The g.Hlamp is a fully programmable system which provides a total of 256 analog input channels each of which can be configured, amplified and converted to digital form (analog to digital conversion). The applied part is digitally isolated. The amplifier receives its power from a dedicated AC/DC adapter, meeting the IEC 601-1 requirements, which feeds in +5V DC. Internally, the +5V DC is further isolated by a dedicated DC/DC type converter.

The g.Hlamp amplifier is intended to be used to acquire biopotentials and transmit them to a computer via the USB port connection. These biopotentials include for example electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), and electrocardiogram (ECG). It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals. The host computer must use Microsoft Windows 7. g.Hlamp comes a driver and with a C Application Programming Interface (C API) which allows to control the device.

The system consists of the AC/DC adapter (power supply unit), g.HIamp (the amplification and digitization unit), electrode connector boxes with cables to the g.HIamp (to connect EEG electrodes), a USB connector cable to connect the device to a host computer and the driver and C API software.

AI/ML Overview

The g.Hlamp device is a physiological signal amplifier. The provided text describes its 510(k) premarket notification. Here’s an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (g.USBamp K060803) rather than defining specific numerical acceptance criteria for clinical performance. The "acceptance criteria" are implied by comparing the g.Hlamp's technical specifications and intended use against those of the predicate device, as well as by adherence to relevant safety standards.

Acceptance Criterion (Implied)	Reported Device Performance (g.Hlamp)
Safety Standards Adherence:
IEC60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)	Met
IEC60601-1-2 (Electromagnetic compatibility)	Met
IEC60601-2-25 (Electrocardiographs)	Met (if applicable to ECG acquisition)
IEC60601-2-26 (Electroencephalographs)	Met
IEC60601-2-40 (Electromyographs and evoked response equipment)	Met (if applicable to EMG acquisition)
MDD 93/42/EEC (Medical Device Directive)	Met
IEC60601-1-4 (Programmable electrical medical systems)	Met
ISO 14971 (Medical devices - Application of risk management to medical devices)	Met
IEC 62304 (Medical device software - Software life cycle processes)	Met
Functional and Technical Equivalence with Predicate (g.USBamp):
Intended Use	Acquisitions of biopotentials (EEG, EMG, EOG, ECG) and transmission to computer. (Similar to predicate but broader phrasing for g.Hlamp)
Full scale input range ($\pm$250 mV)	$\pm$250 mV
A/D Conversion (24 Bit)	24 Bit SAR (Predicate is 24 Bit Sigma-Delta; this is a difference but deemed equivalent)
Sampling rate (user selectable, up to 38400 Hz/channel)	User selectable (256, ... up to 38400 Hz/channel) (Similar to predicate)
CMRR (>90 dB at 60 Hz)	>90 dB at 60 Hz (Predicate is >105 dB, difference noted but deemed acceptable)
Noise (<0.5 µV RMS, <2 µV peak-to-peak)	<0.5 µV RMS, <2 µV peak-to-peak (Predicate is <0.35 µV RMS, <2 µV peak-to-peak; difference noted but deemed acceptable)
Power Supply (External IEC 601-1 mains adapter, 5V DC)	External IEC 601-1 mains adapter, 5V DC
Amplifier-PC Interface (USB)	USB
Use standard sensors and electrodes	Yes
Isolation (Digital isolator, patient isolation CF type)	Digital isolator, patient isolation CF type
Impedance measurement (Performed with specific frequency, low current)	Performed with 10 Hz, patient auxiliary current < 1 uA, hardware limited (Predicate is 20 Hz; difference noted but deemed acceptable)
Input impedance (>100 MOhm)	>100 MOhm
Filters (DC up to 2000 Hz)	DC up to 2000 Hz (depending on sampling frequency)
Frequency response (Linear between 0.1 and 100 Hz)	Linear between 0.1 and 100 Hz
Signal Quality for EEG measurements:	Appropriate signal transmission and amplification for EEG measurements.
Accuracy of Impedance Measurements:	Accurate.

Study Details:

Since the g.Hlamp is a hardware device for acquiring raw biopotential signals (amplifier), and not an AI or diagnostic algorithm, many of the typical study criteria for AI/ML or diagnostic devices do not apply.

2. Sample size used for the test set and the data provenance:
- Test Set: No patient or clinical data test set was used. The device was tested using an "external signal generator" applying "sinusoidal signals with different frequencies and amplitudes."
- Data Provenance: Not applicable, as testing was done with simulated/generated signals.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth would be the known parameters of the signals generated by the external signal generator. No human experts were involved in establishing this "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No human interpretation or adjudication was involved. The performance was assessed by comparing the device's output to the known input signals.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is an amplifier, not an AI or diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, the testing performed was a "standalone" evaluation of the hardware's ability to accurately amplify and transmit signals. The device's performance was measured directly against known input signals from a signal generator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth was established by the known, precisely controlled input signals from an external signal generator. This is a technical ground truth, not a clinical or expert-derived ground truth.
8. The sample size for the training set:
- Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.

Summary of the "Study" (Verification and Validation):

The "study" described for the g.Hlamp amplifier is a technical verification and validation process focused on hardware performance and adherence to safety standards, rather than a clinical trial or a study of diagnostic accuracy.

Methodology:
- Signal Transmission & Amplification: An external signal generator applied sinusoidal signals of varying frequencies and amplitudes to the amplifier inputs. The correctness of signal transmission and amplification was determined using BODE diagrams for each channel.
- Impedance Measurement: Tested using "test impedances."
- Noise: Tested by "short-cutting the input channels."
- Safety: Medical safety was confirmed by evaluating the isolation using digital isolators, DC/DC converters, and a medical power supply unit. The current for impedance measurement was also verified to be limited for safety.
Conclusion:
- The tests demonstrated "appropriate signal quality for EEG measurements" and "accurate impedance measurements."
- The device "amplify sinusoidal signals with varying frequencies and amplitudes in the same way" as the predicate device and is "working substantial equivalent and as effective as the marketed device."
- It uses "the same key components for medical safety" as the predicate and is therefore considered safe.

In summary, the device met its implied acceptance criteria by showing substantial technical equivalence to its predicate device through rigorous engineering and safety testing, rather than through clinical or AI-specific performance metrics.

Summary

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K123255

g.Hlamp 510(k) Premarket Notification

g.tec medical engineering GmbH

510(k) Summary

DEC 20 2012

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

807.92(a)(1)

Submitter Information

g.tec medical engineering GmbH Sierningstrasse 14 4521 Schiedlberg Austria

++43 (7251) 22240-12 ++43 (7251) 22240-39

Contact Person:

Christoph Guger

Date:

Phone:

Fax:

5th June 2012

807.92(1)(2)

Trade Name: g.Hlamp Physiological Signal Amplifier Common Name:

Classification Names(s): Physiological Signal Amplifier

(per 21 CFR section 21 CFR 882.1835)

Product Code:

GWL

807.92(a)(3)

Predicate Device(s)

g.tec medical engineering GmbH

g.USBamp

K060803

{1}------------------------------------------------

g.Hlamp 510(k) Premarket Notification

g.tec medical engineering GmbH

807.92(a)(4)

Device Description

g.Hlamp works in the same manner as the approved and predicate device.

807.92(1)(5)

Intended Use(s)

{2}------------------------------------------------

g.Hlamp 510(k) Premarket Notification

g.tec medical engineering GmbH

807.92(a)(6)

Technological Characteristics

Item	g.tec medical engineeringGmbHg.HlampThis Submission	g.tec medical engineeringGmbHg.USBampK060803
Intended Use	The g.Hlamp amplifier is intended to be used to acquire biopotentials and transmit them to a computer via the USB port connection. These biopotentials include for example electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), and electrocardiogram (ECG).	Measuring, recording and analysis of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG.
EEG/Polygraphic channels	256 monopolar	16 monopolar
DC channel	256	16
Full scale input range	$\pm$ 250 mV	$\pm$ 250 mV
A/D conversion	24 Bit SAR	24 Bit Sigma-Delta
Sampling rate	User selectable (256, ... up to 38400 Hz/channel)	User selectable (32, 64, 128, 256, ... up to 38400 Hz/channel)
CMRR	>90 dB at 60 Hz	>105 dB at 60 Hz
Noise	<0.5 µV RMS, <2 µV peak-to-peak	<0.35 µV RMS, <2 µV peak-to-peak
Power Supply	External IEC 601-1 mains adapter, 5V DC	External IEC 601-1 mains adapter, 5V DC
Rated power consumption	20 VA	7 VA
Internal Storage	N/A	N/A
Amplifier-PC Interface	USB	USB
Other Interfaces	Power on LED	Power on LED
Use standard sensors and electrodes	Yes (electrodes and sensors are not included with the amplifier)	Yes (electrodes and sensors are not included with the amplifier)
Dimension	197 (L) x 197 (W) x 90 (H) mm	197 (L) x 155 (W) x 40 (H) mm
Weight	1.875 kg	1 kg
Isolation	Digital isolator, patient isolation CF type	Digital isolator, patient isolation CF type
Safety standards	IEC60601-1IEC60601-1-2IEC60601-2-25IEC60601-2-26IEC60601-2-40MDD 93/42/EECIEC60601-1-4ISO 14971IEC 62304	IEC60601-1IEC60601-1-2IEC60601-2-25IEC60601-2-26IEC60601-2-40MDD 93/42/EECIEC60601-1-4EN ISO 14971ANSI/AAMI SW68:2001
System Components	Amplifier/DigitizationAC/DC AdapterUSB cableElectrode connector box and connector cable	Amplifier/DigitizationAC/DC AdapterUSB cable
Firmware	Resident	Resident
Digital inputs/outputs	16 inputs, all patient separated, no outputs	8 inputs, 4 outputs, all patient separated
Stimulation unit input/output	Not available	Not available
Patient connection and inputs	256 monopolar inputs - 256 plugs4 ground inputs - 4 plugsUSB - 1 connectorDIGITAL IN - 2 connectors	16 monopolar inputs - 16 plugs4 reference inputs - 4 plugs4 ground inputs - 4 plugsUSB - 1 connector
		connectorsDIG I/O 1 and DIG I/O 2 – 2 connectorsSC (short-cut) – 1 connector
Type of applied part	CF	CF
Impedance measurement	Performed with 10 Hz, patient auxiliarycurrent < 1 uA, hardware limited	Performed with 20 Hz, patient auxiliarycurrent < 1 uA, hardware limited
Input impedance	>100 MOhm	>100 MOhm
Filters	DC up to 2000 Hz (depending onsampling frequency)	DC up to 2000 Hz (depending onsampling frequency)
Frequency response	Linear between 0.1 and 100 Hz	Linear between 0.1 and 100 Hz

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g.Hlamp. 510(k) Premarket Notification

g.tec medical engineering GmbH

807.92(b)(1)

The amplifier was tested with an external signal generator which applies sinusoidal signals with different frequencies and amplitudes to the inputs of the amplifier. The correct signal transmission and amplification are determined with BODE diagrams for each channel. The impedance measurement was tested with test impedances. Noise was tested by short-cutting the input channels. The tests show that the signal quality is appropriate for EEG measurements and that impedance measurements are accurate.

In both devices g.Hlamp and g.USBamp medical safety is realized by isolating the applied part with digital isolators, DC/DC converters and using a medical power supply unit. The current for impedance measurement is limited to be safe.

807.92(b)(2)

Not applicable

807.92(b)(3)

The conclusion is that g.Hlamp and the predicate device amplify sinusoidal signals with varying frequencies and amplitudes in the same way and that the amplifier is working substantial equivalent and as effective as the marketed device. g.Hlamp is using the same key components for medical safety as g.USBamp and is therefore considered to be safe.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines and curved shapes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Public Health Service

December 20, 2012

g.tec medical engineering, GmbH c/o TUV SUD America, Inc. . Mr. Alexander Schapovalov 1775 Old Highway 8, NW New Brighton, MN 55112-1891

Re: K123255

Trade/Device Name: G.Hlamp Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL Dated: October 10, 2012 Received: October 18, 2012

Dear Mr. Schapovalov:

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. 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.

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Page 2 - Mr. Alexander Schapovalov

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 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.

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123255

Device Name: g.Hlamp

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Victor Krauthamer -S 2012.12.19 17:53:42 -05'00'

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K123255

Page 1 of 1

Regulation Number and Section

§ 882.1835 Physiological signal amplifier.

(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).