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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Comby EEG Cap." It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving a novel device meets specific performance criteria through a rigorous clinical trial or AI model validation study.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI/ML device, nor does it describe a study (including sample sizes, expert ground truth, MRMC studies, or training/test set details) that proves a device meets such criteria.

The document primarily addresses:

Device Description: What the Comby EEG Cap is, its components, and how it functions.
Intended Use: For routine clinical settings where rapid placement of EEG electrodes is desired.
Predicate Devices: Comparison to other EEG electrode systems already on the market.
Bench Testing: Reference to performance testing against ANSI/AAMI EC12:2000 (R2015) for Disposable ECG Electrodes (not specific to EEG performance or AI capabilities).
Biocompatibility: Testing conducted per ISO standards.
Substantial Equivalence: The overall argument for why this device is equivalent to existing ones.

The document explicitly states:

"Clinical Data: Clinical testing is not required" (page 6)
"Clinical testing is not required" (page 7)

This indicates that the device's clearance did not rely on clinical performance data proving specific diagnostic or treatment effectiveness beyond basic safety and electrical performance characteristics of electrodes. It is a traditional medical device, not an AI/ML powered one, thus the typical AI/ML validation study elements (acceptance criteria for AI performance, MRMC studies, ground truth establishment, training/test set details) are not present.

Summary

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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

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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

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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)

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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

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5.8 Predicate Devices Descriptions

Predicate device 1	Predicate device 2	Predicate device 3
Electro-Cap System ElectrodeArrays (Predicate) 510(k)#K112319	Disposable EEG Electrodes(MODEL: DL, E-CAP,FLEX-CAP DEVICEK200162	Wave Guard Eemagine Medi-cal (Predicate) 510(k)#K110223
Electro-Cap International Inc011 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 GMBH8870 RAVELLO CTNaples, FL 34114

5.9 Proposed Device Description

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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.

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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.

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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 forUse	The CombyEEG is in-tended foruse in rou-tine clinicalsettingswhere rapidplacementof a largenumber ofEEG elec-trodes is de-sired	Electro-CapSystem Elec-trode ArraysThe Electro-Cap is intendedfor use in rou-tine clinicalset-tings whererapid place-ment of a largenumber of EEG	DisposableEEG Elec-trodes(MODEL: DL,E-CAP, FLEX-CAP) is in-tended for usein routine clini-cal settingswhere rapidplacement of anumber of EEGelectrodesisde-sired.	This is an EEGelectrodesetintended foruse in routineclinical settingswhere rapidplacement of alarge numberof EEGelectrodesisde-sired	Same
Classifi-cation	Class II	Class II	Class II	Class II	Same
Regula-tionnumber	21CFR882.1320	21CFR882.1320	21CFR882.1320	21CFR882.1320	Same
Regula-tion	cutaneouselectrode	cutaneous elec-trode	cutaneous elec-trode	cutaneous elec-trode	Same
Productcode	GXY, Elec-trode, cuta-neous	GXY, Elec-trode, cutane-ous	GXY, Elec-trode, cutane-ous	GXY, Elec-trode, cutane-ous	Same
Environ-ment ofuse	Electro-physiologi-cal	Electrophysio-logical	Electrophysio-logical	Electrophysio-logical	Same
Intendeduser	Neurolo-gists	Neurologists	Neurologists	Neurologists	Same
Targetpatient	Adults andChildren	AdultsandChildren	AdultsandChildren	AdultsandChildren	Same
Whereused	On the head	On the head	On the head	On the head	Same
Numberof con-tacts	2-64	2-256	2-128	1-256	providebetterrecording andpatient comfort
SizeofCaps	Various-BabiestoLarge27cm-62cm	Various-Ba-bies to Large26cm-66cm	Various-Ba-bies to Large26cm-66cm	Various-Ba-bies to Large25cm-61cm	Same
StyleofCaps	Fullheadcap	Full head cap	Full head cap	Full head cap	Same
Ear Slits	yes	yes	yes	yes	Same
Cap ma-terial	High Qual-ity ProfileRubber	Spandex	Spandex	ElasticCoolmax	equivalent
ElectrodeMounts	SEBS	Polyethylene	Silicone	Silicone	The electrodemounts- baseis made ofcomfort-ableSEBS plastic.SEBS behaveslike rubber butis artificial,and theelectrodeholders haveroundedcorners so thatthey are easyto handle andnon-invasiveon the skin.
CableLength	2-5 Feet	Various-feet	0.1m – 3.0m	Not Available	does not effectsafety
Type ofCables	Standardribbon cableand leadwires		Standard rib-bon cable andlead wires	Shielded LeadWires	Same
Elec-trodeMetal	Ag/AgClAgCL sinteredmaterialGold platedpure 99%Silver	Pure Tin, Sil-ver, Silver/Sil-ver-Chloride,Gold plated	1. FLEX-CAP:silver/silverchloride inkprinted elec-trodes on PET(Polyethyleneterephthalate)2 DL and E-CAP silver /sil-ver chlorideplated ABSbase	Silver/Sil-ver/Chloride	Same as predi-cate
Typeofconnect-ors	D-Sub Con-nectors 25-in and 37-pin, TouchProof DinSockets andSpecialConnectorstoEEGEquipment& Comput-ers	D-SubCon-nectors, TouchProofDinSocketsandSpecialCon-nectorstoMatch EEGEquipment&Computers	Touch-proofsafety socketDIN42-802(Φ=1.5mm)	D-SubCon-nectors 25 and35 pins.	Sameasthepredicatede-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 beentested for bio-compatibilityaccording tothe FDA guid-ance, this dif-ference doesnot raise anynew safety oreffectiveness.
Perfor-mancerequire-ments	Needs totransmitelectrophys-iologicalsignals froman individ-ual to datacollectiondevices witha maximumimpedanceof5K/Ohms.Does nottransmitelectricalcurrent, norare they in-tended to beusedforstimulation.	Needs to trans-mit electro-physiologicalsignals from anindividual todata collectiondevices with amaximum im-pedance of5K/Ohms.Does not trans-mit electricalcurrent, nor arethey intendedto be used forstimulation.	1. Re-sistance <100$ Ω $2. AC im-pedance <2kΩ (at 10 Hz)3. DC off-set voltage<100 mV4. Com-bined offset in-stability and in-ternal noise:<150 μV5. Biascurrent toler-ance <100 mV	Needs to trans-mit electro-physiologicalsignals from anindividual todata collectionde-vices with amaximum im-pedance of5K/Ohms.Does not trans-mit electricalcur-rent, norare they in-tended to beused for stimu-lation.	Performance ofthe CombyEEG cap istested as perANSI/AAMIEC12:2000(R2015) Disposa-ble ECG Elec-trodes

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Pamel d.o.o.

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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).