(276 days)
No
The device description and performance studies focus on the chemical composition and biological effects of a perfusion solution, with no mention of AI or ML technologies.
Yes
The device, Servator H SALF solution, is used for the perfusion, flushing, storage, and transportation of donor organs (kidneys, liver, pancreas, and heart) to prolong their viability by inactivating organ function and buffering the extracellular space. This direct intervention on organs to maintain their functionality for transplantation qualifies it as a therapeutic device.
No
The device is a solution for organ preservation and transportation, designed to maintain organ viability by inactivating organ function and buffering the extracellular space. It does not perform any diagnostic function of identifying or characterizing diseases or medical conditions.
No
The device description clearly indicates the device is a "solution" intended for perfusion and flushing of organs, which 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 perfusion and flushing of donor organs (kidneys, liver, pancreas, and heart) for preservation during storage and transportation. This is a direct intervention on the organ itself, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The description details the composition and mechanism of action of the solution in preserving the organ. It does not describe a test or assay.
- Lack of IVD Characteristics: There is no mention of analyzing a sample (blood, urine, tissue, etc.), detecting a substance, or providing diagnostic information. The device's function is to maintain the viability of the organ.
Therefore, the Servator H SALF solution falls under the category of a medical device used for organ preservation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Servator H SALF solution is indicated for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.
Product codes
KDL, MSB
Device Description
The Servator H SALF solution is intended for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal form the donor or immediately after removal from the donor. The solutions is left in the organ vasculature during hypotermic storage and transportation (not for continuous perfusion) to the recipient. Servator H SALF solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive duffering of the extrcellular space by means of histidine/histidine HCI, so as to prolong the period for which organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the Servator H SALF solution is due to the sodium and potassium. The composition of the Servator H SALF is similar to that of extracellular fluid. All of the components of the Servator H SALF solution occur naturally in the body.
The Servator H SALF solution is relatively low in postassium concentrations so that residual solution in the transplanted organ poses no danger to the recipient. This is particularyly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidneys, liver, pancreas, and heart
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)
Biocompatibility testing was required for this device. The Cytotoxicity, Irritation, System Toxicity and Haemocompatibility tests were all performed. The subject device passed all biocompatibility test standards.
Sterilization and Shelf Life testing and evaluation was required for the subject device. The Validation of Sterility, Validation Method LAL Turbidimetric and Stability were all performed and the results passed the device on all test standards performed. Steam sterilization and storage conditions are the same. Shelf life for the subject and predicate device are 12 months.
Electrical Safety and EMC testing was not applicable for this device.
Performance Testing including but not limited to chemical analysis was completed as a direct comparison between the subject and predicate device. The subject device proved to be substantially equivalent to the predicate. The comparison chart is shown in this summary and performance reports are included in the submission.
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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October 20, 2017
S.A.L.F. S.p.A. % Joyce St. Germain Regulatory Department Manager 510k FDA Consulting Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, Florida 32176
Re: K170150
Trade/Device Name: Servator H SALF Solution Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated Kidney Perfusion and Transport System and Accessories Regulatory Class: Class II Product Code: KDL, MSB Dated: September 7, 2017 Received: September 19, 2017
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. 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 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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely, Joyce M. Whang -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170150
Device Name Servator H SALF Solution
Indications for Use (Describe)
The Servator H SALF solution is indicated for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the 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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510k FDA Consulting
Medical Device Clearance
100 East Granada Blvd., Suite 219
Ormond Beach, FL 32176
386-506-8711
510(k) Summary - K170150
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: October 17, 2017
Preparer/Consultant
Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176
Phone: 386-506-8711 Fax: 855-235-7902 Contact: Joyce St. Germain, Regulatory Dept. Mgr (Joyce@510kfda.com) Secondary Contact: Claude Berthoin, President (Claude@denterpriseintl.com)
Device Classification
| Trade/Model Names: | Servator H SALF Solution |
|---|---|
| Common Name: | Organ perfusion and preservation solution |
| Classification Name: | Isolated kidney perfusion and transport system and accessories |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | KDL, MSB |
| Regulatory Class: | 2 |
| Medical Specialty: | Gastroenterology/Urology Panel |
4
Predicate Device
The subject device claims equivalence to the following legally marketed predicate:
| 510(k) Number: | K043461 |
|---|---|
| Date Cleared | February 28, 2005 |
| Trade Name: | Custodiol HTK |
| Common Name: | Organ perfusion and preservation solution |
| Classification Name: | Isolated kidney perfusion and transport system and accessories |
| Regulation Number: | 21 CFR 876.5880 |
| Product Code: | KDL, MSB |
| Regulatory Class: | 2 |
| Medical Specialty: | Gastroenterology/Urology Panel |
Indications for Use
The Servator H SALF solution is indicated for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.
Intended Use
The Servator H SALF Solution is intended for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal from the donor or immediately after removal from the donor. The solution is for single use, is sterile (by steam sterilization) and nonpyrogenic.
Device Description
The Servator H SALF solution is intended for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal form the donor or immediately after removal from the donor. The solutions is left in the organ vasculature during hypotermic storage and transportation (not for continuous perfusion) to the recipient. Servator H SALF solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive duffering of the extrcellular space by means of histidine/histidine HCI, so as to prolong the period for which organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the Servator H SALF solution is due to the sodium and potassium. The composition of the Servator H SALF is similar to that of extracellular fluid. All of the components of the Servator H SALF solution occur naturally in the body.
5
The Servator H SALF solution is relatively low in postassium concentrations so that residual solution in the transplanted organ poses no danger to the recipient. This is particularyly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation.
Comparison of Technological Characteristics with Predicate
The indications for use of the subject and predicate devices are identical and the technologies are substantially equivalent.
The following table compares technological and other characteristics of the subject and predicate device.
Table of Comparison
Table 12.1 -- Technological Comparison
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Device | Servator H SALF | Custodiol HTK | NA |
| 510k Number | K170150 | K043461 | |
| Manufacturer | S.A.L.F. S.p.A. | ||
| (Italy) | Dr. Franz Kohler | ||
| Chemi GmbH | |||
| (Germany) | NA | ||
| Classification & | |||
| Product Code | 876.5880; | ||
| KDL, MSB | 876.5880; | ||
| KDL,MSB | Same | ||
| Classification | |||
| Name | Isolated kidney | ||
| perfusion and | |||
| transport system | |||
| and accessories | Isolated kidney | ||
| perfusion and | |||
| transport system | |||
| and accessories | Same | ||
| Device Description | Set, Perfusion, | ||
| Kidney, Disposable | Set, Perfusion, | ||
| Kidney, Disposable | Same | ||
| Common Name | Organ perfusion and | ||
| preservation solution | Organ perfusion and | ||
| preservation solution | Same | ||
| Indications for Use | The Servator H | ||
| SALF solution is | |||
| indicated for | |||
| perfusion and | |||
| flushing donor | |||
| kidneys, liver, | |||
| pancreas, and heart | |||
| prior to removal | The Custodiol HTK | ||
| solution is indicated | |||
| for perfusion and | |||
| flushing donor | |||
| kidneys, liver, | |||
| pancreas, and heart | |||
| prior to removal | |||
| from the donor or | Same | ||
| from the donor or | |||
| immediately after | |||
| removal from the | |||
| donor. The solution | |||
| is left in the organ | |||
| vasculature during | |||
| hypothermic storage | |||
| and transportation | |||
| (not for continuous | |||
| perfusion) to the | |||
| recipient. | immediately after | ||
| removal from the | |||
| donor. The solution | |||
| is left in the organ | |||
| vasculature during | |||
| hypothermic storage | |||
| and transportation | |||
| (not for continuous | |||
| perfusion) to the | |||
| recipient. | |||
| Intended for Use | The Servator H | ||
| SALF Solution is | |||
| intended for | |||
| perfusion and | |||
| flushing donor | |||
| kidneys, liver, | |||
| pancreas, and heart | |||
| prior to removal | |||
| from the donor or | |||
| immediately after | |||
| removal from the | |||
| donor. The solution | |||
| is for single use, is | |||
| sterile (by steam | |||
| sterilization) and | |||
| non-pyrogenic. | The Custodiol HTK | ||
| Solution is intended | |||
| for perfusion and | |||
| flushing donor | |||
| kidneys, liver, | |||
| pancreas, and heart | |||
| prior to removal | |||
| from the donor or | |||
| immediately after | |||
| removal from the | |||
| donor. | Same | ||
| Meets UNOS Policy | YES | YES | Same |
| Container/Bag | PVC free bags | PVC free bags | Equivalent |
| Protecting | |||
| Overwrap Bag | YES | YES | Same |
| Single Use Only | YES | YES | Same |
| Bag Connections | 1 flip off, 1 needle | ||
| point | 1 flip off, 1 needle | ||
| point | Same | ||
| Used for Organ | |||
| Transplants of | Used for kidneys, | ||
| liver, heart and | |||
| pancreas | Used for kidneys, | ||
| liver, heart and | |||
| pancreas | Same | ||
| Product State | Liquid - Solution | Liquid - Solution | Same |
| Model Numbers | Servator H SALF, | ||
| 1000ml / | |||
| SERVH10DMA | |||
| Servator H SALF, | |||
| 2000ml / | |||
| SERVH20DM | Bag, 1000 ml / | ||
| 25767-735-45 | |||
| Bag, 2000ml / | |||
| 25767-735-49 | |||
| Bag, 5000ml / | |||
| 25767-735-46 | Different Model | ||
| Numbers - due to | |||
| different | |||
| manufactures | |||
| Configurations | Box containing 10 | ||
| bags of 1000ml | |||
| PVC free. | |||
| Box containing 5 | |||
| bags of 2000ml | |||
| PVC free. | Bags 1000 ml, | ||
| 2000 ml and | |||
| 5000 ml. | Equivalent | ||
| Predicate device | |||
| different | |||
| packaging | |||
| available | |||
| Sterilization | |||
| Method | Steam | Steam | Same |
| Physical Properties | pH: 7.02 - 7.20 at | ||
| 25° C; | |||
| 7.40 - 7.45 at 4° C | |||
| Osmolality: 310 | |||
| mOsm/Kg | pH: 7.02 - 7.20 at | ||
| 25° C; | |||
| 7.40 - 7.45 at 4° C | |||
| Osmolality: 310 | |||
| mOsm/Kg | Same | ||
| Manufacture | |||
| Standards of | |||
| Conformity | ISO 9001:2008 | ||
| ISO 13485:2003 | |||
| GMP Certification | Unknown | Subject meets | |
| current standards | |||
| Shelf Life | 12 Months | 12 Months | Same |
| Device Standards of | |||
| Conformity | Subject device | ||
| passed according | |||
| to ISO standards | Unknown | Subject device | |
| passed according | |||
| to ISO standards |
6
7
The above comparison shows the subject and predicate devices are substantially equivalent in technology characteristics. The differences are highlighted and those differences do not make the subject device any less safe and effective as the predicate device. The differences are due to different manufacturers with different model numbers and the predicate has additional sizes of bags and a bottle package.
8
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 testing was required for this device. The Cytotoxicity, Irritation, System Toxicity and Haemocompatibility tests were all performed. The subject device passed all biocompatibility test standards.
Sterilization and Shelf Life testing and evaluation was required for the subject device. The Validation of Sterility, Validation Method LAL Turbidimetric and Stability were all performed and the results passed the device on all test standards performed. Steam sterilization and storage conditions are the same. Shelf life for the subject and predicate device are 12 months.
Electrical Safety and EMC testing was not applicable for this device.
Performance Testing including but not limited to chemical analysis was completed as a direct comparison between the subject and predicate device. The subject device proved to be substantially equivalent to the predicate. The comparison chart is shown in this summary and performance reports are included in the submission.
Conclusion
The subject and predicate devices have the same intended use and are substantially equivalent in technological characteristics and performance (since they have, in fact, the same composition). The Servator H SALF does not raise any questions regarding new questions of safety and effectiveness and is equivalent to the predicate device. The nonclinical data supports and demonstrates the safety of the device.
The conclusion is that Servator H SALF warrants a finding of substantial equivalence to the legally marketed original Custodiol HTK Solution, and therefore, should have clearance for premarket activities in the United States.