Servator P Plus SALF Solution is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Device Description

Servator P Plus SALF Solution is an extracellular electrolyte solution containing Dextran 40. The solution is pre-buffered with 2 mM THAM and pre-supplemented with 0.5 mM CaCl2. Servator P Plus is used for rapid cooling, perfusion, and cold static storage of lungs in connection with transplantation. Administration of the solution at the recommended temperatures will effectively cool the lung to reduce its metabolic requirements. The colloid component, Dextran 40 counteracts tissue oedema and protects the microvasculature against post-ischemic reperfusion injury. Calcium is important to maintain endothelial and epithelial cell integrity and endothelial contractility. The device is buffered with THAM to achieve a physiological ph. that enables safe preservation of lungs for up to 12 hours depending on status of the lung during retrieval. The intended patient population is adult patients in need of a lung transplantation.

AI/ML Overview

The provided text describes a 510(k) submission for the Servator P Plus SALF Solution, an organ perfusion and preservation solution. The submission aims to demonstrate substantial equivalence to a predicate device, Perfadex Plus (K170826).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating substantial equivalence by comparing the subject device (Servator P Plus SALF Solution) to a predicate device (Perfadex Plus). The acceptance criteria are implicitly aligned with the characteristics of the predicate device and relevant industry standards.

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance (Servator P Plus SALF Solution)
Indications for Use	Indicated for flushing, cold static storage, and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.	Met: "Servator P Plus SALF Solution is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient." (Identical to predicate)
Intended Use	Organ perfusion and hypothermic preservation.	Met: "Used for organ perfusion and hypothermic preservation." (Identical to predicate)
Device Description	Extracellular electrolyte solution containing Dextran 40, pre-buffered with 2 mM THAM and pre-supplemented with 0.5 mM CaCl2. Used for rapid cooling, perfusion, and cold static storage of lungs. Protects against tissue oedema and microvasculature injury. Buffered to physiological pH. Enables preservation for up to 12 hours. Intended for adult patients.	Met: "Servator P Plus SALF Solution is an extracellular electrolyte solution containing Dextran 40. The solution is pre-buffered with 2 mM THAM and pre-supplemented with 0.5 mM CaCl2. Servator P Plus is used for rapid cold static storage of lungs in connection with transplantation... Dextran 40 counteracts tissue oedema and protects the microvasculature against post-ischemic reperfusion injury. Calcium is important to maintain endothelial and epithelial cell integrity and endothelial contractility. The device is buffered with THAM to achieve a physiological pH. Servator P Plus SALF enables safe preservation of lungs for up to 12 hours depending on status of the lung during retrieval. The intended patient population is adult patients in need of a lung transplant." (Substantially equivalent/identical to predicate in description)
Chemical Composition	Identical qualitative and quantitative composition to the predicate device.	Met: "The composition list is identical for the subject and predicate device, the subject and predicate devices are identical in chemical composition." Specific concentrations of Dextran 40, Glucose monohydrate, Potassium chloride, Sodium chloride, Magnesium sulphate heptahydrate, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Calcium Chloride dihydrate, THAM, and Water for injections are listed as identical.
Physical Properties	Osmolarity: ~295 mOsmol/l; pH: 7.2 to 7.6; Sterile non-pyrogenic; Clear, colorless, or slightly yellow.	Met: "The solution has a calculated osmolarity of about 295 mOsmol/1. pH: 7.2 to 7.6. Sterile non-pyrogenic solution for organ preservation of Class II. The solution is clear, colorless, or slightly yellow." (Identical to predicate)
Container	PVC free bags.	Met: "PVC free bags" (Identical to predicate). Subject device also has 3000ml bags in addition to 1000ml bags.
Particulate Matter	Particle Counts less than limits for Large Volume Injections per USP <788>.	Met: "Particle Counts less than limits for Large Volume Injections per USP <788>" (Identical to predicate).
Biocompatibility	Biocompatible per ISO 10993-1 battery of tests for Externally Communicating Blood Path Indirect Contact for prolonged periods >24 hours.	Met: "The tests were all performed according to the ISO 10993 series (10993-1, 10993-2, 10993-4, 10993-10, 10993-11, and 10993-12) and the subject device passed all biocompatibility test standards." (Identical to predicate requirements).
Sterilization	Sterilization processes validated according to ISO 17665 or USP Section <1211>. Steam sterilization method.	Met: "Validation of Sterility was performed, and the results passed according to ISO 17655-1. Steam sterilization and storage conditions are the same for the subject and predicate device." (Identical to predicate requirements).
Shelf Life	2 years (24 months).	Met: "Shelf life for the subject and predicate is the same, at 24 months."
Storage Temperature	Store 2.0-25.0ºC. Do not freeze. Store in original container. Do not remove overwrap until immediately before use. Sterile and disposable.	Met: "Store 2.0-25.0ºC. Do not freeze. Store in its original container. Do not remove the overwrap until immediately before use. The device is sterile and disposable." (Identical to predicate).
Risk Management	ISO 14971 performed.	Met: "ISO 14971 was performed for risk." (No specific comparison to predicate, but indicates compliance with standard).
Performance Testing	Chemical comparisons and leachable performance testing.	Met: "Performance Testing... was completed as a direct comparison between the subject and predicate device. The chemical comparisons and leachable performance testing in part supported the substantial equivalence of this device to the predicate."

2. Sample size used for the test set and the data provenance:

The document does not specify a separate "test set" in the context of clinical or image-based studies. The performance data provided is primarily non-clinical, comparing the physical, chemical, and manufacturing characteristics of the subject device to the predicate device and relevant standards.

Test Set Sample Size: Not applicable in the context of clinical/image data. The "test" here refers to non-clinical laboratory testing (e.g., biocompatibility, sterility, chemical analysis). The sample sizes for these lab tests would be determined by the specific ISO standards followed (e.g., number of units tested for sterility validation).
Data Provenance: The studies are non-clinical, related to the manufacturing and composition of the solution. The provenance would be the manufacturing facility in Italy (S.A.L.F. spa) and the laboratories where the testing was conducted, following international standards (ISO, USP). The studies appear to be prospective, as they are conducted to validate the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The device is a medical solution for organ preservation, not an AI/imaging device requiring expert interpretation for ground truth establishment. The "ground truth" for this device relates to its chemical composition, sterility, biocompatibility, and physical properties, which are established through laboratory testing against predefined scientific and regulatory standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or reader studies where human interpretation of data (e.g., images) needs to be reconciled to establish a consensus ground truth. This is not relevant for the non-clinical laboratory testing performed for a medical solution.

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 is not applicable. The Servator P Plus SALF Solution is an organ preservation solution, not an AI-based diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

This is not applicable. As mentioned, the device is a medical solution, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this device, the "ground truth" is established by:

Chemical Analysis: Direct measurement of the qualitative and quantitative composition of the solution, compared against the known composition of the predicate device and formulation targets.
Physical Property Measurements: Laboratory tests to determine pH, osmolarity, and appearance.
Biocompatibility Standards: Adherence to ISO 10993 series standards, which define acceptable biological responses to medical devices.
Sterilization Validation: Demonstrated sterility according to ISO 17665-1.
Particulate Matter Limits: Conformance to USP <788> limits.
Shelf Life Data: Stability studies demonstrating the maintenance of product specifications over time.

These are objective, measurable criteria established by scientific and regulatory bodies, rather than subjective expert consensus or pathology in a clinical sense.

8. The sample size for the training set:

This is not applicable. There is no concept of a "training set" for an organ preservation solution. The development of the solution is based on established biochemical principles and extensive prior knowledge from the predicate device and organ preservation research.

9. How the ground truth for the training set was established:

This is not applicable. As there is no training set for this type of device, there is no ground truth establishment for a training set. The development and validation largely rely on established scientific knowledge, comparison to the predicate, and adherence to performance standards.

Summary

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September 21, 2023

S.A.L.F. spa % Joyce St. Germain Regulatory Consultant The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach, Florida 32174

Re: K230193

Trade/Device Name: Servator P Plus SALF Solution Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: Class II Product Code: KDN Dated: January 24, 2023 Received: January 24, 2023

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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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lence determination does not mean that FDA

Page 2

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/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.

Gema Gonzalez -S

Gema Gonzalez Acting 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) K230193

Device Name Servator P Plus SALF Solution

Indications for Use (Describe)

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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826 The 510k Consulting LLC

Key to success in obtaining your medical device clearanc

1449 Springleaf Dr., Ormond Beach, FL 32174

joyce 5 10kfda@gmail.com

Traditional 510(k) Summary K230193

I. Submitter

S.A.L.F. spa Via Marconi, 2, 24069 Cenate Sotto BG, Italy Phone: +39-035-940097

Contact: Dr. Carmelo Gagliano, (Quality Manager) carmelo.gagliano@salfspa.it

Date Prepared: January 24, 2023

Preparer/Consultant/Contact

The 510k Consulting, LLC

Joyce St. Germain 1449 Springleaf Dr. Ormond Beach, FL 32174 904-477-3203 Primary Contact: Joyce St. Germain, Regulatory Consultant, joyce510kfda@gmail.com

II. Device

Trade Name:	Servator P Plus SALF Solution
Common Name:	Organ perfusion and preservation solution
Classification Name:	System, Perfusion, Kidney
Regulation Name:	Isolated kidney perfusion and transport system and accessories
Regulation Number:	21 CFR 876.5880
Review Panel:	Gastroenterology/Urology
Regulation Class:	II
Product Code:	KDN
Submission Type:	510(k)

III. Predicate Device

510(k) Number:	K170826
Date Cleared:	June 22, 2018

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Manufacturer:	XVIVO Perfusion AB
Trade Name:	Perfadex Plus
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
Review Panel:	Gastroenterology/Urology
Regulatory Class:	II
Product Code:	KDN

This predicate has not been subject to a design-related recall.

IV. Device Description

V. Indications for Use

Note: The Indication for Use statement is equivalent to the predicate device.

Intended Use: Organ perfusion and preservation solution.

VI. Comparison Technological Characteristics with the Predicate Device

Physical properties: The solution has a calculated osmolarity of about 295 mOsmol/1. pH: 7.2 to 7.6. Sterile non-pyrogenic solution for organ preservation of Class II. The solution is clear, colorless, or slightly yellow.

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Feature	SubjectServator P Plus SALFSolution	PredicatePerfadex PlusK170826
IndicationsFor Use	Servator P Plus SALF Solution isindicated for the flushing, cold staticstorage, and transportation of isolatedlungs after removal from the donor inpreparation for eventual transplantationinto a recipient.	Perfadex Plus is indicated for theflushing static cold storage andtransportation of isolated lungs afterremoval from the donor in preparationfor eventual transplantation into arecipient.
Intended Use	Used for organ perfusion andhypothermic preservation.	Used for organ perfusion andhypothermic preservation.
Regulation Number	21 CFR 878.5880	21 CFR 878.5880
Product Code	KDN	KDN
Regulation Name	Isolated kidney perfusion and transportsystem and accessories	Isolated kidney perfusion and transportsystem and accessories
DeviceDescription	Servator P Plus SALF Solution is anextracellular electrolyte solution containingDextran 40. The solution is pre-bufferedwith 2 mM THAM and pre-supplementedwith 0.5 mM CaCl2. Servator P Plus SALFis used for rapid cold static storage of lungsin connection with transplantation.Administration of the solution at therecommended temperatures will effectivelycool the lung to reduce its metabolicrequirements. The colloid component,Dextran 40 counteracts tissue oedema andprotects the microvasculature against post-ischemic reperfusion injury. Calcium isimportant to maintain endothelial andepithelial cell integrity and endothelialcontractility. The device is buffered withTHAM to achieve a physiological pH.Servator P Plus SALF enables safepreservation of lungs for up to 12 hoursdepending on status of the lung duringretrieval. The intended patient populationis adult patients in need of a lungtransplant.	Perfadex Plus is an extracellular electrolytesolution containing Dextran 40. The solutionis pre-buffered with 2 mM THAM andpresupplemented with 0.5 mM CaCl2.Perfadex Plus is used for rapid coolingperfusion and cold static storage of lungs inconnection with transplantation.Administration of the solution at therecommended temperatures will effectivelycool the lung to reduce its metabolicrequirements. The colloid component,Dextran 40 counteracts tissue oedema andprotects the microvasculature against post-ischemic reperfusion injury. Calcium isimportant to maintain endothelial andepithelial cell integrity and endothelialcontractility. The device is buffered withTHAM to achieve a physiological pH.PERFADEX® Plus enables safe preservationof lungs for up to 12 hours depending onstatus of the lung during retrieval. Theintended patient population is adult patientsin need of a lung transplantation.
Meets UNOS	Yes	Yes
Container	PVC free bags	PVC free bags
pH	7.20 - 7.60	7.20 - 7.60
Osmolality	295 mOsm/kg	295 mOsm/kg
Bag Material	PVC free material	PVC free material
ProtectiveOverlap Bag	Yes	Yes
Particulate MatterandBiocompatibility	Particle Counts less than limits forLarge Volume Injections per USP<788>; Biocompatible per ISO 10993-1battery of tests for ExternallyCommunicating Blood Path IndirectContact for prolonged periods >24hours.	Particle Counts less than limits for LargeVolume Injections per USP <788>;Biocompatible per ISO 10993-1 batteryof tests for Externally CommunicatingBlood Path Indirect Contact forprolonged periods >24 hours.
BagConnections	1 flip off, 1 needle point	Click system – connector that clicksonto the port rather than inserting a spikeinto the rubber stopper.
Sterilization	Sterilization processes validated.According to either ISO 17665 orUSP Section <1211>	Sterilization processes validated.According to either ISO 17665 orUSP Section <1211>
SterilizationMethod	Steam	Steam
NominalVolume	1000 mL bags and 3000ml bags	1000 mL bags
StorageTemperatureandShelf-Life	Store 2.0-25.0ºC. Do not freeze.Store in its original container. Do notremove the overwrap until immediatelybefore use.The device is sterile and disposable.The solution must be used for onesingle uninterrupted administrationand any residue must be discardedto avoid risk of contamination due toloss of sterility. Do not use if thesolution is frozen.	Store 2.0-25.0ºC. Do not freeze.Store in its original container. Do notremove the overwrap until immediatelybefore use.The device is sterile and disposable.The solution must be used for onesingle uninterrupted administration andany residue must be discardedtoavoid risk of contamination due to lossof sterility. Do not use if the solution is frozen.
	2 years (24 months) shelf life	2 years (24 months) shelf life
Interactionwith OtherMedicalTechnology	WARNINGS AND PRECAUTIONSFOR USE	WARNINGS AND PRECAUTIONS FORUSE
	Do not use if contamination is evident inthe solution.Use only clear solutions in undamagedcontainers.Servator P Plus is intended for single useonly and MUST NOT BE REUSED.Reuse of Servator P Plus is not allowed dueto the risk for infection.Do not use Servator P Plus if the use bydate has expired.Servator P Plus is not intended forintravenous administration in the humanbody.Ensure that the Servator P Plus bag is notin direct contact with ice.Do not use the injection port foradministration.Servator P Plus is pre-buffered and pe-supplemented with calcium ions.Additional buffer, such as THAM andcalcium ions, MUST NOT be added.Do not use a pressure cuff or add externalpressure on the Servator P Plus bag sincean elevated pressure might introducedamage to the vasculature or the bag mightbreak.	Subject and Predicate descriptionsare the same.
Precautions	No additives are necessary as Servator PPlus is pre-buffered and pre-supplementedwith calcium ions. The solution should bekept chilled and used within 24 hours afterthe container is opened. If any otheradditives are used, chill solution as directed	Subject and Predicate descriptionsare the same.

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prior to adding any additives and mixthoroughly immediately prior to use.
The use of Servator P Plus cannot improvean already damaged lung.
Recovery of healthy lungs under properconditions is essential.
Treatment of children: There is no data onthe use of Servator P Plus on children.
Pregnancy: There is no data on the use ofServator P Plus during pregnancy.
Lactation: It is not known to what extentServator P Plus passes into breast milk.

The above comparison shows the subject and predicate devices are equivalent in each attribute/characteristic.

The Servator P Plus SALF Solution and the predicate device are equivalent in composition as listed below. Both solutions are packaged in plastic containers and are supplied sterile.

Composition of Subject and Predicate Devices

NOTE. . . The composition list is identical for the subject and predicate device, the subject and predicate devices are identical in chemical composition.

Qualitative and quantitative composition.

1000 ml of solution contains:

COMPOSITION
Dextran 40	50	g	Sodium	138	mmol/l
Glucose monohydrate	1	g	Potassium	6	mmol/l
Potassium chloride	0.4	g	Magnesium	0.8	mmol/l
Sodium chloride	8	g	Glucose	5	mmol/l
Magnesium sulphateheptahydrate	0.201	g	Chlorides	143	mmol/l
Potassium dihydrogenphosphate	0.063	g	Sulphates	0.8	mmol/l
Disodium phosphatedihydrate	0.0576	g	TotalPhosphates	0.8	mmol/l
Calcium Chloridedihydrate	0.074	g	Calcium	0.50	mmol/l
THAM	0.24	g	THAM	2.00	mmol/l

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Water for injections q.s. to	1000	ml
------------------------------	------	----	--	--	--

Servator P Plus SALF Solution and the predicate device are solutions packaged in 1-liter bags. The subject device has an additional package of 3-liter bags, as well.

Both the Servator P Plus SALF Solution and the predicate devices are supplied sterile.

Not for Direct Injection or Intravenous Use (Single Use Only) Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. The above comparison shows the subject and predicate devices are substantially equivalent in

technology characteristics.

The Servator P Plus SALF Solution has equivalent indication for use, intended use, design, materials, packaging, and other technological characteristics to the predicate device.

VII. Performance Data

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 (10993-1, 10993-2, 10993-4, 10993-10, 10993-11, and 10993-12) and 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 same for the subject and predicate device. Shelf life for the subject and predicate is the same, at 24 months.

Electrical Safety and EMC . . . testing was not applicable for this device.

Software and Risk Management... software is not applicable for this device; however, ISO 14971 was performed for risk.

Performance Testing ... was completed as a direct comparison between the subject and predicate device. The chemical comparisons and leachable performance testing in part supported the substantial equivalence of this device to the predicate.

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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.

After analyzing verification of device performance by performance tests included in this submission, it is the conclusion of S.A.L.F., spa that Servator P Plus SALF Solution is equivalent to the predicate and does not raise new questions concerning safety and effectiveness.

The Servator P Plus 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 substantial equivalence.

The conclusion is that Servator S SALF Solution warrants a finding of substantial equivalence to the legally marketed Perfadex Plus Solution, K170826 and therefore, should have clearance for premarket activities in the United States.

Regulation Number and Section

§ 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).