AccuPoint Electrode

K162459 · Microprobes For Life Science, Inc. Dba Neuron · GZL · Jun 15, 2017 · Neurology

Device Facts

• Record ID: K162459
• Device Name: AccuPoint Electrode
• Applicant: Microprobes For Life Science, Inc. Dba Neuron
• Product Code: GZL · Neurology
• Decision Date: Jun 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

Neuron AccuPoint™ Electrodes are intended for use in intraoperative recording of single unit neuronal activity or intraoperative stimulation of neural elements in the brain.

Device Story

AccuPoint Electrode is a depth electrode for intraoperative recording/stimulation of single unit neuronal activity; used in stereotactic neurosurgery to assist in target localization for implant placement. Device consists of a tungsten or platinum-iridium core needle insulated with Parylene C, housed within a stainless steel and polyimide cannula. Features include a sliding mechanism for tip extension/retraction, a stop collar for frame placement, and a reference contact. Connects to third-party MER/microstimulation equipment via gold pin connectors. Clinician operates device within a stereotaxic frame; output is electrical signal data displayed on external equipment to guide surgical decision-making. Benefits include precise neural mapping and accurate electrode placement.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-1, cytotoxicity), electrode impedance, continuity, insulation integrity, and dynamic impedance testing to verify performance and safety.

Technological Characteristics

Depth electrode; tungsten or platinum-iridium (80/20) core; Parylene C insulation; stainless steel and polyimide cannula; gold pin connectors. Dimensions: 235.24-291 mm length, 0.200-0.250 mm diameter. Impedance: 0.5-1 MΩ. Sterilization: Ethylene Oxide (EO). Non-pyrogenic. Standalone device connecting to third-party MER/stimulation systems.

Indications for Use

Indicated for intraoperative recording of single unit neuronal activity or intraoperative stimulation of neural elements in the brain during neurosurgical procedures.

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Predicate Devices

• FHC microTargeting Electrode (K033173)
• FHC microTargeting Electrode (K991522)

Reference Devices

• Alpha Omega Sterile Disposables for MER (K120098)
• Insertion and Spacer Tubes/Stylets (K121950)
• Insertion and Spacer Tubes/Stylets (K092562)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

June 15, 2017

Microprobes For Life Science, Inc. dba Neuron Julie Stephens President Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K162459

Trade/Device Name: Accupoint Electrode Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: May 15, 2017 Received: May 16, 2017

Dear Ms. Stephens:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 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/ResourcesforYou/Industry/default.htm. 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

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.

# Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS 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)

K162459

Device Name AccuPoint™ Electrode

Indications for Use (Describe)

Neuron AccuPoint™ Electrodes are intended for use in intraoperative recording of single unit neuronal activity or intraoperative stimulation of neural elements in the brain.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# MicroProbes for Life Science, Inc. dba Neuron Traditional 510(k) - AccuPoint™ Electrode

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.

| Submitted By: | MicroProbes for Life Science, Inc. dba Neuron<br>18247-D Flower Hill Way<br>Gaithersburg, MD 20879<br>Phone: [phone] |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Stephens, President/Consultant<br>Regulatory Resources Group, Inc. |
| Date Prepared: | June 8, 2017 - Revised |

Device Name and Classification:

| Trade/Proprietary Name: | AccuPoint™ Electrode | Common Name: | Depth Electrode |
|-------------------------|----------------------|---------------|-----------------|
| Classification Name: | Depth Electrode | Product Code: | GZL |
| Regulation: | 21 CFR 882.1330 | Class: | II |

#### Legally Marketed Predicate Device:

FHC, Inc. - FHC microTargeting Electrode, 510(k) # K033173 & K991522 Reference device: Alpha Omega - Sterile Disposables for MER, 510(k) # K120098

#### Device Description:

The AccuPoint™ Electrode is used for monitoring, recording, or microstimulation during intraoperative procedures to map the electrical activity of single unit neurons at subsurface levels of the brain. Intraoperative microelectrode recording (MER) and microstimulation equipment is utilized with depth electrodes during stereotactic surgery to assist in localization for further applications such as permanent implant placement.

The MER or microstimulation equipment which connects to the AccuPoint Electrode are supplied by other manufacturers and is not sold by MicroProbes for Life Science, Inc. The AccuPoint Electrode is produced with standard connectors to connect with other manufacturers' cables that then connect to MER and microstimulation equipment.

The AccuPoint Electrode is a long, extremely thin metal needle insulated with a Parylene C coating. This needle will be composed of either tungsten or a platinum-iridium alloy, depending on the preference of the clinician. The tip of this needle is exposed using either an electric arc or laser process, to create an electrode. The tip exposure length can be carefully controlled to imbue the electrode with a particular impedance. This core needle electrode is situated within a stainless steel and polyimide cannula, with the electrode and cannula being employed together as an integrated unit. The electrode will be capable of sliding within the cannula. allowing the clinician to extend the tip during use, or retract the tip back within the cannula during handling and storage. The rear portion of the cannula will be equipped with a "stop collar", or a thick stainless steel ring which assures proper placement of the electrode within the surgical frame. A laver of stainless steel within the cannula will serve as a second electrode or "reference contact". The electrode may or may not be equipped with an outer stainless steel shield. The electrode will be equipped with two gold pin connectors on the back end, which allow the electrode to be connected to the cable leading to the MER or microstimulation equipment possessed by the surqeon. The model number of each electrode configuration was chosen to be analogous to the comparable predicate electrode model from one of two other manufacturers (FHC and Alpha Omega), allowing clinicians to easily adopt the AccuPoint

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# MicroProbes for Life Science, Inc. dba Neuron Traditional 510(k) - AccuPoint™ Electrode

Electrode with minimal confusion. Only a length within 5 cm of the AccuPoint Electrode comes into direct contact with patient tissue.

Accessories include stainless steel spacer and insertion tubes and stylets which are used during stereotaxic functional neurosurgical procedures to accurately guide a microelectrode or instrument into the brain. The insertion tubes with the stylet inserted are initially placed through the stereotaxic frame access locations for determining the estimated depth of the target location to then insert the depth electrode (AccuPoint Electrode).

The AccuPoint Electrodes and Accessories will be sold sterile, for single patient use, and will be disposable.

#### Indications for Use:

Neuron AccuPoint™ Electrodes are intended for use in intraoperative recording of single unit neuronal activity or intraoperative stimulation of neural elements in the brain.

| Characteristics | Device<br>K162459 | Predicate Device<br>K033173; K991522 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | AccuPoint™ Electrode | microTargeting® Electrode |
| Indications For Use | Neuron AccuPoint™ Electrodes are<br>intended for use in intraoperative<br>recording of single unit neuronal<br>activity or intraoperative stimulation of<br>neural elements in the brain. | The FHC microTargeting Electrodes<br>are intended for use in intraoperative<br>recording of single unit neuronal<br>activity or intra-operative stimulation<br>of neural elements in the brain. |
| Anatomical Locations of<br>Use | Use in operating room for<br>neurosurgical procedures where<br>recording of neuronal activity and<br>stimulation of brain neurons will aid in<br>the placement of depth electrodes | Use in operating room for<br>neurosurgical procedures where<br>recording of neuronal activity and<br>stimulation of brain neurons will aid in<br>the placement of depth electrodes |
| Device Materials (Body Contact) | | |
| All Electrodes<br>(Body Contact) | Stainless Steel Tubing<br>Polyimide Shielding<br>Parylene C Insulation<br>Loctite Medical Grade Adhesive | Stainless Steel Tubing<br>Polyimide Shielding<br>Epoxylite Insulation<br>Adhesive |
| • Tungsten Electrodes | Core Electrode - Tungsten | Core Electrode - Tungsten |
| • Platinum Iridium<br>Electrodes | Core Electrode - Platinum Iridium<br>[80% and 20%] Alloy | Core Electrode - Platinum Iridium<br>[80% and 20%] Alloy |
| Use with Other Medical<br>Devices | • Stereotaxic frame<br>• Microdrive system<br>• Connecting cables<br>• Direct connection to microelectrode<br>recording (MER) and<br>microstimulation equipment | • Stereotaxic frame<br>• Microdrive system<br>• Connecting cables<br>• Direct connection to microelectrode<br>recording (MER) and<br>microstimulation equipment |
| Use Condition Provided | Sterile, Single Patient Use<br>[Not sold Non-Sterile] | Sterile, Single Patient Use<br>• Also sold Non-Sterile |
| Method of Sterilization | Ethylene Oxide, EO<br>Non-pyrogenic [Electrodes and<br>Accessories] | Ethylene Oxide, EO<br>Non-pyrogenic [Electrodes]<br>Steam [Accessories] |

#### Substantial Equivalence Matrix:

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| Characteristics | Device<br>(Proposed) | Predicate Device<br>K033173; K991522 |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical and Dimensional Attributes [Comparison of AccuPoint Models to Equivalent FHC Models] | | |
| • Overall Lengths | 235.24 to 291 mm<br>(9.26 to 11.46 in) | 235.24 to 291 mm<br>(9.26 to 11.46 in) |
| • Diameters<br>Core Electrode | 0.200 to 0.250 mm<br>(0.008 to 0.010 in) | 0.200 to 0.250 mm<br>(0.008 to 0.010 in) |
| • Electrode Tip Style | Straight Sharpened Point | Straight Sharpened Point |
| • Electrode Tip Taper | 10-15 degree tip angle | 10-15 degree tip angle |
| Electrode Tip<br>Impedance | 0.5 MΩ-Megohms (+/-30%) to<br>1 MΩ-Megohms (+/-20%) Measured<br>at 1 kHz or 220 Hz | 0.5 MΩ-Megohms (+/-30%) to<br>1 MΩ-Megohms (+/-20%) Measured<br>at 1 kHz or 220 Hz |
| Accessories | Within this Proposed 510(k)<br>• Insertion and Spacer Tubes<br>• Stylets<br>Tubes and Stylets made from 304<br>Stainless Steel<br>Length: Tip to Stop: 179 - 224 mm<br>(7.05 to 8.82 in)<br>Diameter: Varies by Model | 510(k) # K121950 and # K092562<br>• Insertion and Spacer Tubes<br>• Stylets<br>Tubes and Stylets made from 304<br>Stainless Steel<br>Length: Tip to Stop: 179 - 224 mm<br>(7.05 to 8.82 in)<br>Diameter: Varies by Model |
| Expiration Date | One (1) Year¹ | Three (3) Years |

Substantial Equivalence Matrix (Continued):

# Summary of Testing:

The biocompatibility risk assessment was completed as directed by FDA guidance under ISO 10993-1 biocompatibility requirements. Cytotoxicity testing was completed to demonstrate that the known biocompatible materials, the manufacturing processes, and the validated sterilization processes maintained compliance. Performance and safety testing completed for the AccuPoint Electrode included tests for electrode impedance, continuity and insulation integrity, and dynamic impedance to detect short circuiting between the inner and outer electrodes.

### Substantial Equivalence Conclusions:

The completion of the testing demonstrates that the AccuPoint Electrode has the same principles of operation, indications for use, and technological characteristics as the predicate devices.

¹ The Aging Study will be continuing to obtain a longer expiration date.