(32 days)
Not Found
No
The document describes a system for monitoring and stimulating biopotential signals using established neurophysiological techniques. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies. The system performs functions "automatically or manually" but this refers to the execution of pre-programmed neurophysiological tests, not AI/ML-driven analysis or decision-making.
No.
The device is intended for monitoring biopotential signals and providing feedback to assist in diagnosis and prevent injury during surgery, not for directly treating a disease or condition.
Yes
The system is intended for "intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction" and provides feedback to "assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots." These functions involve identifying medical conditions or assisting in clinical decision-making, which are hallmarks of a diagnostic device.
No
The device description explicitly lists multiple hardware components including a console, patient module, electrode preamplifier harness, disposable surface electrodes, and a hand-held probe.
Based on the provided information, the OrthoMon system 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.
- OrthoMon's Function: The OrthoMon system is used to record, monitor, and stimulate/record biopotential signals directly from the patient's body (electromyograph (EMG), evoked response, nerve/muscle potentials). It is used intraoperatively to assess nerve function and guide surgical procedures.
- No Specimen Examination: The system does not examine specimens derived from the human body in a laboratory setting. It interacts directly with the patient's nervous system.
Therefore, the OrthoMon system falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The OrthMon system is intended for use to record, monitor and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.
The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots.
Product codes (comma separated list FDA assigned to the subject device)
GWF, IKN
Device Description
The Orthomon system provides continuous, 8 channel, monitoring of neural motor pathways intraoperatively and is used to locate and assess spinal nerves, verify placement of orthopedic instrumentation in order to reduce the risk of nerve root injury and to access spinal cord motor function.
The system performs these functions automatically or manually and uses several neurophysiological techniques including: free run and stimulus evoked electromyography (EMG), transcranial electrical motor evoked potentials and train of four.
The main OrthoMon system components include: the console, housing the computer, controller and sensory and motor evoked potential electrical stimulator and patient module located at the OR table to route stimuli to the appropriate sites and electrode preamplifier harness. The electrode harnesses contains 8 recording sites. Each site connects to a quick-apply disposable surface electrode.
A pre-sterilized, disposable, hand-held, microprocessor controlled probe operated by the surgeon, connects to the patient module. The probe redirects stimulation to the appropriate site, controls certain test functions and settings and provide visual indication of test results.
The OrthoMon interface is a touch screen with optional keyboard and mouse. A built-in speaker may be used for audible EMG or signal trigger tones.
The system is network compatible for data review within the hospital and permits secure information access over the Internet.
Technologically, OrthoMon is similar to the predicate devices. The exceptions are the use of a surgeon controlled probe to select certain test functions and to direct the stimulation: and use of quick-apply disposable surface electrodes.
OrthoMon was tested functionally using accepted laboratory test procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal nerves, nerve roots, spinal cord
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon and OR team
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)
OrthoMon was tested functionally using accepted laboratory test procedures.
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
MAY 2 3 2006
: 3
510(k) Summary
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of CFR 807.92.
.
| Summary Date:
Submitter's
Information: | April 14, 2006
Howard Bailin
Vice President, C.O.O.
Axon Systems, Inc.
400-2200 Oser Ave
Hauppauge, NY 11788
P: 631 436 5112
F: 631 436 5141
hbailin@axonsystems.com |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | OrthoMon |
| Common Name: | EMG monitor, Evoked Potential System |
| Classification
Name: | Evoked Response, Electromyograph |
| Classification: | Number:
882.1870 Electromyograph Monitor, Surgical Nerve
Stimulator/Locator, Diagnostic Electromyograph,
Evoked Response Stimulator |
| Product Codes: | GWF, IKN |
| Predicate Devices | Axon Systems: Eclipse Neurological Workstation (K050798)
NuVasive: Neurovision JJB (K051384)
Datex-Ohmeda: M-NMT Neuromuscular Transmission
Module (K955026) |
1
Description: The Orthomon system provides continuous, 8 channel, monitoring of neural motor pathways intraoperatively and is used to locate and assess spinal nerves, verify placement of orthopedic instrumentation in order to reduce the risk of nerve root injury and to access spinal cord motor function.
The system performs these functions automatically or manually and uses several neurophysiological techniques including: free run and stimulus evoked electromyography (EMG), transcranial electrical motor evoked potentials and train of four.
The main OrthoMon system components include: the console, housing the computer, controller and sensory and motor evoked potential electrical stimulator and patient module located at the OR table to route stimuli to the appropriate sites and electrode preamplifier harness. The electrode harnesses contains 8 recording sites. Each site connects to a quick-apply disposable surface electrode.
A pre-sterilized, disposable, hand-held, microprocessor controlled probe operated by the surgeon, connects to the patient module. The probe directs stimulation to the appropriate site, controls certain test functions and settings and provide visual indication of test results.
The OrthoMon interface is a touch screen with optional keyboard and mouse. A built-in speaker may be used for audible EMG or signal trigger tones.
The system is network compatible for data review within the hospital and permits secure information access over the Internet.
Technologically, OrthoMon is similar to the predicate devices. The exceptions are the use of a surgeon controlled probe to select certain test functions and to direct the stimulation: and use of quick-apply disposable surface electrodes.
OrthoMon was tested functionally using accepted laboratory test procedures.
2
Image /page/2/Picture/0 description: The image shows the logo for Axon Systems. The logo is in black and white and features the word "AXON" in large, bold letters. Below the word "AXON" is the word "SYSTEMS" in smaller letters. To the right of the logo is the text "pg 3:3" in a handwritten font.
The OrthMon system is intended for use to record, monitor Intended Use: and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.
The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots.
- Conclusions: Based on the technical information provided in this 510(k) and the safety and effectiveness criteria of the design and development process, validated and verified, we claim the OrthoMon to be safe, effective and substantially equivalent to the predicate device(s) noted.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2006
Axon Systems C/o Mr. Howard Bailin Vice President, C.O.O, 400- 2200 Oser Avenue, Hauppauge, NY 11788.
Re: K061113
Trade Name: Orthomon System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Stimulator Regulatory Class: II Product Code: GWF, IKN Dated: April 14, 2006 Received: April 21, 2006
Dear Mr. Bailin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) is togens actment date of the Medical Device Amendments, or to conninered province way 20, 1976, are excordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dictere, mains 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.
4
Page 2 - Mr. Howard Bailin
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) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Hubert Lenoir
Carol N. Miller, MS
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Cover Letter Executive Summary
Indications for Use Statement
510(k) Number
K0611/3
Device Name
OrthoMon
Indications for Use
The OrthMon system is intended for use to record, monitor and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.
The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots.
Hubert Romero
(Division Sign-Off) (Division of General, Restorative,
Division of General, Restorative, Division of Gener Devices
and Neurological Devices
510(k) Number K061113
Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)