(679 days)
Not Found
No
The summary describes a device that uses impedance and EMG monitoring for feedback, which are standard electrophysiological techniques, and does not mention any AI or ML components or capabilities.
No.
The indications for use describe providing feedback to the surgeon and assisting in nerve location and evaluation, not directly treating a condition or disease.
Yes
The PediGuard is explicitly indicated for "intraoperative electromyographic ('EMG') surveillance to assist in the location and evaluation of spinal nerves" and provides feedback to the surgeon via visual and audible alerts based on impedance changes, which are diagnostic functions.
No
The device description explicitly states it is a "hand held, battery operated bi-polar probe" comprised of physical components like a stainless steel shaft, hollow plastic handle, and electronic cartridge, indicating it is a hardware device with embedded electronics, not software-only.
Based on the provided information, the PediGuard device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used during surgery to provide feedback to the surgeon based on impedance changes and for intraoperative EMG surveillance. This is a direct interaction with the patient's body during a surgical procedure.
- Device Description: The description details a hand-held probe used for surgical procedures.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, tissue) outside of the body. IVDs are designed for testing biological samples in a laboratory or clinical setting.
The PediGuard is a surgical device used for real-time monitoring and guidance during spinal surgery.
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 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)
77 ETN, GWF
Device Description
The PediGuard System is a hand held, battery operated bi-polar probe that is comprised of the following components: (1) a stainless steel shaft; (2) a hollow plastic handle; and (3) an electronic cartridge. Its components are manufactured from stainless steel and plastics according to ASTM and USP requirements.
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)
Not Found
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
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
DEC 2 9 2004
510(k) SUMMARY
| NAME OF FIRM: | SpineVision, Inc.
3003 Summit Blvd., Suite 1400
Atlanta, GA 30319
Phone: 404-460-5077 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Lynnette Whitaker
Vice President, Regulatory Affairs
574-269-9776 |
| TRADE NAME: | PediGuard™ Nerve Detector System |
| COMMON NAME: | Nerve Stimulator |
| CLASSIFICATION: | 874.1820 |
| DEVICE PRODUCT CODE: | Product code: 77 ETN |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | Neurosign 800, Magstim Company, Ltd.
(K980148)
NuVasive, Inc.'s INS-1 Intraoperative
Nerve Surveillance System (K002677)
TOEI Electric Co., Ltd.'s JUSTWO Model
TME 601 Root Apex Locator (K022020) |
DEVICE DESCRIPTION AND INTENDED USE:
The PediGuard System is a hand held, battery operated bi-polar probe that is comprised of the following components: (1) a stainless steel shaft; (2) a hollow plastic handle; and (3) an electronic cartridge. Its components are manufactured from stainless steel and plastics according to ASTM and USP requirements.
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 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
1
administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The components of the PediGuard Nerve Monitoring System are similar in design, material, and intended use to other nerve monitoring systems that have been cleared by FDA for spinal use. Testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 2004
Ms. Lynnette Whitaker Vice President, Regulatory Affairs SpineVision, Inc. 3003 Summit Boulevard, Suite 1400 Atlanta, Georgia 30319
Re: K030526 Trade/Device Name: PediGuard Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF Dated: November 24, 2004 Received: November 24, 2004
Dear Ms. Whitaker:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. Lynnette Whitaker
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Sincerely yours,
Mark N. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K030526
Device Name: PediGuard
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 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 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K030526
\\DC - 20739/0001 - 2021134 v1