LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM

• K Number: K140680
• Device Name: LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
• Manufacturer: ALPINE BIOMED APS
• Date Cleared: 2014-12-12 ( 269 days)
• Product Code: GZL
• Regulation Number: 882.1330

Intended Use

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.

Predicate Devices

K071364

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a microelectrode recording system for neurosurgery, focusing on hardware and software for signal acquisition and stimulation. There is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.

Therapeutic

No
The device is used to assist in the precise placement of depth electrodes and for recording neuronal activity and stimulation, not for treating a condition itself.

Diagnostic

Yes

The device records neuronal activity and stimulates brain neurons, which are diagnostic activities used to aid in the placement of depth electrodes.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Leadpoint Focus system "consists of the Leadpoint Focus Software, Focus Hardware, a Macro Stimulator, a MER amplifier and a sterile interconnection cable". This indicates the presence of significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

No, 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, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the living body (in vitro).
• Leadpoint Focus Function: The Leadpoint Focus system is used during a neurosurgical procedure to record and stimulate brain neurons within the living patient's brain. It assists in the placement of depth electrodes. This is an in vivo procedure, not an in vitro one.
• Intended Use: The intended use clearly states it's for assisting in neurosurgical procedures where recording and stimulation of brain neurons will aid in electrode placement. This is a direct interaction with the patient's living tissue.

The device description and intended use clearly indicate that the Leadpoint Focus system is used directly on the patient during surgery, not for testing samples taken from the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

GZL

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Brain neurons

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Operating room by a neurosurgeon, neurologist, or clinical neurophysiologist.

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)

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 Electromagnetic 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.

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

Not Found

Predicate Device(s)

K071364

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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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.

1

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 [phone] or [phone] 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 [phone] or [phone] 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

2

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: [phone]

12/10/2014

5 510(k) Summary - 1 of 8

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510(k) Summary

510(k) Number:

K140680

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

Phone [phone] [phone]

10 December 2014

Submitter's name:

Alpine Biomed ApS Tonsbakken 16-18, DK-2740 Skovlunde, Denmark Tel.: [phone]

Contact Person:

Seamus O'Connor, Email [e-mail] Tel .: [phone]

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: [phone]

12/10/2014

5 510(k) Summary - 2 of 8

5

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

[phone]

Intended use / Indications for use:

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.

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: [phone]

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

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Summary of Technological Characteristics comparison

| Characteristic | Alpine Biomed ApS
Leadpoint Focus
(This submission) | FHC, Inc.
Guideline 4000
(K071364) | Discussion of
Differences |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Indications for Use | | | |
| 1.1 Intended Use /
Indications for Use | 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. | The microTargeting® Guideline
4000 is intended to be used by a
neurosurgeon, neurologist or clinical
neurophysiologist to accurately
position depth electrodes during
functional neurosurgical procedures.
The Guideline 4000 is intended to
be used to accurately position depth
electrodes during functional
neurosurgical procedures. | Similar |
| 1.2 Clinical Users | The Leadpoint microelectrode
targeting system is intended to be
used by a neurosurgeon,
neurologist, or clinical
neurophysiologist. | The Guideline 4000 is intended to
be used by a neurosurgeon,
neurologist or clinical
neurophysiologist. | Similar |
| 1.3 Clinical
Environment | The Leadpoint microelectrode
targeting system is intended to be
used for neurosurgical procedures
in the operating room. | The Guideline 4000 is intended to
be used during functional
neurosurgical procedures. | Similar |

Company Confidential

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

Tel: [phone]

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 [phone] [phone] Fax

General Design
2.1 General systems
approach	Standard PC based equipment with
dedicated hardware peripherals /
components.	Standard PC based equipment with
dedicated hardware peripherals /
components.	Identical
2.2 Configurations	Workstation on cart
Portable notebook PC based
system	Workstation on cart: Guideline
4000TM
Portable notebook PC based
system: Guideline 4000 LP+TM	Identical
2.3 User input device	Window mouse/keyboard driven
graphic interface with dedicated
control panel.	Window mouse/keyboard driven
graphic interface with dedicated
control panel.	Identical
2.4 User output
device	Digital color display, loudspeakers
and commercial printers.	Digital color display, loudspeakers
and commercial printers.	Identical, both
devices uses dual
loudspeakers for high
fidelity audio
monitoring.
2.5 Use of standard
software platform
(Operating System)	Microsoft Windows.	Microsoft Windows.	Identical
2.6 System
components	Main Unit including power supply,
speakers and control panel
Amplifier
Macro Stimulator
Additional for notebook based
system: Notebook PC including
monitor, keyboard, and mouse
Additional for Workstation: PC,
monitor, keyboard, mouse, cart and
isolating transformer	Main Unit including power supply,
speakers and control panel
Amplifier
Macro Stimulator
Notebook PC including monitor,
keyboard, and mouse.
Additional for Workstation: PC,
monitor, keyboard, mouse, cart and
isolating transformer.	Similar
2.7 System –
computer interface	USB	USB	Identical
2.8 System power
supply	Mains (100-120V~50/60Hz or 200-
240V~50/60Hz) through an isolating
transformer.	100/120/220/240VAC~50/60Hz.
400VA	Similar
2.9 Display: Size /
Resolution	Workstation: 22" / 1680 x 1050
Notebook 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: [phone]

5 510(k) Summary - 5 of 8

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

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Microeletrode Recording
3.1 Patient inputs	6 channel amplifier, isolated
All 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 Hz
Low Pass: Analog: 20 kHz. Digital: 3 - 20 kHz
The 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

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Tel: [phone]

5 510(k) Summary - 6 of 8

9

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 [phone] [phone]

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 mA
Coarse 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: [phone]

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 [phone] [phone] 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: [phone]

12/10/2014

5 510(k) Summary - 8 of 8