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510(k) Data Aggregation

    K Number
    K080675
    Device Name
    PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Date Cleared
    2008-06-20

    (102 days)

    Product Code
    BSO,MRZ
    Regulation Number
    868.5120
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K040965,K013041,K063697,K060563
    Why did this record match?
    Device Name :

    PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT

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

    PAJUNK®'s Wound Infiltration Catheter Kit called InfiltraLong is intended for continuous or intemittent praeoperative, perioperative or post-operative delivery of local anesthetics or narcotics to wounds and surgical wound sites. Routes of administration may be intraoperative or percutaneous.

    Device Description

    PAJUNK®'s Wound Infiltration Catheter Kit called InfiltraLong is intended for continuous or intemittent praeoperative, perioperative or post-operative delivery of local anesthetics or narcotlcs to wounds and surgical wound sites. Routes of administration may be intraoperative or percutaneous. The sterile components are available seperately. The kit is available in two basic designs: Design 02 (Coiled catheter (1x/ 2x), Y-connector, FixoLong Catheter fixation device, Adapter, Puncture needle, Permanent teflon cannula, Flat filter) and Design 01 (Coiled catheter (1x/ 2x), Y-connector, FixoLong Catheter fixation device, Adapter, Tear-cannula (also referred to as Split-cannula), Flat filter).

    AI/ML Overview

    The InfiltraLong Wound infiltration catheter kit from PAJUNK® underwent a 510(k) Premarket Notification Submission. The submission focused on establishing substantial equivalence to predicate devices already marketed, confirming the safety and effectiveness of the proposed device.

    Here's an analysis of the provided information regarding acceptance criteria and the study:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission does not explicitly define specific quantitative acceptance criteria for device performance in a table format. Instead, the "Conclusion" section within "Technology Characteristics" states:

    Criterion/Performance AspectReported Device Performance
    Material/Component ComplianceCatheter complies with ISO10555 (Sterile, single-use intravascular catheters) and EN1618 (Catheters for intravascular catheters - Test methods for common properties). Needles comply with ISO7864, ISO594, and ISO9626.
    Sterilization ProcessSame as used for all PAJUNK® products already cleared for market; monitored by FDA; complies with DIN EN ISO 11135 (Ethylene oxide sterilization).
    PackagingIdentical to PAJUNK®'s kits for regional spinal and epidural anesthesia already approved for marketing in the US.
    Overall Safety and EffectivenessComparison with predicate devices and results of bench testing demonstrate that the device is "identical in technical description to devices already cleared for market and therefore demonstrated to be safe and effective."

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

    • The document does not specify a sample size for a test set in the context of clinical data for performance evaluation.
    • The evaluation relies on "Bench Testing" for technical characteristics and comparison with existing predicate devices.
    • The data provenance is for the manufacturing and testing of the device itself rather than clinical patient data. The manufacturer is Pajunk GmbH, located in Germany, and the document indicates their US contact and contract sterilizer are also identified.

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

    • There is no mention of experts or a "ground truth" establishment in the context of clinical performance data for a test set in this 510(k) submission.
    • The assessment is based on compliance of the device components with established international standards (ISO, EN) and comparison to predicate devices, which implies an expert understanding of these standards by the device manufacturer's regulatory and R&D teams.

    4. Adjudication Method for the Test Set

    • No adjudication method is described because there is no multi-expert review or clinical performance test set analysis mentioned in the provided text.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

    • No MRMC comparative effectiveness study was done. This device is a medical catheter kit, not an AI-assisted diagnostic or treatment system. The document does not discuss AI or human reader performance.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • No standalone (algorithm-only) performance study was done. This device is a physical medical instrument, not an algorithm.

    7. The Type of Ground Truth Used

    • The "ground truth" for this submission is based on compliance with international standards (ISO, EN) for medical devices and components, and the established safety and effectiveness of predicate devices. The claim of substantial equivalence is the central "ground truth" or foundational assertion for FDA clearance.
    • There is no mention of pathology, outcomes data, or expert consensus in a clinical trial context.

    8. The Sample Size for the Training Set

    • No training set is applicable or mentioned. This is not a machine learning or AI device. The submission focuses on bench testing and comparison to predicate devices.

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

    • Not applicable, as there is no training set for this device type.
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