CADWELL EASYNET NASAL PRESSURE MODULE

K061705 · Cadwell Laboratories, Inc. · MNR · Nov 21, 2006 · Anesthesiology

Device Facts

• Record ID: K061705
• Device Name: CADWELL EASYNET NASAL PRESSURE MODULE
• Applicant: Cadwell Laboratories, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: Nov 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Cadwell EasyNet Nasal Pressure Module collects respiratory airflow data for adult and pediatric patients. The data is transmitted to a Cadwell EasyNet enabled system where it is displayed. The module may be used in a hospital, clinical or ambulatory setting for EEG studies, sleep disorder studies and other neuromonitoring and neurodiagnostic studies.

Device Story

Device collects respiratory airflow data via oral/nasal cannula; measures pressure changes at nose and mouth. Module (2x1.4x0.8 inches, ~1 oz) attaches to patient chest/shoulder via elastic straps. Data transmitted digitally via proprietary EasyNet communications protocol to Cadwell EasyNet-enabled system. Used in hospital, clinical, or ambulatory settings by clinicians for diagnostic monitoring. Output displayed on host system for clinical review; aids in assessment of sleep disorders and neurological conditions. Device is diagnostic only; not for life support.

Clinical Evidence

Bench testing and clinical setting testing with human subjects performed to confirm accuracy and precision specifications.

Technological Characteristics

Pressure-based respiratory airflow sensor. Dimensions: 2 x 1.4 x 0.8 inches. Weight: ~1 oz. Connectivity: Proprietary EasyNet digital communication protocol via single cable to host system. Power: Not specified. Maintenance: No routine calibration required. Form factor: Wearable (chest/shoulder strap).

Indications for Use

Indicated for adult and pediatric patients requiring respiratory airflow data collection during EEG, sleep disorder, or other neuromonitoring/neurodiagnostic studies. No absolute contraindications.

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

• Pro-Tech PTAF 2 Nasal Pressure Sensor (K982293)

Submission Summary (Full Text)

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

K061705

# 510(k) Summary

| Submitter: | Cadwell Laboratories, Inc. | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Chris Bolkan<br>Safety / Regulatory Specialist<br>Cadwell Laboratories, Inc.<br>909 N. Kellogg Street<br>Kennewick, Washington 99336 | NOV 21 2006 |
| Date Prepared: | May 22, 2006 | |
| Trade Name: | EasyNet® Nasal Pressure Module | |
| Classification Name<br>And Number: | Class II, 21 CFR 868.2375 | |
| Product Code: | MNR | |
| Classification Panel: | Anesthesiology | |
| Predicate Device: | Pro-Tech PTAF 2 Nasal Pressure Sensor, K982293 | |
| Device Description: | The Cadwell EasyNet® Nasal Pressure Module provides<br>respiratory airflow data to Cadwell EasyNet® enabled<br>systems. It outputs a digital representation of the data using<br>the Cadwell proprietary EasyNet® communications<br>protocol. The module measures 2 x 1.4 x .8 inches. It<br>weighs about an ounce and is attached to the patient's chest<br>or shoulder with elastic straps. An oral/nasal cannula is<br>attached from the module to a patient's nose and mouth. A<br>single small cable connects the device to the EasyNet®<br>enabled system. The module requires no routine<br>calibration or maintenance.<br>The Nasal Pressure module determines functional<br>respiratory airflow by recording pressure changes at the<br>nose and mouth. | |
| Indications for Use: | The Cadwell EasyNet Nasal Pressure<br>Module collects respiratory airflow data for adult and<br>pediatric patients. The data is transmitted to a Cadwellmay be used in a hospital, clinical or ambulatory setting for<br>EEG studies, sleep disorder studies and other<br>neuromonitoring and neurodiagnostic studies. | |
| Functional and<br>Safety Testing: | Cadwell's EasyNet® Nasal Pressure Module has been<br>tested both in a development environment and in a clinical<br>setting with human subjects to support the determination of<br>substantial equivalence and confirm conformance to<br>accuracy and precision specifications. | |
| Conclusion: | Cadwell's EasyNet® Nasal Airflow Module is substantially<br>equivalent to the predicate device in terms of safety,<br>accuracy, functional design and principles of operation. | |

-

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

·

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

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chris Bolkan Product Safety/Regulatory Specialist Cadwell Laboratories, Incorporated 909 North Kellogg Street Kennewick, Washington 99336

NOV 2 1 2006

Re: K061705

Trade/Device Name: Cadwell EasyNet Nasal Pressure Module Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: October 10, 2006 Received: October 27, 2006

Dear Mr. Bolkan:

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.

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

#### Page 2 - Mr. Bolkan

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/industry/support/index.html.

Sincerely yours.

Syritte Y. Michu DMD.

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

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

## Indications for Use

| 510(k) Number: | K061705 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Cadwell EasyNet Nasal Pressure Module |
| Indications for use: | The Cadwell EasyNet Nasal Pressure Module collects respiratory<br>airflow data for adult and pediatric patients. The data is transmitted<br>to a Cadwell EasyNet enabled system where it is displayed. The<br>module may be used in a hospital, clinical or ambulatory setting for<br>EEG studies, sleep disorder studies and other neuromonitoring and<br>neurodiagnostic studies. |
| Contraindications: | No absolute contraindications |
| Precautions: | This product is for diagnostic purposes only and is not to be used in<br>a life supporting or life-sustaining situation. |
| Warnings: | The EasyNet Nasal Pressure Module is NOT sealed against the<br>ingress of fluids. Do not bathe while wearing the module. Do not<br>use if wet. |
| | Not for use in the presence of explosive atmosphere or flammable<br>anesthetics |

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)

Muthal Varkey

al Sign-Chi) ്തിന്റെ വിവിധ വിവിധ വിശ്വാസി Hospital,
Cilon Control, Dental Devises Collon Control, Dental Devices övü. İşi Kumbən

Page 1 of __1___