BIS™ Advance pEEG Module

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 13, 2026 Covidien LP Monica Gupta Senior Regulatory Affairs Specialist 15 Hampshire St. Mansfield, MA 02048 Re: K260907 Trade/Device Name: BISTM Advance pEEG Module Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLW Dated: July 7, 2026 Received: July 7, 2026 Dear Monica Gupta: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260907 - Monica Gupta Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K260907 - Monica Gupta Page 3 assistance/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, Bradley Q. Quinn -S Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K260907 Device Name BISTM Advance pEEG Module Indications for Use (Describe) The BISTM Advance pEEG Module when connected to the Host Monitor is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISTM Advance pEEG Module and all its associated parameters, is intended for use on adult and pediatric patients (4 years old and above) within a hospital or medical facility. For adult patients, the BISTM Index, one of the BISTM Advance pEEG Module's output parameters, may be used to guide anesthetic administration of desflurane, isoflurane, propofol and sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain. The use of the BISTM Index for monitoring may be associated with the following when used with propofol anesthesia: reduction in primary anesthetic use; reduction in emergence and recovery time; and reduction in incidence of awareness with recall. For pediatric patients, ages 4 and above, the BISTM Index, one of the BISTM Advance pEEG Module's output parameters, may be used to guide anesthetic administration of sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain. The use of the BISTM Index in pediatric patients, when used with sevoflurane anesthesia, has demonstrated a reduction in primary anesthetic use. 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) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: 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."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} Medtronic BISTM Advance pEEG Module Traditional 510(k) Submission 510(k) Summary # 510(k) SUMMARY # K260907 This summary of 510(k) safety and effectiveness information for the BISTM Advance pEEG Module is submitted in accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with the requirements of 21 CFR 807.92. # I. SUBMITTER INFORMATION | Submitted By: | Covidien llc^{1} 200 Medtronic Dr Lafayette, CO 80026 | | --- | --- | | Contact Person: | Monica Gupta, Senior Regulatory Affairs Specialist Phone: 651-338-8794 Email: monica.gupta@medtronic.com | | Secondary Contact: | Jessica Swafford, Senior Regulatory Affairs Manager Phone: 720-697-0165 Email: jessica.swafford@medtronic.com | | Date: | August 11, 2026 | # II. DEVICE | Trade or Proprietary Name: | BISTM Advance pEEG Module | | --- | --- | | Common Name: | BISTM Advance pEEG Module | | Regulation Number: | 21 CFR § 882.1400 | | Classification Name: | Electroencephalograph | | Regulatory Class: | Class II | | Product Code: | OLW, OMC, OLT, ORT | | Review Panel: | Anesthesiology/Neurology | $^{1}$ Covidien llc is a wholly owned subsidiary of Medtronic Inc. 1 {5} Medtronic BISTM Advance pEEG Module Traditional 510(k) Submission 510(k) Summary ### III. PREDICATE & REFERENCE DEVICES Predicate Device: Predicate Manufacturer: Covidien LLC (acquired by Medtronic) Predicate Device Name: BISX™/BISX4™ Module cleared as part of BIS™ Advance Monitoring System Predicate 510(k): K230693 ### IV. DEVICE DESCRIPTION The BISTM Advance pEEG Module is a finished medical device that, when connected to a compatible host monitor, such as the BISTM Advance Monitor (cleared as part of BISTM Advance Monitoring System under K230693), and paired with the BISTM Sensors (cleared under K143506), monitors the hypnotic state of the brain by acquisition and processing of EEG signals. - The BISTM Advance pEEG Module processes raw EEG data to produce a single number, called the Bi-spectral Index (BISTM index), a single numerical value correlating with the patient's level of hypnosis (depth of anesthesia), and transmits it to the Host Monitor for display on the monitor screen. - Together with calculating the BISTM index value, the BISTM Advance pEEG Module also derives other processed EEG parameters using the raw EEG data to support clinical decisions and sends them to the Host Monitor that may display them on screen. The BISTM Advance pEEG Module connects to the monitor using a Host Cable on one side and to a BISTM Sensor using a Sensor Cable on the other side, see Figure 1. It is capable of processing up to four (4) EEG channels, depending on the type of connected sensor. For 2-channel sensors, the system produces one BISTM index value; for 4-channel sensors, the system produces a total of 2 BISTM index values, one for each brain hemisphere. The module includes a Sensor Cable, which has an internal unit called the Front-End (digital signal converter), which contains software and hardware, and uses them to digitize the EEG signals, detect sensor-related errors and malfunctions, and communicate with the Back-End. The Back-End contains an internal component called the pEEG Module, which houses the “Main Board” and software to process the digitized EEG, produce the processed parameters using the BISTM algorithm, and communicate with both the Host and the Front-End. Both the Front-End and Back-End are equipped with software and hardware components that store encryption keys and perform authentication, encryption, and decryption as necessary. The BISTM Advance pEEG Module is available in several configurations, differentiated by the type of Monitor Connector integrated part of the Host Cable (identified as component "A" in Figure 1) to ensure compatibility with a variety of patient monitors. One configuration is designed for use with the Medtronic 2 {6} Medtronic BISTM Advance pEEG Module Traditional 510(k) Submission 510(k) Summary BISTM Advance Monitor, while the other configurations maintain backward compatibility with host monitors from other legal manufacturers. Each configuration is provided with an eIFU insert directing users to download the Instructions for Use from the Medtronic website. Similar to its predicate, the BISTM Advance pEEG Module is a non-sterile, reusable device. The BISTM Advance pEEG Module maintains the same intended use, core functionality, and BISTM algorithm as the predicate BISXTM/BISX4TM Module (cleared as part of BISTM Advance Monitoring System under K230693) while incorporating updated hardware, software enhancements, and improved ECG artifact filtering. The BISTM Advance pEEG Module is powered by the host monitor via the host cable and does not generate alarms. It stores non-PHI operational data that may be retrieved using the BISTM Advance Connect Application, a non-medical software tool used outside active monitoring. The subject device is compatible with the 510(k) cleared BISTM Sensors (K143506) and is available in multiple configurations with different monitor connectors to support both Medtronic and host monitors from other legal manufacturers. Both the Back-End and Front-End components support authentication and encrypted communication. The BISTM Advance pEEG Module is intended for use by trained healthcare professionals within hospital environments. Table 1: BISTM Advance pEEG Module Components | Identifier | Component | | --- | --- | | A | Monitor Connector (part of the Host Cable and Back End) | | B | pEEG Module Host Cable (Part of Back End) | | C | pEEG Module (Part of Back End) | | D | Sensor Cable Module Connector | | E | pEEG Module Sensor Cable (also called Front-End Cable) | | F | Cable Management Solution | | G | Sensor Cable Clip | | H | Sensor Cable Connector (also called Front-End) | | I | Mount (Also called Cradle) | 3 {7} Medtronic BISTM Advance pEEG Module Traditional 510(k) Submission 510(k) Summary  Figure 1: BISTM Advance pEEG Module Components 4 {8} Medtronic BISTM Advance pEEG Module Traditional 510(k) Submission 510(k) Summary # V. INDICATIONS FOR USE The BISTM Advance pEEG Module when connected to a Host Monitor, is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISTM Advance pEEG Module, and all its associated parameters, is intended for use on adults and pediatric patients (4 years old and above) within a hospital or medical facility. For adult patients, the BISTM Index, one of the BISTM Advance Monitoring System's output parameters, may be used to guide anesthetic administration of desflurane, isoflurane, propofol and sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain. The use of the BISTM Index for monitoring may be associated with the following when used with propofol anesthesia: reduction in primary anesthetic use; reduction in emergence and recovery time; and reduction in incidence of awareness with recall. For pediatric patients, ages 4 and above, the BISTM Index, one of the BISTM Advance Monitoring System's output parameters, may be used to guide anesthetic administration of sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain. The use of the BISTM Index in pediatric patients, when used with sevoflurane anesthesia, has demonstrated a reduction in primary anesthetic use. # VI. TECHNOLOGICAL CHARACTERISTICS COMPARISON Table 2: Comparison of Technological Characteristics with the Predicate Device. | Device Characteristics | Subject Device BISTM Advance pEEG Module | Predicate BISXTM/BISX4TMModule part of BISTM Advance Monitoring System (K230693) | Comments | | --- | --- | --- | --- | | Classification | II | II | Identical | | Product Code | OLW OMC, OLT, ORT | OLW, OMC, OLT, ORT | Identical | | Fundamental Technology | Acquisition and processing of real-time EEG waveforms and processed EEG parameters | Acquisition and processing of real-time EEG waveforms and processed EEG parameters | Identical | | Principle of Operation | EEG signals are transmitted from sensors placed on the patient's head to the Module. The Module filters the data, analyzes it for artifacts, and processes it using digital signal processing techniques, then sends the data to the monitor for display. | EEG signals are transmitted from sensors placed on the patient's head to the Module. The Module filters the data, analyzes it for artifacts, and processes it using digital signal processing techniques, then sends the data to the monitor for display. | Identical | 5 {9} Medtronic BISTM Advance pEEG Module Traditional 510(k) Submission 510(k) Summary | Device Characteristics | Subject Device BISTM Advance pEEG Module | Predicate BISXTM/BISX4TMModule part of BISTM Advance Monitoring System (K230693) | Comments | | --- | --- | --- | --- | | Regulation Number | 882.1400 | 882.1400 | Identical | | Prescription/over the counter | Prescription | Prescription | Identical | | Intended Population | Adult and pediatric, from age 4 years and up | Adult and pediatric, from age 4 years and up. | Identical | | Intended Users | Professionally trained health care providers | Professionally trained health care providers | Identical | | Environment of Use | Hospitals or medical facilities providing patient care | Hospitals or medical facilities providing patient care | Identical | | Sensors Compatibility | BISTM Sensors (cleared under K143506) | BISTM Sensors (cleared under K143506) | Identical | | BISTM Algorithm | 4.1 | 4.1 | Identical | | ECG Artifact Filtering | Enhanced or legacy, on demand-capability (default Enhanced) | Legacy | Different: The subject device is equipped with the enhanced ECG filtering algorithm in the preprocessing phase of the BISTM Algorithm | | EEG Channels | 2 or 4 (single model/enclosure), | BISXTM: 2 BISX4TM: 2 or 4, depending on connected sensor and monitor capability | Different: Subject device supports both 2 and 4 channels within the same hardware unit; predicate device requires separate units for each configuration | | Processed Parameters | SQI EMG SR BC SEF95 MF, SEF 50 ST | SQI EMG SR BC SEF95 MF, SEF 50 | Similar: The ST parameter was not produced by the predicate device; it was calculated by the BISTM Advance Monitor, using data sent from the predicate device. To calculate the ST parameter, the subject device uses the same algorithm that was used by the monitor; therefore, | 6 {10} Medtronic BISTM Advance pEEG Module Traditional 510(k) Submission 510(k) Summary | Device Characteristics | Subject Device BISTM Advance pEEG Module | Predicate BISXTM/BISX4TMModule part of BISTM Advance Monitoring System (K230693) | Comments | | --- | --- | --- | --- | | | | | no differences are expected. | | Memory | 64 GB eMMC | 32 MB Flash | Different: The subject device has increased data storage capacity. | | Software | Moderate Level of Concern | Basic Documentation Level | Similar: Level of Concern remains unchanged. Different terminology: Under the previous software guidance, it was classified "moderate", whereas the updated 2023 guidance refers to it as "basic documentation level". | | Sensor Cable | Terminated to mate with BISTM Sensors Equipped with DSC converter in the Front-End | Terminated to mate with BISTM Sensors | Similar: Terminated to mate with BISTM Sensors. Different: Relocation of the digitization unit (DSC) to the Sensor Cable Front End | | Host Cable | Terminated per OEM to mate with OEM Host (Including BISTM Advance Monitor) | Terminated per OEM to mate with different OEM Hosts (Previously called Monitor Interface Cable (MIC)). | Similar: Terminated per Host Monitor Inlets Different: Different termination on the Module side | | Patient Contacting Materials | Sensor connector: Tritan MX711 (white), soft TPU (Texin TXT70A, Blue), Elastollan 1170AFC (strain relief) Cable management system: Polyamide, POM (Velcro strap) FE Cable jacket: TPU, colored gray Clip: POM- Polyoxymethylene (clip), Tail Tape (PVC), SUS 316L(spring), Aluminum (connecting rivet) | SANTOPRENE 8281-75MED OR 281-73MED (for sensor connector side), PVC (for cable jacket) | Different Patient contacting materials The device has successfully passed Biocompatibility tests per ISO 10993-1 | 7 {11} Medtronic BISTM Advance pEEG Module Traditional 510(k) Submission 510(k) Summary | Device Characteristics | Subject Device BISTM Advance pEEG Module | Predicate BISXTM/BISX4TMModule part of BISTM Advance Monitoring System (K230693) | Comments | | --- | --- | --- | --- | | Standards | IEC 60601-1:2005+A1:2012+A2:2020 IEC 60601-1-2:2014+A1:2020 IEC 60601-1-6:2010+A1:2013+A2:2020 IEC 62366-1:2015+A1:2020 IEC 80601-2-26:2019+A1:2024 | IEC 60601-1:2005+A1:2012+A2:2020 IEC 60601-1-2:2014+A1:2020 IEC 60601-1-6:2010+A1:2013+A2:2020 IEC 62366-1:2015+A1:2020 IEC 80601-2-26:2019 | Similar: Except for the 2024 amendment of the EEG standard (IEC 80601-2-26) | The subject device, BISTM Advance pEEG Module, is substantially equivalent to the predicate device, the BISX™ and BISX™ Modules, previously cleared as part of the BISTM Advance Monitoring System (K230693). The BISTM Advance pEEG Module has been developed to replace the predicate modules due to the end-of-life considerations associated with the main components. While the subject device introduces updated hardware and software architecture, it maintains the same indications for use, principle of operation, core functionality, and fundamental scientific technology as the predicate device. The subject and the predicate devices both acquire and process electroencephalographic (EEG) signals to generate processed EEG parameters, including the Bispectral Index (BISTM), for monitoring patients' level of hypnosis (depth of anesthesia). No changes have been made to the device's intended use, user population, clinical environment, or overall functionality. The key technological differences between the subject device and the predicate device are as follows: - Complete Hardware and Software redesign driven by the end-of- life of component replacement. - Integration of two-channel and four-channel EEG measurement capabilities into a single device enclosure. - Relocation of the digitization unit to the Sensor Cable Front End, improving signal-to-noise ratio and reducing artifacts such as ESU interference. - Hardware platform readiness for future upgrades. - Software redesign required to interface with redesigned hardware. - Enhanced ECG Artifact Detection and Cleaning Algorithm to support improved signal processing stability. - Difference in Patient-Contacting Materials These differences do not raise new questions of safety or effectiveness. Performance testing including electrical safety, EMC, software verification and validation, biocompatibility, and performance bench testing, demonstrates that the BISTM Advance pEEG Module performs equivalently to the predicate 8 {12} Medtronic BISTM Advance pEEG Module Traditional 510(k) Submission 510(k) Summary devices. Based on the comparison of technological characteristics and performance data, the subject device is as safe and effective as the predicate devices and is therefore substantially equivalent. Although the patient-contacting materials of the subject device differ from those of the predicate device, this difference does not raise new questions of safety or effectiveness. The subject device materials were evaluated in accordance with the FDA guidance “Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process” and the device’s identified nature and duration of contact. A comprehensive biocompatibility assessment was performed, and all testing demonstrated that the subject device materials are biologically safe for their intended use. Testing included the endpoints applicable to the device’s contact type, e.g., cytotoxicity, sensitization, irritation, required per ISO 10993-1. All results met acceptance criteria, confirming that the materials do not present additional biological risks compared to the predicate. Based on the successful completion of biocompatibility testing and the absence of adverse findings, the difference in patient-contacting materials does not affect the device’s safety, effectiveness, or overall substantial equivalence. ### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. #### Performance Testing – Bench: In accordance with 21 CFR 807.87(g), bench performance testing was conducted on the subject device, the BISTM Advance pEEG Module, to support a claim of substantial equivalence to the predicate device cleared in K230693 and to demonstrate that the device was designed to meet the design inputs. Verification and validation testing was completed at a system level to ensure safety and effectiveness of the BISTM Advance pEEG Module. Non-clinical testing for the BISTM Advance pEEG Module - Performance - Electrical Safety, EMC, Particular Standards - Human Factors and Usability - Reliability - Software - Cybersecurity - Hardware - Mechanical - Environmental - Labeling 9 {13} **Medtronic** BISTM Advance pEEG Module Traditional 510(k) Submission 510(k) Summary--- - Packaging Additionally, testing illustrated that the subject device complies with the recent amendment of the EEG particular standard: - IEC 80601-2-26 # *Biocompatibility Testing:* Biocompatibility testing of the subject device was performed in accordance with “*Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process*” and the device’s identified nature and duration of contact. # *Electrical Safety, EMC Testing:* Electrical safety and EMC testing were performed on the subject device. The subject device complies with 60601-1 standard for safety and 60601-1-2 standard for EMC. # *Human Factors Evaluation:* A Human Factors assessment was conducted, and the BISTM Advance pEEG Module was found to be in conformance with EN 62366-1 and IEC 62366-1. # *Software Testing:* Software verification and validation testing were conducted and provided as part of this submission as recommended by the FDA Guidance, “*Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff*” (issued June 14, 2023). # *Cybersecurity Testing:* Cybersecurity testing was conducted and provided as part of this submission as recommended by the FDA Guidance, “*Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff*” (issued February 2026). # **Performance Testing – Animal:** No animal performance testing was required to demonstrate subject device safety and effectiveness. # **Performance Testing – Clinical:** No clinical performance testing was required to demonstrate subject device safety and effectiveness. ## VIII. CONCLUSION Based on the information provided in this premarket notification submission, including intended use, device comparisons, and performance testing, the BISTM Advance pEEG Module meets applicable safety and performance standards and performs as intended in a manner identical to the predicate. The different ---10 {14} **Medtronic** BISTM Advance pEEG Module Traditional 510(k) Submission 510(k) Summary technological characteristics do not raise different questions of safety or effectiveness. Therefore, the BISTM Advance pEEG Module is considered substantially equivalent to the predicate device currently marketed for the same intended use. ---11