(53 days)
Not Found
No
The device description focuses solely on the physical construction and function of an EEG electrode net, with no mention of data processing, analysis, or any computational algorithms, let alone AI/ML.
No
The device is described as a headpiece for EEG monitoring that locates electrodes and conducts electrical signals to EEG equipment. It does not state that it treats or cures any condition.
Yes
The device is used as part of an EEG monitoring system, which is a diagnostic tool for measuring electrical activity in the brain.
No
The device description clearly describes a physical "e-Net" that serves to locate electrodes and conduct electrical signals, indicating it is a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device's function is to:
- Locate EEG electrodes on the head.
- Conduct electrical signals from the skin to EEG equipment.
- No Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device interacts directly with the patient's skin to capture electrical signals.
Therefore, this device falls under the category of a medical device used for physiological monitoring (specifically, electroencephalography), not an in vitro diagnostic.
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.
Headpiece (42-48 cm) for EEG Monitoring
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The small e-Net is designed to fit patients with a head size in the range of 42 - 48 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 small e-Net is fabricated from the same materials as the larger version. Only the size of the components was reduced to achieve the proportional fir 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): 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 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 1240 , Small e-Net (42 - 48 cm) |
| Predicate Device: | K930080, HydroDot NeuroMonitoring System |
| Classification: | Class II, CFR 21 Part 882.1320, Cutaneous Electrodes |
| Description: | The small e-Net is designed to fit patients with a head size in the range |
| of 42 - 48 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 small e-Net is fabricated from the same materials as the larger |
| version. Only the size of the components was reduced to achieve the | |
| proportional fir on the intended head sizes. |
(r
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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: K960885
Trade/Device Name: Small e-Net Model 1240 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
Dear Ms. Frazer:
This letter corrects our sustantially 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
Image /page/2/Picture/7 description: The image shows the word "for" written in cursive. The "f" is elongated and loops down below the baseline, while the "o" and "r" are connected and smaller in size. The word is written in black ink on 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
Page 1 of 1
510(k) Number (if known): K960885
Device Name: Model 1240, Small e-Net
Indications For Use:
Headpiece (42-48 cm) for EEG Monitoring
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K960885
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
rescription Use
Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)