(53 days)
No
The device description focuses on the physical construction and function of an EEG headpiece for electrode placement and signal conduction. There is no mention of AI, ML, or any data processing beyond signal conduction.
No
This device is for EEG monitoring, which involves sensing and conducting electrical signals for diagnostic purposes, not for treating a condition.
Yes
The device is a headpiece for EEG monitoring, and EEG (electroencephalography) is a diagnostic procedure used to detect electrical activity in the brain to identify conditions like seizures, sleep disorders, and brain damage.
No
The device description clearly states it is a "Headpiece" and describes its physical construction and function in conducting electrical signals, indicating it is a hardware component.
Based on the provided information, this device 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 description clearly states the device is a "Headpiece (48-54 cm) for EEG Monitoring." It functions by locating EEG electrodes and conducting electrical signals from the skin to EEG equipment.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. It is a physical interface for collecting electrical signals from the surface of the head.
Therefore, the device's function falls outside the scope of in vitro diagnostics. It is a component used in a system for physiological monitoring (EEG).
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.
Product codes
GXY
Device Description
The Medium e-Net is designed to fit patients with a head size in the range of 48 - 54 cm in circumference. It is constructed using the same materials and manufacturing processes as the larger sized net 54 - 62 cm) which is described in K930080. The Medium e-Net is fabricated from the same materials as the larger version. Only the size of the components was reduced to achieve the proportional fit on the intended head sizes.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 HydroSpot System, Model 1500 & 1501
SUMMARY OF SAFETY AND EFFECTIVENESS
| Date: | March 1, 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 1210 , Medium e-Net (48 - 54 cm) |
| Predicate Device: | K930080, HydroDot NeuroMonitoring System |
| Classification: | Class II, CFR 21 Part 882.1320, Cutaneous Electrodes |
| Description: | The Medium e-Net is designed to fit patients with a head size in the |
| range of 48 - 54 cm in circumference. It is constructed using the same | |
| materials and manufacturing processes as the larger sized net 54 - 62 | |
| cm) 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. | |
| Design/Materials: | The Medium e-Net is fabricated from the same materials as the larger |
| version. Only the size of the components was reduced to achieve the | |
| proportional fit on the intended head sizes. |
77
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the upper half 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
Re: K960873
Trade/Device Name: Medium e-Net Model 1210 Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated (Date on orig SE ltr): March 1, 1996 Received (Date on orig SE ltr): March 4, 1996
APR - 9 2012
Dear Ms. Frazer:
This letter corrects our substantially equivalent letter of April 26, 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
Page 2 - Ms. Dawn E. Frazer
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 (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.
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,
Kesia Alexander
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
10(k) Number (if known): K960873
evice Name: Model 1210, Medium e-Net
dications For Use:
eadpiece (48-54 cm) for EEG Monitoring
K96073 K960873
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)