TOF-Cuff monitor

K181894 · Rgb Medical Devices SA · DXN · May 9, 2019 · Cardiovascular

Device Facts

• Record ID: K181894
• Device Name: TOF-Cuff monitor
• Applicant: Rgb Medical Devices SA
• Product Code: DXN · Cardiovascular
• Decision Date: May 9, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

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.

Device Story

TOF-Cuff monitor performs dual-function monitoring of neuromuscular transmission (NMT) and non-invasive blood pressure (NIBP) using a single modified pressure cuff. NMT monitoring utilizes a patented method where stimulating electrodes integrated into the cuff deliver electrical stimuli; the device evaluates the evoked muscle response by measuring pressure changes within the cuff. NIBP is measured via an enhanced oscillometric method. The device features an 'Auto-Pilot Program' to assist anesthesiologists by adjusting stimulation patterns and cycles based on surgical blockade phases. Operated by medical professionals in clinical settings, the device provides systolic, diastolic, and mean arterial pressure, pulse rate, and NMT status on a TFT color display. Alarms are issued for physiological parameters. The device supports manual and automatic measurement modes. By integrating two vital sign monitoring functions into one sensor, the device simplifies intraoperative monitoring, potentially reducing equipment clutter and improving workflow efficiency for the clinician.

Clinical Evidence

Two clinical investigations were conducted. The first study evaluated the device's capacity to simultaneously monitor NIBP and neuromuscular blockade levels induced by relaxant drugs. The second study compared neuromuscular blockade measurements from the TOF-Cuff monitor against the CARESCAPE B450 reference monitor during pharmacologically induced NMB. Both studies supported the device's performance and substantial equivalence.

Technological Characteristics

Device includes a monitor and a modified pressure cuff with integrated stimulating electrodes. Sensing: oscillometric NIBP and pressure-based NMT. Power: AC mains (100-240V) and internal Li-Ion battery. Interface: 800x480 TFT resistive touch display and membrane keys. Connectivity: standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-2-10, IEC 80601-2-30, ISO 10993-1/5/10. Non-sterile.

Indications for Use

Indicated for adult patients during surgery for monitoring neuromuscular transmission and non-invasive blood pressure. Not for home use; must be used in health institutions by trained medical professionals.

Regulatory Classification

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.

Predicate Devices

• BP100A (K181104)
• TwitchView System (K172843)

Reference Devices

• CARESCAPE B450 (K132533)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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### 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: [e-mail].

### CONTACT PERSON:

Ricardo Ruiz Regulatory Affairs Manager Tel.: + 34 913042011 E-Mail: [e-mail]

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#### 1 Device Name

| Trade Name: | TOF-Cuff monitor |
|-----------------------------|--------------------------------------------------|
| Device Classification Name: | Noninvasive blood pressure measurement<br>system |
| Classification Class: | II |
| Primary Product Code: | DXN |
| Regulation: | 21 CFR 870.1130 |
| Review Panel: | Cardiovascular |

#### Secondary Product Code 2

| Regulation<br>Description | Regulation<br>Medical<br>Specialty | Review Panel | Product Code | Regulation<br>Number | Device<br>Classification |
|-------------------------------------------|------------------------------------|----------------|--------------|----------------------|--------------------------|
| Electrical peripheral<br>nerve stimulator | Anesthesiology | Anesthesiology | KOI | 868.2775 | II |

#### Predicate Devices / Reference Device 3

| Device | Predicate / Reference | 510(k) |
|------------------------------------------------|----------------------------|---------|
| BP100A<br>Shenzhen Combei Technology Co., Ltd. | Primary predicate device | K181104 |
| TwitchView System<br>Blink Device Company | Secondary predicate device | K172843 |
| CARESCAPE B450<br>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.

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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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Image /page/7/Picture/1 description: The image shows the logo for RGB medical devices. The logo has the letters RGB in blue, with a green triangle on the left side of the R. Below the letters RGB are the words "medical devices" in a smaller font.

#### 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<br>(New Device) | BP100A<br>(Predicate Device)<br>K181104 | TwitchView System<br>(Predicate Device)<br>K172843 | Carescape B450<br>(Reference Device)<br>K132533 | | | | | |
|-------------------|-------------------------------------|-----------------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | TOF-Cuff monitor | BP100A | TwitchView System | Carescape B450 | Indication for Use | TOF-Cuff monitor is a device<br>intended to monitor<br>neuromuscular transmission<br>and non-invasive blood<br>pressure of adult patients<br>during surgery and issue<br>alarms related with these<br>physiological parameters. It<br>is not a therapeutic device.<br>The monitor should be used<br>exclusively in health<br>institutions by trained<br>medical professionals. The<br>monitor is suitable for use in<br>the presence of<br>electrosurgery. Monitor is not<br>intended to be used in the<br>home environment. The<br>monitor should be used only<br>with a single patient. | The subject device intended to<br>measure the diastolic, systolic<br>blood pressures and pulse rate of<br>an adult individual in hospitals,<br>hospital-type facilities and home<br>environments by using a non-<br>invasive oscillometric technique<br>with a single upper arm cuff (22-<br>42 cm).<br>The device detects the<br>appearance of irregular heart<br>beats during measurement and<br>gives a warning signal with<br>readings.<br>The Subject device is not<br>intended to be diagnostic device. | The TwitchView System<br>is used for the<br>quantitative monitoring<br>of neuromuscular<br>transmission by means<br>of electromyography | The CARESCAPE Monitor<br>B450 is a multi-parameter<br>patient monitor intended for<br>use in multiple areas and<br>intrahospital transport within<br>a professional healthcare<br>facility.<br>The CARESCAPE Monitor<br>B450 is intended for use on<br>adult, pediatric, and neonatal<br>patients and on one patient<br>at a time.<br>The CARESCAPE Monitor<br>B450 is indicated for<br>monitoring of:<br>• hemodynamic (including<br>ECG, ST segment,<br>arrhythmia detection, ECG<br>diagnostic analysis and<br>measurement, invasive<br>pressure, non-invasive<br>blood pressure, pulse<br>oximetry, cardiac output<br>(thermodilution and pulse<br>contour), temperature,<br>mixed venous oxygen<br>saturation and central<br>venous oxygen<br>saturation),<br>• respiratory (impedance<br>respiration, airway gases<br>(CO2, O2, N2O and<br>anesthetic agents), and<br>spirometry)<br>• neurophysiological status<br>(including<br>electroencephalography,<br>Entropy, Bispectral Index<br>(BIS) and neuromuscular<br>transmission).<br>The CARESCAPE Monitor<br>B450 also provides alarms |
| Regulation Number | 870.1130 | 870.1130 | 868.2775 | 870.1025 | | | | | |
| Class | 2 | 2 | 2 | 2 | | | | | |
| Product Code | DXN<br>KOI | DXN | KOI | MHX, BZK, BZL, BZQ, CAP,<br>CBQ, CBR, CBS, CCK, CCL,<br>DPS, DPZ,<br>DQA, DQK, DRT, DSI, DSJ,<br>DSK, DXG, DXN, FLL, GWJ,<br>GWQ,<br>KOI, KRB, MLD, NHO, NHP,<br>NHQ, OLT, OLW, OMC, ORT | | | | | |
| 510(k) number | K181894 | K181104 | K172843 | K132533 | | | | | |

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Image /page/8/Picture/1 description: The image shows 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.

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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<br>(New Device) | BP100A<br>(Predicate Device)<br>K181104 | TwitchView System<br>(Predicate Device)<br>K172843 | Carescape B450<br>(Reference Device)<br>K132533 |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | trends, snapshots and<br>events, and calculations and<br>can be connected to<br>displays, printers and<br>recording devices<br>The CARESCAPE Monitor |
| | | | | B450 is intended for use<br>under the direct supervision<br>of a licensed healthcare<br>practitioner, or by personnel<br>trained in proper use of the<br>equipment in a professionalhealthcare facility. |
| Pattern Types | ST - Single Twitch<br>TOF - Train of Four<br>PTC - Post-Tetanic Count | --- | ST - Single Twitch<br>TOF - Train of Four<br>PTC - Post-Tetanic Count<br>Tetanic stimulation | ST - Single Twitch<br>TOF - Train of Four<br>PTC - Post-Tetanic Count<br>DBS - Double Burst<br>Stimulation<br>Tetanic stimulation |
| ST cycles [s] | 1, 10 | --- | --- | 1, 10, 20 |
| TOF cycles | 12 s, 30 s, 1 min, 2 min, 5<br>min ,10 min, 15 min, 30 min,<br>60 min | --- | --- | 10 s, 12 s, 15 s, 20 s, 1 min,<br>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<br>[mA] | 1-60 | --- | 10-80 | 1-70 |
| Systolic pressure range<br>[mmHg] | 30 to 250 | 30 to 280 | --- | 30 to 260 |
| Diastolic pressure range<br>[mmHg] | 10 to 218 | 30 to 280 | --- | 25 to 220 |
| Mean pressure range<br>[mmHg] | 20 to 234 | --- | --- | 25 to 260 |
| Company | RGB Medical Devices<br>(New Device) | BP100A<br>(Predicate Device)<br>K181104 | TwitchView System<br>(Predicate Device)<br>K172843 | Carescape B450<br>(Reference Device)<br>K132533 |
| Physical Dimensions<br>Width [cm]<br>Height [cm]<br>Depth [cm]<br>Weight [kg]<br>Power Supply | 22.2<br>20.5<br>8<br>1.5<br>TOFCUFF is powered from AC<br>mains supply.<br>100 - 240 VAC, 50 / 60 Hz,<br>0.4 - 0.22 A<br>TOFCUFF includes an internal<br>Li-Ion battery as secondary<br>power supply.<br>11.1 V - 2.60 Ah | 9.2<br>6.1<br>12.8<br>0.49 (including battery)<br>4- Type "AA" alkaline batteries | External AC Adapters<br>Li-Ion battery | 30.0<br>29.0<br>16.0<br>5.0<br>100 - 240 VAC, 50 / 60 Hz,<br>1.8 - 0.8 A<br>Li-Ion battery<br>10.8 V - 3.80 Ah<br>(optionally it can include a<br>second battery |
| User Interface | TOFCUFF includes a TFT color<br>display with the following<br>specifications:<br>Display size: 15.5 cm x 9.3<br>cm Display resolution: 800 x<br>480 pixels User inputs are<br>done through a resistive<br>touch panel and it includes a<br>membrane keyboard with<br>four keys for some functions<br>(Switching on/off the device,<br>Start/Stop NIBP<br>measurement, Stop NMT<br>measurement and Exit). | BP100A includes a custom design<br>LCD with numerical presentation<br>of data and specific symbols<br>integrated.<br>Three specific keys for some<br>functions (On/Off, Setting&Time,<br>Memory). | TFT color display<br>Resistive touch panel<br>and one specific key for<br>switching on/off the<br>device | TFT color display<br>Resistive touch panel and<br>one specific key for switching<br>on/off the device |
| Sterilization | non-sterile | non-sterile | non-sterile | non-sterile |

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Image /page/10/Picture/1 description: The image shows the logo for RGB Medical Devices. The logo features the letters "RGB" in a bold, sans-serif font, with the "R" having a green triangle on the left side. Below the letters, the words "medical devices" are written in a smaller, sans-serif font.

## 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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Image /page/11/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, the words "medical devices" are written in a smaller font.

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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Image /page/12/Picture/1 description: The image shows the logo for RGB Medical Devices. The logo features the letters "RGB" in a bold, sans-serif font, with the "R" having a green triangle on the left side. Below the letters, the words "medical devices" are written in a smaller, sans-serif font.

#### 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.