Predicate Devices

Reference Devices

KDN, K091989

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
The device is a solution used for the flushing, storage, and transportation of isolated lungs for transplantation, and for organ perfusion and hypothermic preservation. It does not treat a disease or condition in a living patient, but rather preserves an organ outside the body.

Diagnostic

No

The device is a solution used for the flushing, storage, and transportation of isolated lungs after removal from the donor, which is a preservation and preparation function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "solution" and is packaged in "PVC free bags" and "Clear glass bottles," indicating it is a physical substance and its containers, 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, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient." This is a solution used to preserve an organ outside of the body for transplantation.
Device Description: The description details a solution for "organ perfusion and hypothermic preservation." It describes its function in protecting the organ's microvessels and preventing edema and thrombi formation.
Lack of Diagnostic Function: There is no mention of this device being used to test a sample from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. IVDs are typically used to analyze blood, urine, tissue, or other bodily fluids or samples.

This device falls under the category of a medical device used for organ preservation, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

KDN

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:

1. PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration.
1. Clear glass bottles 25ml, therefore they are free of phthalates. The solution may be used without any point of use filtration.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lungs

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

Non-Clinical Performance Data

Biocompatibility: 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: 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: Not applicable for this device.

Software: Not applicable for this device.

Performance Testing: 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.

Key Metrics

Not Found

Predicate Device(s)

K091989

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 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.

1

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:

1. PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration.
1. 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 Solution
with THAM	Perfadex and Perfadex
with 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
Regulation
Name	Isolated Kidney Perfusion
and Transport System and
Accessories	Isolated Kidney Perfusion
and Transport System and
Accessories	Same
Device
Classification
Name	System, Perfusion, Kidney	System, Perfusion, Kidney	Same
Common Name	Solution for lung
preservation	Solution for lung
preservation	Same
Device
Description	Servator P SALF Solution
with THAM is a clear to light
yellow, single use only,
sterile (by steam) is indicated
for the flushing, static cold
storage and transportation of
isolated lungs after removal from
the donor in
preparation of eventual
transplantation into
recipient. The solution
is used for organ perfusion
and hypothermic
preservation. It is an ideal
solution for the preservation
of lungs.	Perfadex® and Perfadex®
with TRAM is a clear,
sterile, non-pyrogenic,
colloid
based, lightly buffered so
called "extracellular" low
potassium dextran solution
primarily for rapid cooling,
perfusion and storage of
lungs in connection with
transplantation.	Same

Indication 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.	Perfadex® Solution for
Lung Perfusion is intended
for the flushing, storage
and transportation of
isolated lungs after
removal from the donor in
preparation for eventual
transplantation into a
recipient.	Same
Intended Use	Organ storage and
preservation for
transplantation	Organ storage and
preservation for
transplantation	Same
Mode of
operation	Cold storage	Cold storage	Same
Container/Bag	PVC free bags	PVC free bags	Same
Solution
qualitative and
quantitative
composition	Dextran 40
50g
Glucose monohydrate 1g
Potassium chloride 0.4g
Sodium chloride
8g
Magnesium sulfate
heptahydrate 0.201g
Potassium dihydrogen
phosphate
0.063g
Disodium phosphate
dihydrate
0.0576g
Sodium 138 mmol/l
Potassium 6 mmol/l
Glucose 5 mmol/l
Chlorides 142 mmol/l	Dextran 40
50g
Glucose monohydrate 1g
Potassium chloride
0.4g
Sodium chloride
8g
Magnesium sulfate
heptahydrate 0.201g
Potassium dihydrogen
phosphate
0.063g
Disodium phosphate
dihydrate
0.0576g
Sodium 138 mmol/l
Potassium 6 mmol/l
Glucose 5 mmol/l
Chlorides 142 mmol/l	Same
	Total Phosphates 0.8 mmol/l
Water for injections q.s. to
1000ml	Total Phosphates 0.8
mmol/l
Water for injections q.s. to
1000ml
Meets UNOS
Policy	Yes	Yes	Same
Physical
Properties	The solution has a
calculated osmolarity of
about 295 mOsmol/l. pH:
5.3 to 5.5. Sterile pyrogen-
free solution for organ
preservation of Class II. The
solution is clear, colorless or
slightly yellow.
Before use the pH of the
solution should be adjusted
to 7.4 by adding a suitable
buffer 25 ml of THAM
1mmol/l.	The solution has a
calculated osmolarity of
about 295 mOsmol/l. pH:
5.3 to 5.5. Sterile pyrogen-
free solution for organ
preservation of Class II.
The solution is clear,
colorless or slightly
yellow.
Before use the pH of the
solution should be adjusted
to 7.4 by adding a suitable
buffer 25 ml of THAM
1mmol/l.	Same
Container	PVC free bags	PVC free bags	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 Communicating
Blood Path Indirect Contact
for prolonged periods >24
hours.	Particle Counts less than
limits for Large Volume
Injections per USP ;
Biocompatible per ISO
10993-1 battery of tests
for Externally
Communicating Blood
Path Indirect Contact for
prolonged periods >24
hours.	Same
Device
Standards of
Conformity	ISO 10993-4
ISO 10993-5
ISO 10993-10
ISO 10993-11
ISO 11607-1
ISO 11607-2
ISO 11737-1	ISO 17665
ISO 10993 Series
USP
USP
Exact test series of
predicate device are
unknown	Subject
device
passed
according
to ISO
Standards
	ISO 14971
ISO 15223-1
ISO 17025
ISO 17665-1
USP 39
USP 39
USP 41
USP
Protecting
Overwrap 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 processes
validated according
to ISO 17665 or USP

                                                                                                                                                                                                                                                                                                                                                                           | Sterilization processes

validated according
to ISO 17665 or USP
| Same |
| Sterilization
method | Steam | Steam | Same |
| Nominal value | 1000 mL bags + THAM | 1000 mL bags + THAM | Same |
| Shelf Life | 24 months | 24 months | Same |
| Storage
Temperature | Store below 30°C. Do
not freeze.
Store in its original
container. Do not remove
the overwrap until
immediately before use.
The device is sterile
and disposable. The
solution must be used
for one single
uninterrupted
administration and any
residue must be
discarded to avoid
risk of contamination
due to loss of sterility.
Do not use if the
solution is frozen. | Store below 30°C. Do
not freeze.
Store in its original
container. Do not remove
the overwrap until
immediately before use.
The device is sterile
and disposable. The
solution must be used
for one single
uninterrupted
administration and any
residue must be
discarded to avoid
risk of contamination
due to loss of sterility.
Do not use if the
solution is frozen. | Same |
| Interaction with
other medical
technology | Not intended for continuous
perfusion. Standard
transplantation surgical
expertise and techniques are
required. | Not intended for
continuous perfusion.
Standard transplantation
surgical expertise and
techniques are required. | Same |

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Test	SALF	Predicate
Temperature of storage of
product