Who is the manufacturer of Comby EEG Caps?

Pamel D.O.O filed the 510(k) submission for Comby EEG Caps (K211315).

What is the FDA product code for Comby EEG Caps?

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

What is the regulatory pathway for Comby EEG Caps?

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

What are the predicate devices for Comby EEG Caps?

Electro-Cap System Electrode Arrays (K112319); Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) (K200162); Wave Guard Eemagine Medical (K110223).

Who can help prepare an FDA 510(k) submission like Comby EEG Caps?

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.

Comby EEG Caps

K211315 · Pamel D.O.O · GXY · Nov 9, 2021 · Neurology

Device Facts

Record ID	K211315
Device Name	Comby EEG Caps
Applicant	Pamel D.O.O
Product Code	GXY · Neurology
Decision Date	Nov 9, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1320
Device Class	Class 2
Attributes	Pediatric

Indications for Use

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

Device Story

Comby EEG Cap is an electrode positioning system for EEG recording; consists of high-quality profile rubber net, SEBS plastic electrode holders, and electrodes (sintered Ag/AgCl or gold-coated plates). Used in clinical settings by neurologists; cap secured via Velcro chin strap and chest belt. Electrodes placed per International 10-20 System; conductive gel/paste applied to reduce impedance between scalp and recessed electrodes. Wires exit cap to form cable connecting to EEG equipment via adapter or 25-pin D-sub connector. Device transmits electrophysiological signals; does not provide stimulation. Benefits include rapid electrode placement, consistent positioning, and patient comfort due to SEBS mounts. Shorter cable lengths minimize environmental artifacts.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ANSI/AAMI EC12:2000 (R2015) for electrical safety and performance. Biocompatibility testing conducted per ISO 10993-1, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation and sensitization).

Technological Characteristics

Materials: Profile rubber net, SEBS (thermoplastic elastomer) electrode holders, Ag/AgCl or gold-coated electrodes. Form factor: Full head cap with 2-64 electrodes. Connectivity: Wired (25-pin D-sub or adapter). Standards: ANSI/AAMI EC12:2000 (R2015), ISO 10993-1/5/10. Passive device; no energy source.

Indications for Use

Indicated for use in routine clinical settings for rapid placement of EEG electrodes in adults and children to transmit electrophysiological signals to data collection devices.

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 Electrode Arrays (K112319)
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) (K200162)
Wave Guard Eemagine Medical (K110223)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 9, 2021 Pamel d.o.o % Stefan Bolleininger CEO be-On-Quality GmbH Bahnhofstrasse 85 Neunkirchen am Sand, D-91233 DE Re: K211315 Trade/Device Name: Comby EEG Caps Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: October 13, 2021 Received: October 13, 2021 Dear Stefan Bolleininger: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211315 Device Name Comby EEG Cap Indications for Use (Describe) The Comby EEG Cap is intended for use in routine clinical settings where rapid placement of large number of EEG electrodes is desired. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(K) SUMMARY OR 510(K) STATEMENT ### 5.1 Applicant Date: 21-04-2021 Signature: Name: Pamel d.o.o. Mesekov put 16, 10000, Zagreb, Croatia Address: | Contact Person in Germany: | Stefan Bolleininger | |----------------------------|---------------------------------------| | Telephone: | +49 9131 977986 – 50 | | Fax: | +49 9131 977986 – 449 | | E-Mail: | stefan.bolleininger@be-on-quality.com | PAMEL d.o.o. proizvodnja, trgovina i usluge Dubravica 41 f, Zagreb HR-10090 OIB: 14776088720 ## 5.2 Trade Name : Comby EEG Cap ## 5.3 Common Name or Classification Name Disposable EEG Electrodes system ## 5.4 Establishment Registration Number Not registered # 5.5 Facility Address : Pamel d.o.o. Mesekov put 16, 10000, Zagreb, Croatia ### 5.6 Device Classification 5.6.1 Classification: This is a class II device 5.6.2 Classification panel: Cutaneous electrodes Product code: GXY ### 5.7 Regulation Number 21 CFR 882 1320 {4}------------------------------------------------ #### 5.8 Predicate Devices Descriptions | Predicate device 1 | Predicate device 2 | Predicate device 3 | |----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Electro-Cap System Electrode Arrays (Predicate) 510(k) #K112319 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP DEVICE K200162 | Wave Guard Eemagine Medi- cal (Predicate) 510(k) #K110223 | | Electro-Cap International Inc 011 W Lexington Rd, Eaton, OH 45320, United States | Wuhan Greentek Pty Ltd. Rm 03-2, Flr. 3, Dingye Bldg, Phase, Wuhan CN 430074 | EEMAGINE MEDICAL IM- AGING SOLUTIONS GMBH 8870 RAVELLO CT Naples, FL 34114 | #### 5.9 Proposed Device Description The Comby EEG Cap is an electrode positioning system used to quickly place the standard 20 EEG electrodes or more 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 Comby EEG Cap is made from high quality profile rubber net, electrode plastic holders made of SEBS and electrodes. Electrodes is made of two different conductors, sintered Ag/AgCl and gold coated plates. The EEG Comby Cap is fixed by Velcro tape holders which are fastened beneath the chin of the tested person. The cap holders is fixed to a belt, placed beneath the arms and around the chest of the tested person. The high quality profile rubber net holds the electrodes securely in position during the 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 directly to the equipment with the 25-pin D-sub connector. The electrical activity of the brain is transferred through the conductive Electro-Gel/paste to the recessed electrode and then to the EEG or computer equipment for evaluation. The electrodes on the standard caps are positioned in {5}------------------------------------------------ accordance with the International 10-20 System of electrode placement. In addition, the Comby EEG Cap with as few as 2 to as many as 64 electrodes. Comby EEG are also produced based on customer specified electrode placements, with electrodes made of Ag/AgC1 material. Customized wiring and connectors offer additional options. The Electro-Gel is used with external electrodes as the conductor between the scalp and the (recessed) electrodes. It also reduces impedance (resistance to alternating current) between the electrode surface and the skin "Electroconductive gel is a legally marketed product in US - K111717" information "Company Name: Electra-Cap International, Inc. 1011 West Lexington Road P.O. Box 87 Eaton, OH 45320 Contact: Amy Swallows Phone: 937-456-6099 Fax: 937-456- 7323 Trade Name: Electra-Gel Common Name: Electrode Gel. #### 5.10 Indications for Use Statement The Comby EEG Cap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. #### 5.11 Required Components The Comby EEG Cap needs to be used with conductive gel or paste (such as Electro-Gel), EEG device and computer equipment for evaluation. #### 5.12 Bench Testing The COMBY EEG CAP was tested for performance in order to verify compliance according to the following technical specifications and standards: ANSI/AAMI EC12:2000 (R2015) Disposable ECG Electrodes. Results indicate that the product complies with the applicable standard. The release test is also conducted on the product when it leaves the facility and the Performance release record is available in section 18. Compare to primary predicate devices specified and Comby EEG cap are same in, raw materials, physical features, and same manufacturing processes. The biocompatibility performance equiva- lence evidence of proposed electrode can be demonstrated according to ISO10993-1, ISO10993-5 and ISO10993-10. Clinical Data: Clinical testing is not required Non clinical data:Non clinical tests performed include Performance test :We performed electrical safety. The design of the Comby EEG cap is in conformance with performance in order to verify compliance according to the following technical specifications and standards: ANSI/ AAMI EC12:2000 (R2015) Disposable ECG Electrodes. {6}------------------------------------------------ Styrene-ethylene-butylene-styrene, also known as SEBS, is an important thermoplastic elastomer (TPE) which behaves like rubber without undergoing vulcanization. Mounts made of SEBS provide an effective hold of the electrodes in the position without producing any pressure around the muscles. Muscle pressure artifacts are very common in EEG recording, and should be minimized to achieve the best recording result. SEBS electrode mounts are also more comfortable for the patient. Comby EEG Caps have shorter cables when compared to the predicates. Shorter cables create less artifacts during the recoding form the environment. it is used on purpose to get better results as the recording can be made closer to patient without any environmental disturbance. In COMBY EEEG CAP, maximum of 64 electrodes are required to provide coverage for the complete scalp. The stated differences are made in the purpose of improving the EEG recording quality and patient comfort. Therefore COMBY EEG cap performs minimally as well or better that the predicates. All the differences do not affect the safety and effectiveness of the subject device which is concluded after all the required testing, so there are no safety and effectiveness issues relating to the subject system. Clinical testing is not required We performed electrical safety. The design of the Comby EEG cap is in conformance with performance in order to verify compliance according to the following technical specifications and standards: ANSI/AAMI EC12:2000 (R2015) Disposable ECG Electrodes. Biocompatibility: 1. ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 2. ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity 3. ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization Conclusion- Based on the comparison with predicate device, our Comby EEG cap has the same intended use, structure, and technologies, which is substantially equivalent to predicated device. {7}------------------------------------------------ # 5.13 Summary table of comparison # Predicate Comparison Chart -Table 1 | Feature | Subject device | Predicate device | Predicate device | Predicate device | Discussion | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | | K112319 | K200162 | K110223 | | | Indica- tion for Use | The Comby EEG is in- tended for use in rou- tine clinical settings where rapid placement of a large number of EEG elec- trodes is de- sired | Electro-Cap System Elec- trode Arrays The Electro- Cap is intended for use in rou- tine clinical set-tings where rapid place- ment of a large number of EEG | Disposable EEG Elec- trodes (MODEL: DL, E-CAP, FLEX- CAP) is in- tended for use in routine clini- cal settings where rapid placement of a number of EEG electrodes is de-sired. | This is an EEG electrode set intended for use in routine clinical settings where rapid placement of a large number of EEG electrodes is de-sired | Same | | Classifi- cation | Class II | Class II | Class II | Class II | Same | | Regula- tion number | 21CFR882. 1320 | 21CFR882.132 0 | 21CFR882.132 0 | 21CFR882.132 0 | Same | | Regula- tion | cutaneous electrode | cutaneous elec- trode | cutaneous elec- trode | cutaneous elec- trode | Same | | Product code | GXY, Elec- trode, cuta- neous | GXY, Elec- trode, cutane- ous | GXY, Elec- trode, cutane- ous | GXY, Elec- trode, cutane- ous | Same | | Environ- ment of use | Electro- physiologi- cal | Electrophysio- logical | Electrophysio- logical | Electrophysio- logical | Same | | Intended user | Neurolo- gists | Neurologists | Neurologists | Neurologists | Same | | Target patient | Adults and Children | Adults and Children | Adults and Children | Adults and Children | Same | | Where used | On the head | On the head | On the head | On the head | Same | | Number of con- tacts | 2-64 | 2-256 | 2-128 | 1-256 | provide better recording and patient comfort | | Size of Caps | Various- Babies to Large 27cm-62cm | Various- Ba- bies to Large 26cm-66cm | Various- Ba- bies to Large 26cm-66cm | Various- Ba- bies to Large 25cm-61cm | Same | | Style of Caps | Full head cap | Full head cap | Full head cap | Full head cap | Same | | Ear Slits | yes | yes | yes | yes | Same | | Cap ma- terial | High Qual- ity Profile Rubber | Spandex | Spandex | Elastic Coolmax | equivalent | | Electrode Mounts | SEBS | Polyethylene | Silicone | Silicone | The electrode mounts- base is made of comfort-able SEBS plastic. SEBS behaves like rubber but is artificial, and the electrode holders have rounded corners so that they are easy to handle and non-invasive on the skin. | | Cable Length | 2-5 Feet | Various- feet | 0.1m – 3.0m | Not Available | does not effect safety | | Type of Cables | Standard ribbon cable and lead wires | | Standard rib- bon cable and lead wires | Shielded Lead Wires | Same | | Elec- trode Metal | Ag/AgClAg CL sintered material Gold plated pure 99% Silver | Pure Tin, Sil- ver, Silver/Sil- ver-Chloride, Gold plated | 1. FLEX-CAP: silver/silver chloride ink printed elec- trodes on PET (Polyethylene terephthalate) 2 DL and E- CAP silver /sil- ver chloride plated ABS base | Silver/Sil- ver/Chloride | Same as predi- cate | | Type of connect- ors | D-Sub Con- nectors 25- in and 37- pin, Touch Proof Din Sockets and Special Connectors to EEG Equipment & Comput- ers | D-Sub Con- nectors, Touch Proof Din Sockets and Special Con- nectors to Match EEG Equipment & Computers | Touch-proof safety socket DIN42-802 (Φ=1.5mm) | D-Sub Con- nectors 25 and 35 pins. | Same as the predicate de- vice | | Biocom- patibility | ISO 10993- 1, ISO 10993- 5, ISO 10993- 10 | None was Con- ducted | ISO 10993-1, ISO 10993-5, ISO 10993-10 | ISO 10993-1, ISO 10993-5, ISO 10993-10 | The subject de- vice has been tested for bio- compatibility according to the FDA guid- ance, this dif- ference does not raise any new safety or effectiveness. | | Perfor- mance require- ments | Needs to transmit electrophys- iological signals from an individ- ual to data collection devices with a maximum impedance of 5K/Ohms. Does not transmit electrical current, nor are they in- tended to be used for stimulation. | Needs to trans- mit electro- physiological signals from an individual to data collection devices with a maximum im- pedance of 5K/Ohms. Does not trans- mit electrical current, nor are they intended to be used for stimulation. | 1. Re- sistance <100 $ Ω $ 2. AC im- pedance <2 kΩ (at 10 Hz) 3. DC off- set voltage <100 mV 4. Com- bined offset in- stability and in- ternal noise: <150 μV 5. Bias current toler- ance <100 mV | Needs to trans- mit electro- physiological signals from an individual to data collection de-vices with a maximum im- pedance of 5K/Ohms. Does not trans- mit electrical cur-rent, nor are they in- tended to be used for stimu- lation. | Performance of the Comby EEG cap is tested as per ANSI/AAMI EC12:2000(R 2015) Disposa- ble ECG Elec- trodes | {8}------------------------------------------------ {9}------------------------------------------------ ______________________________________________________________________________________________________________________________________________________________________________ {10}------------------------------------------------ Pamel d.o.o. {11}------------------------------------------------

Comby EEG Caps

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Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Submission Summary (Full Text)

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Indications for Use

Device Story

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Indications for Use

Regulatory Classification

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Predicate Devices

Submission Summary (Full Text)

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