NEUROSIGN AVALANCHE MOTOR NERVE MONITOR

{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<br>Thyroid Motor Nerve<br>Monitor<br>(Subject Device) | Neurosign Avalanche<br>EMG Motor Nerve<br>Monitor<br>(Subject Device) | Neurosign 400 Motor<br>Nerve Monitor<br>(Predicate Device) | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description | Motor Nerve Monitor,<br>based upon standard<br>computer components,<br>running Windows XP<br>embedded operating<br>system; information is<br>provided to the surgeon<br>via a waveform graph of<br>EMG activity, and audio<br>amplification of this<br>signal so that the<br>surgeon hears this as<br>he/she is operating | Motor Nerve Monitor,<br>based upon standard<br>computer components,<br>running Windows XP<br>embedded operating<br>system; information is<br>provided to the surgeon<br>via a waveform graph of<br>EMG activity, and audio<br>amplification of this<br>signal so that the<br>surgeon hears this as<br>he/she is operating | Motor Nerve Monitor,<br>based upon proprietary<br>hardware and software;<br>information is provided<br>to the surgeon via a<br>waveform graph of<br>EMG activity, and audio<br>amplification of this<br>signal so that the<br>surgeon hears this as<br>he/she is operating | | Intended<br>Use | Intra-operative<br>monitoring and<br>stimulation of peripheral<br>motor nerves | Intra-operative<br>monitoring and<br>stimulation of cranial<br>and peripheral motor<br>nerves | Intra-operative<br>monitoring and<br>stimulation of cranial<br>and peripheral motor<br>nerves | | Specific<br>Indications<br>For Use | Thyroidectomy,<br>parathyroidectomy,<br>mastoidectomy, cochlear<br>implant | Thyroidectomy,<br>parathyroidectomy,<br>mastoidectomy,<br>parotidectomy, cochlear<br>implant, acoustic<br>neuroma, facial nerve<br>neuroma, meningioma | Mastoidectomy,<br>parotidectomy, skull-<br>base | | Hardware | Standard PC | Standard PC | Proprietary | | (main unit)<br>Headbox<br>Bandwidth | components<br>2 channel<br>8Hz - 8kHz ±3dB | components<br>4 channel<br>8Hz - 8kHz ±3dB | microprocessor design<br>4 channel<br>10Hz - 5kHz ±3dB | | Signal Gain | 500 | 500 | 477 | | Software<br>Screen | Windows XP Embedded<br>15" colour touchscreen | Windows XP Embedded<br>15" colour touchscreen | C++ proprietary code<br>6" electroluminescent<br>display | | Method of<br>control | Touchscreen - all<br>controls via software<br>except power ON/OFF | Touchscreen - all<br>controls via software<br>except power ON/OFF | Controls via dedicated<br>buttons or via software<br>using menus selected<br>using front-panel<br>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<br>Stimulation<br>Type | Square wave, negative<br>edge, 200µs pulse width,<br>constant current | Square wave, negative<br>edge, 200µs pulse<br>width, constant current | Square wave, negative<br>edge, default 200µs<br>pulse width, selectable<br>from 100 to 500µs,<br>constant current,<br>constant voltage | | | 3 or 30Hz | 3 or 30Hz | 3 or 30 Hz | | Stimulation<br>Frequency | | | | | Stimulation<br>Probes | Monopolar, bipolar,<br>concentric | Monopolar, bipolar,<br>concentric | Monopolar, bipolar,<br>concentric | | Electrodes | Laryngeal electrode;<br>needle electrodes | Laryngeal electrode;<br>needle electrodes | Laryngeal electrode;<br>needle electrodes | | Training<br>Required<br>for Use | Yes; both for surgeon<br>and OR staff | Yes; both for surgeon<br>and OR staff | Yes; both for surgeon<br>and OR staff | | Location of<br>Use | Operating Room | Operating Room | Operating Room | | Audio | Amplified raw EMG to<br>provide audio (10W<br>output) | Amplified raw EMG to<br>provide audio (10W<br>output) | Amplified raw EMG to<br>provide audio (14W<br>output) | | Display and<br>Storage | Waveform signals<br>displayed on screen;<br>stimulated responses<br>may be optionally<br>automatically recorded<br>to disc | Waveform signals<br>displayed on screen;<br>stimulated responses<br>may be optionally<br>automatically recorded<br>to disc | Waveform signals<br>displayed on screen;<br>individual screens may<br>be stored in non-volatile<br>memory | | Print<br>Capacity | Waveform data and<br>patient information can<br>be printed using the<br>internal thermal printer<br>or via an external Letter<br>sized inkjet printer for<br>the generation of reports<br>using stored data and<br>annotated comments | Waveform data and<br>patient information can<br>be printed using the<br>internal thermal printer<br>or via an external Letter<br>sized inkjet printer for<br>the generation of reports<br>using stored data and<br>annotated comments | Waveform data can be<br>printed to a proprietary<br>external thermal printer | | Power | 110/230V 50/60Hz | 110/230V 50/60Hz | 110/230V 50/60Hz | | Electrical<br>Safety | EN60601-1; Type BF,<br>Class IIA | EN60601-1; Type BF,<br>Class IIA | UL260601-1; Type BF,<br>Class I | | Compliance<br>Standards | CE Mark; EN ISO 13485 | CE Mark; EN ISO 13485 | CE Mark; BS EN 9001;<br>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 Page*1*of*1* K083242 510(k) Number.