(297 days)
No
The summary describes standard physiological monitoring techniques (NMT via pressure changes, NIBP via oscillometry) and automated/manual modes based on user-defined intervals. There is no mention of AI, ML, or any learning algorithms used for data analysis, interpretation, or decision-making beyond pre-programmed logic.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not a therapeutic device." The device is described as a monitor of physiological parameters.
Yes
The device is intended to "monitor neuromuscular transmission and non-invasive blood pressure," which are diagnostic activities to assess physiological parameters.
No
The device description explicitly states that the device consists of the "TOF-Cuff monitor and the TOF-Cuff pressure cuff," indicating the presence of hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The TOF-CUFF monitor measures neuromuscular transmission and non-invasive blood pressure. These are physiological parameters measured directly on the patient's body, not on samples taken from the body.
- Intended Use: The intended use describes monitoring physiological parameters during surgery. This aligns with a medical device used for patient monitoring, not an IVD.
Therefore, the TOF-CUFF monitor falls under the category of a medical device, specifically a patient monitor, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TOF-CUFF monitor is a device intended to monitor neuromuscular transmission and non-invasive blood pressure of adult patients during surgery and issue alarms related with these physiological parameters. It is not a therapeutic device.
The monitor should be used exclusively in health institutions by trained medical professionals. The monitor is suitable for use in the presence of electrosurgery. Monitor is not intended to be used in the home environment. The monitor should be used only with a single patient.
Product codes
DXN, KOI
Device Description
The device consists of the TOF-Cuff monitor and the TOF-Cuff pressure cuff. The applied part of the device is the TOF-Cuff pressure cuff.
TOF-CUFF monitors the neuromuscular transmission (NMT) using the patented TOF-Cuff® method.
TOF-Cuff® is a new method of monitoring neuromuscular blockade that has several advantages over previous methods. It is based on a modified pressure cuff that incorporates stimulating electrodes. The evoked muscle response is evaluated through the changes in pressure of the cuff generated by the muscular reaction after the electrical stimulus. The modified pressure cuff is also used for NIBP (Non-invasive Blood Pressure) measurement. Thus it is possible to monitor both parameters with only one patient sensor.
NMT can work either in manual or automatic modes. In manual mode the user starts a measurement by touching buttons of main menu. In automatic mode the measurement is performed at reqular intervals. The time interval between measurements is selectable by the user. In automatic mode the user can start a measurement at any time. The user can stop a NMT measurement at any moment by pressing the NMT Stop key.
TOF-CUFF monitor offers the possibility to start an automatic procedure for Neuromuscular Blockade (NMB) monitoring during the complete surgical process. The Auto-Pilot Program is designed to facilitate the work of the anaesthesiologist and change pattern type and stimulation cycle according to the different blockade phases during surgery, but NMT monitoring requires adequate vigilance and supervision by the anaesthesiologist
TOF-CUFF monitor provides systolic, diastolic and mean arterial pressure values, as well as the pulse rate, in a non-invasive way, by means of an enhanced version of the oscillometric method. The validation has been performed using as reference the intra-arterial pressure measurement
NIBP can work either in manual or automatic modes. In manual mode a measurement is performed only when Start/Stop NIBP key is pressed. In automatic mode, the measurement is performed at regular intervals. The time interval between measurements is selectable by the user. In automatic mode the user can start a measurement at any time by pressing the Start/Stop NIBP key and the next measurement would start once the selected time interval has elapsed. If Start/Stop NIBP key is pressed while a NIBP measurement is in progress, the process is stopped and the cuff deflated. During the measurement a button is also shown in the main menu area that, when pressed, stops the process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
trained medical professionals / health institutions
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)
Non-clinical and clinical testing has been performed showing that the device performs as intended and is substantially equivalent to the primary predicate device (K181104), the secondary predicate device (K172843).
Two clinical investigations were performed on the TOF-cuff monitor.
The general objective of the first study was to determine the capacity of the TOF-cuff monitor of monitoring with the same device the non-invasive arterial pressure and the level of neuromuscular blockade induced with relaxant drugs.
The main objective of the second study is to compare the values of neuromuscular blockade measured with the TOF-CUFF monitor with neuromuscular blockade values measured with the CARESCAPE B450 monitor during the pharmacologically induced NMB and evaluate the degree of equivalence.
Both studies showed that the TOF-Cuff monitor supports the determination of substantial equivalence regarding its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
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RGB Medical Devices SA Ricardo Ruiz Regulatory Affairs Manager Calle de Alfonso Gomez 42 Madrid, Spain, 28037
Re: K181894
Trade/Device Name: TOF-Cuff Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, KOI Dated: April 9, 2019 Received: April 12, 2019
Dear Ricardo Ruiz:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
ht" Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing. Respiratory and Anesthesia 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181894
Device Name TOF-CUFF monitor
Indications for Use (Describe)
TOF-CUFF monitor is a device intended to monitor neuromuscular transmission and non-invasive blood pressure of adult patients during surgery and issue alarms related with these physiological parameters. It is not a therapeutic device.
The monitor should be used exclusively in health institutions by trained medical professionals. The monitor is suitable for use in the presence of electrosurgery. Monitor is not intended to be used in the home environment. The monitor should be used only with a single patient.
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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K181894
VOLUME 006
510(k) Summary
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DATE OF PREPARATION:
APPLICANT:
APRIL 9, 2019
RGB Medical Devices SA Calle de Alfonso Gómez 42 28037 Madrid Spain Tel: + 34 913042011 E-Mail: rgb@rgb-medical.com.
CONTACT PERSON:
Ricardo Ruiz Regulatory Affairs Manager Tel.: + 34 913042011 E-Mail: rruiz@rgb-medical.com
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1 Device Name
| Trade Name: | TOF-Cuff monitor |
|---|---|
| Device Classification Name: | Noninvasive blood pressure measurement |
| system | |
| Classification Class: | II |
| Primary Product Code: | DXN |
| Regulation: | 21 CFR 870.1130 |
| Review Panel: | Cardiovascular |
Secondary Product Code 2
| Regulation
Description | Regulation
Medical
Specialty | Review Panel | Product Code | Regulation
Number | Device
Classification |
|-------------------------------------------|------------------------------------|----------------|--------------|----------------------|--------------------------|
| Electrical peripheral
nerve stimulator | Anesthesiology | Anesthesiology | KOI | 868.2775 | II |
Predicate Devices / Reference Device 3
| Device | Predicate / Reference | 510(k) |
|---|---|---|
| BP100A | ||
| Shenzhen Combei Technology Co., Ltd. | Primary predicate device | K181104 |
| TwitchView System | ||
| Blink Device Company | Secondary predicate device | K172843 |
| CARESCAPE B450 | ||
| General Electric Finland Oy. | Reference device | K132533 |
Device Description এ
The device consists of the TOF-Cuff monitor and the TOF-Cuff pressure cuff. The applied part of the device is the TOF-Cuff pressure cuff.
TOF-CUFF monitors the neuromuscular transmission (NMT) using the patented TOF-Cuff® method.
TOF-Cuff® is a new method of monitoring neuromuscular blockade that has several advantages over previous methods. It is based on a modified pressure cuff that incorporates stimulating electrodes. The evoked muscle response is evaluated through the changes in pressure of the cuff generated by the muscular reaction after the electrical stimulus. The modified pressure cuff is also used for NIBP (Non-invasive Blood Pressure) measurement. Thus it is possible to monitor both parameters with only one patient sensor.
NMT can work either in manual or automatic modes. In manual mode the user starts a measurement by touching buttons of main menu. In automatic mode the measurement is performed at reqular intervals. The time interval between measurements is selectable by the user. In automatic mode the user can start a measurement at any time. The user can stop a NMT measurement at any moment by pressing the NMT Stop key.
6
Image /page/6/Picture/1 description: The image contains the logo for RGB Medical Devices. The logo has the letters "RGB" in blue, with a green triangle to the left of the "R". Below the letters is the text "medical devices" in a smaller font.
TOF-CUFF monitor offers the possibility to start an automatic procedure for Neuromuscular Blockade (NMB) monitoring during the complete surgical process. The Auto-Pilot Program is designed to facilitate the work of the anaesthesiologist and change pattern type and stimulation cycle according to the different blockade phases during surgery, but NMT monitoring requires adequate vigilance and supervision by the anaesthesiologist
TOF-CUFF monitor provides systolic, diastolic and mean arterial pressure values, as well as the pulse rate, in a non-invasive way, by means of an enhanced version of the oscillometric method. The validation has been performed using as reference the intra-arterial pressure measurement
NIBP can work either in manual or automatic modes. In manual mode a measurement is performed only when Start/Stop NIBP key is pressed. In automatic mode, the measurement is performed at regular intervals. The time interval between measurements is selectable by the user. In automatic mode the user can start a measurement at any time by pressing the Start/Stop NIBP key and the next measurement would start once the selected time interval has elapsed. If Start/Stop NIBP key is pressed while a NIBP measurement is in progress, the process is stopped and the cuff deflated. During the measurement a button is also shown in the main menu area that, when pressed, stops the process.
5 Intended Use
TOF-CUFF monitor is a device intended to monitor neuromuscular transmission and noninvasive blood pressure of adult patients during surgery and issue alarms related with these physiological parameters. It is not a therapeutic device.
The monitor should be used exclusively in health institutions by trained medical professionals. The monitor is suitable for use in the presence of electrosurgery. Monitor is not intended to be used in the home environment.
The monitor should be used only with a single patient. The monitor is intended for Adult patients.
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Comparison of Technological Characteristics 6
A comparison of technological characteristics of the TOF-Cuff monitor to the predicate and reference device was conducted.
6.1 Device Characteristics Table
| Company | RGB Medical Devices
(New Device) | BP100A
(Predicate Device)
K181104 | TwitchView System
(Predicate Device)
K172843 | Carescape B450
(Reference Device)
K132533 | | | | | |
|-------------------|-------------------------------------|-----------------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | TOF-Cuff monitor | BP100A | TwitchView System | Carescape B450 | Indication for Use | TOF-Cuff monitor is a device
intended to monitor
neuromuscular transmission
and non-invasive blood
pressure of adult patients
during surgery and issue
alarms related with these
physiological parameters. It
is not a therapeutic device.
The monitor should be used
exclusively in health
institutions by trained
medical professionals. The
monitor is suitable for use in
the presence of
electrosurgery. Monitor is not
intended to be used in the
home environment. The
monitor should be used only
with a single patient. | The subject device intended to
measure the diastolic, systolic
blood pressures and pulse rate of
an adult individual in hospitals,
hospital-type facilities and home
environments by using a non-
invasive oscillometric technique
with a single upper arm cuff (22-
42 cm).
The device detects the
appearance of irregular heart
beats during measurement and
gives a warning signal with
readings.
The Subject device is not
intended to be diagnostic device. | The TwitchView System
is used for the
quantitative monitoring
of neuromuscular
transmission by means
of electromyography | The CARESCAPE Monitor
B450 is a multi-parameter
patient monitor intended for
use in multiple areas and
intrahospital transport within
a professional healthcare
facility.
The CARESCAPE Monitor
B450 is intended for use on
adult, pediatric, and neonatal
patients and on one patient
at a time.
The CARESCAPE Monitor
B450 is indicated for
monitoring of:
• hemodynamic (including
ECG, ST segment,
arrhythmia detection, ECG
diagnostic analysis and
measurement, invasive
pressure, non-invasive
blood pressure, pulse
oximetry, cardiac output
(thermodilution and pulse
contour), temperature,
mixed venous oxygen
saturation and central
venous oxygen
saturation),
• respiratory (impedance
respiration, airway gases
(CO2, O2, N2O and
anesthetic agents), and
spirometry)
• neurophysiological status
(including
electroencephalography,
Entropy, Bispectral Index
(BIS) and neuromuscular
transmission).
The CARESCAPE Monitor
B450 also provides alarms |
| Regulation Number | 870.1130 | 870.1130 | 868.2775 | 870.1025 | | | | | |
| Class | 2 | 2 | 2 | 2 | | | | | |
| Product Code | DXN
KOI | DXN | KOI | MHX, BZK, BZL, BZQ, CAP,
CBQ, CBR, CBS, CCK, CCL,
DPS, DPZ,
DQA, DQK, DRT, DSI, DSJ,
DSK, DXG, DXN, FLL, GWJ,
GWQ,
KOI, KRB, MLD, NHO, NHP,
NHQ, OLT, OLW, OMC, ORT | | | | | |
| 510(k) number | K181894 | K181104 | K172843 | K132533 | | | | | |
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Image /page/9/Picture/1 description: The image shows the logo for RGB medical devices. The letters RGB are in blue, with a green triangle to the left of the R. Below the letters RGB, the words "medical devices" are written in a smaller font.
| Company | RGB Medical Devices
(New Device) | BP100A
(Predicate Device)
K181104 | TwitchView System
(Predicate Device)
K172843 | Carescape B450
(Reference Device)
K132533 |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | trends, snapshots and
events, and calculations and
can be connected to
displays, printers and
recording devices
The CARESCAPE Monitor |
| | | | | B450 is intended for use
under the direct supervision
of a licensed healthcare
practitioner, or by personnel
trained in proper use of the
equipment in a professionalhealthcare facility. |
| Pattern Types | ST - Single Twitch
TOF - Train of Four
PTC - Post-Tetanic Count | --- | ST - Single Twitch
TOF - Train of Four
PTC - Post-Tetanic Count
Tetanic stimulation | ST - Single Twitch
TOF - Train of Four
PTC - Post-Tetanic Count
DBS - Double Burst
Stimulation
Tetanic stimulation |
| ST cycles [s] | 1, 10 | --- | --- | 1, 10, 20 |
| TOF cycles | 12 s, 30 s, 1 min, 2 min, 5
min ,10 min, 15 min, 30 min,
60 min | --- | --- | 10 s, 12 s, 15 s, 20 s, 1 min,
5 min, 15 min |
| PTC tetanic period [s] | 5 | --- | 5 | 5 |
| Measurement modes | Automatic and manual | --- | Automatic and manual | Automatic and manual |
| Stimulation current range
[mA] | 1-60 | --- | 10-80 | 1-70 |
| Systolic pressure range
[mmHg] | 30 to 250 | 30 to 280 | --- | 30 to 260 |
| Diastolic pressure range
[mmHg] | 10 to 218 | 30 to 280 | --- | 25 to 220 |
| Mean pressure range
[mmHg] | 20 to 234 | --- | --- | 25 to 260 |
| Company | RGB Medical Devices
(New Device) | BP100A
(Predicate Device)
K181104 | TwitchView System
(Predicate Device)
K172843 | Carescape B450
(Reference Device)
K132533 |
| Physical Dimensions
Width [cm]
Height [cm]
Depth [cm]
Weight [kg]
Power Supply | 22.2
20.5
8
1.5
TOFCUFF is powered from AC
mains supply.
100 - 240 VAC, 50 / 60 Hz,
0.4 - 0.22 A
TOFCUFF includes an internal
Li-Ion battery as secondary
power supply.
11.1 V - 2.60 Ah | 9.2
6.1
12.8
0.49 (including battery)
4- Type "AA" alkaline batteries | External AC Adapters
Li-Ion battery | 30.0
29.0
16.0
5.0
100 - 240 VAC, 50 / 60 Hz,
1.8 - 0.8 A
Li-Ion battery
10.8 V - 3.80 Ah
(optionally it can include a
second battery |
| User Interface | TOFCUFF includes a TFT color
display with the following
specifications:
Display size: 15.5 cm x 9.3
cm Display resolution: 800 x
480 pixels User inputs are
done through a resistive
touch panel and it includes a
membrane keyboard with
four keys for some functions
(Switching on/off the device,
Start/Stop NIBP
measurement, Stop NMT
measurement and Exit). | BP100A includes a custom design
LCD with numerical presentation
of data and specific symbols
integrated.
Three specific keys for some
functions (On/Off, Setting&Time,
Memory). | TFT color display
Resistive touch panel
and one specific key for
switching on/off the
device | TFT color display
Resistive touch panel and
one specific key for switching
on/off the device |
| Sterilization | non-sterile | non-sterile | non-sterile | non-sterile |
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6.2 Conclusion of Comparison of Technological Characteristics
Each of the two vital signs monitored by the TOF-Cuff (NIBP, NMT), are also monitored by the selected predicate devices. In addition, the reference device CARESCAPE B450 can monitor several vital signs including neuromuscular transmission (NMT) and non-invasive blood pressure (NIBP), which are the two vital signs monitored by the TOF-Cuff.
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The maximum NIBP measurement time specified for the TOF-CUFF monitor is below the maximum limit allowed by the requirement 201.104 of the IEC 80601-2-30. The device is in compliance with current FDA recognized standard, therefore this difference does not raise any different questions of safety or effectiveness of the device.
The technological characteristics of the TOF-Cuff monitor are substantially equivalent to the technological characteristics of the chosen predicates and reference device. There are no differences between the devices which may raise different questions of safety or effectiveness.
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7 Performance Data
Non-clinical and clinical testing has been performed showing that the device performs as intended and is substantially equivalent to the primary predicate device (K181104), the secondary predicate device (K172843).
7.1 Biocompatibility
An evaluation of biocompatibility according ISO 10993-1 was performed. Furthermore biological tests according ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation) were performed to demonstrate the biocompatibility of the device.
7.2 Electrical Safety and Electromagnetic Compatibility
Electrical safety and EMC testing were conducted. The TOF-Cuff monitor is in compliance with IEC 60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-1-8, IEC 60601-2-10, IEC 80601-2-30 as well as IEC 60601-1-2.
7.3 Software Verification and Validation Testing
Software verification and validation was conducted and the necessary software documentation according to the defined level of concern was provided.
The TOF-Cuff monitor provides different parameters that the user can select to set the operating mode of the device. The right operation of these parameters has been tested during the design & development process.
7.4 Clinical Testing
Two clinical investigations were performed on the TOF-cuff monitor.
The general objective of the first study was to determine the capacity of the TOF-cuff monitor of monitoring with the same device the non-invasive arterial pressure and the level of neuromuscular blockade induced with relaxant drugs.
The main objective of the second study is to compare the values of neuromuscular blockade measured with the TOF-CUFF monitor with neuromuscular blockade values measured with the CARESCAPE B450 monitor during the pharmacologically induced NMB and evaluate the degree of equivalence.
Both studies showed that the TOF-Cuff monitor supports the determination of substantial equivalence regarding its intended use.
ထ Substantial Equivalence Summary / Conclusion
Based on the provided information and performed clinical testing our device the TOF-Cuff monitor is substantially equivalent to the primary predicate device BP100A, the secondary predicate device TwitchView System and to the reference device Carescape B450 in terms of indication for use, technology and performance specifications. There are no differences between the devices which may raise different questions of safety or effectiveness.