The Leadpoint Focus microelectrode targeting system is intended to assist in neurosurgical procedures where recording of neuronal activity and stimulation of brain neurons will aid in the placement of depth electrodes.
The Leadpoint Focus microelectrode targeting system is intended to be used in the operating room by a neurosurgeon, neurologist, or clinical neurophysiologist.

Device Description

Intraoperative microelectrode recording (MER) has been introduced to improve the target localization during stereotactic surgery. The Leadpoint Focus is a MER system which consists of the Leadpoint Focus Software, Focus Hardware, a Macro Stimulator, a MER amplifier and a sterile interconnection cable (MER Cable) that connects the system to a Microelectrode. The Microelectrode is supplied by another manufacturer and is not part of the Leadpoint Focus system.

AI/ML Overview

The provided text describes the Leadpoint Focus Microelectrode Targeting System, its intended use, and a comparison to a predicate device (FHC, Inc. Guideline 4000). It also mentions performance data related to software and electrical safety/EMC testing, but it does not contain information about studies measuring device performance against acceptance criteria in a clinical context.

Therefore, I cannot populate many of the requested fields as detailed clinical study information is absent from the provided document.

Here's what can be extracted based on the document:

1. Table of acceptance criteria and the reported device performance:

The document describes technical compliance rather than clinical performance criteria.

Acceptance Criteria (Technical/Compliance)	Reported Device Performance
Software Compliance:
FDA guidance: "The content of premarket submissions for software contained in medical devices, 11 May 05"	Tested in accordance with this guidance.
FDA guidance: "Off-the-shelf software use in medical devices, 09 Sep 99"	Tested in accordance with this guidance.
Electrical Safety:
IEC 60601-1:1988 + A1:1991 + A2:1995	Complies with this standard.
Electromagnetic Compatibility (EMC):
EN/(IEC) 60601-1-2:2007 (3rd edition)	Complies with this standard.
EN/(IEC) 60601-2-40:1998, section 5	Complies with this standard.
EN/(IEC) 61000-3-2:2006+A1+A2	Complies with this standard.
EN/(IEC) 61000-3-3:2008	Complies with this standard.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No information provided. The document focuses on technical compliance and comparison to a predicate device, not clinical validation with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

No information provided. (Not applicable as no clinical test set is described).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No information provided. (Not applicable as no clinical test set is described).

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 information provided. This device is a microelectrode targeting system, not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study in the context of "human readers improving with AI."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No information provided. The device is intended to "assist in neurosurgical procedures" and be "used in the operating room by a neurosurgeon, neurologist, or clinical neurophysiologist," inherently indicating human-in-the-loop operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

No information provided about clinical ground truth. The "ground truth" demonstrated here is compliance with technical and safety standards.

8. The sample size for the training set:

No information provided. (Not applicable as the document describes a medical device, not an AI/ML model requiring a training set in the conventional sense).

9. How the ground truth for the training set was established:

No information provided. (Not applicable).

Summary of available information regarding the "study that proves the device meets the acceptance criteria":

The document primarily describes various technical compliance tests (software, electrical safety, EMC) to demonstrate that the Leadpoint Focus system adheres to established industry standards. These tests serve as the "study" proving it meets the technical acceptance criteria. The specific methodologies mentioned are in accordance with the listed FDA guidances and IEC/EN standards. The conclusion states that the comparison to the predicate device and these performance data demonstrate the system is "safe and effective for its intended use and is substantially equivalent to the predicate devices." No clinical performance study with patient data or expert assessments is provided in this summary.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 12, 2014

Alpine Biomed ApS Seamus O'Connor Tonsbakken 16-18 DK-2740 Skovlunde, Denmark

Re: K140680

Trade/Device Name: Leadpoint Focus Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: Class II Product Code: GZL Dated: November 10, 2014 Received: November 12, 2014

Dear Mr. O'Connor:

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. Isting 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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

Felipe Aquel -S

Carlos L. Peña, PhD, MS for 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) K140680

Device Name Leadpoint Focus

Indications for Use (Describe)

The Leadpoint microelectrode targeting system is intended to assist in neurosurgical procedures where recording of neuronal activity and stimulation of brain neurons will aid in the placement of depth electrodes.

The Leadpoint microelectrode targeting system is intended to be used in the operating room by a neurosurgeon, neurologist, or clinical neurophysiologist.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5 510(k) Summary

Company Confidential

Alpine Biomed Aps, Tonsbakken 16-18 DK-2740 Skovlunde

Tel: +45 44 57 90 00

12/10/2014

5 510(k) Summary - 1 of 8

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Image /page/4/Picture/1 description: The image is a logo for Alpine BioMed. The logo is divided into two sections, with the left section containing a green and blue circular design with a white line running through it. The right section contains the words "ALPINE" in blue, "bioMed" in green, and a green line separating the two words. Below the logo, the words "a division of natus" are written in a smaller font.

510(k) Summary

510(k) Number:

K140680

O Alpine Biomed ApS Tonsbakken 16-18 DK-2740 Skovlunde Denmark

Phone +45 44 57 90 00 +45 44 57 90 10

10 December 2014

Submitter's name:

Alpine Biomed ApS Tonsbakken 16-18, DK-2740 Skovlunde, Denmark Tel.: +45 4457 9000

Contact Person:

Seamus O'Connor, Email seamus.oconnor@natus.com Tel .: +353-(0)87-6330532

Trade name: Leadpoint Focus

Device Class Class II

Classification name:

Depth electrode.

Product code and Regulation:

21CFR 882.1330 GZL

Predicate devices:

The Leadpoint Focus is substantially equivalent to the predicate device K071364 Guideline 4000 from FHC, Inc.

Company Confidential

Alpine Biomed Aps, Tonsbakken 16-18 DK-2740 Skovlunde

Tel: +45 44 57 90 00

12/10/2014

5 510(k) Summary - 2 of 8

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Image /page/5/Picture/20 description: The image is a logo for Alpine BioMed. The logo is in a blue box with a green and blue symbol on the left. To the right of the symbol is the text "ALPINE" in blue, with a green line underneath it. Below that is the text "bioMed" in green and blue. Below the logo is the text "a division of natus."

Alpine Biomed ApS DK-2740 Skovlunde

+45 44 57 90 10

Intended use / Indications for use:

The Leadpoint Focus microelectrode targeting system is intended to be used in the operating room by a neurosurgeon, neurologist, or clinical neurophysiologist.

Device Description:

The recognized upper limit for safe stimulation is 30μC/cm2 per phase.

Microelectrode Connection

A MER Cable is an electrode cable composed of strands of insulated electrical conductors intended to connect a Microelectrode from a patient to the Leadpoint Focus system.

The MER Cable is an optional consumable part.

The MER cable is for single use only and delivered sterile.

Company Confidential

Alpine Biomed Aps, Tonsbakken 16-18 DK-2740 Skovlunde

Tel: +45 44 57 90 00

5 510(k) Summary - 3 of 8

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Image /page/6/Picture/1 description: The image is a logo for Alpine BioMed, a division of Natus. The logo is blue and green, and it features a stylized mountain range with a heartbeat line in the negative space. The text "ALPINE bioMed" is written in blue and green, with "bioMed" in a smaller font. Below the logo, the text "a division of natus." is written in a smaller font.

O Alpine Biomed ApS Tonsbakken 16-18 DK-2740 Skovlunde Denmark

□ Phone +45 44 57 90 00 +45 44 57 90 10 Fax

Summary of Technological Characteristics comparison

Characteristic	Alpine Biomed ApSLeadpoint Focus(This submission)	FHC, Inc.Guideline 4000(K071364)	Discussion ofDifferences
Indications for Use
1.1 Intended Use /Indications for Use	The Leadpoint Focusmicroelectrode targeting system isintended to assist in neurosurgicalprocedures where recording ofneuronal activity and stimulation ofbrain neurons will aid in theplacement of depth electrodes.The Leadpoint Focusmicroelectrode targeting system isintended to be used in the operatingroom by a neurosurgeon,neurologist, or clinicalneurophysiologist.	The microTargeting® Guideline4000 is intended to be used by aneurosurgeon, neurologist or clinicalneurophysiologist to accuratelyposition depth electrodes duringfunctional neurosurgical procedures.The Guideline 4000 is intended tobe used to accurately position depthelectrodes during functionalneurosurgical procedures.	Similar
1.2 Clinical Users	The Leadpoint microelectrodetargeting system is intended to beused by a neurosurgeon,neurologist, or clinicalneurophysiologist.	The Guideline 4000 is intended tobe used by a neurosurgeon,neurologist or clinicalneurophysiologist.	Similar
1.3 ClinicalEnvironment	The Leadpoint microelectrodetargeting system is intended to beused for neurosurgical proceduresin the operating room.	The Guideline 4000 is intended tobe used during functionalneurosurgical procedures.	Similar

Company Confidential

Alpine Biomed Aps, Tonsbakken 16-18 DK-2740 Skovlunde

Tel: +45 44 57 90 00

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image is a logo for Alpine BioMed, a division of Natus. The logo features a blue square with a green and blue design inside. The words "ALPINE" and "bioMed" are written in blue, with a green line separating the two words. The words "a division of natus" are written in black below the square.

O Alpine Biomed ApS Tonsbakken 16-18 DK-2740 Skovlunde Denmark

□ Phone +45 44 57 90 00 +45 44 57 90 10 Fax

General Design
2.1 General systemsapproach	Standard PC based equipment withdedicated hardware peripherals /components.	Standard PC based equipment withdedicated hardware peripherals /components.	Identical
2.2 Configurations	Workstation on cartPortable notebook PC basedsystem	Workstation on cart: Guideline4000TMPortable notebook PC basedsystem: Guideline 4000 LP+TM	Identical
2.3 User input device	Window mouse/keyboard drivengraphic interface with dedicatedcontrol panel.	Window mouse/keyboard drivengraphic interface with dedicatedcontrol panel.	Identical
2.4 User outputdevice	Digital color display, loudspeakersand commercial printers.	Digital color display, loudspeakersand commercial printers.	Identical, bothdevices uses dualloudspeakers for highfidelity audiomonitoring.
2.5 Use of standardsoftware platform(Operating System)	Microsoft Windows.	Microsoft Windows.	Identical
2.6 Systemcomponents	Main Unit including power supply,speakers and control panelAmplifierMacro StimulatorAdditional for notebook basedsystem: Notebook PC includingmonitor, keyboard, and mouseAdditional for Workstation: PC,monitor, keyboard, mouse, cart andisolating transformer	Main Unit including power supply,speakers and control panelAmplifierMacro StimulatorNotebook PC including monitor,keyboard, and mouse.Additional for Workstation: PC,monitor, keyboard, mouse, cart andisolating transformer.	Similar
2.7 System –computer interface	USB	USB	Identical
2.8 System powersupply	Mains (100-120V~~50/60Hz or 200-240V~~50/60Hz) through an isolatingtransformer.	100/120/220/240VAC~50/60Hz.400VA	Similar
2.9 Display: Size /Resolution	Workstation: 22" / 1680 x 1050Notebook based system: 15.6" /1920 x 1080	Notebook based system: 17" /UXGA (1600 x 1200)	Similar
2.10 Safety Isolation	Type BF	Type BF	Identical

Company Confidential

Alpine Biomed Aps, Tonsbakken 16-18 DK-2740 Skovlunde

Tel: +45 44 57 90 00

5 510(k) Summary - 5 of 8

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Image /page/8/Picture/1 description: The image shows the logo for Alpine BioMed, which is enclosed in a blue box. The logo includes a green and blue symbol on the left, followed by the text "ALPINE" in blue, a green line, and "bioMed" in blue. Below the logo, the text "a division of natus." is written in a smaller font.

O Alpine Biomed ApS Tonsbakken 16-18 DK-2740 Skovlunde Denmark

□ Phone +45 44 57 90 00 +45 44 57 90 10 Fax

Microeletrode Recording
3.1 Patient inputs	6 channel amplifier, isolatedAll active channels continuously displayed.	2 channel amplifier, isolated.Expandable recording channels to a maximum of ten.All active channels continuously displayed.	Standard single sided MER procedures requires simultaneous recording from 1-5 channels.This can be done with both systems.
3.2 Bilateral procedure	Supported with up to 2 x 3 channels	Supported with up to 2 x 5 channels.	Standard MER recordings for bilateral procedures are performed with 2 x 1 channels.This can be performed with both systems
3.5 Input Impedance	>1000Mohm//30pF with electrode cable capacitance reduction	$10^{13}\Omega$ // 0.2 pF AC, 200M $\Omega$ DC Differential$10^{13}\Omega$ // 7.0 pF AC, 200M $\Omega$ DC Common Mode	Both within the range required for MER. Leadpoint Focus through use of electrode capacitance reduction and the predicate device through unusual high impedances
3.6 Filters	High Pass: 0.01 – 3000 Hz (16 steps)Low Pass: 20 Hz - 13 kHz (12 Steps)	High Pass: Analog: 0 or 240 Hz.Digital: 0 – 1000 HzLow Pass: Analog: 20 kHz. Digital: 3 - 20 kHzThe digital filters are continually adjustable.	Both within the range required for MER. Both systems secure minimal noise: Leadpoint Focus through many steps in the filters and the predicate device via continually adjustable filters.
3.7 Connection Types	1.5mm Touch Proof / DIN socket / Micro D-sub	5 pin DIN socket	Both within the range required for MER.
3.8 Signal acquisition	24 bit analog to digital conversion at 48kHz sample rate	16 bit analog to digital conversion at 48kHz sample rate	Both within the range required for MER.
3.9 Display	Up to six analysis windows.	Up to five analysis windows.	Both within the range required for MER.
3.10 Impedance test	Integrated 220 Hz sine wave, max. 1V / max. 0.1μΑ	Adjustable 100 Hz - 5 kHz sine wave.	Both within the range required for MER.
3.11 Impedance test range	10 ΜΩ	Auto ranging 100 kΩ, 1 ΜΩ or 10 ΜΩ.	Both within the range required for MER.
3.12 Epoch Recording	Max. 80 s per Epoch	2, 10 or 30 sec	Both within the range required for MER.
3.13 Audio Modes	Raw or clipped sound	Raw or clipped sound	Identical
3.14 Stereotactic systems	Most common	Most common	Identical

Company Confidential

Alpine Biomed Aps, Tonsbakken 16-18 DK-2740 Skovlunde

Tel: +45 44 57 90 00

5 510(k) Summary - 6 of 8

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Image /page/9/Picture/1 description: The image is a logo for Alpine BioMed. The logo features a blue square with a green circle inside. Inside the green circle is a white line that resembles a heartbeat. To the right of the square is the text "ALPINE bioMed" in blue and green. Below the logo is the text "a division of natus".

Alpine Biomed ApS Tonsbakken 16-18 DK-2740 Skovlunde Denmark

Phone +45 44 57 90 00 +45 44 57 90 10

Macro Stimulation
4.1 Type	Constant Current (CC)	Constant Current (CC)	Identical
4.2 Max output intensity	10 mA	10 mA	Identical
4.3 Voltage Range	0-50 V	0-50 V	Identical
4.4 Intensity resolution	Fine setting: 0.02 mACoarse setting: 0.1 mA	0.1 mA	Both within the range required for MER
4.5 Stimulus Duration	20 µs – 1 ms (9 steps)	50 µs – 1 ms (8 steps)	Both within the range of required stimulation frequencies (typical 50 µs)
4.6 Repetition Rate	0.1 – 200 Hz (19 steps)	10 - 300Hz (12 steps)	The added range from 0.1 to 10(0) Hz does not add any new risks.
4.7 Stimulus Polarity	Monophasic or biphasic stimulation	Monophasic or biphasic	Identical to the Leadpoint Focus system
4.8 Remote control	Yes, handheld device with controls for stimulation On/Off and intensity	Yes, handheld device with controls for stimulation On/Off and intensity	Identical

Performance data.

Software Test.

The Leadpoint Focus software was tested in accordance with:

FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05;

FDA quidance: Off-the-shelf software use in medical devices, 09 Sep 99.

Electrical Safety and Electromaqnetic Compatibility (EMC) Test.

The Leadpoint Focus was tested for electrical safety. Test results demonstrated that the Leadpoint Focus complies with:

IEC 60601-1:1988 + A1:1991 + A2:1995.

Electromagnetic Compatibility (EMC) testing was conducted on the Leadpoint Focus according to the applicable standard. Test results indicated that the system complies with the following:

EN/(IEC) 60601-1-2:2007 (3rd edition)

EN/(IEC) 60601-2-40:1998, section 5

EN/(IEC) 61000-3-2:2006+A1+A2

EN/(IEC) 61000-3-3:2008

Company Confidential

Alpine Biomed Aps, Tonsbakken 16-18 DK-2740 Skovlunde

12/10/2014

Tel: +45 44 57 90 00

5 510(k) Summary - 7 of 8

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Image /page/10/Picture/1 description: The image is a logo for Alpine BioMed, a division of Natus. The logo features a blue square with a green circle inside, and a white line that resembles a heartbeat. The words "ALPINE" and "bioMed" are written in blue and green, respectively, above the words "a division of natus" in black. The logo is simple and professional, and it conveys a sense of trust and reliability.

O Alpine Biomed ApS Tonsbakken 16-18 DK-2740 Skovlunde Denmark

O Phone +45 44 57 90 00 +45 44 57 90 10 Fax

Conclusion.

The comparison to the predicate devices demonstrates that the Leadpoint Focus system is safe and effective for its intended use and is substantially equivalent to the predicate devices

Company Confidential

Alpine Biomed Aps, Tonsbakken 16-18 DK-2740 Skovlunde

Tel: +45 44 57 90 00

12/10/2014

5 510(k) Summary - 8 of 8

Regulation Number and Section

§ 882.1330 Depth electrode.

(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).