(205 days)
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.
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.
The provided text describes a 510(k) premarket notification for the "Snap Model 5TM" device, which is a modification of an existing device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a standalone performance study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for detecting apnea or snoring, nor does it present a table of such performance. Instead, it relies on demonstrating substantial equivalence to an existing predicate device ("Digi-Snap™ Testing Device," K984169).
The "Performance testing" section in the Substantial Equivalence Chart simply states "Summarized above," but no performance data or acceptance criteria are actually summarized above or elsewhere in the provided document. The conclusion states: "The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device."
2. Sample Size for Test Set and Data Provenance
The document does not specify any sample size for a test set (e.g., number of patients or recordings used for evaluation). It mentions "user testing data" but provides no details on its composition or origin.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth or their qualifications. The evaluation appears to be based on the device's functional equivalence to a previously cleared device.
4. Adjudication Method for Test Set
The document does not describe any adjudication method, as it doesn't detail a study involving expert review or grading of cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission is focused on device modification and substantial equivalence, not on comparing reader performance with and without AI assistance.
6. Standalone Performance Study
A standalone performance study (algorithm only performance without human-in-the-loop) is not described. The submission focuses on the modified device's functionality and its equivalence to the predicate device, stating that "The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device." However, no numerical results from such testing are provided.
7. Type of Ground Truth Used
Given the absence of a detailed performance study, the document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The implicit "ground truth" for the modified device's performance appears to be the established performance of the predicate device.
8. Sample Size for Training Set
The document does not mention a training set or its sample size. This is consistent with the nature of the submission, which is for a modification to an existing device rather than a de novo submission for a new AI algorithm requiring extensive training data.
9. How Ground Truth for Training Set Was Established
Since no training set is mentioned, there is no information on how its ground truth would have been established.
Summary of what is indicated:
The submission for the "Snap Model 5TM" is a 510(k) for a modification to an already cleared device ("Digi-Snap™"). The core argument for clearance is substantial equivalence to the predicate device, focusing on changes in hardware (personal computer instead of specialized microcomputer, floppy disk instead of Zip drive) and updates to labeling and instructions. The performance claim is that the modified device is "as safe and effective as the predicate device," based on unspecified "bench and user testing data," but no quantitative performance metrics, test set details, or ground truth methodologies are provided in this document.
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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
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- 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
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- 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.
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- 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
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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.
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- Substantial Equivalence Chart
| Characteristic | Predicate device: Digi-SNAPT™ testing deviceK984169 | Modified device:"Snap Model 5тм" |
|---|---|---|
| Labeling: | (Original submission) | The User's Manual has beenupdated to show the newconfiguration, with new operationinstructions. Certain instructionswill now appear on the computermonitor screen instead of on theequipment. |
| Intended Use: | Recording and analysis of snoringand apnea | Same |
| Physical characteristics: | ||
| Recording device: | 100 MB "Zip" Drive andproprietary interface. | Personal computer hard disk andfloppy 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, NoninOEM II or Xpod. | Personal computer, cannula,microphone, and Oximeter: NoninXpod only. |
| Energy Source: | 90-240 V, 50/60~ internal Medicalgrade 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.
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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.
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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
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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)
§ 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).