Servator P SALF Solution with THAM

K202652 · S.A.L.F. Spa · KDN · Aug 19, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K202652
• Device Name: Servator P SALF Solution with THAM
• Applicant: S.A.L.F. Spa
• Product Code: KDN · Gastroenterology, Urology
• Decision Date: Aug 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5880
• Device Class: Class 2

Indications for Use

Organ storage and preservation for transplantation of lungs.

Device Story

Servator P SALF Solution with THAM is a sterile, single-use, colloid-based, low-potassium dextran solution used for flushing, static cold storage, and transportation of isolated lungs post-donor removal. The solution, cooled to 4° to 8° C, is applied to the organ immediately after removal. Dextran 40 acts as a colloidal component to protect microvessels from post-ischemic reperfusion damage by preventing pathological leukocyte-endothelial interactions, edema, and thrombi formation. The device is used by transplant clinicians in a clinical or surgical setting. The solution is supplied in PVC-free bags or glass bottles and does not require point-of-use filtration. It is not intended for continuous perfusion. By maintaining the organ in a hypothermic state, the solution preserves lung viability for eventual transplantation, potentially improving patient outcomes by reducing organ damage during transport.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including chemical composition analysis, leachable performance testing, biocompatibility testing (ISO 10993 series), and sterility validation (ISO 17665).

Technological Characteristics

Sterile, colloid-based, low-potassium dextran solution. Composition: Dextran 40, Glucose monohydrate, Potassium chloride, Sodium chloride, Magnesium sulfate heptahydrate, Potassium dihydrogen phosphate, Disodium phosphate dihydrate. Osmolarity ~295 mOsmol/l; pH 5.3-5.5 (adjusted to 7.4 with THAM buffer). Supplied in PVC-free bags or glass bottles. Sterilization: Steam (ISO 17665). Standards: ISO 10993 (biocompatibility), ISO 11607 (packaging), USP <788> (particulate matter).

Indications for Use

Indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Regulatory Classification

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.

Predicate Devices

• Perfadex® with THAM (K091989)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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 [e-mail]

# 510(k) Summary

## Submitter/Applicant

S.A.L.F. S.p.A Via Marconi, 2, Cenate Sotto, BG, Italy Phone: [phone] Contact: Dr. Carmelo Gagliano (Quality Manager) [e-mail]

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, [e-mail] |

#### 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.
- 2) 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<br>with THAM | Perfadex and Perfadex<br>with THAM | NA |
| Manufacturer | SALF spa, Italy | XVIVO Perfusion AB,<br>Sweden | NA |
| 510(k) Number | NA | K091989 | NA |
| Classification &<br>Product Code | 876.5880; KDN | 876.5880; KDN | Same |
| Regulation<br>Name | Isolated Kidney Perfusion<br>and Transport System and<br>Accessories | Isolated Kidney Perfusion<br>and Transport System and<br>Accessories | Same |
| Device<br>Classification<br>Name | System, Perfusion, Kidney | System, Perfusion, Kidney | Same |
| Common Name | Solution for lung<br>preservation | Solution for lung<br>preservation | Same |
| Device<br>Description | Servator P SALF Solution<br>with THAM is a clear to light<br>yellow, single use only,<br>sterile (by steam) is indicated<br>for the flushing, static cold<br>storage and transportation of<br>isolated lungs after removal from<br>the donor in<br>preparation of eventual<br>transplantation into<br>recipient. The solution<br>is used for organ perfusion<br>and hypothermic<br>preservation. It is an ideal<br>solution for the preservation<br>of lungs. | Perfadex® and Perfadex®<br>with TRAM is a clear,<br>sterile, non-pyrogenic,<br>colloid<br>based, lightly buffered so<br>called "extracellular" low<br>potassium dextran solution<br>primarily for rapid cooling,<br>perfusion and storage of<br>lungs in connection with<br>transplantation. | Same |
| | | | |
| Indication for<br>Use | Servator P SALF Solution<br>with THAM is indicated for<br>flushing, storage and<br>transportation of isolated<br>lungs after removal from<br>the donor in preparation for<br>eventual transplantation<br>into a recipient. | Perfadex® Solution for<br>Lung Perfusion is intended<br>for the flushing, storage<br>and transportation of<br>isolated lungs after<br>removal from the donor in<br>preparation for eventual<br>transplantation into a<br>recipient. | Same |
| Intended Use | Organ storage and<br>preservation for<br>transplantation | Organ storage and<br>preservation for<br>transplantation | Same |
| Mode of<br>operation | Cold storage | Cold storage | Same |
| Container/Bag | PVC free bags | PVC free bags | Same |
| Solution<br>qualitative and<br>quantitative<br>composition | Dextran 40<br>50g<br>Glucose monohydrate 1g<br>Potassium chloride 0.4g<br>Sodium chloride<br>8g<br>Magnesium sulfate<br>heptahydrate 0.201g<br>Potassium dihydrogen<br>phosphate<br>0.063g<br>Disodium phosphate<br>dihydrate<br>0.0576g<br>Sodium 138 mmol/l<br>Potassium 6 mmol/l<br>Glucose 5 mmol/l<br>Chlorides 142 mmol/l | Dextran 40<br>50g<br>Glucose monohydrate 1g<br>Potassium chloride<br>0.4g<br>Sodium chloride<br>8g<br>Magnesium sulfate<br>heptahydrate 0.201g<br>Potassium dihydrogen<br>phosphate<br>0.063g<br>Disodium phosphate<br>dihydrate<br>0.0576g<br>Sodium 138 mmol/l<br>Potassium 6 mmol/l<br>Glucose 5 mmol/l<br>Chlorides 142 mmol/l | Same |
| | Total Phosphates 0.8 mmol/l<br>Water for injections q.s. to<br>1000ml | Total Phosphates 0.8<br>mmol/l<br>Water for injections q.s. to<br>1000ml | |
| Meets UNOS<br>Policy | Yes | Yes | Same |
| Physical<br>Properties | The solution has a<br>calculated osmolarity of<br>about 295 mOsmol/l. pH:<br>5.3 to 5.5. Sterile pyrogen-<br>free solution for organ<br>preservation of Class II. The<br>solution is clear, colorless or<br>slightly yellow.<br>Before use the pH of the<br>solution should be adjusted<br>to 7.4 by adding a suitable<br>buffer 25 ml of THAM<br>1mmol/l. | The solution has a<br>calculated osmolarity of<br>about 295 mOsmol/l. pH:<br>5.3 to 5.5. Sterile pyrogen-<br>free solution for organ<br>preservation of Class II.<br>The solution is clear,<br>colorless or slightly<br>yellow.<br>Before use the pH of the<br>solution should be adjusted<br>to 7.4 by adding a suitable<br>buffer 25 ml of THAM<br>1mmol/l. | Same |
| Container | PVC free bags | PVC free bags | Same |
| Particulate<br>Matter and<br>Biocompatibility | Particle Counts less than<br>limits for Large Volume<br>Injections per USP <788>;<br>Biocompatible per ISO<br>10993-1 battery of tests for<br>Externally Communicating<br>Blood Path Indirect Contact<br>for prolonged periods >24<br>hours. | Particle Counts less than<br>limits for Large Volume<br>Injections per USP <788>;<br>Biocompatible per ISO<br>10993-1 battery of tests<br>for Externally<br>Communicating Blood<br>Path Indirect Contact for<br>prolonged periods >24<br>hours. | Same |
| Device<br>Standards of<br>Conformity | ISO 10993-4<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-11<br>ISO 11607-1<br>ISO 11607-2<br>ISO 11737-1 | ISO 17665<br>ISO 10993 Series<br>USP <788><br>USP <1211><br>Exact test series of<br>predicate device are<br>unknown | Subject<br>device<br>passed<br>according<br>to ISO<br>Standards |
| | ISO 14971<br>ISO 15223-1<br>ISO 17025<br>ISO 17665-1<br>USP 39 <71><br>USP 39 <85><br>USP 41 <151><br>USP <1211> | | |
| Protecting<br>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<br>validated according<br>to ISO 17665 or USP<br><1211> | Sterilization processes<br>validated according<br>to ISO 17665 or USP<br><1211> | Same |
| Sterilization<br>method | Steam | Steam | Same |
| Nominal value | 1000 mL bags + THAM | 1000 mL bags + THAM | Same |
| Shelf Life | 24 months | 24 months | Same |
| Storage<br>Temperature | Store below 30°C. Do<br>not freeze.<br>Store in its original<br>container. Do not remove<br>the overwrap until<br>immediately before use.<br>The device is sterile<br>and disposable. The<br>solution must be used<br>for one single<br>uninterrupted<br>administration and any<br>residue must be<br>discarded to avoid<br>risk of contamination<br>due to loss of sterility.<br>Do not use if the<br>solution is frozen. | Store below 30°C. Do<br>not freeze.<br>Store in its original<br>container. Do not remove<br>the overwrap until<br>immediately before use.<br>The device is sterile<br>and disposable. The<br>solution must be used<br>for one single<br>uninterrupted<br>administration and any<br>residue must be<br>discarded to avoid<br>risk of contamination<br>due to loss of sterility.<br>Do not use if the<br>solution is frozen. | Same |
| Interaction with<br>other medical<br>technology | Not intended for continuous<br>perfusion. Standard<br>transplantation surgical<br>expertise and techniques are<br>required. | Not intended for<br>continuous perfusion.<br>Standard transplantation<br>surgical expertise and<br>techniques are required. | Same |

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| Test | SALF | Predicate |
|--------------------------------------|-----------------------|-----------|
| Temperature of storage of<br>product | <30°C*; Do not freeze | 2°-25°C |
| Temperature of transport | 4-8°C | 4-8°C |
| Shelf life | 2 years | 2 years |
| Shelf life after<br>reconstitution | 24 hours | 24 hours |

*It is calculated on basis of stability study. The product is stable at 25℃ for 2 years and at least 6months at 40°C.

About the storage condition please let me know if we have to restrict the rage from <30°C*; Do notfreeze to 2°-25°C.

The above comparison shows the subject and predicate devices are identical in eachattribute/characteristic.

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

NOTE. . . The composition list is identical for the subject and predicate 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 Servator P SALF Solution with THAM have the same indication for use, intended use, design, materials, packaging and other technological characteristics to the predicate device.

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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 ... 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. 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 . . . 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 leachable 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 P SALF Solution with THAM does not raise any 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 P SALF Solution with THAM warrants a finding of substantial equivalence to the legally marketed Perfadex® with THAM solution, and therefore, should have clearance for premarket activities in the United States.