(87 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard signal acquisition and analysis techniques without mentioning AI/ML components. The modification described is a hardware change (removal of diodes).
No
The device is described as a "Diagnostic Electromyography (EMG)/Evoked Response Electrical Stimulation System for the diagnosis of nervous and muscular system disorders," which clearly states its purpose is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Advantage EMG System, Model #A100 is a Diagnostic Electromyography (EMG)/Evoked Response Electrical Stimulation System for the diagnosis of nervous and muscular system disorders..."
No
The device description explicitly mentions hardware components such as surface electrodes, needle electrodes, a headbox, control modules, and a computer. It also describes modifications to pre-amplifier circuitry, which is a hardware component.
Based on the provided information, the Advantage EMG System, Model #A100 is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states it's for the "diagnosis of nervous and muscular system disorders in adult and pediatric patients" by recording signals from the body or providing electrical stimulation. This is a direct interaction with the patient's body.
- Device Description: The description details how it records signals from the skin, nerves, or muscles using electrodes and can provide electrical stimulation. This is a physiological measurement and stimulation device.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. This device does not process or analyze such specimens.
Therefore, the Advantage EMG System is a physiological diagnostic device, not an IVD.
N/A
Intended Use / Indications for Use
The Advantage EMG System, Model #A100 is a Diagnostic Electromyography (EMG)/Evoked Response Electrical Stimulation System for the diagnosis of nervous and muscular system disorders in adult and pediatric patients.
Product codes
IKN
Device Description
The Advantage EMG System, Model #A100 is a Diagnostic Electromyography (EMG)/Evoked Response Electrical Stimulation System. Signals are recorded from the surface of the skin, or directly from the nerves or muscles by means of needle electrodes using surface electrodes. It is also possible to provide a timed stimulus to the patient, so that the response to the stimulus can be recorded and analyzed. The signals from the subject are taken through the headbox to the control modules and the computer for display and analysis. The computer is based on the Intel XX086 architecture. The only modification made to the device is the removal of diodes contained in the pre-amplifier circuitry.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
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)
A failure investigation, along with electrostatic discharge and actual use testing were conducted consistent with 21 C.F.R. &&20.100 (corrective and preventive action) and 820.198(d) (failure investigations). The analyses and testing confirmed that the proposed corrective action is effective, and that it did not affect the safety or effectiveness of the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).
0
K 974010
510(k) SUMMARY II.
:
・・・・・・・
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
| JAN 16 1998 | |
|---|---|
| Date: | October 16, 1997 |
| Submitter's Name and Address: | Advantage Medical |
| A Division of CME Telemetrix, Inc. | |
| 100 - 100 Collip Circle | |
| London, ON Canada N6G 4X8 | |
| Contact Person: | Robert Snow |
| General Manager | |
| Advantage Medical | |
| A Division of CME Telemetrix, Inc. | |
| 100 - 100 Collip Circle | |
| London, ON Canada N6G 4X8 | |
| Tel # 519-858-5011 | |
| Fax # 519-858-5020 | |
| Trade Name: | Advantage EMG System, Model #A100 |
| Common Name: | EMG System |
| Classification Name: | Diagnostic Electromyograph |
| Substantial Equivalent | |
| Device: | Advantage EMG System, Model #A100 (K885246) |
| Classification: | Class II, 21 C.F.R. § 890.1375 |
| Intended Use: | The Advantage EMG System, Model #A100 is a |
| Diagnostic Electromyography (EMG)/Evoked Response | |
| Electrical Stimulation System for the diagnosis of nervous | |
| and muscular system disorders in adult and pediatric | |
| patients. | |
| Technological | |
| Characteristics: | The technological characteristics remain unchanged |
| as a result of the modification to the device. Using | |
| surface electrodes, signals are recorded from the | |
| surface of the skin, or directly from the nerves or | |
| muscles by means of needle electrodes. It is also |
WA01A/130252
1
possible to provide a timed stimulus to the patient, so that the response to the stimulus can be recorded and analyzed.
The signals from the subject are taken through the headbox to the control modules and the computer for display and analysis. The computer is based on the Intel XX086 architecture.
The only modification made to the device is the removal of diodes contained in the pre-amplifier circuitry. P
Testing to Support Substantial Equivalence:
To provide support that the proposed corrective modification would be effective, and would not adversely affect the device, a failure investigation, along with electrostatic discharge and actual use testing were conducted consistent with 21 C.F.R. &&20.100 (corrective and preventive action) and 820.198(d) (failure investigations). The analyses and testing confirmed that the proposed corrective action is effective, and that it did not affect the safety or effectiveness of the product.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right, and its body is composed of three curved lines. The seal is simple and iconic, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·General Manaqer JAN 16 1998 Advantage Medical The Research Park, University of Western Ontario #100 - 100 Collip Circle London, Ontario N6G 4X8
K974010 Re: Advantage EMG System, Model #A100 Trade Name: Requlatory Class: II Product Code: IKN 1997 Dated: October 20, October 21, 1997 Received:
Dear Mr. Snow:
Mr. Robert Snow
Canada
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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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. Robert Snow
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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
a M. Witten, Ph.D., M.D. Celi Director Division of General and Restorative Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
K 974010
510(k) Number:
Device Name:
、・
Advantage EMG System, Model #A100
p
Indications for Use:
The Advantage EMG System, Model #A100 is a Diagnostic Electromyography (EMG)/Evoked Response Electrical Stimulation System for the diagnosis of nervous and muscular system disorders in adult and pediatric patients.
(Please Do Not Write Below This Line - Continue on Another Page if Needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| General Restorative Devices | |
| 510(k) Number | 1974010 |
Prescription Use or Over-The-Counter Use
WA01A/136286.1