(211 days)
Servator C SALF Solution is intended for flushing and cold storage of hearts at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
Servator C SALF Solution is a clear to light yellow, single use only, sterile (by steam sterilization) and non-pyrogenic for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the recipient. The solution is slightly alkaline (pH 7.3 ± 0.2 at 20°C), slightly hypertonic (approximate calculated osmolarity 242-368 mOsmol/L) with low viscosity (1.15 cSt), and has a high buffering capacity (acidic approximately 11 mmol, alkaline approximately 7 mmol). After removal from refrigerated storage (2°-8°C or 36°-46°F), the cold solution is used to flush the heart immediately before removal from the donor and/or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation. The primary containers used for the device are PVC free bags in 1000ml, therefore they are free of phthalates. The containers are in accordance with the reference European Pharmacopoeia and USP Pharmacopeia.
This document describes the Servator C SALF Solution, an organ perfusion and preservation solution, and its substantial equivalence to a predicate device (Celsior Cold Flush, Storage and Transport Solution for Hearts). The information provided focuses on non-clinical performance data to support this equivalence.
Here's the breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Servator C SALF Solution are not explicitly stated as numerical targets in the same way one might see for an AI algorithm's sensitivity or specificity. Instead, the acceptance criteria are demonstrated by proving substantial equivalence to the predicate device across various technological characteristics and performance tests. The "reported device performance" is essentially that the Servator C SALF Solution matches or passes the same standards as the predicate or relevant ISO standards.
| Feature / Acceptance Criteria | Reported Device Performance (Servator C SALF Solution) | Comparison to Predicate |
|---|---|---|
| Indications for Use | Flushing and cold storage of hearts at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient. | Identical |
| Intended Use | Organ storage and preservation for transplantation. | Identical |
| Device Description (Color, sterility, pyrogenicity, hypothermic cardiac flushing/storage, pH, osmolarity, viscosity, buffering capacity) | Clear to light yellow, single use, sterile, non-pyrogenic, slightly alkaline (pH 7.3 ± 0.2 at 20°C), slightly hypertonic (242-368 mOsmol/L), low viscosity (1.15 cSt), high buffering capacity (acidic approx. 11 mmol, alkaline approx. 7 mmol). Used for flushing before/after removal and left in organ during storage/transport. | Identical |
| Container (Material) | PVC free bags, free of phthalates, in compliance with European and USP Pharmacopeia. | Identical |
| Packaging | Bags with overbags for single use. | Identical |
| Quantitative Composition (Mannitol, Lactobionic Acid, Glutamic Acid, Histidine, Calcium Chloride, Potassium Chloride, Magnesium Chloride, Sodium Hydroxide, Reduced Glutathione, Water for Injection) | Identical to predicate device formulation. | Identical |
| pH | 7.3 ± 0.2 at 20°C | Identical |
| Osmolality | 242-368 mOsm/Kg | Identical |
| Bag Material | PVC free material | Identical |
| Particulate Matter | Particle Counts less than limits for Large Volume Injections per USP <788>. | Same |
| Biocompatibility | Biocompatible per ISO 10993-1 battery of tests for Externally Communicating Blood Path Indirect Contact for prolonged periods >24 hours. | Same |
| Protecting Overwrap Bag | Yes, contains an oxygen absorber. | Identical |
| Bag Connections | 1 flip off, 1 needle point. | Identical |
| Single Use Only | Yes | Identical |
| Shelf Life | 24 months | Identical |
| Storage Temperature | Refrigerated Storage between 2℃ to 8℃, without freezing (36° - 46° F). | Identical |
| Sterilization Method | Steam | Different (predicate uses ethylene oxide for bag, aseptic processing for solution). Both validated to ISO standards. |
| Device Standards of Conformity | ISO 10993-1, -2, -4, -5, -10, -11; ISO 11607-1, -2; ISO 11737-1; ISO 14971; ISO 15223-1; ISO 17025; ISO 17665-1; USP 39 <71>, <85>; USP 41 <151>. | Subject device passed according to ISO Standards (predicate's exact test series unknown, but states ISO 17665, ISO 10993 Series, USP <788>, USP <1211>). |
| Chemical Comparisons and Leachables Performance Testing | Demonstrated substantial equivalence to the predicate. | Demonstrated equivalence |
The overall acceptance criterion is based on demonstrating that the Servator C SALF Solution is substantially equivalent to the predicate device (Celsior Cold Flush, Storage and Transport Solution for Hearts) in terms of safety and effectiveness, despite a minor difference in sterilization method.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of clinical trials with human subjects for efficacy. The studies performed are primarily non-clinical performance data focusing on chemical, physical, and biological properties of the solution and its packaging materials.
- Sample Size: Not specified in terms of number of organs or human subjects. The tests mentioned (e.g., biocompatibility guidance per ISO standards, particulate count per USP <788>) involve samples of the device components/solution itself. For instance, biocompatibility testing would involve a certain number of test specimens of the device material in contact with various biological environments.
- Data Provenance: The document does not specify country of origin for the non-clinical test data, but the manufacturer is SALF S.p.A., Italy. The studies are by nature prospective in the sense that they are designed and conducted specifically to test the new device's compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the studies are non-clinical, comparing the device's characteristics against established standards and a predicate device, rather than against a ground truth established by medical experts for a diagnostic or AI performance study. Compliance with standards like ISO 10993 and USP <788> is determined by accredited laboratories and their qualified technical staff.
4. Adjudication Method for the Test Set
Not applicable. The performance is assessed against predefined scientific standards and direct comparison with the predicate device's known characteristics, rather than through adjudication of medical decisions.
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 device is an organ preservation solution, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies involving human readers and AI are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established by:
- Established scientific and regulatory standards: Such as ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization, and USP <788> for particulate matter.
- The chemical and physical properties of the legally marketed predicate device: The Servator C SALF Solution's composition, pH, osmolarity, etc., are directly compared to the Celsior solution, aiming for identical or equivalent characteristics.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm.
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August 14, 2019
S.A.L.F. Spa % Joyce St. Germain Regulatory Consultant The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach, FL 32174
Re: K190063
Trade/Device Name: Servator C SALF Solution Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion And Transport System And Accessories Regulatory Class: Class II Product Code: MSB Dated: July 10, 2019 Received: July 15, 2019
Dear Joyce St. Germain:
We have reviewed vour 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
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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/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 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 medical devices and radiation-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,
Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastro-Renal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190063
Device Name Servator C SALF Solution
Indications for Use (Describe)
Servator C SALF Solution is intended for flushing and cold storage of hearts at the time of their 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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K190063 Page 1 of 8
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The 510k Consulting LLC
1449 Springleaf Dr., Ormond Beach, FL
Key to success in obtaining your medical device clearance
510(k) Summary - к190063
Submitter/Applicant
32174
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: January 9, 2019
Preparer/Consultant
The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach, FL 32174
Phone: 904-477-3203 Joyce St. Germain, Regulatory Consultant, joyce510kfda@gmail.com Contact:
Device Classification
| Trade/Model Names: | Servator C SALF Solution |
|---|---|
| Submitter: | SALF, S.p.A., Italy |
| Common Name: | Organ perfusion and preservation solution |
| Classification Name: | System and Accessories, Isolated Heart, Transportand Preservation |
| Regulation Name: | Isolated kidney perfusion and transport system andaccessories |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | MSB |
| 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: | K991594 |
|---|---|
| Date Cleared | July 30, 1999 |
| Submitter: | SangStat Medical Corporation, Fremont, CA |
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K190063 Page 2 of 8
| Trade Name: | Celsior Cold Flush, Storage and Transport Solution for Hearts |
|---|---|
| Common Name: | Organ perfusion and preservation solution |
| Classification Name: | System and Accessories, Isolated Heart, Transport and Preservation |
| Regulation Name: | Isolated kidney perfusion and transport system and accessories |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | MSB |
| Regulatory Class: | II |
| Medical Specialty: | Gastroenterology/Urology Panel |
Indications for Use
Servator C SALF Solution is intended for flushing and cold storage of hearts at the time of their 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 C SALF Solution is a clear to light yellow, single use only, sterile (by steam sterilization) and non-pyrogenic for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the recipient.
The solution is slightly alkaline (pH 7.3 ± 0.2 at 20°C), slightly hypertonic (approximate calculated osmolarity 242-368 mOsmol/L) with low viscosity (1.15 cSt), and has a high buffering capacity (acidic approximately 11 mmol, alkaline approximately 7 mmol). After removal from refrigerated storage (2°-8°C or 36°-46°F), the cold solution is used to flush the heart immediately before removal from the donor and/or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation.
The primary containers used for the device are PVC free bags in 1000ml, therefore they are free of phthalates. The containers are in accordance with the reference European Pharmacopoeia and USP Pharmacopeia.
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
Technological Comparison
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Device | Servator C SALFSolution | Celsior Solution ColdFlush Storage andTransport Solution | NA |
| Manufacturer | SALF spa, Italy | SangStat Medical Corp.,USA | NA |
| 510(k) Number | K190063 | K991594 | NA |
| Classification &Product Code | 876.5880; MSB | 876.5880; MSB | Same |
| RegulationName | Isolated KidneyPerfusion and TransportSystem and Accessories | Isolated KidneyPerfusion and TransportSystem and Accessories | Same |
| DeviceClassificationName | System and Accessories,Isolated Heart, Transportand Preservation | System and Accessories,Isolated Heart, Transportand Preservation | Same |
| Common Name | Cold Storage Solution | Cold Storage Solution | Same |
| DeviceDescription | Servator C is a clear toslightly yellow, sterile,non-pyrogenic,extracellular solution forhypothermic flushing andstorage of hearts. Thesolution is slightlyalkaline (pH 7.3 ± 0.2 at20°C), slightly hypertonic(approximate calculatedosmolarity 242-368mOsmol/L) with lowviscosity (1.15 cSt), andhas a high bufferingcapacity (acidicapproximately 11 mmol, | Celsior is a clear toslightly yellow, sterile,non-pyrogenic,extracellular solution forhypothermic flushing andstorage of hearts. Thesolution is slightlyalkaline (pH 7.3 ± 0.2 at20°C), slightly hypertonic(approximate calculatedosmolarity 242-368mOsmol/L) with lowviscosity (1.15 cSt), andhas a high bufferingcapacity (acidicapproximately 11 mmol, | Same |
| alkaline approximately 7mmol). After removalfrom refrigerated storage(2°- 8°C or 36°- 46°F),the cold solution is usedto flush the heartimmediately beforeremoval from the donorand/or immediately afterremoval from the donor.The solution is left in theorgan vasculature duringhypothermic storage andtransportation. Thissolution is to be used forcold storage of hearts andnot for continuousmachine perfusion.Administration of thesolution at therecommendedtemperatures willeffectively cool the heartand should reduce itsmetabolic requirements. | alkaline approximately 7mmol). After removalfrom refrigerated storage(2°- 8°C or 36°- 46°F),the cold solution is usedto flush the heartimmediately beforeremoval from the donorand/or immediately afterremoval from the donor.The solution is left in theorgan vasculature duringhypothermic storage andtransportation. Thissolution is to be used forcold storage of hearts andnot for continuousmachine perfusion.Administration of thesolution at therecommendedtemperatures willeffectively cool the heartand should reduce itsmetabolic requirements. | ||
| Indication forUse | Servator C SALF isintended for flushing andcold storage of hearts atthe time of their removalfrom the donor inpreparation for storage,transportation, andeventual transplantationinto a recipient. | Celsior is intended forflushing and cold storageof hearts at the time oftheir removal from thedonor in preparation forstorage, transportation,and eventualtransplantation into arecipient. | Same |
| Intended Use | Organ storage andpreservation fortransplantation | Organ storage andpreservation fortransplantation | Same |
| DeviceClassificationNameMode ofoperation | System and Accessories,Isolated Heart, Transportand Preservation | System and Accessories,Isolated Heart, Transportand Preservation | SameSame |
| Container/Bag | PVC free bags | PVC free bags | Same |
| Solutionqualitative andquantitativecomposition of1000 ml ofsolution | Servator C is used forhypothermic cardiacflushing and storage inpreparation fortransportation andeventual transplantationof the heart into therecipient. Thequantitative compositionsof Servator C is:Mannitol 60 mmolLactobionic Acid 80mmolGlutamtic Acid 20mmolHistidine 30mmolCalcium Chloride 0.25 mmolPotassium Chloride 15mmolMagnesium Chloride 13mmolSodium Hydroxide 100mmolReduced Glutathione 3mmolWater for Injection, Up to 1Liter | Celsior is used forhypothermic cardiacflushing and storage inpreparation fortransportation andeventual transplantationof the heart into therecipient. Thequantitative compositionsof Celsior is:Mannitol 60 mmolLactobionic Acid 80mmolGlutamtic Acid 20mmolHistidine 30mmolCalcium Chloride 0.25 mmolPotassium Chloride 15mmolMagnesium Chloride 13mmolSodium Hydroxide 100mmolReduced Glutathione 3mmolWater for Injection, Up to 1Liter | Same |
| pH | pH 7.3 ± 0.2 at 20°C | pH 7.3 ± 0.2 at 20°C | Same |
| Osmolality | 242-368 mOsm/K | 242-368 mOsm/Kg | Same |
| Bag material | PVC free material | PVC free material | Same |
| ParticulateMatter andBiocompatibility | Particle Counts less thanlimits for Large VolumeInjections per USP<788>; Biocompatibleper ISO 10993-1 batteryof tests for Externally | Particle Counts less thanlimits for Large VolumeInjections per USP<788>; Biocompatibleper ISO 10993-1 batteryof tests for Externally | Same |
| Communicating BloodPath Indirect Contact forprolonged periods >24hours. | Communicating BloodPath Indirect Contact forprolonged periods >24hours. | ||
| DeviceStandards ofConformity | ISO 10993-1ISO 10993-2ISO 10993-4ISO 10993-5ISO 10993-10ISO 10993-11ISO 11607-1ISO 11607-2ISO 11737-1ISO 14971ISO 15223-1ISO 17025ISO 17665-1USP 39 <71>USP 39 <85>USP 41 <151> | ISO 17665ISO 10993 SeriesUSP <788>USP <1211>Exact test series ofpredicate device areunknown | Subjectdevicepassedaccordingto ISOStandards |
| ProtectingOverwrap bag | Yes and contains anoxygen absorber | Yes and contains anoxygen absorber | Same |
| Bag connections | 1 flip off, 1 needle point | 1 flip off, 1 needle point | Same |
| Single use only | Yes | Yes | Same |
| Sterilizationmethod | Steam | Bag is sterilized byethylene oxide andsolution is asepticallyprocessed. | Different |
| Nominal value | 1000 mL bags | 1000 mL bags | Same |
| Shelf Life | 24 months | 24 months | Same |
| StorageTemperature | Refrigerated Storagebetween 2℃ to 8℃,without freezing(36° - 46° F) | Indoor controlledbetween 2℃ to 8℃,without freezing(36° - 46° F) | Same |
| Interaction withother medicaltechnology | Not intended forcontinuous perfusion.Standard transplantation | Not intended forcontinuous perfusion.Standard transplantation | Same |
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NOTE. . . The composition list is identical to the subject 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 minor differences do not make the subject device any less safe and effective as the predicate device.
The Servator C SALF Solution is the same in 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.
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. The subject and predicate device have a different method of sterilization; however, both devices are provided sterile and have been validated per ISO standards. 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 C SALF Solution does not raise any
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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 C SALF Solution warrants a finding of substantial equivalence to the legally marketed Celsior™ Cold Storage 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).