(270 days)
Not Found
No
The summary describes a passive electrode device for recording and stimulating electrical signals. There is no mention of any computational analysis or algorithms, let alone AI/ML. The performance studies focus on physical and electrical properties of the electrodes and cables.
No.
The device is intended for recording and stimulation of electrical signals on the surface of the brain to support the definition of epileptogenic foci and brain mapping, which are diagnostic purposes, not therapeutic.
Yes
Explanation: The device is intended for "recording, and stimulation of electrical signals on the surface of the brain" and "The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping," which are diagnostic purposes.
No
The device description and performance studies clearly indicate that this is a physical medical device (electrodes and cables) intended for implantation and physical testing. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Blackrock NeuroCoG Subdural Cortical Electrodes are used to record and stimulate electrical signals directly on the surface of the brain. This is an in vivo (within the living body) procedure, not an in vitro (outside the living body) test.
- Intended Use: The intended use clearly states recording and stimulation of electrical signals on the surface of the brain to support the definition of epileptogenic foci and brain mapping. This is a diagnostic and potentially therapeutic procedure performed directly on the patient.
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).
0
February 14, 2020
Blackrock Microsystems Rachelle Frischknecht Regulatory Affairs Specialist 630 Komas Drive, Suite 200 Salt Lake City, Utah 84108
Re: K191346
Trade/Device Name: Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: January 12, 2020 Received: January 15, 2020
Dear Rachelle Frischknecht:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
Indications for Use (Describe)
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image contains the logo for Blackrock Microsystems. The logo consists of a stylized black bird-like figure to the left of the company name. The word "BLACKROCK" is printed in black, and the word "MICROSYSTEMS" is printed in blue below it.
Traditional 510(k) Summary
| 1. | Summary Date: | February 13, 2020 |
|---|---|---|
| 2. | Applicant Name: | Blackrock Microsystems, LLC |
| 630 Komas Drive, Suite 200 | ||
| Salt Lake City, UT 84108 | ||
| USA | ||
| Establishment Registration Number: 3007323246 | ||
| 3. | Correspondent: | Rachelle Frischknecht |
| 4. | Trade Name: | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) |
| 5. | Common Name: | Cortical Electrode, Subdural Strips and Grids |
| 6. | Description: | Cortical Electrode (Per FDA Classification) |
| 7. | Manufacturing Site: | Blackrock Microsystems, LLC |
| E-mail: rfrischknecht@blackrockmicro.com | ||
| FDA Establishment Number: 3007323246 | ||
| 8. | Sterilization Site: | Sterilization Site: Life Science Outsourcing, Inc. |
| FDA Establishment Number: 2031093 | ||
| 9. | Classification Regulation, Class, Product Code, and Panel: | |
| 21 CFR 882.1310 Neurology | ||
| Class II | ||
| Product Code: GYC | ||
| Panel: Neurology | ||
| 10. | Reason for Traditional 510(k): | New submission |
| 11. | Predicate Device(s): | 510(k) Number: K053363 |
| Manufacturer: Ad-Tech Medical Instrument Corporation | ||
| Trade Name: AD-TECH Subdural Cortical Electrodes (Dual-Sided | ||
| Interhemispheric, Grid, Intraoperative, Strip, Wyler) | ||
| Product Code: GYC | ||
| Classification: 21 CFR 882.1310 |
- Compliance to Special Controls / Performance Standards There are no special controls/performance standards associated with Product Code GYC. However, conformance to the following recognized consensus standards is declared:
- AAMI TIR12:2010 Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health . Care Facilities: A Guide for Medical Device Manufacturers
- AAMI TIR30:2011(R)2016 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria ● for Cleaning Reusable Medical Devices
- ANSI/AAMI/ISO 10993-1:2009/(R)2013 Biological Evaluation of Medical Devices Part 1: Evaluation and ● Testing Within a Risk Management Process
- ANSI/AAMI/ISO 11737-1:2018 Sterilization of Health Care Products -Microbiological Methods Part 1: ● Determination of a Population of Microorganisms on Products
Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission
4
- ANSI/AAMI/ST72:2011/(R)2016 Bacterial Endotoxins Test Methods, Routine Monitoring, and ● Alternatives to Batch Testing
- . ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM D4332-14 Standard Practice for Containers, Packages, or Packaging Components for Testing
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F1886-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual ● Inspection
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal ● Pressurization
- ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
- BS/EN/ISO 11607-1:2017 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier System, and Packaging Systems
- . BS/EN/ISO 11737-2:2009 Sterilization of Medical Devices – Microbiological Methods – Part 2: Tests of Sterility Performed in the Definition, Validation, and Maintenance of a Sterilization Process
- . IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of Usability Engineering to Medical Devices [Including CORRIGENDUM 1 (2016)]
- ISO 10993-4 Third Edition 2017-04 Biological Evaluation of Medical Devices Part 4: Selection of Test ● for Interactions with Blood
- ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices – Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-6 Third Edition 2016-12-01 Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation
- ISO 10993-7 Second Edition 2008-10-15 Biological Evaluation of Medical Devices: Ethylene Oxide ● Sterilization Residuals
- ISO 10993-10 Third Edition 2010-08-01 Biological Evaluation of Medical Devices Part 10: Tests for ● Irritation and Skin Sensitization
- ISO 10993-11 Third Edition 2017-09 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
- ISO 11135-1 Second Edition 2014-07-15 Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization for Medical Devices
- ISO 11138-1 Third Edition 2017-03 Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements
- . ISO 11138-2 Third Edition 2017-03 Sterilization of Health Care Products - Biological Indicators - Part 2: Biological Indicators for Ethylene Oxide Sterilization Processes
-
- Indications for Use
The Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary ( 30 days.
CAUTION: Federal Law (U.S.A.) restricts this Device to
sale by or on the order of a physician
CAUTION: Reuse of this Device is prohibited as it may
malfunction and cause contamination and risk to the
patient
CAUTION: Disconnect from monitoring equipment during
cardiac defibrillation.
CAUTION: Do not use NeuroCoG if packaging is
damaged.
CAUTION: Handle the electrode with care to prevent
damage. Avoid pulling or stressing the pigtail, rings or
electrodes, which could result in loss of contact recordings.
CAUTION: If suturing the electrode, avoid suturing
contacts, wires, and/or pigtail, as damage may result.
CAUTION: Handle the electrode with care to prevent
damage. Avoid pulling or stressing the pigtail, rings or
electrodes, which could result in loss of contact recordings. | For Single Patient Use Only. Do not Re-
Sterilize or Reuse. Not intended of
Implantation (21 CFR 860.3(d): > 30 days.
For Surgical Use Only. Do not use if
packaging is damaged.
CAUTION: Federal Law (U.S.A.) restricts
this Device to sale by or on the order of a
physician
CAUTION: Reuse of this Device is
prohibited as it may malfunction and cause
contamination and risk to the patient,
CAUTION: Disconnect from monitoring
equipment during cardiac defibrillation. | device.
Therefore,
Substantially
Equivalent.
Additional Cautions
statement for user
performance issues
only and do not raise
any questions on safety
or efficacy. Therefore,
Substantially
Equivalent. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NeuroCoG
Cautionary
Statements | Do not use NeuroCoG Patient Cable if pogo pins are
recessed or aggressively clean Pogo Pins such that they
recess. Use with recessed pogo pins may result in
damaging the devices or incomplete signal path. | | Ad-Tech did not
qualify a Patient Cable
as device-specific in
their submission. |
12
| Sterility status of
the electrodes | Sterile only | Both sterile and non-sterile devices were
originally offered. Only sterile electrodes are
offered currently | Identical sterility status
of the currently
marketed devices of
the predicate. |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Identical to the
predicate. |
| Sterility status of
patient cable | Non-Sterile | -- | Ad-Tech did not
qualify a Patient Cable
as device-specific in
their submission. |
| Non-Pyrogenic | Labeled as non-pyrogenic | Not so labeled | Labeling the devices as
non-pyrogenic is not a
regulatory requirement.
Doing so is done for
marketing purposes
and does not raise any
new questions of safety
or effectiveness.
Therefore,
Substantially
Equivalent. |
| Single Patient Use,
Disposable | Yes | Yes | Identical to the
predicate. |
| Shelf Life | Currently 1 year (per accelerated aging) and 1-year and 5-
year real-time aging studies are ongoing) | 5 years (Launched with 1 year accelerated
aging) | After 5 years, identical
to the predicate. |
| Packaging
Configuration | The Blackrock NeuroCoG Subdural Cortical Electrode
(Strips and Grids) is double (Tyvek) pouched and placed in
a chipboard box.
The NeuroCoG Patient Cable is placed in a poly bag and
then cleaned and disinfected by the end-user. | The device is double (Tyvek) pouched and
placed in a chipboard box. | Identical to the
predicate. |
13
Image /page/13/Picture/0 description: The image shows the logo for Blackrock Microsystems. The logo consists of a stylized bird-like figure on the left, followed by the word "BLACKROCK" in bold, black letters. Below "BLACKROCK" is the word "MICROSYSTEMS" in a smaller, blue font. The logo is clean and modern, with a focus on the company name.
| ELECTRODE CONTACT INFORMATION | |||
|---|---|---|---|
| Number of Electrode | |||
| Contacts | Strips: 4 to 16, Inclusive | ||
| Grids: 4 to 128, inclusive | 1 to 128, inclusive | Within the boundaries of the | |
| predicate. | |||
| Electrode Contact | |||
| Spacing | 10 mm, 5 mm | ||
| Other variations can be requested by the | |||
| customer. | 10 mm | ||
| Other variations can be requested by the | |||
| customer. | Identical to the predicate. | ||
| Electrode Contact | |||
| Material | 90:10 Platinum:iridium or Stainless Steel | 90:10 Platinum or Stainless Steel | Identical to the predicate. |
| Electrode Contact | |||
| Size (exposed | |||
| surface area) | 2.3 mm diameter | 1.5 mm x 1.5 mm, 1.5 mm x 3.0 mm, 2.3 mm | |
| diameter, 4.0 mm diameter - per K053363 | |||
| submission | |||
| 1.17, 1.8 mm, 5 mm dia. (exposed) currently | |||
| marketed | Within the boundaries of the | ||
| predicate. | |||
| ELECTRODE PIGTAIL INFORMATION | |||
| Maximum contacts | |||
| per pigtail | 32 | 16 | The proposed device offers more |
| potential contacts per pigtail than | |||
| the predicate. Doing so reduces the | |||
| number of incisions needed to | |||
| tunnel the pigtails away from the | |||
| surgical site. Less pigtails implies | |||
| fewer block connectors under the | |||
| wrap leading to better patient | |||
| comfort. Although this aspect of | |||
| the electrodes is viewed to be a | |||
| feature of the design process, and | |||
| in theory reduces the potential for | |||
| infection, it does not affect the | |||
| overall design intent/indication for | |||
| use of the device. Additionally, | |||
| having more contacts per pigtail | |||
| reduces the likelihood of making an | |||
| electrical misconnection but this | |||
| feature does not affect the overall |
Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission
14
Image /page/14/Picture/0 description: The image shows the logo for Blackrock Microsystems. The logo features a stylized penguin-like figure on the left, followed by the word "BLACKROCK" in bold, black letters. Below "BLACKROCK" is the word "MICROSYSTEMS" in a smaller, blue font. A circled "R" trademark symbol is located to the right of the word "BLACKROCK".
| Connection Cable
(510(k) Exempt) | The connection cable terminates in a safety
female DIN leads connector or Q-Connector.
It connects the electrode cable per the
connector to the amplifier / stimulator. | TECH-ATTACH and Cabrio™ Connection
Systems which connect to a patient cable that
terminates in a safety female Din connector. It
connects the electrode cable per the connector
to the amplifier / stimulator | design intent/indication for use of
the device. Therefore, Substantially
Equivalent
Although per 21 CFR 890.1175,
the electrode-to-EEG/Stimulator
cables are 510(k) exempt, their use
is still vital to connect the
proposed/predicate devices to a
third-party EEG. Although the
specific manufacturing methods
vary, both the proposed and
predicate device comply with the
applicable safety standards and
share the same overall design
intent. Therefore, Substantially
Equivalent. |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURING & PERFORMANCE CHARACTERISTICS | | | |
| Stimulation
Parameters | As stated on the instructions for use, a safe
level of stimulation is below 30 μC/cm2.
This is a function of exposed electrode
contact size, pulse duration and stimulation
current. | As stated on the instructions for use, a safe
level of stimulation is below 30 μC/cm2. This is
a function of exposed electrode contact size,
pulse duration and stimulation current. | Identical to the predicate. |
| Electrode
Manufacturing
Technique | NeuroCoG subdural cortical electrodes are
hand-made. The device consists of a silicone
mat into which the pad electrodes
comprising of platinum:iridium or stainless
steel contacts are embedded. The electrode
contacts' conducting paths are electrically
connected to their contact rings per insulated
stainless steel wires encapsulated in the
pigtail. | Ad-Tech electrodes are hand-made. The
electrodes' contacts are sandwiched in between
layers of liquid silicone and trimmed to size.
Insulated wires extend from each electrode
through a flexible silicone or polyurethane tube
to a connector for EEG monitoring | Manufacturing methods may vary
in comparison to the predicates, but
the overall design intent and
materials are identical. |
Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission
15
Image /page/15/Picture/0 description: The image shows the logo for Blackrock Microsystems. The logo consists of a stylized black bird-like figure on the left, followed by the word "BLACKROCK" in bold, black letters. Below "BLACKROCK" is the word "MICROSYSTEMS" in a smaller, blue font. A circled "R" trademark symbol is located to the right of the word "BLACKROCK".
| Interactions with
Third Party EEGs/
Stimulators | Subdural electrodes themselves are non-
active and serve simply as conductors for the
EEG signals produced by the CNS and/or for
the currents produced by the stimulators. In a
sense, they simply serve as electrical
pathways. | While not formally stated in the predicate's
510(k) summary statement or labeling, it is
known that the predicate 510(k) submission
maintained that the devices are non-active and
serve simply as conductors for the EEG signals
produced by the CNS and/or for the currents
produced by the stimulators. In a sense, they
simply serve as electrical pathways. | Both devices are essentially 'wires'
that simply conduct electricity.
Therefore, Substantially
Equivalent. |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Standards Cited | • AAMI TIR12:2010 Designing, Testing,
and Labeling Reusable Medical Devices
for Reprocessing in Health Care Facilities:
A Guide for Medical Device
Manufacturers
• AAMI TIR30:2011(R)2016 A
Compendium of Processes, Materials, Test
Methods, and Acceptance Criteria for
Cleaning Reusable Medical Devices
• ANSI/AAMI/ISO 10993-1:2009/(R)2013
Biological Evaluation of Medical Devices
- Part 1: Evaluation and Testing Within a
Risk Management Process
• ANSI/AAMI/ISO 11737-1:2018
Sterilization of Health Care Products –
Microbiological Methods – Part 1:
Determination of a Population of
Microorganisms on Products
• ANSI/AAMI/ST72:2011/(R)2016
Bacterial Endotoxins – Test Methods,
Routine Monitoring, and Alternatives to
Batch Testing
• ASTM D4169-16 Standard Practice for
Performance Testing of Shipping
Containers and Systems | STANDARDS
None cited | Citing the applicable standards
does not raise any new questions of
safety or effectiveness. Therefore,
Substantially Equivalent. |
Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission
16
| ASTM D4332-14 Standard Practice for
Conditioning Containers, Packages, or
Packaging Components for Testing ASTM F88/F88M-15 Standard test
Method for Seal Strength of Flexible
Barrier Materials ASTM F756-17 Standard Practice for
Assessment of Hemolytic Properties of
Materials ASTM F1886-16 Standard Test Method
for Determining Integrity of Seals for
Flexible Packaging by Visual Inspection ASTM F1980-16 Standard Guide for
Accelerated Aging of Sterile Barrier
Systems for Medical Devices ASTM F2096-11 Standard Test Method
for Detecting Gross Leaks in Medical
Packaging by Internal Pressurization ASTM F2901-19 Standard Guide for
Selecting Tests to Evaluate Potential
Neurotoxicity of Medical Devices BS/EN/ISO 11607-1:2017 Packaging for
Terminally Sterilized Medical Devices –
Part 1: Requirements for Materials, Sterile
Barrier System and Packaging Systems BS/EN/ISO 11737-2:2009 Sterilization of
Medical Devices – Microbiological
Methods – Part 2: Tests of Sterility
Performed in the Definition, Validation,
and Maintenance of a Sterilization Process IEC 62366-1 Edition 1.0 2015-02 Medical
Devices - Part 1: Application of Usability
Engineering to Medical Devices
| [Including CORRIGENDUM 1 (2016)] | |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
17
| • ISO 10993-4 Third Edition 2017-04
Biological Evaluation of Medical Devices
– Part 4: Selection of Test for Interactions
| with Blood | |
|---|---|
| • ISO 10993-5 Third Edition 2009-06-01 | |
| Biological Evaluation of Medical Devices |
- Part 5: Tests for in Vitro Cytotoxicity | |
| • ISO 10993-6 Third Edition 2016-12-01
Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After
Implantation | |
| • ISO 10993-7 Second Edition 2008-10-15
Biological Evaluation of Medical Devices:
Ethylene Oxide Sterilization Residuals | |
| • ISO 10993-10 Third Edition 2010-08-01
Biological Evaluation of Medical Devices
– Part 10: Tests for Irritation and Skin
Sensitization | |
| • ISO 10993-11 Third Edition 2017-09
Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity | |
| • ISO 11135-1 Second Edition 2014-07-15
Sterilization of Health Care Products –
Ethylene Oxide – Part 1: Requirements for
Development, Validation, and Routine
Control of a Sterilization Validation for
Medical Devices | |
| • ISO 11138-1 Third Edition 2017-03
Sterilization of Health Care Products –
Biological Indicators - Part 1: General
Requirements | |
| • ISO 11138-2 Third Edition 2017-03
Sterilization of Health Care Products –
Biological Indicators - Part 2: Biological | |
Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission
18
| | Indicators for Ethylene Oxide Sterilization
Processes | | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical
Performance Testing | As part of the manufacturing process, the
Blackrock NeuroCoG Subdural Electrodes
(Strips and Grids) are checked for electrical
continuity and resistance.
The devices were physically tested for
dielectric strength, impedance, resistance
and charge injection capacity on new and
aged products.
The NeuroCoG Patient Cable was tested for
channel mapping, resistance, shorts,
dielectric strength, and impedance. | As part of the manufacturing process, the
electrodes are checked for electrical continuity
and lack of cross-talk between channels. It is
known that the submission contained
theoretical calculations for dielectric
breakdown of the insulation and the current-
carrying capacity of the internal electrode
wires. No formal test results were submitted. | The proposed device underwent
formal electrical testing while the
predicate did not. However, being
more rigorous does not raise any
new questions of safety or
effectiveness. Therefore,
Substantially Equivalent. |
| Mechanical
Performance Testing | The Blackrock NeuroCoG Subdural
Electrodes (Strips and Grids) were
physically tested for tensile strength,
bending, and chemical compatibility on new
and aged products as well as underwent
extensive verification of their mechanical
properties.
The NeuroCoG Patient Cable was tested for
tensile strength, mating, bending, dropping,
and chemical compatibility. | Not Stated. It is known that the submission did
not include formal mechanical testing. | The proposed device underwent
formal mechanical testing while the
predicate did not. However, being
more rigorous does not raise any
new questions of safety or
effectiveness. Therefore,
Substantially Equivalent. |
| MRI Testing | The Blackrock NeuroCoG Subdural
Electrodes and NeuroCoG Patient Cable
(Strips and Grids) are MR Unsafe. | Not Stated | Labeling the device as not being
evaluated for safety and
compatibility in the MR
environment while the predicate
device does not raise any new
questions of safety or effectiveness.
Therefore, Substantially Equivalent
Identical to the predicate. |
| Contains
Software/Firmware | No | No | Identical to the predicate |
19
Image /page/19/Picture/0 description: The image is a logo for Blackrock Microsystems. The logo features a stylized penguin-like figure on the left, followed by the text "BLACKROCK" in bold, black letters. Below "BLACKROCK" is the word "MICROSYSTEMS" in a smaller, blue font.
| Electrical Safety
| Testing | Not Conducted. Not Applicable | Not Conducted. Not Applicable | Identical to the predicate. |
|---|---|---|---|
| EMC Testing | Not Conducted. Not Applicable | Not Conducted. Not Applicable | Identical to the predicate. |
| Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) Biocompatibility Evaluation | |||
|---|---|---|---|
| Test | Standard | Method | Results |
| Hemolysis | ISO 10993-4:2017 | ||
| ASTM F756-17 | |||
| ASTM F2901:2019 | Indirect Contact | Non-hemolytic | |
| Cytotoxicity | ISO 10993-5:2009 | L929 MEM Elution | Non-cytotoxic |
| Implantation | ISO 10993-6:2016 | Subdural Rabbit | |
| Brain | Non-demyelinating, | ||
| Non-neurodegenerative, | |||
| Non-astrocytotic, and | |||
| Non-microglial-proliferative | |||
| Irritation | ISO 10993-10:2010 | Intracutaneous | |
| Reactivity | Non-irritant | ||
| Sensitization | ISO 10993-10:2010 | Kligman | |
| Maximization | Non-sensitizer | ||
| Acute Systemic | |||
| Toxicity | ISO 10993-11:2017 | Systemic | |
| Injection | Non-toxic |
Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission
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| Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) Biocompatibility Evaluation | |||
|---|---|---|---|
| Test | Standard | Method | Results |
| BET/LAL | ANSI/AAMI | ||
| ST72:2011/(R)2016 | Kinetic | ||
| Chromogenic | |||
| Technique |
The Endotoxin
limit applied to the
NeuroCoG is 2.15
EU/Device (0.06
EU/ml). The
selected endotoxin
limit is based on
the potential
contact with
Cerebrospinal
Fluid. | Non-pyrogenic |
| Patient Cable | | | |
| Test | Standard | Method | Results |
| Cleaning | AAMI TIR12:2010
AAMI
TIR30:2011(R)2016 | British soil,
CaviWipes and
CaviCide | Protein Marker:
$