(188 days)
No
The document describes standard electrophysiological data acquisition and analysis, and explicitly states that the device does not provide diagnostic conclusions. There is no mention of AI, ML, or related concepts in the description of the device's functionality or analysis methods.
No.
This device detects physiological function and supports diagnosis of neuromuscular diseases, but does not provide therapy or treatment.
Yes
The device is used to detect the physiologic function of the nervous system and to support the diagnosis of neuromuscular diseases or conditions.
No
The device description explicitly lists multiple hardware components as part of the system, including a console base unit, amplifier, computer, display monitor, and various optional accessories like stimulators and probes.
Based on the provided information, the Cadwell Sierra Summit and Ascent devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Cadwell Sierra Summit/Ascent Function: These devices acquire, display, store, and analyze electrophysiological data (EMG, NCS, EP, RR Interval Variability) directly from the human body. They measure electrical activity within the nervous and muscular systems.
- No Specimen Analysis: The description clearly states that the devices work with data from the human nervous and muscular systems, not with specimens taken from the body.
Therefore, the Cadwell Sierra Summit and Ascent are considered in vivo diagnostic devices, as they are used to diagnose conditions by examining the body directly.
N/A
Intended Use / Indications for Use
Cadwell Sierra Summit:
Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.
The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and serves as an aid in confirming the results of the aforementioned modalities.
Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.
Cadwell Sierra Ascent:
Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.
The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system.
Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.
Product codes (comma separated list FDA assigned to the subject device)
IKN, GWF, JXE, GWJ, GWE, GZP
Device Description
The Cadwell Sierra Summit and Ascent systems are designed for the acquisition, display, analysis, storage, and reporting of electrophysiologic information from the human nervous and muscular systems. The systems are designed to perform nerve conduction studies (NCS), needle electromyography (EMG) studies and evoked potential (EP) studies. The Sierra Summit is the full featured version and also includes autonomic (RR Interval) studies and an interface to allow display and control of non-invasive third-party imaging modalities.. Hereafter, the Sierra Summit is described as the full featured variant. The Summary of Technical Characteristics table below details the differences between the Summit and Ascent systems.
The Sierra Summit provides a variety of test protocols spanning the various test modalities above.
The Cadwell Sierra Summit consists of the following major components:
- Sierra Summit console base unit with integrated control panel
- Amplifier (available in two types: 2 channel with two non-switched differential channels, or a 12 channel with 4 non-switched differential and 8 switched referential channels. The number of available channels is controlled by a software license)
- Laptop or Desktop computer (Windows OS) with keyboard and mouse
- Display monitor
- Summit software
The Sierra Summit has the following optional accessories/components:
- Remote Head Box (for 3-12 channel amplifier)
- StimTroller (Hand Held Electrical Stimulator)
- Electrical Stimulator Switch Box
- Footswitch (single)
- Visual Stimulators (LED Goggles, LCD Checks)
- VEP Calibration Sensor
- Headphones or other auditory transducers
- Reflex Hammer
- Temperature Probe
- Cart
- Isolation Transformer or Medical Grade Power Strip
- Printer
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Peripheral nerve, muscle, central nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical practitioners
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)
Biocompatibility:
The Sierra Summit and Ascent have no patient contact materials, and therefore this section does not apply.
The hand-held StimTroller, LED Goggles, and accessories for use with the Sierra Summit and Ascent have patient contact materials and are made from medical grade biocompatible materials.
The appropriate component materials for these accessories were verified to be biocompatibility in accordance with the following standard:
- ISO 10993-1: 2009, Biological evaluation of medical devices Part 1: Evaluation and testing within . a risk management process.
Verification results indicate that the appropriate component materials comply with the standard.
Software:
The Cadwell Sierra Summit and Ascent software contains MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following guidance documents:
- FDA guidance: The content of premarket submissions for software contained in medical devices, 11 Mav 05.
- FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99.
- FDA guidance: General principles of software validation: Final guidance for industry and FDA staff. 11 Jan 02.
- FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14.
- . IEC 62304: 2006, Medical device software - Software life cycle processes
Test results indicate that the software complies with its predetermined specifications and the applicable guidance documents.
Electrical Safety:
The Sierra Summit was tested as worst case for safety and essential performance in accordance with the following standard(s):
- ANSI/AAMI ES60601-1: 2005/(R)2012, A1:2012, C1:2009/(R)2012, A2:2010/(R)2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
- IEC 60529: 1989, Am1: 1999, Am2: 2013, Cor2: 2015, Degrees of protection provided by enclosures (IP Code).
Test results indicate that the Sierra Summit and Ascent comply with the applicable standards.
Electromagnetic Compatibility:
The Sierra Summit was tested as worst case in accordance with the following standard:
- IEC 60601-1-2: 2014, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests.
Test results indicate that the Sierra Summit and Ascent comply with the applicable standards.
Performance Testing - Bench:
The Sierra Summit was tested as worst case for performance in accordance with internal requirements and the following standards:
- IEC 60068-2-27: 2008, Environmental testing – Part 2-27: Tests – Test Ea and guidance: Shock
- IEC 60068-2-64: 2008, Environmental testing – Part 2-64: Tests – Test Fh: Vibration, broadband random and guidance
- IEC 60601-2-40: 1998, Medical electrical equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
- IEC 60601-1-6: 2010. Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366: 2007, Medical devices Application of usability engineering to medical devices.
- MIL-STD-810E, Environmental Test Methods and Engineering Guidelines
- ISTA Procedure 2a, Partial simulation performance test procedure Packaged-products 150 lb (68 kg) or less.
Test results indicate that the Sierra Summit and Ascent comply with the predetermined specifications and the applicable standards.
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
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2017
Cadwell Industries, Inc. Christopher Bolkan QA/RA Engineer 909 North Kellogg Street Kennewick, Washington 99336
Re: K162383
Trade/Device Name: Cadwell Sierra Summit, Cadwell Sierra Ascent Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II Product Code: IKN, GWF, JXE, GWJ, GWE, GZP Dated: January 19, 2017 Received: January 23, 2017
Dear Christopher Bolkan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162383
Device Name Cadwell Sierra Summit, Cadwell Sierra Ascent
Indications for Use (Describe)
Cadwell Sierra Summit:
Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.
The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and serves as an aid in confirming the results of the aforementioned modalities.
Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.
Cadwell Sierra Ascent:
Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.
The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system.
Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
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510(k) Summary Cadwell Sierra Summit and Ascent
[A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92]
1. Submitter / 510(k) Holder:
| Name | Cadwell Industries, Inc. |
|---|---|
| Address | 909 N. Kellogg Street, Kennewick, Washington 99336 |
| Establishment Reg No. | 3020018 |
| Contact person | Mr. Chris Bolkan |
| Phone number | 509-735-6481 |
| Fax number | 509-783-6503 |
| ChrisB@Cadwell.com | |
| Date Prepared | August 5, 2016 |
2. Device Name:
| Proprietary name | Cadwell Sierra Summit, Cadwell Sierra Ascent |
|---|---|
| Common name | Diagnostic Electromyograph |
| Device Class | Class II |
| Classification name | Electromyograph, Diagnostic |
| Stimulator, Electrical, Evoked Response | |
| Device, Nerve Conduction Velocity Measurement | |
| Stimulator, Auditory, Evoked Response | |
| Stimulator, Photic, Evoked Response | |
| Stimulator, Mechanical, Evoked Response | |
| Product Code, Regulation | IKN 21 CFR 890.1375 |
| GWF 21 CFR 882.1870 | |
| JXE 21 CFR 882.1550 | |
| GWJ 21 CFR 882.1900 | |
| GWE 21 CFR 882.1890 | |
| GZP 21 CFR 882.1880 |
5
Image /page/5/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word is a black circle with a white heartbeat symbol inside. The letters of the word are connected to each other, creating a single, unified shape. The overall design is modern and professional.
| 3. Predicate Devices: | 510(k) Number | Device Name |
|---|---|---|
| Primary Predicate | K112052 | Carefusion Nicolet EDX with Viking Software |
| Reference Predicates | K971214 | Cadwell Kilowin (Easy II EEG, Sierra II |
| EMG/EP, Cascade IOM) |
4. Device Description:
The Cadwell Sierra Summit and Ascent systems are designed for the acquisition, display, analysis, storage, and reporting of electrophysiologic information from the human nervous and muscular systems. The systems are designed to perform nerve conduction studies (NCS), needle electromyography (EMG) studies and evoked potential (EP) studies. The Sierra Summit is the full featured version and also includes autonomic (RR Interval) studies and an interface to allow display and control of non-invasive third-party imaging modalities.. Hereafter, the Sierra Summit is described as the full featured variant. The Summary of Technical Characteristics table below details the differences between the Summit and Ascent systems.
The Sierra Summit provides a variety of test protocols spanning the various test modalities above.
The Cadwell Sierra Summit consists of the following major components:
- Sierra Summit console base unit with integrated control panel ●
- Amplifier (available in two types: 2 channel with two non-switched differential channels, or a 12 ● channel with 4 non-switched differential and 8 switched referential channels. The number of available channels is controlled by a software license)
- Laptop or Desktop computer (Windows OS) with keyboard and mouse ●
- Display monitor ●
- Summit software
The Sierra Summit has the following optional accessories/components:
- Remote Head Box (for 3-12 channel amplifier) ●
- StimTroller (Hand Held Electrical Stimulator)
- Electrical Stimulator Switch Box ●
- Footswitch (single) ●
- Visual Stimulators (LED Goggles, LCD Checks)
- VEP Calibration Sensor
- Headphones or other auditory transducers
- Reflex Hammer
- Temperature Probe ●
- Cart
- Isolation Transformer or Medical Grade Power Strip
- Printer
6
Image /page/6/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word, there is a black circle with a white line running through it, resembling a heartbeat symbol. The letters are closely spaced, creating a solid, impactful visual.
5. Indications for Use
Sierra Summit:
Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.
The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and muscles, and serves as an aid in confirming the results of the aforementioned modalities.
Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.
Sierra Ascent:
Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.
The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system.
Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.
6. Summary of Technical Characteristics Compared to the Predicate Devices
The Cadwell Sierra Summit and Ascent are substantially equivalent to predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device through comparison in areas that include intended use, design, functionality, principle of operation, specifications, material composition, and performance.
| 1. General | |||||
|---|---|---|---|---|---|
| This Submission | This Submission | Reference Predicate | Primary Predicate | ||
| Characteristics | Cadwell Sierra | ||||
| Summit | Cadwell Sierra Ascent | ||||
| (variant of Summit) | Cadwell Kilowin | ||||
| (Sierra II EMG/EP) | |||||
| (K971214) | Carefusion Nicolet EDX | ||||
| with Viking Software | |||||
| (K112052) | |||||
| 1.1 Indications | |||||
| for Use | |||||
| Cadwell Sierra Summit | |||||
| is indicated for | |||||
| acquisition, display, | |||||
| storage, transmission, | |||||
| analysis, and reporting | |||||
| of electrophysiological | |||||
| and environmental | |||||
| data including | |||||
| Electromyography | |||||
| (EMG), Nerve | |||||
| Conduction Studies | |||||
| (NCS), Evoked | |||||
| Potentials (EP), and | |||||
| Autonomic Reponses | |||||
| (RR Interval | |||||
| Variability). The | |||||
| Cadwell Sierra Summit | |||||
| is used as an aid in the | |||||
| location of neural | |||||
| structures or muscle, | |||||
| to detect the | |||||
| physiologic function of | |||||
| the nervous system, | |||||
| and to support the | |||||
| diagnosis of | |||||
| neuromuscular | |||||
| diseases or conditions. | |||||
| The listed modalities | |||||
| do include overlap in | |||||
| functionality. In | |||||
| general, Nerve | |||||
| Conduction Studies | |||||
| measure the electrical | |||||
| responses of the | |||||
| peripheral nerve; | |||||
| Electromyography | |||||
| measures the | |||||
| electrical activity of | |||||
| the muscle, and | |||||
| Evoked Potentials | |||||
| measure the electrical | |||||
| activity from the | |||||
| central nervous | |||||
| system. The interface | |||||
| for third-party non- | |||||
| invasive imaging | |||||
| display and control is | Cadwell Sierra Ascent is | ||||
| indicated for | |||||
| acquisition, display, | |||||
| storage, transmission, | |||||
| analysis, and reporting | |||||
| of electrophysiological | |||||
| and environmental | |||||
| data including | |||||
| Electromyography | |||||
| (EMG), Nerve | |||||
| Conduction Studies | |||||
| (NCS), and | |||||
| Somatosensory Evoked | |||||
| Potentials (SEP). The | |||||
| Cadwell Sierra Ascent is | |||||
| used as an aid in the | |||||
| location of neural | |||||
| structures or muscle, to | |||||
| detect the physiologic | |||||
| function of the nervous | |||||
| system, and to support | |||||
| the diagnosis of | |||||
| neuromuscular | |||||
| diseases or conditions. | |||||
| The listed modalities do | |||||
| include overlap in | |||||
| functionality. In | |||||
| general, Nerve | |||||
| Conduction Studies | |||||
| measure the electrical | |||||
| responses of the | |||||
| peripheral nerve; | |||||
| Electromyography | |||||
| measures the electrical | |||||
| activity of the muscle, | |||||
| and Evoked Potentials | |||||
| measure the electrical | |||||
| activity from the | |||||
| central nervous system. | |||||
| Cadwell Sierra Ascent is | |||||
| indicated for use by | |||||
| qualified medical | |||||
| practitioners. This | |||||
| device does not | |||||
| provide any diagnostic | |||||
| conclusion about the | Kilowin is an | ||||
| electrodiagnostic | |||||
| device designed to | |||||
| measure and display | |||||
| the electrical signals | |||||
| generated by | |||||
| peripheral nerve, | |||||
| muscle, and central | |||||
| nervous system. It | |||||
| will acquire the data | |||||
| necessary for | |||||
| electroencephalograp | |||||
| hy (EEG), | |||||
| electronystagmograph | |||||
| y (ENG), | |||||
| electrocardiology | |||||
| (ECG), | |||||
| electromyography | |||||
| (EMG), nerve | |||||
| conduction velocity | |||||
| (NCV, F Wave, and H | |||||
| reflex), evoked | |||||
| potentials (EP, | |||||
| brainstem, visual, | |||||
| somatosensory), | |||||
| repetitive nerve | |||||
| stimulation and sleep | |||||
| assessment. | |||||
| The Kilowin | |||||
| instrument is designed | |||||
| for use during the | |||||
| duration of the | |||||
| procedure only. | |||||
| Use of the proposed | |||||
| device is to be | |||||
| administered under | |||||
| the direction of a | |||||
| trained physician, | |||||
| surgeon, neurologist, | |||||
| or electrophysiologist | |||||
| in the operating room | |||||
| or clinic. | |||||
| The Kilowin device(s) | |||||
| are intended for use | |||||
| during | The CareFusion Nicolet | ||||
| EDX is intended for the | |||||
| acquisition, display, | |||||
| analysis, storage, | |||||
| reporting, and | |||||
| management of | |||||
| electrophysiologic | |||||
| information from the | |||||
| human nervous and | |||||
| muscular systems | |||||
| including Nerve | |||||
| Conduction (NCS), | |||||
| Electromyography | |||||
| (EMG), Evoked | |||||
| Potentials (EP), | |||||
| Autonomic Responses | |||||
| and Intra-Operative | |||||
| monitoring including | |||||
| Electroencephalography | |||||
| (EEG). | |||||
| Evoked Potentials (EP) | |||||
| includes Visual Evoked | |||||
| Potentials (VEP), | |||||
| Auditory Evoked | |||||
| Potentials (AEP), | |||||
| Somatosensory Evoked | |||||
| Potentials (SEP), | |||||
| Electroretinography | |||||
| (ERG), | |||||
| Electrooculography | |||||
| (EOG), P300, Motor | |||||
| Evoked Potentials | |||||
| (MEP). The Nicolet EDX | |||||
| with Viking Software | |||||
| may be used to | |||||
| determine autonomic | |||||
| responses to physiologic | |||||
| stimuli by measuring the | |||||
| change in electrical | |||||
| resistance between two | |||||
| electrodes (Galvanic Skin | |||||
| Response). Autonomic | |||||
| testing also includes | |||||
| assessment of RR | |||||
| Interval variability. The | |||||
| listed modalities do | |||||
| include overlan in | |||||
| used to visualize the | |||||
| morphology and | |||||
| location of nerves and | |||||
| muscles, and serves as | |||||
| an aid in confirming | |||||
| the results of the | |||||
| aforementioned | |||||
| modalities. |
Cadwell Sierra Summit
is indicated for use by
qualified medical
practitioners. This
device does not
provide any diagnostic
conclusion about the
patient's condition to
the user. | patient's condition to
the user. | electroencephalograp
y (EEG),
electronystagmograph
y (ENG),
electromyography
(EMG), nerve
conduction velocity
(NCV, F wave, and H
reflex), evoked
potentials (brainstem,
visual,
somatosensory)
repetitive nerve
stimulation testing
and sleep assessment. | functionality. In general,
Nerve Conduction
Studies measure the
electrical responses of
the nerve,
Electromyography
measures the electrical
activity of the muscle
and Evoked Potentials
measure electrical
activity from the Central
Nervous System.
The Nicolet EDX with
Viking Software is
intended to be used by a
qualified healthcare
provider. | |
| 1.2 Warnings | Items related to off-
label use or misuse. | Items related to off-
label use or misuse. | Items related to off-
label use or misuse. | Items related to off-label
use or misuse. | |
| 1.3 Contra-
indications | Items related to
design and indicated
use limitations, such
as, not for use in the
presence of
flammable anesthetics
or in conjunction with
defibrillation
equipment. | Items related to design
and indicated use
limitations, such as, not
for use in the presence
of flammable
anesthetics or in
conjunction with
defibrillation
equipment. | Items related to
design and indicated
use limitations, such
as, not for use in the
presence of
flammable anesthetics
or in conjunction with
defibrillation
equipment. | Items related to design
and indicated use
limitations, such as, not
for use in the presence
of flammable
anesthetics or in
conjunction with
defibrillation equipment. | |
| 2. General Design | | | | | |
| 2.1 General
Systems Approach | Computer based
equipment with
dedicated hardware
peripherals /
components. | Computer based
equipment with
dedicated hardware
peripherals /
components. | Computer based
equipment with
dedicated hardware
peripherals /
components. | Computer based
equipment with
dedicated hardware
peripherals /
components. | |
| 2.2 User Input
Device | Windows mouse/keyboard driven graphic interface with dedicated control panel. | Windows mouse/keyboard driven graphic interface with dedicated control panel. | Windows mouse/keyboard driven graphic interface with dedicated control panel. | Windows mouse/keyboard driven graphic interface with dedicated control panel. | |
| 2.3 User Output
Device | Digital color display and commercial printers. | Digital color display and commercial printers. | Digital color display and commercial printers. | Digital color display and commercial printers. | |
| 2.4 Patient Inputs | 1 to 12 channel amplifier, isolated. | 2 channel amplifier, isolated. | 2 or 4 channel amplifier, isolated. | 2 to 8 channel amplifier, isolated. | |
| 2.5 Signal
Acquisition | Analog to digital conversion at 100 kHz (EMG channels), 25 kHz (EP channels). | Analog to digital conversion at 100 kHz. | Analog to digital conversion at 76.8 kHz (2 channel), 38.4 kHz (4 channel). | Analog to digital conversion at 48kHz sample rate | |
| 2.6 Trigger Input
(synchronization
to external
events). | Yes (4) | Yes (2) | No | Yes (2) | |
| 2.7 Trigger
Output
(synchronization
for external
devices) | Yes (4) | Yes (2) | Yes (1) | Yes (2) | |
| 2.8 Footswitch
for hands-free
operation | Yes | Yes | Yes | Yes | |
| 2.9 Use of
standard software
platform
(Operating
System) | Yes, Microsoft Windows | Yes, Microsoft Windows | Yes, Microsoft Windows | Yes, Microsoft Windows | |
| 2.10
Customization of
protocols | Via storage / retrieval of user defined settings | Via storage / retrieval of user defined settings | Via storage / retrieval of user defined settings | Via storage / retrieval of user defined settings | |
| 2.11 Application
flexibility /
expandability | Via software update | Via software update | Via software update | Via software update | |
| 2.12 Safety
Standards | U.S. and Canada:
UL60601-1:2006 CSA C22.2#601.1 ANSI/AAMI ES60601-1:2006 CSA C22.2#60601-1:2008 | U.S. and Canada:
UL60601-1:2006 CSA C22.2#601.1 ANSI/AAMI ES60601-1:2006 CSA C22.2#60601-1:2008 | UL60601
CSA601-1
EN60601-1 (safety)
EN60601-1-1 (medical systems)
EN60601-2-40
(EMG/FP equipment) | EN/IEC 60601-1:1998+A1:1991+A2:1995
IEC 60601-1-1:2000
EN/IEC 60601-1-2:Ed. 2.0+A1:2004
IEC 60601-2-40:1998, Ed. 1 | |
| | IEC60601-
1:2005 Ed.3 EN60601-1-
2:2007 EN
ISO14971:20
12 IEC60601-1-
6:2010 IEC
62366:2007 60601-1 Ed2: IEC60601-1
Ed.2 IEC60601-2-
40:1998 EMC: IEC60601-1-
2:2007 EN60601-1-
2:2007 FCC Part 15
Subpart B
Section
15.107 &
15.109 LED Goggles light
output: ISO 15004 European Community CE Mark 0344
Quality Management
System EN ISO
13485:2012 | IEC60601-
1:2005 Ed.3 EN60601-1-
2:2007 EN
ISO14971:201
2 IEC60601-1-
6:2010 IEC
62366:2007 60601-1 Ed2: IEC60601-1
Ed.2 IEC60601-2-
40:1998 EMC: IEC60601-1-
2:2007 EN60601-1-
2:2007 FCC Part 15
Subpart B
Section 15.107
& 15.109 European Community CE Mark 0344
Quality Management
System EN ISO
13485:2012 | EN60601-1-1-2 (EMC)
ISO 13485 (quality
system) | ED1
Rev:2003/06/30
CAN/CSA-C22.2 no. 601-
1-M90
Issue:1990/01/01
Rev:2003/11
European Community
(CE Mark) | |
| 2.13 Patient
circuitry isolation | Optic/transformer | Optic/transformer | Optic/transformer | Optic/transformer | |
| | | | | | |
| 2.14 System | Summit base console | Ascent base console | Kilowin base console | EDX base console | |
| Components | including 2 electrical | including 1 electrical | including 1 electrical | including 2 electrical | |
| | stimulators, auditory | stimulator, trigger | stimulator, auditory | stimulators, auditory | |
| | stimulator, trigger | input/output, Control | and visual stimulator, | stimulator, trigger | |
| | input/output, LED | Panel, USB Hub, dual | trigger output, LED | input/output, LED | |
| | goggle interface, | speakers; | goggle interface, | goggle interface; | |
| | Control Panel, USB | | Control Panel, | | |
| | Hub, dual speakers; | 2 Ch. Amplifier; | Ethernet port, single | Control panel; | |
| | | Computer, monitor, | speaker. | Amplifier; | |
| | 1-2 Ch. Amplifier; | keyboard, mouse, | | Computer, monitor, | |
| | 3-12 Ch. Amplifier; | printer; | 2 Ch. Amplifier | keyboard, mouse, | |
| | Computer, monitor, | | 4 Ch. Amplifier | printer; | |
| | keyboard, mouse, | | Computer, monitor, | | |
| | printer; | | keyboard, mouse, | | |
| | | | printer | | |
| 2.15 System | USB | USB | Ethernet (RJ-45) | USB | |
| computer | | | | | |
| interface | | | | | |
| 2.16 System | Mains (100-240 VAC) | Mains (100-240 VAC) | Mains (100-240 VAC) | Mains (100-240 VAC) | |
| power supply | thru an isolation | thru an isolation | thru an isolation | thru an isolation | |
| | transformer | transformer depending | transformer | transformer | |
| | depending on system | on system | depending on system | | |
| | configuration | configuration | | | |
| 2.17 Amplifier | 12 VDC from base | 12 VDC from base | 12 VDC from base | 15 VDC from base | |
| power supply | console | console | console | console | |
| 2.18 Size (L/W/D) | 37.6 x 38.1 x 6.4 (base | 37.6 x 38.1 x 6.4 (base | | 35.6 x 34.3 x 8.6 (base | |
| cm | console) | console) | | console) | |
| 2.19 Weight kg | 3.4 (base console) | 3.4 (base console) | | 3.5 (base console) | |
| | | | | | |
| 3. Design - Acquisition | | | | | |
| 3.1 Number of | 1 to 12 | 2 | 2 or 4 | 2 to 8 | |
| channels | | | | | |
| 3.2 CMRR | >115 dB | >115 dB | >115 dB | >110 dB | |
| 3.3 Noise | 1000 ΜΩ | >1000 ΜΩ | >1000 ΜΩ | >1000 ΜΩ | |
| Impedance | | | | | |
| 3.5 Low Filter | 0.3 Hz to 2 kHz | 0.3 Hz to 2 kHz | 0.04 Hz to 2 kHz | 0.05 Hz to 5 kHz | |
| 3.6 High Filter | 30 Hz to 20 kHz | 30 Hz to 20 kHz | 30 Hz to 10 kHz | 30 Hz to 20 kHz | |
| 3.7 Notch Filter | 50/60 selectable | 50/60 selectable | 50/60 selectable | 50/60 selectable | |
| 3.8 A/D | 16 bit | 16 bit | 16 bit | 24 bit | |
| conversion | | | | | |
| 3.9 Sampling rate | 600 kHz | 200 kHz | 153.6 kHz | 384 kHz | |
| (cumulative) | | | | | |
| 3.10 Time base | 0.1 to 10,000 ms | 0.1 to 10,000 ms | 0.1 to 10,000 ms | 0.01 to 5000 ms | |
| range | | | | | |
| 3.11 Number of | Single | Single | Single | Multiple | |
| Time bases | | | | | |
| allowed | | | | | |
| 3.12 Trigger mode | Free-run, internal, external | Free-run, internal, external | Free-run, external | Free-run, internal, external | |
| 3.13 Signal delay (pre/post) | -9 to +9 divisions, depending on time base | -9 to +9 divisions, depending on time base | -9 to +9 divisions, depending on time base | -3000 to +500 ms | |
| 3.14 Impedance meter | 0.1Ω to 100 kΩ | 0.1Ω to 100 kΩ | 0.1Ω to 100 kΩ | 500Ω to 480kΩ | |
| 4. Design – Stimulators | | | | | |
| 4.1 Electrical Stimulator | | | | | |
| 4.1.1 Type | Constant Current | Constant Current | Constant Current | Constant Current or Constant Voltage | |
| 4.1.2 Number | 1 or 2 | 1 | 1 | 1 or 2 | |
| 4.1.3 Maximum Output | 100mA or 400V | 100mA or 400V | 100mA or 400V | 100mA or 400V | |
| 4.1.4 Duration | 0.05 to 1 ms | 0.05 to 1 ms | 0.05 to 1 ms | 0.01 to 1 ms | |
| 4.1.5 Mode | Single or Train | Single or Train | Single or Train | Single or Train | |
| 4.1.6 Biphasic | Yes | Yes | No | Yes | |
| 4.2 Auditory Stimulator | | | | | |
| 4.2.1 Type | Click, Pip, Burst | N/A | Click, Pip, Burst | Click, Pip, Burst | |
| 4.2.2 Intensity | 0 to 140 dB pSPL | N/A | 0 to 128 dB pSPL | 0 to 139 dB pSPL | |
| 4.2.3 Polarity | Condensation, Rarefaction, Alternating | N/A | Condensation, Rarefaction, Alternating | Condensation, Rarefaction, Alternating | |
| 4.2.4 Tone Frequency | 250 to 8000 Hz | N/A | 250 to 8000 Hz | 250 to 8000 Hz | |
| 4.2.5 Click Duration | 0.05 to 1 ms | N/A | 0.1 ms | 0.05 to 1 ms | |
| 4.2.6 Side | Left, Right, Both | N/A | Left, Right, Both | Left, Right, Both | |
| 4.2.7 Transducers | TDH 39, Inserts, Bone Vibrator | N/A | TDH 39, Inserts, Bone Vibrator | TDH 39, TIP 300, Bone Vibrator | |
| 4.3 Visual Stimulator | | | | | |
| 4.3.1 Type | LCD Checks, LED Goggles | N/A | CRT Checks, LED Goggles | CRT Checks, LED Goggles | |
| 4.3.2 Latency Delay Calibrator (for LCD Checks) | Yes | N/A | N/A | N/A | |
| 5. EMG Application Modules | | | | | |
| 5.1 Free Run Acquisition | Yes | Yes | Yes | Yes | |
| 5.2 Nerve Conduction Study (NCS) | Yes | Yes | Yes | Yes | |
| 5.3 Stimulator
Triggered | Yes | Yes | Yes | Yes | |
| 5.4 Signal
Triggered
Acquisition | Yes | Yes | Yes | Yes | |
| 5.5 Spontaneous
Activity (SPA) | Yes | Yes | Yes | Yes | |
| 5.6 Single Fiber
EMG (SFEMG) | Yes | No | Yes | Yes | |
| 5.7 Motor Unit
Analysis | Yes | Yes | Yes | Yes | |
| 5.8 F-Wave | Yes | Yes | Yes | Yes | |
| 5.9 H Reflex | Yes | Yes | Yes | Yes | |
| 5.10 Sympathetic
Skin Response
(SSR) | Yes | Yes | Yes | Yes | |
| 5.11 RR Interval
Variability | Yes | No | Yes | Yes | |
| 5.12 Repetitive
Nerve Stim | Yes | Yes | Yes | Yes | |
| 6. Evoked Potential Application Modules | | | | | |
| 6.1
Somatosensory EP
(SEP) | Yes | Yes | Yes | Yes | |
| 6.2 Auditory EP
(AEP) | Yes | No | Yes | Yes | |
| 6.3 Visual EP (VEP) | Yes | No | Yes | Yes | |
| 6.4 P300 | Yes | No | Yes | Yes | |
| 7. Other Application Modules | | | | | |
| 7.1 Multi-modality
IONM | No | No | No | Yes | |
| 7.2 EEG | No | No | No | Yes | |
| 7.3 ENG | No | No | No | Yes | |
| 7.4 ECG | No | No | No | No | |
| 7.5 Sleep (PSG) | No | No | No | No | |
| 8. Image Display and Control Interface | | | | | |
| 8.1 Display and
control of non-
invasive third-
party imaging
modality
(example:
Ultrasound) | Yes
Integrated
(concurrent)
ultrasound display
and control using the
Telemed Ultrasound
System (K113184)
with Echo Wave II
software. | No | No | No
Supports ultrasound by
running a third-party
scanner in a non-
integrated, non-
concurrent format
(launched separately
from desktop). Interson
USB Ultrasound Probe
System K070907 | |
7
Image /page/7/Picture/0 description: The image is a logo for Cadwell. The logo is black and white and features a circle with a heartbeat line going through it. The word "CADWELL" is written in bold, sans-serif letters to the right of the circle.
8
Image /page/8/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. The "C" is replaced with a circle containing a waveform symbol. The letters are connected, creating a single, unified design. The overall impression is modern and professional.
9
Image /page/9/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, sans-serif font. To the left of the word, there is a circular graphic with a waveform inside, resembling a heart rate monitor. The waveform extends horizontally to connect with the letter "C" of the word "CADWELL", creating a unified logo.
10
Image /page/10/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word is a black circle with a white line running through it, resembling a heartbeat symbol. The letters of the word are connected, forming a single, unified shape.
11
Image /page/11/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. The "O" in "CADWELL" is represented by a circle with a line running through it, resembling a heart rate monitor symbol. The letters are connected, creating a single, unified shape.
12
Image /page/12/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word, there is a black circle with a white heartbeat symbol inside. The heartbeat symbol extends to the letter "C" in "CADWELL", connecting the symbol to the word.
13
Image /page/13/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word, there is a circular graphic with a white line running through it, resembling a heartbeat or electrical signal. The letters of the word are connected, forming a single, unified shape.
14
Image /page/14/Picture/0 description: The image is a logo for "CADWELL". The logo is in black and white and features a stylized design. The first letter, "C", is represented by a circle with a line going through it. The rest of the letters are in a bold, sans-serif font.
7. Summary of Performance Testing
Biocompatibility:
The Sierra Summit and Ascent have no patient contact materials, and therefore this section does not apply.
The hand-held StimTroller, LED Goggles, and accessories for use with the Sierra Summit and Ascent have patient contact materials and are made from medical grade biocompatible materials.
The appropriate component materials for these accessories were verified to be biocompatibility in accordance with the following standard:
- ISO 10993-1: 2009, Biological evaluation of medical devices Part 1: Evaluation and testing within . a risk management process.
Verification results indicate that the appropriate component materials comply with the standard.
Software:
The Cadwell Sierra Summit and Ascent software contains MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following guidance documents:
- FDA guidance: The content of premarket submissions for software contained in medical devices, 11 Mav 05.
- FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99.
- FDA guidance: General principles of software validation: Final guidance for industry and FDA staff. 11 Jan 02.
- FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14.
- . IEC 62304: 2006, Medical device software - Software life cycle processes
Test results indicate that the software complies with its predetermined specifications and the applicable guidance documents.
Electrical Safety:
The Sierra Summit was tested as worst case for safety and essential performance in accordance with the following standard(s):
- ANSI/AAMI ES60601-1: 2005/(R)2012, A1:2012, C1:2009/(R)2012, A2:2010/(R)2012, Medical ● electrical equipment – Part 1: General requirements for basic safety and essential performance.
- IEC 60529: 1989, Am1: 1999, Am2: 2013, Cor2: 2015, Degrees of protection provided by enclosures ● (IP Code).
15
Image /page/15/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word is a black circle with a white line running through it, resembling a heartbeat symbol. The letters of the word are connected, creating a unified design. The overall impression is a strong and recognizable logo.
Test results indicate that the Sierra Summit and Ascent comply with the applicable standards.
Electromagnetic Compatibility:
The Sierra Summit was tested as worst case in accordance with the following standard:
- IEC 60601-1-2: 2014, Medical electrical equipment Part 1-2: General requirements for basic ● safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests.
Test results indicate that the Sierra Summit and Ascent comply with the applicable standards.
Performance Testing - Bench:
The Sierra Summit was tested as worst case for performance in accordance with internal requirements and the following standards:
- IEC 60068-2-27: 2008, Environmental testing – Part 2-27: Tests – Test Ea and guidance: Shock
- IEC 60068-2-64: 2008, Environmental testing – Part 2-64: Tests – Test Fh: Vibration, broadband random and guidance
- IEC 60601-2-40: 1998, Medical electrical equipment Part 2-40: Particular requirements ● for the safety of electromyographs and evoked response equipment
- IEC 60601-1-6: 2010. Medical electrical equipment Part 1-6: General requirements for ● basic safety and essential performance - Collateral standard: Usability
- IEC 62366: 2007, Medical devices Application of usability engineering to medical ● devices.
- MIL-STD-810E, Environmental Test Methods and Engineering Guidelines
- ISTA Procedure 2a, Partial simulation performance test procedure Packaged-products 150 lb (68 ● kg) or less.
Test results indicate that the Sierra Summit and Ascent comply with the predetermined specifications and the applicable standards.
8. Conclusion
Verification and validation activities were conducted to establish the performance and safety characteristics of the Sierra Summit and Ascent. The results of these activities demonstrate that the Summit and Ascent are as safe, effective, and performance is substantially equivalent to the predicate devices.