APNEACHECK

K022294 · Im Systems · MNR · Apr 25, 2003 · Anesthesiology

Device Facts

• Record ID: K022294
• Device Name: APNEACHECK
• Applicant: Im Systems
• Product Code: MNR · Anesthesiology
• Decision Date: Apr 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Indications for 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.

Device Story

SleepCheck is a pager-sized, battery-powered monitor for sleep apnea screening. Patient self-applies device at home, clipping it to nightshirt and placing an air cannula sensor under nostrils/above lip. Device captures nasal and oral airflow via pressure-based sensor. Microprocessor filters and digitizes airflow signals at 10 samples/second. Device detects apnea events defined as airflow reduction for 10+ seconds. LCD displays total apnea count, Apnea-Hypopnea Index (AHI), and a dynamic bar graph for real-time breathing verification. Upon waking, patient returns device to physician. Physician reviews LCD readout to assess disordered breathing and determine if further clinical polysomnography is required. Benefits include convenient, non-tethered home screening for sleep-disordered breathing.

Clinical Evidence

Six clinical studies (111 subjects, 151 sleep nights) conducted at home and in sleep labs, sponsored by NIH. Validated against gold-standard polysomnography (PSG). Results showed high agreement with PSG: sensitivity 1.00, specificity 0.88, and correlation (r) to PSG of 0.99. Comparator SleepStrip reported sensitivity 0.97, specificity 0.67, and correlation 0.71.

Technological Characteristics

Pager-sized monitor; ABS plastic casing; pressure-based airflow sensor (Pro-Tech #1294 or Braebon #0589/0588); microprocessor-controlled; alkaline battery-powered; LCD readout; 10 samples/second sampling rate; non-tethered; single-night monitoring capacity (up to 9 hours).

Indications for Use

Indicated for patients requiring screening for sleep-disordered breathing to determine the need for clinical diagnosis and evaluation by polysomnography.

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

• SleepStrip (K002135)

Reference Devices

• PAM-RL (K010997)
• Pro-Tech model #1294 (K982293)
• Braebon model #0589/0588 (K984431)
• EPM EasyFlow (K922112)

Submission Summary (Full Text)

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## APR 2 5 2003

"SleepCheck" 510(k) Premarket Notification, April 17, 2003 Individual Monitoring Systems, Inc.

## 510(k) SUMMARY:

K022294

"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: [phone], Fax: [phone]

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

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#### 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.

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# 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 |

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## 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.

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## 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.

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| | 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.

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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.

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#### 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 [phone]. 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 [phone] or [phone] 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

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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