DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR

K040069 · Dymedix, Inc. · MNR · May 5, 2004 · Anesthesiology

Device Facts

• Record ID: K040069
• Device Name: DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
• Applicant: Dymedix, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: May 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The DYMEDIX Incorporated Reusable Airflow/Snore Sensor is used with existing recording devices in support of diagnostic recording of nasal, oral airflow and breath sounds (snore). The sensors are used with patients who require a sleep study.

Device Story

Reusable sensor for sleep disorder evaluation; detects nasal/oral airflow and breath sounds (snore). Input: temperature differential between exhaled air and ambient air; vibration from breath sounds. Principle: Polarized Polyvinylidene Fluoride (PVDF) film generates small voltage signals via pyroelectric and piezoelectric effects. Output: electrical signal transmitted to external diagnostic recording equipment. Used in clinical sleep study settings; operated by physicians, clinicians, or licensed medical practitioners. Healthcare providers interpret displayed signals to diagnose sleep and airflow disorders. Benefits: enables objective recording of respiratory and snoring events for clinical assessment.

Clinical Evidence

Bench testing only. Representative laboratory data provided to demonstrate equivalent performance of the reusable sensor compared to the predicate Gemini Sensor.

Technological Characteristics

Sensing material: Polarized Polyvinylidene Fluoride (PVDF) film. Housing/lead wire material: PVC. Sensing principle: Pyroelectric (temperature-based) and piezoelectric (vibration-based) signal generation. Form factor: Reusable sensor housing. Connectivity: Wired connection to external diagnostic recording equipment.

Indications for Use

Indicated for patients requiring a sleep study for diagnostic recording of nasal/oral airflow and breath sounds (snore).

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

• Gemini Sensor (Disposable) (K990321)
• Cannula-Style Thermocouple Airflow Sensor (K913396)

Submission Summary (Full Text)

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### Summary of Safety and Effectiveness

| Company Name: | DYMEDIX, Inc.<br>3989 Central Ave. NE<br>Suite 116<br>Minneapolis, MN 55421 | | | | | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---------|--------------|------------------------|-------------|-------------------------------------------|
| Contact: | Bill Ham, President, COO | | | | | | |
| Phone: | [phone] | | | | | | |
| Fax: | [phone] | | | | | | |
| Summary Date: | February 9, 2004 | | | | | | |
| Trade Name: | DYMEDIX Reusable Airflow/Snore Sensor | | | | | | |
| Common Name: | Airflow Sensor | | | | | | |
| Classification Name: | Predicate airflow/snore sensors have been found substantially equivalent<br>to 21 CFR 868.2375, Breathing Frequency Monitor, Class II, BZQ. | | | | | | |
| Predicate Devices: | | | | | | | |
| | <table><tr><td>510(k) Number:</td><td>K990321</td></tr><tr><td>Manufacture:</td><td>DYMEDIX Incorporated</td></tr><tr><td>Trade Name:</td><td>Gemini Sensor (Disposable)</td></tr></table> | 510(k) Number: | K990321 | Manufacture: | DYMEDIX Incorporated | Trade Name: | Gemini Sensor (Disposable) |
| 510(k) Number: | K990321 | | | | | | |
| Manufacture: | DYMEDIX Incorporated | | | | | | |
| Trade Name: | Gemini Sensor (Disposable) | | | | | | |
| | <table><tr><td>510(k) Number:</td><td>K913396</td></tr><tr><td>Manufacture:</td><td>Pro-Tech Services Inc.</td></tr><tr><td>Trade Name:</td><td>Cannula-Style Thermocouple Airflow Sensor</td></tr></table> | 510(k) Number: | K913396 | Manufacture: | Pro-Tech Services Inc. | Trade Name: | Cannula-Style Thermocouple Airflow Sensor |
| 510(k) Number: | K913396 | | | | | | |
| Manufacture: | Pro-Tech Services Inc. | | | | | | |
| Trade Name: | Cannula-Style Thermocouple Airflow Sensor | | | | | | |

#### Description of the Reusable Airflow/Snore Sensor 1.0

During evaluation of sleep disorders and other clinical applications for airflow recording, an airflow sensor is applied to the patient, typically under the nasal passages, to support recording of airflow signals. During the evaluation of sleep disorders and other clinical applications for breath sounds (snore) recording, a snore sensor is applied to the patient to support recording of snore signals. These recorded signals are analyzed by a qualified physician, clinician or licensed medical practitioner in support of diagnosis of sleep and airflow disorders.

The Reusable Airflow/Snore Sensor is a pyroelectricity (pyro) and piezoelectric (piezo) sensor. The temperature difference between patient exhaled air and ambient air generates

File: RevA Reuseable Sensor 510(k) FDA Reply 2-9-2004.doc

.

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a small voltage signal, which can be recorded as airflow by diagnostic recording equipment. The vibration from breath sounds (snoring) produce a small voltage signal, which can be recorded as snoring by diagnostic recording equipment. The user's recording device displays the resulting signal for interpretation by a trained physician or clinician.

Polarized Polyvinylidene Fluoride Film (PVDF) is the temperature sensing matcrial. The polarized PVDF material has pyro (temperature) signal generation capability. Polarized PVDF material self generates a small electrical charge in the presence of temperature. The predicate Disposable Airflow/Snore Sensor (K990321) applied the same PVDF Film airflow and breath sound (snore) sensing technology.

The DYMEDIX Airflow/Snore Sensor consists of a temperature sensitive material (PVDF) molded into a reusable housing. The molding material is PVC. This same PVC material is used in the lead wires from the sensor. This same PVC material is used with the predicate DYMEDIX Disposable Airflow/Snore Sensor lead wires, reference K990321.

#### 2.0 Intended Use of the Reusable Airflow/Snore Sensor

The DYMEDIX Incorporated Reusable Airflow/Snore Scnsor is used with existing recording devices in support of diagnostic recording of nasal, oral airflow and breath sounds (snore). The sensors are used with patients who require a sleep study.

#### 3.0 Technological Characteristics

Polarized Polyvinylidene Fluoride Film (PVDF) is the temperature sensing material. The polarized PVDF material has pyro (temperature) signal generation capability. Polarized PVDF material self generates a small electrical charge in the presence of temperature.

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#### 4.0 Data Summary

Representative laboratory data are presented to demonstrate equivalent performance of the Reusable Airflow/Snore Sensor to the predicate Gemini Sensor.

#### 5.0 Conclusions

The laboratory data and standards certifications support the conclusion of the safety and effectiveness the Reusable Airflow/Snore Sensor.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2004

Dymedix, Incorporated C/O Mr. Robert Mosenkis CITECH 5200 Butler Pike Plymouth Mecting, Pennsylvania 19462-1298

Re: K040069

Trade/Device Name: Dymedix Reusable Airflow/Snorc Sensor Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: April 27, 2004 Received: April 28, 2004

Dear Mr. Mosenkis:

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 8010 tartoon. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Robert Mosenkis

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,

Chia-Lin, Ph.D.

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: Reusable Airflow/Snore Sensor

Indications for Use:

The DYMEDIX Incorporated Reusable Airflow/Snore Sensor is used with existing recording devices in support of diagnostic recording of nasal, oral airflow and breathing sounds (snore). The sensors are used with patients who require a sleep study.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Ave Sch

General Hospital.

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510(k) Number

(Posted November 13, 2003)