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K Number
K222370
Device Name
SpO2 Extension Cable
Manufacturer
Beijing Rongrui-Century Science & Technology Co., Ltd.
Date Cleared
2023-04-02

(240 days)

Product Code
DSA
Regulation Number
870.2900
Type
Traditional
Panel
AN
Reference & Predicate Devices
K192404
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

SpO2 Extension Cables are intended to be used to connect SpO2 sensors, placed at appropriate sites on the patient to a monitoring device for SpO2 monitoring by health care professional.

Device Description

SpO2 Extension Cables are intended to be used to connect SpO2 sensors, placed at appropriate sites on the patient to a monitoring device for SpO2 monitoring by health care professional.

The SpO2 Extension Cable is the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after manufacturers for their respective monitors.

The SpO2 Extension Cable is comprised of Plug, Cable/Leadwires and Connector. It's intended to plug into monitoring device and connect with SpO2 sensor, for transmitting signals which generated by SpO2 sensor to monitoring device.

By using the same types of construction and technological characteristics to the compatible patient monitor and SpO2 sensor, the SpO2 Extension Cable can avoid measured data corrupted.

AI/ML Overview

This document is an FDA 510(k) clearance letter for an SpO2 Extension Cable. It confirms that the device is substantially equivalent to a predicate device and is subject to general controls. It does not contain information about clinical studies with AI or human readers, or detailed acceptance criteria for an AI-based device.

Therefore, I cannot answer your specific questions related to acceptance criteria, study design for AI evaluation, sample sizes, expert involvement, or ground truth establishment as this information is not present in the provided text for this specific device.

The document primarily focuses on the device's classification, general controls, and non-clinical testing to demonstrate substantial equivalence to a predicate device, which is a different type of evaluation than what you typically find for AI/ML-driven medical devices.

Summary of available information (and absence of requested information):

  • 1. A table of acceptance criteria and the reported device performance: Not explicitly stated as pass/fail criteria from a performance study. The "performance" is demonstrated through compliance with electrical safety, performance, and EMC standards, and biocompatibility, as well as functional compatibility.

    • Acceptance Criteria (Inferred from compliance):
      • Biocompatibility: Meet ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation).
      • Electrical Safety & Performance: Meet IEC 60601-1, ISO 80601-2-61 (Pulse Oximeter equipment), and ANSI AAMI EC53 (ECG trunk cables and patient leadwires).
      • EMC: Meet IEC 60601-1-2.
      • Compatibility: No measured data corruption during communication between SpO2 sensors and host monitors.
    • Reported Device Performance (Inferred from conclusions):
      • "The test results demonstrated that the proposed device complies with the following standards..." (listed above).
      • "SpO2 Extension Cable has also been evaluated the performance accuracy through Compatibility testing, which proves that no measured data corrupt during communication between SpO2 sensors and host monitors."

  • 2. Sample sized used for the test set and the data provenance: Not applicable. This is a hardware device, not an AI model. Testing involved standards compliance and compatibility, not a data-driven test set for an algorithm.

  • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant here. Device performance is assessed against engineering standards and functional requirements.

  • 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

  • 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: No, this is not an AI device.

  • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI device.

  • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is compliance with established international and national standards for medical electrical equipment, biocompatibility, and functional compatibility.

  • 8. The sample size for the training set: Not applicable. This is a hardware device.

  • 9. How the ground truth for the training set was established: Not applicable.

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).