LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K092923
    Device Name
    CYTORI PUREGRAFT 250/PURE SYSTEM
    Manufacturer
    CYTORI THERAPEUTICS, INC.
    Date Cleared
    2010-01-06

    (105 days)

    Product Code
    MUU
    Regulation Number
    878.5040
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K072587,K050797,K081848
    Why did this record match?
    Device Name :

    CYTORI PUREGRAFT 250/PURE SYSTEM

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

    The Cytori PureGraft 250/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

    Device Description

    The Cytori PureGraft 250/PURE System is a sterile, single use, closed-loop tubing and bag system intended for delivering adipose tissue back to the same patient for cosmetic and reconstructive surgery applications. Cytori PureGraft 250/PURE consists of collection bags, tubing and syringe adaptors that all have unique connectors and fittings to assure proper assembly.

    AI/ML Overview

    The Cytori PureGraft 250/PURE System is a medical device used for processing autologous fat tissue for reinjection. The provided text outlines its similarity to predicate devices rather than detailing specific performance testing with acceptance criteria.

    Based on the provided text, a table of acceptance criteria and reported device performance cannot be fully constructed because the document focuses on demonstrating substantial equivalence to predicate devices rather than presenting explicit performance metrics and thresholds for the Cytori PureGraft 250/PURE System itself.

    However, we can infer some "acceptance criteria" through the lens of substantial equivalence and outline what information regarding device performance is available:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Inferred from Substantial Equivalence to Predicate Devices)Reported Device Performance (as described in the document)
    Indications for Use: Ability to harvest, filter, and transfer autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.Performance: "The Cytori PureGraft 250/PURE System and the predicate devices are substantially equivalent with respect to their indications for use, as they are all indicated for the same surgical procedures of harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient."
    Design and Materials: Single-use, polymer-constructed, manually operated system with a filtration mechanism.Performance: "The design and materials of the Cytori PureGraft 250/PURE System and the predicate devices are substantially equivalent, as they are all single-use, polymer constructed, manually operated systems that receive adipose tissue, filter the adipose tissue, and temporarily hold the adipose tissue until it is removed or placed into a syringe that delivers / re-injects the adipose tissue back into the same patient during the same surgical procedure."
    Filtration Mechanism: Polymeric housing chamber with a filter unit, allowing fluids and small debris to pass through to a waste container while retaining adipose tissue.Performance: "The Cytori PureGraft 250/PURE System is substantially equivalent to the predicate devices as they all consist of a polymeric housing chamber with a filter unit within the chamber... contain a filtering mechanism of various pore sizes that restricts the movement of adipose tissue and only allows fluids and small debris to pass through the filter and become deposited into a waste container." (Specifically mentions 1,000 micron and 74 micron filters for the PureGraft 250mL Bag).
    Tissue Volume Capacity: Comparable to predicate devices.Performance: "The Cytori PureGraft 250/PURE System is also substantially equivalent to the predicate devices as they all have substantially equivalent tissue volume capacities."
    Sterility: Must be sterile.Performance: "The Cytori PureGraft 250/PURE System is sterilized with gamma irradiation." (Implied performance is that it is sterile.)
    Mechanical Integrity/Durability: Must function as intended without failure.Performance: "Mechanical testing of the Cytori PureGraft 250/PURE System demonstrates that the device is substantially equivalent to the predicate devices." (Implied performance is robust similar to predicates.)
    Material Composition: Medical grade and DEHP-free.Performance: "The Cytori PureGraft 250/PURE System is fabricated from medical grade, DEHP free materials." (Implied performance is that it meets these standards.)

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

    • The document does not provide details on a specific "test set" with a sample size for the Cytori PureGraft 250/PURE System's performance in harvesting, filtering, and transferring fat tissue in a clinical or simulated environment.
    • The primary evidence presented is a comparison to predicate devices, focusing on substantial equivalence in design, materials, and indications for use.
    • The "Mechanical testing" mentioned is general and does not specify sample sizes or data provenance.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which primarily relies on comparison to existing legally marketed devices rather than de novo clinical performance studies that require ground truth establishment by experts in the context of diagnostic or efficacy claims.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • This information is not provided as there is no described test set that would necessitate an adjudication method for establishing ground truth.

    5. 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:

    • An MRMC study is not applicable to this device. The Cytori PureGraft 250/PURE System is a medical device for processing fat tissue, not an AI or imaging diagnostic tool that would involve human readers or AI assistance in interpretation.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • This concept is not applicable to this device. The Cytori PureGraft 250/PURE System is a physical medical device.

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

    • The concept of "ground truth" as typically applied to performance studies of diagnostic or image analysis systems is not directly relevant or explicitly stated for this device in the provided text.
    • The "ground truth" for substantial equivalence here relies on the established safety and effectiveness of the predicate devices for their indicated uses, and ensuring the new device shares fundamental technological characteristics and indications.

    8. The sample size for the training set:

    • This information is not applicable as the device is not an AI/machine learning model that requires a training set.

    9. How the ground truth for the training set was established:

    • This information is not applicable as the device is not an AI/machine learning model.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1