Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.
The Comby EEG Cap is an electrode positioning system that transmits electrophysiological signals for data collection, but it does not treat or cure a disease or condition itself.

Diagnostic

No.

The Comby EEG Cap is an electrode positioning system that transmits electrophysiological signals to data collection devices; it does not analyze or interpret these signals to provide a diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components such as a rubber net, plastic holders, electrodes (made of Ag/AgCl and gold), Velcro tape, a belt, wires, and a cable. It is a hardware device for electrode placement and signal transmission.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The Comby EEG Cap is an electrode positioning system that transmits electrophysiological signals from the body (specifically the brain's electrical activity) to data collection devices. It does not analyze samples taken from the body.
Intended Use: The intended use is for rapid placement of EEG electrodes in routine clinical settings to record brain activity. This is a direct measurement of a physiological signal, not an analysis of a biological sample.
Device Description: The description focuses on the physical components for electrode placement and signal transmission, not on reagents or methods for analyzing biological specimens.

Therefore, the Comby EEG Cap falls under the category of a medical device that measures physiological signals, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

GXY

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

On the head

Indicated Patient Age Range

Adults and Children

Intended User / Care Setting

Neurologists in routine clinical settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 equivalence evidence of proposed electrode can be demonstrated according to ISO10993-1, ISO10993-5 and ISO10993-10.
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.
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
Key Results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K112319, K200162, K110223

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).

Summary

0

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)

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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