(294 days)
Based on the provided text, there is no explicit mention of an AI model being used in the Silent Night V device.
Here's why:
- No mention of AI, DNN, or ML: The text specifically states "Mentions AI, DNN, or ML: Not Found".
- Focus on data collection and scoring: The description details the types of data collected (SP02, pulse rate, respiration effort, sound) and how this data is stored and then processed by software on a personal computer for scoring and display.
- Comparison to traditional polysomnography: The performance study compares the Silent Night V's results to a standard polysomnograph, which is a traditional method for sleep studies that does not inherently rely on AI.
- Description of scoring: The text mentions "Software has been developed to retrieve, score, display and print the collected data". While scoring algorithms can be complex, this description doesn't necessarily imply the use of AI. It could be based on predefined rules and thresholds.
While it's possible that some form of advanced signal processing or pattern recognition is used in the scoring software, the provided text does not indicate the presence of a machine learning or deep learning model within the device itself or explicitly as part of the scoring process.
No
The device is indicated for diagnostic evaluation of sleep disorders, not for treatment.
Yes
The "Intended Use / Indications for Use" states that "The Silent Night V is indicated for use in the diagnostic evaluation of adults with possible sleep disorders." The device description also details how it collects data to aid in the diagnosis of sleep-disordered breathing.
No
The device description explicitly states it consists of a "bedside unit" and "sensors" which are hardware components, in addition to the software for data retrieval, scoring, display, and printing.
Based on the provided information, the Silent Night V is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Silent Night V Function: The Silent Night V is a portable device that monitors physiological signals directly from the patient's body (arterial oxygen saturation, pulse rate, respiration effort, respiration sound) during sleep. It does not analyze samples taken from the body.
- Intended Use: The intended use is for the diagnostic evaluation of adults with possible sleep disorders by recording and scoring physiological data. This is a direct physiological measurement, not an in vitro analysis.
Therefore, the Silent Night V falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Silent Night V is indicated for use in the diagnostic evaluation of adults with possible sleep apnea. The Silent Night V can score obstructive apneas, which includes mixed apneas.
Product codes
MNR
Device Description
The Silent Night V is a portable, line-powered ventilatory effort recorder for use in the home for the diagnostic evaluation of sleep-disordered breathing. The device consists of a bedside unit which is positioned on the patient and the sensors are positioned on the patient's body and connect into the patient module with a cable. The Silent Night V contains the same functions as its predecessor, Silent Night II, with the adding of two other functions. The functionality of Silent Night V has been expanded from the previous estimation functionality of Silent Night II to encompass full ventilatory effort monitoring. The Silent Night V provides the following data:
- Arterial oxygen saturation level (SPO2)
- Pulse rate
- Respiration effort signal
- Respiration sound corrected for ambient room noise.
Throughout a typical sleep study, sleep-disordered breathing information and statistics are stored into the memory. The stored information includes time and duration of apneas and hypopneas, blocked air passages, respiratory effort in the thoracic and abdominal movements, oxygen saturation levels, pulse rate, respiratory effort level, sound measurements in intervals. Current storage capacity is 5 L Kbytes, which is sufficient to retain three 8-hour studies. Software has been developed to retrieve, score, display and print the collected data on a personal computer (IBM-PC compatible system). The software provided to the physician to view the sleep data.
The Silent Night V is indicated for use in the diagnostic evaluation of adults with possible sleep apnea.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
home
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
Clinical data - Silent Night V was evaluated in the clinical setting. Patients underwent a sleep laboratory evaluation with a standard polysomnograph. Silent Night V was used concomitantly for a side-by-side comparison. The number of apneas, hypopneas and the resulting Respiratory Disturbance Index (RDI) scored by the Silent Night V were compared with the data gathered simultaneously by the standard polysomnograph. The data were compared on an event-by-event basis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering data - Silent Night V was evaluated according to appropriate standards for mechanical and environmental testing. The device is in compliance with IEC 60601-1 and IEC 801-X (for mechanical and environmental stresses) standards.
Clinical data - The RDI scores were determined and compared with the RDI score from the PSG using the Pearson r. The correlation coefficient between the PSG and the Silent Night V was 97.7%. Using the total number of apneas as the basis for calculation, the sensitivity between the two devices for apnea detection was 83.2% and the number of false positive events per hour was 3.5 (# of false positive apneas per hour). Using the total number of events (apneas and hypopneas) as the basis for calculation, the overall sensitivity was 90.7% and the number of false positive events per hour was 3.8.
The definition for RDI is the total number of apneas and hypopneas, divided by the study duration (in hours). For RDI, using the overall number of patients as the basis of calculation, and a cut-off of RDI=15, the Silent Night V achieved a sensitivity of 95% and a specificity of 91% when compared to the PSG.
The results of the clinical study demonstrated the performance of the Silent Night V in detecting disordered breathing events, which can be indicative of sleep apnea.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Correlation coefficient between PSG and Silent Night V for RDI: 97.7%
- Sensitivity for apnea detection (based on total apneas): 83.2%
- False positive apneas per hour: 3.5
- Overall sensitivity (based on total events - apneas and hypopneas): 90.7%
- False positive events per hour (based on total events): 3.8
- Sensitivity for RDI (cut-off RDI=15): 95%
- Specificity for RDI (cut-off RDI=15): 91%
Predicate Device(s)
K973902, K973902, K9810, K915850
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 1 6 2000
SLEEP SOLUTIONS, INC. Paio Alto, CA
510 (k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the f
eather and the 1900 and 21 CEP & 807 92 This summary of SMDA 1990 and 21 CFR § 807.92.
| Submitted by: | Sleep Solutions, Inc. |
|---|---|
| 2450 El Camino Real, Suite 101 Palo Alto CA 94306 | |
| Phone: (650) 320-8090 Fax: (650) 320-8190 |
November 14, 2000 Date of Summary:
Silent Night V Device Name:
Ventilatory effort recorder (MNR) Class 1 1 Device Classification Name:
Devices of Devices to Which Equivalence is Claimed: The Egally murketed predicate devices Legally Marketed Toeries to Which Equivalence is Claimed: Trip it more of and the Sessentedies 4000
arc the Silent Vight To Stadust (K973902), the Stadust (K973902), the Sess 2005 - 11 (K9810). The Silent Night V was celented in the clinical setting in comparison to the legally
Series (K915850). The Silent Night V was celaused in the clinical sett Series (K915850). The Sucht Right + Was Fries sleep system (K915856).
Device Description: The Silent Night V is a portable, line-powered ventilatory of a bedside unit Device Description: The Silent Night V is a portuble, Inte-powers, The device oursists of a bedside unit
for use in the home for the diagnostic evalualion of the positioned o for use in the home for the diagnostic which is positioned on the patient and the sensors are with a cable the patient's body and connect into the patient module. The Silent Vight V contains the sume functions as its predecessor, Silent Night II, with the widting of two other finctions, The sume functions as its predecessor, Silent Night II, who use assumation device, (Silent Night II
functionality of Silent Night V has been expanded from the previous estimation functionality of Silent Night V bas been expunded Iron the previous generatory effort monitoring. The Silent Night V provides the following data:
- Arterial oxygen saturation level (SP02) ●
- Pulse rate �
- Respiration effort signal ●
- Resphanon circa corrected for ambient room noise .
Throughout a typical sleep study, siccp-disordered breathing information and statistics are stored into the Throughout a typical sleep stilled beating modulation of announces and hypopulas, block anyem
memory. The stored includes time and duration of apped and hambers and paused ti memory. The stored information includes time includes and intension in the more and possed ime.
saturation levels, pulse respiratory effort level, sound measury level open in intervals, pulservite, respiratory effor level, some maint to retain thee 8-hour studies.
intervals. Current storage and is 5 L Kbytes, which is and print the collected data Software has been developed to retireve, score, display and print the collected data on a personal
Software has been developed to retireve, score, display and print the colle Software has been developed to retrieve, score, display and provided to the physician to view the sleep data.
Comment Chec. The Silent Night V is indicated for use in the diagnostic of adults with possible Intended Use: The Silent Night V is indicated for use in the diaground of the Supplied appeas.
1
SLEEP SOLUTIONS, INC. Palo Alto, CA
Performance Data:
Engineering data - Silent Night V was evaluated according to appropriate stadiance IDCCALL LLCC mechanical and environmentul wsting. The device is in compliance with IBC 60601-1 and IEC 801-X (for mechanical and environmental stresses) standards.
Clinical data - Silent Night V was evaluated in the clinical setting. Patients underwent a sleep laboratory evaluation with a standard polysomnograph. Silent Night V was used concomitantly for a side-by-side comparison. The number of apneas, bypopneas and the resulting Respiratory Disturbance Index (RDI) companson. The number of appeared with the data gathered simultaneously by the standard polysomnograph. The dala were compared on an event-by-event basis. The RDI scares were determined and compared with the RDI score from the PSG using the Peurson r. The correlation coefficient between the PSG and the Silent Night V was 97.7%. Using the total number of apneas as the basis for calculation, the sensitivity between the two devices for apnea detection was 83.2% and the number of false positive wents per hour was 3.5 (# of false positive apness per hour). Using the total number of events (appreas and hypopuleas) as the basis for calculation, the overall schsitivity was 90.7% and the number of false positive events per hour was 3.8.
The definition for RDI is the 10tal number of apneas and hypopneas, divided by the study duration (in hours). For RDI, using the overall number of patients as the hasis of calculation, and a cut-off of RDI=15, the Silent Night V achieved a sensitivity of 95% and a specificity of 91% when compared to the 1786.
The results of the clinical study demonstrated the performance of the Silent Night V in detecting disordered breathing events, which can be indicative of sleep apnea. In view of the noninvasive, userfricadly design and simple operational features of the Silent Night V offers potential benefit as a cost effective home use device for the evaluation of patients with possible sleep disorders.
Conclusion: The information and data, provided in this 510(k) notification established that the Silem Night V is substantially equivalent to legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular and contains an emblem of a bird-like figure with three curved lines representing its wings. The bird-like figure is positioned in the center of the circle. The text "U.S. Department of Health & Human Services" is arranged around the upper half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2000
Mr. J. Scott Adams Sleep Solutions, Inc. 2450 El Camino Real, Suite 101 94306 Palo Alto, CA
K000253 Re : Silent Night V II (two) Regulatory Class: 73 MNR Product Code: October 5, 2000 Dated: October 6, 2000 Received:
Dear Mr. Adams:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is the device ferenced above and no 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 interstate Commerce prior co May con results have been reclassified in accordance with the provisions of the Federal Food, Drag, and In accordance with the provisione, market the device, subject to cosmeral controls provisions of the Act. The general controls the general concroro provinements for annual registration, provisions of the nee incrumentacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II Special II your device IS classiciou (ket Approval), it may be subject to such Controls) of Class III (Fremaintains affecting your device additional concrold. Entrol Fegulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. co 033. A Subbeansed in ufacturing Practice requirements, as set with 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 Failure to comply with the GMP regulation may result in assumptions. assumptions. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this concerning your as retification submission does not affect any response to your premained have under sections 531 through 542 of the Act obrigation you might have andric Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. J. Scott Adams
This letter will allow you to begin marketing your device as described inis fected will arrow you co ication. The FDA finding of substantial in your 310(K) premarket necessarily marketed predicate device would equivalence of your device of a vour device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advicionally 809.10 for in vitro regulation (21 cr. Farlease comment the Office of Compliance at ulaghostic devices), presse y, for questions on the promotion and (301) 394-4090. Addresmaily, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (301) 39-4059. Tirov promarket notification" (21 CFR 807.97).
"Misbranding by reference to premarket notification under the Agt may "MISDFanding by reference to pour responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its interest be obcained from the bridge. I or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
sincerely yours,
flm
a James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INTENDED USE STATEMENT 3.0
K 000 253 510(k) Number (if known):
【Jnknown
Device Name:
Silent Night V
Indications for Use:
Indications for USe:
The Silent Night V is indicated for use in the diamostic evaluation withod one many The Stient Night V is might V can score obstructive apneas, which includes mixed apacas.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CITR 801.109)
OR
Over-the Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number K000253
CONFIDENTIAL
11/14/2000