(109 days)
The Multi-Parameter Mobile CarcGuide™ 3100 Oximeter with Tablet 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 may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended to allow for display of SmO2 and pHm data on an Android Tablet display, which would interface with the Multi-Parameter Mobile CareGuide 3100 Oximeter via USB connection. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet provides display of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet 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 3100 Oximeter with Tablet has not been demonstrated in disease states.
The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet uses Near Infrared (NIR) Spectroscopy to calculate muscle oxygen saturation (SmO2) and muscle pH (pHm) and displays those parameters as real-time values and historical trends on a tablet device. The sensor contains algorithms that calculate SmO2 and pHm from collected spectra and communicates the current SmO2 and pHm results to an Android tablet with display software through a proprietary protocol. The Android tablet (qualified models Acer A500 and Asus Google Nexus 7) contains 3d party software that locks down the tablet so that only the CareGuide software may run and no other application or operating software can be modified. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet reusable sensor contains the optical and electronic elements necessary to collect spectra from skin, fat and muscle. The sensor has a 3m long cord with a USB connection to the Android tablet. The sensor is identical to the predicate (K130079) Multi-parameter Mobile CareGuide 3100 Oximeter. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet uses the same disposable element as the Multi-Parameter Mobile CareGuide 3100 Oximeter, a disposable sleeve that isolates the sensor optical elements from the patient's skin.
The provided text describes a 510(k) premarket notification for the Multi-Parameter Mobile CareGuide™ 3100 Oximeter with Tablet. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily by integrating an Android tablet as a display component.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
No specific clinical study comparing the new device's performance against detailed quantitative acceptance criteria is presented. The safety and effectiveness claim is based on demonstrating substantial equivalence to predicate devices because the core measurement technology and algorithms for SmO2 and pHm remain unchanged. The primary change is the integration of a dedicated Android tablet for display.
Instead of a new clinical study with performance metrics, the submission relies on the established performance of the predicate device and extensive bench and software testing to ensure the new display integration does not compromise the device's functionality.
1. Table of Acceptance Criteria and Reported Device Performance
As there isn't a new clinical study with specific quantitative acceptance criteria for this 510(k) submission, the table below reflects what can be inferred from the "Rationale for Substantial Equivalence." The "acceptance criteria" here refer to maintaining the established performance and features of the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in submission) |
|---|---|
| Principle of Operation: Identical to predicate devices (NIR spectroscopy) | "The principle of operation... is identical to that of the predicate CareGuide devices. They use the exact same NIR spectroscopic platform to measure tissue oxygen saturation and muscle." |
| Algorithms: Same software quantitative algorithm for SmO2 and pHm as predicate | "The same software quantitative algorithm for SmO2 and pHm is used in both devices." |
| Reusable Components: Identical sensor hardware to predicate (CPU board, battery, optical board, USB interfaces, housing, cables) | "The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is equivalent to the ● Multi-Parameter Mobile CareGuide 3100 Oximeter predicate in reusable components. Both devices use the exact same sensor hardware: main sensor CPU board, battery, optical board (light sources, spectrometer and microprocessor), USB interfaces, plastic housing and cables." |
| Disposable Components: Identical disposable sheath and sensor check device to predicate | "The Multi-Parameter Mobile CareGuide 3100 Oximeter with Table is equivalent to the Multi-Parameter Mobile CareGuide 3100 Oximeter predicate in disposable components. Both devices use the exact same disposable sheath ('Ray') and disposable sensor check device ('Cradle')." |
| Light Source: Identical underlying LED light source and wavelength range (700-900 nm) to predicate | "The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet has the identical underlying LED light source as the CareGuide predicates, with the exact same range of wavelength (700-900 nm)." |
| Display Functionality: Dedicated Android tablet is functionally equivalent to predicate's display, showing real-time parameters and historical trends. | "The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet and the predicated CareGuide 1100 Oximeter are equivalent. The CareGuide 1100 System includes a Monitor display while the CareGuide 3100 {subject of this 510(k)} includes a dedicated Android display. Both displays are functionally equivalent. Both CareGuide 1100 and 3110 displays are tools that interface with the CareGuide oximeter and display real-time parameters and historical trends per their cleared indications for use." |
| Compatibility: New device with tablet supports specified communications protocol. | "The predicate Multi-Parameter Mobile CareGuide 3100 Oximeter is compatible with any USB-connected display device that supports the specified communications protocol. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet {subject of this 510(k)} now includes such a USB-connected display device (i.e. dedicated Android tablet), supporting that specified communications protocol." |
| Safety and Effectiveness: Meets relevant consensuses and FDA recognized standards. | "Bench testing demonstrates that the Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is safe and effective, meeting all relevant consensuses and FDA recognized standards. The bench and software test results in this submission demonstrate that the Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet meets the expected performance requirements for an Oximeter." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a specific clinical test set in terms of sample size or data provenance for this 510(k) submission. The submission relies on "Bench testing" and "software test results" to demonstrate that the new device (with the integrated tablet) performs as expected and is equivalent to the predicate. The performance of the underlying oximetry and pHm measurements would have been established in previous 510(k) clearances for the predicate devices (K130079 and K113656).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The submission does not detail a new clinical study requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. No new clinical test set requiring adjudication is described.
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 not an AI-assisted diagnostic tool for human readers. It is a medical device for direct physiological measurement and display.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device's core functionality is standalone in terms of generating SmO2 and pHm values from collected spectra using internal algorithms. The 510(k) mainly addresses the display mechanism. "Bench testing" and "software test results" were performed to confirm that the entire system (including the new display component) functions correctly. Therefore, the performance evaluated was the standalone device's ability to measure and display parameters accurately, consistent with the predicate.
7. The Type of Ground Truth Used
For the current 510(k), the "ground truth" for proving substantial equivalence was primarily:
- Engineering specifications and design documents: Demonstrating identical hardware, software algorithms, and principle of operation to the predicate devices.
- Bench testing standards: Adherence to "relevant consensuses and FDA recognized standards" for oximeters, confirming the overall system functions as expected.
For the original clearance of the oximetry (SmO2) and pHm features (in the predicate devices K130079 and K113656), the ground truth would have been established through methods appropriate for physiological measurements, likely involving:
- Reference standard instruments: Comparing SmO2 and pHm measurements against established, more invasive, or laboratory-based reference methods.
- Induced physiological changes: Studies where oxygen saturation and pH are systematically varied in subjects to test the device's accuracy across a range of values.
8. The Sample Size for the Training Set
Not applicable for this 510(k) submission. This is not an AI/ML device that requires a distinct training set for its algorithms. The core algorithms were established and validated during the previous clearance of the predicate devices.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no new training set is described. The ground truth for the underlying algorithms of the predicate devices would have been established through a combination of physiological research, established oximetry principles, and potentially in-vivo and in-vitro studies comparing the device's measurements to reference standards.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).