(88 days)
Not Found
No
The document describes a standard EMG/EP system with hardware and software for signal acquisition and analysis, but there is no mention of AI or ML technologies being used for the analysis or any other function.
No
The device is described as a "Diagnostic Electromyography/Evoked Response Electrical Stimulation (EMG/EP) System" intended for "monitoring and analysis of electromyography data" to "diagnose disorders of the nervous and muscular systems." It does not provide treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Advantage 3000 system diagnoses disorders of the nervous and muscular systems." and "A variety of electrophysiologic tests can be performed to determine whether disease of peripheral nerves or muscles is present in adult and pediatric patients."
No
The device description explicitly mentions hardware components such as surface electrodes, needle electrodes, a headbox, a control module, and a computer, indicating it is not a software-only device.
Based on the provided information, the Advantage 3000 system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Advantage 3000 Function: The description clearly states that the Advantage 3000 system records signals from the surface of the skin or directly from the nerves or muscles using electrodes. It also provides electrical stimulation to the patient. This involves direct interaction with the patient's body, not the analysis of samples taken from the body.
- Intended Use: The intended use is to diagnose disorders of the nervous and muscular systems by analyzing electromyography data and evoked responses to electrical stimulation. These are physiological measurements taken directly from the patient.
Therefore, the Advantage 3000 is a diagnostic device that operates in vivo (within the living body), not in vitro (in glass or outside the living body).
N/A
Intended Use / Indications for Use
The Advantage 3000 system diagnoses disorders of the nervous and muscular systems.
The Advantage 3000 is a Diagnostic Electromyography/Evoked Response Electrical Stimulation (EMG/EP) System designed for the monitoring and analysis of electromyography data. A variety of electrophysiologic tests can be performed to determine whether disease of peripheral nerves or muscles is present in adult and pediatric patients.
Product codes
IKN
Device Description
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 possible to provide a timed stimulus to the patient, so that the response to the stimulus can be recorded and analysed.
The signals from the subject are taken through the headbox to the control module and the computer for display and analysis. The computer is based on the Intel Pentium architecture.
Differences from the predicate device are the inclusion of a constant voltage stimulator, a more efficient operating interface, a reduction in the wattage of the speaker, the availability of a portable system, and the size reduction of the laboratory based system. Beyond these differences both devices have the same technological characteristics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerves or muscles
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)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Advantage Medical, a division of CME Telemetrix. The word "Advantage" is in a bold, sans-serif font and is set against a black background. Below that, the word "Medical" is in a similar font but is not set against a black background. Below that, the text "A Division of CME Telemetrix" is in a smaller font.
DEC - 5 1997
510(k) SUMMARY
Date: September 4, 1997
Submitter's Name and Address:
Advantage Medical A Division of CME Telemetrix 100 - 100 Collip Circle London, ON Canada N6G 4X8
Contact Name:
Mr. Robert Snow Advantage Medical A Division of CME Telemetrix 100 - 100 Collip Circle London, ON Canada N6G 4X8
Tel: 519-858-5011 Fax: 519-858-5020
1
K 973355
| Trade Name: | ADVANTAGE 3000 |
|---|---|
| Common Name: | EMG/EP System |
| Classification Name: | Diagnostic Electromyography / Evoked |
| Response Electrical Stimulation System | |
| Substantially Equivalent to: | Advantage EMG/EP System |
| K885246 | |
| Classification: | Class II, 21 C.F.R. §890.1375 & |
| §882.1870 | |
| Intended use: | The Advantage 3000 system diagnoses |
| disorders of the nervous and muscular | |
| systems. | |
| Technological characteristics: | 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 | |
| possible to provide a timed stimulus to the | |
| patient, so that the response to the | |
| stimulus can be recorded and analysed. | |
| The signals from the subject are taken | |
| through the headbox to the control module | |
| and the computer for display and analysis. | |
| The computer is based on the Intel Pentium | |
| architecture. | |
| Differences from the predicate device are | |
| the inclusion of a constant voltage | |
| stimulator, a more efficient operating | |
| interface, a reduction in the wattage of the | |
| speaker, the availability of a portable | |
| system, and the size reduction of the | |
| laboratory based system. Beyond these | |
| differences both devices have the same | |
| technological characteristics. |
2
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 forming its wing. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC = 5 1997
Mr. Robert Snow Advantage Medical Division of CME Telemetrix 100 Collip Circle #100 London Ontario N6G 4X8 CANADA
Re: K973355 Trade Name: Advantage 3000 Regulatory Class: II Product Code: IKN Dated: September 4, 1997 Received: September 8, 1997
Dear Mr. Snow:
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 requirements , 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
3
Page 2 - Mr. Snow
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
cella
ia 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
INDICATIONS FOR USE
510(k) Number: K973355
Device Name:
Advantage 3000
Indications for use:
The Advantage 3000 is a Diagnostic Electromyography/Evoked Response Electrical Stimulation (EMG/EP) System designed for the monitoring and analysis of electromyography data. A variety of electrophysiologic tests can be performed to determine whether disease of peripheral nerves or muscles is present in adult and pediatric patients.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K973355 |
| Prescription Use | ✓ |
|---|---|
| or | |
| Over-The-Counter Use |