MODEL 1220, OR E-NET (54-62 CM)

K961609 · Physiometrix, Inc. · GXY · May 10, 1996 · Neurology

Device Facts

• Record ID: K961609
• Device Name: MODEL 1220, OR E-NET (54-62 CM)
• Applicant: Physiometrix, Inc.
• Product Code: GXY · Neurology
• Decision Date: May 10, 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

The OR e-Net is a headpiece designed for EEG monitoring in the operating room. It functions as a component of the HydroDot NeuroMonitoring System to position electrodes according to the 10-20 International System and conduct electrical signals from the patient's skin to EEG equipment. The device is a modified version of the predicate Large e-Net, featuring a removed section below the ear and an extended inion tab for secure attachment to the neck. It is intended for use by clinicians in an OR setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cutaneous electrode headpiece; 54-62 cm circumference; 10-20 International System electrode placement; passive signal conduction; non-sterile; no software or electronic components.

Indications for Use

Indicated for EEG recording in the operating room environment for patients with a head circumference of 54-62 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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K961609
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
[phone]
[phone] |
| 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. |

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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: 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 ltr): 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.

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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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Physiometrix, Inc.
510(k), Premarket Notification
OR e-Net (54 - 62 cm)

510(K) Number (if known): Unknown K961609

Device Name: Model 1220, OR e-Net (54 - 62 cm)

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

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