Who is the manufacturer of EasiSlush?

Bridge TO Life, Ltd. filed the 510(k) submission for EasiSlush (K191006).

What is the FDA product code for EasiSlush?

KDN. It is classified under 21 CFR 876.5880 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for EasiSlush?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EasiSlush?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EasiSlush

K191006 · Bridge TO Life, Ltd. · KDN · Sep 24, 2019 · Gastroenterology, Urology

Device Facts

Record ID	K191006
Device Name	EasiSlush
Applicant	Bridge TO Life, Ltd.
Product Code	KDN · Gastroenterology, Urology
Decision Date	Sep 24, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5880
Device Class	Class 2
Attributes	Therapeutic

Indications 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.

Device Story

EasiSlush is a sterile, nonpyrogenic, isotonic 0.9% Sodium Chloride solution (1.25L in 2L bag) used for topical cooling of abdominal donor organs. During organ recovery, the solution is delivered to the open peritoneal cavity to create hypothermia by cooling external organ surfaces. During storage and transport, it is used to surround a sealed primary organ bag containing the organ and preservation solution, acting as a cooling medium within a secondary bag or tertiary container. The device is used by transplant teams in clinical settings (OR/OPO). It does not flush or perfuse the organ. The solution is terminally sterilized via gamma irradiation. The device benefits patients by slowing biological deterioration of donor organs through effective hypothermic maintenance.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993), leachable analysis, sterility validation (ANSI/AAMI/ISO 11137-2), and temperature performance testing demonstrating effective hypothermic maintenance for over 36 hours without freezing the organ surface.

Technological Characteristics

0.9% Sodium Chloride Irrigation (USP 34). 1.25L volume in PVC-free bag. Terminally sterilized via gamma irradiation (SAL 10^-6). Biocompatible per ISO 10993. No electronic components or software.

Indications for Use

Indicated for topical cooling of in-situ abdominal donor organs during intraoperative recovery and for maintaining organ hypothermia during storage and transport to the transplant 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

CoStorSol® (K073693)

Reference Devices

MaPerSol® (K080432)

Submission Summary (Full Text)

{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) | | |-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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.…

EasiSlush

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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EasiSlush

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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