(15 days)
Not Found
No
The summary describes a physical headpiece for EEG monitoring and explicitly states that AI, DNN, or ML were not found in the document.
No
The device is a headpiece designed for EEG monitoring, which involves sensing and conducting electrical signals from the skin to EEG equipment. It does not provide any treatment or therapy to the patient.
No
The device is described as a headpiece that locates EEG electrodes and conducts electrical signals from the skin to EEG equipment. It does not perform any analysis or interpretation of the signals to diagnose a condition, but rather facilitates the collection of data for a diagnostic procedure.
No
The device description clearly describes a physical headpiece (e-Net) with electrodes that conducts electrical signals. This is a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Headpiece for EEG Monitoring in Operating Room." This describes a device used to acquire physiological signals (electrical activity of the brain) from a living patient.
- Device Description: The description details a headpiece that positions electrodes on the scalp and conducts electrical signals. This is consistent with a device used for in-vivo measurement.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body), such as blood, urine, tissue, etc. The device directly interacts with the patient's body to collect data.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The e-Net serves two functions as a part of the Hydro Dot NeuroMonitoring System. First, it locates the EEG electrodes according the 10-20 International System. Secondly, it conducts the electrical signal sensed by the electrodes from the skin to the EEG equipment.
EEG recording in OR environment.
Headpiece for EEG Monitoring in Operating Room
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The OR e-Net is designed to fit patients with a head size in the range of 54 - 62 cm in circumference. It is constructed using the same materials and manufacturing processes as the predicate device, Large e-Net which is described in K930080.
The OR e-Net is fabricated from the same materials as the larger version. Two changes were made to make the product more suitable for the OR environment. First, the material located below the ear was removed and secondly, the inion tab was extended to allow it be secured to the neck.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Physiometrix, Inc. 510(k), Premarket Notification OR e-Net (54 - 62 cm)
MAY 10 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
:
| Date: | April 22, 1996 |
|---|---|
| Company: | Physiometrix, Inc. |
| Five Billerica Park | |
| 101 Billerica Avenue | |
| N. Billerica, MA 01862 | |
| Contact: | Dawn E. Frazer |
| Director, Regulatory Affairs & Quality Assurance | |
| (508) 670-2422 | |
| (800) 474-9746 | |
| Subject Device: | Model 1220 , OR e-Net (54 - 62 cm) |
| Predicate Device: | K930080, HydroDot NeuroMonitoring System |
| Classification: | Class II, CFR 21 Part 882.1320, Cutaneous Electrodes |
| Description: | The OR e-Net is designed to fit patients with a head size in the range of |
| 54 - 62 cm in circumference. It is constructed using the same materials | |
| and manufacturing processes as the predicate device, Large e-Net | |
| which is described in K930080. | |
| Intended Use: | The e-Net serves two functions as a part of the Hydro Dot |
| NeuroMonitoring System. First, it locates the EEG electrodes according | |
| the 10-20 International System. Secondly, it conducts the electrical | |
| signal sensed by the electrodes from the skin to the EEG equipment. | |
| Indication for Use: | EEG recording in OR environment. |
| Design/Materials: | The OR e-Net is fabricated from the same materials as the larger |
| version. Two changes were made to make the product more suitable | |
| for the OR environment. First, the material located below the ear was | |
| removed and secondly, the inion tab was extended to allow it be | |
| secured to the neck. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Dawn E. Frazer Director, Regulatory Affairs & Quality Assurance Physiometrix, Inc. Five.Billerica Park 101 Billerica Avenue N. Billerica, Massachusetts 01862
APR - 9 2012
Re: K961609
Trade/Device Name: Model 1220, OR e-Net (54-62 cm) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated (Date on orig SE ltr): April 22, 1996 Received (Date on orig SE Itr): April 25, 1996
Dear Ms. Frazer:
This letter corrects our substantially equivalent letter of May 10, 1996.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
2
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Kesia Alexander
Image /page/2/Picture/7 description: The image contains a handwritten word, "for", in cursive script. The letter 'f' is characterized by a long, sweeping stroke that descends below the baseline and curves back up to form the main body of the letter. The 'o' is a simple, closed loop connected to the 'f', and the 'r' is a small, curved stroke that extends from the 'o'. The writing is in black ink against a white background.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Physiometrix, Inc. 510(k), Premarket Notification OR e-Net (54 - 62 cm)
| 510(K) Number (if known): | |
|---|---|
| --------------------------- | -- |
Device Name:
Model 1220, OR e-Net (54 - 62 cm)_
Unknown_
Indications for Use:
Headpiece for EEG Monitoring in Operating Room_
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K961609 |
Prescription Use Per 21 CFR 801.109)
OR
Over-The-Counter Use
8