MICROMESAM BASIC-SET

K040576 · Map Medizintechnik Fur Arzt Und Patient GmbH · MNR · Jul 1, 2004 · Anesthesiology

Device Facts

• Record ID: K040576
• Device Name: MICROMESAM BASIC-SET
• Applicant: Map Medizintechnik Fur Arzt Und Patient GmbH
• Product Code: MNR · Anesthesiology
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Indications for Use

The microMESAM® Basic-Set is used for recording the patient's respiratory nasal pressure during sleep. 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 test score.

Device Story

Single-channel, battery-powered respiratory pressure sensor system; records nasal pressure during sleep. Patient wears device at home, attached to chest via belt, with nasal cannula for signal collection. After recording, device returned to physician; data downloaded via USB to PC. Software automatically analyzes flow-time curves to detect apneas, hypopneas, flow limitations, and snoring. Physician reviews generated report to determine need for further clinical diagnosis or polysomnography. Benefits include screening for sleep-disordered breathing (SDB) in a home environment, facilitating timely clinical intervention.

Clinical Evidence

Prospective study of 50 patients suspected of obstructive sleep apnea. Compared automated analysis of MicroMESAM flow-time curves against manual scoring of simultaneous PSG data and pneumotachograph curves. Results: 95% correspondence with pneumotachograph; high correlation for apneas (r=0.99), hypopneas (r=0.81), and AHI (r=0.98). Sensitivity/specificity for SDB: 97.3%/46% at AHI=5; 100%/87.5% at AHI=10.

Technological Characteristics

Single-channel, battery-powered (AA/NiMH) recorder. Uses solid-state pressure sensor to convert pressure changes to electrical signals. Includes disposable plastic nasal cannula. Connectivity via USB 1.1 for data download to PC. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60068-2-1, and ISO 10993-1.

Indications for Use

Indicated for adult patients suspected of having sleep-related respiratory disorders to screen for the need for clinical diagnosis and 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

• Aplab™ (K030379)

Submission Summary (Full Text)

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# 1.2 510(k) SUMMARY of Safety & Effectiveness

| Submitter: | MAP Medizin-Technologie GmbH<br>Fraunhoferstrasse 16<br>82152 Martinsried<br>GERMANY |
|---------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Torsten Schlichtholz<br>Director Quality Management and Regulatory Affairs |
| Phone No.: | [phone] |
| Fax No.: | [phone] |
| Date Prepared: | 1 March 2004 |
| Classification Reference: | 21 CFR 868.2375 |
| Product Code: | MNR – Ventilatory Effort Recorder |
| Device Class: | Class II |
| Common/Usual Name: | Ventilatory Effort Recorder |
| Proprietary Name: | microMESAM® Basic-Set |
| Predicate Device: | Aplab™ (K030379) |
| Distribution: | the product will be marketed in the USA by<br>ResMed Corp. |

#### Intended Use:

The microMESAM® Basic-Set is used for recording the patient's respiratory nasal pressure during sleep. 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 test score.

### Device Description:

The MicroMESAM® Basic-Set consists of:

| Number of | Type | Article No.: |
|-----------|------------------------------------------------------------------------------------|--------------|
| 1 | Reusable microMESAM® recorder | 161800 |
| 50 | Disposable nasal pressure cannula and microMESAM®<br>patient's instruction manuals | 1619 |
| 1 | microMESAM® installation CD | 167340 |
| 1 | System instruction manual for specialist medical personnel | 561761 |
| 2 | Batteries 1,5V Mignon | 85030 |
| 1 | Reusable belt for attaching the microMESAM® recorder | 629050 |
| 1 | USB cable | 629051 |
| 1 | Carrying bag | 530002 |
| 10 | Luer-lock caps | 626027 |

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The microMESAM® recorder is a single channel battery-powered respiratory pressure sensor system and provides recordings of respiratory pressure during sleep. The physician prescribed device will help to recognise sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may actually perform the recording at home by himself. The microMESAM® recorder must be fastened with the reusable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal pressure cannula. The disposable plastic nasal pressure cannula is connected to the microMESAM® recorder and fixed at the patient's nose. After recording, the microMESAM® recorder must be returned to the physician. With the microMESAM® software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analysed data.

### Device Technological Characteristics and Comparison to Predicate Device:

The comparison table below, is provided, to demonstrate that the microMESAM® Basic-Set has no siqnificant differences from the predicate device that would adversely affect product safety and effectiveness.

| Comparison Parameter | Sector Medical Corp.<br>ApLab™ | microMESAM® Basic-Set |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | ApLab™ is intended for use<br>in recording respiratory nasal<br>pressure during sleep. The<br>device is intended for use as<br>a screening device to<br>determine the need for<br>clinical diagnosis and<br>evaluation by<br>polysomnography based on<br>the patient's score. | The microMESAM® Basic-Set<br>is used for recording<br>patient's respiratory nasal<br>pressure during sleep. The<br>device is intended for use as<br>a screening device to<br>determine the need for<br>clinical diagnosis and<br>evaluation by<br>polysomnography based on<br>the patient's test score. |
| Intended Environment | recording - at-home<br>analysing - Sector Medical,<br>physician's practice, sleep<br>clinic | recording - at-home<br>analysing – physician's<br>practice, sleep clinic |
| Population | 2 yrs or older | adults |
| Power Source recorder | 3-Volt Lithium battery | 2 x batteries: LR6 / Mignon /<br>AA / 1.5V / at least 1.9 Ah<br>or<br>2 x NiMh accumulators:<br>Mignon / AA / 1.2V / at least<br>1.9 Ah |
| Number of channels | Single channel | Single channel |
| Method of connection to the<br>Patient | Plastic tubing and cannula<br>for pressure sensing; elastic<br>cloth material belt to support<br>unit. The device is to be<br>attached to a patient's arm | Plastic tubing and cannula<br>for pressure sensing; elastic<br>cloth material belt to support<br>unit. The device is to be<br>attached to a patient's chest. |

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| Safety Characteristics | Use non-conducting,<br>disposable, plastic cannula. | Use non-conducting,<br>disposable, plastic cannula. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Re-use | Plastic cannula is single use<br>disposable. Remaining<br>portions require cleaning | Plastic cannula is single use<br>disposable. Remaining<br>portions require cleaning |
| Sensor Technology | Utilizes solid-state pressure<br>sensor that converts pressure<br>changes to electrical signal<br>levels | Utilizes solid-state pressure<br>sensor that converts pressure<br>changes to electrical signal<br>levels. |
| Analysing the recorded data | The recorded data may be<br>downloaded into the<br>ApLab™ software through<br>an USB 1.1 connector<br>plugged into the device.<br>Afterwards the recorded<br>data are automatically<br>analysed and a report can be<br>generated. | The recorded data may be<br>downloaded into the<br>microMESAM® software<br>through an USB 1.1<br>connector plugged into the<br>device. Afterwards the<br>recorded data are<br>automatically analysed and a<br>report can be generated. |

### Performance data:

The microMESAM® Basic-Set complies with the following standards:

- IEC 60601-1 -
- IEC 60601-1-2 -
- IEC 60068-2-1/ and the following -
- IEC 10993-1 -

# Clinical tests:

Introduction: Polysomnography (PSG) is considered the gold standard in the diagnosis of sleep disordered breathing (SDB). Because of costs and labor-intensity it is, however, performed last in graded diagnostic protocols that often involve respiratory pressure measurements via nasal pressure cannula as an alternative sensitive method for DSB detection. MicroMESAM, a newly developed screening device based on this method, allows automated analysis of apnoeas, hypopnoeas, flow limitations and snoring.

Aim and Methods: To validate the device, we first compared signal quality of MicroMESAM flow-time curves with those generated by a pneumotachograph. Then, in 50 patients suspected of having obstructive sleep apnoea, we compared MicroMESAMgenerated automated analysis with manually scored results of simultaneously collected PSG data.

MicroMESAM-generated flow-time curves corresponded Results: with oneumotachograph-generated curves in 95% of respiratory events, resulting in less 4±2% difference in respective area under the curves. MicroMESAM and PSG generated numbers of apnoeas (r=0.99) and hypopnoea (r=0.81), as well as AHI (r=0.98) correlated highly, displaying mean differences in AHI of 3.8, and in 1.96 intervall of +11.1 to -3.5/h. Sensitivities and specificities for SDB were 97.3%, respective 46% at SDB-defining AHI of 5, and 100%, respective 87.5%, at SDB-defining AHI of 10.

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Summary: MicroMESAM-qenerated flow-time curves correspond well well with pneumotachograph generated curves, producing automated AHls that are highly sensitive in detecting SDB. MicroMESAM, therefore, is suitable as a screening device for SDB.

## Conclusion:

The MicroMESAM® Basic-Set is substantially equivalent to the predicate SECTOR Medical Corp. ApLabTM™. Both Ventilatory Effort Recorders have the same intended use. Based on verification and validation testing completed on the microMESAM® Basic-Set we conclude that the differences do not affect safety and effectiveness of the MicroMESAM® Basic-Set.

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Image /page/4/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus symbol with three wavy lines representing the human services aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

JUL 01 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Map Medizintechnik Fur Arzt Und Patient GMBH C/O Mr. David D' Cruz Vice President ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K040576

Trade/Device Name: microMESAM Basic-Set Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: June 3, 2004 Received: June 7, 2004

Dear Mr. D' Cruz

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. D' Cruz

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 (QS) 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,

Chiu Lin, Ph.D.

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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### Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

microMESAM® Basic-Set is used for recording the patient's respiratory nasal pressure during sleep. The device is intended for respiratory hasal p device to determine the need for clinical ase as a sereeming action by polysomnography based on the patient's test score.

| | yes |
|-------------------------------------------------|-----|
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | |

AND/OR

| | no |
|------------------------------------------------|----|
| Over-The-Counter Use<br>(21 CFR 807 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quy Suhom

(Division Sign Off) Division of Anesthesiology, General Hos Infection Corirol, Dental Dev

510(k) Number:

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