(190 days)
The Digital NeuroPort Biopotential Signal Processing System supports recording, processing, and display of biopotential signals from user-supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electroculography (EOG), and Evoked Potential (EP).
The Digital NeuroPort Biopotential Signal Processing System is used to acquire, process, visualize, archive/record signals as acquired from user-supplied electrodes for biopotential monitoring. Signals are acquired using a headstage relay that attaches to the pedestal interface and digitizes the signal through the hub. The Digital NeuroPort System uses preamplifiers, analog to digital converters, a signal processing unit, and software running on a personal computer to visualize and record biopotentials from electrodes in contact with the body.
The document describes the Digital NeuroPort Biopotential Signal Processing System, which is a physiological signal amplifier. The device's substantial equivalence to a predicate device (K090957, NeuroPort Biopotential Signal Processing System) is affirmed based on various performance data.
Here's an analysis of the acceptance criteria and the supporting studies:
-
Table of Acceptance Criteria and Reported Device Performance:
Test / Characteristic Acceptance Criteria Reported Device Performance NeuroPlex E Functional Testing Mating Screws down on pedestal and LED turns green Pass Crosstalk Isolation resistance of 1kΩ at 500 V DC Pass Label Durability IEC 60601-1:2005/A1:2012, Edition 3.1 7.1.3 Pass Digital Accuracy Appropriate voltages for different filters (0.02-10 kHz Wide, 0.3-7.5 kHz Standard); Peak-to-peak of 500mV ±10% Pass Input Impedance ≥10MΩ Pass Impedance Measurement 820 ± 15% kOhms and 170 ± 15% kOhms Pass Current Rating <1A Pass Stability All channels have neural data from a simulator after 90 attachments and detachments Pass Attachment Two-Finger Tightness Pass Input Noise ≤3 RMS Pass Crosstalk <44mV Pass Leakage IEC 60601-1:2005/A1:2012, Edition 3.1 Pass Breakaway <14lbf Pass Digital Hub Functional Testing Input Power Supply External, medical-grade Pass FPGA Testing from Headstage Accommodates up to 128 channels and channel priority starts with first channel and ends with fourth channel. Pass Output Power Supply to Headstage 4.8V Pass Full-Scale Analog Input ±8.192mV. Pass Burn in Test Hub can run continuously for 12 hours. Pass Compatibility Test Validated data packets received at hub and NeuroPlex E is powered. Pass Digital Neural Signal Simulator (DNSS) Functional Testing Rechargeable Battery Battery life is ≥10 hours. Pass Power Charge battery by Digital Data Cable or USB Pass Digital Digital Hub recognizes DNSS connected through Data Cable. Pass System Functional Testing Synchronization Timestamps aligned within 100 microseconds with maximum capacity of four 128-channel Es, four 128-channel hubs (only one digital data cable from one E to one hub), and two 256 NSPs. Pass Channel Count Facilitates up to 512 channels. Pass Usability Testing IFU Readability Users are able to configure intended settings, assemble the system, and perform maintenance activities all from instruction in the IFU. Pass Impedance, Reference, and Ground Switching Users are able to achieve each possible configuration prompted by the facilitator. Pass Cleaning Users do not damage the device during cleaning. Users identify the proper cleaning solutions. Users indicate that the instructions are sufficiently clear. Pass Other Performance Data Electrical Safety/EMC Compliance with IEC 60601-1:2012, Ed 3.1 and IEC 60601-1-2:2014, Ed 4.0 Compliant Biocompatibility Endpoints assessed: cytotoxicity, irritation, or sensitization, per ISO 10993-1:2018 (for NeuroPlexE and pedestal) Achieved Sterility Sterilized with 100% EtO to a SAL of 10^-6, per ISO 11135-1:2014/07/15 Achieved Residuals (EtO) EO levels < 4mg/24hr, ECH levels < 9mg/24hr; both < 60mg/30 days, per ISO 10993-7:2008/10/15 Achieved Shelf Life (Sterile) 18 months, validated by accelerated aging per ASTM F1980-16 for representative device Patient Cable. Packaging conforms to ISO 11607-1:2019, ASTM D4332-14, ASTM D4169-16, ASTM F1886-09/(R)2013, ASTM F2096-11, F88/F88M-15. 18 months achieved -
Sample size used for the test set and the data provenance:
The document focuses on engineering performance testing, usability testing, and bench testing, rather than studies involving patient data or clinical datasets. Therefore, information about a "test set" in the context of clinical data (e.g., medical images, physiological recordings from patients for algorithm evaluation) is not provided. The samples used for testing are the physical components of the device (NeuroPlex E, Digital Hub, Digital Neural Signal Simulator (DNSS), and the full system). The provenance of these test samples is not explicitly stated beyond being the components of the "Digital NeuroPort Biopotential Signal Processing System." The types of tests conducted are typically performed retrospectively using manufactured device units in a lab setting. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the type of testing described. The document describes engineering, electrical, mechanical, and usability tests for a physiological signal processing system. Ground truth in this context is established by engineering specifications, international standards (e.g., IEC, ISO, ASTM), and predefined functional requirements, not by expert interpretation of patient data. For usability testing, "users" are involved, but their specific qualifications (e.g., specific clinical experience) or number are not detailed beyond "users" being able to interact with the device and its instructions. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in clinical studies when establishing ground truth from multiple expert interpretations of patient data. The current document reports on bench testing, functional verification, and safety compliance, where results are measured against objective criteria from standards or specifications. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The Digital NeuroPort Biopotential Signal Processing System is a device for recording, processing, and display of biopotential signals. It is not described as an AI-powered diagnostic or interpretive tool that assists human "readers" (e.g., radiologists, cardiologists) in making diagnoses. Therefore, an MRMC study or AI-assisted performance improvement analysis is outside the scope of this submission. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. As noted above, the device is a signal processing system, not an AI algorithm intended for standalone diagnostic performance evaluation. The "performance data" presented is about the physical and electrical functioning of the device components and the system as a whole, not about an algorithm's diagnostic accuracy. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the functional and safety tests, the "ground truth" or reference values are defined by:- International Standards: e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 10993-1, ISO 11135-1, ISO 10993-7, ISO 11607-1, ASTM D4169-09, ASTM D4332-14, ASTM F88/F88M-15, ASTM F1886-09/(R)2013, ASTM F1980-16, ASTM F2096-11.
- Engineering Specifications: e.g., isolation resistance (1kΩ), digital accuracy (500mV ±10%), input impedance (≥10MΩ), current rating (<1A), input noise (≤3 RMS), Synchronization within 100 microseconds, channel count (up to 512), battery life (≥10 hours), output power supply (4.8V), full-scale analog input (±8.192mV).
- Functional Demonstrations: e.g., "Screws down on pedestal and LED turns green" for mating, "All channels have neural data from a simulator after 90 attachments and detachments" for stability.
- Usability Objectives: Users' ability to configure settings, assemble the system, perform maintenance, or use cleaning solutions correctly.
-
The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set of data. The "training" in this context refers to the manufacturing and testing of hardware and software against pre-defined specifications. -
How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of AI/ML for this device. The development and validation of the device components and system are based on engineering principles and regulatory standards.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Blackrock Microsystems Rachelle Frischknecht Regulatory Affairs Specialist 630 Komas Drive, Suite 200 Salt Lake City, Utah 84108
Re: K202174
Trade/Device Name: Digital NeuroPort Biopotential Signal Processing System Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, GWL, GWK Dated: December 21, 2020 Received: December 28, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 (OS) 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,
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
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Indications for Use
510(k) Number (if known) K202174
Device Name
Digital NeuroPort Biopotential Signal Processing System
Indications for Use (Describe)
The Digital NeuroPort Biopotential Signal Processing System supports recording, processing, and display of biopotential signals from user-supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electroculography (EOG), and Evoked Potential (EP).
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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I. Submitter, Device, Predicate
| Sponsor/Applicant | Blackrock Microsystems630 Komas Drive, Suite 200Salt Lake City, UT 84108 |
|---|---|
| Primary Contact | Rachelle FrischknechtRegulatory Affairs Specialist(801) 994-5668rfrischknecht@blackrockmicro.com |
| Date Summary Prepared | January 20, 2021 |
| 510(k) Submission Type | Special |
| Device Name | Digital NeuroPort Biopotential Signal Processing System |
| Common/Usual Name | Physiological signal amplifier; Physiological signal conditioner |
| Classification Name | Physiological signal amplifier (21 CFR 882.1835) |
| Regulatory Class | II |
| Product Code | GWL; GWK |
| Predicate Device | K090957, Blackrock NeuroPort Biopotential SignalProcessing System |
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II. Device Description
The Digital NeuroPort Biopotential Signal Processing System is used to acquire, process, visualize, archive/record signals as acquired from user-supplied electrodes for biopotential monitoring. Signals are acquired using a headstage relay that attaches to the pedestal interface and digitizes the signal through the hub. The Digital NeuroPort System uses preamplifiers, analog to digital converters, a signal processing unit, and software running on a personal computer to visualize and record biopotentials from electrodes in contact with the body. Components include:
- Central Software Suite: Used to receive, display and store data, configure signal processing . characteristics.
- · Neural Signal Processor: Used for signal processing.
- · Digital Hub: Used to connect digital headstage accessories and perform digital to optical conversion to pass data over fiberoptic cable to SignalProcessor.
The Digital Headstage Accessory Devices are devices that interface with the electrodes connected to the patient. Headstage devices and accessories include:
- · NeuroPlex E Headstages: Interface to percutaneous connector of NeuroPort Electrode. Acquires signal from connected electrode and performs signal processing before sending to output connector, which connect to Digital Hub via Digital Data Cable. Provided in both sterile and nonsterile configurations.
- Digital Data Cable: 1.5M Digital Data Cables connected to Digital Hub. Hub powers Digital Headstages (4.8VDC), and Headstages provide digitized biopotential signals to Hub. Provided in both sterile and non-sterile configurations.
III. Indications for Use
The Digital NeuroPort Biopotential Signal Processing System supports recording, processing, and display of biopotential signals from user-supplied electrodes. Biopotential signals include:
Electrocorticography (ECoG), Electroencephalography (EEG), Electromyography (EMG), Electrocardiography (ECG), Electrooculography (EOG), and Evoked Potential (EP)
IV. Comparison of Technological Characteristics withthe Predicate Device
At a high level, the following technological differences exist between the subject and predicate devices:
- · Electrical/EMC:
- · Change in power supply configuration (moved into DigitalHub)
- Change in headstage device and accessory (NeuroPlexE and Digital data cable, versus patient and blue ribbon cables)
- · Change in simulator (Digital Simulator replaces Analog Simulator)
- Digitization of signals to reduce signal atentuation
- Stage of signal conversion (pre-amplifier/headstage level) to improve system synchronization and reduce noise
- · Change in patient protection circuitry: Patient Cable in K090957 uses capacitor and resistor;
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whereas, ASIC in NeuroPlex E uses diodes.
- Higher frequency data transmission over new 1.5m Digital Data Cable.
- Expansion of band pass to detect neural signals
- · Digital Hub clock communicates over 1.5m Digital Data Cable to headstage instead of all on internal printed circuit boards.
- NeuroPlex E has option for wideband hardware filter that Patient Cable does not.
- NeuroPlex E has a Delrin wheel; whereas, Patient Cable has a 300 SSwheel.
- · Digital Data Cable uses common connector type.
- Digital Data Cable is a commercially available cable type (HDMI A to Dconnector).
- · Longer cable.
- · Labeling of reference selection switches changed from A, B, C, D to Ref 1, Ref 2, andGnd.
- · Shelf Life/Packaging
- 1 year to 18 months.
- Single to double pouch configuration as a sterile barrier.
- Software
- · Update to patient cable programming to handle increase in channels (E96 vs. 128)
- New calculation for impedance detection.
| Comparison of the Predicate and Subject Device | ||
|---|---|---|
| Predicate Device:NeuroPort Biopotential SignalProcessing System (K090957) | Subject Device:Digital NeuroPort Biopotential SignalProcessing System | |
| FDA Regulatory Information | ||
| Manufacturer | Blackrock Microsystems | Same as predicate |
| FDA ProductCode | GWL, GWK | Same as predicate |
| Classification | Class II - 21 CFR 882.1835, 882.1845 | Same as predicate |
| Classification Name | Physiological signal amplifier | Same as predicate |
| Indications for Use | ||
| Comparison of the Predicate and Subject Device | ||
| Predicate Device:NeuroPort Biopotential SignalProcessing System (K090957) | Subject Device:Digital NeuroPort Biopotential SignalProcessing System | |
| Indications forUse | The Digital NeuroPort BiopotentialSignal Processing Systemsupports recording, processing,and display of biopotential signalsfrom user-supplied electrodes.Biopotential signals include:Electrocorticography (ECoG),electroencephalography (EEG),electromyography (EMG),electrocardiography (ECG),electrooculography (EOG), andEvoked Potential (EP). | Same as predicate |
| Device Design | ||
| Principles ofOperation | Preamplification, amplification, analogto digital conversion, digital to opticalconversion, signal processing,visualization, and archiving/recording | Same as predicate |
| ConnectionMechanism | Pedestal | Same as predicate |
| Sterility | The cables may be supplied sterile ornon-sterile. | Same as predicate. |
| Fast Settle | 5V TTL Input | Same as predicate |
| Noise | < 3 µVrms | Same as predicate |
| Sampling Rate | Up to 30,000 Hz | Same as predicate |
| ElectricalSafety/EMCTesting | Testing in accordance with:IEC 60601-1:1998IEC 60601-1-2:2001IEC 60601-2-26:2002 | Testing in accordance with:IEC 60601-1:2005/A1:2012IEC 60601-1-2:2014IEC 60601-2-26:2002 |
| Sterility and Shelf Life | ||
| ProvidedSterile BarrierPackagingConfiguration | Tyvek | Same as predicate |
| ProvidedSterilePackaging Unit | 1 unit per box | Same as predicate |
| Comparison of the Predicate and Subject Device | ||
| Predicate Device:NeuroPort Biopotential SignalProcessing System (K090957) | Subject Device:Digital NeuroPort Biopotential SignalProcessing System | |
| SterilityAssuranceLevel(SAL) | 10-6 | Same as predicate |
| SterilizationMethod | Ethylene oxide | Same as predicate |
| Sterile ShelfLife | 1 year | 18 months |
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V. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
| Table 1. Test Results Summary | |
|---|---|
| Test | Standard/Methods |
| Safety | IEC 60601-1:2005/A1:2012 |
| EMC | IEC 60601-1-2:2014 |
| EEG | IEC 60601-2-26:2002 |
| Usability | IEC 60601-1-6/A1:2013 |
| Biocompatibility | ISO 10993-1:2018 |
| Sterilization | ISO 10993-7 Second Edition 200810/15 |
| ISO 11135-1 Second Edition 2014/07/15 | |
| Cleaning | No pitting, spotting, discoloration, or corrosion |
| with IPA, ethanol, or CaviWipes | |
| Packaging | ISO 11607-1:2019 ASTM D4169-09 |
| ASTM D4332-14 ASTM F88/F88M-15 | |
| ASTM F1886-09/(R)2013 ASTM F1980-16 | |
| ASTM F2096-11 |
Electrical Safety/Electromagnetic Compatibility
The Digital NeuroPort Biopotential Signal Processing System was evaluated for electrical safety and electromagnetic compatibility in accordance with IEC 60601-1:2012, Edition 3.1 and IEC 60601-1-2:2014, Edition 4.0, with results demonstrating that the Digital NeuroPort Biopotential Signal Processing System continues to be compliant upon field deployment.
Design Verification, Software Verification and Validation and Usability
The Digital NeuroPort Biopotential Signal Processing System was evaluated with respect to design verification and validation, software verification and validation, and usability.
| Table 2. Functional Testing for NeuroPlex E | ||
|---|---|---|
| Test | Acceptance Criteria | Result |
| Mating | Screws down on pedestal andLED turns green | Pass |
| Crosstalk | Isolation resistance of 1kohmsat 500 V DC | Pass |
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| Table 2. Functional Testing for NeuroPlex E | ||
|---|---|---|
| Label Durability | IEC 60601-1:2005/A1:2012,Edition 3.1 7.1.3 | Pass |
| Digital Accuracy | Appropriate voltages fordifferent filters.Filtering:.02-10 kHz (Wide).3-7.5 kHz (Standard)Peak-to-peak of 500mV ±10% | Pass |
| Input Impedance | ≥10MΩ | Pass |
| Impedance Measurement | 820 ± 15% kOhms and 170 ±15% kOhms | Pass |
| Current Rating | <1A | Pass |
| Stability | All channels have neural datafrom a simulator after 90attachments and detachments | Pass |
| Attachment | Two-Finger Tightness | Pass |
| Input Noise | ≤3 RMS | Pass |
| Crosstalk | <44mV | Pass |
| Leakage | IEC 60601-1:2005/A1:2012,Edition 3.1 | Pass |
| Breakaway | <14lbf | Pass |
| Table 3. Functional Testing for Digital Hub | ||
|---|---|---|
| Test | Acceptance Criteria | Result |
| Input Power Supply | External, medical-grade | Pass |
| FPGA Testing fromHeadstage | Accommodates up to 128channels and channel prioritystarts with first channel andends with fourth channel. | Pass |
| Output Power Supply toHeadstage | 4.8V | Pass |
| Full-Scale Analog Input | ±8.192mV. | Pass |
| Burn in Test: | Hub can run continuously for12 hours. | Pass |
| Compatibility Test | Validated data packetsreceived at hub andNeuroPlex E is powered. | Pass |
| Table 4. Functional Testing forDigital Neural Signal Simulator (DNSS) | ||
|---|---|---|
| Test | Acceptance Criteria | Result |
| Rechargeable Battery | Battery life is ≥10 hours. | Pass |
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| Table 4. Functional Testing forDigital Neural Signal Simulator (DNSS) | ||
|---|---|---|
| Power | Charge battery by Digital Data Cable or USB | Pass |
| Digital | Digital Hub recognizes DNSS connected through Data Cable. | Pass |
| Table 5. Functional Testing for System | ||
|---|---|---|
| Test | Acceptance Criteria | Result |
| Synchronization | Timestamps aligned within100 microseconds withmaximum capacity of four 128-channel Es, four 128-channelhubs, (only one digital datacable from one E to one hub),and two 256 NSPs. | Pass |
| Channel Count | Facilitates up to 512 channels. | Pass |
| Table 6. Usability Testing | ||
|---|---|---|
| Test | Acceptance Criteria | Result |
| IFU Readability | Users are able to configureintended settings, assemblethe system, and performmaintenance activities all frominstruction in the IFU. | Pass |
| Impedance, Reference, andGround Switching | Users are able to achieveeach possible configurationprompted by the facilitator. | Pass |
| Cleaning | Users do not damage thedevice during cleaning. Usersidentify the proper cleaningsolutions. Users indicate thatthe instructions are sufficientlyclear. | Pass |
Biocompatibility
Of the subject device system components, the NeuroPlexE and pedestal components have some extent of patient contact during intraoperative use, with both components being used in sterile configurations.
Specific to the NeuroPlexE which is new to the subject device system, while not intended to be a patient-contacting device there is potential for incidental contact with skin intraoperatively when a patient or surgeon touches the device. It was evaluated in accordance with ISO 10993-1 Fifth Edition 2018/18 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process. Given the contact classification and cumulative duration of contact, the endpoints assessed were cytotoxicity, irritation, or sensitization.
Sterility and Shelf Life
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Components of the system that are available in both sterile and non-sterile configurations are the NeuroPlex E and Digital Data Cable. NeuroPlex E briefly contacts the percutaneous portion of the electrode before implantation, and the Digital Data Cable attaches to the NeuroPlex E.
The devices are sterilized with 100% ethylene oxide (EtO) in accordance with ISO 11135-1 Second Edition 2014/07/15 Sterilization of Health Care Products – Ethylene Oxide – Part I: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices to a Sterility Assurance Level of 10 € using Overkill Method with three half cycles.
Residuals: The NeuroPlex E and Digital Data Cable are no more difficult to sterilize than PCD NeuroPort Electrode (as cleared in K042384, K070272, and K110010) which meets the requirements of ISO 10993-7 Second Edition 2008/10/15 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals for the limit of toxic sterilant residuals and has been adopted into the NeuroPort Electrode sterilization per AAMI TIR28:2016 Product Adoption and Process Equivalence for Ethylene Oxide Sterilization. An exhaustive extraction procedure was performed and the ethylene oxide levels are <4mg and the ethylene chlorohydrin levels are <9mg per 24 hours and both residuals were <60mg per 30 days.
Packaging Sterile:
NeuroPlex E and Digital Data Cables: The NeuroPlexE and Digital Data Cable devices are packaged separately. The sterile barrier is double-pouched in 1073B uncoated Tyvek/.00048 PET .002 LDPE film. The transportation/shelf-life barrier is an inner and outer pouch, then a foam base, ring, and lid in a chipboard box in a 51 ECT cardboard overshipper. The packaging conforms to ISO 11607-1:2019. Conditioning per ASTM D4332- 14 and Distribution Simulation per ASTM D4169-16 was performed on representative device CerePlex E. Accelerated aging testing was conducted per ASTM F1980-16 on representative device Patient Cable to validate an 18- month shelf-life. Following conditioning and distribution simulation and accelerated aging, samples were tested for Visual Inspection per ASTM F1886-09/(R)2013, Bubble Emissions per ASTM F2096-11, Seal Strength per F88/F88M-15, and functionality. The devices met the requirements of the applicable standards and functional testing following conditioning, distribution simulation, and accelerated aging studies.
Non-Sterile:
NeuroPlex E: The non-sterile NeuroPlex E is in a three-piece foam enclosure with a Plastazote foam conductive polyethelene primary base, Plastazote foam conductive polyethelene small base, and PE Black Conductive LD30 XLPE device holder and placed in a necklace box. The necklace box is then placed into a black photoreactive resin foam and then into a small UPS box.
Digital Data Cables: The non-sterile Digital Data Cables are placed in a poly bag. Digital Hub: The non-sterile Digital Hub is placed in a 32 ECT/B Flute corrugated box in a suspension packaging insert of cardboard with cellophane.
VI. CONCLUSIONS
The non-clinical data support the safety and effectiveness of the device, with the testing performed demonstrating that the Digital NeuroPort Biopotential Signal Processing System device performs comparably to the predicate device that is currently marketed for the same intended use and should perform as intended in the specified use conditions.
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).