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.

Device Description

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 data analysis software is essentially unchanged from that used with both predicate devices.

AI/ML Overview

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.

Summary

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K080321 Page 1 of 5

SECTION 6 - Corrected 510(k) Summary

MAY 2 3 2008

SAFETY AND EFFECTIVENESS SUMMARY

Safety and effectiveness information concerning the SNAP Model 7 device is summarized below.

PREPARED BY: Gil Raviv, Ph.D President SNAP laboratories INT., LLC 5210 Capitol Drive Wheeling, IL 60090

TELEPHONE: (847) 777-0000

FAX: (847) 465-3404

CONTACT PERSON: Gil Raviv, Ph.D

DATE ON WHICH THE SUMMARY WAS PREPARED: March 31, 2008

NAME OF DEVICE: SNAP Model 7 ™

COMMON NAME: Snoring and Apnea Recording and Analysis Device

CLASSIFICATION NAME: MNR Ventilatory Effort Recorder

PREDICATE DEVICE: There are two predicate devices, both being earlier existing versions Snoring/Apnea Recording Systems designed by SNAP Laboratories. These 510(k) #K002095 - SNAP Model 6™ are:

510(k) #K992322 - SNAP Model 5™ .

The new SNAP Model 7™ employs a combination of features from these two devices.

DESCRIPTION OF THE DEVICE: The SNAP Model 7™ system consists of several components, many of them essentially unchanged from the predicate devices. The componently many of the Model 7 Data Recorder, which is an updated design design modification to the Model 6 predicate device. Other major elements of the system are modificultion to the moder o phich run on a PC in the physician's office, and the data analysis software located on computers at the SNAP laboratories central location. The andiyals bonward 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 DLL/GUI software is similar to that of the Model 6 predicate device, except that the rne been of the recorder is transferred to the computer via USB communication instead of data from the roofder lorive cartridge. Also, the Model 6 interface was via serial port.

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K080321 Page 2 of 5

The data analysis software is unchanged from that which is used in the predicate devices.

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 GUI calls DLL functions to program the recorder, check status, clear memory, check USB connectivity, retrieve serial number, retrieve patient data, get time, etc.. The GUI interacts with the website to identify the patient for the programming step and to transfer the collected patient data to the web server. The GUI also functions as a dedicated browser to the website, to navigate the website and identify the patient (and optionally enter new patient information). Once the patient is selected, the recorder is programmed with information regarding the patient name and which sensors are required for the test. After the programming is completed, the patient goes home with it and following the instructions for connection and startup prior to going to sleep. After the patient uses the recorder to collect overnight sleep data, the recorder is returned to the doctor's office, connected to the DLL/GUI computer via the USB port, where the patient data record is programmatically matched to the on-line patient record. After a manual confirmation step, the intermediate files are zipped up and uploaded (via secure, encrypted https) to the web server.

The GUI functions as a dedicated web browser to the website. This allows the GUI to be used for the various data entry steps. The website stores patient information, patient reports, and serves as a "way station" for the raw patient data before it get processed by the data analysis component. Demographic information is collected for the patient along with insurance and credit-card information. Contact and identifying information is collected for the patient's referring physicians. The test results are delivered to the referring physician based on this information. Access to the website is login and password protected. Various roles and user types are in place to safeguard inappropriate access to patient information. All pages of the website run in secure mode (https). The data analysis follows a pre-existing procedure that is already in place for earlier recorder models. The patient data from the website is securely downloaded to analysis workstations at SNAP Laboratories for analysis and processing. The resulting report is then securely uploaded back to the website so it can be made available to the referring physician by a transfer mechanism of their choice.

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INTENDED USE:

The Model 7TM 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.

CAUTION: US Federal law restricts this device to sale by or on the order of a physician. 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 Model 7 ™ device.

PATIENT POPULATION: Adults and pediatric patients.

SAFETY AND EFFECTIVENESS SUMMARY

The SNAP Model 7™ is an evolutionary design modification to the above-listed predicate devices. It is physically similar to the SNAP Model 6™, in that it is a small, separate recorder located in the general vicinity of the patient, with all sleep sensors connected from the patient to the recorder box. As with all SNAP devices, there are no electrical connections to the patient. In addition, the Model 7 uses a medical grade power supply, and there are no exposed metal connectors or controls, further minimizing any electrical risk to the patient or the user. The Model 7 has been tested and certified to the International Standard EN 60601-1-2:2005, the accepted EMC/EMI standard for medical devices. The sensors, transducers and accessories used with the Model 7 are the same as those used with one or more of the predicate devices, and all instructions for use, for Recorder, oximeter, respiratory effort belt, etc., are appropriate for their intended use.

The PC computer interface to the Model 7 is via the USB interface, the current standard for simple and effective computer accessory connections. The Model 6 predicate device uses a similar (but obsolete) serial port interface. The Model 5 predicate device did not use a separate hardware Recorder. The program running on the PC in the doctor's office (used for Recorder setup and data uploading from the Recorder) is very similar to that used with the Model 6 predicate device, except for changes in communication protocols required because of the change from serial port to USB, and changes as required because of the different Recorder hardware. The Model 5 predicate device introduced the use of secure data transmission over the Internet for uploading patient data and demographic information to the SNAP Laboratories central

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K080321 Page 4 of 5

location for analysis and reporting. The Model 7 uses this same method, basically unchanged from that used with the Model 5, to enable the software running on the doctor's office computer to connect to the central data analysis site via the Internet. The SNAP data analysis software, which runs on PC computers at the SNAP Laboratories central location, is essentially unchanged from that used with both predicate devices. The secure https:// method for secure data transmission, using data encryption methods standard with most high-security financial transactions, is employed by the Model 7 software. Analysis is performed and reports are generated at the SNAP laboratories central site, and these reports are faxed to the physician and/or placed onto the SNAP Labs web site for access and retrieval by the referring physicians.

Characteristic	SNAP Model 7 - Subject of this510(k)	Predicate DeviceSNAP Model 5	Predicate DeviceSNAP Model 6
Labeling	The User's Manual and devicelabeling has been updated to shownew configuration and operationalinformation. Labeling onaccessories (oximeter, respiratoryeffort belt, etc.) are unchangedfrom predicate devices.	Each SNAP modelhas labelingappropriate for thefeatures available andthe way it is to beused.	Each SNAP model haslabeling appropriate forthe features availableand the way it is to beused.
Intended Use	Recording and analysis of snoringand apnea.	Same as Model 7.	Same as Model 7.
Physical andTechnicalCharacteristics	Small, handheld device with allinterfaces necessary for patientconnection.	Uses PC for all datarecording and patientinterface.	Same as Model 7.
RecordingDeviceMemory	Hardware-detectable removableSD flash media card, up to 128MB, 32K RAM buffer	Personal computerhard disk and floppydisk.	100 MB ZIP drive andproprietary interface.
DataAcquisition	Four A/D channels, 12-bitresolution, up to 2,350 samples persecond; for snoring audio,respiratory effort, body position.Oximetry provided via digitalinterface.	Snoring sound,Oximetry, pulse rate& value.	Same as Model 7.
UserEquipment	Cannula, microphone, oximeter,respiratory effort belt, body positionmonitor.	Same as Model 7,except no respiratoryeffort & body position.	Same as Model 7,except Model 6 alsohad limb movement.
EnergySource	External medical grade powersupply, 90-240 VAC 50/60 Hzprimary, 9 volt secondary.	Personal Computersupply, 120 VAC,50/60 Hz.	Internal medical gradepower supply.
AnatomicalSites	Upper lip, finger probe, respiratoryeffort belt with body position.	Upper lip and fingerprobe only.	Same as Model 7,except Model 6 alsohad limb movement.
PerformanceTesting	Extensive testing, as summarizedin other sections of this document.	Same as Model 7.	Same as Model 7.
SafetyCharacteristics	No direct electrical connection topatient. Medical grade powersupply (IEC 60601-1) used.EMI/EMC testing performed.	Same as Model 7,except PC powersupply used forpower.	Same as Model 7.
ElectricalSafety	Designed to meet IEC 60601-1,power supply is medical grade, andthere are no electrical connectionsto the patient.	Same as Model 7,except PC powersupply used forpower.	Same as Model 7.
EMI	Tested and certified to meetEN 60601-1-2:2005.	FCC Part 11 Class B.	FCC Part 11 Class B.
Oximetry	Nonin OEM internal oximetermodule.	Nonin Xpod Oximeter	Same as Model 7.
Intendedpopulation	Adults and pediatrics.	Same as Model 7.	Same as Model 7.
Home Use?	Yes, may be used in home or inlaboratory.	Same as Model 7.	Same as Model 7.
ComputerAnalysisSoftware	The Model 7 uses the sameanalysis software as all SNAPdevices have used since theoriginal 510(k) submissionK984169.	Same as Model 7.	Same as Model 7.
Data quality	A/D is 12-bit resolution, dataquality is appropriate for dataanalysis performed.	Same as Model 7.	Same as Model 7.
FundamentalScientificTechnology	Similar to all predicate devices. Nonew scientific technologyintroduced in the Model 7. Doesnot include sleep staging or EEG.	Same as Model 7.	Same as Model 7.
DataAcquisitionRate	Up to 2,350 samples per second.	Approximately 2 KHz,after low-passfiltering.	Same as Model 7.
Data ReductionAlgorithm	Data reduction reduces storagespace requirements and datatransmission time.	Same as Model 7	Does not use datareduction algorithm.
Connectionfrom Recorderto Computer	The SNAP Model 7 interfaces tothe host computer via a USB port.	No separate recorder,sensors interfacedirectly to thecomputer	Uses a serial portinstead of USB port.
Packaging orexpirationdating	There are no expiration datesapplicable to any parts oraccessories of the SNAP Model 7,including the packaging.	Same as Model 7.	Same as Model 7.
Sterilization	Not applicable.	Same as Model 7.	Same as Model 7.

Substantial Equivalence Comparison Chart

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K080521 Page 5 of 5

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2008

Dr. Gil Raviv President SNAP Laboratories International, LLC 5210 Capitol Drive Wheeling, Illinois 60090

Re: K080321

Trade/Device Name: SNAP Model 7™ Snoring and Apnea Recording and Analysis System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: May 12, 2008 Received: May 15, 2008

Dear Dr. Raviv:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Raviv

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Shia, John, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 5 - Corrected Indications for Use Statement

INDICATIONS FOR USE STATEMENT

Page 1 of 1

K080321 510(k) Number (if known):

Device Name: SNAP Model 7™ Snoring and Apnea Recording and Analysis System

Indications For Use:

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.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K08032

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).