DSG Connect Technology

K201454 · Spineguard S.A. · PDQ · Feb 10, 2021 · Ear, Nose, Throat

Device Facts

Record IDK201454
Device NameDSG Connect Technology
ApplicantSpineguard S.A.
Product CodePDQ · Ear, Nose, Throat
Decision DateFeb 10, 2021
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 874.1820
Device ClassClass 2

Intended Use

The PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard system is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The PediGuard Threaded System is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebration. PediGuard Threaded System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard Threaded System is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. PediGuard Threaded System also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The Zavation Screw System is indicated for use with the Zavation Spinal System during pedicle screw insertion to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the pedicle screw and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The Zavation Screw System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine, with options of direct insertion of the screw in bone or after a step of preparation of the pilot hole with sensor equipped instruments.

Device Story

DSG Connect Technology integrates wireless connectivity into existing PediGuard and Zavation screw systems. Device inputs include electrical impedance measurements at the probe/screw tip and EMG signals. The system processes these inputs to provide real-time visual and audible alerts to the surgeon regarding tissue type (bone vs. soft tissue) and potential cortex perforation. A Bluetooth-enabled module transmits data to a tablet running the DSG Connect App, which provides a graphical representation of the signal, allowing for display and recording of conductivity changes over time. Used in OR settings by surgeons during spinal fusion procedures. The output assists surgeons in navigating pedicle screw placement, reducing the risk of nerve injury or cortical breach by providing immediate feedback on tissue contact.

Clinical Evidence

Bench testing only. Performance data included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), wireless coexistence, and verification of pulse output, sound evaluation, and low-battery detection. System design validation was performed in a pig lab. No clinical data provided.

Technological Characteristics

System includes sensor-equipped surgical instruments (probes/screws) with integrated electronics, Bluetooth (BLE) communication module, and a tablet-based application. Sensing principle: electrical impedance measurement at the tip. Energy source: battery-powered. Connectivity: wireless transmission to a commercial tablet (Microsoft Go). Software: firmware for data management and BLE transmission. Sterilization: not specified.

Indications for Use

Indicated for patients undergoing open or percutaneous (MIS) spinal surgery requiring pedicle screw pilot hole drilling or screw insertion; assists in nerve location via EMG surveillance and provides feedback on potential vertebral cortex perforation or soft tissue contact.

Regulatory Classification

Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. SpineGuard, S.A. % John Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004 Re: K201454 Trade/Device Name: DSG Connect Technology Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ, ETN Dated: January 21, 2021 Received: January 21, 2021 ## Dear John Smith: 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, 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) K201454 Device Name DSG Connect Technology | Indications for Use (Describe) | |---------------------------------------------| | PediGuard and PediGuard Cannulated systems: | The PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard system is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. PediGuard Threaded System: The PediGuard Threaded System is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebration. PediGuard Threaded System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard Threaded System is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. PediGuard Threaded System also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. DSG Zavation screw system: The Zavation Screw System is indicated for use with the Zavation Spinal System during pedicle screw insertion to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the pedicle screw and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The Zavation Screw System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine, with options of direct insertion of the screw in bone or after a step of preparation of the pilot hole with sensor equipped instruments. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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." {4}------------------------------------------------ ### 510(k) SUMMARY ### DSG Connect Technology #### l. Submitter SpineGuard S.A. 10 Cours Louis Lumière Vincennes, France 94300 Phone: +33 1 45 18 45 19 Facsimile: +33 1 45 18 45 20 Contact Person: Stephane Bette Date Prepared: June 1, 2020 II. Device Name of Device: DSG Connect Technology Common or Usual Name: Nerve Stimulator Classification Name: 21 C.F.R. §874.1820 (Surgical Nerve stimulator/ locator) Regulatory Class: Class II Product Code: PDQ, ETN #### lll. Predicate Devices K143159, PediGuard devices, SpineGuard SA K143159, Cannulated PediGuard devices, SpineGuard SA K152747, PediGuard Threaded systems, SpineGuard SA K162884, DSG Zavation screw system, SpineGuard SA #### IV. Device Description The DSG Connect technology is a pedicle screw system used for bone drilling procedure during open or minimally invasive spinal fusion. The devices provide visual and audible alerts to a surgeon to indicate a change in electrical conductivity at the tip of the probe that may indicate contact of the tip with soft tissues. The DSG Connect Technology provides the user with an optional visual graphical presentation of the electrical conductivity information communicated by the DSG Connect devices to a tablet, with the App providing a visual representation of the audio signal emitted by the device handle. The App allows for display and recording of the signal, including graphing of changes in the audio signal over time. {5}------------------------------------------------ The DSG Connect technology is incorporated in to the handles of the Cannulated PediGuard Threaded system, and DSG Zavation screw system. #### V. Indications for Use ### PediGuard and PediGuard Cannulated systems: The PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard system is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. ### PediGuard Threaded System: The PediGuard Threaded System is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. PediGuard Threaded System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. PediGuard Threaded System is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine. PediGuard Threaded System also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. ### DSG Zavation screw system: The Zavation Screw System is indicated for use with the Zavation Spinal System during pedicle screw insertion to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the pedicle screw and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The Zavation Screw System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine, with options of direct insertion of the screw in bone or after a step of preparation of the pilot hole with sensor equipped instruments. {6}------------------------------------------------ K201454 #### VI. Comparison of Technological Characteristics With the Predicate Devices The following technological differences exist between the subject and predicate devices: - Integration of DSG Connect Technology ● - Modification of electronics board to include wireless transmitter O - Added Connect App using commercial tablet as Hardware platform (Microsoft Go) o - Hardware changes ● - o Change of audio technology (speaker→ buzzer) - Change of integration of low battery threshold detection into design O - Changes to some electronic components, manufacturing process & configuration of board O - Change in electronic component for device activation (replacement of legacy electronic contact O blade, PediGuard device only) - O Added BLE communication module (Bluetooth) - Software changes ● - Addition of low battery threshold detection o - Monitoring of new parameters (battery voltage, reference voltage, microcontroller (MCU) O temperature) - Added firmware to manage BLE transmission of data pushed by MCU o #### VII. Performance Data The following performance data were provided in support of the substantial equivalence determination. - Electrical safety in accordance with IEC 60601-1 ● - Electromagnetic compatibility in accordance with IEC 60601-1-2 ● - Wireless coexistence | Name | Description | |-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Autonomy test | Verify the autonomy of the modified<br>electronics | | Impaction,<br>weight and cap<br>resistance test | Verify the mechanical resistance of the<br>plastic casing with the modified inner<br>geometry | | Low-battery<br>mode<br>verification and<br>re-usage<br>prevention | Verify the correct implementation of the low<br>battery detection and the reusage prevention<br>feature in the modified electronics /<br>embedded software | | Pulse output | Verify that the electrical pulse is sent within<br>the specifications in terms of duration /<br>frequency / intensity | | Output signal<br>evaluation | Verify that the output signal of the modified<br>device (modified electronics / embedded<br>software) is equivalent to the predicate<br>device for similar conductivity levels | | Sound<br>evaluation | Verify that the sound volume of the modified<br>device (using a buzzer) is at least equivalent<br>to the predicate device (using a speaker) | {7}------------------------------------------------ ### K201454 | System<br>Evaluation | System design validation by surgeon in a pig<br>lab | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Bluetooth<br>communication | Verify the proper connection between the<br>devices and that the data transferred and<br>displayed on the tablet are correct | | Safety features | Verify the correct implementation of the<br>various safety features in the modified<br>electronics / embedded software (LED and<br>buzzer status when device is on in air, on in<br>conductive medium, on with shortcut, on with<br>low battery and off) | | DSG Connect<br>App GUI<br>verification | Design verification of the DSG Connect App<br>Graphic User Interface (GUI) | | Maximum<br>regulated pulse<br>output | Verify that the maximum current that is sent<br>into the patient is within the specifications<br>and as per the predicate device (below<br>5.5mA) | | Curve<br>smoothing /<br>Amplification | Memo on the data treatment to ensure the<br>signal is displayed adequately | #### VIII. Conclusions The DSG Connect family of products are comparable to the predicate PediGuard devices, Cannulated PediGuard, PediGuard Threaded, and DSG Zavation Screw systems, with the technological differences in comparison to the predicate devices not raising new or different questions of safety and effectiveness. Additionally, the non-clinical data support the safety and effectiveness of the DSG Connect family of systems when used as intended in the specified use conditions.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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