(161 days)
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.
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.
The provided text is a 510(k) summary for EasiSlush™ (Sodium Chloride Solution for Sterile Slush Preparation). It describes the device, its intended use, and a comparison to predicate devices, focusing on the concept of substantial equivalence.
However, the summary does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 of your prompt. The document explicitly states:
- "No clinical testing has been performed on this device." (Page 10)
This means there was no multi-reader multi-case (MRMC) study, no standalone algorithm performance, and no test or training sets with associated ground truth established by experts.
The acceptance criteria and performance data discussed are limited to non-clinical performance testing (biocompatibility, leachables, sterility, and performance bench tests related to temperature and USP standards).
Therefore, I cannot provide a detailed response to your request, as the necessary information regarding clinical study design, acceptance criteria based on clinical outcomes, sample sizes for test/training sets, expert involvement, and ground truth establishment from such studies is absent from this document.
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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.
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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
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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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| 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.
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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 | IntermountainLife Sciences,UT, USA | PreservationSolutions Inc.,WI, USA | PreservationSolutions Inc.,WI, USA | ||
| Classification& ProductCode | 876.5880; KDN | 876.5880; KDN | 876.5880; KDN | Same | |
| DeviceClassification Name | Isolated kidneyperfusion andtransport systemand accessories | Isolated kidneyperfusion andtransport systemand accessories | Isolated kidneyperfusion andtransport systemand accessories | Same | |
| Common Name | 0.9% Saline SlushSolution | Organ StorageSolution | Organ PreservationSolution | ||
| DESCRIPTION,INDICATIONS,& INTENDEDUSE | |||||
| Device Description | EasiSlush™ is a clear,colorless 0.9%Sodium Chloridesolution forpreparation of slushedsolution to providehypothermia duringthe recovery, storage,and transport of donororgans fortransplantation.The solution is sterile,non-pyrogenic,isotonic and iscontained in a 2Lsterile, flexible, non- | CoStorSol® is a clearto light yellow,sterile, non-pyrogenic solutionfor hypothermicflushing and storageof organs.The solution ispackaged in 1-literbags, which must bechilled to between 2ºand 6°C prior to use.The solution may beused without anypoint of usefiltration. | MaPerSol® is acolorless, sterile,non-pyrogenic, non-toxic solution for in-vitro flushing andcontinuous perfusionof explantedkidneys.The solution ispackaged in 1-literbags. | SimilarSubject deviceis an accessoryto organpreservationsolutions. Allsolutions areused in theorganprocurementand transplantprocess perstandard organpreservationpractices. | |
| Indications for Use | Organ Recovery | Belzer UW® Cold | Pre-cool the kidney by | Similar | |
| Prior to organrecovery, EasiSlush™slushed solution isdelivered to the openperitoneal cavity ofthe donor to assist increating hypothermiaby topically coolingexternal surfaces oforgans for recovery. | Storage Solution mustbe cooled to 2º to 6°C(36° to 43°F) prior touse. The cold solutionis used to flush theisolated organimmediately beforeremoval from the donorand/or immediatelyafter removal from thedonor. | vascular flush-out usingBelzer MPS® or othercooled solutions (2°-8°C) (Belzer UW ColdStorage Solution,Ringers, or saline). | Subject device is anaccessory to organpreservationsolutions. All devicesare used at coldtemperatures, perstandard preservationpractices, to slowbiologicaldeterioration inorgans removed fromtheir physiologicalenvironment. | ||
| During organrecovery, if icecrystals are nolonger visible, thetemperature of thesaline solution willbegin to rise andadditional EasiSlushslushed solutionmay be deliveredper establishedtransplant teamprocedures.(Temperature risemay be assessedwith temperatureprobes, beingcareful that theprobe is measuringthe solution and isnot in contact withthe organ). | The solution is then leftin the organ vasculatureduring hypothermicstorage andtransportation. BelzerUW Cold StorageSolution is to be usedfor cold storage of theorgan and is notacceptable forcontinuous machineperfusion. | The kidney should beperfused following themanufacturer's orperfusion center'sprotocol. | Specifically: Use #1– Similar. Duringorgan retrieval,subject deviceaugments predicateto createhypothermia, bytopical/externalcooling of organ. | ||
| Organ Storage/Transport | |||||
| For organstorage/transport,EasiSlush™ slushedsolution may beused to topicallycool externalsurfaces of a sterile,sealed, primaryorgan bagcontaining chilledpreservationsolution and theorgan. In thisapplication,EasiSlush may beadded to a | Use #2 - SimilarDuring storage andtransport, subjectdevice augmentspredicate inmaintaining organhypothermia, bycooling the organand preservationsolution, which aresealed in a medical-grade bag. | ||||
| secondary bag or to | Use #3 - DifferentNot ApplicableSubject device is notintended to flush,perfuse, or be left inthe organ. | ||||
| a tertiary hard container tosurround the primaryorgan bag. Once bagged,the organ can be placed ina bed of non-sterile ice inan insulated transportcontainer, which is thenclosed. Actual use shouldfollow standard practicesof the OPO or hospital fortransporting and storingspecific types of donororgans using sterile, slushsolutions. | |||||
| Intended Use | EasiSlush™ slushedsolution is intended fortopical cooling of in-situ, abdominal donororgans duringintraoperativerecovery from thedonor. It is alsointended to maintainorgan hypothermiaduring storage andtransport to thetransplant recipient. | CoStorSol® isintended for theflushing and coldstorage of kidney,liver and pancreasorgans at the time oforgan removal fromthe donor inpreparation forstorage, transportationand eventualtransplantation into arecipient. | MaPerSol® organpreservation solutionis intended for in-vitro flushing andcontinuoushypothermicperfusion ofexplanted kidneys. | SimilarSubject device isan accessory toorgan preservationsolutions. Alldevices areintended for use atcold temperatures,to slow biologicaldeterioration inorgans removedfrom theirphysiologicalenvironment perstandard organpreservationpractices. | |
| TECNOLOGICALCHARACTERISTICS | |||||
| StorageTemperature | 2° to 25° C | 2° to 25° C | 2° to 25° C | Same | |
| Pre-Cooling | Pre-cool solution priorto use (-4° to -15°C) | Pre-cool solution priorto use (2° to 6° C) | Pre-cool solutionprior to use (2° to 8°C) | SimilarSubject solutionis used as"slush" (mixtureof ice andliquid), whilepredicate isused as a verycold liquid | |
| In-Situ OrganCooling | Topical cooling ofexternal organsurfaces from directcontact with subjectdevice. | Internal cooling oforgan by perfusion ofcold solution throughorgan blood vessels | Internal cooling oforgan fromperfusion of coldsolution throughorgan bloodvessels | SimilarSubject device iscomplementaryand augmentsperformance ofpredicate forintended use. | |
| Maintain ColdOrgan TemperatureDuring Storage andTransport | Indirectly maintainscold organtemperature bycontact with, andcooling of, the outersurface of a sealedcontainer whichcontains preservationsolution and theorgan. | Directly cools organexternal and internalsurfaces via contactwith cold solution. | Directly coolsorgan external andinternal surfacesvia contact withcold solution. | SimilarSubject deviceaugments overallsystemperformance bycooling/maintainingtemperature ofpredicate deviceand the organ. | |
| Product State | Liquid - Solution | Liquid - Solution | Liquid - Solution | Same | |
| Composition | Buffered salinesolution. 0.9%Sodium ChlorideIrrigation USP | Saline solution withadditive salt andorganic compounds. | Saline solutionwith additive saltand organiccompounds. | DifferentNot ApplicableSubject devicedoes not includeadditivechemicals fororganpreservation. | |
| Osmolality | 308 mOsm (calc) | 320 mOsm | 300 mOsm | Similar | |
| pH | 4.5-7.0(per USP monographfor 0.9% SodiumChloride Irrigation) | 7.2-7.6 | 7.2-7.6 | SimilarDevice meets USPstandard. Predicatemeets FDA-clearedspecifications. | |
| 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 | |
| SecondaryOverwrapPouch(es) | Sterile barrierpouch (Tyvek®-poly)PLUSDust cover pouch(poly) | Dust cover pouch(poly) | Dust cover pouch(poly) | Similar | |
| Shelf Life | 12 Months Initially;extended to 24Months based onsuccessful executionof stability protocol. | 24 Months | 24 Months | Same | |
| SAFETY | |||||
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | Non-Pyrogenic | Same | |
| Sterility | Sterile solution.Sterile exteriorsurface of bag. | Sterile solution | Sterile solution | SameSubject devicealso includessterile bagexterior forsafe handlingand dispensingwithin sterile,surgical field. | |
| Sterilization | Terminal gammairradiation | Aseptic processing andsterile filtration | Aseptic processing andsterile filtration | SameAll devices sterile. | |
| Biocompatibility | Biocompatible pertesting to ISO 10993-1 | Biocompatible pertesting to ISO 10993-1 | Biocompatible pertesting to ISO 10993-1 | Same | |
| Sterile Dispensing/Administration | Sterile bag is cutwith sterileinstrument andcontents dispensed todesired location. | Fluid is dispensed viasterile port on bag. | Fluid is dispensed viasterile port on bag. | Similar | |
| Bag Connections | None | Fluid port providedfor organ flushing | Fluid port providedfor organ flushing | DifferentSubject deviceis not intendedfor organflushing, so noport isprovided. |
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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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K191006 Page 7 of 8
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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K191006 Page 8 of 8
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.
§ 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).