(339 days)
Servator P SALF Solution with THAM is indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Servator P SALF Solution with THAM is a clear to light yellow, single use only, sterile (by steam sterilization) is indicated for the flushing, static cold storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into recipient. The solution is used for organ perfusion and hypothermic preservation. It is an ideal solution for the preservation of lungs.
The solution cooled to 4° to 8° C (39° to 46° F) is used to spray the organ isolated immediately after removal from the donor. The colloidal component Dextran 40 protects in particular microvessels from a possible damage caused by the post-ischemic reperfusion, since it prevents pathological leukocyte-endothelial interactions. In addition, Dextran 40 prevents edema and the formation of thrombi.
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.
-
- Clear glass bottles 25ml, therefore they are free of phthalates. The solution may be used without any point of use filtration.
The provided FDA 510(k) summary for "Servator P SALF Solution with THAM" does not describe an AI/ML-based medical device. Instead, it details a solution used for organ preservation (specifically lungs) during transplantation.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment for an AI/ML device is not applicable to this submission.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Perfadex® with THAM) based on:
- Identical Indications for Use and Intended Use.
- Identical Chemical Composition: This is explicitly stated multiple times ("The composition list is identical for the subject and predicate device composition and therefore, the subject and predicate devices are identical in chemical composition.").
- Similar Technological Characteristics: Such as mode of operation (cold storage), container type, and sterilization method (steam).
- Non-Clinical Performance Data:
- Biocompatibility: Tests performed according to ISO 10993 series. The subject device passed all biocompatibility test standards.
- Sterilization and Shelf Life Validation: Sterility validated according to ISO 17655-1. Shelf life is 24 months, identical to the predicate.
- Performance Testing: Chemical comparisons and leachable performance testing were conducted to demonstrate substantial equivalence to the predicate.
In summary, this 510(k) submission establishes substantial equivalence through direct comparison of the product's attributes and non-clinical testing, rather than through a study proving an AI/ML device meets specific performance criteria.
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August 19, 2021
S.A.L.F. S.p.A % Joyce St. Germain Regulatory Consultant The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach, FL 32174
Re: K202652
Trade/Device Name: Servator P SALF Solution with THAM Regulation Number: 21 CFR§ 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDN Dated: July 15, 2021 Received: July 19, 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.
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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-regulatoryinformation/postmarketing-safety-reporting-combination-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,
for Carolyn Y. Neuland, Ph.D. 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
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Indications for Use
510(k) Number (if known) K202652
Device Name Servator P SALF Solution with THAM
Indications for Use (Describe)
Servator P SALF Solution with THAM is indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
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)
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The 510k Consulting LLC
to success in obtaining your medical device clearance ingleaf Dr., Ormond Beach, FL 32174 da@gmail.com
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: September 4, 2020
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/Device Name: | Servator P SALF Solution with THAM |
|---|---|
| Common Name: | Solution for lung preservation |
| 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 |
| 510k Review Panel: | Gastroenterology/Urology Panel |
Predicate Device
The subject device claims equivalence to the following legally marketed predicate:
| 510(k) Number: | K091989 |
|---|---|
| Date Cleared | October 1, 2010 |
| Submitter: | XVIVO Perfusion AB |
| Trade Name: | Perfadex® with THAM |
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| Common Name: | Solution for lung preservation |
|---|---|
| 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 P SALF Solution with THAM is indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Intended Use
Organ storage and preservation for transplantation of lungs.
Device Description
Servator P SALF Solution with THAM is a clear to light yellow, single use only, sterile (by steam sterilization) is indicated for the flushing, static cold storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into recipient. The solution is used for organ perfusion and hypothermic preservation. It is an ideal solution for the preservation of lungs.
The solution cooled to 4° to 8° C (39° to 46° F) is used to spray the organ isolated immediately after removal from the donor. The colloidal component Dextran 40 protects in particular microvessels from a possible damage caused by the post-ischemic reperfusion, since it prevents pathological leukocyte-endothelial interactions. In addition, Dextran 40 prevents edema and the formation of thrombi.
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.
-
- Clear glass bottles 25ml, therefore they are free of phthalates. The solution may be used without any point of use filtration.
Comparison of Technological Characteristics with Predicate
- The indications for use and intended use of the subject and predicate devices are identical.
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- 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 P SALF Solutionwith THAM | Perfadex and Perfadexwith THAM | NA |
| Manufacturer | SALF spa, Italy | XVIVO Perfusion AB,Sweden | NA |
| 510(k) Number | NA | K091989 | NA |
| Classification &Product Code | 876.5880; KDN | 876.5880; KDN | Same |
| RegulationName | Isolated Kidney Perfusionand Transport System andAccessories | Isolated Kidney Perfusionand Transport System andAccessories | Same |
| DeviceClassificationName | System, Perfusion, Kidney | System, Perfusion, Kidney | Same |
| Common Name | Solution for lungpreservation | Solution for lungpreservation | Same |
| DeviceDescription | Servator P SALF Solutionwith THAM is a clear to lightyellow, single use only,sterile (by steam) is indicatedfor the flushing, static coldstorage and transportation ofisolated lungs after removal fromthe donor inpreparation of eventualtransplantation intorecipient. The solutionis used for organ perfusionand hypothermicpreservation. It is an idealsolution for the preservationof lungs. | Perfadex® and Perfadex®with TRAM is a clear,sterile, non-pyrogenic,colloidbased, lightly buffered socalled "extracellular" lowpotassium dextran solutionprimarily for rapid cooling,perfusion and storage oflungs in connection withtransplantation. | Same |
| Indication forUse | Servator P SALF Solutionwith THAM is indicated forflushing, storage andtransportation of isolatedlungs after removal fromthe donor in preparation foreventual transplantationinto a recipient. | Perfadex® Solution forLung Perfusion is intendedfor the flushing, storageand transportation ofisolated lungs afterremoval from the donor inpreparation for eventualtransplantation into arecipient. | 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 |
| Solutionqualitative andquantitativecomposition | Dextran 4050gGlucose monohydrate 1gPotassium chloride 0.4gSodium chloride8gMagnesium sulfateheptahydrate 0.201gPotassium dihydrogenphosphate0.063gDisodium phosphatedihydrate0.0576gSodium 138 mmol/lPotassium 6 mmol/lGlucose 5 mmol/lChlorides 142 mmol/l | Dextran 4050gGlucose monohydrate 1gPotassium chloride0.4gSodium chloride8gMagnesium sulfateheptahydrate 0.201gPotassium dihydrogenphosphate0.063gDisodium phosphatedihydrate0.0576gSodium 138 mmol/lPotassium 6 mmol/lGlucose 5 mmol/lChlorides 142 mmol/l | Same |
| Total Phosphates 0.8 mmol/lWater for injections q.s. to1000ml | Total Phosphates 0.8mmol/lWater for injections q.s. to1000ml | ||
| Meets UNOSPolicy | Yes | Yes | Same |
| PhysicalProperties | The solution has acalculated osmolarity ofabout 295 mOsmol/l. pH:5.3 to 5.5. Sterile pyrogen-free solution for organpreservation of Class II. Thesolution is clear, colorless orslightly yellow.Before use the pH of thesolution should be adjustedto 7.4 by adding a suitablebuffer 25 ml of THAM1mmol/l. | The solution has acalculated osmolarity ofabout 295 mOsmol/l. pH:5.3 to 5.5. Sterile pyrogen-free solution for organpreservation of Class II.The solution is clear,colorless or slightlyyellow.Before use the pH of thesolution should be adjustedto 7.4 by adding a suitablebuffer 25 ml of THAM1mmol/l. | Same |
| Container | PVC free bags | PVC free bags | Same |
| ParticulateMatter andBiocompatibility | Particle Counts less thanlimits for Large VolumeInjections per USP <788>;Biocompatible per ISO10993-1 battery of tests forExternally CommunicatingBlood Path Indirect Contactfor prolonged periods >24hours. | Particle Counts less thanlimits for Large VolumeInjections per USP <788>;Biocompatible per ISO10993-1 battery of testsfor ExternallyCommunicating BloodPath Indirect Contact forprolonged periods >24hours. | Same |
| DeviceStandards ofConformity | ISO 10993-4ISO 10993-5ISO 10993-10ISO 10993-11ISO 11607-1ISO 11607-2ISO 11737-1 | ISO 17665ISO 10993 SeriesUSP <788>USP <1211>Exact test series ofpredicate device areunknown | Subjectdevicepassedaccordingto ISOStandards |
| ISO 14971ISO 15223-1ISO 17025ISO 17665-1USP 39 <71>USP 39 <85>USP 41 <151>USP <1211> | |||
| 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 |
| Sterilization | Sterilization processesvalidated accordingto ISO 17665 or USP<1211> | Sterilization processesvalidated accordingto ISO 17665 or USP<1211> | Same |
| Sterilizationmethod | Steam | Steam | Same |
| Nominal value | 1000 mL bags + THAM | 1000 mL bags + THAM | Same |
| Shelf Life | 24 months | 24 months | Same |
| StorageTemperature | Store below 30°C. Donot freeze.Store in its originalcontainer. Do not removethe overwrap untilimmediately before use.The device is sterileand disposable. Thesolution must be usedfor one singleuninterruptedadministration and anyresidue must bediscarded to avoidrisk of contaminationdue to loss of sterility.Do not use if thesolution is frozen. | Store below 30°C. Donot freeze.Store in its originalcontainer. Do not removethe overwrap untilimmediately before use.The device is sterileand disposable. Thesolution must be usedfor one singleuninterruptedadministration and anyresidue must bediscarded to avoidrisk of contaminationdue to loss of sterility.Do not use if thesolution is frozen. | Same |
| Interaction withother medicaltechnology | Not intended for continuousperfusion. Standardtransplantation surgicalexpertise and techniques arerequired. | Not intended forcontinuous perfusion.Standard transplantationsurgical expertise andtechniques are required. | Same |
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| Test | SALF | Predicate |
|---|---|---|
| Temperature of storage ofproduct | <30°C*; Do not freeze | 2°-25°C |
| Temperature of transport | 4-8°C | 4-8°C |
| Shelf life | 2 years | 2 years |
| Shelf life afterreconstitution | 24 hours | 24 hours |
*It is calculated on basis of stability study. The product is stable at 25℃ for 2 years and at least 6months at 40°C.
About the storage condition please let me know if we have to restrict the rage from <30°C*; Do notfreeze to 2°-25°C.
The above comparison shows the subject and predicate devices are identical in eachattribute/characteristic.
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 P SALF Solution with THAM have the same indication for use, intended use, design, materials, packaging and other technological characteristics to the predicate device.
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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. Steam sterilization and storage conditions are the subject and predicate device. 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 leachable 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 P SALF Solution with THAM 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 P SALF Solution with THAM warrants a finding of substantial equivalence to the legally marketed Perfadex® with THAM 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).