(254 days)
Not Found
No
The document describes a device that provides feedback based on electrical conductivity changes and EMG monitoring. There is no mention of AI or ML algorithms being used for analysis, interpretation, or decision-making. The "App" mentioned provides a visual representation of the audio signal and allows for display and recording, which is data visualization, not AI/ML.
No
Explanation: The device provides feedback to the surgeon during pedicle screw placement and assists in locating spinal nerves. It does not directly treat a disease or condition. Its purpose is diagnostic and guidance-oriented during surgery, not therapeutic.
Yes
Explanation: The device provides feedback to the surgeon via visual and audible alerts based on changes in impedance, which can indicate contact with soft tissues or possible vertebral cortex perforation. It also specifically mentions intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves. These functions are diagnostic in nature, as they provide information to aid in identifying conditions or anatomical locations.
No
The device description explicitly states that the technology is "incorporated in to the handles of the Cannulated PediGuard Threaded system, and DSG Zavation screw system," indicating a hardware component. While there is an accompanying app, the core technology is embedded in physical instruments.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that the PediGuard and Zavation systems are used during surgical procedures to provide real-time feedback based on electrical impedance changes at the tip of the instrument as it interacts with tissues within the body. They are not analyzing samples like blood, urine, or tissue biopsies.
- The device provides feedback during surgery. The purpose is to guide the surgeon in real-time during pedicle screw placement and nerve location, not to diagnose a condition based on laboratory analysis of a sample.
- The performance studies focus on device functionality and safety in vivo or simulated in vivo conditions. The studies mentioned (electrical safety, mechanical resistance, pulse output, system evaluation in a pig lab) are typical for surgical instruments and not for IVDs, which would focus on analytical performance (sensitivity, specificity, accuracy of sample analysis).
The device is a surgical instrument that uses electrical impedance and EMG monitoring to provide guidance to the surgeon during spinal procedures. This falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
PDQ, ETN
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.
The DSG Connect technology is incorporated in to the handles of the Cannulated PediGuard Threaded system, and DSG Zavation screw system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, operative site
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Autonomy test: Verify the autonomy of the modified electronics
- Impaction, weight and cap resistance test: Verify the mechanical resistance of the plastic casing with the modified inner geometry
- Low-battery mode verification and re-usage prevention: Verify the correct implementation of the low battery detection and the reusage prevention feature in the modified electronics / embedded software
- Pulse output: Verify that the electrical pulse is sent within the specifications in terms of duration / frequency / intensity
- Output signal evaluation: Verify that the output signal of the modified device (modified electronics / embedded software) is equivalent to the predicate device for similar conductivity levels
- Sound evaluation: Verify that the sound volume of the modified device (using a buzzer) is at least equivalent to the predicate device (using a speaker)
- System Evaluation: System design validation by surgeon in a pig lab
- Bluetooth communication: Verify the proper connection between the devices and that the data transferred and displayed on the tablet are correct
- Safety features: Verify the correct implementation of the various safety features in the modified electronics / embedded software (LED and buzzer status when device is on in air, on in conductive medium, on with shortcut, on with low battery and off)
- DSG Connect App GUI verification: Design verification of the DSG Connect App Graphic User Interface (GUI)
- Maximum regulated pulse output: Verify that the maximum current that is sent into the patient is within the specifications and as per the predicate device (below 5.5mA)
- Curve smoothing / Amplification: Memo on the data treatment to ensure the signal is displayed adequately
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.1820 Surgical nerve stimulator/locator.
(a)
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.(b)
Classification. Class II.
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
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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
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 |
| electronics | |
| Impaction, | |
| weight and cap | |
| resistance test | Verify the mechanical resistance of the |
| plastic casing with the modified inner | |
| geometry | |
| Low-battery | |
| mode | |
| verification and | |
| re-usage | |
| prevention | Verify the correct implementation of the low |
| battery detection and the reusage prevention | |
| feature in the modified electronics / | |
| embedded software | |
| Pulse output | Verify that the electrical pulse is sent within |
| the specifications in terms of duration / | |
| frequency / intensity | |
| Output signal | |
| evaluation | Verify that the output signal of the modified |
| device (modified electronics / embedded | |
| software) is equivalent to the predicate | |
| device for similar conductivity levels | |
| Sound | |
| evaluation | Verify that the sound volume of the modified |
| device (using a buzzer) is at least equivalent | |
| to the predicate device (using a speaker) |
7
K201454
| System
Evaluation | System design validation by surgeon in a pig
lab |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bluetooth
communication | Verify the proper connection between the
devices and that the data transferred and
displayed on the tablet are correct |
| Safety features | Verify the correct implementation of the
various safety features in the modified
electronics / embedded software (LED and
buzzer status when device is on in air, on in
conductive medium, on with shortcut, on with
low battery and off) |
| DSG Connect
App GUI
verification | Design verification of the DSG Connect App
Graphic User Interface (GUI) |
| Maximum
regulated pulse
output | Verify that the maximum current that is sent
into the patient is within the specifications
and as per the predicate device (below
5.5mA) |
| Curve
smoothing /
Amplification | Memo on the data treatment to ensure the
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.