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K Number
K241411
Device Name
Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
Manufacturer
Welch Allyn, Inc.
Date Cleared
2024-12-20

(217 days)

Product Code
MWI,BZQ,DQA,DXN,FLL
Regulation Number
870.2300
Type
Traditional
Panel
CV
Reference & Predicate Devices
K142356,K193242
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Connex Spot Monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Monitoring respiration rate from photoplethysmogram (Masimo RRp®) is indicated for adult and pediatric patients greater than two years old. The most likely locations for patients to be monitored are general medical or surgical floors and general hospital and alternate care environments.

This product is available for sale only upon the order of a physician or licensed health care professional.

Device Description

Welch Allyn Connex® Spot Monitor (CSM) is an integrated, configurable vital signs monitor. CSM is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The specific vital sign measurements available are determined by the sensor/processing technology integrated into the base unit including:

  • · Noninvasive blood pressure (NIBP) provides measurements of noninvasive blood pressure and pulse rate
  • · Spo2 provides pulse rate, respiration rate, and noninvasive functional oxygen saturation of arteriolar hemoglobin
  • · Thermometer measures temperature in neonatal, pediatric, and adult patients
  • · Respiration rate from photoplethysmogram (RRp)
  • The custom scores option provides custom calculations based on patient vital sign values and modifiers determined by the user

The CSM 1.53, in the same manner as the CSM predicate device, can display and transmit patient data that is electronically or manually entered from external and accessory devices, including weight and height data, manually entered respiration rate, barcode scanned patient and clinician data, and other patient or facility information to a connected Host system. Data is transmitted electronically via USB, Wi-Fi, Bluetooth or ethernet communications to electronic record systems, and for remote display and alarming (e.g., at a central station).

AI/ML Overview

This FDA 510(k) summary provides information for the Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM), which is receiving an update to include Masimo RRp® (respiration rate from photoplethysmogram). However, the document does not contain a specific table of acceptance criteria for this new feature nor detailed results of a study proving the device meets said criteria.

Instead, the document states:

  • "Non-clinical testing was performed on the CSM to verify safety and efficacy of the device."
  • "All updates were implemented through the design control process and verified to not impact safety and efficacy of the device."
  • "The non-clinical tests performed confirm that the subject CSM device is substantially equivalent to the legally marketed predicate CSM (K142356)."

Therefore, I cannot provide the specific details requested in your prompt as they are not present in the provided text. The document focuses on regulatory compliance through substantial equivalence, listing general standards applied, rather than specific performance metrics and a detailed study report for the RRp feature.

To answer your request based only on the provided text, the following information is unavailable:

  1. A table of acceptance criteria and the reported device performance: Not provided.
  2. Sample size used for the test set and the data provenance: Not provided. The testing is referred to as "non-clinical testing," but no specifics on test data are given.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
  4. Adjudication method for the test set: Not provided.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not conducted, as this is a medical device for vital sign monitoring, not an AI-assisted diagnostic imaging device requiring human reader improvement studies.
  6. If a standalone performance study was done: "Non-clinical testing" was performed, indicating testing of the algorithm/device itself, but specific details of a standalone study (like methodologies, results, and metrics) are not provided.
  7. The type of ground truth used: Not provided.
  8. The sample size for the training set: Not provided.
  9. How the ground truth for the training set was established: Not provided.

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).