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510(k) Data Aggregation
(107 days)
The SNAP Model 7™ device is indicated for use in the diagnostic evaluation of patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.
The SNAP Model 7™ testing system 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.
The SNAP Model 7™ system consists of several components, many of them essentially unchanged from the predicate devices. The major components of the system are the Model 7 Data Recorder, which is an updated design modification to the Model 6 predicate device. Other major elements of the system are the DLL (Dynamic Link Library) and GUI (Graphical User Interface) software which run on a PC in the physician's office, and the data analysis software located on computers at the SNAP laboratories central location. The DLL contains low-level routines for setup, control and data transfer, whereas the GUI is a high-level program which provides the interface between the user (doctor's office) and the DLL.
The SNAP Model 7™ Data Recorder is a small DC powered device designed to be simple and easy to use by a patient. It is self-contained, with integrated microcontroller and LCD display and all necessary interface electronics to perform all system recording functions. It does not require connection to a host computer in order to perform the recording functions. The data recorder consists of the physical hardware and firmware that interfaces to the patient to collect the physiological data. The recorder has sensors to collect sound, pulse oximetry, respiration effort (belt), and body position. The information is digitized and stored on a removable solid state memory card. The data on the removable data card is accessed through a USB port on the device, connecting to a PC running the DLL software.
The DLL software provides the interface for all communication between the recorder and the computer in the doctor's office. This DLL handles the low-level USB communications as well as parsing and storing intermediate files on the connecting computer. The DLL also interacts with a higher-level GUI client application. The GUI calls DLL functions to interact with the data recorder. The GUI also interacts through the Internet with the central website to transfer the patient data, and provides various data entry functions.
The data analysis software is essentially unchanged from that used with both predicate devices.
This 510(k) summary (K080321) for the SNAP Model 7™ device focuses on establishing substantial equivalence to predicate devices and describes the device's design, intended use, and safety features. It does not include a detailed study proving the device meets specific acceptance criteria in terms of performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity for apnea/snoring detection).
The document primarily states that the SNAP Model 7™ is an evolutionary design modification to earlier versions (SNAP Model 5™ and SNAP Model 6™) and uses essentially the same core data analysis software as its predecessors. The "Performance Testing" row in the Substantial Equivalence Comparison Chart states "Extensive testing, as summarized in other sections of this document," but these other sections are not provided in the given input. Therefore, I cannot extract specific performance metrics, sample sizes, or details about ground truth establishment for a diagnostic accuracy study.
However, based on the provided text, I can infer some general "acceptance criteria" related to functionality, safety, and equivalence, and how the device is claimed to meet them.
Here's an attempt to structure the information based on your request, highlighting what's present and what's missing from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As the provided document focuses on substantial equivalence rather than a detailed performance study with quantitative diagnostic metrics, the "acceptance criteria" are implied by the claims of equivalence and compliance with standards.
| Acceptance Criteria (Implied) | Reported Device Performance (from K080321) |
|---|---|
| Functional Equivalence to Predicate Devices | The SNAP Model 7™ employs a combination of features from Model 5 and Model 6. The DLL/GUI software is similar to Model 6. The data analysis software is unchanged from predicate devices. Sensors, transducers, and accessories are the same as those used with one or more predicate devices. The data acquisition (4 A/D channels, 12-bit resolution, up to 2,350 samples/second for snoring audio, respiratory effort, body position, digital oximetry) is the same as Model 6. |
| Intended Use | "Recording and analysis of snoring and apnea." (Same as Model 7, Model 6, Model 5). The device is indicated for use in the diagnostic evaluation of patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring. |
| Safety - Electrical | No direct electrical connections to the patient. Uses a medical grade power supply (IEC 60601-1). No exposed metal connectors or controls. Tested and certified to EN 60601-1-2:2005 (EMC/EMI standard). Electrical safety designed to meet IEC 60601-1. |
| Data Integrity and Security | Data on removable solid-state memory card. Secure data transmission over the Internet using secure, encrypted https (same method as Model 5). Analysis performed off-site at SNAP Labs central location; reports uploaded securely to website or faxed. "The Model 7 uses the same analysis software as all SNAP devices have used since the original 510(k) submission K984169." Data reduction algorithm reduces storage and transmission time. |
| Patient Population Appropriateness | Adults and pediatric patients. (Same as Model 7, Model 6, Model 5). |
| Operating Environment | May be used in home or in laboratory. (Same as Model 7, Model 6, Model 5). |
| Data Quality (Resolution/Rate) | A/D is 12-bit resolution. Data acquisition rate up to 2,350 samples per second. (Same as Model 6, similar to Model 5's 2 KHz). Asserted that data quality is appropriate for data analysis performed. |
| Ease of Use | Designed to be simple and easy to use by a patient. Self-contained, with integrated microcontroller and LCD display. Does not require connection to a host computer to perform recording functions. USB interface for connection to PC (an updated standard compared to Model 6's serial port). |
| Compliance with Regulations/Standards | Tested and certified to EN 60601-1-2:2005. Designed to meet IEC 60601-1. (Predicate devices met FCC Part 11 Class B, implying similar regulatory compliance). 510(k) cleared based on substantial equivalence to predicate devices under 21 CFR 868.2375 (Breathing Frequency Monitor, Class II). Restricted by US Federal law to sale by or on order of a physician. |
| Absence of Specific Performance Metrics (e.g., Sensitivity, Specificity for Apnea/Snoring detection) | Not reported in this document. The document extensively details physical and functional equivalence to predicate devices, and safety standards, but does not present a study with quantitative diagnostic performance metrics for apnea or snoring detection using the SNAP Model 7 itself. It relies on the assertion that the "data analysis software is essentially unchanged" and data quality is "appropriate for data analysis performed," thereby inferring performance akin to its cleared predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified in the provided document. No clinical performance study data is included.
- Data Provenance: Not specified. There is no mention of the country of origin of any data, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified. No clinical performance study is detailed, thus no information on ground truth establishment by experts is present.
- Qualifications of Experts: Not specified.
4. Adjudication Method (for the test set)
- Adjudication Method: Not specified. Since no clinical performance study is detailed, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document does not describe an MRMC comparative effectiveness study, nor does it quantify any effect size of human readers improving with AI vs. without AI assistance. The device is a "Snoring and Apnea Recording and Analysis Device," implying it provides data for clinicians rather than acting as an AI assistant to human readers in the sense of image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance)
- Standalone Performance Study: Not explicitly described with quantitative metrics. While the device performs analysis and generates reports based on its algorithm (the "data analysis software"), the document focuses on the hardware's equivalence and safety, stating the software itself is unchanged from predicate devices. There are no standalone performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard for apnea/snoring events) provided for the algorithm's output in this document. The "analysis is performed and reports are generated at the SNAP laboratories central site," which sounds like a standalone algorithmic analysis, but its performance is not detailed here.
7. Type of Ground Truth Used
- Type of Ground Truth: Not specified. Without a detailed performance study, the type of ground truth (e.g., expert consensus, pathology, polysomnography, outcomes data) used for validating the device's diagnostic capabilities is not mentioned.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable/Not specified. The document states that the "data analysis software is essentially unchanged from that used with both predicate devices." This implies that the software's underlying algorithms and any "training" it might have undergone would have happened prior to the predicate devices or at least were not re-evaluated for a new training set specific to the Model 7. There is no mention of a newly trained algorithm or a training set for the Model 7.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable/Not specified. As there is no mention of a specific training set or new training for the Model 7's algorithms, there is no information on how ground truth would have been established for it.
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