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510(k) Data Aggregation
(116 days)
Connex Spot Monitor,901058 Vital Signs Monitor Core
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. The most likely locations for patients to be monitored are general med/surg. floors, general hospital and alternate care environments.
The Welch Allyn Connex® Spot Monitor (CSM) is an integrated, configurable monitor designed to facilitate the workflows of its users. The Welch Allyn Connex® Spot Monitor is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The particular vital sign measurements available are determined by the sensor/processing technology integrated into the base unit including; NIBP, provides measurements of noninvasive blood pressure and pulse rate, SpO2 , provides pulse rate and noninvasive functional oxygen saturation of arteriolar hemoglobin, Thermometer measures temperature, e.g., in neonatal, pediatric, and adult patients. The Custom Scores option provides custom calculations based on patient vital sign values and modifiers determined by the user. The CSM can also display and transmit patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications including Bluetooth, for example, to electronic record systems and for remote display and alarming (e.g., central station).
The Welch Allyn Connex® Spot Monitor (CSM) has undergone various tests to demonstrate its safety and effectiveness, leading to its classification as substantially equivalent to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes several non-clinical tests performed on the Welch Allyn Connex® Spot Monitor. The acceptance criteria are implicitly defined by the standards and guidance documents against which the device was tested. The reported device performance for these tests is simply "Pass."
| Test Category | Specific Test / Standard | Acceptance Criteria / Objective | Reported Device Performance |
|---|---|---|---|
| General Safety & Performance | IEC 60601-1 (3ED 2005, AMD 1 2012) | Medical electrical equipment - part 1: general requirements for basic safety and essential performance | Pass |
| Electromagnetic Compatibility | IEC 60601-1-2 (3 ED 2007) | Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests | Pass |
| Alarm Systems | IEC 60601-1-8 (2nd edition 2006) | Medical electrical equipment - part 1-8: general requirements for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | Pass |
| NIBP | IEC 80601-2-30 (1ED 2009, COR 1 2010) | Medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers | Pass |
| SpO2 | ISO 80601-2-61 (1ED 2011) and FDA SpO2 guidance; Pulse Oximeters-Premarket Notification Submissions Guidance for Industry and Food and Drug Staff, March 4, 2013 | Medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment. Ensure the accuracy and communication of the OEM FDA cleared SpO2 technologies per the FDA SpO2 guidance. | Pass |
| Temperature | ISO 80601-2-56 (2009 First edition) | Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. | Pass |
| Risk Management | EN/ISO 14971 (2007) | Medical devices - application of risk management to medical devices | Pass |
| Shipping Performance | Device Ship Test ISTA-2A and ISTA 1A | Ensure device, enclosed in the selected shipping container, meets ISTA 2A 2011 specifications. | Pass |
| Wireless Communication | Wireless radio communication | Ensure device can communicate via wireless radio in its intended environment. | Pass |
| Bluetooth Communication | Bluetooth radio communication | Ensure device can communicate via Bluetooth radio in its intended environment. | Pass |
| Usability | Formative Usability Testing | Ensure device meets the user needs. | Pass |
| Biocompatibility | ISO-10993 (for accessories) | The CSM itself does not contact the patient. Accessories used with the CSM have been cleared under previous 510(k)'s and have been tested in accordance with ISO-10993. Therefore, the acceptance criteria are met by proxy through the predicate device's cleared accessories. | Pass |
| Software | Software Verification and Validation Testing | Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was considered a "major" level of concern. | Documentation Provided |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of units tested for shipping, number of subjects for SpO2 accuracy). It refers to testing against established standards and guidance documents, which typically dictate sample size requirements.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective, as the studies are described as non-clinical and bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the non-clinical tests described. These tests primarily rely on established engineering standards and technical measurements rather than expert human interpretation. For the SpO2 Functional Accuracy testing, the ground truth would be against a reference oximeter or validated physiological measurements as per the FDA guidance. For Formative Usability Testing, user feedback would be gathered, but the number and qualifications of "experts" are not detailed.
4. Adjudication Method for the Test Set
No adjudication method is described, as the tests are non-clinical and the results are performance against established metrics or standards (resulting in a "Pass").
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No MRMC study was done. The document explicitly states: "No clinical studies were conducted as part of submission to prove substantial equivalence." This is a device for measuring vital signs, and the substantial equivalence is primarily based on technological similarity and non-clinical performance to an existing predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance tests described are inherently standalone in nature, as they evaluate the device's technical specifications and adherence to standards (e.g., accuracy of NIBP, SpO2, Temperature, communication capabilities). There isn't an "algorithm only" component presented distinctly from the device's integrated functionality. The software verification and validation would fall under this category as an evaluation of the device's core processing independent of human interaction during the test.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is based on:
- Established engineering standards and regulatory guidance: For safety (IEC 60601-1), EMC (IEC 60601-1-2), alarm systems (IEC 60601-1-8), specific vital sign measurements (IEC 80601-2-30 for NIBP, ISO 80601-2-61 for SpO2, ISO 80601-2-56 for temperature), and risk management (EN/ISO 14971).
- Reference measurements/equipment: For functional accuracy of SpO2, it would be compared against a 'gold standard' or reference pulse oximeter as per FDA guidance.
- Specifications: For wireless/Bluetooth communication, the ground truth is successful communication within defined parameters.
- User feedback: For formative usability testing, user needs and expectations serve as a form of ground truth.
8. The Sample Size for the Training Set
The document does not mention a "training set" as it relates to machine learning or AI algorithms. The device's vital sign algorithms (NIBP, SpO2, Temperature) are stated to be "unchanged from CVSM" (the predicate device). Therefore, any "training" (if applicable to these types of algorithms, which often rely on established physiological models rather than machine learning training sets) would have been conducted for the predicate device. For this submission, no new training data or process is described.
9. How the Ground Truth for the Training Set Was Established
Since no training set for new algorithms is described for the CSM (as the algorithms are carried over from the predicate device), the method for establishing ground truth for a training set is not applicable to this submission.
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