Who is the manufacturer of ELECTRO-CAP SYSTEM?

Electro-Cap Intl., Inc. filed the 510(k) submission for ELECTRO-CAP SYSTEM (K112319).

What is the FDA product code for ELECTRO-CAP SYSTEM?

GXY. It is classified under 21 CFR 882.1320 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for ELECTRO-CAP SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ELECTRO-CAP SYSTEM?

Electro-Cap System (K780045); Electrode Array Cap (K071446); Quik-Cap EEG Electrode Positioning System Cap (K000865); WaveGuard EEG Cap (K110223).

Who can help prepare an FDA 510(k) submission like ELECTRO-CAP SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ELECTRO-CAP SYSTEM

K112319 · Electro-Cap Intl., Inc. · GXY · Jan 27, 2012 · Neurology

Device Facts

Record ID	K112319
Device Name	ELECTRO-CAP SYSTEM
Applicant	Electro-Cap Intl., Inc.
Product Code	GXY · Neurology
Decision Date	Jan 27, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1320
Device Class	Class 2
Attributes	Pediatric

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.

Device Story

The Electro-Cap System is an EEG electrode positioning device used in clinical and research settings to facilitate rapid, consistent placement of electrodes on the scalp. It consists of a spandex cap with recessed electrodes (tin, silver/silver chloride, gold-plated, or silver) held in plastic mounts. The device acts as a matrix pathway between the scalp (via conductive Electro-Gel) and external EEG recording equipment. It is operated by neurologists or trained technicians. The cap is secured via chin straps or body harnesses. Wires from the electrodes exit the cap to form a cable, which connects to EEG equipment via standard connectors. The device does not perform signal processing or analysis; it serves solely as a passive interface for transmitting electrophysiological signals to data collection devices. It does not transmit electrical current and is not intended for stimulation.

Clinical Evidence

Bench testing only. The device relies on established technological characteristics and compliance with AAMI and IEC standards for electrode positioning systems. No clinical data was required or provided.

Technological Characteristics

Spandex fabric cap; polyethylene electrode mounts; electrodes made of tin, silver, silver/silver chloride, or gold-plated metal. Passive sensing principle; no energy source. Dimensions range from 26cm to 66cm. Connectivity via ribbon cables and D-Sub or touch-proof DIN connectors. Conforms to AAMI EC53-1995 and IEC 60601-1 (Subclause 56.3, c).

Indications for Use

Indicated for use in routine clinical and research settings for rapid placement of EEG electrodes in adults and children.

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

Electro-Cap System (K780045)
Electrode Array Cap (K071446)
Quik-Cap EEG Electrode Positioning System Cap (K000865)
WaveGuard EEG Cap (K110223)

Submission Summary (Full Text)

{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 | | l of 3 {4}------------------------------------------------ ## 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. 3 of 3 {6}------------------------------------------------ ### 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 __

ELECTRO-CAP SYSTEM

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

ELECTRO-CAP SYSTEM

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps

Welcome

Check your email

Welcome!