(286 days)
No
The device description focuses on the physical characteristics and function of an electrode for recording and stimulating neural activity, with no mention of AI or ML for data analysis or processing.
No.
The device is intended for intraoperative recording of neuronal activity or stimulation of neural elements for mapping and localization, not for treating a condition or disease.
Yes
Explanation: The device is intended for "intraoperative recording of single unit neuronal activity" and "intraoperative stimulation of neural elements in the brain" to "map the electrical activity of single unit neurons," which are diagnostic purposes for guiding surgical procedures.
No
The device description clearly details a physical electrode (needle, cannula, connectors, etc.) and accessories, indicating it is a hardware device, not software-only.
Based on the provided information, the Neuron AccuPoint™ Electrodes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Neuron AccuPoint™ Electrode Use: The description clearly states that the Neuron AccuPoint™ Electrodes are intended for use in the brain during surgery. They are used for intraoperative recording and stimulation of neural elements within the body.
Therefore, since the device is used directly within the patient's body for real-time monitoring and stimulation, it falls under the category of an in vivo device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
GZL
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anatomical Locations of Use: Use in operating room for neurosurgical procedures where recording of neuronal activity and stimulation of brain neurons will aid in the placement of depth electrodes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Use in operating room for neurosurgical procedures
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
Indications for Use
510(k) Number (if known)
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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3
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
18247-D Flower Hill Way
Gaithersburg, MD 20879
Phone: (301) 330-9788 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Stephens, President/Consultant
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
4
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
K162459 | Predicate Device
K033173; K991522 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | AccuPoint™ Electrode | microTargeting® Electrode |
| 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. | The FHC microTargeting Electrodes
are intended for use in intraoperative
recording of single unit neuronal
activity or intra-operative stimulation
of neural elements in the brain. |
| Anatomical Locations of
Use | Use in operating room for
neurosurgical procedures where
recording of neuronal activity and
stimulation of brain neurons will aid in
the placement of depth electrodes | Use in operating room for
neurosurgical procedures where
recording of neuronal activity and
stimulation of brain neurons will aid in
the placement of depth electrodes |
| Device Materials (Body Contact) | | |
| All Electrodes
(Body Contact) | Stainless Steel Tubing
Polyimide Shielding
Parylene C Insulation
Loctite Medical Grade Adhesive | Stainless Steel Tubing
Polyimide Shielding
Epoxylite Insulation
Adhesive |
| • Tungsten Electrodes | Core Electrode - Tungsten | Core Electrode - Tungsten |
| • Platinum Iridium
Electrodes | Core Electrode - Platinum Iridium
[80% and 20%] Alloy | Core Electrode - Platinum Iridium
[80% and 20%] Alloy |
| Use with Other Medical
Devices | • Stereotaxic frame
• Microdrive system
• Connecting cables
• Direct connection to microelectrode
recording (MER) and
microstimulation equipment | • Stereotaxic frame
• Microdrive system
• Connecting cables
• Direct connection to microelectrode
recording (MER) and
microstimulation equipment |
| Use Condition Provided | Sterile, Single Patient Use
[Not sold Non-Sterile] | Sterile, Single Patient Use
• Also sold Non-Sterile |
| Method of Sterilization | Ethylene Oxide, EO
Non-pyrogenic [Electrodes and
Accessories] | Ethylene Oxide, EO
Non-pyrogenic [Electrodes]
Steam [Accessories] |
Substantial Equivalence Matrix:
5
| Characteristics | Device
(Proposed) | Predicate Device
K033173; K991522 |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical and Dimensional Attributes [Comparison of AccuPoint Models to Equivalent FHC Models] | | |
| • Overall Lengths | 235.24 to 291 mm
(9.26 to 11.46 in) | 235.24 to 291 mm
(9.26 to 11.46 in) |
| • Diameters
Core Electrode | 0.200 to 0.250 mm
(0.008 to 0.010 in) | 0.200 to 0.250 mm
(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
Impedance | 0.5 MΩ-Megohms (+/-30%) to
1 MΩ-Megohms (+/-20%) Measured
at 1 kHz or 220 Hz | 0.5 MΩ-Megohms (+/-30%) to
1 MΩ-Megohms (+/-20%) Measured
at 1 kHz or 220 Hz |
| Accessories | Within this Proposed 510(k)
• Insertion and Spacer Tubes
• Stylets
Tubes and Stylets made from 304
Stainless Steel
Length: Tip to Stop: 179 - 224 mm
(7.05 to 8.82 in)
Diameter: Varies by Model | 510(k) # K121950 and # K092562
• Insertion and Spacer Tubes
• Stylets
Tubes and Stylets made from 304
Stainless Steel
Length: Tip to Stop: 179 - 224 mm
(7.05 to 8.82 in)
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.