(205 days)
No
The document describes a modification to an existing device that replaces a specialized microcomputer with a personal computer for data recording. It focuses on hardware changes and data storage/transfer, with no mention of AI or ML algorithms for analysis. The analysis is performed at a service center, implying human interpretation of the recorded data.
No
The device is used for screening and analysis of apnea and snoring, which are diagnostic purposes, not therapeutic. It records events but does not treat them.
Yes.
Explanation: The device is intended to "screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring," which are diagnostic activities. It records oximetry and snoring sounds to identify specific medical conditions.
No
The device description explicitly states that the modification involves using a personal computer and connecting an oximeter and microphone/cannula apparatus. This indicates the device includes hardware components beyond just software.
Based on the provided information, the "Snap Model 5™" device is an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is intended to "screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring." This involves analyzing physiological signals (oximetry and snoring sounds) collected from the patient to provide diagnostic information related to a medical condition (apnea and snoring).
- Analysis of Biological Samples/Signals: While it doesn't analyze traditional biological samples like blood or urine, it analyzes physiological signals (oximetry from the finger and snoring sounds from the upper lip/cannula). These signals are collected in vitro (outside the body) for analysis.
- Diagnostic Purpose: The purpose is to aid in the diagnosis or screening of a medical condition (apnea and snoring).
- Regulatory Language: The "CAUTION: US Federal law restricts this device to sale by or on the order of a physician" is typical language for medical devices, including IVDs.
While the device description focuses on the hardware and data collection, the core function of analyzing collected physiological data to provide diagnostic information aligns with the definition of an IVD. The fact that the analysis can be done remotely at an analysis service center further supports the idea that the device is part of a system for in vitro analysis of collected data.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
73MNR, 74DQA
Device Description
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. The oximeter is connected to the unit along with 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper lip and finger probe
Indicated Patient Age Range
Both pediatric and adult patients
Intended User / Care Setting
Home, Sleep laboratory. 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
2 2000 FEB
EXHIBIT 2
Snap Laboratories, LLC 3633 West Lake Avenue Suite 406 Glenview, IL 60025 USA 847-657-8100 Fax: 847-657-8105 Contact Name: Gil Raviv, President July 9, 1999
510(k) Summary of Safety and Effectiveness
-
- 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
-
- 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.
-
- 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.
-
- Substantial Equivalence Chart
| Characteristic | Predicate device: Digi-
SNAPT™ testing device
K984169 | Modified device:
"Snap Model 5тм" |
|---------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labeling: | (Original submission) | The User's Manual has been
updated to show the new
configuration, with new operation
instructions. Certain instructions
will now appear on the computer
monitor screen instead of on the
equipment. |
| Intended Use: | Recording and analysis of snoring
and apnea | Same |
| Physical characteristics: | | |
| Recording device: | 100 MB "Zip" Drive and
proprietary interface. | Personal computer hard disk and
floppy disk |
| Channels acquired: | Snoring sounds, Oximetry level,
and pulse | Snoring sounds, Oximetry level,
pulse rate, and pulse value. |
| User equipment: | Zip unit, Zip Disk, cannula,
microphone, and Oxmieter, Nonin
OEM II or Xpod. | Personal computer, cannula,
microphone, and Oximeter: Nonin
Xpod only. |
| Energy Source: | 90-240 V, 50/60~ internal Medical
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "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 (800) 638-2041 or (301) 443-6597 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)