Sense System with IBT Electrodes

K182112 · Infinite Biomedical Technologies, LLC · GXY · Oct 5, 2018 · Neurology

Device Facts

• Record ID: K182112
• Device Name: Sense System with IBT Electrodes
• Applicant: Infinite Biomedical Technologies, LLC
• Product Code: GXY · Neurology
• Decision Date: Oct 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: AI/ML, Therapeutic

Indications for Use

Sense System with IBT Electrodes is to be used exclusively for external prosthetic fittings of upper limbs.

Device Story

Sense System is a surface electromyography (EMG) electrode system for upper limb prosthetic control. It utilizes up to 8 IBT Electrodes to detect EMG signals from the patient's residual limb. These signals are processed by a Signal Processing Box using a pattern recognition algorithm to translate muscle activity into standardized control signals (analog, digital, or motor). The system is installed by a prosthetist into a prosthetic socket. A companion User Interface (UI) software allows for calibration of the pattern recognition classifier and pre-prosthetic practice using a virtual arm. The device outputs signals to compatible prosthetic hands, wrists, or elbows. By enabling intuitive control of prosthetic components, the system aims to improve functional outcomes for amputees. It is powered by the FlexCell battery system and communicates via Bluetooth to the UI for parameter updates.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was validated through design verification, software V&V, and usability testing (simulated installation, practitioner/patient UI use, simulated prosthetic component integration, lifetime/reliability, and battery safety). Compliance with IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2 standards was demonstrated.

Technological Characteristics

System includes 8 titanium (Grade 1) contact electrodes, signal processing box (59 x 27.8 x 9.8mm), and UI software. Housing: ABS/PC plastic blend. Sensing: surface EMG, 90-500 Hz bandwidth. Connectivity: Bluetooth. Power: 5-10 VDC. Output: 0-5V analog, 0-3.3V digital, 0-8.2V motor. Software: Pattern recognition algorithm with digital gain adjustment (1-7). Sterilization: Not specified. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, UN38.3 (battery).

Indications for Use

Indicated for patients requiring external prosthetic fittings of upper limbs. Prescription use only, intended for operation by a prosthetist or trained clinician.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• COMPLETE CONTROL System (K162891)

Reference Devices

• Element System with IBT Electrodes (K173571)

Submission Summary (Full Text)

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Infinite Biomedical Technologies, LLC Rahul Kaliki CEO 8 Market Place, Suite 500 Baltimore, Maryland 21202

Re: K182112

Trade/Device Name: Sense System with IBT Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY, IQZ Dated: August 2, 2018 Received: August 6, 2018

Dear Rahul Kaliki:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 medical devices and radiation-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,

# Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K182112

Device Name Sense System with IBT Electrodes

#### Indications for Use (Describe)

Sense System with IBT Electrodes is to be used exclusively for external prosthetic fittings of upper limbs.

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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## 510(k) Summary Sense System

#### 1. SUBMITTER'S INFORMATION

| Name/Manufacturer | Infinite Biomedical Technologies, LLC |
|-------------------|---------------------------------------------|
| Address | 8 Market Pl, Suite 500, Baltimore, MD 21202 |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Contact Person | Rahul Kaliki, PhD, Chief Executive Officer |
| Date Prepared | August 1, 2018 |

#### 2. DEVICE INFORMATION

| Trade Name | Sense System with IBT Electrodes |
|-------------------------|------------------------------------------------|
| Common Name | Powered, External Upper Limb Prosthetic System |
| Classification | Cutaneous Electrode (21 CFR § 882.1320) |
| Product Code | GXY (Electrode, Cutaneous) |
| Subsequent Product Code | IQZ (Hand, External Limb, Component, Powered) |

#### PREDICATE DEVICE INFORMATION 3.

| Device Name | COMPLETE CONTROL System |
|---------------|-------------------------|
| 510(k) Number | K162891 |

#### 4. REFERENCE DEVICE INFORMATION

| Device Name | Element System with IBT Electrodes |
|---------------|------------------------------------|
| 510(k) Number | K173571 |

#### 5. INDICATIONS FOR USE STATEMENT

Sense System with IBT Electrodes is to be used exclusively for external prosthetic fittings of upper limbs.

#### 6. DEVICE DESCRIPTION

The Sense System is a surface electromyography (EMG) electrode system designed to enhance control of upper limb prosthetic devices. The Sense System detects EMG signals using the IBT Electrodes (previously approved by the FDA under 510k, K173571). The electrode signals are then processed using a pattern recognition algorithm and translated to output signals that are standardized to be compatible with an array of connected prosthetic devices, such as hands, wrists or elbows. The Sense System does not replace or modify any functionality of connected prosthetic components.

The Sense System is compatible with most hands, wrists, and elbows that accept industry standard signals. It is typically sold with three-port kidney-style output connectors; however, alternative connectors may be used to ensure compatibility with other components. The Sense System accepts power from IBT's FlexCell Battery system and outputs control signals to hands, wrists, and other prosthetic components. The Sense System is installed in the prosthesis by a trained prosthetist and connected to prosthetic components selected to meet the needs of the individual user.

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Sense System components:

- IBT Electrodes (up to 8)
- Signal Processing Box
- User Interface Software
- . Fabrication dummies for electrodes and processing box

## 7. TECHNOLOGICAL CHARACTERISTICS

Table 1 provides a summary of technological characteristics of the product in comparison to the predicate device as well as in comparison to the reference device.

#### Table 1: Technological Summary

| Manufacturer | Infinite Biomedical<br>Technologies, LLC | Coapt, LLC | Device<br>Comparison | Reference Device -<br>Infinite Biomedical<br>Technologies LLC | Reference<br>Device<br>Comparison |
|--------------------------------------------------------|----------------------------------------------------|------------------------------------------------------------------------|----------------------|---------------------------------------------------------------|-----------------------------------|
| Trade Name | Sense System with<br>IBT Electrodes | COMPLETE CONTROL<br>System | | Element System<br>with IBT Electrodes | |
| | | System | | | |
| Power Source<br>included? | No | No | Same | No | Same |
| Terminal device<br>(Hand, Wrist or<br>Elbow) included? | No | No | Same | No | Same |
| Wireless<br>communication | Bluetooth® | RF Transmitter,<br>Complete<br>Communicator<br>21.8 x 69.2 x 16.1mm | Differs | Bluetooth® | Same |
| Clinical Software<br>Tool | Yes<br>User Interface<br>Application | Yes<br>Complete<br>Controlroom | Similar | Yes<br>User Interface<br>Application | Similar |
| Software/Firmwar<br>e/ Microprocessor<br>Control? | Yes | Yes | Similar | Yes | Similar |
| Input Voltage | 5 to 10 VDC | 5.3-16.8 VDC | Differs | 5 to 10 VDC | Same |
| Output Signal | 0-5V analog, 0-3.3V<br>digital and 0-8.2V<br>motor | Analog, motor<br>(ranges unknown) | Unknown | 0-5V analog | Similar |
| | | Processing Unit | | | |
| Processing Unit | Processing Box | Complete Controller | | Processing Box | |
| (L x W x H) | 59 x 27.8 x 9.8mm | 66.1 x 25.9 x 13.5<br>mm | Similar | 38 x 23 x 8 mm | Similar |
| Control options | Pattern Recognition | Pattern Recognition | Same | None | Differs |
| Input button | None | Complete Calibrate<br>27.6 x 17.8 x 11.7<br>mm | Differs | None | Same |
| Electrode | | | | | |
| Electrode /<br>Amplifier | IBT Electrode | Complete Co-Amp<br>47.8 x 21.4 x 9.6 mm<br>+ Cables and metal<br>domes | | IBT Electrode | |
| (L x W x H) | 29 x 17 x 7 | 47.8 x 21.4 x 9.6 mm<br>+ Cables and metal<br>domes | Similar | 29 x 17 x 7 | Same |
| Temperature<br>range | -10°C to 50°C | 0°C to 35°C | Differs | -10°C to 50°C | Same |
| infinite biomedical technologies | | | | | |
| Manufacturer | Infinite Biomedical<br>Technologies, LLC | Coapt, LLC | Device<br>Comparison | Reference Device -<br>Infinite Biomedical<br>Technologies LLC | Reference<br>Device<br>Comparison |
| Trade Name | Sense System with<br>IBT Electrodes | COMPLETE CONTROL<br>System | Device Comparison | Element System<br>with IBT Electrodes | Reference Device Comparison |
| Housing Material | Plastics (ABS/PC<br>Blend) | Unknown | Unknown | Plastics (ABS/PC<br>Blend) | Same |
| Contact Area | Titanium (Grade 1) | Stainless Steel or<br>gold plated | Differs | Titanium (Grade 1) | Same |
| Bonding Agent | Cyanoacrylate | Unknown | Unknown | Cyanoacrylate | Same |
| Signal processing | Digital | Digital | Same | Digital | Same |
| Frequency<br>Bandwidth | 90 - 500 Hz | Unknown | Unknown | 90 - 500 Hz | Same |
| Adjustment | Digital gain 1-7 | Digital gain | Similar | Digital gain 1-7 | Same |
| Installation | suspension arms /<br>suction socket | suspension arms /<br>suction socket | Same | suspension arms /<br>suction socket | Same |

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#### 8. Substantial Equivalence Discussion

The Sense system with IBT Electrodes is substantially equivalent to the Coapt COMPLETE CONTROL System (K162891). A comparison of the indications for use, technology, and performance is provided herein to support this determination. For instances where technological differences are identified in the previous section, additional discussion describes how these differences do not raise new or different questions of safety and effectiveness. When appropriate, performance data is cited to provide evidence that the subject device is as safe and as effective as the legally marketed predicate device.

The Sense System with IBT Electrodes also uses the Electrodes (K173571) as the reference device. This is because the Bluetooth module and communication protocol, the Ul framework, the electrodes used as well as the recommended power supply are identical to those in the Element System with the IBT Electrode which was previously cleared under K173571.

## Indications for Use

Both the subject device and the predicate device are intended to be used exclusively for external prosthetic fittings of upper limbs. Both products are prescription use devices, intended by a prosthetist or trained clinician.

#### Table 2. Indications for Use

| Characteristic | Subject Device | Predicate Device (K162891) |
|---------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| | Sense System | COMPLETE CONTROL System |
| Indications for Use | The Sense System is to be used<br>exclusively for external prosthetic fittings<br>of upper limbs. | The COMPLETE CONTROL System is to be<br>used exclusively for external prosthetic<br>fittings of the upper limbs. |

Minor differences in the written text do not affect the meaning (in other words, they are semantics).

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## Technology

The Sense System contains similar components as the COMPLETE CONTROL System (K162891), as delineated in Table 3.

| Component | Subject Device<br>Sense System | Predicate Device (K162891)<br>COMPLETE CONTROL System |
|---------------------|--------------------------------|-------------------------------------------------------|
| Processing unit | Signal Processing Box | Complete Controller |
| EMG electrode | IBT Electrode | Complete Co-amp, with cabling<br>and domes |
| Adjustment software | User Interface Application | Complete Controlroom |
| Input Button | Not needed | Complete Calibrate |
| Communication | Use internal | Complete Communicator |

#### Table 3: System Components

Based upon a technical review of both systems, IBT has identified the following technical differences:

- Wireless Communication ●
- Input Voltage
- Output Signals
- Calibration Method
- . Electrode Material and Suction Seal Compatibility

These areas are described and discussed herein.

#### Wireless Communication

| Wireless Communication Description & Comparison: | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Sense signal processing box communicates with the user interface via<br>Bluetooth® to update the pattern recognition classifier and other<br>parameters. The predicate uses a non-Bluetooth®-based RF wireless<br>technology to do the same. | |
| Wireless Communication Discussion: | |
| Wireless communication with the user interface is not related to user<br>safety. The use of Bluetooth® in the Sense system does not introduce any<br>additional safety risks over the predicate device. In fact, the Sense<br>System Bluetooth® communication is identical to the previously<br>approved Element system (K123759), has been tested extensively and<br>found to be stable. Additionally, the Bluetooth® module has passed FCC<br>requirements. | |
| Input Voltage Description & Comparison: | |
| The Sense System has an input voltage range of 5-10 V. The predicate<br>device has an input range of 5.3-16.8 V. | |
| Input Voltage Discussion: | |
| The input voltage range of the Sense System is similar to most electrodes<br>and controllers currently sold on the market today. The Sense System is<br>only intended to be compatible with a separately sold battery, FlexCell,<br>which is rated at a nominal voltage of 7.4V. Many other battery systems<br>are also rated at this voltage. This difference in voltage requirements has<br>no impact on the safety or effectiveness profile; furthermore, compatible<br>components are listed for customers. | |
| Output Signals | |
| Description & Comparison: | The processing box determines what type of signal the Sense System<br>outputs. Sense has a great variety of outputs, which include 0-5V analog,<br>0-3.3V digital, and 0-8.2V motor signals, all based on compatibility testing<br>with a range of prosthetic components. The COMPLETE CONTROL system<br>does not specifically list the output types, but based on the list of<br>compatible components provided, the system likely have similar analog<br>and motor inputs. |
| Discussion: | The two systems share a similar list of compatible components, and<br>therefore must have similar output standards. Majority of components<br>listed are compatible with the industry standard 5V output analog<br>electrode. Those that are motor driven have been tested through<br>verifications. Therefore, the outputs of Sense and COMPLETE CONTROL<br>are likely similar. Additionally, both systems use industry standard<br>connection types. |
| Calibration Method | |
| Description & Comparison: | The Sense System offers users the option to calibrate their pattern<br>recognition algorithm through a user interface. The option of a PC pre-<br>installed with the software is available to reduce the burden on the<br>patient and their practitioner. The predicate device offers an input button<br>connected to the controller that activates a prosthesis-guided calibration<br>session. The PC-based GUI is provided as a back-up only for use by<br>practitioners. |
| Discussion: | IBT developed the user interface as the main form of calibration in order<br>to allow users more options for their control, including the ability to<br>calibrate only one movement in the classifier Additionally, the user<br>interface provides the option to practice control pre-prosthetically with<br>a virtual arm, allowing patients to practice control before the final<br>prosthesis is completed. The calibration methodology used in the Sense<br>system does not introduce any additional risks related to patient safety. |
| Electrode Material | |
| Description & Comparison: | The Sense System includes 8 active, encased electrodes which digitizes<br>the signals on board and communicates with the processing box. The<br>contacts are titanium and the plastic is biocompatible. Alternatively, the<br>COMPLETE CONTROL system uses commercially available electrode<br>dome contacts which are typically stainless steel. These are the only<br>components to interface with the skin; signals are processed remotely in<br>the Complete Co-amp. |
| Discussion: | The IBT Electrodes were designed to be self-contained through early<br>digitization and be easily replaceable in case of damage. Additionally, all<br>materials were selected with reduction of skin irritation in mind. The<br>titanium contacts do not contain nickel, which is a common skin allergy.<br>The electrodes have been tested for and successfully passed<br>biocompatibility. Differences in material and size do not increase risks to<br>the patient. |

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# infinite biomedical technologies

Description & Comparison: A specific requirement for certain prosthetic applications is to include electrodes capable of maintaining suction on the patient's limb when the prosthesis is donned. The Sense system with IBT Electrodes can be fabricated into a suction seal socket. The predicate device uses domed electrodes which need to be individually fabricated into a suction socket. Discussion: The electrode size could impact installation (maintaining suction) and performance (signal detection). Neither aspect is unique or representative of a new/different question of safety or effectiveness.

#### 9. Performance Data

IBT has conducted performance tests to demonstrate the safety and effectiveness of the Sense system with IBT Electrodes, compared to the predicate device (see Table below)

| Performance Test | Subject Device<br>Sense System with IBT Electrodes | Comparison to Predicate Device<br>Complete Control System (K162891) |
|-----------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Software V&V and Design V&V | Passed Internal Testing Regimen | As with any device, predicate would also<br>be tested to determine if user and device<br>requirements are met. |

The Sense System was tested to ensure its safety and effectiveness. The following Performance Standards were used for performance testing on Sense and the IBT Electrodes:

| Category | No | Title | Version | Comparison to Predicate<br>Device (K162891)<br>COMPLETE CONTROL<br>System |
|----------------------------------|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------|
| Safety | IEC/EN 60601-1 | Medical electrical equipment<br>Part 1: General requirements<br>for basic safety and essential<br>performance | 2012<br>(IEC)/2006<br>(EN) | Similar - predicate was<br>tested to 2007 standards |
| | IEC 60601-1-11 | General requirements for basic<br>safety and essential<br>performance - Collateral<br>Standard: Requirements for<br>medical electrical equipment<br>and medical electrical systems<br>used in the home healthcare<br>environment | 2010 | Predicate was not tested to<br>this standard |
| Electromagnetic<br>Compatibility | IEC 60601-1-2 | Medical electrical equipment -<br>Part 1-2: General requirements<br>for basic safety and essential<br>performance - Collateral<br>standard: Electromagnetic<br>compatibility - Requirements<br>and tests | 2007 | Equivalent |

The IBT Electrodes have been previously cleared by the FDA under K173571.

The Sense System also underwent design verification and validation, software verification and validation, and usability testing to demonstrate its ability to achieve its intended use safely and effectively. The tables below outline the validation testing that was performed on Sense with IBT Electrodes.

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# infinite biomedical technologies

| Test Name | Result |
|------------------------------------------|--------|
| Simulated installation of Sense | Pass |
| IBT Use of UI | Pass |
| Practitioner Use of UI | Pass |
| Patient Use of UI | Pass |
| Simulated Use with Prosthetic Components | Pass |
| Lifetime and Reliability Testing | Pass |
| Battery Life | Pass |
| Packaging Drop Test | Pass |

#### Validation testing on Sense with IBT Electrodes

The FlexCell battery was also tested to ensure its safety and effectiveness. The following Performance Standards were used for performance testing of the FlexCell battery:

| Category | No | Title | Version |
|----------------|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Safety | IEC 60601-1 | Medical electrical equipment Part 1: General<br>requirements for basic safety and essential<br>performance | 2012 (IEC) |
| | IEC 62133 | Secondary cells and batteries containing alkaline<br>or other non-acid electrolytes - Safety<br>requirements for portable sealed secondary cells,<br>and for batteries made from them, for use in<br>portable applications | 2002 (1st edition) |
| Transportation | UN38.3 | Transportation Testing for Lithium Batteries | ST/SG/AC.10/11/Rev.5/Amend.1<br>&<br>ST/SG/AC.10/11/Rev.5/Amend.2 |

The FlexCell battery also underwent design verification and usability testing to demonstrate its ability to function safely and effectively. The following testing was performed on the device:

| Test Name | Result |
|------------------------------------------|--------|
| FlexCell Major Component Test | Pass |
| FlexCell V&V Test Specification Plans | Pass |
| FlexCell Charger Update V&V Test Plan | Pass |
| FlexCell Charger IC Update V&V Test Plan | Pass |

#### 10. Conclusions

Based upon the discussion provided herein and the supporting data, IBT believes that the Sense System, which includes Sense, the IBT Electrodes, and the UI Application, is as safe and as effective as the predicate device (COMPLETE CONTROL System, K162891) for its intended use, making it substantially equivalent to a legally marketed predicate device.