(268 days)
Not Found
No
The description focuses on signal acquisition, processing, and display of compound muscle action potentials, without mentioning AI/ML techniques for analysis or interpretation. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is intended to monitor nerve activity and help surgeons locate and preserve nerves, not to treat a condition or disease.
Yes
Explanation: The device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery by acquiring and displaying compound muscle action potentials, which are used to evaluate the integrity of nerves. This process involves detecting and assessing physiological signals to determine a medical condition or state, fulfilling the definition of a diagnostic device.
No
The device description explicitly mentions hardware components such as a monitor screen, built-in audio amplifier and loudspeaker, and a built-in thermal array printer. It is a physical medical device with integrated software.
Based on the provided information, the Neurosign Avalanche nerve monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Neurosign Avalanche Function: The Neurosign Avalanche directly monitors nerve activity in vivo (within the living body) during surgery. It acquires electrical signals (compound muscle action potentials) from target muscles in response to nerve stimulation.
- Intended Use: The intended use is to help surgeons locate, identify, and preserve cranial motor nerves during surgery. This is a real-time monitoring and guidance tool, not a laboratory test performed on a specimen.
The device's function and intended use clearly fall outside the scope of an IVD. It's a surgical monitoring device.
N/A
Intended Use / Indications for Use
The Neurosign Avalanche nerve monitor is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery.
The intended uses of the Neurosign Avalanche Motor Nerve Monitor is:
2 channel thyroidectomy and parathyroidectomy, mastoidectomy
parotidectomy, mastoidectomy, skull-base 4 channel
Product codes (comma separated list FDA assigned to the subject device)
ETN
Device Description
The Neurosign Avalanche Motor Nerve Monitor is a 2 or 4 channel nerve monitor for intraoperative use in general surgery, skull-base surgery and ENT. The Neurosign Avalanche Motor Nerve Monitor allows the user to detect motor nerves and to check their integrity by acquiring the compound muscle action potentials at the target muscles. The acquired signals are processed by the monitor and displayed as waveforms on the monitor screen and played back acoustically via the built in audio amplifier and loudspeaker.
The Neurosign Avalanche Motor Nerve Monitor provides additional information to the user, helping the surgeon to locate nerves by using an electrical stimulator. The sound is independent from the waveform display on the monitor's screen.
The displayed waveforms can be printed along with the patient information via the built in thermal array printer, or as a generated report in Word format.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial motor nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, OR staff; Operating Room
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)
The Neurosign 400 and the Neurosign Avalanche XT Thyroid and EMG nerve monitors were assessed in a non-clinical setting and were determined to be similar in the following areas: Intended use, Method of operation, Stimulation frequency, Method of display, Audio, Signal detection.
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.
Neurosign® 400 Motor Nerve Monitor (reference K991583)
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
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
0
K083242
1 of 5
SECTION 5: 510(k) Summary or 510(k) Statement
JUL 2 9 2009
Image /page/0/Picture/4 description: The image shows the word "magstim" in a bold, sans-serif font. The letters are outlined in black and filled with a textured pattern. The word appears to be a logo or brand name.
Spring Gardens · W Carmarthenshire · Wa
4 (0) 1994 240798 (0) 1994 240061 info@magstim.com www.magstim.com
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 17 July 2009
Contact information:
Anwen Evans (Ms) The Magstim Company Ltd Spring Gardens, Whitland Carmarthenshire, Wales, UK SA34 OHR Tel: +44 (0) 1994 242902 Fax: +44 (0) 1994 240061 E-mail: anwen.evans@magstim.com
The product information is as follows:
Neurosign Avalanche Motor Nerve Monitor
| Product: | Neurosign Avalanche |
|---|---|
| Class: | Class CFR 874.1820 |
| Panel: | Ear, Nose and Throat |
| Product Code: | ETN |
Classification name: Surgical Nerve Stimulator/Locator Common or usual names: Nerve Monitor Proprietary name: Neurosign Avalanche Motor Nerve Monitor
C The Magstim Company Ltd
5-2
1
SECTION 5: 510(k) Summary or 510(k) Statement
5.1 Description of the Devices
The Neurosign Avalanche Motor Nerve Monitor is a 2 or 4 channel nerve monitor for intraoperative use in general surgery, skull-base surgery and ENT. The Neurosign Avalanche Motor Nerve Monitor allows the user to detect motor nerves and to check their integrity by acquiring the compound muscle action potentials at the target muscles. The acquired signals are processed by the monitor and displayed as waveforms on the monitor screen and played back acoustically via the built in audio amplifier and loudspeaker.
The Neurosign Avalanche Motor Nerve Monitor provides additional information to the user, helping the surgeon to locate nerves by using an electrical stimulator. The sound is independent from the waveform display on the monitor's screen.
The displayed waveforms can be printed along with the patient information via the built in thermal array printer, or as a generated report in Word format.
5.2 Intended Use of the Devices
The Neurosign Avalanche Motor Nerve Monitor is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery.
The intended uses of the Neurosign Avalanche Motor Nerve Monitor are:
- thyroidectomy and parathyroidectomy, mastoidectomy 2 channel
- 4 channel parotidectomy, mastoidectomy, skull-base
Predicate Devices 5.3
The predicate device used in this submission is:
- Neurosign® 400 Motor Nerve Monitor (reference K991583). .
Comparison with the predicate device 5.3.1
5-3
2
K083242
3 of 5
SECTION 5: 510(k) Summary or 510(k) Statement
| | Neurosign Avalanche
Thyroid Motor Nerve
Monitor
(Subject Device) | Neurosign Avalanche
EMG Motor Nerve
Monitor
(Subject Device) | Neurosign 400 Motor
Nerve Monitor
(Predicate Device) |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | Motor Nerve Monitor,
based upon standard
computer components,
running Windows XP
embedded operating
system; information is
provided to the surgeon
via a waveform graph of
EMG activity, and audio
amplification of this
signal so that the
surgeon hears this as
he/she is operating | Motor Nerve Monitor,
based upon standard
computer components,
running Windows XP
embedded operating
system; information is
provided to the surgeon
via a waveform graph of
EMG activity, and audio
amplification of this
signal so that the
surgeon hears this as
he/she is operating | Motor Nerve Monitor,
based upon proprietary
hardware and software;
information is provided
to the surgeon via a
waveform graph of
EMG activity, and audio
amplification of this
signal so that the
surgeon hears this as
he/she is operating |
| Intended
Use | Intra-operative
monitoring and
stimulation of peripheral
motor nerves | Intra-operative
monitoring and
stimulation of cranial
and peripheral motor
nerves | Intra-operative
monitoring and
stimulation of cranial
and peripheral motor
nerves |
| Specific
Indications
For Use | Thyroidectomy,
parathyroidectomy,
mastoidectomy, cochlear
implant | Thyroidectomy,
parathyroidectomy,
mastoidectomy,
parotidectomy, cochlear
implant, acoustic
neuroma, facial nerve
neuroma, meningioma | Mastoidectomy,
parotidectomy, skull-
base |
| Hardware | Standard PC | Standard PC | Proprietary |
| (main unit)
Headbox
Bandwidth | components
2 channel
8Hz - 8kHz ±3dB | components
4 channel
8Hz - 8kHz ±3dB | microprocessor design
4 channel
10Hz - 5kHz ±3dB |
| Signal Gain | 500 | 500 | 477 |
| Software
Screen | Windows XP Embedded
15" colour touchscreen | Windows XP Embedded
15" colour touchscreen | C++ proprietary code
6" electroluminescent
display |
| Method of
control | Touchscreen - all
controls via software
except power ON/OFF | Touchscreen - all
controls via software
except power ON/OFF | Controls via dedicated
buttons or via software
using menus selected
using front-panel
buttons |
| Manner of | Electrical stimulation via | Electrical stimulation via | Electrical stimulation via |
| Stimulation | a probe | a probe | a probe |
| Stimulation | 0.05mA - 10mA | 0.05mA - 10mA | 0.05mA - 5mA |
| Range
Stimulation
Type | Square wave, negative
edge, 200µs pulse width,
constant current | Square wave, negative
edge, 200µs pulse
width, constant current | Square wave, negative
edge, default 200µs
pulse width, selectable
from 100 to 500µs,
constant current,
constant voltage |
| | 3 or 30Hz | 3 or 30Hz | 3 or 30 Hz |
| Stimulation
Frequency | | | |
| Stimulation
Probes | Monopolar, bipolar,
concentric | Monopolar, bipolar,
concentric | Monopolar, bipolar,
concentric |
| Electrodes | Laryngeal electrode;
needle electrodes | Laryngeal electrode;
needle electrodes | Laryngeal electrode;
needle electrodes |
| Training
Required
for Use | Yes; both for surgeon
and OR staff | Yes; both for surgeon
and OR staff | Yes; both for surgeon
and OR staff |
| Location of
Use | Operating Room | Operating Room | Operating Room |
| Audio | Amplified raw EMG to
provide audio (10W
output) | Amplified raw EMG to
provide audio (10W
output) | Amplified raw EMG to
provide audio (14W
output) |
| Display and
Storage | Waveform signals
displayed on screen;
stimulated responses
may be optionally
automatically recorded
to disc | Waveform signals
displayed on screen;
stimulated responses
may be optionally
automatically recorded
to disc | Waveform signals
displayed on screen;
individual screens may
be stored in non-volatile
memory |
| Print
Capacity | Waveform data and
patient information can
be printed using the
internal thermal printer
or via an external Letter
sized inkjet printer for
the generation of reports
using stored data and
annotated comments | Waveform data and
patient information can
be printed using the
internal thermal printer
or via an external Letter
sized inkjet printer for
the generation of reports
using stored data and
annotated comments | Waveform data can be
printed to a proprietary
external thermal printer |
| Power | 110/230V 50/60Hz | 110/230V 50/60Hz | 110/230V 50/60Hz |
| Electrical
Safety | EN60601-1; Type BF,
Class IIA | EN60601-1; Type BF,
Class IIA | UL260601-1; Type BF,
Class I |
| Compliance
Standards | CE Mark; EN ISO 13485 | CE Mark; EN ISO 13485 | CE Mark; BS EN 9001;
EN ISO13485 |
":
:
.
.
3
K083242
4 of 5
SECTION 5: 510(k) Summary or 510(k) Statement
5.4 Non-Clinical Tests Undertaken
、
The Neurosign 400 and the Neurosign Avalanche XT Thyroid and EMG nerve monitors were assessed in a non-clinical setting and were determined to be similar in the following areas:
4
K083242
5 of 5
SECTION 5: 510(k) Summary or 510(k) Statement
| Feature | Neurosign 400 | Neurosign Avalanche | Comments |
|---|---|---|---|
| Intended use | Cranial motor nerve monitoring | Cranial motor nerve monitoring | All the machines are intended for the same purpose, with the Thyroid version restricted to simpler applications |
| Method of operation | EMG monitor and stimulator | EMG monitor and stimulator | All machines detect EMG and amplify it so it is audible to the surgeon, as well as displaying the EMG in a graphical format |
| Stimulation frequency | 3 or 30Hz | 3 or 30Hz | All machines use the same frequencies, pulse width and rectangular waveform |
| Method of display | Display shows amplitude triggered response for continuous monitoring, and switches to stimulator triggered response when using the stimulator | Screen is divided into 2 sections, 1 showing amplitude triggered responses in real time, the other showing stimulator triggered responses | The information displayed is the same, but presented in different manner |
| Audio | 14W rms amplifier | 10W rms amplifier | All machines amplify the EMG signal to generate an audible response. The sound is simply amplified and is proportional to the input signal. It is intended to interact directly with the surgeon |
| Signal detection | Needle and Laryngeal electrode | Needle and Laryngeal electrode | The same electrodes and stimulating probes are used |
Based upon these criteria, it was considered that the Neurosign 400 was a suitable predicate device for the Neurosign Avalanche XT Thyroid and XT EMG monitors.
5.5 Conclusions
The Neurosign Avalanche Motor Nerve Monitor is both safe and effective and is similar in its risks and benefits, as well as its manner of performance, to the predicate device listed above.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle-like bird with three wing-like extensions, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Magstim Company Limited c/o Anwen Evans Regulatory Affairs Manager Spring Gardens, Whitland Carmarthenshire, Wales, UK SA34 OHR
IJUL 2 9 2009
Re: K083242
Trade/Device Name: Neurosign® Avalanche Motor Nerve Monitor Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: II Product Code: ETN Dated: July 9, 2009 Received: July 14, 2009
Dear Ms. Evans:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
6
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Q. C. Riem, m. f.
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K 083242
Device Name: Neurosign® Avalanche Motor Nerve Monitor
Indications for Use:
The Neurosign Avalanche nerve monitor is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery.
The intended uses of the Neurosign Avalanche Motor Nerve Monitor is:
2 channel thyroidectomy and parathyroidectomy, mastoidectomy
parotidectomy, mastoidectomy, skull-base 4 channel
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
scription Use.
er 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
Page1of1
510(k) Number.