(158 days)
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.
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.
The Cadwell EasyNet Nasal Pressure Module (K061705) is a device that collects respiratory airflow data for adult and pediatric patients in various clinical settings. The provided information is a 510(k) summary, which outlines the device's substantial equivalence to a predicate device rather than a detailed study protocol and results with specific acceptance criteria and performance metrics. Therefore, some of the requested information, particularly quantitative measures of performance against specific acceptance criteria, sample sizes for test and training sets, and details of ground truth establishment by experts, are not explicitly present in the provided document.
However, based on the available information, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for respiration measurement accuracy (e.g., specific thresholds for mean absolute error or agreement rates). Instead, it relies on the concept of "substantial equivalence" to a predicate device (Pro-Tech PTAF 2 Nasal Pressure Sensor, K982293).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to predicate device | "The Cadwell EasyNet® Nasal Airflow Module is substantially equivalent to the predicate device in terms of safety, accuracy, functional design and principles of operation." |
| Safety (e.g., electrical, mechanical, biocompatibility) | The device was subjected to "Functional and Safety Testing" in a development and clinical setting. Overall conclusion of "substantial equivalence to the predicate device in terms of safety." |
| Accuracy of respiratory airflow data collection | "confirm conformance to accuracy and precision specifications." (Specific specifications are not detailed in this summary.) "Substantially equivalent to the predicate device in terms of... accuracy." |
| Precision of respiratory airflow data collection | "confirm conformance to accuracy and precision specifications." (Specific specifications are not detailed in this summary.) |
| Suitability for indicated uses (EEG, sleep disorder, neuromonitoring) | "The Cadwell EasyNet® Nasal Pressure Module collects respiratory airflow data for adult and pediatric patients." Data is transmitted and displayed by an EasyNet® enabled system. "May be used in a hospital, clinical or ambulatory setting for EEG studies, sleep disorder studies and other neuromonitoring and neurodiagnostic studies." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical setting with human subjects" for testing but does not specify the sample size for this test set.
- Sample Size for Test Set: Not specified.
- Data Provenance: The device was tested "in a clinical setting with human subjects." The country of origin for the data is implied to be where Cadwell Laboratories, Inc. is located or where their clinical studies were conducted, but this is not explicitly stated. The study appears to be prospective as it involved testing the device "with human subjects" as part of its development and validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the device's performance.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported in this 510(k) summary. This device is a sensor for collecting physiological data, not an AI-assisted diagnostic tool for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device itself is a standalone sensor/module that collects and transmits data. Its performance is evaluated on its ability to accurately measure respiratory airflow. The "Functional and Safety Testing" mentioned implies a standalone performance evaluation of the device's accuracy and precision, though the specific methodology is not detailed. There is no "algorithm" in the sense of an AI model being evaluated here; it's a physical sensor.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance evaluation. For a device measuring physiological parameters like respiratory airflow, ground truth would typically involve:
- Comparison to a gold standard reference device known for accurate respiratory airflow measurement.
- Potentially, expert observation or interpretation of respiration patterns synchronized with the device's output, but this is not specified.
8. The Sample Size for the Training Set
This device does not involve a "training set" in the context of machine learning. It is a hardware sensor. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set Was Established
As this device does not involve a "training set" for machine learning, this question is not applicable.
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510(k) Summary
| Submitter: | Cadwell Laboratories, Inc. | |
|---|---|---|
| Contact Person: | Chris BolkanSafety / Regulatory SpecialistCadwell Laboratories, Inc.909 N. Kellogg StreetKennewick, Washington 99336 | NOV 21 2006 |
| Date Prepared: | May 22, 2006 | |
| Trade Name: | EasyNet® Nasal Pressure Module | |
| Classification NameAnd 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 providesrespiratory airflow data to Cadwell EasyNet® enabledsystems. It outputs a digital representation of the data usingthe Cadwell proprietary EasyNet® communicationsprotocol. The module measures 2 x 1.4 x .8 inches. Itweighs about an ounce and is attached to the patient's chestor shoulder with elastic straps. An oral/nasal cannula isattached from the module to a patient's nose and mouth. Asingle small cable connects the device to the EasyNet®enabled system. The module requires no routinecalibration or maintenance.The Nasal Pressure module determines functionalrespiratory airflow by recording pressure changes at thenose and mouth. | |
| Indications for Use: | The Cadwell EasyNet Nasal PressureModule collects respiratory airflow data for adult andpediatric patients. The data is transmitted to a Cadwellmay be used in a hospital, clinical or ambulatory setting forEEG studies, sleep disorder studies and otherneuromonitoring and neurodiagnostic studies. | |
| Functional andSafety Testing: | Cadwell's EasyNet® Nasal Pressure Module has beentested both in a development environment and in a clinicalsetting with human subjects to support the determination ofsubstantial equivalence and confirm conformance toaccuracy and precision specifications. | |
| Conclusion: | Cadwell's EasyNet® Nasal Airflow Module is substantiallyequivalent 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.
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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 respiratoryairflow data for adult and pediatric patients. The data is transmittedto a Cadwell EasyNet enabled system where it is displayed. Themodule may be used in a hospital, clinical or ambulatory setting forEEG studies, sleep disorder studies and other neuromonitoring andneurodiagnostic studies. |
| Contraindications: | No absolute contraindications |
| Precautions: | This product is for diagnostic purposes only and is not to be used ina life supporting or life-sustaining situation. |
| Warnings: | The EasyNet Nasal Pressure Module is NOT sealed against theingress of fluids. Do not bathe while wearing the module. Do notuse if wet. |
| Not for use in the presence of explosive atmosphere or flammableanesthetics |
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)
Muthal Varkey
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Cilon Control, Dental Devises Collon Control, Dental Devices övü. İşi Kumbən
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§ 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).