(240 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biological effects of a preservation solution, with no mention of AI or ML technologies.
No.
The device is a solution for preserving organs for transplantation, not for treating a disease or condition in a patient.
No
The device is a solution used for the preservation and transportation of isolated lungs for transplantation, not for diagnosing a condition or disease.
No
The device description clearly states it is an "extracellular electrolyte solution" and describes its chemical composition and function in preserving lungs, indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the flushing, cold static storage and transportation of isolated lungs after removal from a donor. This is a process performed outside the living body to preserve an organ for transplantation.
- Device Description: The device is a solution used to maintain the viability of the lung tissue. It's not used to diagnose a condition, monitor a physiological state, or screen for diseases by analyzing samples from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information. The solution's function is purely for organ preservation.
IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
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.
Product codes
KDN
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 SALF is used for rapid 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
adult patients
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
1
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
2
Indications for Use
510(k) Number (if known) K230193
Device Name Servator P Plus SALF Solution
Indications for Use (Describe)
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.
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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3
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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 |
4
| 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
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.
V. Indications for Use
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.
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.
5
| Feature | Subject
Servator P Plus SALF
Solution | Predicate
Perfadex Plus
K170826 |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
For Use | 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. | Perfadex Plus is indicated for the
flushing static cold storage and
transportation of isolated lungs after
removal from the donor in preparation
for eventual transplantation into a
recipient. |
| Intended Use | Used for organ perfusion and
hypothermic preservation. | Used for organ perfusion and
hypothermic preservation. |
| Regulation Number | 21 CFR 878.5880 | 21 CFR 878.5880 |
| Product Code | KDN | KDN |
| Regulation Name | Isolated kidney perfusion and transport
system and accessories | Isolated kidney perfusion and transport
system and accessories |
| 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 SALF
is used for rapid 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.
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. | Perfadex Plus is an extracellular electrolyte
solution containing Dextran 40. The solution
is pre-buffered with 2 mM THAM and
presupplemented with 0.5 mM CaCl2.
Perfadex 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.
PERFADEX® Plus 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. |
| 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 |
| Protective
Overlap Bag | Yes | Yes |
| 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. |
| Bag
Connections | 1 flip off, 1 needle point | Click system – connector that clicks
onto the port rather than inserting a spike
into the rubber stopper. |
| Sterilization | Sterilization processes validated.
According to either ISO 17665 or
USP Section | Sterilization processes validated.
According to either ISO 17665 or
USP Section |
| Sterilization
Method | Steam | Steam |
| Nominal
Volume | 1000 mL bags and 3000ml bags | 1000 mL bags |
| Storage
Temperature
and
Shelf-Life | 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.
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 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.
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. |
| | 2 years (24 months) shelf life | 2 years (24 months) shelf life |
| Interaction
with Other
Medical
Technology | WARNINGS AND PRECAUTIONS
FOR USE | WARNINGS AND PRECAUTIONS FOR
USE |
| | Do not use if contamination is evident in
the solution.
Use only clear solutions in undamaged
containers.
Servator P Plus is intended for single use
only and MUST NOT BE REUSED.
Reuse of Servator P Plus is not allowed due
to the risk for infection.
Do not use Servator P Plus if the use by
date has expired.
Servator P Plus is not intended for
intravenous administration in the human
body.
Ensure that the Servator P Plus bag is not
in direct contact with ice.
Do not use the injection port for
administration.
Servator P Plus is pre-buffered and pe-
supplemented with calcium ions.
Additional buffer, such as THAM and
calcium ions, MUST NOT be added.
Do not use a pressure cuff or add external
pressure on the Servator P Plus bag since
an elevated pressure might introduce
damage to the vasculature or the bag might
break. | Subject and Predicate descriptions
are the same. |
| Precautions | No additives are necessary as Servator P
Plus is pre-buffered and pre-supplemented
with calcium ions. The solution should be
kept chilled and used within 24 hours after
the container is opened. If any other
additives are used, chill solution as directed | Subject and Predicate descriptions
are the same. |
6
7
8
| prior to adding any additives and mix
| thoroughly immediately prior to use. |
|---|
| The use of Servator P Plus cannot improve |
| an already damaged lung. |
| Recovery of healthy lungs under proper |
| conditions is essential. |
| Treatment of children: There is no data on |
| the use of Servator P Plus on children. |
| Pregnancy: There is no data on the use of |
| Servator P Plus during pregnancy. |
| Lactation: It is not known to what extent |
| Servator 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 sulphate | |||||
| heptahydrate | 0.201 | g | Chlorides | 143 | mmol/l |
| Potassium dihydrogen | |||||
| phosphate | 0.063 | g | Sulphates | 0.8 | mmol/l |
| Disodium phosphate | |||||
| dihydrate | 0.0576 | g | Total | ||
| Phosphates | 0.8 | mmol/l | |||
| Calcium Chloride | |||||
| dihydrate | 0.074 | g | Calcium | 0.50 | mmol/l |
| THAM | 0.24 | g | THAM | 2.00 | mmol/l |
9
| Water for injections q.s. to | 1000 | ml | |||
|---|---|---|---|---|---|
| ------------------------------ | ------ | ---- | -- | -- | -- |
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.
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.
10
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.