatile Perfusion Solution |
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| Common Name: | Cold Storage Solution |
|---|---|
| Classification Name: | Set, Perfusion, Kidney, Disposable |
| Regulation Name: | Isolated kidney perfusion and transport system andaccessories |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | KDL |
| Regulatory Class: | II |
| Medical Specialty: | Gastroenterology/Urology Panel |
Indications for Use
Servator M SALF Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
Intended Use
Organ perfusion and preservation solution.
Device Description
The Servator M SALF is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion preservation of explained kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 rnEq/L, and a pH of approximately 7.4 at room temperature. The primary containers used for the device are PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration. Servator M SALF is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
Type of device.
Sterile, non-pyrogen solution for perfusion/protection and preservation of organs. NOT FOR INJECTION.
Package
Box containing 10 bags per carton of 1000 ml PVC free.
Model Number of Device: SERVM10DMA
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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.
- 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
Technological Comparison
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Device | Servator M SALF Solution | PERF-GENQ® PulsatilePerfusion Solution | NA |
| Manufacturer | SALF spa, Italy | Waters Medical Syustems,LLC, Rochester, MN | NA |
| 510(k) Number | K211842 | K121736 | NA |
| Classification &Product Code | 876.5880; KDL | 876.5880; KDL | Same |
| RegulationName | Isolated Kidney Perfusionand Transport System andAccessories | Isolated Kidney Perfusionand Transport System andAccessories | Same |
| DeviceClassificationName | System, Perfusion, Kidney,Disposable | System, Perfusion, Kidney,Disposable | Same |
| Common Name | Cold Storage Solution | Cold Storage Solution | Same |
| DeviceDescription | The Servator M SALFSolution is a clear, sterile,non-pyrogenic, non-toxicsolution for the in-vitroflushing and temporarycontinuous perfusionpreservation of explainedkidneys. This solution hasan approximate calculatedosmolarity of 300 | The PERF-GENO PulsatilePerfusion Solution (PERF-GEN Solution) is a clear,sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing andtemporary continuousperfusion preservation ofexplained kidneys. Thissolution has an | Same |
| mOsm/kg, a sodiumconcentration of 100mEq/L, a potassiumconcentration of 25mEq/L, and a pH ofapproximately 7.4 at roomtemperature. | approximate calculatedosmolarity of 300mOsm/kg, a sodiumconcentration of 100mEq/L, a potassiumconcentration of 25 mEq/L,and a pH of approximately7.4 at room temperature. | ||
| Indication forUse | Servator M SALFSolution is intended to beused for flushing andcontinuous hypothermicmachine perfusion ofkidneys at the time of theirremoval from the donor inpreparation for storage,transportation, andeventual transplantationinto a recipient. | The PERF-GENQ®Pulsatile Perfusion Solutionis intended to be used forflushing and continuoushypothermic machineperfusion of kidneys at thetime of their removal fromthe donor in preparation forstorage, transportation, andeventual transplantation intoa recipient. | Same |
| Intended Use | Organ storage andpreservation fortransplantation | Organ storage andpreservation fortransplantation | Same |
| Mode ofoperation | Cold storage | Cold storage | Same |
| Container/Bag | PVC free bags | PVC free bags | Same |
| Meets UNOSPolicy | Yes | Yes | Same |
| pH | 6.90-7.50 at 20°C | 6.90-7.50 at 20°C | Same |
| Container | PVC free bags | PVC free bags | Same |
| ParticulateMatter andBiocompatibility | Particle Counts less thanlimits for Large VolumeInjections per USP <788>;Biocompatible per ISO | Particle Counts less thanlimits for Large VolumeInjections per USP <788>;Biocompatible per ISO | Same |
| 10993-1 battery of tests forExternally CommunicatingBlood Path IndirectContact for prolongedperiods >24 hours. | 10993-1 battery of tests forExternally CommunicatingBlood Path IndirectContact for prolongedperiods >24 hours. | ||
| DeviceStandards ofConformity | ISO 10993-1ISO 10993-4ISO 10993-5ISO 10993-10ISO 10993-11ISO 14971ISO 15223-1ISO 17665-1USP 39 <71>USP 39 <85> | ISO 10993 SeriesExact test series ofpredicate device areunknown | Subjectdevicepassedaccordingto ISOStandards |
| ProtectingOverwrap bag | Yes | Yes | Same |
| Bag connections | 1 flip off, 1 needle point | 1 flip off, 1 needle point | Same |
| Single use only | Yes | Yes | Same |
| Sterilizationmethod | Steam | Steam | Same |
| Nominal value | 1000 mL bags | 1000 mL bags | Same |
| Shelf Life | 24 months | 24 months | Same |
| StorageTemperature | Indoors with temperature at2°-25°C, without freezing. | Indoors with temperature at2° - 25°C, without freezing. | Same |
| Interaction withother medicaltechnology | Check the expiration datestated on the container. Theexpiration date refers to theproduct in unopenedpackaging.CAUTION: do not use thedevice after the expiry datestated on the container.Even though within its | Check the expiration datestated on the container. Theexpiration date refers to theproduct in unopenedpackaging.CAUTION: do not use thedevice after the expiry datestated on the container.Even though within its shelf | Same |
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| shelf life (device notexpired), the solution mustnot be used, if thecontainer is damaged or ifthere are visible particles,precipitates orcontaminations. | life (device not expired), thesolution must not be used, ifthe container is damaged orif there are visible particles,precipitates orcontaminations. |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Solution qualitative and quantitative composition / Same for both Subject and Predicate
| CONSTITUENT | Amount 1000 ml | Concentration (mM) |
|---|---|---|
| Adenine (free base) | 0.68 g | 5 |
| Calcium Chloride (dihydrate) | 0.068 g | 0.5 |
| Dextrose (+) | 1.80 g | 10 |
| Glutathione (reduced) | 0.92 g | 3 |
| HEPES (free acid) | 2.38 g | 10 |
| Hydroxyethyl Starch | 50.0 g | N/A |
| Magnesium Gluconate (anhydrous) | 1.13 g | 5 |
| Mannitol | 5.4 g | 30 |
| Potassium Phosphate (monobasic) | 3.4 g | 25 |
| Ribose, D(-) | 0.75 g | 5 |
| Sodium Gluconate | 17.45 g | 80 |
| Sodium Hydroxide | 0.70 g | N/A |
| Sterile Water for injection | to 1000 ml Volume | N/A |
The above comparison shows the subject and predicate devices are identical in each attribute/characteristic.
NOTE. . . The composition list is identical for the subject and predicate device composition and therefore, the subject and predicate devices are identical in chemical composition.
The above comparison shows the subject and predicate devices are substantially equivalent in technology characteristics.
The Servator M SALF Solution has the same indication for use, intended use, design, materials, packaging and other technological characteristics to the predicate device.
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.
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Biocompatibility ... is required for this device. The tests were all performed according to the ISO 10993 series that are listed in the Table of Comparison above. 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. Steam sterilization and storage conditions are the subject and predicate device. Shelf life for the subject is 24 months and the predicate device is 12 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 M 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.
The conclusion is that Servator M SALF Solution warrants a finding of substantial equivalence to the legally marketed PERF-GENQ® Pulsatile Perfusion 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).