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510(k) Data Aggregation

    K Number
    K120328
    Device Name
    ORIGINS LIPOHARVESTING SYSTEM
    Manufacturer
    SOUND SURGICAL TECHNOLOGIES LLC.
    Date Cleared
    2012-09-17

    (228 days)

    Product Code
    MUU
    Regulation Number
    878.5040
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K092482,K101713
    Why did this record match?
    Device Name :

    ORIGINS LIPOHARVESTING SYSTEM

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

    The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of autologous tissue. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
    The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of adipose autologous tissue for aesthetic body contouring. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation.

    Device Description

    The Origins LipoHarvesting System consists of a reusable, closed loop tissue collection system comprised of a medical grade canister, a drain port and a lid intended to be used with a standard liposuction aspiration pump to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient, it enters the collection canister via a port in the canister lid. The physician removes unwanted waste materials from the collection system via the drain port at the base. This process leaves fatty tissue that can be transferred to syringes for autologous fat re-injection.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Origins LipoHarvesting System:

    Acceptance Criteria and Device Performance for Origins LipoHarvesting System (K120328)

    Based on the provided 510(k) summary, the device is a suction lipoplasty system used for harvesting and transferring autologous adipose tissue. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and performance testing related to materials and basic functionality, rather than clinical efficacy.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / Performance AspectReported Device PerformanceComments / Study Details
    Material BiocompatibilityComplies with ISO 10993-1: 2009Test results and analyses indicated compliance.
    Performance - Bench TestingComplies with predetermined specificationsTested for performance in accordance with Section 11, Device Description - Performance Specifications. No specific quantitative criteria or results are provided in the summary.
    Sterilization (by user)To be validated prior to commercial distribution in accordance with ISO 17665-1: 2006 (Moist heat)The device is not provided sterile. The user is responsible for sterilization. The validation of this user-performed sterilization process is a pre-market commitment.
    Absence of SoftwareNo software componentsNo software testing was applicable.
    Absence of Electrical ComponentsNo electrical componentsNo electromagnetic compatibility or electrical safety testing was applicable.
    Substantial EquivalenceConsidered substantially equivalent to predicate devicesDemonstrated through comparison of technological characteristics and performance testing.

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

    The provided summary does not mention any studies involving a "test set" in the context of human or animal data. The performance testing described is limited to bench testing for material biocompatibility and general performance against pre-determined specifications. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature for a test set of data is not applicable/provided.

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

    As there is no mention of a "test set" involving human or animal data needing a ground truth established by experts, this information is not applicable/provided in the summary. The studies described are primarily engineering and material conformance tests.

    4. Adjudication Method for the Test Set

    Not applicable, as there is no human or animal test set described.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

    No MRMC comparative effectiveness study was described or performed. The submission is for a physical device for tissue collection, not an imaging or diagnostic AI-powered device.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

    Not applicable. The device does not contain an algorithm or software. It is a mechanical system.

    7. The Type of Ground Truth Used

    For the biocompatibility testing, the "ground truth" would be the standards themselves (ISO 10993-1: 2009). The material properties were tested against the requirements of this standard.

    For the bench performance testing, the "ground truth" would be the predetermined specifications for the device's function.

    8. The Sample Size for the Training Set

    No training set is applicable or mentioned. The device is a physical system, not an AI or machine learning model.

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

    Not applicable, as there is no training set.

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