(279 days)
Not Found
No
The description focuses on measuring electrical impedance and providing real-time visual and auditory feedback based on changes in impedance, which is a direct measurement and not indicative of AI/ML processing. There is no mention of AI, ML, or related concepts in the document.
No.
The device provides feedback to the surgeon and assists in locating and evaluating spinal nerves, but it does not directly treat or cure any condition.
Yes
The device provides feedback via visual and audible alerts indicating a change in impedance, which may indicate contact with soft tissues and possible vertebral cortex perforation during pedicle screw pilot hole drilling. It also assists in locating and evaluating spinal nerves by administering low voltage electrical energy and monitoring muscle groups via EMG, all of which are diagnostic functions.
No
The device description explicitly states the devices are composed of stainless steel and plastic, and include a handle containing electronics and a stainless steel shaft with a distal sensor. This indicates the device is a physical medical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The PediGuard devices described here are used during surgery to provide real-time feedback to the surgeon based on electrical impedance changes within the patient's body during pedicle screw placement and for nerve monitoring. They are not analyzing samples taken from the body.
- Intended Use: The intended use clearly states the devices are used during pedicle screw pilot hole drilling and for intraoperative EMG surveillance. This is an in-vivo application, not in-vitro.
Therefore, the PediGuard devices are surgical instruments with integrated sensing capabilities, not IVDs.
N/A
Intended Use / Indications for Use
The PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are 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 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.
Product codes (comma separated list FDA assigned to the subject device)
PDQ, ETN
Device Description
The PediGuard® 2.5mm XS and PediGuard® Curv XS are single use, single piece devices composed of stainless steel and plastic that are provided sterile, and consist of a handle containing the electronics and a stainless steel shaft with distal sensor for measuring electrical impedance of the tissues immediately in contact with the sensor during use. The devices product visual and audible signal to indicate changes in impedance associated with possible vertebral perforation.
The Cannulated PediGuard® Needle #2 is the needle part of a single-use modular device provided sterile, consisting of a handle containing the electronics, a stainless steel cannulated outer shaft and a stainless steel inner sensor needle for measuring electrical impedance of the tissues immediately in contact with the sensor during use.
PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) provide realtime visual and auditory feedback to the surgeon during the preparation of the pedicle screw pilot holes, sounding an alert when the tip of the sensor senses a change in the impedance of the surrounding tissues, which may indicate that the tip is in contact with soft tissues and a possible vertebral cortex perforation.
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
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)
Performance data that evaluated static bending, electrical signal emission, impedance detection actability and the ability to convey changes in impedance to the user demonstrate that the PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are as safe and effective as the cleared PediGuard Nerve Detector, Thus, the PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and. Cannulated PediGuard® Needle#2 (model P2ND1002) are substantially equivalent to the predicate device.
Static bending testing was performed on the shafts. All device models performed as intended in a manner directly comparable to the predicate devices. All device models have completed firmware verification and validation testing.
In addition to these standards, testing was conducted on the devices to demonstrate that the electrical signal emitted by the modified PediGuard was directly comparable to that of the predicate. The ability to measure changes in impedance and the volume of the audible signal emitted by the device were also measured and found to be directly comparable.
The following design verification and validation testing was performed to support the substantial equivalence of the modification to the original predicate performance levels: Surgeon testing, Bending tests, Sensor Testing, Drill durability testing. Compliance with ASTM standards, Compliance with biocompatibility standards, 100% testing of firmware, Battery function testing, and Destructive testing.
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
123390
8 2013 AUG
510(k) SUMMARY
SpineGuard's PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS model (P1-U451) and Cannulated PediGuard Needle#2 model (P2ND1002)
Submitter:
SpineGuard, S.A. 5-7 rue l' Amiral Courbet 94160 Saint Mande France Phone: +(33) 1 45 18 45 19
Contact Person:
Donald W. Guthner Orgenix LLC 111 Hill Road Douglassville, PA 19518 646-460-2984 Phone: Facsimile: 484-363-5879
July 30, 2013 Date Prepared:
Name of Device:
PediGuard 2.5mm XS (Model P1-AU414) PediGuard Curv XS (Model P1-AU451) Cannulated PediGuard Needle#2 (Model P2ND1002)
Common or Usual Name: Classification Name: Review Panel: Product Code: Device Class: Regulation:
Nerve Stimulator Surgical Nerve Stimulator/Locator Neurology PDQ and ETN Class II 21 C.F.R. §874.1820
Predicate Devices
SpineGuard S.A., PediGuard Nerve Detector (K030526)
Device Description
The PediGuard® 2.5mm XS and PediGuard® Curv XS are single use, single piece devices composed of stainless steel and plastic that are provided sterile, and consist of a handle containing the electronics and a stainless steel shaft with distal sensor for measuring electrical impedance of the tissues immediately in contact with the sensor during use. The devices product visual and audible signal to indicate changes in impedance associated with possible vertebral perforation.
NDC・(13865)2000000) - 4712449 \ 2
1
1
The Cannulated PediGuard® Needle #2 is the needle part of a single-use modular device provided sterile, consisting of a handle containing the electronics, a stainless steel cannulated outer shaft and a stainless steel inner sensor needle for measuring electrical impedance of the tissues immediately in contact with the sensor during use.
PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) provide realtime visual and auditory feedback to the surgeon during the preparation of the pedicle screw pilot holes, sounding an alert when the tip of the sensor senses a change in the impedance of the surrounding tissues, which may indicate that the tip is in contact with soft tissues and a possible vertebral cortex perforation.
Intended Use/Indications for Use
The PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are 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 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.
Substantial Equivalence
The PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) have the same intended use/indications for use, and similar technological characteristics and principles of operation as the cleared PediGuard Nerve Detector. The materials in the modified devices are directly comparable to the predicate and the impedance detection algorithm is identical. The minor differences in shaft diameter, shaft materials or electronics (firmware and power source) do not raise any new questions of safety or effectiveness. Performance data that evaluated static bending, electrical signal emission, impedance detection actability and the ability to convey changes in impedance to the user demonstrate that the PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are as safe and effective as the cleared PediGuard Nerve Detector, Thus, the PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and. Cannulated PediGuard® Needle#2 (model P2ND1002) are substantially equivalent to the predicate device.
Substantial Equivalence Chart
| SpineGuard Cleared Device | PediGuard® 2.5mm XS (P1- | Cannulated PediGuard Needle#2 |
|---|---|---|
| PediGuard (K030526) | AU414) PediGuard® Curv XS | |
| (P1-AU451) | (P2ND1002) |
いDC - 038659/00000】 - 47 12-419 12
2
| Intended Use / Indications
for Use | The SpineGuard, PediGuard
Nerve Detector 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 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 PediGuard® 2.5mm XS
(model P1-AU414), and
PediGuard® Curv XS (model
P1-AU451) are 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 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 PediGuard® Cannulated
PediGuard® Needle#2 (model
P2ND1002) 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 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. |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Handle Shape | Straight - screwdriver | Gearshift T-Handle | T-handle |
| Components | Single Piece or Modular,
Stainless Steel shaft, plastic
handle, PEEK insulator | Single Piece, Stainless Steel
shaft, plastic handle, ceramic
insulator | Modular unit with Cannulated
outer shaft, active sensory
needle, and ceramic insulation |
| Shaft Material | Inner electrode: 316L Stainless
Steel (ASTM F138) Outer
electrode: 316L Stainless Steel
(ASTM F138) | Inner electrode: 316L Stainless
Steel (ASTM F138) Outer
electrode or shaft: 316L
Stainless Steel and/or 17-4PH
(ASTM F899) | Inner electrode: 316L Stainless
Steel (ASTM F138) (Electrode)
Outer electrode and shaft: 304
Stainless steel (ASTM F899) |
| 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. | Device cannot be turned off until
battery exhausted. Prevents
reuse of device. |
| Power Source | Silver Oxide Battery | Lithium-Ion Battery | Lithium-Ion Battery |
| Sterility | Sterile | Sterile | Sterile |
| Single Use or Reusable | Single-use | Single-use | Single-use |
| Distal Shaft shape | Straight | Curved or straight | Straight with removable inner
starter stylet (optional) and
sensory needle. |
| Dimensions | 3.2mm and 4.0 mm shaft
diameter | 2.5mm shaft diameter / tapered
for 2mm to 4mm | 3.0mm shaft diameter |
| Circuit board | Capacitors, Resistors and Diodes | Capacitors, Resistors and
Diodes - Firmware
(programmable chip) on circuit
board | Capacitors, Resistors and Diodes
- Firmware (programmable chip)
on circuit board |
Biocompatibility
Biocompatibility testing was conducted on the PediGuard® models in accordance with the testing recommendations in ISO 10993 -1 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing) and the FDA's Blue Book Memorandum # G95-1for a device in limited (≤ 24 hours) contact with tissue/bone. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. The tests and results are summarized in the table below.
3
| Tests | Results1 | Conclusion1 |
|---|---|---|
| In vitro Cytotoxicity test | ||
| (ISO MEM Elution assay with | ||
| quantitative evaluation of | ||
| cytotoxicity) - ISO 10993-5 | No evidence of cytotoxicity | Non-cytotoxic |
| Intracutaneous Reactivity test | ||
| (irritation) - ISO 10993-10 | No evidence of irritation | Non-irritant |
| Sensitization test (Guinea pig | ||
| maximization) - ISO 10993-10 | No evidence of | |
| sensitization | Non-sensitizing | |
| Acute Systemic Toxicity test - | ||
| ISO 10993-11 | No signs of toxicity | Not systemically toxic |
1Separate biocompatibility testing was conducted for the PediGuard Curv, PediGuard Curv XS, and the Cannulated PediGuard models. Results and conclusions are summarized for all three models unless otherwise noted.
As shown in the table, biocompatibility testing found the PediGuard® models to be non-cytotoxic, non-irritating, non-sensitizing, and non-toxic (acute systemic).
Performance Data
Static bending testing was performed on the shafts. All device models performed as intended in a manner directly comparable to the predicate devices. All device models have completed firmware verification and validation testing. The PediGuard® models conform to the following standards:
- ASTM F138-08, Standard specification for wrought 18 Chromium 14 Nickel . - 2.5 Molybdenum Stainless Steel Bar and Wire for surgical implants (UNS S31673) (Version 8) (2008).
- ASTM F899-1, Standard specification for wrought stainless steel for surgical . instruments (Version 11) (2009).
- IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for . safety. Amendment 1. Amendment 2.
- 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 (1999).
- ISO 10993-10, Biological Evaluation of Medical Devices: Tests for irritation . and sensitization.
- ISO 10993-11. Biological Evaluation of Medical Devices: Tests for systemic ● toxicity.
- 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 (2007).
いDC・038654910(x)(x)) ・ ・ ・ 7 | 244 ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・
4
- ISO 10993-7, Biological evaluation of medical devices: Ethylene Oxide . sterilization residuals (2008).
- 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 (2000).
- 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).
- 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 dye penetration.
- ASTM F1980, Standard guide for accelerated aging of sterile medical device ● packages (2007).
- ASTM D4169. Standard practice for performance testing of shipping . containers and systems (2005).
- In addition to these standards, testing was conducted on the devices to demonstrate that the electrical signal emitted by the modified PediGuard was directly comparable to that of the predicate. The ability to measure changes in impedance and the volume of the audible signal emitted by the device were also measured and found to be directly comparable.
The following design verification and validation testing was performed to support the substantial equivalence of the modification to the original predicate performance levels: Surgeon testing, Bending tests, Sensor Testing, Drill durability testing. Compliance with ASTM standards, Compliance with biocompatibility standards, 100% testing of firmware, Battery function testing, and Destructive testing.
Conclusion
The comparison to the predicate devices demonstrates that the PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1- AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are safe and effective for its intended use and are substantially equivalent to the predicate devices
5
Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Aveque Document Control Center - WO66-G609 Silver Spring MD 20993-0002
August 8, 2013
SpineGuard, S.A. c/o Mr. John J. Smith Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004
Re: K123390
Trade/Device Name: PediGuard 2.5mm XS (Model P1-AU414) PediGuard Curv XS (Model P1-AU451) Cannulated PediGuard Needle#2 (Model P2ND1002) Regulation Number: 21 C.F.R. §874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDQ and ETN Dated: November 2, 2012 Received: December 11, 2012
Dear Mr. Smith
We have reviewed your Section 510(k) premarket notification of intent to market the device we nove and have determined the device is substantially equivalent (for the indications for use stated in the cnclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce provisions 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). and Costlette Act (Act) that of not roquine to the general controls provisions of the Act. The I bu may, alcreible, market the act include requirements for annual registration, listing of general connois provisions of are feel 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 It may be subject to additional controlor and to 898. In addition, FDA may Iound in the Code of I casia. Nogeraing your device in the Federal Register,
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a subscribes with other requirements of the Act that FDA has made a octorinination in administered by other Federal agencies. You must or any Federal Statutes and regulations annualing, but not limited to: registration and listing (ZI CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CFK Fall 607), labeling (21 OFR 803); good manufacturing practice requirements as set
6
Page 2 - Mr. John J. Smith
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/defuult.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 Small Manufacturers, International and Consumer Assistance 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,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): _ K123390
Device Name: PediGuard 2.5mm XS (Model P1-AU414) PediGuard Curv XS (Model P1-AU451) Cannulated PediGuard Needle#2 (Model P2ND1002)
Indications For Use:
The PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ND1002) are 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 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.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Joyce M. Whang -S | |
| (Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD) | |
| 510(k) Number | K123390 |
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