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510(k) Data Aggregation

    K Number
    K211084
    Device Name
    Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
    Manufacturer
    Shanghai Caremate Medical Device Co. Ltd
    Date Cleared
    2021-10-19

    (190 days)

    Product Code
    DXQ,LDE
    Regulation Number
    870.1120
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K192500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Caremate Medical Device Co. Ltd

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

    The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

    Device Description

    The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. The proposed device is non-invasive, non-automated, non-sterile, reusable device. The proposed device is consisting of manometer, cuff, cuff bladder, inflation bulb and with/without stethoscope. There are eight models including CM-BPM, CM-BPM-S, CM-BPM-D, CM-BPM-R, CM-PBPM-1, CM-PBPM-2, CM-PBPM-3 and CM-PBPM-C. The differences of eight models are on the size and material of manometer, material of cuff bladder, material of inflation bulb and stethoscope type if the device has stethoscope.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for an Aneroid Sphygmomanometer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/CADe device.

    Therefore, the information required to answer the prompt (acceptance criteria and study details for an AI/CADe device) is not present in the provided document. The document details a traditional medical device (a manual blood pressure cuff) and its compliance with standards like ISO 81060-1 for non-automated sphygmomanometers, and biocompatibility standards. It explicitly states: "No clinical study is included in this submission."

    The prompt asks for details typical of an AI/CADe device submission, such as:

    1. Acceptance criteria table and reported performance: This document lists "Accuracy: +/- 3 mmHg of reading" as a specification, derived from ISO 81060-1, but this is a design specification, not an AI model's performance on a test set. There is no reported performance against this.
    2. Sample size and data provenance for a test set: No test set is specified for evaluating AI performance.
    3. Number of experts and qualifications for ground truth: Not applicable as there is no AI model or ground truth establishment based on expert consensus.
    4. Adjudication method: Not applicable.
    5. MRMC comparative effectiveness study: Not applicable.
    6. Standalone (algorithm only) performance: Not applicable.
    7. Type of ground truth: Not applicable.
    8. Training set sample size: Not applicable.
    9. Ground truth for training set: Not applicable.

    In summary, this document is for a non-AI/non-CADe medical device. It does not contain the type of study information requested for an AI/CADe device.

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