(83 days)
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Not Found
No
The summary describes a device that detects body position and provides output data. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description is purely functional and does not suggest any learning or adaptive capabilities.
No
The device is intended to detect body positions and provide output data for physiological recording, specifically for EEG and sleep disorder studies. It does not directly provide therapy or treatment for any medical condition.
Yes
The device is described as detecting body positions during physiological recording and providing output data corresponding to five body positions. This data is used in EEG and sleep disorder studies, which are diagnostic processes.
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only or includes hardware components.
Based on the provided information, the Cadwell Easy Body Position Module is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Cadwell Easy Body Position Module detects body positions. It does not analyze biological samples from the body.
- Intended Use: The intended use is to detect body positions during physiological recording (EEG and sleep studies), not to diagnose a disease or condition based on analysis of bodily fluids or tissues.
Therefore, the device falls outside the scope of what is considered an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cadwell Easy Body Position Module is intended for use to detect body positions during physiological recording. It provides output data that corresponds to five body positions (supine, prone, left side, right side and sitting up). It may be used in a clinical or ambulatory setting for both EEG and sleep disorder studies.
Product codes
MNR, LEL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Body
Indicated Patient Age Range
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Intended User / Care Setting
Clinical or ambulatory setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 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. In the center of the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them.
(JUL 0 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris L. Bolkan Product Safety and Regulatory Specialist Cadwell Laboratories, Inc. 909 N. Kellogg Street Kennewick. Washington 99336
Re: K040932
Trade/Device Name: EasyNet Body Position Module Regulation Number: 21 CFR 868.2375, Unclassified Regulation Name: Breathing frequency monitor, Sleep assessment device Regulatory Class: II Product Code: MNR and LEL Dated: March 17, 2004 Received: April 27, 2004
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.
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.
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Page 2 - Mr. Chris L. Bolkan
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number: | K040932 |
|---|---|
| ---------------- | --------- |
Device Name: EasyNet Body Position Module
Indications for use: The Cadwell Easy Body Position Module is intended for use to detect body positions during physiological recording. It provides output data that corresponds to five body positions (supine, prone, left side, right side and sitting up). It may be used in a clinical or ambulatory setting for both EEG and sleep disorder 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 Easy Body Position 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 × (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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K040932