(182 days)
No
The summary describes a standard neurophysiological monitoring system that acquires, displays, and stores physiological data. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The functions described are typical for this type of device and do not inherently require AI/ML.
No
Explanation: The device is described as an "electroneurodiagnostic device" that "acquires, displays, and stores physiologic data." Its functions are related to measuring and monitoring nerve and brain activity (e.g., EPs, EEG, EMG), not directly treating a condition.
Yes
The device is explicitly described as an "electroneurodiagnostic device" and its intended use is to acquire, display, and store physiologic data from various parts of the nervous system, which are functions directly related to diagnosing conditions.
No
The device description explicitly states that the Guardian system requires hardware components including a Power Comm, Guardian Base, electrical Transcranial Stimulator, and optional amplifiers and stimulators, in addition to the software.
Based on the provided information, the Cadwell Guardian with Cascade Surgical Studio software is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The Guardian device acquires physiological data directly from the patient's body in vivo (within the body). It measures electrical activity from nerves, muscles, and the central nervous system.
- The intended use and device description clearly state that it is an "electroneurodiagnostic device" used for "acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system". This is a direct measurement of the body's electrical signals.
Therefore, the Guardian device falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Guardian with Cascade Surgical Studio software is an electroneurodiagnostic device that acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system, generated either spontaneously or elicited by stimuli.
Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), and Train of Four (TOF) analysis.
Guardian can provide remote review outside of the operating room.
Guardian is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing.
The following functions are specifically supported individually or in combination:
Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered.
Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp.
Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes.
Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves.
Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results.
Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results.
Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results.
Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results.
Nerve Conduction Study (NCS): Guardian can measure, display, record, and store sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system.
Train of Four (TOF): Guardian can deliver a train of four pulses, and measure, display, record, and store the results.
Product codes (comma separated list FDA assigned to the subject device)
GWF, ETN, GWE, GWJ, GWQ, GZO, IKN, JXE, OLT, PDQ
Device Description
The Cadwell Guardian is a multi-modality intraoperative neurophysiological monitoring system with up to 80 channels of data acquisition.
The Guardian system is designed to be flexible and scalable depending on customer and procedural requirements. All systems require a Power Comm and Guardian Base, which contains an electrical Transcranial Stimulator. The user may select up to two Omni Amplifiers, two ES-10 electrical stimulators, one AVX auditory and visual stimulator, and one SMX-32 EEG amplifier that contains a low current electrical stimulator, in order to meet specific requirements.
The Guardian requires a (PC) with Windows operating system. The Guardian system uses a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software. Surgical Studio acquires, stores and reviews a wide range of intraoperative neurophysiological data, such as EMG, EEG, SSEP, BAEP, VEP, MEP and TOF, and includes Report Generation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral sensory and motor nerves, muscles, and the central nervous system.
Brain (scalp and directly from brain), cerebral cortex, cranial and peripheral nerves, spinal cord.
Indicated Patient Age Range
Newborn to geriatric
Intended User / Care Setting
Licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing.
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)
Performance Testing: The Cadwell Guardian was tested in accordance with internal software requirements, system requirements, and usability requirements. Test results indicate that the Cadwell Guardian complies with its predetermined specifications.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the Cadwell Guardian. The results of these activities demonstrate that the Cadwell Guardian is as safe, as effective, and performs as well as the predicate devices. Therefore, the Cadwell Guardian is considered substantially equivalent to the predicate devices.
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.
Cadwell Industries, Inc. Cascade IOMAX™ Intraoperative Monitor K162199, Inomed ISIS Headboxes and Neurostimulator K212166
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.
Cadwell Industries, Inc. Cadwell Zenith System (K181466), Cadwell Industries, Inc. Sierra Summit (K162383), Nihon Kohden Neuromaster G1 Mee2000 (K142624)
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
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
August 17, 2023
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Cadwell Industries, Inc. Jason Ford Regulatory Affairs Manager 909 North Kellogg Street Kennewick, Washington 99336
Re: K230415
Trade/Device Name: Cadwell Guardian Regulation Number: 21 CFR §882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Code: GWF, ETN, GWE, GWJ, GWQ, GZO, IKN, JXE, OLT, PDQ Dated: July 20, 2023 Received: July 21, 2023
Dear Jason Ford:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
-2
Patrick Antkowiak
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Cadwell Guardian
Indications for Use (Describe)
The Guardian with Cascade Surgical Studio software is an electroneurodiagnostic device that acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system, generated either spontaneously or elicited by stimuli.
Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), and Train of Four (TOF) analysis.
Guardian can provide remote review outside of the operating room.
Guardian is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing.
The following functions are specifically supported individually or in combination:
Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered.
Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp.
Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes.
Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves.
Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results.
Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results.
Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results.
Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results.
Nerve Conduction Study (NCS): Guardian can measure, display, record, and store sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system.
Train of Four (TOF): Guardian can deliver a train of four pulses, and measure, display, record, and store the results.
3
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Image /page/4/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, sans-serif font. To the left of the word is a circular logo containing a heartbeat symbol. A registered trademark symbol is located to the right of the word.
| Submitter: | Cadwell Industries, Inc.
909 N. Kellogg Street
Kennewick, Washington 99336
509-735-6481 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jason Ford
Email: jasonf@cadwell.com |
| Date Prepared: | February 9, 2023 |
| Trade Name: | Cadwell Guardian™ |
| Regulation
Name: | Evoked response stimulator |
| Regulation
Number: | 21 CFR §882.1870 |
| Regulatory
Classification: | Class II |
| Product Codes: | GWF, ETN, GWE, GWJ, GWQ, GZO, IKN, JXE, OLT, PDQ |
| Classification
Panel: | Neurology |
| Primary
Predicate
Device: | Cadwell Industries, Inc. Cascade IOMAX™ Intraoperative Monitor
Product Code: GWF, DQA, ETN, GWE, GWJ, GWQ, GZO, IKN, JXE, OLT, PDQ
510(k) Number: K162199 |
| Secondary
Predicate
Device: | Inomed ISIS Headboxes and Neurostimulator
Product Code: GWF, GWJ, GWQ, ETN, IKN
510(k) Number: K212166 |
| Reference
Predicate
Devices: | Cadwell Industries, Inc. Cadwell Zenith System (K181466)
Cadwell Industries, Inc. Sierra Summit (K162383)
Nihon Kohden Neuromaster G1 Mee2000 (K142624) |
| Device | The Cadwell Guardian is a multi-modality intraoperative neurophysiological |
Description: monitoring system with up to 80 channels of data acquisition.
5
The Guardian system is designed to be flexible and scalable depending on customer and procedural requirements. All systems require a Power Comm and Guardian Base, which contains an electrical Transcranial Stimulator. The user may select up to two Omni Amplifiers, two ES-10 electrical stimulators, one AVX auditory and visual stimulator, and one SMX-32 EEG amplifier that contains a low current electrical stimulator, in order to meet specific requirements.
The Guardian requires a (PC) with Windows operating system. The Guardian system uses a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software. Surgical Studio acquires, stores and reviews a wide range of intraoperative neurophysiological data, such as EMG, EEG, SSEP, BAEP, VEP, MEP and TOF, and includes Report Generation.
Indications for
Use:
The Guardian with Cascade Surgical Studio software is an electroneurodiagnostic device that acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system, generated either spontaneously or elicited by stimuli.
Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), nerve conduction studies (NCS), and Train of Four (TOF) analysis.
Guardian can provide remote review outside of the operating room.
Guardian is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing.
The following functions are specifically supported individually or in combination:
Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered.
Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp.
Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes.
Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves.
6
Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results.
Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results.
Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results.
Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results.
Nerve Conduction Study (NCS): Guardian can measure, display, record, and store sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system.
Train of Four (TOF): Guardian can deliver a train of four pulses, and measure, display, record, and store the results.
7
Technology Comparison:
| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Predicate Device
Inomed ISIS (K212166) | Predicate Device
Cadwell Zenith (K181466) | Discussion of Major Differences |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Guardian with Cascade
Surgical Studio software is an
electroneurodiagnostic device
that acquires, displays, and
stores physiologic data from
peripheral sensory and motor
nerves, muscles, and the central
nervous system, generated either
spontaneously or elicited by
stimuli.
Guardian can perform
somatosensory, auditory, and
visual evoked potentials (EPs),
electroencephalography (EEG),
electrocorticography (ECoG),
spontaneous and triggered
electromyography (EMG),
transcranial motor evoked
potentials (TCMEP), direct
cortical stimulation (DCS),
direct nerve stimulation (TEMG,
DNS), nerve conduction studies
(NCS), and Train of Four (TOF)
analysis.
Guardian can provide remote
review outside of the operating
room.
Guardian is used by or under the
direction of a licensed
physician, surgeon, or
neurologist in a professional | The Cascade IOMAXTM
Intraoperative Monitor with
Surgical Studio software
(IOMAX) is an
electroneurodiagnostic device
that acquires, displays and stores
physiologic data from peripheral
sensory and motor nerves,
muscles and the central nervous
system, generated either
spontaneously or elicited by
well-defined stimuli. The
acquired data are necessary to
perform somatosensory, auditory
and visual evoked potentials
(EPs), electroencephalography
(EEG), electromyography
(EMG), transcranial motor
evoked potentials (TcMEPs),
direct cortical stimulation, nerve
conduction studies and Train of
Four (TOF) analysis.
SpO2 measures and displays
oxygen saturation and heart rate
information.
The system also delivers direct
nerve stimulation required for
specific surgical procedures.
Evoked Potentials (EPs):
IOMAX provides electrical,
auditory or visual stimulation
and measures, displays,
records, and stores the
electrical activity of the | ISIS Headbox 5042XX: The
products are intended for
intraoperative
neuromonitoring; for the
recording of
electrophysiological signals
and stimulating nerve and
muscle tissues. The products
are intended for use in the
operating room to measure
and display the electrical
signals generated by muscle,
peripheral nerves, and the
central nervous system. The
products support the clinical
application of
Electroencephalography
(EEG), Electromyography
(EMG), Somatosensory
Evoked Potentials (SEP),
Motor Evoked Potentials
(MEP), and Auditory
Evoked Potentials (AEP).
The products are not
intended for monitoring life-
sustaining functions.
ISIS Neurostimulator
504180: The ISIS
Neurostimulator is intended
for the provision of
neurophysiological
stimulation when used in
surgical procedures and for
diagnostics. It is suitable for | The Cadwell Zenith is an
electroneurodiagnostic
device that accepts,
measures, displays,
records, and stores
electrical activity of the
brain via scalp and
intracranial
electroencephalography
(EEG) signals, and,
utilizing an integrated
switch matrix, relays
stimulation signals to the
patient. It can obtain,
display and store
electrophysiological data
from the central nervous
system, generated either
spontaneously or elicited
by well-defined stimuli.
The data is used to
perform neurodiagnostic
evaluations, including
EEG and direct cortical
stimulation. Zenith is used
with Cadwell acquisition
software.
Zenith is used by or under
the direction of a licensed
physician, surgeon, or
neurologist in a professional
healthcare facility
environment for pre-
operative, intraoperative | The indications for use between the proposed
device and the predicates have no
substantive differences.
The proposed device does not include SpO2
because this measurement is not a customer
requirement.
The proposed device describes the use of
ECoG, which was previously described in
general terms under EEG in the predicate
device IFU.
EEG and ECoG are listed separately to
differentiate between direct brain recording
and scalp recording, however both are
recordings obtained from 2 or more
electrodes attached to the patient head, as
described in the predicate device IFU.
These differences in the proposed device do
not raise new questions of safety or
effectiveness, and is therefore considered
substantially equivalent. |
| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Predicate Device
Inomed ISIS (K212166) | Predicate Device
Cadwell Zenith (K181466) | Discussion of Major Differences |
| healthcare facility environment
for pre-operative, intraoperative
and post-operative testing.
The following functions are
specifically supported
individually or in combination:
Evoked Potentials (EPs):
Guardian can provide electrical,
auditory, and visual stimulation
and measure, display, record,
and store the electrical activity
of the nervous system in
response to the stimulations
delivered.
Electroencephalography (EEG):
Guardian can measure, display,
record, and store electrical
activity of the brain from two or
more electrodes on the scalp.
Electrocorticography (ECoG):
Guardian can measure, display,
record, and store electrical
activity directly from the brain
using two or more electrodes.
Free Run Electromyography
(EMG): Guardian can acquire,
display, record, and store EMG
activity of motor nerves.
Triggered Electromyography
(TEMG): Guardian can
electrically stimulate motor
nerves, and display, record, and
store the results. | nervous system in response to
the stimulation.
EEG: IOMAX measures,
displays, records, and stores
electrical activity of the brain
from two or more electrodes on
the head.
Free Run EMG: IOMAX
acquires, displays, records, and
stores spontaneous EMG
activity of motor nerves by
continually displaying a live
stream of mechanically
induced myotome contractions.
Triggered EMG (TEMG):
IOMAX electrically stimulates
the motor nerves, and displays,
records, and stores the
resulting compound muscle
action potentials in the
innervated muscle.
TcMEP: IOMAX delivers
transcranial stimulation via
dedicated outputs for
intraoperative assessment.
Cortical Stimulation: IOMAX
delivers Low Current
Stimulation (LCS) during
surgical procedures to map
various areas of the cortex.
Nerve Conduction Study
(NCS): IOMAX measures,
displays, records, and stores
sensory and motor nerve
conduction time (latency) by
applying a stimulus to | continuous operation and can
be used in the following
fields:
Transcranial electrical
stimulation (TES)
Direct cortical stimulation
(DCS)
Direct nerve stimulation
(DNS) Transcutaneous
electrical nerve stimulation
(TNS)
Direct muscle stimulation
(DMS) | and post-operative testing
on patients of all ages. | | |
| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Predicate Device
Inomed ISIS (K212166) | Predicate Device
Cadwell Zenith (K181466) | Discussion of Major Differences |
| | Transcranial Motor Evoked
Potentials (TcMEP): Guardian
can deliver electrical
transcranial stimulation, and
display, record, and store the
results.
Direct Cortical Stimulation
(DCS): Guardian can deliver
electrical stimulation to various
areas of the cerebral cortex, and
display, record, and store the
results.
Direct Nerve Stimulation
(DNS): Guardian can
electrically stimulate cranial and
peripheral nerves, and display,
record, and store the results.
Nerve Conduction Study (NCS):
Guardian can measure, display,
record, and store sensory and
motor nerve conduction time
(latency) by applying a stimulus
to peripheral nerves, the spinal
cord, and the central nervous
system.
Train of Four (TOF): Guardian
can deliver a train of four pulses,
and measure, display, record, and
store the results. | peripheral nerves, the spinal
cord, and the central nervous
system.
Train of Four (TOF) or Twitch
Test: IOMAX delivers a train
of four pulses and measures,
displays, records, and stores
the compound muscle action
potential amplitude fade for
analysis.
SpO2: IOMAX measures and
displays oxygen saturation and
heart rate information
Remote Reader: IOMAX
provides passive, real time
remote review of intraoperative
monitoring for a physician
outside of the operating room.
IOMAX is used by or under the
direction of a licensed physician,
surgeon, or neurologist in a
professional healthcare facility
environment for pre-operative,
intraoperative and post-operative
testing. | | | |
| Population | Age: Newborn to geriatric
Weight: > 2.5 kg | Age: Newborn to geriatric
Weight: > 2.5 kg | None stated. | Patients of all ages. | No significant difference. |
| Modalities | Evoked potential (EP) in the
form of:
• Brainstem auditory | Evoked potential (EP) in the
form of:
• Brainstem auditory | EEG, EMG, SEP, MEP,
AEP, TES, DCS, DNS,
TNS, DMS | Electroencephalogram
(EEG) External cortical | Guardian does not include SpO2.
These differences in the proposed device do
not raise new questions of safety or |
| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Predicate Device
Inomed ISIS (K212166) | Predicate Device
Cadwell Zenith (K181466) | Discussion of Major Differences |
| | Visual Somatosensory Transcranial electrical motor
evoked potential (TcMEP) Electromyography (EMG) Electroencephalogram (EEG) Electrocorticography (EcoG) Nerve conduction studies (NCS)
including: NCV F wave H reflex Train of four (TOF) Photic Stimulation Threshold mode Direct cortical stimulation Direct nerve stimulation | Visual Somatosensory Transcranial electrical motor
evoked potential (TcMEP) Electromyography (EMG) Electroencephalogram (EEG) Nerve conduction studies in the
form of: NCV F wave H reflex Train of four (TOF) SpO2 and heart rate values Threshold mode Direct cortical Stimulation | | stimulation
Photic stimulation
Video | effectiveness, and is therefore considered
substantially equivalent. |
| System
Configuration | Computer based equipment with
dedicated hardware peripherals/
components, and custom
acquisition software.
USB cable connected from base
unit to computer
Modules interconnected via
interconnect cables (ethernet,
multi-pin) | Same | Same | Same | - |
| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Predicate Device
Inomed ISIS (K212166) | Predicate Device
Cadwell Zenith (K181466) | Discussion of Major Differences |
| | Software installed and operated on computer | | | | |
| System
Components | One (1) Power Comm module providing device power and communication, and USB connection to PC.
One (1) Base Unit containing the following: | One (1) Power Comm module providing device power and communication, with Two (2) trigger inputs and Two (2) trigger outputs, and USB connection to PC.
Up to one (1) Cortical Module, containing the following: | Unspecified | IOMAX Cortical Module (acts as an external cortical stimulation source for the amplifier) | Both the proposed device and the IOMAX predicate device have the same types of measurement functionality and the same types of stimulation functionality. Both contain the following: |
| | Up to two (2) removable 24 channel amplifiers, each with up to two (2) amplifier input extenders | One (1) 16 channel amplifier | | Photic stimulator (connected to the personal computer (PC) upon | |
| | One (1) transcranial stimulator (TCS) with 9 multiplexed outputs, with one (1) TCS output extender | | | which the acquisition hardware is deployed). | |
| | Two (2) Trigger inputs
Two (2) Trigger outputs | One (1) Stereo Auditory Stimulator with up to (1) Insert Earphones
One (1) Stereo Visual Stimulator with up to (1) VEP Goggles | | Patient event button (connected to the IOMAX Base Module). | |
| | Up to two (2) ES-10 Stimulators, each containing 1 medium current stimulator (MCS) multiplexed to 8 output pairs, and 1 low current stimulator (LCS) multiplexed to 2 output pairs | | | Video recorders (connected to the PC or to the user's network). | |
| | Up to one (1) SMX-32 32 channel EEG amplifier with one (1) integrated low current stimulator (LCS) | | One (1) transcranial stimulator (TCS) with 9 multiplexed outputs
One (1) Low Current Stimulator (LCS)
Up to four (4) Limb Modules, each containing the following:
8 multipurpose recording channels | | |
| | | | | | Power Comm
Transcranial Stimulation (TCS)
Medium Current Stimulation (MCS)
Low Current Stimulation (LCS)
Multiplexing of various electrical stimulators
Multiple general-purpose Amplifiers
Two (2) Trigger Inputs
Two (2) Trigger Outputs
Stereo Audio Stimulator
Stereo Visual Stimulator
VEP Goggles
AEP Insert Earphones
Guardian hardware does not have built-in SpO2 functionality.
Guardian does have up to one (1) SMX-32 EEG amplifier that can be compared to the amplifier in the reference predicate (Zenith Amplifier).
These differences in the proposed device do not raise new questions of safety or |
| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Predicate Device
Inomed ISIS (K212166) | Predicate Device
Cadwell Zenith (K181466) | Discussion of Major Differences |
| | Up to one (1) AVX device
containing auditory stimulator
and visual stimulator. Up to (1)
VEP Glow Goggle. Up to (1)
Insert Earphones OR
Headphones. | One (1) medium current
stimulator (MCS)
multiplexed to 5 output
pairs.
SpO2 monitor | | | effectiveness, and is therefore considered
substantially equivalent. |
| | Up to four (4) Auxiliary Cables
to connect ES-10, SMX-32,
and/or AVX to the Base Unit | | | | |
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VELL 510(k) Summary S
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VELL 510(k) Summary S
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| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Discussion of Major Differences |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Auditory
Stimulator | | | |
| Output Type | Earphones and head phones | Earphones | Earphones and headphones have the same acoustic
specification.
These differences in the proposed device do not
raise new questions of safety or effectiveness, and
is therefore considered substantially equivalent. |
| Stimulus
Waveform | User defined clicks, tones, chirps,
pips | Click | Similar to reference predicate device, Neuromaster
G1 (K142624).
These differences in the proposed device do not
raise new questions of safety or effectiveness, and
is therefore considered substantially equivalent. |
| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Discussion of Major Differences |
| Presentation | Left, right, or both ears | Same | - |
| Stimulus Phase
(Polarity) | Condensation (positive),
Rarefaction (negative), alternating | Same | - |
| Stimulus
Intensity | 33 to 125 dB peak sound pressure
level (SPL) | 70 to 125 dB peak sound
pressure level (SPL) | Maximum stimulation is same as IOMAX predicate.
Stimulation intensities are within range of reference predicate device, Neuromaster G1 (0-135 dB SPL) (K142624).
These differences in the proposed device do not raise new questions of safety or effectiveness, and is therefore considered substantially equivalent. |
| Contralateral
White Noise
Masking | Contralateral masking from 0-60 dB below stimulus level maximum of 100 dB SPL, or off | Same | - |
| Click Pulse
Duration or
Rate | Pulse duration: 0.1 mS
Repetition rate: 0.1-100Hz depending on sweep speed and interleave setup | Pulse Duration: Same
Repetition Rate: 0.1 to 40 Hz depending on sweep speed and interleave setup | Proposed device repetition rate is equivalent to reference predicate device, Sierra Summit (0.1-90Hz) (K162383).
These differences in the proposed device do not raise new questions of safety or effectiveness, and is therefore considered substantially equivalent. |
| Tone Burst
Frequency | 250-10,000 Hz | Not applicable | Within in range of reference device Neuromaster G1 (50-10,000 Hz) (K142624).
These differences in the proposed device do not raise new questions of safety or effectiveness, and is therefore considered substantially equivalent. |
| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Discussion of Major Differences |
| Rise/Fall Time
of Tone Burst | 4-100 mS | Not applicable. | No difference from reference predicate device,
Sierra Summit (4-100mS) (K162383).
These differences in the proposed device do not
raise new questions of safety or effectiveness, and
is therefore considered substantially equivalent. |
| Visual
Stimulators | | | |
| Stimulus Modes | LED Goggle: Flash, left, right, or
bilateral presentation. Pattern
Reversal | LED goggles: Flash, left, right,
or bilateral presentation | Proposed device includes Pattern Reversal. No
difference from reference predicate device,
Neuromaster G1 (K142624)
These differences in the proposed device do not
raise new questions of safety or effectiveness, and
is therefore considered substantially equivalent. |
| Patterns | Checkerboard | Not applicable. | No difference from reference predicate device,
Neuromaster G1 (K142624).
These differences in the proposed device do not
raise new questions of safety or effectiveness, and
is therefore considered substantially equivalent. |
| Number of
Horizontal
Divisions | 4, 8, 16, 32, 64, 128 | Not applicable. | No difference from reference predicate device,
Neuromaster G1 (4, 8, 16, 32, 64, 128) (K142624).
These differences in the proposed device do not
raise new questions of safety or effectiveness, and
is therefore considered substantially equivalent. |
| LED Flash
Pulse Duration
or Rate | Pulse duration up to 5mS | Same | - |
| Computer
Hardware | | | |
| Type | PC | Same | - |
| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Discussion of Major Differences |
| Memory | 8 GB | Same | - |
| Network | 10/100/1,000 Mb/s Ethernet | Same | - |
| CPU | Minimum: Dual Core i7, 3.0 GHz
or faster
Recommend Quad Core i7 | Same | - |
| Storage
Capacity | 128+ GB | Same | - |
| Display | | | |
| Number of
Waveform
Traces | Unlimited | Same | - |
| Specific
Waveform
Display Modes | EP: Averaged, Live, Waterfall,
Cursor Trends
EEG: Default, Horizontal,
Vertical, CSA, DSA
EMG: Default, Horizontal,
Vertical, Waterfall
TOF: Vertical, Horizontal,
Histogram, Table
MEP: Default, Waterfall, Cursor
Trend | Same | - |
| Cursors | Unlimited | Same | - |
| Display Scale | 0.1 - 100,000 uV/Div
1 - 1,000 ms/Div | Same | - |
| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Discussion of Major Differences |
| Computer
Software | | | |
| Operating
System | Windows 10 or 11 | Windows® 7 or 10 Professional
64-bit | No significant difference.
These differences in the proposed device do not
raise new questions of safety or effectiveness, and
is therefore considered substantially equivalent. |
| Application
Software | Cadwell Surgical Studio 4.0 or
higher | Cadwell Surgical Studio 3.2 or
higher | |
| Physical
Dimensions | | | |
| Power Comm | 7.1 in x 5.8 in x 2.1 in
(18.0x14.8x5.3 cm)
Weight: 1.65 lb (0.75 kg) | 6.5 in x 5.2 in x 2.8 in
(16.5 x 13.3 x 7.1 cm)
Weight: 2.0 Lbs (0.9 kg) | The proposed device dimension and weight are
similar.
These differences in the proposed device do not
raise new questions of safety or effectiveness, and
is therefore considered substantially equivalent. |
| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Discussion of Major Differences |
| Major System
Components | Base Module: 12 in x 15.3 in x 3 in
(30.5 x 38.9 x 7.6 cm)
Weight: 6.0 lbs (2.7 kg)
SMX-32: 6.8 in x 5.3 in x 2.0 in
(17.3 x 13.5 x 5.1 cm)
Weight: 1.15 lb (0.52 kg)
ES-10: 6.8 in x 5.3 in x 2.0 in
(17.3 x 13.5 x 5.1 cm)
Weight: 1.15 lb (0.52 kg)
AVX: 6.8 in x 5.3 in x 2.0 in (17.3
x 13.5 x 5.1 cm)
Weight: 1.15 lb (0.52 kg) | Cortical Module: 253 mm x 215
mm x 60 mm (10.0 in x 8.5 in x
2.4 in)
Weight: 2.7 kg (6.0 lbs)
Limb Module: 253 mm x 122
mm x 60 mm (10.0 in x 4.8 in x
2.4 in)
Weight: 1.5 kg (3.4 lbs) | The proposed device dimensions and weights are
similar.
These differences in the proposed device do not
raise new questions of safety or effectiveness, and
is therefore considered substantially equivalent. |
| Electrical
Power | | | |
| AC Mains | Power Comm: 100-240 VAC | Same | - |
| Frequency | Power Comm: 50 to 60 Hz | Same | - |
| Environmental | | | |
| Operating
Temperature | All modules: 10 to 40 °C (50 to
104 °F) | All Modules: 10 to 35 °C (50 to
95 °F) | These differences in the proposed device do not
raise new questions of safety or effectiveness, and
is therefore considered substantially equivalent. |
| Operating
Humidity | All modules: 20 to 95%, non-
condensing | All Modules: 30 to 95 %, non-
condensing | These differences in the proposed device do not
raise new questions of safety or effectiveness, and
is therefore considered substantially equivalent. |
| Operating
Pressure | All modules: 700 to 1060 hPa | All Modules: Same | - |
| Characteristics | Proposed Device
Cadwell Guardian | Predicate Device
Cadwell Cascade IOMAX
(K162199) | Discussion of Major Differences |
| Storage
Temperature | All modules: -20C (-40F) to 65C
(149F) | All Modules: Same | - |
| Storage
Humidity | All modules: 5% to 95%, non-
condensing | All Modules: 10 to 95 %, non-
condensing | These differences in the proposed device do not
raise new questions of safety or effectiveness, and
is therefore considered substantially equivalent. |
| Storage
Pressure | All modules: 500 to 1060 hPa | All Modules: Same | - |
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TELL 510(k) Summary
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Image /page/19/Picture/0 description: The image shows the Cadwell logo and the text "510(k) Summary". The Cadwell logo is on the left side of the image, and the text "510(k) Summary" is on the right side of the image. The text is in a bold, sans-serif font.
The Cadwell Guardian was tested for safety and essential performance in accordance Electrical Safety: with the following safety standards: ES60601-1:2005+A1:2012 ● IEC 60601-1-6:2010+A1:2013 ● IEC 62304: 2006+A1:2015 ● IEC 80601-2-26:2019 ● IEC 60601-2-40:2016 ● Test results indicate that the Cadwell Guardian complies with the applicable standards. Electromagnetic The Cadwell Guardian was tested for performance in accordance with the following Disturbances: standards: IEC 60601-1-2:2014 + A1:2020 . Test results indicate that the Cadwell Guardian complies with the applicable standards. Performance The Cadwell Guardian was tested in accordance with internal software requirements, Testing: system requirements, and usability requirements. Test results indicate that the Cadwell Guardian complies with its predetermined specifications. Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the Cadwell Guardian. The results of these activities demonstrate that the Cadwell Guardian is as safe, as effective, and performs as well as the predicate devices. Therefore, the Cadwell Guardian is considered substantially equivalent to the predicate devices.