(226 days)
No
The summary describes a device that interprets bioelectrical signals and user key presses, but there is no mention of AI or ML algorithms being used for signal processing, interpretation, or any other function. The device description focuses on basic hardware and software interpretation of direct inputs.
No
The device aids in guiding injections but does not directly treat a disease or condition; it is a monitoring device.
No
The device is used to detect bioelectrical signals from muscles for the purpose of guiding injections, which is an interventional or procedural guidance function, not a diagnostic one.
No
The device description explicitly states it is composed of a handheld monitor, a reusable patient interface cable, and a disposable injector needle electrode, which are hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. This device detects bioelectrical signals from muscles within the body using electrodes and a needle. It is not analyzing a sample like blood, urine, or tissue in a laboratory setting.
- The intended use is for guiding injections into the body. The purpose is to help a healthcare professional accurately target muscles for injections, not to diagnose a condition based on analysis of a biological sample.
The device is an electromyography (EMG) monitor used for real-time guidance during procedures, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The subject monitor detects bioelectrical signals from muscles for the purpose of guiding injections into the muscles identified. Although the monitor is indicated for guidance of any muscle-specific injection, it is typically used for injections into muscles of the head and neck. This includes botulinum toxin injections of facial and laryngeal muscles.
The subject monitor is intended to detect bioelectrical signals from muscles for the subject monitor in intentions into the muscles identified, including botulinum toxin injections of eye muscles.
Product codes (comma separated list FDA assigned to the subject device)
77 ENT, 89 CAB, 89 IKT, 89 GXZ, GXZ, IKT, CAB
Device Description
The proposed EMG monitoring system is composed of a small, handheld monitor, a reusable patient interface cable and a disposable injector needle electrode. Commercially available surface electrodes, to act as references, may elcotrode. Onlinerally aranabitropoposed system as these are readily available or may not be provided with the proposed keys on the front console -- ON/OFF, at the politic of the of Check, Volume Down, and Mute. The software of the proposed EMG monitoring system interprets console key presses from the user and performs the action associated with that key.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscles of the head and neck, facial and laryngeal muscles, eye muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
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
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
0
XOMED® K 990793
OCT 22 1999
510(k) Summary EMG Monitor
- 1.0 Date Prepared March 5, 1999
- Submitter (Contact) 2.0 David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532
3.0 Device Name
Proprietary Name:
AccuGuide Muscle Injection Monitor (The product's trade name has not been finalized and may be changed at a later date.)
Common Name(s):
Electromyographic (EMG) Monitor, Muscle locator
Classification Name:
Electromyographic (EMG) Monitor Nerve locator / stimulator,
4.0 Device Classification
Current NIM EMG monitors manufactured by Xomed were classified via K934426 and K982595 as follows:
Nerve locator / stimulator 21 CFR 874.1820 Procode 77 ENT Class II ;
Electromyographic (EMG) Monitor Procode 89 CAB Class II ; 21 CFR 890.1375
The accessory, disposable, injector needle electrodes that are provided with the system could be classified as follows:
Electromyograph needle electrode Procode 89 IKT Class II: 21 CFR 890.1385
Needle electrode Procode 89 GXZ Class II: 21 CFR 882.1350
132
1
REVISED) 10/19/91
Device Description 5.0
Device Description
The proposed EMG monitoring system is composed of a small, handheld monitor, a reusable patient interface cable and a disposable injector needle electrode. Commercially available surface electrodes, to act as references, may elcotrode. Onlinerally aranabitropoposed system as these are readily available or may not be provided with the proposed keys on the front console -- ON/OFF, at the politic of the of Check, Volume Down, and Mute. The software of the proposed EMG monitoring system interprets console key presses from the user and performs the action associated with that key.
6.0 Intended Use
The subject monitor detects bioelectrical signals from muscles for the purpose of guiding injections into the muscles identified. Although the monitor is indicated for guidance of any muscle-specific injection, it is typically used for injections into muscles of the head and neck. This includes botulinum toxin injections of facial and laryngeal muscles.
7.0 Substantial Equivalence
Currently marketed EMG monitors are used to locate specific target muscles prior to making an injection of a solution or medication, such as botulinum toxin. Typically, the currently marketed monitors are large and contain features that are not necessary for merely locating target muscles. A simple raw EMG monitor is all that is needed.
Allergan, Inc. is currently marketing the BOTOX® Injection Amplifier, a simple EMG monitor specifically intended for guiding muscle specific injections. The 510k for the monitor is believed to be K900098, and the needle electrodes sold with this system are manufactured by TECA Corporation as cleared via K973444. The Xomed EMG monitoring system proposed in this 510k, a nandheld, battery-operated EMG monitor with iniection needle electrodes, is equivalent to the Allergan BOTOX® Injection Amplifier and Allergan / TECA Myoject needle electrodes, respectively.
Both systems use identical injection needle electrodes to pick-up EMG from the target muscle, which is then processed by the EMG monitor. As with other commercially available EMG monitors (e.g. Xomed's NIM monitors), both the proposed AccuGuide and predicate Allergan system transform the EMG signal into an audible response. In the case of the proposed AccuGuide monitor, the EMG signal is also transformed into a visible response via an LCD bargraph display. The presence of an appropriate EMG response, in conjunction with a specific muscle movement, confirms the location of the injection needle. Once confirmed, the solution or medication is injected through the injection needle electrode using a standard disposable syringe (not provided with this system).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
OCT 22 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Timlin Manager, Regulatory Affairs XOMED Surgical Products, Inc. 6743 Southpoint Drive, North Jacksonville, Florida 32216
Re: K990793
Trade Name: Electromyography (EMG) Monitor Regulatory Class: II Product Code: GXZ, IKT, CAB Dated: July 22, 1999 Received: July 26, 1999
Dear Mr. Timlin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 -- Mr. David Timlin
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
tosefa
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_
Electromyography (EMG) Monitor Device Name:
Indications for Use:
The subject monitor is intended to detect bioelectrical signals from muscles for the subject monitor in intentions into the muscles identified, including botulinum toxin injections of eye muscles.
(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 of General Restorative Devices K990793
510(k) Number.
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | X |
| Over-the-Counter Use |
(Optional Format 1-2-96)