MODEL 1210, MEDIUM E-NET

K960873 · Physiometrix, Inc. · GXY · Apr 26, 1996 · Neurology

Device Facts

• Record ID: K960873
• Device Name: MODEL 1210, MEDIUM E-NET
• Applicant: Physiometrix, Inc.
• Product Code: GXY · Neurology
• Decision Date: Apr 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

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.

Device Story

Medium e-Net (Model 1210) is a headpiece designed for EEG monitoring; fits patients with head circumference 48-54 cm. Device functions as part of Hydro Dot NeuroMonitoring System; locates EEG electrodes per 10-20 International System; conducts electrical signals from skin to EEG equipment. Used in clinical settings by healthcare professionals. Benefits patient by providing standardized electrode placement and signal conduction for diagnostic EEG monitoring.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Cutaneous electrode headpiece; 48-54 cm form factor; utilizes same materials and manufacturing processes as predicate K930080. Passive signal conduction; no energy source; non-sterile.

Indications for Use

Indicated for EEG monitoring in patients with a head circumference of 48-54 cm.

Regulatory Classification

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.

Predicate Devices

• HydroDot NeuroMonitoring System (K930080)

Submission Summary (Full Text)

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K960873
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
[phone]
[phone] |
| 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. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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: 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

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.

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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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,


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

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Page 1 of 1

10(k) Number (if known): K960873

Device Name: Model 1210, Medium e-Net

Indications For Use:

Headpiece (48-54 cm) for EEG Monitoring


K960873

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Description Use ☐
Per 21 CFR 801.109

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)