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    K Number
    K991594
    Device Name
    CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
    Manufacturer
    SANGSTAT MEDICAL CORP.
    Date Cleared
    1999-08-05

    (90 days)

    Product Code
    MSB
    Regulation Number
    876.5880
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K900492,K883782
    Why did this record match?
    Device Name :

    CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Celsior™ is intended for flushing and cold storage of a heart at the time of its removal from a donor in preparation for storage, transportation, and eventual transplantation into a recipient.

    Device Description

    Celsior (SangStat Medical Corporation, Fremont, CA) is a clear to slightly yellow, sterile, non-pyrogenic, extracellular solution for hypothermic flushing and storage of hearts. The solution is slightly acidic (pH 7.3 + 0.10), slightly hypertonic (osmolarity 320-360 mOsmol) with low viscosity (1.15 cSt), and has a high buffering capacity (acidic approximately 11 mmol, alkaline approximately 7 mmol). The composition of Celsior is thus consistent with that of an extracellular solution.

    Celsior is filled into 1 liter ethylene-vinyl acetate copolymer (EVA) bags. The EVA bags are sterilized (ethylene oxide) and aseptically filled up to 1,000 mL in a sterile area. After filling, each EVA bag is enveloped by an aluminum protected bag containing an oxygen absorbent sachet. This product must be stored under refrigerated conditions at 2° to 8°C (36° to 46°F) until it is used.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Celsior™ Cold Storage Solution, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implicit by Predicate Equivalence)Reported Device Performance (Celsior™)
    Primary Efficacy Endpoint: 7-day patient survival comparable to predicate and other standard preservation solutions.Clinical Studies:
    Secondary Efficacy Endpoints: 30-day patient and graft survival comparable to predicate and other standard preservation solutions.- "The primary efficacy endpoint of seven (7) day patient survival was comparable between groups" (Celsior vs. ViaSpan and other standard preservation solutions).
    Safety Endpoints: Similar adverse event profiles to predicate and other standard preservation solutions.- "as were the secondary endpoints of 30 day patient and graft survival."
    - "In the first 30 days posttransplant, significantly fewer subjects receiving Celsior-treated hearts had one or more cardiac-related serious adverse events based on one-sided 95% confidence interval analysis." (This suggests Celsior may have even better safety in this specific regard).
    - "Clinical studies demonstrated that Celsior and ViaSpan had similar adverse event profiles and that adverse events using Celsior were also similar to that for other hospital solutions currently used to prepare hearts for transplant."
    Biocompatibility: Demonstrated biocompatibility (cytotoxicity, intracutaneous, in vitro hemolysis, in vivo hemolysis, osmotic fragility).Preclinical Studies:
    Sterility: Demonstrated sterility following processing.- "Preclinical studies also demonstrate the biocompatibility (e.g., cytotoxicity, intracutaneous, in vitro hemolysis, in vivo hemolysis, osmotic fragility), sterility (ethylene oxide, ethylene chlorohydrin, and ethylene glycol), and stability of Celsior."
    Stability: Demonstrated stability under storage conditions.- "Preclinical studies also demonstrate the biocompatibility (e.g., cytotoxicity, intracutaneous, in vitro hemolysis, in vivo hemolysis, osmotic fragility), sterility (ethylene oxide, ethylene chlorohydrin, and ethylene glycol), and stability of Celsior."
    Preclinical Performance: Performed at least as well as predicate in preclinical models.- "Preclinical studies conducted in isolated rabbit hearts and mongrel canines demonstrate that Celsior-treated hearts performed better than ViaSpan-treated hearts."

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not explicitly stated for the overall clinical trial. The document mentions "subjects receiving Celsior-treated hearts" but does not give a total N.
    • Data Provenance:
      • Country of Origin: The primary clinical study was conducted in the U.S. (IDE file number G970052), described as a "multicenter" trial.
      • Type: Clinical studies are inherently prospective.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • This information is not provided in the given text. Clinical endpoints like patient survival and adverse events are typically recorded by clinical staff (doctors, nurses) as part of standard medical practice and trial protocols, rather than being "established" by a specific number of experts in a ground truth panel. The safety and efficacy data would be gathered by the clinical trial investigators.

    4. Adjudication Method for the Test Set

    • This information is not provided in the given text. While clinical trials often have data monitoring committees or adjudication processes for serious adverse events, the specific method is not detailed here.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. Celsior is a medical solution used for organ preservation, not a diagnostic tool requiring reader interpretation.

    6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

    • No, a standalone algorithm performance study was not done. Celsior is a medical solution, not an algorithm. The "performance" refers to its biological effect on organs and patient outcomes.

    7. Type of Ground Truth Used

    • For the clinical studies, the "ground truth" was based on patient outcomes data, specifically:
      • 7-day patient survival
      • 30-day patient survival
      • 30-day graft survival
      • Cardiac-related serious adverse events
      • Overall adverse event profiles
    • For preclinical studies, the "ground truth" was based on physiological performance metrics in isolated animal hearts and live animal models (e.g., "Celsior-treated hearts performed better than ViaSpan-treated hearts").
    • For biocompatibility, sterility, and stability studies, the "ground truth" was based on laboratory test results (e.g., cytotoxicity assays, sterility cultures, chemical stability analysis).

    8. Sample Size for the Training Set

    • This concept of a "training set" is not applicable here as Celsior is not an AI/ML device. The clinical trials would involve a patient cohort, but it's not a "training set" in the machine learning sense. The text does not provide an overall sample size for the clinical trial, just that it was a "multicenter" trial conducted in the U.S.

    9. How the Ground Truth for the Training Set Was Established

    • As in point 8, this question is not applicable as there is no "training set" in the context of an AI/ML device. The clinical trial data for Celsior versus controls would be used for direct comparison to demonstrate substantial equivalence, not for training a model.
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