SILENT NIGHT II
Device Facts
| Record ID | K981034 |
|---|---|
| Device Name | SILENT NIGHT II |
| Applicant | Sleep Solutions, Inc. |
| Product Code | MNR · Anesthesiology |
| Decision Date | Oct 30, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
Indications for Use
The Silent Night II is indicated for use in the diagnostic evaluation of adults with possible Obstructive Sleep Apnea. It is intended to record a patient's respiratory pattern during sleep. The device is designed for prescription use in home screening of adults with possible sleep disorders. Information provided by the device includes the numbers of apneic and hypopneic events and the proportion of these events to the total sleep duration; and snoring levels (in decibels). The device is capable of recording four nights or up to 40 hours for an individual patient, after which time the sleep data are downloaded for provision to the prescribing physician.
Device Story
Portable, line-powered ventilatory effort recorder for home sleep screening. Uses two microphones attached via nasal cannula: one sensing microphone (under nose) for respiratory sounds; one ambient microphone (side of nose) for room noise/snoring levels. Device filters and processes sound signals to classify events as regular breathing, snoring, hypopnea, or apnea. Records up to four nights of data. Patient initiates study via START/STOP buttons; LCD provides status and sound level verification. Data downloaded to PC via specialized software for physician review. Output includes apnea/hypopnea counts, event proportions, and snoring levels (dB). Assists physicians in diagnosing sleep disorders; provides cost-effective home-based alternative to lab polysomnography.
Clinical Evidence
Clinical evaluation compared Silent Night II against standard polysomnography (Sensormedics Model 4100 Somnostar). Study measured Apneas and Respiratory Disturbance Index (RDI). Results showed high positive correlation and strong positive linear association between devices. High sensitivity and specificity reported for detecting Disordered Breathing Events.
Technological Characteristics
Portable, line-powered device in metal enclosure. Uses two microphones (sensing and ambient) via nasal cannula. Records respiratory sounds; processes data via internal software. Connectivity: PC download for data analysis. No specific ASTM standards cited.
Indications for Use
Indicated for diagnostic evaluation of adults with possible Obstructive Sleep Apnea. Intended for prescription home screening of adults with possible sleep disorders.
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
- Silent Night™ I (K963597)
Reference Devices
- Sensormedics 4000 Series Sleep System (K915856)
- Sensormedics Model 4100 Somnostar system
Submission Summary (Full Text)
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## OCT 30 1998
## 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
Submitter's Name: Local Silence, Inc. 1340 S. DeAnza Blvd., Suite 208 San José, CA 95129 USA Contact person: Tony Matouk, Chief Operating Officer
Date of Summary: March 13, 1998
Device Name: Silent Night™ II
Device Classification Name: Ventilatory Effort Recorder (73 MNR); Class II
Legally Marketed Devices to which Equivalence is Claimed: The legally marketed predicate device is the Silent Night™ I (K963597), determined to be substantially equivalent to a legally marketed (preAmendment) device on January 23, 1997. The Silent Night II was evaluated in the clinical setting in comparison to the legally marketed Sensormedics 4000 Series Sleep System (K915856), determined to be substantially equivalent to a legally marketed (preAmendment) device on October 26, 1992.
Device Description: The Silent Night™ II is a modified version of the legally marketed Silent Night I. The device is a portable, line-powered ventilatory effort recorder intended for use in the home screening of possible sleep disorders. The metal box has two receptacle connectors: one for input power and another for the microphone cable. The sensing microphone and the ambient noise microphone are located at the distal end of the cable, and are attached to the user by means of a modified conventional plastic oxygen cannula. The sensing microphone, located directly beneath the patient's nose, senses respiratory sounds during sleep. The ambient microphone, angled to the side of the patient's nose, senses room ambient noise and measures snoring levels. The Silent Night II is capable of recording up to four nights of sleep study data. The beginning and end of the sleep study are controlled by the use of the START and STOP buttons, located on the front of the unit. An LCD indicates operational status and has a sound level bar, used by the patient at the beginning of the study to verify adequate sensing of breathing sounds by the device.
The device operates by sensing the sound field (breathing sounds + room ambient noise) via the two microphones. Breathing sounds are extracted from all sounds received. The signals are filtered, analyzed, and processed to differentiate between types of sounds and to classify sounds as regular snoring or breathing, hypopnea, or annes. When beep study is completed, the cumulatively logged
data are downloaded by Local Site a personal computer. Specialized software and provides, for each night of the sleep study, information about apneas, hypopneas, and snoring levels.
Intended Use: The Silent Night II is indicated for use in the diagnostic evaluation of adults with possible Obstructive Sleep Apnea. It is intended to record a patient's respiratory pattern. The device is designed for prescription use in home screening of adults with possible sleep disorders. The intended use of the Silent Night II is identical to that of the predicate device, the Silent Night I, and is a subset of the intended use of the legally marketed Sensormedics 4000 Series Sleep System.
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Descriptive Summary of Technological Characteristics and those of Predicate Devices: The Silent Night II is a portable, line-powered device which detects and records respiratory patterns during sleep. The device components are housed in a metal box, which contains the hardware and software required for device function. The Silent Night II employs two microphones. The sensing microphone, located directly beneath the patient's nose, senses respiratory sounds during sleep. The ambient microphone, angled to the side of the patient's nose, senses room ambient noise and measures snoring levels. Sleep study data are downloaded to a computer for printing.
As with the Silent Night II, the legally marketed Silent Night I is a portable, line-powered device which detects and records respiratory patterns during sleep. An enclosure contains the device components and software required for device function. The Silent Night I also employs two microphones; however, the sensing microphone of the Silent Night I is aerial and is located 1 to 2 feet from the mouth of the patient, while the ambient microphone is built into the rear of the box. Device function and principle of operation are identical between the two devices. Respiratory sounds are differentiated by the device and classified as regular snoring or breathing, hypopnea, or apnea. In the Silent Night I, these classified events are logged cumulatively and displayed on the control panel on the top of the device.
The Sensormedics 4000 Series Sleep System is intended to collect, score and report data from sleep studies such as the electroencephalograph, electro-oculograph, electromyograph and electrocardiograph. The product is also used for recording respiratory signals from devices such as thermistors and thermocouples, and breathing sounds detected by transducers or microphones. The device is intended for use in a hospital or sleep laboratory setting.
## Performance Data:
Engineering: In view of the modifications made to the Silent Night J, Loeal Siteme, Inc. evaluated the need and requirements for additional testing of Silent Night II. With the exception of electrostatic discharge testing (which was completed with acceptable results), it was determined that due to the extensive similarities in design, materials and construction of the Silent Night II to Silent Night I, additional mechanical and environmental testing was not warranted.
Clinical: The Silent Night II was evaluated in the clinical setting. Patients were subjected to sleep laboratory evaluation with a standard polysomnograph (the Sensormedics Model 4100 Somnostar system) and the additional use of the Silent Night II. The number of Apneas and resulting Respiratory Disturbance Index (RDI) calculated by the Silent Night II were compared with data gathered simultaneously on these parameters by the Sensormedics device.
Statistical analysis of the test results indicated a high positive correlation between the measurements obtained by the two devices. Further analysis indicated that there is a strong positive linear association between the measurements obtained from the two devices. Additional analyses indicated a high degree of both specificity and sensitivity.
The study results establish the efficacy of the Silent Night II in detecting Disordered Breathing Events. which can be indicative of sleep apnea or another sleep disorder. In view of the noninvasive, userfriendly design and simple operational features of the Silent Night II offers potential benefit as a cost-effective home-use device for the screening of patients with possible sleep disorders.
Conclusion: The information and data provided in this 510(k) Notification establish that the Silent Night II is substantially equivalent to the legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle with three lines representing the head, body, and tail.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 1998
Ms. Lisa S. Jones Sleep Solutions, Inc. c/o Devices for the Future, Inc. 9223 Ilona Lane Houston, TX 77025
Re: K981034 Silent Night™ II Regulatory Class: II (two) Product Code: 73 MNR Dated: August 7, 1998 Received: August 10, 1998
Dear Ms. Jones:
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 Regulations, 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 requlation (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 requlatory 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 - Ms. Lisa S. Jones
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 (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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August 7, 1998
Page 1 of 1
510(k) Number: K981034
Device Name: Silent Night II
Indications for Use: The Silent Night II is indicated for use in the diagnostic evaluation of adults with possible Obstructive Sleep Apnea. It is intended to record a patient's respiratory pattern during sleep. The device is designed for prescription use in home screening of adults with possible sleep disorders. Information provided by the device includes the numbers of apneic and hypopneic events and the proportion of these events to the total sleep duration; and snoring levels (in decibels). The device is capable of recording four nights or up to 40 hours for an individual patient, after which time the sleep data are downloaded for provision to the prescribing physician.
(Concurrence of CDRH, Office of Device Evaluation (ODE)
Lark Mudro 10-29-98
510(k) Number _
(Division Sign-Off) (Division Sign-Oit)
Division of Cardiovascular, Respiratory, Bivision of Givision Devices
Over-the-Counter Use
Prescription Use (Per 21 CFR 801.109)
63
