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.

AI/ML Overview

The Electro-Cap System is a device designed for rapid placement of EEG electrodes. The provided 510(k) summary (K112319) indicates that the device is substantially equivalent to its predicate devices, rather than performing a specific study to prove it meets acceptance criteria with quantifiable metrics. The substantial equivalence argument relies on comparing the device's technological characteristics, indications for use, and performance requirements to those of existing legally marketed predicate devices.

Here's an breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in the format of pass/fail metrics. Instead, it compares the proposed device's characteristics and performance requirements to those of predicate devices to establish substantial equivalence. The key performance requirement is the ability to transmit electrophysiological signals with a maximum impedance of 5K/Ohms.

Feature / Performance Requirement	Acceptance Criteria (Implied by Predicate Devices)	Reported Device Performance (Electro-Cap System K112319)
Indication for Use	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. (Later updated to "routine clinical and research settings")
Environment of Use	Electrophysiological	Electrophysiological
Intended User	Neurologists	Neurologists
Target Patient	Adults and Children	Adults and Children
Where Used	On the head	On the head
Number of Contacts	1 to 256 electrodes (range among predicates)	2 - 256
Size of Caps	Various- babies to Large (25 cm to 65 cm range among predicates)	Various- babies to Large (26 cm to 66 cm)
Performance (Signal Transmission)	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. (Stated as conforming to predicate requirements)
Biocompatibility Testing	No biocompatibility testing conducted by most predicates.	None was conducted.
Conformity to Standards/Specifications	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).	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).

Note: The document focuses on demonstrating that the new device shares fundamental technological characteristics and performance requirements with devices already on the market, implying that these established characteristics represent the "acceptance criteria" for this type of device. No specific clinical trial or performance study comparing the device against a quantitative acceptance threshold is presented.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document describes a comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical performance study with a dedicated test set. Therefore, there is no sample size for a test set or data provenance in the context of an evaluative study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As no clinical performance study with a test set was conducted, there were no experts establishing ground truth for such a set. The "experts" involved are implicitly the regulatory bodies and the manufacturer's internal team who determined the device's characteristics and its equivalence to predicates.

4. Adjudication Method for the Test Set

Not applicable. No test set or an adjudication method for one is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any evaluation of human reader improvement with or without AI assistance. This device is a physical EEG electrode positioning system, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a physical medical device (EEG electrode positioning system), not an algorithm or AI. Therefore, a "standalone algorithm performance" study is not relevant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable. The "ground truth" in this context is the established functionality and safety of the predicate devices. The new device is deemed substantially equivalent because its fundamental design, intended use, and performance requirements align with these existing, approved devices. No new ground truth for a novel claim is being established beyond this equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this device is a physical product and not an algorithm requiring training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned, the establishment of ground truth for it is not relevant.

Summary

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K112319

JAN 2 7 2012

510K summary

Company Name:	Electro-Cap International, Inc.1011 West Lexington RoadP.O. Box 87Eaton, 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

]

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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.

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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.)

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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-CAPSYSTEM510(k) # K112319	Electro-Cap System(Predicate)510(k) # K780045	Electrode-Array Cap(Predicate)510(k) # K071446	Eemagine MedicalImaging SolutionsGmbH (Predicate)510(k) # K110223	Quik-CapNeuroscan, Inc.(Predicate)510(k) # K000865	SubstantialEquivalenceComments
Indication for Use	The Electro-Cap isintended for use inroutine clinicalsettings where rapidplacement of anumber of EEGelectrodes is desired.	The Electro-Cap isintended for use inroutine clinical settingswhere rapid placementof a number of EEGelectrodes is desired.	The Electrode ArrayCap is intended forroutine clinicalsettings where rapidplacement of largenumbers of EEGelectrodes is desired.	This is an EEG electrodeset intended for intendedfor routine clinicalsettings where rapidplacement of largenumbers of EEGelectrodes is desired.	The Quik-Cap isintended for the sameuse as the predicateElectro-Cap and isintended for routineclinical settings whererapid placement oflarge numbers of EEGelectrodes is desired.	Electro-Cap has thesame/equivalentIndication for Use aspredicates
Environment ofUse	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 ofContacts	2 - 256	20	1 to 256	1 to 256	12 to 256	Same as/equivalentthe predicates
Size of Caps	Various- babies toLarge26 cm to 66 cm	Various- Extra Small toLarge46cm to 62 cm	Various- children toLarge44 cm to 62 cm	Various- babies to Large25cm to 61 cm	Various- babies toLarge34cm to 65 cm	Same as/equivalentthe 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/equivalentthe 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/equivalentthe predicates
Electrode Mounts	Polyethylene	Polyethylene	PVC	Silicone	Rubber Material	Same as/equivalentthe predicates
Location ofWiring	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/equivalentthe predicates
Type of Cables	Standard RibbonCable and LeadWires	Standard Ribbon Cableand Lead Wires	Shielded Lead Wires	Shielded Lead Wires	Standard Ribbon Cableand Lead Wires	Same as/equivalentthe predicates
Type of ElectrodeDrop	Detachable and NonDetachable	Detachable and NonDetachable	Non Detachable	Non Detachable	Non Detachable	Same as predicates
Electrode Metal	Pure Tin, Silver,Silver/SilverChloride, GoldPlated	Pure Tin	Silver/Silver/Chloride	Silver/Silver/Chloride	Tin, Silver,Silver/Silver Chloride,Gold and AgCL	Same as/equivalentthe predicates
Type ofConnectors	D-Sub Connectors,Touch Proof DinSockets andSpecial Connectorsto Match EEGEquipment andComputers	D-Sub Connectors,Touch Proof DinSockets andSpecial Connectors toMatch EEG Equipmentand Computers	Alden Pulse LokConnectors, Touchproof Din Sockets andD-Sub Connectors andTrack-it connectors.	D-Sub Connectors 25and 35 pins.	D-Sub Connectors,Touch Proof DinSockets andSpecial Connectors toMatch EEG Equipmentand Computers	Same as/equivalentthe predicates
BiocompatibilityTesting	None was conducted	None was conducted	None was conducted	Nonclinical test	None was conducted	Same as mostPredicates

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4.0 SPECIFICATIONS/COMPARISONS TO PREDICATE DEVICES

PerformanceRequirements	Needs to transmitelectrophysiologicalsignals from anindividual to datacollection deviceswith a maximumimpedance of5K/Ohms. Does nottransmit electricalcurrent, nor are theyintended to be usedfor stimulation.	Needs to transmitelectrophysiologicalsignals from anindividual to datacollection devices witha maximum impedanceof 5K/Ohms. Does nottransmit electricalcurrent, nor are theyintended to be used forstimulation.	Needs to transmitelectrophysiologicalsignals from anindividual to datacollection devices witha maximumimpedance of5K/Ohms. Does nottransmit electricalcurrent, nor are theyintended to be used forstimulation.	Needs to transmitelectrophysiologicalsignals from anindividual to datacollection devices with amaximum impedance of5K/Ohms. Does nottransmit electricalcurrent, nor are theyintended to be used forstimulation.	Needs to transmitelectrophysiologicalsignals from anindividual to datacollection devices witha maximum impedanceof 5K/Ohms. Does nottransmit electricalcurrent, nor are theyintended to be used forstimulation.	Same as predicates
ManufacturingMethods	Caps sewn andassembled internally.Lead wirespurchased from FDAapprovedmanufacturer.	Caps sewn andassembled internally.Lead wires purchasedfrom FDA approvedmanufacturer.	Caps sewn by thirdparty vendor.Lead wires purchasedfrom FDA approvedmanufacturer.	Not Available	Not Available	Same as/equivalentthe predicates
Type ofAdditionalElectrodes	Various metal DiskElectrodes forReference.Electrodes madefrom Tin, GoldPlated, Silver andSilver/SilverChloride.	Disk Electrodes (PureTin Cups) forReference. May beattached with ear clipsor Adhesive ElectrodePads.	Not Available	Not Available	Various metal DiskElectrodes forReference. Electrodesmade from Tin, GoldPlated, Silver andSilver/Silver Chloride.	Same as/equivalentthe 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

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

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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

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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

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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 __

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).