(389 days)
No
The description focuses on hardware components, signal processing (specifically EMG and AMG), and established electrical stimulation techniques for nerve localization and monitoring. There is no mention of AI, ML, or any learning algorithms. The term "intelligent EMG signal processing module" likely refers to sophisticated, but not necessarily AI/ML-based, signal filtering and analysis.
No.
The device is used for monitoring the efficacy of neuromuscular blocking agents and for nerve localization, not for treating a disease or condition.
Yes
The device is described as a "quantitative Neuromuscular Transmission (NMT) Monitor," which provides "real-time quantitative feedback" for monitoring the efficacy of Neuromuscular Blocking Agents and localizing nerves, all of which fall under diagnostic functions.
No
The device description explicitly mentions hardware components such as surface electrodes, a Nerve Mapping Probe, invasive needles, a conducting needle, a NMT Monitoring Cable (EMG), and an intelligent EMG signal processing module (µEMG). It also describes the device as a "quantitative Neuromuscular Transmission (NMT) Monitor" and a "precision nerve locating tool," indicating a physical device with hardware functionality beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The STIMPOD NMS450 is a nerve stimulation device that works directly on the patient's body. It uses electrical stimulation and measures the resulting neuromuscular response (either through acceleromyography or electromyography).
- Intended Use: The intended uses described are all related to procedures performed on the patient during anesthesia (monitoring neuromuscular blocking agents, nerve mapping, and nerve locating).
- Device Description: The description focuses on the device's ability to stimulate nerves and measure muscle response, not on analyzing biological samples.
Therefore, the STIMPOD NMS450 falls under the category of a medical device used for diagnosis and monitoring in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is a nerve stimulation device designed to be used by an anesthetist during:
-
General anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes.
-
Regional anesthesia, for the purpose of:
i. nerve mapping using the non-invasive Nerve Mapping Probe (supplied)
ii. nerve locating using invasive needles (not supplied)
Product codes (comma separated list FDA assigned to the subject device)
BXN
Device Description
The STIMPOD NMS450 is a quantitative Neuromuscular Transmission (NMT) Monitor which provides real-time quantitative feedback utilizing tri-axial accelerometery.
The STIMPOD NMS450 is also a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response.
The STIMPOD NMS450 currently makes use of 3 dimensional acceleromyography (AMG) as the measurement technology of choice for objective Neuromuscular Transmission (NMT) monitoring in surgery. Although AMG is still the de-facto standard in industry, the use of electromyography (EMG) has gained renewed interest in NMT monitoring applications where the introduction of robotic surgeries, new surgical techniques, and changes in workflow, for instance, made the use of AMG impracticable.
In order to address this steadily increasing market demand for EMG sensor technology in NMT monitoring applications, Xavant identified the need to design and develop a dedicated NMT Monitoring Cable (EMG) that could be used interchangeably with the existing NMT Monitoring Cable (AMG) already in use with the STIMPOD NMS450.
The NMT Monitoring Cable (EMG) was specifically designed for use with the STIMPOD NMS450 to assist anaesthesiologists in theatre with monitoring the efficacy of Neuromuscular Blocking Agents (NMBAs).
The NMT Monitoring Cable (EMG) was designed with an intelligent EMG signal processing module (henceforth referred to as the µEMG) on one end of the cable for connection to an EMG electrode, and with a standard FireWire connector on the other end for connection to the STIMPOD NMS450.
The µEMG makes provision for the following interfaces:
-
- a wireline communications interface to exchange information with the STIMPOD NMS450,
-
- an electrical interface to condition and sample the EMG signals picked up by the measurement contact points of an attached EMG electrode array,
-
- an electrical interface to (i) detect the stimulation signals generated by the STIMPOD NMS450, and (ii) route them to the stimulation contact points of an attached EMG electrode array,
-
- a visual interface to indicate the state (powered, connected etc.) of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Distal stimulation of the Ulnar Nerve with CMAP recording of the Adductor Pollicis muscle.
Indicated Patient Age Range
The patient population includes patients of all ages, weight, and nationality (excluding neonates for electromyography).
Intended User / Care Setting
used by an anesthetist / theatre
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance tests were conducted on the subject device in support of the claim for substantial equivalence:
-
- Functional Performance Testing.
-
- Electrical safety (in accordance with IEC 60601-1).
-
- Electromagnetic compatibility (in accordance with IEC 60601-1-2 and IEC 60601-2-40).
-
- Biocompatibility testing (in accordance with ISO10993-1).
-
- Usability testing.
-
- Battery life testing.
-
- Tensile strength testing of the electrode.
-
- Stimulation Performance Testing of the electrode (Charge Density, Current Density and Power Density)
The subject device met or exceeded the stated acceptance criteria for each performance test which were all confirmed to be the same or very similar to the performance specifications of the predicate device, and/or where relevant, to the reference device. The resultant test data therefore provided sufficient evidence to support the claim that the subject device is at least as safe and as effective as the predicate device in monitoring the muscle relaxation of a patient that has been subjected to the administration of a Neuromuscular Blocking Agent.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
October 16, 2022
Xavant Technology (Pty) Ltd Roche Van Rensburg Chief Executive Officer Unit 102 Tannery Industrial Park, 309 Derdepoort Road Silverton Pretoria, Gauteng 0184 South Africa
Re: K213049
Trade/Device Name: STIMPOD NMS450 Nerve Stimulator Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: Class II Product Code: BXN Dated: September 1, 2022 Received: September 12, 2022
Dear Roche Van Rensburg:
We have reviewed vour 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
1
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 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).
Sincerely,
James J. Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthsia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213049
Device Name STIMPOD NMS450 Nerve Stimulator
Indications for Use (Describe)
This device is a nerve stimulation device designed to be used by an anesthetist during:
-
General anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes.
-
Regional anesthesia, for the purpose of:
i. nerve mapping using the non-invasive Nerve Mapping Probe (supplied)
ii. nerve locating using invasive needles (not supplied)
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)
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3
Image /page/3/Picture/1 description: The image is a logo for Xavant Technology. The logo features a stylized letter X with a circular orbit around it. The word "AVANT" is in red, and the word "TECHNOLOGY" is in gray below it.
This 510(k) Summary was prepared in accordance with the requirements of 21CFR807.92
5.1 Date Prepared
08 September, 2022
5.2 Submitter's Information
| Company Name: | XAVANT TECHNOLOGY (PTY) LTD |
|---|---|
| Street Address: | Unit 102 Tannery Industrial Park |
| 309 Derdepoort Road | |
| Silverton | |
| City: | Pretoria |
| State/Province: | Gauteng |
| Country: | South Africa |
| Telephone: | +27(0) 12 743 5959 |
| Fax: | +27(0) 86 547 0026 |
| Contact Person: | Roche Janse van Rensburg |
| Contact Title: | Chief Executive Officer |
| Contact Email: | compliance@xavant.com |
5.3 Trade Name, Common Name, Classification
| Type of 510(k) submission | Traditional |
|---|---|
| Trade Name: | STIMPOD NMS450 Nerve Stimulator |
| Common Name: | Battery Powered Peripheral Nerve Stimulator |
| Classification Name: | Battery Powered Nerve Stimulator |
| per 21 CFR § 868.2775 | |
| Regulatory Class: | Class II |
| Product Code: | BXN |
| Panel: | Anesthesiology |
| Reason for Submission | New Accessory |
4
5.4 Identification of Predicate/Reference Device(s)
| PREDICATE DEVICE |
|---|
| Xavant Technology, STIMPOD NMS450 |
| (K102084) |
| This predicate device has not been subject to a design-related recall. |
| REFERENCE DEVICE |
| Senzime, Tetragraph |
| (K190795) |
| This reference device has not been subject to a design-related recall. |
5.5 Description of the Device
The STIMPOD NMS450 is a quantitative Neuromuscular Transmission (NMT) Monitor which provides real-time quantitative feedback utilizing tri-axial accelerometery.
The STIMPOD NMS450 is also a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response.
The STIMPOD NMS450 currently makes use of 3 dimensional acceleromyography (AMG) as the measurement technology of choice for objective Neuromuscular Transmission (NMT) monitoring in surgery. Although AMG is still the de-facto standard in industry, the use of electromyography (EMG) has gained renewed interest in NMT monitoring applications where the introduction of robotic surgeries, new surgical techniques, and changes in workflow, for instance, made the use of AMG impracticable.
In order to address this steadily increasing market demand for EMG sensor technology in NMT monitoring applications, Xavant identified the need to design and develop a dedicated NMT Monitoring Cable (EMG) that could be used interchangeably with the existing NMT Monitoring Cable (AMG) already in use with the STIMPOD NMS450.
The NMT Monitoring Cable (EMG) was specifically designed for use with the STIMPOD NMS450 to assist anaesthesiologists in theatre with monitoring the efficacy of Neuromuscular Blocking Agents (NMBAs).
The NMT Monitoring Cable (EMG) was designed with an intelligent EMG signal processing module (henceforth referred to as the µEMG) on one end of the cable for connection to an EMG electrode, and with a standard FireWire connector on the other end for connection to the STIMPOD NMS450.
5
The µEMG makes provision for the following interfaces:
-
- a wireline communications interface to exchange information with the STIMPOD NMS450,
-
- an electrical interface to condition and sample the EMG signals picked up by the measurement contact points of an attached EMG electrode array,
-
- an electrical interface to (i) detect the stimulation signals generated by the STIMPOD NMS450, and (ii) route them to the stimulation contact points of an attached EMG electrode array,
-
- a visual interface to indicate the state (powered, connected etc.) of the device.
5.6 Substantial Equivalence Discussion
The following device comparisons are made:
-
- The STIMPOD NMS450 to the predicate device STIMPOD NMS450. STIMPOD NMS450's 510(k) clearance (K102084) means it is legally marketed;
-
- The STIMPOD NMS450 to the reference device Tetragraph Neuromuscular Transmission Monitor from Senzime AB. Tetragraph's 510(k) clearance (K190795) means it is legally marketed.
Intended Use
FDA product Code of the predicate device and that of the subject device is given as "BXN" while that of the reference device is given as "KOI" - both products codes, however, are assigned under Regulation No. 21 CFR 868.2775 which applies to "Electrical Peripheral Nerve Stimulators" with the following intended use:
"An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases".
Indications for Use
This device is a nerve stimulation device designed to be used by an anaesthetist during:
-
- General anaesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes.
-
- Regional anaesthesia, for the purpose of:
- i. Nerve mapping using the non-invasive Nerve Mapping Probe (supplied)
- ii. Nerve locating using invasive needles (not supplied).
The subject and predicate devices have identical Indications for Use. The subject and reference devices are compared with respect to their mutual indications only. Both the devices are indicted for monitoring the efficacy (which can be defined as "the relaxation of the patient" as indicated in the reference device Indications for Use statement) of a Neuromuscular Blocking Agent.
Intended User and Patient Population
The intended user for both the subject device and predicate device is identical:
- The subject device and predicate device are both indicated for use by medical . professionals with knowledge of anatomy
6
The patient population for both the subject device and predicate device is similar:
- . The reference device is for use with patients (excluding neonates). For the subject device, the patient population includes patients of all ages, weight, and nationality (excluding neonates for electromyography).
Substantial Equivalence Table
To demonstrate substantial equivalence with respect to intended use, technological characteristics, and principles of operation, two tables of Comparison of Characteristics are presented. The first table shows a comparison between the STIMPOD NMS450 (subject device) and the predicate device. The second table shows a comparison between the STIMPOD NMS450 (subject) device and the reference device for those characteristics where the subject device and predicate device had differences. The tables are accompanied by a discussion of all similarities and differences between the devices and therefore provide sufficient detailed information regarding the basis for the determination of substantial equivalence.
| Characteristic | Subject Device | Predicate Device | Discussion |
|---|---|---|---|
| Trade Name | STIMPOD NMS450 | STIMPOD NMS450 | Identical |
| Product Code | BXN | BXN | Identical |
| Device Class | Class II | Class II | Identical |
| Classification | |||
| Name | Electrical Peripheral Nerve | ||
| Stimulator | Electrical Peripheral Nerve | ||
| Stimulator | Identical | ||
| Regulation No. | 886.2775 | 886.2775 | Identical |
| Classification | |||
| Panel | Anaesthesiology | Anaesthesiology | Identical |
| Intended Use | An electrical peripheral nerve | ||
| stimulator (neuromuscular | |||
| blockade monitor) used to apply | |||
| an electrical current to a patient | |||
| to test the level of | |||
| pharmacological effect | |||
| of anesthetic drugs and gases | An electrical peripheral nerve | ||
| stimulator (neuromuscular | |||
| blockade monitor) used to apply | |||
| an electrical current to a patient | |||
| to test the level of | |||
| pharmacological effect | |||
| of anesthetic drugs and gases | Identical | ||
| Indication for | |||
| Use | This device is a nerve stimulation | ||
| device designed to be used by | |||
| an anaesthetist during: |
- general anesthesia, for the
purpose of establishing the
efficacy of a Neuromuscular
Blocking Agent using non-
invasive surface electrodes. | This device is a nerve stimulation
device designed to be used by
an anaesthetist during: - general anesthesia, for the
purpose of establishing the
efficacy of a Neuromuscular
Blocking Agent using non-
invasive surface electrodes. | Identical |
| Characteristic | Subject Device | Predicate Device | Discussion |
| | 2. regional anesthesia, for the
purpose of:
i. nerve mapping using the
non-invasive Nerve
Mapping Probe (supplied)
ii. nerve locating using
invasive needles (not
supplied) | 2. regional anesthesia, for the
purpose of:
i. nerve mapping using the
non-invasive Nerve Mapping
Probe (supplied)
ii. nerve locating using
invasive needles (not
supplied) | Identical |
| Device
Components | 1. Nerve Stimulator/s
i. STIMPOD NMS450 | 1. Nerve Stimulator/s
i. STIMPOD NMS450 | Identical |
| | 2. Patient Cable/s
i. NMT Monitoring Cable (AMG)
ii. Nerve Locating Cable
iii. Nerve Mapping/Locating Cable | 2. Patient Cable/s
i. NMT Monitoring Cable (AMG)
ii. Nerve Locating Cable
iii. Nerve Mapping/Locating Cable | Identical |
| | 3. Applied Part/s
i. AMG Sensor | 3. Applied Part/s
i. AMG Sensor | Identical |
| | 4. Power Cable/s
None. | 4. Power Cable/s
None. | Identical |
| Waveform | Monophasic, constant current,
square pulse | Monophasic, constant current,
square pulse | Identical |
| Pulse Width | 200μS | 200μS | Identical |
| Stimulation
Patterns | Waveform: Monophasic,
constant current, square pulse
with a fixed pulse width of
200ms
Pulse Repetition Frequency:
i. TOF: 4 pulses at 2Hz
ii. TWI(Twitch): 1Hz, 2Hz,
5Hz
iii. Tetanic Stimulus: 50Hz
or 100Hz
iv. PTC Stimulation: 50Hz
Tetanic stimulus for 5
seconds, followed by 20
TWI pulses at 1Hz | Waveform: Monophasic,
constant current, square pulse
with a fixed pulse width of
200ms
Pulse Repetition Frequency:
i. TOF: 4 pulses at 2Hz
ii. TWI(Twitch): 1Hz, 2Hz,
5Hz
iii. Tetanic Stimulus: 50Hz
or 100Hz
iv. PTC Stimulation: 50Hz
Tetanic stimulus for 5
seconds, followed by 20
TWI pulses at 1Hz | Identical |
| Current
Characteristics | Electrode/Skin Resistance:
0-5000 ohm maximum
Current: 5-80mA peak
Voltage: 0 - 400V peak,
depending on skin impedance | Electrode/Skin Resistance:
0-5000 ohm maximum
Current: 5-80mA peak
Voltage: 0 - 400V peak,
depending on skin impedance | Identical |
| Control
Mechanism | Digitally controlled by a
microprocessor | Digitally controlled by a
microprocessor | Identical |
| Characteristic | Subject Device | Predicate Device | Discussion |
| Energy Type | Battery:
4 X AAA alkaline batteries, 6V,
1.2Ah
Charger:
None. | Battery:
4 X AAA alkaline batteries, 6V,
1.2Ah
Charger:
None. | Identical |
| NMT Monitoring
Cable (AMG) | Type: Reusable | Type: Reusable | |
| | Communications: STIMPOD
proprietary. | Communications: STIMPOD
proprietary. | Identical |
| | Attachment: Integral friction
strap. | Attachment: Integral friction
strap. | |
| NMT Monitoring
Cable (EMG) | Type: Reusable
Communications: STIMPOD
proprietary.
EMG Electrode Connector:
Proprietary frictional & magnetic
Retention mechanism. | Not applicable | The predicate
device does
not include
the NMT
Monitoring
Cable (EMG)
as this is a
new addition.
Comparison
provided with
reference
device. |
| EMG Electrode | Type: Self-adhesive, Single Use
Evoked Response Monitoring:
Electromyography.
Form Factor: 2 Stimulation
contact pads and 2 recording
contact pads.
Ambidexterity: Usable on left
and right hand.
Application Site: Distal
stimulation of the Ulnar Nerve
with CMAP recording of the
Adductor Pollicis muscle. | Not applicable | The predicate
device does
not include
the EMG
Electrode as
this is a new
addition.
Comparison
provided with
reference
device. |
Comparison between Subject Device and Predicate Device
7
8
Comparison between Subject Device and Reference Device
| Characteristic | Subject Device | Reference Device | Discussion |
|---|---|---|---|
| Trade Name | STIMPOD NMS450 | Tetragraph | Trade names are |
| different. | |||
| Product Code | BXN | KOI | Similar. No new |
| questions of | |||
| safety and | |||
| effectiveness | |||
| raised. | |||
| Device Class | Class II | Class II | Identical |
| Classification | |||
| Name | Electrical Peripheral Nerve | ||
| Stimulator | Electrical Peripheral Nerve | ||
| Stimulator | Identical | ||
| Characteristic | Subject Device | Reference Device | Discussion |
| Regulation No. | 886.2775 | 868.2775 | Identical |
| Classification | |||
| Panel | Anaesthesiology | Anesthesiology | Identical |
| Device | |||
| Components | 1. Patient Cable/s | ||
| i. NMT Monitoring Cable (EMG) | 1. Patient Cable/s | ||
| i. TetraCord EMG Patient Cable | Similar. No new | ||
| questions of | |||
| safety and | |||
| effectiveness | |||
| raised. | |||
| 2. Applied Part/s | |||
| EMG Electrode | 2. Applied Part/s | ||
| i. TetraSense EMG Electrode | Similar. No new | ||
| questions of | |||
| safety and | |||
| effectiveness | |||
| raised. | |||
| NMT Monitoring | |||
| Cable (EMG) | Type: Reusable | Type: Reusable | Both cables are |
| reusable. | |||
| Communications: STIMPOD | |||
| proprietary. | Communications: TetraGraph | ||
| proprietary | |||
| EMG Electrode Connector: | |||
| Proprietary frictional & | |||
| magnetic Retention | |||
| mechanism. | EMG Electrode Connector: | ||
| Proprietary frictional Retention | |||
| mechanism. | See discussion | ||
| of differences | |||
| below. | |||
| EMG Electrode | Type: Self-adhesive, Single | ||
| Use | Type: Self | ||
| Adhesive, Single Use | |||
| Evoked Response | |||
| Monitoring: | |||
| Electromyography. | Evoked Response | ||
| Monitoring: | |||
| Electromyography | The type, | ||
| measuring | |||
| technology, form | |||
| factor and | |||
| application site | |||
| are identical. | |||
| Form Factor: 2 Stimulation | |||
| contact pads and 2 recording | |||
| contact pads. | Form Factor: 2 Stimulation | ||
| contact pads and 2 recording | |||
| contact pads. | |||
| Ambidexterity: Usable on left | |||
| and right hand. | Ambidexterity: Usable on left | ||
| and right hand. | See discussion | ||
| of differences | |||
| below. | |||
| Application Site: Distal | |||
| stimulation of the Ulnar Nerve | |||
| with CMAP recording of the | |||
| Adductor Pollicis muscle. | Application Site: Distal | ||
| stimulation of the Ulnar Nerve | |||
| with CMAP recording of the | |||
| Adductor Pollicis muscle. |
9
Discussion of differences:
NMT Monitoring
-
- The specific means of communication that is used by the subject device to transfer measured EMG data from the electrode can be achieved in multiple different ways, and therefor does not need to be the same as that being used by the reference device.
-
- The materials and construction of the NMT Monitoring Cable (EMG) used for the subject device differs from that of the EMG cable used for the reference device. As above, the patient cable for the two devices can be built from multiple different materials and
10
constructed in multiple different ways, and therefore do not need to be the same to achieve the same intended purpose.
-
- The retention mechanism used in the construction of the patient cables for both devices is different, but the retention force offered by the connector used for the subject device is better or larger than that of the connector used for the reference device.
EMG Electrode
-
- The materials used in the construction of the EMG electrodes of the two devices are different, however, both electrodes satisfy the biocompatibility requirements of IEC 10993-1.
-
- The EMG electrodes for both devices furthermore satisfy the electrical and adhesion performance requirements of AAMI EC12.
- Finally, the EMG electrode of the subject device exhibits same or better safety and 6. performance characteristics (charge density current density and power density) at the skin/electrode interface than that of the reference device.
The comparative analysis presented above does not raise any new questions in terms of risk and performance of the subject device, and is supported by the performance data captured under paragraph 5.7.
5.7 Performance Testing
The following performance tests were conducted on the subject device in support of the claim for substantial equivalence:
-
- Functional Performance Testing.
-
- Electrical safety (in accordance with IEC 60601-1).
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- Electromagnetic compatibility (in accordance with IEC 60601-1-2 and IEC 60601-2-40).
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- Biocompatibility testing (in accordance with ISO10993-1).
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- Usability testing.
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- Battery life testing.
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- Tensile strength testing of the electrode.
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- Stimulation Performance Testing of the electrode (Charge Density, Current Density and Power Density)
The subject device met or exceeded the stated acceptance criteria for each performance test which were all confirmed to be the same or very similar to the performance specifications of the predicate device, and/or where relevant, to the reference device. The resultant test data therefore provided sufficient evidence to support the claim that the subject device is at least as safe and as effective as the predicate device in monitoring the muscle relaxation of a patient that has been subjected to the administration of a Neuromuscular Blocking Agent.
5.8 Clinical Performance
No clinical testing was conducted to demonstrate that the subject device is substantially equivalent to the predicate device, since the two devices were already proven to have similar
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technological characteristics. There was no clinical testing conducted to demonstrate that the subject was substantially equivalent to the reference device, as the reference device has similar technological characteristics.
5.9 Conclusion (Statement of Equivalence)
A detailed comparative analysis involving the identified subject, predicate and references devices, has provided sufficient evidence in support of the following conclusion:
The subject device when compared to the predicate device and reference device has the same intended use, user profile and patient population, and the same or very similar technological characteristics. Differences in the technological characteristics of the two devices did not raise any new questions of safety and effectiveness, and the resultant test data from the performance tests, demonstrated that the subject device is at least as safe and effective as the reference device in terms of the use of EMG in NMT Monitoring applications.
There are no significant differences between the STIMPOD NMS450 Nerve Stimulator and the predicate and reference devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.