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510(k) Data Aggregation

    K Number
    K203480
    Device Name
    DOUBLEFLO system
    Manufacturer
    Hemodia SAS
    Date Cleared
    2021-04-05

    (129 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K192921
    Predicate For
    K221919
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DOUBLEFLO system represents an arthroscopy system using fluid from saline bags (0.9% NaCl). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.

    Device Description

    The DOUBLEFLO system (pump) contains as a main component a microprocessor-controlled pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump connects via cable to various interfaces. The pump can be connected to various shaver systems. The pump has to be used with the following tube sets: DAY TUBE Set, Patient Tube Set, Inflow Tube Set, Outflow Tube Set.

    AI/ML Overview

    The provided text is a 510(k) summary for the DOUBLEFLO system, an arthroscopy system. It describes the device, its intended use, a comparison with a predicate device, and performance data used to demonstrate substantial equivalence.

    Here's an analysis of the acceptance criteria and the study information based only on the provided text. Many of the requested fields are not applicable or not explicitly stated in this type of FDA submission.

    Acceptance Criteria and Device Performance

    The provided document describes various performance tests rather than specific acceptance criteria with numerical targets. The "Results" column largely states that the device "demonstrated to be substantially equivalent to the predicate device." Therefore, numerical acceptance criteria are inferred from the predicate device's performance or general safety/effectiveness standards.

    Test CategoryAcceptance Criteria (Implied/Standard)Reported Device Performance
    SoftwareConformity with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304 standard (Medical Device Software - Life Cycle Process) for a "moderate" level of concern. Software should perform as intended, without directly or indirectly causing minor injury.Software was developed, tested, and verified according to specified FDA guidance and IEC 62304. Unit, integration, system, and verification tests were performed. Overall software validation report confirmed conformity with user needs and intended use. Demonstrated intended performance without raising new safety/effectiveness questions.
    Electrical Safety and Electromagnetic Compatibility (EMC)Compliance with IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility.The device complies with IEC 60601-1 and IEC 60601-1-2. Evaluation and testing demonstrated substantial equivalence to the predicate device.
    BiocompatibilityCompliance with FDA Guidance Document: Use of International Standard ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 for externally communicating devices in indirect contact with tissue/bone for a limited time (<24h). No cytotoxicity, sensitization, irritation, or acute systemic toxicity.Biocompatibility requirements were met. Tests performed: Cytotoxicity, Sensitization, Irritation, and Acute systemic toxicity. Demonstrated substantial equivalence to the predicate device.
    Sterilization ValidationCompliance with ISO 11135, ISO 11135-1, ISO 14937, and ISO 10993-7. Ethylene oxide (EO) < 4 mg, ethylene chlorohydrin (ECH) < 5 mg after 3 days aeration. Sterility Assurance Level (SAL) of 10^-6. Package and product integrity per ISO 11607-1 and ASTM-F-1980:2002.Validation performed according to standards. EO < 4 mg and ECH < 5 mg after 3 days of aeration. SAL was 10^-6. Package and product integrity tested. Demonstrated substantial equivalence to the predicate device.
    Performance Testing - Bench (Functional and Usability)Device performs as intended for fluid distension, irrigation, and suction in specified joint cavities. Tubing sets maintain strength and leak integrity at t0 and after 3 years accelerated aging. Usability meets IEC 62366-1.Functional tests of the DOUBLEFLO system and accessories were conducted. Usability tests were conducted per IEC 62366-1. Functional tests of tubing sets (strength, leak, and tensile) at t0 and after 3 years of accelerated aging were performed. Demonstrated intended performance and substantial equivalence.
    Pressure RegulationMaintain constant pressure when flow rate is changed. Max allowable pressure of 150 mmHg. Min allowable pressure of 5 mmHg. Default pressure at start of pump of 50 mmHg.The subject device maintains pressure constant when flow rate is changed. Max allowable pressure: 150 mmHg. Min allowable pressure: 5 mmHg. Default pressure at start: 50 mmHg. These values are lower than or substantially equivalent to the predicate.
    Flow Rates (Cannula & Shaver Suction)Cannula: Min 100 mL/min, Max 600 mL/min. Shaver: Min 200 mL/min, Max 800 mL/min.Cannula flow rates: 100 mL/min to 600 mL/min. Shaver flow rates: 200 mL/min to 800 mL/min. Identical to predicate device.

    Study Details

    1. Sample size used for the test set and the data provenance:

      • Software, Biocompatibility, Sterilization, Electrical Safety/EMC: Not explicitly mentioned as a "test set" in the context of clinical or image data. The tests were performed on the device and its components (tubing sets). The provenance of these components is not stated.
      • Bench Tests: The functional tests, usability tests, and strength/leak/tensile tests were conducted on the DOUBLEFLO system and its tubing sets. The number of samples for these tests is not specified in the document.
      • Data Provenance: The document does not describe the origin of data in terms of retrospective/prospective or country of origin, as these were non-clinical bench and lab studies.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to non-clinical, performance-based testing in a laboratory setting, not studies requiring expert interpretation for ground truth.

    3. Adjudication method for the test set: Not applicable. This refers to non-clinical, performance-based testing.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an arthroscopy fluid management system, not an AI-powered diagnostic tool for interpretation by human readers.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes standalone performance testing of the device itself (pump, tubing sets), without a human-in-the-loop, for aspects like fluid flow, pressure, electrical safety, etc. There is no "algorithm only" performance study in the context of AI, as this is a physical medical device.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

      • For Software, the ground truth was the defined software requirements and intended functionality, validated against user needs.
      • For Electrical Safety, EMC, Biocompatibility, Sterilization, and Bench Tests, the ground truth was adherence to established international standards (IEC, ISO, ASTM) and the specified performance parameters (e.g., pressure, flow rates, material properties, sterility levels).

    7. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.

    8. How the ground truth for the training set was established: Not applicable.

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