(161 days)
No
The document describes a sterile saline solution used for topical cooling of organs. There is no mention of any computational or analytical capabilities that would involve AI or ML. The performance studies focus on physical properties like temperature and sterility.
No
The device is used for topical cooling of donor organs to maintain hypothermia during recovery, storage, and transport. It does not directly treat a disease or condition in a living patient, but rather preserves organs for transplantation.
No
Explanation: The device is a slushed solution intended for topical cooling of donor organs to maintain hypothermia during recovery, storage, and transport. It does not diagnose or detect specific conditions or diseases.
No
The device description clearly states it is a "1.25L sterile 0.9% Sodium Chloride Solution in a 2L bag" and is used for topical cooling. This is a physical substance and container, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the topical cooling of in-situ, abdominal donor organs during recovery, storage, and transport. This is a physical process applied directly to the organ.
- Device Description: The device is a sterile sodium chloride solution used to create a slush for cooling.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. It does not analyze blood, tissue, or any other biological sample to detect diseases, conditions, or states of health.
The device is a medical device used for therapeutic/preservation purposes (maintaining hypothermia), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
EasiSlush™ slushed solution is intended for topical cooling of in-situ, abdominal donor organs during intraoveralive recovery from the donor. It is also intended to maintain organ hypothermia during storage and transport to the transplant recipient.
EasiSlush™ slushed solution is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.
Organ Recovery
Prior to organ recovery, EasiSlush™ slushed solution is delivered to the open peritoneal cavity of the donor to assist in creating hypothermia by topically cooling external surfaces of organs for recovery.
During orqan recovery, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional EasiSlush slushed solution may be delivered per established transprocedures. (Temperature rise may be assessed with temperature probes, being careful that the probe is measuring the solution and is not in contact with the organ).
Organ Storage/Transport
For organ storage/transport, EasiSlush™ slushed to topically cool external surfaces of a sterile, sealed, primary organ bag containing chilled preservation and the organ. In this application, EasiSlush may be added to a secondary bag or to a tertiary hard container to surround the primary organ bag. Once bagged, the organ can be placed in a bed of non-sterile ice in an insulated transport container, which is then closed. Actual follow standard practices of the OPO or hospital for transporting and storing specific types of donor organs using sterile, slush solutions.
Product codes
KDN
Device Description
EasiSlush (Sodium Chloride Solution for Sterile Slush Preparation) is 1.25L sterile 0.9% Sodium Chloride Solution in a 2L bag. It meets the USP 34 monograph for Sodium Chloride Irrigation. It is a sterile, nonpyrogenic, isotonic solution that is chilled for the preparation of slushed solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal donor organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OPO or hospital
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 Testing:
Biocompatibility: A biocompatibility assessment was completed successfully according to ISO 10993 and the FDA guidance document titled "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."" Tests performed include Cytotoxicity, Sensitization, Irritation - IC Reactivity, Systemic Toxicity – Acute, Hemocompatibility - Hemolysis, USP Rabbit Pyrogen. Conclusion: EasiSlush satisfies the applicable biocompatibility assessments.
Leachables: Studies were completed to determine the leachable amounts of chemical compounds from the EasiSlush bag system. Tests included Volatile Organic Compounds (VOC) by GC/MS, Semi-Volatile Organic Compounds (SVOC) by Solvent Extraction GC/MS, Target Non-Volatile Organic Compounds (NVOC) and Organic Acids by LC/MS, Non-Target NVOC by LC/UV-Vis. Conclusion: The leachables identified are not toxicologically significant.
Sterility: EasiSlush, including the exterior surfaces of the solution bag and the interior surfaces of the sterile barrier pouch, are terminally sterilized to Sterility Assurance Level (SAL) 10-6 by gamma irradiation. The irradiation sterilization dose range was established by completion of the AAMI/ISO validation dose setting protocol as described in ANSI/AAMI/ISO 11137-2. Conclusion: The device is provided sterile.
Performance Bench Tests:
Temperature: Bench tests were performed to demonstrate that the temperature of EasiSlush, when prepared per the Directions for Use, was at or above the temperature at which the exterior of an organ might freeze, and when in contact with a simulated organ, that simulated organ did not near a freezing temperature.
Temperature: Bench tests were performed to demonstrate a worst case in which EasiSlush, at about -15°C, delivered to a simulated organ did not cause the exposed organ surfaces to reach a freezing temperature.
Temperature: Bench test were performed to measure the temperature of EasiSlush prepared according to the Instructions for Use. These tests demonstrated that the temperature of EasiSlush at the time of delivery were higher than the temperature that would present a freezing risk to the external surfaces of organs.
Temperature in Storage/Transport Container: Bench tests were performed to measure the temperature of EasiSlush when it was used in a secondary container surrounding the sterile, sealed, primary organ bag containing chilled preservation solution and the organ. The organ was then placed in a cooler with frozen non-sterile crushed ice. Hypothermic temperature of the EasiSlush was maintained for over 36 hours.
Conclusion: The studies demonstrated that the temperatures were appropriate to provide the rapid organ cooling desired without risk of freezing the surface of the organ.
United States Pharmacopeia: EasiSlush meets the monograph for Sodium Chloride Irrigation.
Clinical Performance Testing: No clinical testing has been performed on this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 24, 2019
Bridge to Life Ltd. % Richard O. Wood Senior Member The Wood Burditt Group LLC 10 E. Scranton Ave, Ste. 201 Lake Bluff, IL 60044
Re: K191006
Trade/Device Name: EasiSlush™ (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP) Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDN Dated: August 21, 2019 Received: August 23, 2019
Dear Richard Wood:
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.
1
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 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.
Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastro-Renal, 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)
K191006
Device Name
EasiSlush™ (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP)
Indications for Use (Describe)
EasiSlush™ slushed solution is intended for topical cooling of in-situ, abdominal donor organs during intraoveralive recovery from the donor. It is also intended to maintain organ hypothermia during storage and transport to the transplant recipient.
EasiSlush™ slushed solution is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.
Organ Recovery
Prior to organ recovery, EasiSlush™ slushed solution is delivered to the open peritoneal cavity of the donor to assist in creating hypothermia by topically cooling external surfaces of organs for recovery.
During orqan recovery, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional EasiSlush slushed solution may be delivered per established transprocedures. (Temperature rise may be assessed with temperature probes, being careful that the probe is measuring the solution and is not in contact with the organ).
Organ Storage/Transport
For organ storage/transport, EasiSlush™ slushed to topically cool external surfaces of a sterile, sealed, primary organ bag containing chilled preservation and the organ. In this application, EasiSlush may be added to a secondary bag or to a tertiary hard container to surround the primary organ bag. Once bagged, the organ can be placed in a bed of non-sterile ice in an insulated transport container, which is then closed. Actual follow standard practices of the OPO or hospital for transporting and storing specific types of donor organs using sterile, slush solutions.
| 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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3
| 5. 510(k) Summary | Bridge to Life EasiSlush™ |
|---|---|
| (sodium chloride solution for sterile slush preparation) |
Submitter Information:
Bridge to Life Ltd. 128 Suber Rd. Suite A Columbia, SC 29210
| Contact Person: | Richard O. Wood, the Wood Burditt Group |
|---|---|
| Phone: | (847) 234-7500 x 203 |
| Fax: | (847) 574-0728 |
| Email: | rowood@woodburditt.com |
| Date Prepared: | September 13, 2019 |
Device Name:
| Proprietary Name: | EasiSlush™ (Sodium Chloride Solution for Sterile Slush Preparation) |
|---|---|
| Classification Name: | Isolated kidney perfusion and transport system and accessories |
| Device Classification: | Class II, 876.5880 |
| Product Code: | KDN |
Predicate Devices:
| Company | Device | K Number | Predicate Status |
|---|---|---|---|
| Preservation Solutions Inc. | CoStorSol® | K073693 | Primary |
| Preservation Solutions Inc. | MaPerSol® | K080432 | Reference |
Description of Device:
EasiSlush (Sodium Chloride Solution for Sterile Slush Preparation) is 1.25L sterile 0.9% Sodium Chloride Solution in a 2L bag. It meets the USP 34 monograph for Sodium Chloride Irrigation. It is a sterile, nonpyrogenic, isotonic solution that is chilled for the preparation of slushed solution.
Indication for Use:
EasiSlush™ slushed solution is intended for topical cooling of in-situ, abdominal donor organs during intraoperative recovery from the donor. It is also intended to maintain organ hypothermia during storage and transport to the transplant recipient.
EasiSlush™ slushed solution is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.
Organ Recovery
Prior to organ recovery, EasiSlush™ slushed solution is delivered to the open peritoneal cavity of the donor to assist in creating hypothermia by topically cooling external surfaces of organs for recovery.
During organ recovery, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional EasiSlush slushed solution may be delivered per established transplant team procedures. (Temperature rise may be assessed with temperature probes, being careful that the probe is measuring the solution and is not in contact with the organ).
Organ Storage/Transport
For organ storage/transport, EasiSlush™ slushed solution may be used to topically cool external surfaces of a sterile, sealed, primary organ bag containing chilled preservation solution and the organ. In this application, EasiSlush may be added to a secondary bag or to a tertiary hard container to surround the primary organ bag. Once bagged, the organ can be placed in a bed of non-sterile ice in an insulated transport container, which is then closed. Actual use should follow standard practices of the OPO or hospital for transporting and storing specific types of donor organs using sterile, slush solutions.
4
Technological Characteristics and Comparison
For its Intended Uses, EasiSlush™ slushed solution is substantially equivalent to both the Predicate and Reference preservation solutions and the subset of their intended uses to create hypothermia during organ recovery, storage, and transport to slow biological deterioration in organs to be removed from their physiological environment per standard organ preservation practices. Both the Predicate and Reference Devices are also intended for use to flush, perfuse and/or remain in the organ after retrieval. Such intended uses are not claimed for EasiSlush.
The following table provides a comparison of attributes between the proposed device and the predicate and reference devices:
| Subject Device | Predicate Device | Reference Device | Comparison | ||
|---|---|---|---|---|---|
| Device | EasiSlush™ | CoStorSol® | MaPerSol® | ||
| 510k Number | K191006 | K073693 | K080432 | ||
| Manufacturer | Intermountain | ||||
| Life Sciences, | |||||
| UT, USA | Preservation | ||||
| Solutions Inc., | |||||
| WI, USA | Preservation | ||||
| Solutions Inc., | |||||
| WI, USA | |||||
| Classification | |||||
| & Product | |||||
| Code | 876.5880; KDN | 876.5880; KDN | 876.5880; KDN | Same | |
| Device | |||||
| Classificatio | |||||
| n Name | Isolated kidney | ||||
| perfusion and | |||||
| transport system | |||||
| and accessories | Isolated kidney | ||||
| perfusion and | |||||
| transport system | |||||
| and accessories | Isolated kidney | ||||
| perfusion and | |||||
| transport system | |||||
| and accessories | Same | ||||
| Common Name | 0.9% Saline Slush | ||||
| Solution | Organ Storage | ||||
| Solution | Organ Preservation | ||||
| Solution | |||||
| DESCRIPTION, | |||||
| INDICATIONS, | |||||
| & INTENDED | |||||
| USE | |||||
| Device Description | EasiSlush™ is a clear, | ||||
| colorless 0.9% | |||||
| Sodium Chloride | |||||
| solution for | |||||
| preparation of slushed | |||||
| solution to provide | |||||
| hypothermia during | |||||
| the recovery, storage, | |||||
| and transport of donor | |||||
| organs for | |||||
| transplantation. | |||||
| The solution is sterile, | |||||
| non-pyrogenic, | |||||
| isotonic and is | |||||
| contained in a 2L | |||||
| sterile, flexible, non- | CoStorSol® is a clear | ||||
| to light yellow, | |||||
| sterile, non- | |||||
| pyrogenic solution | |||||
| for hypothermic | |||||
| flushing and storage | |||||
| of organs. | |||||
| The solution is | |||||
| packaged in 1-liter | |||||
| bags, which must be | |||||
| chilled to between 2º | |||||
| and 6°C prior to use. | |||||
| The solution may be | |||||
| used without any | |||||
| point of use | |||||
| filtration. | MaPerSol® is a | ||||
| colorless, sterile, | |||||
| non-pyrogenic, non- | |||||
| toxic solution for in- | |||||
| vitro flushing and | |||||
| continuous perfusion | |||||
| of explanted | |||||
| kidneys. | |||||
| The solution is | |||||
| packaged in 1-liter | |||||
| bags. | Similar | ||||
| Subject device | |||||
| is an accessory | |||||
| to organ | |||||
| preservation | |||||
| solutions. All | |||||
| solutions are | |||||
| used in the | |||||
| organ | |||||
| procurement | |||||
| and transplant | |||||
| process per | |||||
| standard organ | |||||
| preservation | |||||
| practices. | |||||
| Indications for Use | Organ Recovery | Belzer UW® Cold | Pre-cool the kidney by | Similar | |
| Prior to organ | |||||
| recovery, EasiSlush™ | |||||
| slushed solution is | |||||
| delivered to the open | |||||
| peritoneal cavity of | |||||
| the donor to assist in | |||||
| creating hypothermia | |||||
| by topically cooling | |||||
| external surfaces of | |||||
| organs for recovery. | Storage Solution must | ||||
| be cooled to 2º to 6°C | |||||
| (36° to 43°F) prior to | |||||
| use. The cold solution | |||||
| is used to flush the | |||||
| isolated organ | |||||
| immediately before | |||||
| removal from the donor | |||||
| and/or immediately | |||||
| after removal from the | |||||
| donor. | vascular flush-out using | ||||
| Belzer MPS® or other | |||||
| cooled solutions (2°- | |||||
| 8°C) (Belzer UW Cold | |||||
| Storage Solution, | |||||
| Ringers, or saline). | Subject device is an | ||||
| accessory to organ | |||||
| preservation | |||||
| solutions. All devices | |||||
| are used at cold | |||||
| temperatures, per | |||||
| standard preservation | |||||
| practices, to slow | |||||
| biological | |||||
| deterioration in | |||||
| organs removed from | |||||
| their physiological | |||||
| environment. | |||||
| During organ | |||||
| recovery, if ice | |||||
| crystals are no | |||||
| longer visible, the | |||||
| temperature of the | |||||
| saline solution will | |||||
| begin to rise and | |||||
| additional EasiSlush | |||||
| slushed solution | |||||
| may be delivered | |||||
| per established | |||||
| transplant team | |||||
| procedures. | |||||
| (Temperature rise | |||||
| may be assessed | |||||
| with temperature | |||||
| probes, being | |||||
| careful that the | |||||
| probe is measuring | |||||
| the solution and is | |||||
| not in contact with | |||||
| the organ). | The solution is then left | ||||
| in the organ vasculature | |||||
| during hypothermic | |||||
| storage and | |||||
| transportation. Belzer | |||||
| UW Cold Storage | |||||
| Solution is to be used | |||||
| for cold storage of the | |||||
| organ and is not | |||||
| acceptable for | |||||
| continuous machine | |||||
| perfusion. | The kidney should be | ||||
| perfused following the | |||||
| manufacturer's or | |||||
| perfusion center's | |||||
| protocol. | Specifically: Use #1 | ||||
| – Similar. During | |||||
| organ retrieval, | |||||
| subject device | |||||
| augments predicate | |||||
| to create | |||||
| hypothermia, by | |||||
| topical/external | |||||
| cooling of organ. | |||||
| Organ Storage/ | |||||
| Transport | |||||
| For organ | |||||
| storage/transport, | |||||
| EasiSlush™ slushed | |||||
| solution may be | |||||
| used to topically | |||||
| cool external | |||||
| surfaces of a sterile, | |||||
| sealed, primary | |||||
| organ bag | |||||
| containing chilled | |||||
| preservation | |||||
| solution and the | |||||
| organ. In this | |||||
| application, | |||||
| EasiSlush may be | |||||
| added to a | Use #2 - Similar | ||||
| During storage and | |||||
| transport, subject | |||||
| device augments | |||||
| predicate in | |||||
| maintaining organ | |||||
| hypothermia, by | |||||
| cooling the organ | |||||
| and preservation | |||||
| solution, which are | |||||
| sealed in a medical- | |||||
| grade bag. | |||||
| secondary bag or to | Use #3 - Different | ||||
| Not Applicable | |||||
| Subject device is not | |||||
| intended to flush, | |||||
| perfuse, or be left in | |||||
| the organ. | |||||
| a tertiary hard container to | |||||
| surround the primary | |||||
| organ bag. Once bagged, | |||||
| the organ can be placed in | |||||
| a bed of non-sterile ice in | |||||
| an insulated transport | |||||
| container, which is then | |||||
| closed. Actual use should | |||||
| follow standard practices | |||||
| of the OPO or hospital for | |||||
| transporting and storing | |||||
| specific types of donor | |||||
| organs using sterile, slush | |||||
| solutions. | |||||
| Intended Use | EasiSlush™ slushed | ||||
| solution is intended for | |||||
| topical cooling of in- | |||||
| situ, abdominal donor | |||||
| organs during | |||||
| intraoperative | |||||
| recovery from the | |||||
| donor. It is also | |||||
| intended to maintain | |||||
| organ hypothermia | |||||
| during storage and | |||||
| transport to the | |||||
| transplant recipient. | CoStorSol® is | ||||
| intended for the | |||||
| flushing and cold | |||||
| storage of kidney, | |||||
| liver and pancreas | |||||
| organs at the time of | |||||
| organ removal from | |||||
| the donor in | |||||
| preparation for | |||||
| storage, transportation | |||||
| and eventual | |||||
| transplantation into a | |||||
| recipient. | MaPerSol® organ | ||||
| preservation solution | |||||
| is intended for in- | |||||
| vitro flushing and | |||||
| continuous | |||||
| hypothermic | |||||
| perfusion of | |||||
| explanted kidneys. | Similar | ||||
| Subject device is | |||||
| an accessory to | |||||
| organ preservation | |||||
| solutions. All | |||||
| devices are | |||||
| intended for use at | |||||
| cold temperatures, | |||||
| to slow biological | |||||
| deterioration in | |||||
| organs removed | |||||
| from their | |||||
| physiological | |||||
| environment per | |||||
| standard organ | |||||
| preservation | |||||
| practices. | |||||
| TECNOLOGICAL | |||||
| CHARACTERISTICS | |||||
| Storage | |||||
| Temperature | 2° to 25° C | 2° to 25° C | 2° to 25° C | Same | |
| Pre-Cooling | Pre-cool solution prior | ||||
| to use (-4° to -15°C) | Pre-cool solution prior | ||||
| to use (2° to 6° C) | Pre-cool solution | ||||
| prior to use (2° to 8° | |||||
| C) | Similar | ||||
| Subject solution | |||||
| is used as | |||||
| "slush" (mixture | |||||
| of ice and | |||||
| liquid), while | |||||
| predicate is | |||||
| used as a very | |||||
| cold liquid | |||||
| In-Situ Organ | |||||
| Cooling | Topical cooling of | ||||
| external organ | |||||
| surfaces from direct | |||||
| contact with subject | |||||
| device. | Internal cooling of | ||||
| organ by perfusion of | |||||
| cold solution through | |||||
| organ blood vessels | Internal cooling of | ||||
| organ from | |||||
| perfusion of cold | |||||
| solution through | |||||
| organ blood | |||||
| vessels | Similar | ||||
| Subject device is | |||||
| complementary | |||||
| and augments | |||||
| performance of | |||||
| predicate for | |||||
| intended use. | |||||
| Maintain Cold | |||||
| Organ Temperature | |||||
| During Storage and | |||||
| Transport | Indirectly maintains | ||||
| cold organ | |||||
| temperature by | |||||
| contact with, and | |||||
| cooling of, the outer | |||||
| surface of a sealed | |||||
| container which | |||||
| contains preservation | |||||
| solution and the | |||||
| organ. | Directly cools organ | ||||
| external and internal | |||||
| surfaces via contact | |||||
| with cold solution. | Directly cools | ||||
| organ external and | |||||
| internal surfaces | |||||
| via contact with | |||||
| cold solution. | Similar | ||||
| Subject device | |||||
| augments overall | |||||
| system | |||||
| performance by | |||||
| cooling/ | |||||
| maintaining | |||||
| temperature of | |||||
| predicate device | |||||
| and the organ. | |||||
| Product State | Liquid - Solution | Liquid - Solution | Liquid - Solution | Same | |
| Composition | Buffered saline | ||||
| solution. 0.9% | |||||
| Sodium Chloride | |||||
| Irrigation USP | Saline solution with | ||||
| additive salt and | |||||
| organic compounds. | Saline solution | ||||
| with additive salt | |||||
| and organic | |||||
| compounds. | Different | ||||
| Not Applicable | |||||
| Subject device | |||||
| does not include | |||||
| additive | |||||
| chemicals for | |||||
| organ | |||||
| preservation. | |||||
| Osmolality | 308 mOsm (calc) | 320 mOsm | 300 mOsm | Similar | |
| pH | 4.5-7.0 | ||||
| (per USP monograph | |||||
| for 0.9% Sodium | |||||
| Chloride Irrigation) | 7.2-7.6 | 7.2-7.6 | Similar | ||
| Device meets USP | |||||
| standard. Predicate | |||||
| meets FDA- | |||||
| cleared | |||||
| specifications. | |||||
| Fluid Volume | 1,250 ml | 1,000 ml | 1,000 ml | Similar | |
| Single Use Only | Yes | Yes | Yes | Same | |
| Primary Container | PVC-Free Bag | PVC-Free Bag | PVC-Free Bag | Same | |
| Secondary | |||||
| Overwrap | |||||
| Pouch(es) | Sterile barrier | ||||
| pouch (Tyvek®- | |||||
| poly) | |||||
| PLUS | |||||
| Dust cover pouch | |||||
| (poly) | Dust cover pouch | ||||
| (poly) | Dust cover pouch | ||||
| (poly) | Similar | ||||
| Shelf Life | 12 Months Initially; | ||||
| extended to 24 | |||||
| Months based on | |||||
| successful execution | |||||
| of stability protocol. | 24 Months | 24 Months | Same | ||
| SAFETY | |||||
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | Non-Pyrogenic | Same | |
| Sterility | Sterile solution. | ||||
| Sterile exterior | |||||
| surface of bag. | Sterile solution | Sterile solution | Same | ||
| Subject device | |||||
| also includes | |||||
| sterile bag | |||||
| exterior for | |||||
| safe handling | |||||
| and dispensing | |||||
| within sterile, | |||||
| surgical field. | |||||
| Sterilization | Terminal gamma | ||||
| irradiation | Aseptic processing and | ||||
| sterile filtration | Aseptic processing and | ||||
| sterile filtration | Same | ||||
| All devices sterile. | |||||
| Biocompatibility | Biocompatible per | ||||
| testing to ISO 10993-1 | Biocompatible per | ||||
| testing to ISO 10993-1 | Biocompatible per | ||||
| testing to ISO 10993-1 | Same | ||||
| Sterile Dispensing/ | |||||
| Administration | Sterile bag is cut | ||||
| with sterile | |||||
| instrument and | |||||
| contents dispensed to | |||||
| desired location. | Fluid is dispensed via | ||||
| sterile port on bag. | Fluid is dispensed via | ||||
| sterile port on bag. | Similar | ||||
| Bag Connections | None | Fluid port provided | |||
| for organ flushing | Fluid port provided | ||||
| for organ flushing | Different | ||||
| Subject device | |||||
| is not intended | |||||
| for organ | |||||
| flushing, so no | |||||
| port is | |||||
| provided. |
5
6
7
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Substantial Equivalence Discussion
In the comparison above, it is shown that the predicate and reference organ preservation solutions provide two principal benefits: 1) they are formulated to maintain the intracellular electrolyte balance of the organ; and 2) they are delivered chilled to rapidly create hypothermia in the organ during recovery, storage and transport. Substantial equivalence of EasiSlush to the predicate solution is based solely on the use of EasiSlush to create hypothermia during recovery, storage and transport, which hypothermia is long-standing and universally accepted goal in organ transplant. The differences between the subject device and predicate and reference devices related to hypothermia creation do not raise issues of safety and effectiveness.
Performance Data
Non-Clinical Performance Testing
Biocompatibility: A biocompatibility assessment was completed successfully according to ISO 10993 and the FDA guidance document titled "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.""
Cytotoxicity Based on the criteria of the protocol of ISO 10993-5 Sensitization Based on the criteria of the protocol of ISO 10993-10 Irritation - IC Reactivity Based on the criteria of the protocol of ISO 10993-10
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Systemic Toxicity – Acute Based on the criteria of the protocol of ISO 10993-11 Hemocompatibility - Hemolysis Based on the criteria of the protocol of ISO 10993-4 USP Rabbit Pyrogen Based on the criteria of the protocol of ISO 10993-11
Conclusion: EasiSlush satisfies the applicable biocompatibility assessments.
Leachables: Studies were completed to determine the leachable amounts of chemical compounds from the EasiSlush bag system, which included a determination of:
Volatile Organic Compounds (VOC) by GC/MS Semi-Volatile Organic Compounds (SVOC) by Solvent Extraction GC/MS Target Non-Volatile Organic Compounds (NVOC) and Organic Acids by LC/MS Non-Target NVOC by LC/UV-Vis
Conclusion: The leachables identified are not toxicologically significant.
Sterility: EasiSlush, including the exterior surfaces of the solution bag and the interior surfaces of the sterile barrier pouch, are terminally sterilized to Sterility Assurance Level (SAL) 106 by gamma irradiation. The irradiation sterilization dose range was established by completion of the AAMI/ISO validation dose setting protocol as described in ANSI/AAMII/ISO 11137-2.
Conclusion: The device is provided sterile.
Performance Bench Tests:
Temperature: Bench tests were performed to demonstrate that the temperature of EasiSlush, when prepared per the Directions for Use, was at or above the temperature at which the exterior of an organ might freeze, and when in contact with a simulated organ, that simulated organ did not near a freezing temperature.
Temperature: Bench tests were performed to demonstrate a worst case in which EasiSlush. at about -15°C, delivered to a simulated organ did not cause the exposed organ surfaces to reach a freezing temperature.
Temperature: Bench test were performed to measure the temperature of EasiSlush prepared according to the Instructions for Use. These tests demonstrated that the temperature of EasiSlush at the time of delivery were higher than the temperature that would present a freezing risk to the external surfaces of organs.
Temperature in Storage/Transport Container: Bench tests were performed to measure the temperature of EasiSlush when it was used in a secondary container surrounding the sterile, sealed, primary organ bag containing chilled preservation solution and the organ. The organ was then placed in a cooler with frozen non-sterile crushed ice. Hypothermic temperature of the EasiSlush was maintained for over 36 hours.
Conclusion: The studies demonstrated that the temperatures were appropriate to provide the rapid organ cooling desired without risk of freezing the surface of the organ.
United States Pharmacopeia:
EasiSlush meets the monograph for Sodium Chloride Irrigation.
Finally, a risk analysis on the proposed device in accordance with ISO 14971:2007 was conducted. By considering the issues raised in the FDA guidance document on the subject, all identified risks have been addressed through device design, verification or through documentation (labeling and Instructions for Use) provided to the user.
Clinical Performance Testing
No clinical testing has been performed on this device.
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Conclusion on Substantial Equivalence: Substantial equivalence of EasiSlush to the predicate solution is based solely on the use of EasiSlush to create hypothermia during recovery, storage and transport, which hypothermia is long-standing and universally accepted goal in organ transplant. The differences between the subject device and predicate and reference devices related to hypothermia creation do not raise issues of safety and effectiveness.