(81 days)
Not Found
No
The device description focuses on real-time impedance measurement and simple threshold-based alerts, with no mention of AI/ML terms or complex data processing beyond basic signal analysis.
Yes.
The device's function is to assist in the location and evaluation of spinal nerves and to provide feedback to the surgeon during pedicle screw pilot hole drilling, which directly relates to diagnosing and treating a disease or condition by providing information and guidance to the surgeon for a medical procedure.
Yes
The device provides feedback (visual and audible alerts) to the surgeon indicating a change in impedance, which may signal contact with soft tissues or possible vertebral cortex perforation during pedicle screw pilot hole drilling. It also assists in the location and evaluation of spinal nerves through EMG surveillance. These functions are diagnostic in nature, providing information about the patient's internal state to guide surgical actions.
No
The device description explicitly states it is composed of stainless steel and plastic, and consists of a handle containing electronics and a stainless steel shaft with a distal sensor. This indicates it is a hardware device with integrated electronics and a sensor, not a software-only 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 intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- PediGuard's Function: The PediGuard operates in vivo (within the living body) during surgery. It measures electrical impedance directly at the tip of the probe within the patient's spine. It also performs intraoperative EMG surveillance by applying electrical energy to tissues and monitoring muscle responses.
- No Specimen Examination: The device does not examine specimens (blood, tissue, etc.) that have been removed from the body.
The PediGuard is an intraoperative surgical device that provides real-time feedback to the surgeon based on direct measurements within the patient's body.
N/A
Intended Use / Indications for 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 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)
PDO, ETN
Device Description
The PediGuard® modular and single-piece devices are single use, devices composed of stainless steel and plastic, and are provided sterile. The PediGuard devices 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 produce visual and audible signals to indicate changes in impedance associated with possible vertebral perforation.
All PediGuard® models provide real-time 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, spinal nerves
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)
Cadaver trial: Performed on thoracolumbar pedicle screws placed at T10-L5 level in cadavers. Results showed a 60% reduction in screw breach and an 86.8% reduction of total fluoroscopy shots when using the Cannulated PediGuard over use of the Jamshidi needle.
Clinical study: Performed on PediGuard in both open posterior pedicle screw fixation (PPSF) procedures and MIS posterior spine arthrodesis procedures. Results showed no difference in optimal screw placement when using the PediGuard in either open or MIS surgery.
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right. The profiles are connected by a flowing line that forms a wave-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
Donald W. Guthner Orgenix LLC 111 Hill Road Douglassville, PA 19518
Re: K143159
Trade/Device Name: Modular Models
P2ND1001 - Cannulated PediGuard® Needle#1 (165mm) P2ND1002 - Cannulated PediGuard® Needle#2 (165mm) P2ND1101 - Cannulated PediGuard® Needle (120mm) P2HE1000 - Cannulated PediGuard® Handle Single-Piece Models P1-AU411 - PediGuard® Tri Tip Ø4.0mm P1-AU412 - PediGuard® Tr Tip Ø3.2mm P1-AU413 - PediGuard® Tri Tip Ø2.5mm P1-AU414 - PediGuard® Ø2.5mm XS P1-AU450 - PediGuard® Curv P1-AU451 - PediGuard® Curv XS Regulation Number: 21 CFR §874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II
Product Code: PDO, ETN
Dated: November 3, 2014 Received: November 3, 2014
Dear Dr. Guthner:
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
1
Page 2 - Dr. Donald W. Guthner
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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 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" (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/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,
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Carlos L Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143159
Device Name
Cannulated PediGuard® Needle - P2ND1001, P2ND1002, P2ND1101; Cannulated PediGuard® Handle - P2HE1000 PediGuard® Tri Tip - P1-AU411, P1-AU412, P1-AU413; PediGuard® Ø2.5mm XS - P1-AU414; PediGuard® Curv - P1-AU450, P1-AU451
Indications for Use (Describe)
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 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.
| 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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3
510(k) SUMMARY
SpineGuard's PediGuard®
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 Phone: 646-460-2984 Facsimile: 484-363-5879
Date Prepared: December 19, 2014
Name of Device:
Modular Models P2ND1001 - Cannulated PediGuard® Needle#1 (165mm) P2ND1002 - Cannulated PediGuard® Needle#2 (165mm) P2ND1101 - Cannulated PediGuard® Needle (120mm) P2HE1000 - Cannulated PediGuard® Handle Single-Piece Models P1-AU411 - PediGuard® Tri Tip Ø4.0mm P1-AU412 - PediGuard® Tr Tip Ø3.2mm P1-AU413 - PediGuard® Tri Tip Ø2.5mm P1-AU414 - PediGuard® Ø2.5mm XS P1-AU450 - PediGuard® Curv
P1-AU451 - PediGuard® Curv XS
| Common or Usual Name: | Nerve Stimulator |
|---|---|
| Classification Name: | Surgical Nerve Stimulator/Locator |
| Review Panel: | Neurology |
| Product Code: | PDQ and ETN |
| Device Class: | Class II |
| Regulation: | 21 C.F.R. §874.1820 |
Predicate Devices
SpineGuard S.A., PediGuard Nerve Detector (K030526; K123390)
4
Device Description
The PediGuard® modular and single-piece devices are single use, devices composed of stainless steel and plastic, and are provided sterile. The PediGuard devices 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 produce visual and audible signals to indicate changes in impedance associated with possible vertebral perforation.
All PediGuard® models provide real-time 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 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 quidance 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 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 subject PediGuard® models are identical with the corresponding predicate models. No hardware or software changes were made to the current devices to prepare for the requested change to the Indications for Use statement. The only technological difference between the subject PediGuard and the predicate device is the introduction of a 120mm Cannulated PediGuard. The 120mm length device is identical in all aspects (materials, electronics, connectors and dimensions) to the cleared 160mm Cannulated PediGuard, with the exception of being shorter. These minor technological raise no new issues of safety or effectiveness. Thus, the subject PediGuard is substantially equivalent to the cleared predicated PediGuard (K123390).
Substantial Equivalence Chart
| | Subject PediGuard® models | Cleared PediGuard® models
(K123390) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for 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 | 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 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. | 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 | Gearshift T-Handle | |
| Components | Single Piece, Stainless Steel shaft, plastic handle, ceramic insulator or 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) | |
| Safety Features | Device cannot be turned off until battery exhausted. Prevents reuse of device. | |
| Power Source | Lithium-Ion Battery | |
| Sterility | Sterile | |
| Single Use or Reusable | Single-use | |
| Distal Shaft shape | Curved or straight; or straight (cannulated) with removable inner starter stylet (optional) and sensory needle. | |
| Dimensions | 2.5mm shaft diameter / tapered for 2mm to 4mm; 3.0 mm shaft diameter (cannulated) | |
| Circuit board | Capacitors, Resistors and Diodes - Firmware (programmable chip) on | |
5
6
| circuit board | circuit board |
|---|---|
| --------------- | --------------- |
Performance Data
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).
- . 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 support of this clarification to the indications for use of the PediGuard, SpineGuard conducted a cadaver trial in which thoracolumbar pedicle screws were placed at T10-L5 level in cadavers. The
7
results show a 60% reduction in screw breach and an 86.8% reduction of total fluoroscopy shots when using the Cannulated PediGuard over use of the Jamshidi needle. In addition, the company submitted a clinical study of PediGuard in both open posterior pedicle screw fixation (PPSF) procedures and MIS posterior spine arthrodesis procedures. The results of this study showed no difference in optimal screw placement when using the PediGuard in either open or MIS surgery.
Conclusion
The PediGuard has the same intended use and similar indications for use and technological characteristics as the predicate PediGuard. As confirmed through bench and clinical testing data, the PediGuard® is as safe and effective for its intended use as its predicate device. Accordingly, the PediGuard is substantially equivalent.