(261 days)
Not Found
No
The device description focuses on real-time impedance sensing and providing audio/visual feedback based on pre-defined thresholds, which is a traditional signal processing approach, not AI/ML. There is no mention of learning, training data, or complex algorithms typically associated with AI/ML.
No
The device is primarily a drill system for preparing pedicle screw holes, with additional functions for providing feedback to the surgeon and assisting in nerve location, rather than directly treating a disease or condition.
Yes
The device provides feedback (visual and audible alerts, EMG monitoring) to the surgeon to assist in determining tissue density, potential breaches of the cortical wall, and location and evaluation of spinal nerves during surgery. These functions are diagnostic as they help identify a medical condition or characteristic.
No
The device description clearly details physical components like a sensor, shaft, threaded portion, and cutting flutes, indicating it is a hardware device with integrated technology, not software-only.
Based on the provided information, the DSG™ Threaded Drill System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- DSG™ Threaded Drill System Function: This device is used during surgery to prepare pedicle screw holes and provide real-time feedback based on tissue impedance and for intraoperative EMG surveillance. It interacts directly with the patient's tissues in situ rather than analyzing a sample taken from the body.
The device's function is to assist the surgeon during a surgical procedure by providing real-time information about the tissue being drilled and for nerve monitoring, not to diagnose a condition by analyzing a sample outside the body.
N/A
Intended Use / Indications for Use
The DSG™ Threaded Drill 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. The DSG™ Threaded Drill System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. DSG™ Threaded Drill System is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine.
The DSG™ Threaded Drill 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 with those nerves.
Product codes
PDQ
Device Description
The DSG™ Threaded Drill System is designed to prepare pedicle screw holes. The sensor at the distal 3mm of the shaft detects the electrical impedance of the tissue immediately surrounding the sensor and provides real-time audio and visual information to the surgeon to assist the surgeon to determine the relative density of the tissue at the tip of the shaft. A skilled surgeon can interpret the varying pitch and cadence of the feedback to determine potential breaches of the cortical wall. The first 6mm at the instrument are very similar to the cleared PediGuard models, with a pointy awl type design to penetrate the bone. After that, a threaded portion of 25mm in length, featuring cutting flutes, allows for an easy insertion in bone. The threads allow for a smooth and progressive penetration in bone that results in steady and consistent readings of the impedance of the tissue, making the determination of potential breaches of the cortical wall easy for the surgeon.
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 / Intraoperative, Surgical approaches to the spine (open and percutaneous/MIS)
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 SpineGuard DSG™ Threaded Drill System was tested mechanically (bending tests of the shaft) to show the sensor characteristics were identical to the predicate devices. The detection performance of the new length of pins was also demonstrated to be equivalent to the predicates. In addition, the device durability was tested. Cleaning and sterilization validation demonstrated that the reusable components can be adequately cleaned and sterilized prior to reuse.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three figures representing health, services, and human aspects.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2016
SpineGuard, S.A. c/o Dr. John J. Smith Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004
Re: K152747
Trade/Device Name: SpineGuard DSGTM Threaded Drill System Regulation Number: 21 C.F.R. §874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: II Product Code: PDQ Dated: May 9, 2016 Received: May 9, 2016
Dear Dr. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
William J.
Heetderks -A
Digitally signed by William J. Heetderks -A
DN: c=US, o=U.S. Government, ou=HHS, ou=NI
ou=People,
0.9.2342.19200300.100.1.1=0010149848,
cn=William J. Heetderks -A
Date: 2016061013-50-34-04'00'
for
Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name DSGTM Threaded Drill System
Indications for Use (Describe)
The DSG™ Threaded Drill 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. The DSG™ Threaded Drill System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. DSG™ Threaded Drill System is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine.
The DSG™ Threaded Drill 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 with those nerves.
| 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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510(k) SUMMARY
SpineGuard, S.A.'s DSG™ Threaded Drill System (K152747)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
SpineGuard, S.A. 10 cours Louis Lumière 94300 Vincennes - France France Phone: +(33) 1 45 18 45 19
- Contact Person: Stephane Bette Chief Technology Officer SpineGuard, S.A. 1388 Sutter Street Suite 510 San Francisco, CA 94109 Phone + 1 415 512 2504
Date Prepared: June 7, 2016
Name of Device
SpineGuard DSG™ Threaded Drill System
Common or Usual Name
Nerve Stimulator
Classification Name
21 C.F.R. §874.1820 Surgical Nerve Stimulator/Locator, PDQ
Predicate Devices
SpineGuard S.A., Cannulated PediGuard Nerve Detector (K143159)
Purpose of the 510(k) notice
The DSG™ Threaded Drill System is a modification to the cleared PediGuard System intended to add additional options for the surgeon to create pilot holes for pedicles screw systems.
Indication for Use
The DSG™ Threaded Drill System is intended to be used for the preparation of pedicle screw holes. The DSG™ Threaded Drill 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. The DSG™ Threaded Drill System is indicated for use in both open and percutaneous (MIS) surgical approaches to the spine. The DSG™ Threaded Drill System is also indicated for use with fluoroscopic guidance in percutaneous (MIS) surgical approaches to the spine.
The DSG™ Threaded Drill System also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal
4
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.
Technological Characteristics
The DSG™ Threaded Drill System is designed to prepare pedicle screw holes. The sensor at the distal 3mm of the shaft detects the electrical impedance of the tissue immediately surrounding the sensor and provides real-time audio and visual information to the surgeon to assist the surgeon to determine the relative density of the tissue at the tip of the shaft. A skilled surgeon can interpret the varying pitch and cadence of the feedback to determine potential breaches of the cortical wall. The first 6mm at the instrument are very similar to the cleared PediGuard models, with a pointy awl type design to penetrate the bone. After that, a threaded portion of 25mm in length, featuring cutting flutes, allows for an easy insertion in bone. The threads allow for a smooth and progressive penetration in bone that results in steady and consistent readings of the impedance of the tissue, making the determination of potential breaches of the cortical wall easy for the surgeon.
Performance Data
The SpineGuard DSG™ Threaded Drill System was tested mechanically (bending tests of the shaft) to show the sensor characteristics were identical to the predicate devices. The detection performance of the new length of pins was also demonstrated to be equivalent to the predicates. In addition, the device durability was tested. Cleaning and sterilization validation demonstrated that the reusable components can be adequately cleaned and sterilized prior to reuse.
The SpineGuard DSG™ Threaded Drill System complies with the following recognized standards:
- . ASTM F138-13, Standard specification for wrought 18 chromium-14 nickel-2.5 molybdenum stainless steel bar and wire for surgical implants (2013).
- . ASTM F899-12b, Standard specification for wrought stainless steel for surgical instruments (2012).
- . IEC 60601-1 Medical Electrical Equipment - Part 1: General requirements for safety, Amendment 1 (2007).
- IEC 60601-1-4, Medical Electrical Equipment Part 1-4: General requirements for safety, . Collateral Standard: Programmable electrical medical systems, Edition 1.1
- . ISO 10993-5, Biological Evaluation of Medical Devices: Tests for in vitro cytotoxicity (2010).
- . ISO 10993-7, Biological evaluation of medical devices: Ethylene Oxide sterilization residuals (2008).
- . ISO 10993-10, Biological Evaluation of Medical Devices: Tests for irritation and sensitization (2010).
- ISO 10993-11, Biological Evaluation of Medical Devices: Tests for systemic toxicity (2009).
- ISO 11607-1, Packaging for terminally sterilized medical devices: Requirements for materials, sterile barrier systems and packaging systems (2006).
- ISO 11607-2, Packaging for terminally sterilized medical devices: Validation requirements for . forming, sealing and assembly processes (2006).
- . ISO 11737-1, Sterilization of medical devices - Microbiological methods: Determination of a population of microorganisms on products (2006).
- . ISO 11737-2, Sterilization of medical devices - Microbiological methods: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (2010).
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- ASTM D4169, Standard practice for performance testing of shipping containers and systems . (2014).
- ASTM F88, Standard test method for seal strength of flexible barrier materials (2009).
- ASTM F1929, Standard test method for detecting seal leaks in porous medical packaging by . dve penetration.
- . ASTM F1980, Standard guide for accelerated aging of sterile medical device packages (2011).
- . ISO 11135-1, Sterilization of health care products - Ethylene oxide: Requirements for the development, validation and routine control of a sterilization process for medical devices (2014).
- ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for . the development, validation and routine control of a sterilization process for medical devices (2006).
Substantial Equivalence
The SpineGuard DSG™ Threaded Drill System has the same intended use and similar indications, principles of operation, and technological characteristics as the cleared PediGuard System. The minor differences in the DSG™ Threaded Drill System's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the SpineGuard DSG™ Threaded Drill System is substantially equivalent to the cleared PediGuard System.
| | Subject DSG™ Threaded Drill
System (K152747) | Cannulated PediGuard® models
(K143159) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use / Indications
for Use | The DSG™ Threaded Drill System
is intended to be used for the
preparation of pedicle screw holes.
The DSG™ Threaded Drill 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. | 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 DSG™ Threaded Drill System
is indicated for use in both open
and percutaneous (MIS) surgical
approaches to the spine. The
DSG™ Threaded Drill System is
also indicated for use with
fluoroscopic guidance in
percutaneous (MIS) surgical
approaches to the spine. | 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 DSG™ Threaded Drill System
also is specifically indicated for
use in intraoperative
electromyographic ("EMG") | The PediGuard also is specifically
indicated for use in intraoperative
electromyographic ("EMG")
surveillance to assist in the |
6
| | 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. | 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. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Handle Shape | T-Handle with Ratchet | T-Handle |
| Components | Stainless Steel shaft, plastic
handle, ceramic insulator, modular
with removable handle, ratchet
and reusable shaft | Stainless Steel shaft, plastic
handle, ceramic insulator, modular
with removable handle |
| Shaft Material | Inner electrode: 316L Stainless
Steel (ASTM F138) Outer
electrode and/or shaft:
304 Stainless Steel (ASTM F899),
316L Stainless Steel and/or 17-
4PH (ASTM F899); Ceramic
Zirconium Oxide Insulator | Inner electrode: 316L Stainless
Steel (ASTM F138) Outer
electrode and/or shaft:
304 Stainless Steel (ASTM F899),
316L Stainless Steel and/or 17-
4PH (ASTM F899); Ceramic
Zirconium Oxide Insulator |
| Safety Features | Device cannot be turned off until
battery exhausted. Prevents
reuse of device. | Device cannot be turned off until
battery exhausted. Prevents reuse
of device. |
| Power Source | Lithium-Ion Battery | Lithium-Ion Battery |
| Sterility | Sterile/Non-sterile | Sterile |
| Single Use or Reusable | Single-use (T-Handle and Active
Stylet)
Re-usable (Ratcheting Handle,
Threaded Drill Shaft and Sleeve) | Single Use |
| Distal Shaft Shape | Straight (cannulated) and active
stylet | Straight (cannulated) with
removable inner starter stylet
(optional) and active stylet |
| Dimensions | 1.7mm inner diameter (hole)
cannulated metal shaft with
flanges (threads) and cutting
edges; Thread outer diameters of
4.0, 5.5 and 8.0mm. | Cannulated, inner diameter:
2.5mm; Tapered shaft outer
diameter from 3 to 4mm. |
| Circuit Board | Capacitors, Resistors and Diodes
- Firmware (programmable chip)
on circuit board | Capacitors, Resistors and Diodes - Firmware (programmable chip)
on circuit board |