ALPHAMED GEMINI SENSOR, SNORING SENSOR

K990321 · Alphamed, Inc. · MNR · Jun 1, 1999 · Anesthesiology

Device Facts

• Record ID: K990321
• Device Name: ALPHAMED GEMINI SENSOR, SNORING SENSOR
• Applicant: Alphamed, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: Jun 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Indications for Use

The disposable sensors are applied to the patient during a sleep study evaluation. The sensors provide a signal which is recorded as airflow and/or breath sounds. Trained professionals (physicians, clinicians) interpret the recorded signals in support of sleep study diagnosis. The sensors are contraindicated for use as apnea monitoring sensors.

Device Story

Disposable, single-patient-use sensors for sleep study evaluations. Input: temperature changes (airflow) and vibrations (breath sounds). Principle: self-generating signal technology; no internal electronics or software. Application: medical-grade tape under nostrils/above lip (airflow) or on throat (breath sounds). Connection: AlphaMed Adapter Cable to existing sleep recording equipment. Output: raw signal for recording/amplification by external device. Operation: clinician-applied in clinical sleep study settings. Benefit: provides diagnostic data for sleep study interpretation. Does not perform apnea monitoring.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993 and electrical safety certification per IEC 601-1, Subclause 56.3, Paragraph c.

Technological Characteristics

Temperature and vibration sensitive material with conductive ink electrodes. Lead wires comply with 21 CFR Part 898. Passive, self-generating signal technology. No internal electronics or software. Disposable, single-patient use. Interfaces with existing recording equipment via proprietary adapter cables.

Indications for Use

Indicated for patients undergoing sleep study evaluations requiring recording of nasal/oral airflow and breath sounds. Contraindicated for apnea monitoring.

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

• EdenTrace Airflow Cable Model 3171 and Sleep Lab Airflow Cable Model 3170 Sensor (K913749)
• Snoring Microphone (K940015)

Submission Summary (Full Text)

{0}------------------------------------------------

# AlphaMed, Inc. 3989 Central Av. N.E. Suite 560 Minneapolis, MN., 55421

# Summary of Safety and Effectiveness

| Company Name: | AlphaMed, Inc.<br>3989 Central Ave. NE<br>Suite 560<br>Minneapolis, MN 55421 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Peter Stasz, President CEO |
| Phone: | [phone] |
| Fax: | [phone] |
| Summary Date: | January 28, 1999 |
| Trade Name: | AlphaMed Breathing/Snoring Sensors, Snoring Sensors |
| Common Name: | Breathing Sensors, Snoring Sensor |
| Classification Name: | Predicate breathing sensors have been found to be substantially<br>equivalent to 21 CFR 868.2375, Breathing Frequency Monitor.<br>Class II, BZQ<br><br>Predicate snoring sensors have been found substantially<br>equivalent to 21 CFR 868.2375, Ventilatory Effort Recorder,<br>Class II, MNR |
| Predicate Device(s): | 510(k) Number: K913749<br>Manufacture: EdenTec inc.<br>Trade Name: EdenTrace Airflow Cable Model 3171and Sleep<br>Lab Airflow Cable Model 3170 Sensor<br><br>510(k) Number: K940015<br>Manufacture: Pro-Tech Inc.<br>Trade Name: Snoring Microphone |

## 1.0 Description of Sensors

The Breathing/Snoring Sensors and Snoring Sensors are disposable, single patient use devices. The Breathing/Snoring Sensors combine breathing and snoring sound sensing capabilities in one sensor.

{1}------------------------------------------------

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The sensors use a self-generating signal technology. The sensors contain no electronics or software and require no special interface electronics.

The sensors attach to the patient with medical grade tape. The Breathing/Snoring Sensors are applied under the nostrils and above the lip. The Breath Sounds sensors are applied to the throat of the patient.

The sensors connect to existing recording equipment by means of an AlphaMed Adapter Cable. The existing recording equipment amplifies the signal the sensors generate in response to a temperature change and/or a vibration due to breath sounds. The existing recording device provides patient electrical isolation for the applied sensors.

### 2.0 Intended Use of Sensors

The disposable sensors are applied to the patient during a sleep study evaluation. The sensors provide a signal which is recorded as airflow and/or breath sounds. Trained professionals (physicians, clinicians) interpret the recorded signals in support of sleep study diagnosis. The sensors are contraindicated for use as apnea monitoring sensors.

### 3.0 Technological Characteristics

The sensors consist of a temperature and vibration sensitive material covered with conductive ink to collect the electrical charge generated by the temperature and vibration sensitive material. The conductive ink surface has electrodes lead wires attached. The lead wires comply with 21 CFR Part 898 Performance Standards for Electrode Lead Wires and Patient Cables.

The lead wires interface to existing sleep recording devices by a supplied Adapter Cable. Different Adapter Cables are available to support interface to various sleep recording instruments.

{2}------------------------------------------------

### 4.0 Data Summary

Laboratory data are presented to establish the performance of the Breathing/Snoring Sensors and Breath Sounds Sensors. Material biocompatibility data in compliance with ISO 10993 are provided or prior use of materials with other medical devices establishes the biocompatibility of the sensor materials. A Certification of Conformance to the Medical Device Safety Standard IEC 601-1, Subclause 56.3, Paragraph c is provided.

### 5.0 Conclusions

The laboratory data, biocompatibility information and certification presented support the conclusion of the safety and effectiveness of the Breathing/Snoring Sensors and Breath Sounds sensors.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus in the logo is depicted with a single staff entwined by a serpent, topped with a pair of wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1000

Mr. Peter Stasz AlphaMed, Inc. 3989 Central Avenue, N.E., Suite 560 Minneapolis, MN 55421

Re: K990321 AlphaMed Breathing/Snoring/Sensors, Snoring Sensors Regulatory Class: II (two) Product Code: 73 MNR Dated: April 29, 1999 Received: April 30, 1999

Dear Mr. Stasz:

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 requlations 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 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. regulatory 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.

{4}------------------------------------------------

Page 2 - Mr. Peter Stasz

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

{5}------------------------------------------------

# AlphaMed, Inc. 3989 Central Av. N.E. Suite 560 Minneapolis, MN., 55421

# Summary of Safety and Effectiveness

| Company Name: | AlphaMed, Inc.<br>3989 Central Ave. NE<br>Suite 560<br>Minneapolis, MN 55421 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Peter Stasz, President CEO |
| Phone: | [phone] |
| Fax: | [phone] |
| Summary Date: | January 28, 1999 |
| Trade Name: | AlphaMed Breathing/Snoring Sensors, Snoring Sensors |
| Common Name: | Breathing Sensors, Snoring Sensor |
| Classification Name: | Predicate breathing sensors have been found to be substantially<br>equivalent to 21 CFR 868.2375, Breathing Frequency Monitor.<br>Class II, BZQ<br><br>Predicate snoring sensors have been found substantially<br>equivalent to 21 CFR 868.2375, Ventilatory Effort Recorder,<br>Class II, MNR |
| Predicate Device(s): | 510(k) Number: K913749<br>Manufacture: EdenTec inc.<br>Trade Name: EdenTrace Airflow Cable Model 3171and Sleep<br>Lab Airflow Cable Model 3170 Sensor<br><br>510(k) Number: K940015<br>Manufacture: Pro-Tech Inc. |

## Description of Sensors 1.0

The Breathing/Snoring Sensors and Snoring Sensors are disposable, single patient use devices. The Breathing/Snoring Sensors combine breathing and snoring sound sensing capabilities in one sensor.

{6}------------------------------------------------

The sensors use a self-generating signal technology. The sensors contain no electronics or software and require no special interface electronics.

The sensors attach to the patient with medical grade tape. The Breathing/Snoring Sensors are applied under the nostrils and above the lip. The Breath Sounds sensors are applied to the throat of the patient.

The sensors connect to existing recording equipment by means of an AlphaMed Adapter Cable. The existing recording equipment amplifies the signal the sensors generate in response to a temperature change and/or a vibration due to breath sounds. The existing recording device provides patient electrical isolation for the applied sensors.

### 2.0 Intended Use of Sensors

The disposable sensors are applied to the patient during a sleep study evaluation. The sensors provide a signal which is recorded as airflow and/or breath sounds. Trained professionals (physicians, clinicians) interpret the recorded signals in support of sleep study diagnosis. The sensors are contraindicated for use as apnea monitoring sensors.

### 3.0 Technological Characteristics

The sensors consist of a temperature and vibration sensitive material covered with conductive ink to collect the electrical charge generated by the temperature and vibration sensitive material. The conductive ink surface has electrodes lead wires attached. The lead wires comply with 21 CFR Part 898 Performance Standards for Electrode Lead Wires and Patient Cables.

The lead wires interface to existing sleep recording devices by a supplied Adapter Cable. Different Adapter Cables are available to support interface to various sleep recording instruments.

{7}------------------------------------------------

### Data Summary 4.0

Laboratory data are presented to establish the performance of the Breathing/Snoring Sensors and Breath Sounds Sensors. Material biocompatibility data in compliance with ISO 10993 are provided or prior use of materials with other medical devices establishes the biocompatibility of the sensor materials. A Certification of Conformance to the Medical Device Safety Standard IEC 601-1, Subclause 56.3, Paragraph c is provided.

### 5.0 Conclusions

The laboratory data, biocompatibility information and certification presented support the conclusion of the safety and effectiveness of the Breathing/Snoring Sensors and Breath Sounds sensors.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 1 1999 JUN

Mr. Peter Stasz AlphaMed, Inc. 3989 Central Avenue, N.E., Suite 560 Minneapolis, MN 55421

Re : к990321 AlphaMed Breathing/Snoring/Sensors, Snoring Sensors Regulatory Class: II (two) Product Code: 73 MNR Dated: April 29, 1999 Received: April 30, 1999

Dear Mr. Stasz:

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 requlations 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 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. regulatory 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.

{9}------------------------------------------------

Page 2 - Mr. Peter Stasz

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{10}------------------------------------------------

Page 2-2

Arth A. Cal.

(Division Sign-Off)
Division of Cardiovascular, Respiratory,

and Neurological Devices

510(k) Number

The sensors are contraindicated for support of apnea monitoring.

(Optional Format 3-10-98)

oTC

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

existing recording devices in support of diagnostic recording of nasal and oral airflow and recording of breath sounds. The sensors are used with patients who require a sleep study recording.

The disposable AlphaMed Inc. Breathing/Snoring Sensors and Snoring Sensor are used with

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