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The SNAP Diagnostics SAM Model 9-10000 device is intended to record airflow, breathing effort and body position, and is indicated for use as an aid for diagnostic evaluation of patients for apnea and snoring.

The SNAP Diagnostics SAM Model 9-10000 is not intended as a substitute for full polysomnography when additional parameters such as sleep stages or EEG activity are required.

The target population consists of patients who are suspected of apnea and/or complain about snoring. The majority of the test procedures will take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.

Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the use of the Snap Diagnostics SAM Model 9-10000 device.

The Snap Diagnostics SAM Model 9-10000 is an upgraded version of the Snap Diagnostics Model 8 (K110064, the predicate device) where the only area of change is the data logger component of the Model 8 sleep apnea home sleep test (HST) and recording system. The SAM Model 9-10000 is meant to be used with previously-cleared components of the predicate device including Snap Model 8 accessories and Snap Model 8 analysis software.

The Snap Diagnostics SAM Model 9-10000 differs from the K110064 predicate in the implementation of built in piezo electric effort and body position sensors rather than using external sensors, incorporation of the device electronics into the belt-worn effort sensor enclosure, and support for external wrist worn oximeters (Wellue CheckMe Oximeter cleared under K191088 and Nonin 3150 Oximeter cleared under K102350).

The Snap Diagnostics SAM Model 9-10000 interfaces with the K110064 predicate analysis software only by way of exporting files using the USB port, and this occurs at Snap Diagnostics or a lab location. The SAM Model 9-10000 cannot transfer files over the internet. These files are identical in format to the files output by the predicate data logger. The K110064 predicate analysis software is unchanged and is not the subject of this 510(k).

Just like the Snap Diagnostics Model 8 predicate device, the Snap Diagnostics SAM Model 9-10000 is designed to be used in the patient's home. A SAM Model 9-10000 with a fully charged battery is delivered to the patient along with accessories. The patient uses the data logger for one or more overnight recordings, then returns the device and accessories to Snap Diagnostics or the lab. A technician retrieves the data from the SAM Model 9-10000 using the USB port. The previously-cleared analysis software (K110064) is then used by a supervising technician to review the data and generate a home sleep test (HST) report. This HST report is sent by Snap Diagnostics to the patient's clinical team, who interpret the HST in the context of other relevant clinical data. Just like for the predicate device, Snap Diagnostics or a lab wipes the SAM Model 9-10000 of all data, cleans, inspects, and recharges it, and then provides the SAM Model 9-10000 to the next patient for use.

The Snap Diagnostics SAM Model 9-10000 is capable of logging the heart rate and blood oxygenation data from external wrist worn oximeters (Wellue CheckMe Oximeter cleared under K191088 and Nonin 3150 Oximeter cleared under K102350), but does not itself measure or otherwise manipulate those data.

Just like the predicate, the Snap Diagnostics SAM Model 9-10000 itself measures sound/airflow, respiratory effort, and acceleration/position.

The Snap Diagnostics SAM Model 9-10000 data logger does not perform sleep scoring or any other diagnostic, analysis, visualization, or data transform function, nor does the device have the capacity for alarms or the triggering of actions or therapies.

The provided text does not contain information about "acceptance criteria and the study that proves the device meets the acceptance criteria". The document primarily focuses on demonstrating substantial equivalence to a predicate device (Snap Model 8, K110064) based on regulatory parameters, indications for use, and technological characteristics.

Specifically, the document states:

• "Comparative performance evaluations between the Snap SAM Model 9-10000 and the predicate device, the Snap Model 8 (K110064), demonstrated that the two devices are substantially equivalent in performance."
• "Bench testing confirmed that the device met design requirements and the requirements of applicable standards."

However, it does not provide:

1. A table of specific acceptance criteria (e.g., accuracy, sensitivity, specificity for diagnostic parameters) or reported device performance against such criteria.
2. Details about sample size, data provenance, number or qualifications of experts, or adjudication methods for any test set that would establish diagnostic performance or ground truth.
3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
4. Specific standalone algorithm performance.
5. The type of ground truth used to establish performance.
6. The sample size for a training set or how ground truth was established for it.

The document lists various standards that the device underwent comprehensive performance testing against (e.g., IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 10993-1, IEC 62133-2), which typically cover safety, electromagnetic compatibility, and biological compatibility, but not diagnostic performance metrics for apnea and snoring.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and the study proving the device meets them based on the provided text.

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