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510(k) Data Aggregation

    K Number
    K202009
    Device Name
    Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026
    Manufacturer
    Shenzhen Juzhong Technology Co., Ltd
    Date Cleared
    2021-03-22

    (244 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K102508
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Probe Cover is intended for use as a barrier that is used as an accessory to oral or axillary for digital thermometers. This Probe Cover is non-sterile and is intended for single patient use only.

    Device Description

    The Probe Cover is a plastic covering used for oral/axillary digital thermometer. This device is not made with natural rubber latex. Refer to user manual for the recommend thermometers that probe covers can be used with.

    AI/ML Overview

    The provided text describes the 510(k) summary for a medical device called "Probe Cover." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where specific acceptance criteria are defined and then proven by the device's performance in a standalone or comparative effectiveness study.

    Therefore, the requested information elements cannot be fully generated from the provided text as it does not contain a study that uses acceptance criteria in the manner typically seen for performance evaluation of a new device's efficacy.

    However, I can extract information related to the non-clinical performance data and the standards to which the device was tested, which serve a similar purpose in demonstrating safety and effectiveness for a 510(k) submission.

    Here's the breakdown of what can be extracted and what is not available in the document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" and "reported device performance" in a quantitative table format for specific clinical or diagnostic outcomes. Instead, it relies on adherence to established international and ASTM standards for biocompatibility and performance to demonstrate substantial equivalence to a predicate device.

    The "acceptance criteria" can be inferred as successful adherence to the requirements of these standards.

    Acceptance Criteria (Inferred from Standards)Reported Device Performance (Compliance)
    Biocompatibility:
    - ISO 10993-5:2009 (Tests for in vitro cytotoxicity)Test result is qualified (safe and effective).
    - ISO 10993-10:2010 (Tests for Irritation and Skin sensitization)Test result is qualified (safe and effective).
    Performance:
    - ASTM E1104-98 (Reapproved 2016): Standard Specification for Clinical Thermometer Probe Covers and SheathsPerformance test conducted. Result is qualified. All sizes tested were safe and effective.
    - ASTM E1112-00 (Reapproved 2011): Standard Specification for Electronic Thermometer for Intermittent Determination of Patient TemperaturePerformance test conducted. Result is qualified. All sizes tested were safe and effective.

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

    The document does not specify general "sample sizes" for a test set in the context of a clinical study or a labeled dataset for AI evaluation. The testing refers to non-clinical performance data and biocompatibility tests on the physical device.

    • Sample size for non-clinical tests: Not explicitly stated as "sample size." The tests were performed on the device itself and its materials.
    • Data provenance: Not applicable in the context of clinical data for an AI/device performance study as described. The testing performed is laboratory-based and adheres to international/ASTM standards.
    • Retrospective/Prospective: Not applicable.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    Not applicable. The document describes a non-clinical performance study and biocompatibility tests where the "ground truth" is adherence to established international standards and specifications for material safety and product functionality. There is no mention of expert consensus for a test set.

    4. Adjudication Method (for the test set)

    Not applicable. There is no expert review or adjudication process described for the non-clinical testing. The assessment is based on the test results against the requirements of the specified standards.

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

    Not applicable. This is a submission for a Probe Cover (a physical accessory for a thermometer), not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance effect size is discussed.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    Not applicable. This is not an algorithm-based device. The device itself (the probe cover) is the subject of the performance evaluation.

    7. Type of Ground Truth Used

    The "ground truth" in this context is the adherence to specified international and ASTM standards for biocompatibility and performance of the medical device. This is based on objective laboratory testing protocols defined by those standards, rather than expert consensus on clinical cases, pathology, or outcomes data.

    8. Sample Size for the Training Set

    Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that sense.

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

    Not applicable (as above).

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