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510(k) Data Aggregation
(59 days)
MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER
The Multi-Parameter Mobile CareGuide™ 4100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation and pH of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 4100 Oximeter is intended to allow for display of SmO2 and pHm data on a third party or Reflectance supplied device, which would interface with the Multi-Parameter Mobile CareGuide 4100 Oximeter via a powered USB connection. The Multi-Parameter Mobile CareGuide 4100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional inside and outside a hospital. The Multi-Parameter Mobile CareGuide 4100 Oximeter provides output of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 4100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Multi-Parameter Mobile CareGuide 4100 Oximeter has not been demonstrated in disease states.
The Multi-Parameter Mobile CareGuide 4100 is a noninvasive optical sensor that determines two separate medical parameters and reports them out for display to the user in real-time. Light sources in the sensor illuminate the skin with near infrared (NIR) light passes through the skin and fat with only some loss to be primarily absorbed by small blood vessels in the muscle tissue. Light which is not absorbed is scattered back and analyzed by the spectroscopic detector, also contained in the sensor. The microprocessor in the sensor converts the reflected light to an absorbance spectrum which is then analyzed by two separate algorithms, also stored in the sensor's microprocessor. The two algorithms calculate muscle oxygen saturation (Sm22), and muscle pH (pHm).
The sensor is attached to the patient using the CareGuide Disposable. One Disposable is used per patient, but the CareGuide Sensor is reusable. To use, the adhesive liner is removed from the Disposable and, with the sensor clipped into the Disposable, is adhered to the patient's skin over either the deltoid, calf or thigh muscle.
When the sensor is first placed on the patient, software checks to make sure the LEDs are functioning properly and then the sensor automatically performs an optimization routine which sets up the spectral data collection parameters for the individual patient. Once conditions are established the sensor begins collecting spectra and reporting parameter values.
The Multi-Parameter Mobile CareGuide 4100 measures and provides for output of SmO2 and pHm data. The Multi-Parameter Mobile CareGuide 4100 communicates with either a 3ª party display or monitoring device, or RMI-supplied tablet, which is compliant with the Mobile CareGuide communications protocol. Sm02 and pHm values suitable for display and trending are sent via the Mobile CareGuide communications protocol to the display device as well as error information and device states.
The provided text describes the Multi-Parameter Mobile CareGuide 4100 Oximeter and its substantial equivalence to predicate devices, but it does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested.
Instead, the document focuses on demonstrating that the new device operates on the same technological principles, has similar components, and identical intended use as previously cleared predicate devices. It lists several standards and internal tests that were conducted to ensure safety and effectiveness, but it does not provide quantitative performance data for these tests against specific acceptance criteria.
Therefore, I cannot populate the table or answer most of the requested questions directly from the provided text.
Here's what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance:
| Parameter/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy, functionality, and safety as an Oximeter | Not explicitly stated (implied to be equivalent to predicate devices and meeting standards) | "The accuracy, functionality and safety of the Multi-Parameter Mobile CareGuide 4100 Oximeter is the equivalent to the predicate device." |
| IEC60825-1 Ed 2.0 (2007) - Laser Safety | (Assumed compliance) | Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter" |
| IEC 60601-1-1: 2005 - Medical Electrical Equipment Safety | (Assumed compliance) | Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter" |
| IEC 60601-1-2: 2007-03 - EMC | (Assumed compliance) | Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter" |
| ISO 10993-5 2009 - In vitro cytotoxicity | (Assumed compliance) | Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter" |
| ISO 10993-10 2010 - Irritation and delay-type hypersensitivity | (Assumed compliance) | Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter" |
| AAMI TIR 12:2010 - Reprocessing | (Assumed compliance) | Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter" |
| AAMI TIR 30:2003 - Cleaning reusable medical devices | (Assumed compliance) | Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter" |
| ISTA 1A - Packaging | (Assumed compliance) | Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter" |
| Internal Tests (Vibration & shock, Auto-start, Sensor optimization, algorithm updates) | (Assumed internal criteria) | Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter" and verify minor updates to the algorithm. |
Missing Information/Not Applicable based on the text:
- 2. Sample size used for the test set and the data provenance: Not mentioned. The document primarily discusses technical equivalence and compliance with standards, not a specific clinical performance study with a defined test set.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth is described.
- 4. Adjudication method 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: Not applicable. This device is an oximeter, not an AI-assisted diagnostic tool that would involve human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states the device "automatically performs an optimization routine" and "begins collecting spectra and reporting parameter values." This implies a standalone algorithm for measurement, but no specific performance metrics are provided.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not explicitly stated. For oximeters, ground truth typically involves comparison to a reference standard (e.g., co-oximetry of arterial blood samples), but this detail is not provided in this submission summary. The phrase "The accuracy, functionality and safety... is the equivalent to the predicate device" suggests reliance on the predicate's established performance rather than a new full-scale ground truth study.
- 8. The sample size for the training set: Not mentioned. No specific training set for an algorithm is described, though the document refers to "two separate algorithms" stored in the sensor's microprocessor.
- 9. How the ground truth for the training set was established: Not mentioned.
Summary of available information:
The document serves as a 510(k) summary focused on demonstrating substantial equivalence to previously cleared predicate devices. The primary argument for meeting acceptance criteria is that the Multi-Parameter Mobile CareGuide 4100 Oximeter utilizes identical technology (NIR spectroscopy hardware and software), has similar components, and the same intended use as its predicates. Compliance with various safety, electrical, biological, and packaging standards is listed as evidence of safety and effectiveness, but no quantitative performance data from a specific clinical study with defined acceptance criteria is provided.
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