(158 days)
Not Found
No
The description focuses on data collection and transmission of respiratory airflow data based on pressure changes, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device collects data for diagnostic purposes (EEG, sleep disorder, neuromonitoring, neurodiagnostic studies) and does not provide therapy or treatment.
Yes
The device collects respiratory airflow data for various studies (EEG, sleep disorder, neuromonitoring, neurodiagnostic), which are inherently diagnostic in nature. It measures functional respiratory airflow by recording pressure changes, providing information used to identify conditions or diseases.
No
The device description clearly outlines a physical module with dimensions, weight, and physical connections (cannula, cable). It measures pressure changes, indicating a hardware component is involved in data acquisition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device directly measures a physiological parameter (respiratory airflow via pressure changes at the nose and mouth) from the patient. It does not analyze a sample taken from the patient.
The device is a physiological monitoring device used to collect data directly from the patient's body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The Cadwell EasyNet® Nasal Pressure Module provides respiratory airflow data to Cadwell EasyNet® enabled systems. It outputs a digital representation of the data using the Cadwell proprietary EasyNet® communications protocol. The module measures 2 x 1.4 x .8 inches. It weighs about an ounce and is attached to the patient's chest or shoulder with elastic straps. An oral/nasal cannula is attached from the module to a patient's nose and mouth. A single small cable connects the device to the EasyNet® enabled system. The module requires no routine calibration or maintenance. The Nasal Pressure module determines functional respiratory airflow by recording pressure changes at the nose and mouth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Hospital, clinical or ambulatory setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Cadwell's EasyNet® Nasal Pressure Module has been tested both in a development environment and in a clinical setting with human subjects to support the determination of substantial equivalence and confirm conformance to accuracy and precision specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) Summary
| Submitter: | Cadwell Laboratories, Inc. | |
|---|---|---|
| Contact Person: | Chris Bolkan | |
| Safety / Regulatory Specialist | ||
| Cadwell Laboratories, Inc. | ||
| 909 N. Kellogg Street | ||
| Kennewick, Washington 99336 | NOV 21 2006 | |
| Date Prepared: | May 22, 2006 | |
| Trade Name: | EasyNet® Nasal Pressure Module | |
| Classification Name | ||
| 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 | |
| respiratory airflow data to Cadwell EasyNet® enabled | ||
| systems. It outputs a digital representation of the data using | ||
| the Cadwell proprietary EasyNet® communications | ||
| protocol. The module measures 2 x 1.4 x .8 inches. It | ||
| weighs about an ounce and is attached to the patient's chest | ||
| or shoulder with elastic straps. An oral/nasal cannula is | ||
| attached from the module to a patient's nose and mouth. A | ||
| single small cable connects the device to the EasyNet® | ||
| enabled system. The module requires no routine | ||
| calibration or maintenance. | ||
| The Nasal Pressure module determines functional | ||
| respiratory airflow by recording pressure changes at the | ||
| nose and mouth. | ||
| Indications for Use: | The Cadwell EasyNet Nasal Pressure | |
| Module collects respiratory airflow data for adult and | ||
| pediatric patients. The data is transmitted to a Cadwellmay be used in a hospital, clinical or ambulatory setting for | ||
| EEG studies, sleep disorder studies and other | ||
| neuromonitoring and neurodiagnostic studies. | ||
| Functional and | ||
| Safety Testing: | Cadwell's EasyNet® Nasal Pressure Module has been | |
| tested both in a development environment and in a clinical | ||
| setting with human subjects to support the determination of | ||
| substantial equivalence and confirm conformance to | ||
| accuracy and precision specifications. | ||
| Conclusion: | Cadwell's EasyNet® Nasal Airflow Module is substantially | |
| equivalent to the predicate device in terms of safety, | ||
| accuracy, functional design and principles of operation. |
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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
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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 |
| 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. | |
| Contraindications: | No absolute contraindications |
| Precautions: | This product is for diagnostic purposes only and is not to be used in |
| a life supporting or life-sustaining situation. | |
| Warnings: | The EasyNet Nasal Pressure Module is NOT sealed against the |
| ingress of fluids. Do not bathe while wearing the module. Do not | |
| use if wet. | |
| Not for use in the presence of explosive atmosphere or flammable | |
| 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
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