Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical composition, physical properties, and biocompatibility of a solution for organ preservation, with no mention of AI or ML.

Therapeutic

No.
The device is a solution used for flushing and cold storage of hearts for transplantation, which is a supportive role in a medical procedure, not a direct therapeutic intervention on a patient's condition.

Diagnostic

No

Justification: The device is a solution intended for flushing and cold storage of hearts for transplantation, not for providing diagnostic information about the heart or patient.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a solution for flushing and storage of hearts, packaged in bags. This is a physical substance and container, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for flushing and cold storage of hearts for transplantation. This is a direct intervention on an organ, not a test performed on a sample from the body to diagnose a condition.
Device Description: The description details a solution used to preserve an organ. It doesn't describe a test kit, reagent, or instrument used to analyze a biological sample.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting for testing.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is organ preservation, which falls outside the scope of IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

MSB

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hearts

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K991594

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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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

1

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

joyce510kfda@gmail.com

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, 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
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 SALF
Solution	Celsior Solution Cold
Flush Storage and
Transport 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
Regulation
Name	Isolated Kidney
Perfusion and Transport
System and Accessories	Isolated Kidney
Perfusion and Transport
System and Accessories	Same
Device
Classification
Name	System and Accessories,
Isolated Heart, Transport
and Preservation	System and Accessories,
Isolated Heart, Transport
and Preservation	Same
Common Name	Cold Storage Solution	Cold Storage Solution	Same
Device
Description	Servator C is a clear to
slightly yellow, sterile,
non-pyrogenic,
extracellular solution for
hypothermic flushing and
storage of hearts. 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,	Celsior is a clear to
slightly yellow, sterile,
non-pyrogenic,
extracellular solution for
hypothermic flushing and
storage of hearts. 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,	Same
	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. This
solution is to be used for
cold storage of hearts and
not for continuous
machine perfusion.
Administration of the
solution at the
recommended
temperatures will
effectively cool the heart
and should reduce its
metabolic requirements.	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. This
solution is to be used for
cold storage of hearts and
not for continuous
machine perfusion.
Administration of the
solution at the
recommended
temperatures will
effectively cool the heart
and should reduce its
metabolic requirements.
Indication for
Use	Servator C SALF 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.	Celsior 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.	Same
Intended Use	Organ storage and
preservation for
transplantation	Organ storage and
preservation for
transplantation	Same
Device
Classification
Name
Mode of
operation	System and Accessories,
Isolated Heart, Transport
and Preservation	System and Accessories,
Isolated Heart, Transport
and Preservation	Same
Same
Container/Bag	PVC free bags	PVC free bags	Same
Solution
qualitative and
quantitative
composition of
1000 ml of
solution	Servator C is used for
hypothermic cardiac
flushing and storage in
preparation for
transportation and
eventual transplantation
of the heart into the
recipient. The
quantitative compositions
of Servator C is:
Mannitol 60 mmol
Lactobionic Acid 80mmol
Glutamtic Acid 20mmol
Histidine 30mmol
Calcium Chloride 0.25 mmol
Potassium Chloride 15mmol
Magnesium Chloride 13mmol
Sodium Hydroxide 100mmol
Reduced Glutathione 3mmol
Water for Injection, Up to 1
Liter	Celsior is used for
hypothermic cardiac
flushing and storage in
preparation for
transportation and
eventual transplantation
of the heart into the
recipient. The
quantitative compositions
of Celsior is:
Mannitol 60 mmol
Lactobionic Acid 80mmol
Glutamtic Acid 20mmol
Histidine 30mmol
Calcium Chloride 0.25 mmol
Potassium Chloride 15mmol
Magnesium Chloride 13mmol
Sodium Hydroxide 100mmol
Reduced Glutathione 3mmol
Water for Injection, Up to 1
Liter	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
Particulate
Matter and
Biocompatibility	Particle Counts less than
limits for Large Volume
Injections per USP
; Biocompatible
per ISO 10993-1 battery
of tests for Externally	Particle Counts less than
limits for Large Volume
Injections per USP
; Biocompatible
per ISO 10993-1 battery
of tests for Externally	Same
	Communicating Blood
Path Indirect Contact for
prolonged periods >24
hours.	Communicating Blood
Path Indirect Contact for
prolonged periods >24
hours.
Device
Standards of
Conformity	ISO 10993-1
ISO 10993-2
ISO 10993-4
ISO 10993-5
ISO 10993-10
ISO 10993-11
ISO 11607-1
ISO 11607-2
ISO 11737-1
ISO 14971
ISO 15223-1
ISO 17025
ISO 17665-1
USP 39
USP 39
USP 41	ISO 17665
ISO 10993 Series
USP
USP
Exact test series of
predicate device are
unknown	Subject
device
passed
according
to ISO
Standards
Protecting
Overwrap bag	Yes and contains an
oxygen absorber	Yes and contains an
oxygen absorber	Same
Bag connections	1 flip off, 1 needle point	1 flip off, 1 needle point	Same
Single use only	Yes	Yes	Same
Sterilization
method	Steam	Bag is sterilized by
ethylene oxide and
solution is aseptically
processed.	Different
Nominal value	1000 mL bags	1000 mL bags	Same
Shelf Life	24 months	24 months	Same
Storage
Temperature	Refrigerated Storage
between 2℃ to 8℃,
without freezing
(36° - 46° F)	Indoor controlled
between 2℃ to 8℃,
without freezing
(36° - 46° F)	Same
Interaction with
other medical
technology	Not intended for
continuous perfusion.
Standard transplantation	Not intended for
continuous 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.