The Servator H SALF solution is indicated for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.

Device Description

The Servator H SALF solution is intended for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal form the donor or immediately after removal from the donor. The solutions is left in the organ vasculature during hypotermic storage and transportation (not for continuous perfusion) to the recipient. Servator H SALF solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive duffering of the extrcellular space by means of histidine/histidine HCI, so as to prolong the period for which organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the Servator H SALF solution is due to the sodium and potassium. The composition of the Servator H SALF is similar to that of extracellular fluid. All of the components of the Servator H SALF solution occur naturally in the body.

AI/ML Overview

The provided document is a 510(k) summary for the Servator H SALF Solution, which is an organ perfusion and preservation solution. It primarily focuses on demonstrating substantial equivalence to a predicate device (Custodiol HTK) rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics of the device as an AI or diagnostic tool.

Therefore, many of the requested details about acceptance criteria, study design, ground truth establishment, sample sizes for training/test sets, expert involvement, and MRMC studies are not applicable or not explicitly detailed in this type of regulatory submission.

However, based on the non-clinical performance data section, we can infer some "acceptance criteria" through the tests conducted.

Here's a breakdown of the information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim for a physical solution and not an AI/diagnostic device, acceptance criteria are generally related to safety, sterility, biocompatibility, and chemical composition matching the predicate.

Acceptance Criteria Category	Specific Test/Characteristic	Reported Device Performance (Servator H SALF)	Conclusion against Predicate
Biocompatibility	Cytotoxicity	Passed Biocompatibility Test Standards	Equivalent to predicate (implied)
	Irritation	Passed Biocompatibility Test Standards	Equivalent to predicate (implied)
	System Toxicity	Passed Biocompatibility Test Standards	Equivalent to predicate (implied)
	Haemocompatibility	Passed Biocompatibility Test Standards	Equivalent to predicate (implied)
Sterilization & Shelf Life	Validation of Sterility	Passed all test standards	Same as predicate (Steam Sterilization)
	Validation Method LAL Turbidimetric	Passed all test standards	Same as predicate (implied)
	Stability	Passed all test standards	Shelf life of 12 months (same as predicate)
Physical Properties	pH (at 25°C)	7.02 - 7.20	Same as predicate
	pH (at 4°C)	7.40 - 7.45	Same as predicate
	Osmolality	310 mOsm/Kg	Same as predicate
Chemical Analysis	(Between subject and predicate device)	Proved to be substantially equivalent	Substantially Equivalent
Safety and Effectiveness	New Questions of Safety and Effectiveness	Does not raise any new questions	Equivalent to predicate

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "performance data" and "test standards" but does not detail sample sizes for any specific tests or the provenance of the data beyond the manufacturer being S.A.L.F. S.p.A. (Italy).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a chemical solution for organ preservation, not a diagnostic device requiring expert interpretation for ground truth.

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

This information is not applicable for the same reason as above.

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 as the device is not an AI-assisted diagnostic tool or an imaging device.

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

This information is not applicable as the device is a chemical solution, not an algorithm.

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

For this type of device (organ preservation solution), "ground truth" is established through:

Chemical composition analysis: Comparing the exact chemical constituents and their concentrations to the predicate device.
Biocompatibility testing: Standardized in-vitro and in-vivo tests to assess toxicity, irritation, etc.
Sterility testing: Confirmation of absence of microbial contamination.
Stability testing: Confirmation that the solution maintains its properties over its shelf life.

The document states that a "direct comparison between the subject and predicate device" was completed for performance testing including chemical analysis, and that "performance reports are included in the submission." This implies that the ground truth for chemical and physical properties was the established characteristics of the predicate device.

8. The sample size for the training set

This information is not applicable as the device is a chemical solution, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as above.

Summary

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October 20, 2017

S.A.L.F. S.p.A. % Joyce St. Germain Regulatory Department Manager 510k FDA Consulting Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, Florida 32176

Re: K170150

Trade/Device Name: Servator H SALF Solution Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion and Transport System and Accessories Regulatory Class: Class II Product Code: KDL, MSB Dated: September 7, 2017 Received: September 19, 2017

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. 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 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely, Joyce M. Whang -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170150

Device Name Servator H 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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510k FDA Consulting

Medical Device Clearance

100 East Granada Blvd., Suite 219

Ormond Beach, FL 32176

386-506-8711

510(k) Summary - K170150

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: October 17, 2017

Preparer/Consultant

Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176

Phone: 386-506-8711 Fax: 855-235-7902 Contact: Joyce St. Germain, Regulatory Dept. Mgr (Joyce@510kfda.com) Secondary Contact: Claude Berthoin, President (Claude@denterpriseintl.com)

Device Classification

Trade/Model Names:	Servator H SALF Solution
Common Name:	Organ perfusion and preservation solution
Classification Name:	Isolated kidney perfusion and transport system and accessories
Regulation Number:	21 CFR 876.5880
Product Code:	KDL, MSB
Regulatory Class:	2
Medical Specialty:	Gastroenterology/Urology Panel

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Predicate Device

The subject device claims equivalence to the following legally marketed predicate:

510(k) Number:	K043461
Date Cleared	February 28, 2005
Trade Name:	Custodiol HTK
Common Name:	Organ perfusion and preservation solution
Classification Name:	Isolated kidney perfusion and transport system and accessories
Regulation Number:	21 CFR 876.5880
Product Code:	KDL, MSB
Regulatory Class:	2
Medical Specialty:	Gastroenterology/Urology Panel

Indications for Use

Intended Use

The Servator H SALF Solution is intended for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal from the donor or immediately after removal from the donor. The solution is for single use, is sterile (by steam sterilization) and nonpyrogenic.

Device Description

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The Servator H SALF solution is relatively low in postassium concentrations so that residual solution in the transplanted organ poses no danger to the recipient. This is particularyly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation.

Comparison of Technological Characteristics with Predicate

The indications for use of the subject and predicate devices are identical and the technologies are substantially equivalent.

The following table compares technological and other characteristics of the subject and predicate device.

Table of Comparison

Table 12.1 -- Technological Comparison

	Subject Device	Predicate Device	Comparison
Device	Servator H SALF	Custodiol HTK	NA
510k Number	K170150	K043461
Manufacturer	S.A.L.F. S.p.A.(Italy)	Dr. Franz KohlerChemi GmbH(Germany)	NA
Classification &Product Code	876.5880;KDL, MSB	876.5880;KDL,MSB	Same
ClassificationName	Isolated kidneyperfusion andtransport systemand accessories	Isolated kidneyperfusion andtransport systemand accessories	Same
Device Description	Set, Perfusion,Kidney, Disposable	Set, Perfusion,Kidney, Disposable	Same
Common Name	Organ perfusion andpreservation solution	Organ perfusion andpreservation solution	Same
Indications for Use	The Servator HSALF solution isindicated forperfusion andflushing donorkidneys, liver,pancreas, and heartprior to removal	The Custodiol HTKsolution is indicatedfor perfusion andflushing donorkidneys, liver,pancreas, and heartprior to removalfrom the donor or	Same
	from the donor orimmediately afterremoval from thedonor. The solutionis left in the organvasculature duringhypothermic storageand transportation(not for continuousperfusion) to therecipient.	immediately afterremoval from thedonor. The solutionis left in the organvasculature duringhypothermic storageand transportation(not for continuousperfusion) to therecipient.
Intended for Use	The Servator HSALF Solution isintended forperfusion andflushing donorkidneys, liver,pancreas, and heartprior to removalfrom the donor orimmediately afterremoval from thedonor. The solutionis for single use, issterile (by steamsterilization) andnon-pyrogenic.	The Custodiol HTKSolution is intendedfor perfusion andflushing donorkidneys, liver,pancreas, and heartprior to removalfrom the donor orimmediately afterremoval from thedonor.	Same
Meets UNOS Policy	YES	YES	Same
Container/Bag	PVC free bags	PVC free bags	Equivalent
ProtectingOverwrap Bag	YES	YES	Same
Single Use Only	YES	YES	Same
Bag Connections	1 flip off, 1 needlepoint	1 flip off, 1 needlepoint	Same
Used for OrganTransplants of	Used for kidneys,liver, heart andpancreas	Used for kidneys,liver, heart andpancreas	Same
Product State	Liquid - Solution	Liquid - Solution	Same
Model Numbers	Servator H SALF,1000ml /SERVH10DMAServator H SALF,2000ml /SERVH20DM	Bag, 1000 ml /25767-735-45Bag, 2000ml /25767-735-49Bag, 5000ml /25767-735-46	Different ModelNumbers - due todifferentmanufactures
Configurations	Box containing 10bags of 1000mlPVC free.Box containing 5bags of 2000mlPVC free.	Bags 1000 ml,2000 ml and5000 ml.	EquivalentPredicate devicedifferentpackagingavailable
SterilizationMethod	Steam	Steam	Same
Physical Properties	pH: 7.02 - 7.20 at25° C;7.40 - 7.45 at 4° COsmolality: 310mOsm/Kg	pH: 7.02 - 7.20 at25° C;7.40 - 7.45 at 4° COsmolality: 310mOsm/Kg	Same
ManufactureStandards ofConformity	ISO 9001:2008ISO 13485:2003GMP Certification	Unknown	Subject meetscurrent standards
Shelf Life	12 Months	12 Months	Same
Device Standards ofConformity	Subject devicepassed accordingto ISO standards	Unknown	Subject devicepassed accordingto ISO standards

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The above comparison shows the subject and predicate devices are substantially equivalent in technology characteristics. The differences are highlighted and those differences do not make the subject device any less safe and effective as the predicate device. The differences are due to different manufacturers with different model numbers and the predicate has additional sizes of bags and a bottle package.

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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 testing was required for this device. The Cytotoxicity, Irritation, System Toxicity and Haemocompatibility tests were all performed. The subject device passed all biocompatibility test standards.

Sterilization and Shelf Life testing and evaluation was required for the subject device. The Validation of Sterility, Validation Method LAL Turbidimetric and Stability were all performed and the results passed the device on all test standards performed. Steam sterilization and storage conditions are the same. Shelf life for the subject and predicate device are 12 months.

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

Performance Testing including but not limited to chemical analysis was completed as a direct comparison between the subject and predicate device. The subject device proved to be substantially equivalent to the predicate. The comparison chart is shown in this summary and performance reports are included in the submission.

Conclusion

The subject and predicate devices have the same intended use and are substantially equivalent in technological characteristics and performance (since they have, in fact, the same composition). The Servator H SALF does not raise any questions regarding new questions of safety and effectiveness and is equivalent to the predicate device. The nonclinical data supports and demonstrates the safety of the device.

The conclusion is that Servator H SALF warrants a finding of substantial equivalence to the legally marketed original Custodiol HTK Solution, 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).