SNAP MODEL 5

K992322 · Snap Laboratories, LLC · MNR · Feb 2, 2000 · Anesthesiology

Device Facts

• Record ID: K992322
• Device Name: SNAP MODEL 5
• Applicant: Snap Laboratories, LLC
• Product Code: MNR · Anesthesiology
• Decision Date: Feb 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the "Snap Model 5™" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring. The "Snap Model 5™" testing system is only intended for short term monitoring such as to record the oximetry and snoring sounds continuously during the night. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements or EEG activity are required. The target population is patients who are suspected of apnea and/or complain about snoring. The majority of the screenings are going to take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested. 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 5TM" device.

Device Story

Device records snoring sounds, oximetry levels, and pulse rate/value; inputs collected via microphone, cannula, and finger-worn Nonin Xpod oximeter sensor. System utilizes personal computer for digital recording; replaces specialized microcomputer/Zip drive of predicate. Patient operates device at home or in sleep lab; records data overnight. Data returned to analysis service center on disk for evaluation. Output provides quantitative/qualitative analysis of apnea and snoring events to assist physicians in screening. Benefits include convenient home-based screening for sleep-disordered breathing.

Clinical Evidence

Bench testing and user testing performed. No clinical trial data provided. Results indicate the modified device is as safe and effective as the predicate device.

Technological Characteristics

Digital recording system using personal computer hard disk/floppy disk. Sensors: microphone, cannula, and Nonin Xpod oximeter. Electrical safety: UL listed PC. EMI: FCC Part 15 Class B. Connectivity: Standalone recording with offline analysis at service center.

Indications for Use

Indicated for pediatric and adult patients suspected of apnea or complaining of snoring. Used for short-term, continuous overnight monitoring of oximetry and snoring sounds. Not intended as a substitute for full polysomnography.

Regulatory Classification

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.

Predicate Devices

• Digi-Snap Testing Device (K984169)
• Nonin Model Xpod (K893221)

Submission Summary (Full Text)

{0}------------------------------------------------

K992322

2 2000 FEB

## EXHIBIT 2

Snap Laboratories, LLC 3633 West Lake Avenue Suite 406 Glenview, IL 60025 USA 847-657-8100 Fax: [phone] Contact Name: Gil Raviv, President July 9, 1999

## 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device Proprietary-Trade Name: "Snap Model 5 TM" Classification Name: 73MNR Apnea/Snoring Recording and analysis Device and 74DQA, Oximeter. Common/Usual Name: Snoring and Apnea Recording and Analysis Device
- 2. Equivalent legally marketed devices This product is similar in design and function to the "Digi-Snap TM" Testing Device," K984169, and incorporates a the same Pulse Oximeter, Nonin Model Xpod, K893221.
- 3. The intended use of the "Snap Model 5TM" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring. The "Snap Model 5TM" testing system is only intended for short term monitoring such as to record the oximetry and snoring sounds continuously during the night. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements or EEG activity are required. The target population is patients who are suspected of apnea and/or complain about snoring. The majority of the screenings are going to take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.

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 5TM" device.

- 4. Description of the Device: This notification is for a modification to the existing device, the "Digi-Snap™" Testing Device. The modified device is called the "Snap Model 5™4" The modification involves the use of a personal computer with certain options installed instead of the specialized microcomputer and Zip drive system.
- న్న Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device. The modified device is easy for the user to set up at home or in the sleep laboratory. The modification involves the use of a fully digital recording technique. The oximeter is connected to the unit along with

{1}------------------------------------------------

the usual microphone/cannula apparatus and the oximeter sensor is slipped over the patient's finger in the usual manner. The patient turns on the unit, then goes to sleep. Apnea and snoring events are then recorded. After awakening, the patient returns the disk and the equipment to the analysis service center, where the disk is analyzed. If the patient's own personal computer was used, only a disk is returned to the analysis center for evaluation.

- 6. Substantial Equivalence Chart

| Characteristic | Predicate device: Digi-<br>SNAPT™ testing device<br>K984169 | Modified device:<br>"Snap Model 5тм" |
|---------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labeling: | (Original submission) | The User's Manual has been<br>updated to show the new<br>configuration, with new operation<br>instructions. Certain instructions<br>will now appear on the computer<br>monitor screen instead of on the<br>equipment. |
| Intended Use: | Recording and analysis of snoring<br>and apnea | Same |
| Physical characteristics: | | |
| Recording device: | 100 MB "Zip" Drive and<br>proprietary interface. | Personal computer hard disk and<br>floppy disk |
| Channels acquired: | Snoring sounds, Oximetry level,<br>and pulse | Snoring sounds, Oximetry level,<br>pulse rate, and pulse value. |
| User equipment: | Zip unit, Zip Disk, cannula,<br>microphone, and Oxmieter, Nonin<br>OEM II or Xpod. | Personal computer, cannula,<br>microphone, and Oximeter: Nonin<br>Xpod only. |
| Energy Source: | 90-240 V, 50/60~ internal Medical<br>grade power supply | 120 V, 50/60~ (Personal computer) |
| Anatomical sites: | Upper lip and finger probe | Same |
| Performance testing: | Summarized above | |
| Safety characteristics: | | |
| Electrical safety: | Per applicable sections of UL-2601 | UL listed personal computer |
| EMI: | Per FCC part 15 Class A | FCC part 15 Class B |
| Oximetry | Included | Same |
| Intended population | Adults and pediatrics | Same |
| Home use | Yes | Same |

## 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Snap Laboratories that the "Snap Model 5TM" testing snoring and apnea testing device is as safe and effective as the predicate device and has no new indications for use, thus rendering it substantially equivalent to the predicate Snap Testing Device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2000 FEB 1

Gil Raviv, Ph.D. Snap Laboratories, LLC 3633 West Lake Avenue Suite 406 Glenview,IL 60025 USA

K992322 Re: Device: Snap Model 5™ Requlatory Class: II Product Code: 73 MNR 74 DQA Dated: July 09,1999 Received: July 12,1999

Dr. Gil Raviv:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Gil Raviv, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

a M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## j) Indications for Use

510(k) Number

Device Name: "Snap Model 5TM" Snoring and Apnea recording and analysis system

Indications for Use:

The intended use of the "Snap Model 5™" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.

The "Snap Model 5™" testing system is only intended for short term monitoring such as to record the oximetry and snoring sounds continuously during the night. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements or EEG activity are required.

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

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 5TM" device.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off)
Division of Cardiovascular, Respiratory,

Division of Cardiovascular, Hospital,
and Neurological Devices K992322
510(k) Number

Prescription Use \checkmark ***_*** OR Over the Counter Use ***_***
(Per 21 CFR 801.109)