(283 days)
No
The description focuses on basic airflow sensing and counting of events based on a fixed duration (10 seconds). There is no mention of adaptive algorithms, learning from data, or complex pattern recognition that would indicate AI/ML.
No.
The device is described as a "prescreening tool" and a "screening device" to determine the need for diagnosis, rather than providing or supporting a therapeutic intervention itself.
No
Explanation: The device is explicitly stated as a "prescreening tool" and "screening device to determine the need for clinical diagnosis and evaluation by polysomnography," rather than providing a definitive diagnosis itself.
No
The device description clearly states it is a "pager-sized monitor" that "clips onto the patient's nightshirt" and utilizes an "air cannula sensor" and an "LCD readout". These are all physical hardware components, not software.
Based on the provided information, the SleepCheck device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The SleepCheck device monitors nasal and oral airflow directly from the patient. It does not collect or analyze biological samples like blood, urine, or tissue.
- The intended use is to monitor airflow and screen for the need for further clinical evaluation. This is a physiological measurement and a screening tool, not a diagnostic test performed on a biological sample.
- The device description focuses on capturing airflow and counting events based on that airflow. This reinforces that it's a physiological monitoring device.
Therefore, the SleepCheck falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SleepCheck is intended for use in monitoring nasal and oral airflow. The device is intended for use as a prescreening tool to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The SleepCheck is a pager-sized monitor that clips onto the patient's nightshirt. The monitor utilizes an air cannula sensor to capture the patient's nasal and oral airflow. The sensor cannula, containing 3 airflow ports, is placed under the nostrils, above the lip and held in place around the ears with a lanyard. The unit has an LCD readout that displays the total number of apneas and the apnealhypopnea index (AHI). The LCD also flashes a warning if the sensor is improperly applied or displaced. The LCD also provides a dynamic bar graph that displays the breathing pattern. As the patient inhales and exhales, the bar moves back and forth, verifying proper sensor application and monitor operation. When breathing decreases or is interrupted for 10 seconds or longer, this event is considered an apnea episode and is tallied on the LCD readout. The patient self-applies the unit before going to bed and wears the unit through the night. Upon waking, the patient will take off the unit and return it to the physician. The physician will check the LCD to learn the number of apneas and the rate of apnea events (AHI) that occurred throughout the night. The technical validity of the test is also indicated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal and oral airflow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
In total, six clinical studies were conducted to validated the accuracy of the apnea detection technology and the functionally of the SleepCheck device against the gold standard PSG. These studies consisted of 111 sleep tests totaling 151 sleep nights. All studies were sponsored by the National Institutes of Health (#N43-NS-5-2328 – NINDS; #N43-NS-8-2328 – NINDS; #1R43HL65166-01A1 – NIHLB). The results of these studies were both submitted to NIH and presented at various National Sleep Disorder Conferences. All studies conducted both at-home and in the sleep laboratory indicated a highly positive agreement with full PSG, with high sensitivity and specificity. Based on these results, the apnea detection technology provided by SleepCheck measuring single oral/nasal channel airflow is substantially equivalent in performance to the gold standard PSG for the intended use as a prescreening tool to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 1.00
Specificity: .88
r to PSG (gold standard): .99
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.
K982293, K984431, K922112, K010997
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
APR 2 5 2003
"SleepCheck" 510(k) Premarket Notification, April 17, 2003 Individual Monitoring Systems, Inc.
510(k) SUMMARY:
"This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
Submitter's Name and Address:
David T. Krausman, Ph.D.
Individual Monitoring Systems, Inc. (DBA IM Systems)
1055 Taylor Avenue, Suite 300
Baltimore, MD 21286
Phone: 410-296-7723, Fax: 410-321-0643
Contact Person: David T. Krausman, Ph.D.
Date Summary was prepared:
April 17, 2003
Name of Device:
Trade Name: SleepCheck
Common Name: Sleep Apnea Screening Device
Classification Name: Ventilatory Effort Recorder
ldentification of predicate device:
Number: K002135, "SleepStrip", Influent Ltd.
Product Code: 73 MNR
1
Statement of Intended Use:
The SleepCheck is intended for use in monitoring nasal and oral airflow. The device is intended for use as a prescreening tool to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.
Description of Device:
The SleepCheck is a pager-sized monitor that clips onto the patient's nightshirt. The monitor utilizes an air cannula sensor to capture the patient's nasal and oral airflow. The sensor cannula, containing 3 airflow ports, is placed under the nostrils, above the lip and held in place around the ears with a lanyard. The unit has an LCD readout that displays the total number of apneas and the apnealhypopnea index (AHI). The LCD also flashes a warning if the sensor is improperly applied or displaced. The LCD also provides a dynamic bar graph that displays the breathing pattern. As the patient inhales and exhales, the bar moves back and forth, verifying proper sensor application and monitor operation. When breathing decreases or is interrupted for 10 seconds or longer, this event is considered an apnea episode and is tallied on the LCD readout. The patient self-applies the unit before going to bed and wears the unit through the night. Upon waking, the patient will take off the unit and return it to the physician. The physician will check the LCD to learn the number of apneas and the rate of apnea events (AHI) that occurred throughout the night. The technical validity of the test is also indicated.
2
Comparison Inventory:
| Function: | SleepCheck | SleepStrip |
|---|---|---|
| Intended Use | Monitor sleep apnea events | Monitor sleep apnea events |
| Method of Measurement | Airflow sensor-pressure | Airflow sensor-thermal |
| Sensor placement site | Rests over the lip, under the nose | Rests over the lip, under the nose |
| Sensor elements | 3 prongs - two nasal, one oral | 3 prongs - two nasal, one oral |
| Measured variable | Oral and nasal airflow | Oral and nasal airflow |
| Sensor attachment | Air-cannula lanyard style | Stick-on adhesive-backed |
| Display type | Liquid crystal display element | Chemical display element |
| Breathing Indicator | Moving-bar display | Blinking-light display |
| Signal loss indicator | Yes, on display | Yes, on display |
| Apnea detection counter | 254 per hour maximum | 126 per hour maximum |
| Index scoring | AHI per sleep period | AHI per sleep period |
| Event score | Total apnea event count | AHI x 5 = total apnea event count |
| Display function | Numeric readout - decimal counter | Numeric readout - binary counter |
| Sleep night use | Single night monitoring | Single night monitoring |
| Maximum run-time | 9 hours | 5 hours |
| Controller | Microprocessor | Microprocessor |
| Airflow signal conditioning | Filtered and digitized | Filtered and digitized |
| Sampling method | Analog to digital conversion | Analog to digital conversion |
| Sample rate | 10 per second continuous | 10 per second continuous |
| Apnea detection criterion | Signal decrease 10 sec. or longer | Signal decrease 10 sec. or longer |
| Monitor application | Patient self-applies | Patient self-applies |
| Download | None - display readout only | None - display readout only |
| Physical Characteristics | Small, non-tether monitor | Small, non-tether monitor |
| Power | Alkaline battery | Lithium battery |
| Clinical Studies | Clinically tested against PSG | Clinically tested against PSG |
| Sensor | FDA Number and Date | |
| SleepCheck | Pro-Tech model #1294 | #K982293 July 13, 1998 |
| Braebon model #0589/0588 | #K984431 Dec. 30, 1998 | |
| SleepStrip | EPM EasyFlow | #K922112 Dec 7, 1992 |
3
Comparable characteristics of the SleepCheck and SleepStrip devices:
The SleepCheck and the predicate device SleepStrip (#K002135) manufactured by Influent, Ltd., are substantially equivalent in technology, function, and intended use: both wireless breathing monitors are indicated to screen patients for sleep disordered breathing; both devices use airflow sensors to detect nasal and oral airflow; both use a microprocessor to analyze airflow; both devices measure disordered breathing based on reduced air-flow; both devices use a low-power battery; and both devices have a display to show the recorded results to a physician. The major functions of both devices are to demonstrate on the display the amount of disordered breathing the patient experienced; both tools are intended as a screening device. Both the SleepCheck and SleepStrip devices have been validated in clinical studies using polysomnography.
The SleepCheck has one minor variation with respect to its predicate device: the SleepCheck airflow sensors are FDA Cleared single-use units (Pro-Tech FDA#K982293 - model #1294; or Braebon FDA#K984431 - model #0589/0588), while the SleepStrip airflow sensor is an FDA Cleared singleuse thermistor unit (EPM #K9221120). The airflow signals produced by these sensors are substantially equivalent for their intended use. Please see Table 1 for a comparison of the components of the SleepCheck and the predicate device SleepStrip.
Table 1: Component Characteristics of SleepCheck & Predicate Device
Based on the information provided above and herein, the SleepCheck is substantially equivalent to the SleepStrip with respect to intended use, technological characteristics, and performance.
4
Biocompatibility characteristics of SleepCheck
Two components of the SleepCheck contact the wearer for the sleep period (usually 1-9 hours). Both components have been FDA cleared. The first component is the airflow sensor. The SleepCheck requires the use of either a Pro-Tech or Braebon airflow sensor (see Table 2). Both airflow sensors are clearly marked as single-use components. The second component is the casing. The ABS plastic casing of the SleepCheck is identical to the ABS plastic casing of the PAM-RL as it was approved in #K010997. Oct. 15, 2001 (see Table 2), in formulation, processing, and sterilization, and no other chemicals have been added. No adjustments have been made to either the airflow sensors or to the casing.
Table 2.0: FDA-Cleared SleepCheck Components
| Part | Title | FDA Number and Date |
|---|---|---|
| Airflow Sensors | Pro-Tech model #1294 | #K982293 July 13, 1998 |
| Airflow Sensors | Braebon model #0589/0588 | #K984431 Dec. 30, 1998 |
| Casing | PAM-RL casing | #K010997, Oct. 15, 2001 |
Assessment of SleepCheck Performance Data:
In total, six clinical studies were conducted to validated the accuracy of the apnea detection technology and the functionally of the SleepCheck device against the gold standard PSG. These studies consisted of 111 sleep tests totaling 151 sleep nights. All studies were sponsored by the National Institutes of Health (#N43-NS-5-2328 – NINDS; #N43-NS-8-2328 – NINDS; #1R43HL65166-01A1 – NIHLB). The results of these studies were both submitted to NIH and presented at various National Sleep Disorder Conferences. All studies conducted both at-home and in the sleep laboratory indicated a highly positive agreement with full PSG, with high sensitivity and specificity. See Table 3. Based on these results, the apnea detection technology provided by SleepCheck measuring single oral/nasal channel airflow is substantially equivalent in performance to the gold standard PSG for the intended use as a prescreening tool to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.
5
| SleepCheck1 | Sleep Strip2 | |
|---|---|---|
| Sensitivity: | 1.00 | .97 |
| Specificity | .88 | .67 |
| r to PSG (gold standard) | .99 | .71 |
Table 3.0: Performance Characteristics of SleepCheck & Predicate Device
'Spiro et al. (2002) Sleep: 25(supplement), A275. 2 Lavie et al (2000) Sleep: 23(Supplement 2), A7.
6
Image /page/6/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2003
David T. Krausman, Ph.D. Individual Monitoring Systems, Incorporated 1055 Taylor Avenue, Suite 300 Baltimore, Maryland 21286
Re: K022294
Trade/Device Name: SleepCheck Regulation Number: 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: II Product Code: MNR Dated: January 31, 2003 Received: February 10, 2003
Dear Mr. Krausman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
7
Page 2 - Mr. Krausman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section. 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Patrice Cimentiffe
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Individual Monitoring Systems, Inc. "SleepCheck" 510(k) Premarket Notification, April 17, 2003
K022294 Intended Use:
The SleepCheck is a small monitor designed to assess nasal and oral airflow. Apnea breathing events are counted based on a reduction in airflow. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score.
Prescription Use Only /
Pabian Cucciaste
(Division Sign-Off)
510(k) Number: K022294