(188 days)
No
The document describes a solution for organ preservation and does not mention any computational or analytical capabilities that would involve AI/ML.
No
The device is a solution used for the preservation of organs (kidneys) for transplantation, not for direct therapeutic treatment of a patient's disease or condition. Its function is to maintain organ viability ex-vivo.
No
The device is a solution intended for the preservation and transportation of kidneys, not for diagnosing medical conditions.
No
The device description clearly states it is a "clear, sterile, non-pyrogenic, non-toxic solution" and is packaged in "PVC free bags," indicating it is a physical substance and its container, not software.
Based on the provided information, the Servator M SALF Solution is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for transplantation. This is a process performed on the organ itself, outside of the living body, but it's not about analyzing a sample from the body to diagnose a condition.
- Device Description: The description details a solution used for preserving an organ. It doesn't mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Metrics: The "Key Metrics" section is marked as "Not Applicable," which is consistent with a device that doesn't perform diagnostic testing.
- Predicate Device: The predicate device is also a perfusion solution for organ preservation, not an IVD.
IVDs are typically used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Servator M SALF Solution's purpose is to preserve an organ for transplantation, which is a therapeutic procedure, not a diagnostic one.
N/A
Intended Use / Indications for Use
Servator M SALF Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation, and eventual transportation, and eventual transplantation into a recipient.
Product codes
KDL
Device Description
The Servator M SALF is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion preservation of explained kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 rnEq/L, and a pH of approximately 7.4 at room temperature. The primary containers used for the device are PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration. Servator M SALF is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidneys
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)
Non-Clinical Performance Data:
Biocompatibility: Tests were performed according to the ISO 10993 series, and 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 same for the subject and predicate device. Shelf life for the subject device is 24 months.
Electrical Safety and EMC: Not applicable.
Software: Not applicable.
Performance Testing: Completed as a direct comparison between the subject and predicate devices. 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)
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 20, 2021
S.A.L.F. S.p.A. % Joyce St. Germain Owner The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach, Florida 32174
Re: K211842
Trade/Device Name: Servator M SALF Solution Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion And Transport System And Accessories Regulatory Class: II Product Code: KDL Dated: December 10, 2021 Received: December 16, 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. You must comply with all the Act's
1
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 (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,
Glenn B. Bell. Ph.D. 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) K211842
Device Name Servator M SALF Solution
Indications for Use (Describe)
Servator M SALF Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation, and eventual 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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The 510k Consulting LLC
to success in obtaining your medical device clearance ringleaf Dr., Ormond Beach, FL 32174 da@gmail.com
510(k) Summary K211842
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: May 28,2021
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/Model Names: | Servator M SALF Solution |
|---|---|
| Submitter: | SALF, S.p.A., Italy |
| Common Name: | Cold Storage Solution |
| Classification Name: | System, Perfusion, Kidney, Disposable |
| Regulation Name: | Isolated kidney perfusion and transport system and accessories |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | KDL |
| 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: | K121736 |
|---|---|
| Date Cleared | August 16, 2013 |
| Submitter: | Waters Medical Systems, LLC, Rochester, MN |
| Trade Name: | PERF-GENQ® Pulsatile Perfusion Solution |
4
| Common Name: | Cold Storage Solution |
|---|---|
| Classification Name: | Set, Perfusion, Kidney, Disposable |
| Regulation Name: | Isolated kidney perfusion and transport system and |
| accessories | |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | KDL |
| Regulatory Class: | II |
| Medical Specialty: | Gastroenterology/Urology Panel |
Indications for Use
Servator M SALF Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
Intended Use
Organ perfusion and preservation solution.
Device Description
The Servator M SALF is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion preservation of explained kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 rnEq/L, and a pH of approximately 7.4 at room temperature. The primary containers used for the device are PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration. Servator M SALF is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
Type of device.
Sterile, non-pyrogen solution for perfusion/protection and preservation of organs. NOT FOR INJECTION.
Package
Box containing 10 bags per carton of 1000 ml PVC free.
Model Number of Device: SERVM10DMA
5
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.
- 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 M SALF Solution | PERF-GENQ® Pulsatile | |
| Perfusion Solution | NA | ||
| Manufacturer | SALF spa, Italy | Waters Medical Syustems, | |
| LLC, Rochester, MN | NA | ||
| 510(k) Number | K211842 | K121736 | NA |
| Classification & | |||
| Product Code | 876.5880; KDL | 876.5880; KDL | 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, | ||
| Disposable | System, Perfusion, Kidney, | ||
| Disposable | Same | ||
| Common Name | Cold Storage Solution | Cold Storage Solution | Same |
| Device | |||
| Description | The Servator M SALF | ||
| Solution is a clear, sterile, | |||
| non-pyrogenic, non-toxic | |||
| solution for the in-vitro | |||
| flushing and temporary | |||
| continuous perfusion | |||
| preservation of explained | |||
| kidneys. This solution has | |||
| an approximate calculated | |||
| osmolarity of 300 | The PERF-GENO Pulsatile | ||
| Perfusion Solution (PERF- | |||
| GEN Solution) is a clear, | |||
| sterile, non-pyrogenic, non- | |||
| toxic solution for the in- | |||
| vitro flushing and | |||
| temporary continuous | |||
| perfusion preservation of | |||
| explained kidneys. This | |||
| solution has an | Same | ||
| mOsm/kg, a sodium | |||
| concentration of 100 | |||
| mEq/L, a potassium | |||
| concentration of 25 | |||
| mEq/L, and a pH of | |||
| approximately 7.4 at room | |||
| temperature. | approximate calculated | ||
| osmolarity of 300 | |||
| mOsm/kg, a sodium | |||
| concentration of 100 | |||
| mEq/L, a potassium | |||
| concentration of 25 mEq/L, | |||
| and a pH of approximately | |||
| 7.4 at room temperature. | |||
| Indication for | |||
| Use | Servator M SALF | ||
| Solution is intended to be | |||
| used for flushing and | |||
| continuous hypothermic | |||
| machine perfusion of | |||
| kidneys at the time of their | |||
| removal from the donor in | |||
| preparation for storage, | |||
| transportation, and | |||
| eventual transplantation | |||
| into a recipient. | The PERF-GENQ® | ||
| Pulsatile Perfusion Solution | |||
| is intended to be used for | |||
| flushing and continuous | |||
| hypothermic machine | |||
| perfusion of kidneys 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 | ||
| Mode of | |||
| operation | Cold storage | Cold storage | Same |
| Container/Bag | PVC free bags | PVC free bags | Same |
| Meets UNOS | |||
| Policy | Yes | Yes | Same |
| pH | 6.90-7.50 at 20°C | 6.90-7.50 at 20°C | 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 | Particle Counts less than | ||
| limits for Large Volume | |||
| Injections per USP ; | |||
| Biocompatible per ISO | Same | ||
| 10993-1 battery of tests for | |||
| Externally Communicating | |||
| Blood Path Indirect | |||
| Contact for prolonged | |||
| periods >24 hours. | 10993-1 battery of tests for | ||
| Externally Communicating | |||
| Blood Path Indirect | |||
| Contact for prolonged | |||
| periods >24 hours. | |||
| Device | |||
| Standards of | |||
| Conformity | ISO 10993-1 | ||
| ISO 10993-4 | |||
| ISO 10993-5 | |||
| ISO 10993-10 | |||
| ISO 10993-11 | |||
| ISO 14971 | |||
| ISO 15223-1 | |||
| ISO 17665-1 | |||
| USP 39 | |||
| USP 39 | ISO 10993 Series | ||
| Exact test series of | |||
| predicate device are | |||
| unknown | Subject | ||
| device | |||
| passed | |||
| according | |||
| to ISO | |||
| Standards | |||
| 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 | |||
| method | Steam | Steam | Same |
| Nominal value | 1000 mL bags | 1000 mL bags | Same |
| Shelf Life | 24 months | 24 months | Same |
| Storage | |||
| Temperature | Indoors with temperature at | ||
| 2°- | |||
| 25°C, without freezing. | Indoors with temperature at | ||
| 2° - 25°C, without freezing. | Same | ||
| Interaction with | |||
| other medical | |||
| technology | Check the expiration date | ||
| stated on the container. The | |||
| expiration date refers to the | |||
| product in unopened | |||
| packaging. | |||
| CAUTION: do not use the | |||
| device after the expiry date | |||
| stated on the container. | |||
| Even though within its | Check the expiration date | ||
| stated on the container. The | |||
| expiration date refers to the | |||
| product in unopened | |||
| packaging. | |||
| CAUTION: do not use the | |||
| device after the expiry date | |||
| stated on the container. | |||
| Even though within its shelf | Same |
6
7
8
| shelf life (device not
expired), the solution must
not be used, if the
container is damaged or if
there are visible particles,
precipitates or
contaminations. | life (device not expired), the
solution must not be used, if
the container is damaged or
if there are visible particles,
precipitates or
contaminations. |
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Solution qualitative and quantitative composition / Same for both Subject and Predicate
| CONSTITUENT | Amount 1000 ml | Concentration (mM) |
|---|---|---|
| Adenine (free base) | 0.68 g | 5 |
| Calcium Chloride (dihydrate) | 0.068 g | 0.5 |
| Dextrose (+) | 1.80 g | 10 |
| Glutathione (reduced) | 0.92 g | 3 |
| HEPES (free acid) | 2.38 g | 10 |
| Hydroxyethyl Starch | 50.0 g | N/A |
| Magnesium Gluconate (anhydrous) | 1.13 g | 5 |
| Mannitol | 5.4 g | 30 |
| Potassium Phosphate (monobasic) | 3.4 g | 25 |
| Ribose, D(-) | 0.75 g | 5 |
| Sodium Gluconate | 17.45 g | 80 |
| Sodium Hydroxide | 0.70 g | N/A |
| Sterile Water for injection | to 1000 ml Volume | N/A |
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 M SALF Solution has the same indication for use, 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.
9
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 is 24 months and the predicate device is 12 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 M 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 the safety of the device.
The conclusion is that Servator M SALF Solution warrants a finding of substantial equivalence to the legally marketed PERF-GENQ® Pulsatile Perfusion Solution, and therefore, should have clearance for premarket activities in the United States.