Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical components and function of an EEG electrode positioning system, with no mention of AI or ML for data analysis or interpretation.

Therapeutic

No
The device is used to position electrodes for diagnostic purposes (EEG recording), not to deliver therapy.

Diagnostic

No

The device is an EEG electrode positioning system that transmits electrophysiological signals for data collection; it does not perform diagnosis itself.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like a spandex cap, electrodes, wires, and cables, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Electro-Cap System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to facilitate the placement of EEG electrodes for transmitting electrophysiological signals from an individual to data collection devices. This is a process performed on the body (in vivo), not on samples taken from the body (in vitro).
Device Description: The description details a system for positioning electrodes on the head and body to capture electrical signals. It doesn't involve analyzing biological samples like blood, urine, or tissue.
Lack of IVD Characteristics: The description doesn't mention any components or processes typically associated with IVD devices, such as reagents, assays, or analysis of biological specimens.

Therefore, the Electro-Cap System is a medical device used for physiological signal acquisition, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Electro-Cap System is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.

Product codes (comma separated list FDA assigned to the subject device)

GXY

Device Description

The Electro-Cap System is an EEG electrode positioning system used to quickly place the standard 20 EEG electrodes and also a large number of electrodes in a uniform and consistent manner on the head and body in order to transmit electrophysiological signals from an individual to data collection devices. The Electro-Cap is made from a spandex type material with recessed electrodes in plastic mounts attached to the cap. The standard cap covers the entire scalp and is held in place with chin straps, or with cap straps attached to a body harness. The Surgical Cap material is cut slightly different to allow the cap to fit securely over the ears to hold it in place. The spandex type material holds the electrodes securely in position during an EEG recording. Wires are attached to each electrode and exit the cap to form a cable, which is used to connect the cap to the EEG equipment, either through an adapter cable, or in some instances, directly to the equipment with the connector on the cap. The electrical activity of the brain is transferred through the Electro-Gel to the recessed electrode and then to the EEG or computer equipment for evaluation.

The electrodes on the standard caps are positioned to the International Ten-Twenty System (10-20) of Electrode Placement. In addition, Electro-Caps with as few as 2 or as many as 256 electrodes, have been built with the placement of the electrodes conforming to the 10-10 American Electrocencephalographic Society positioning system. Electro-Caps are also produced based on customer specified electrode placements, with electrodes made of either tin or silver/silver chloride, gold plated or silver. Dropped wires, small mounts, thin mounts and customized wiring and connectors offer additional options.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

On the head

Indicated Patient Age Range

Adults and Children

Intended User / Care Setting

Neurologists, routine clinical and research settings

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.

K780045, K071446, K110223, K000865

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

Regulation Number and Section

§ 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).

Summary

0

K112319

JAN 2 7 2012

510K summary

| Company Name: | Electro-Cap International, Inc.
1011 West Lexington Road
P.O. Box 87
Eaton, OH 45320 |
|----------------------|-----------------------------------------------------------------------------------------------|
| Contact: | Amy B. Swallows |
| Phone: | 937-456-6099 |
| Fax: | 937-456-7323 |
| Summary Date: | January 19, 2012 |
| Trade Name: | Electro-Cap System |
| Common Name: | EEG Electrode Positioning System |
| Classification Name: | Electrode, Cutaneous |
| Regulation Number: | 21 CFR 882.1320 |

GXY

Trade Name:

Product Code:

Predicate Device(s):

510(k) Number:	K780045
Manufacture:	Electro-Cap International, Inc.
Trade Name:	Electro-Cap System
510(k) Number:	K071446
Manufacture:	Electrode Arrays
Trade Name:	Electrode Array Cap
510(k) Number:	K000865
Manufacture:	Neuroscan (Neurosoft, Inc.)
Trade Name:	Quik-Cap EEG Electrode Positioning System Cap
510(k) Number:	K110223
Manufacture:	Eemagine Medical Imaging Solutions GmbH

WaveGuard EEG Cap

Description of Device 1.0

The Electro-Cap System is an EEG electrode positioning system used to quickly place the standard 20 EEG electrodes and also a large number of electrodes in a uniform and consistent manner on the head and body in order to transmit electrophysiological signals from an individual to data collection devices. The Electro-Cap is made from a spandex type material with recessed electrodes in plastic mounts attached to the cap. The standard cap covers the entire scalp and is held in place with chin straps, or with cap straps attached to a body harness. The Surgical Cap material is cut slightly different to allow the cap to fit securely over the ears to hold

]

1

it in place. The spandex type material holds the electrodes securely in position during an EEG recording. Wires are attached to each electrode and exit the cap to form a cable, which is used to connect the cap to the EEG equipment, either through an adapter cable, or in some instances, directly to the equipment with the connector on the cap. The electrical activity of the brain is transferred through the Electro-Gel to the recessed electrode and then to the EEG or computer equipment for evaluation.

The electrodes on the standard caps are positioned to the International Ten-Twenty System (10-20) of Electrode Placement. In addition, Electro-Caps with as few as 2 or as many as 256 electrodes, have been built with the placement of the electrodes conforming to the 10-10 American Electrocencephalographic Society positioning system. Electro-Caps are also produced based on customer specified electrode placements, with electrodes made of either tin or silver/silver chloride, gold plated or silver. Dropped wires, small mounts, thin mounts and customized wiring and connectors offer additional options

2.0 Intended Use of Device

The Electro-Cap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.

3.0 Predicate Comparison

The Electro-Cap has the same technological characteristics as the predicate devices. It serves as a matrix electrode pathway between the scalp/conductive gel and the EEG recorders. The design of the Electro-Cap System is in conformance with AAMI Standards Specifications for ECG Cables and Lead-Wires and Other Devices that use Patient Cables, EC53-1995, and the IEC Standard 60601-1 Subclause 56.3, (c). Like the predicates the Electro-Cap consists of a stretch fabric cap, metal disk electrodes, electrode holders and electrode lead wires.

Technologically, the Electro-Cap functions in exactly in the same manner as the predicate devices. The electrode holder is a two part component made of Polyethylene which allows the 2 parts to snap together with the fabric between. The electrode lead wires are on the inside of the standard caps giving the technician easy access to the electrodes without interference of the lead wires.

Available Electro-Cap Options:

A list of the various options which the company offers is shown below. It is important to recognize that all variants carry the same intended use, fundamental scientific technology and clinical considerations:

Size of caps, babies to extra large (26 to 66cm).

Regular or surgical style caps. Special cut (!ow front or back).

Number of electrodes: Density and placement to conform to International 10/20 electrode placement system and /or the 10-10 American Electrocencephalographic Society positioning system.

Ear Slits.

Electrode mounts: Standard, Small and thin.

2

Types of electrode drops, detachable/non-detachable.

Size of electrode drops or separate lead wires: 9mm, 6mm, Bio-Potential, Ear clip.

Electrode metals: Tin. Silver/Silver Chloride. Gold Plated or Silver.

Caps with electrode placement holes only.

Caps with electrode mounts only.

Caps with electrodes and electrode mounts only, no lead wires.

Caps with outside wiring on the cap.

Caps complete except for connectors.

All Electro-Caps use the same ribbon cable but may have fewer or more wires in the cable to match the number of electrodes on the cap, individual lead wires or shielded lead wires.

All Electro-Caps use the same type of D-Sub connectors except the connectors may have 10 to 80 pln or sockets, or other commercially available connectors as required by the customer that will allow the caps to be plugged directly into their EEG equipment.

Accessories:

As stated on the Company's Certificate to Foreign Government as well as listed with the FDA, the Electro-Cap System uses the following accessories:

E1 Electro-Caps E2 Electro Board Adapter E3 Body Harness E4 Quick Insert Electrodes E5 Ear Electrodes E6 Disposable Sponge Disk E7 Needle/Syringe Kit E8 Special Blunted Needle E12 Head Measuring Tape E13 Cap Straps E16 Ivory Detergent E17 Bio-Potential Electrode E19 Spare Electrode Disk
E20 Spare Electrode Mounts E21 Disk Electrode E22 Extra Placement on Cap E23 Chin Straps E24 Chin Straps Pads E25 Adhesive Electrode Pads E26 Orange Sticks . E27 Disposable ECG Electrode E28 Alligator Clip Adapter E40 Converter Pin/Socket I 1 Infa Caps 1 2 infa Body harness 1 3 Infa Head Measuring Tape

(Please refer to the comparison table on the following three pages.)

3

4.0 SPECIFICATIONS/COMPARISONS TO PREDICATE DEVICES

..

Table 4.0 compares features and specifications of the proposed Electro-Cap System, including additional research features of any Trans to compress and use y Cap manufactured by Electroce Arrays and WaveGuard EEG Cap by Econopiae Medical Indones Online and the Quik Cap by Neuroscan, Inc.

		Table 4.0: Comparison to Predicate Devices
Feature	ELECTRO-CAP
SYSTEM
510(k) # K112319	Electro-Cap System
(Predicate)
510(k) # K780045	Electrode-Array Cap
(Predicate)
510(k) # K071446	Eemagine Medical
Imaging Solutions
GmbH (Predicate)
510(k) # K110223	Quik-Cap
Neuroscan, Inc.
(Predicate)
510(k) # K000865	Substantial
Equivalence
Comments
Indication for Use	The Electro-Cap is
intended for use in
routine clinical
settings where rapid
placement of a
number of EEG
electrodes is desired.	The Electro-Cap is
intended for use in
routine clinical settings
where rapid placement
of a number of EEG
electrodes is desired.	The Electrode Array
Cap is intended for
routine clinical
settings where rapid
placement of large
numbers of EEG
electrodes is desired.	This is an EEG electrode
set intended for intended
for routine clinical
settings where rapid
placement of large
numbers of EEG
electrodes is desired.	The Quik-Cap is
intended for the same
use as the predicate
Electro-Cap and is
intended for routine
clinical settings where
rapid placement of
large numbers of EEG
electrodes is desired.	Electro-Cap has the
same/equivalent
Indication for Use as
predicates
Environment of
Use	Electrophysiological	Electrophysiological	Electrophysiological	Electrophysiological	Electrophysiological	Same as predicates
Intended user	Neurologists	Neurologists	Neurologists	Neurologists	Neurologists	Same as predicates
Target Patient	Adults and Children	Adults and Children	Adults and Children	Adults and Children	Adults and Children	Same as predicates
Where Used	On the head	On the head	On the head	On the head	On the Head	Same as predicates
Number of
Contacts	2 - 256	20	1 to 256	1 to 256	12 to 256	Same as/equivalent
the predicates
Size of Caps	Various- babies to
Large
26 cm to 66 cm	Various- Extra Small to
Large
46cm to 62 cm	Various- children to
Large
44 cm to 62 cm	Various- babies to Large
25cm to 61 cm	Various- babies to
Large
34cm to 65 cm	Same as/equivalent
the predicates
Style of Caps	Full Head Cap	Full Head Cap	Full Head Cap	Full Head Cap	Full Head Cap	Same as predicates
Ear Slits	Yes	No	Yes	Yes	Yes	Same as/equivalent
the predicates

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4.0 SPECIFICATIONS/COMPARISONS TO PREDICATE DEVICES

| Cap Material | Spandex | Spandex | Light Duty Lycra | Elastic Coolmax | Heavy Duty Lycra | Same as/equivalent
the predicates |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Electrode Mounts | Polyethylene | Polyethylene | PVC | Silicone | Rubber Material | Same as/equivalent
the predicates |
| Location of
Wiring | Inside Cap | Inside Cap | Inside Cap | Inside Cap | Outside Cap | Same as predicates |
| Cable Length | Various - 3 to 5 feet | 3 feet | 1 Foot | Not Available | 5 Feet | Same as/equivalent
the predicates |
| Type of Cables | Standard Ribbon
Cable and Lead
Wires | Standard Ribbon Cable
and Lead Wires | Shielded Lead Wires | Shielded Lead Wires | Standard Ribbon Cable
and Lead Wires | Same as/equivalent
the predicates |
| Type of Electrode
Drop | Detachable and Non
Detachable | Detachable and Non
Detachable | Non Detachable | Non Detachable | Non Detachable | Same as predicates |
| Electrode Metal | Pure Tin, Silver,
Silver/Silver
Chloride, Gold
Plated | Pure Tin | Silver/Silver/Chloride | Silver/Silver/Chloride | Tin, Silver,
Silver/Silver Chloride,
Gold and AgCL | Same as/equivalent
the predicates |
| Type of
Connectors | D-Sub Connectors,
Touch Proof Din
Sockets and
Special Connectors
to Match EEG
Equipment and
Computers | D-Sub Connectors,
Touch Proof Din
Sockets and
Special Connectors to
Match EEG Equipment
and Computers | Alden Pulse Lok
Connectors, Touch
proof Din Sockets and
D-Sub Connectors and
Track-it connectors. | D-Sub Connectors 25
and 35 pins. | D-Sub Connectors,
Touch Proof Din
Sockets and
Special Connectors to
Match EEG Equipment
and Computers | Same as/equivalent
the predicates |
| Biocompatibility
Testing | None was conducted | None was conducted | None was conducted | Nonclinical test | None was conducted | Same as most
Predicates |

· 2 of 3

5

4.0 SPECIFICATIONS/COMPARISONS TO PREDICATE DEVICES

| Performance
Requirements | Needs to transmit
electrophysiological
signals from an
individual to data
collection devices
with a maximum
impedance of
5K/Ohms. Does not
transmit electrical
current, nor are they
intended to be used
for stimulation. | Needs to transmit
electrophysiological
signals from an
individual to data
collection devices with
a maximum impedance
of 5K/Ohms. Does not
transmit electrical
current, nor are they
intended to be used for
stimulation. | Needs to transmit
electrophysiological
signals from an
individual to data
collection devices with
a maximum
impedance of
5K/Ohms. Does not
transmit electrical
current, nor are they
intended to be used for
stimulation. | Needs to transmit
electrophysiological
signals from an
individual to data
collection devices with a
maximum impedance of
5K/Ohms. Does not
transmit electrical
current, nor are they
intended to be used for
stimulation. | Needs to transmit
electrophysiological
signals from an
individual to data
collection devices with
a maximum impedance
of 5K/Ohms. Does not
transmit electrical
current, nor are they
intended to be used for
stimulation. | Same as predicates |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Manufacturing
Methods | Caps sewn and
assembled internally.
Lead wires
purchased from FDA
approved
manufacturer. | Caps sewn and
assembled internally.
Lead wires purchased
from FDA approved
manufacturer. | Caps sewn by third
party vendor.
Lead wires purchased
from FDA approved
manufacturer. | Not Available | Not Available | Same as/equivalent
the predicates |
| Type of
Additional
Electrodes | Various metal Disk
Electrodes for
Reference.
Electrodes made
from Tin, Gold
Plated, Silver and
Silver/Silver
Chloride. | Disk Electrodes (Pure
Tin Cups) for
Reference. May be
attached with ear clips
or Adhesive Electrode
Pads. | Not Available | Not Available | Various metal Disk
Electrodes for
Reference. Electrodes
made from Tin, Gold
Plated, Silver and
Silver/Silver Chloride. | Same as/equivalent
the predicates |

4.0 Comparison Summary

As shown above in Table 4.0, the proposed device is identical/equivalent in all aspects to the inclusion of the variant parameters demonstrates that the device itself is manufactured for the same patient population with equivalent manufacturing methods and technologies.

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4.0 Conclusions

י

.

..

A comparison of the technological characteristics demonstrates that the device is substantially equivalent to the legally marketed predicated devices.

4

7

Image /page/7/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 stripes forming its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Electro-Cap International, Inc. c/o Ms. Amy Swallows Director of Marketing 1011 West Lexington Road PO Box 87 Eaton, OH 45320

SEP 1 4 2012

Re: K112319

Trade/Device Name: Electro-Cap System Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: December 20, 2011 Received: December 21, 201

Dear Ms. Swallows:

This letter corrects our substantially equivalent letter of January 27, 2012.

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 (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.

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.

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

8

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/ResourcesforYou/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

9

Indications for Use

510(k) Number (if known): K112319

Device Name: Electro-Cap System

Indications for Use:

The Electro-Cap System is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Luynh Hoang

(Division: Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

KIL2319 510(k) Number __