(121 days)
Not Found
No
The description focuses on standard EMG signal processing and compatibility with existing prosthetic components, with no mention of AI/ML algorithms for signal interpretation or control.
No
The device is described as a myoelectric exoprosthetic fitting system for the upper limb, which helps control prosthetic devices by detecting EMG signals. It does not actively treat a medical condition or restore a bodily function, but rather enables the function of a prosthetic device.
No
Explanation: The device is described as an EMG electrode system intended for myoelectric exoprosthetic fittings to provide control signals to prosthetic devices. It does not mention any diagnostic capabilities or the interpretation of EMG signals for medical diagnosis.
No
The device description explicitly lists "IBT Electrodes" and a "Signal Processing Box" as system components, which are hardware elements. The software component ("Element Desktop Software") is only one part of the overall system.
Based on the provided information, the Element system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "exclusively for myoelectric exoprosthetic fittings of the upper limb." This describes a device used externally on the body to assist with movement, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description clearly states it's a "surface electromyography (EMG) electrode system" that detects signals from the user's skin and outputs them to prosthetic devices. This is a biofeedback and control system for a prosthetic, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
Therefore, the Element system falls under the category of a medical device used for rehabilitation and control of a prosthetic limb, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Element system is intended to be used exclusively for myoelectric exoprosthetic fittings of the upper limb.
Product codes (comma separated list FDA assigned to the subject device)
GXY, IQZ
Device Description
The Element system is a surface electromyography (EMG) electrode system that is to be used with upper limb prosthetic devices. Element outputs standard envelop EMG signals detected from EMG electrodes (IBT Electrodes) placed on the user's skin. These signals are used as inputs by connected prosthetic devices, such as hands, wrists or elbows. The Element system is an alternative to standard suction socket myoelectrodes, with the advantages of a lower profile, digital signal processing, and wireless gain adjustment. Element does not replace or modify any functionality of connected prosthetic components.
Element is compatible with most hands, wrists, and elbows that accept standard analog EMG electrode inputs. The Element system is typically sold with three-port kidney-style output connectors, however alternative connectors may be used to ensure compatibility with other terminal devices. The Element system accepts power from IBT's FlexCell Battery system and outputs control EMG signals to hands, wrists, or other prosthetic components. The Element system is installed in the prosthesis by a trained prosthetist and connected to prosthetic components selected to meet the needs of the individual user.
System components:
- IBT Electrodes (up to 2)
- Signal Processing Box
- Element Desktop Software
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prosthetist or trained clinician
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 Element system with IBT Electrodes was tested to ensure its safety and effectiveness. The following Performance Standards were used for performance testing of the Element system:
- IEC/EN 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (2012 (IEC)/2006 (EN))
- IEC 60601-1-11 General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (2010)
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (2007)
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (2009)
- ISO 10993-5 Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity (2009)
- ISO 10993-10 Biological evaluation of medical devices Part 10: Test for irritation and skin sensitization (2009)
The Element system with IBT Electrodes 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 following validation testing was performed on the device:
- Compatibility with IBT Electrodes (Pass)
- Simulated installation of Element (Pass)
- Simulated Use of Element Software and Electrode Placement (Pass)
- Simulated Use with Commonly used Prosthetic Components (Pass)
- Lifetime and Reliability Testing (Pass)
- Testing Report Summary (Pass)
- Signal Performance during Simulated Use (Pass)
- Simulated battery life with Element (Pass)
- Simulated use with Region Specific Noise (Pass)
- Packaging Drop Test (Pass)
- Simulated Installation of IBT Electrodes (Pass)
- Simulated Seal (Pass)
- Simulated Cleaning (Pass)
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:
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (2012 (IEC))
- IEC 62133 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications (2002 (1st edition))
- UN38.3 Transportation Testing for Lithium Batteries (ST/SG/AC.10/11/Rev.5/Amend.1 & 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:
- 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)
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1320 Cutaneous electrode.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2018
Infinite Biomedical Technologies, LLC Rahul Kaliki CEO 1101 E 33rd Street, Suite E305 Baltimore, Maryland 21218
Re: K173571
Trade/Device Name: Element System with IBT Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY, IQZ Dated: January 19, 2018 Received: January 23, 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. 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
1
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
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
2
Indications for Use
510(k) Number (if known) K173571
Device Name Element System with IBT Electrodes
Indications for Use (Describe)
The Element system is intended to be used exclusively for myoelectric exoprosthetic fittings of the upper limb.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows a red infinity symbol against a black background. The symbol is centered in the frame and is the only object in the image. The red color of the symbol contrasts sharply with the black background, making it stand out.
510(k) Summarv Element System with IBT Electrodes
SUBMITTER'S INFORMATION 1.
| Name/Manufacturer | Infinite Biomedical Technologies, LLC |
|---|---|
| Address | 1101 E. 33rd Street, Suite E305, Baltimore, MD 21218 |
| Phone Number | (443) 451-7177 |
| Fax Number | (443) 451-7179 |
| Contact Person | Rahul Kaliki, PhD, Chief Executive Officer |
| Date Prepared | March 21, 2018 |
DEVICE INFORMATION 2.
| Trade Name | Element 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 | Axon-Bus Prosthetic System |
|---|---|
| 510(k) Number | K123795 |
4. INDICATIONS FOR USE STATEMENT
The Element system is intended to be used exclusively for myoelectric exoprosthetic fittings of the upper limb.
DEVICE DESCRIPTION 5.
The Element system is a surface electromyography (EMG) electrode system that is to be used with upper limb prosthetic devices. Element outputs standard envelop EMG signals detected from EMG electrodes (IBT Electrodes) placed on the user's skin. These signals are used as inputs by connected prosthetic devices, such as hands, wrists or elbows. The Element system is an alternative to standard suction socket myoelectrodes, with the advantages of a lower profile, digital signal processing, and wireless gain adjustment. Element does not replace or modify any functionality of connected prosthetic components.
Element is compatible with most hands, wrists, and elbows that accept standard analog EMG electrode inputs. The Element system is typically sold with three-port kidney-style output connectors, however alternative connectors may be used to ensure compatibility with other terminal devices. The Element system accepts power from IBT's FlexCell Battery system and outputs control EMG signals to hands, wrists, or other prosthetic components. The Element system is installed in the prosthesis by a trained prosthetist and connected to prosthetic components selected to meet the needs of the individual user.
System components:
- IBT Electrodes (up to 2) ●
- Signal Processing Box ●
- . Element Desktop Software
4
Image /page/4/Picture/0 description: The image shows a red infinity symbol against a black background. The symbol is a figure eight on its side, with smooth, rounded curves. The red color of the symbol contrasts sharply with the black background, making it stand out. The image is simple and minimalist, with the focus entirely on the infinity symbol.
6. TECHNOLOGICAL CHARACTERISTICS
Table 1 provides a summary of technological characteristics of the product in comparison to the predicate device.
| Manufacturer | Infinite Biomedical
Technologies, LLC | Otto Bock Health
Care Product GmbH | Device
Comparison |
|-----------------------------------------------------|--------------------------------------------|---------------------------------------|----------------------|
| Trade Name | Element System with
IBT Electrodes | Axon bus Prosthetic
System | |
| System | | | |
| Power Source included? | No | Yes | Differs |
| Terminal device (Hand,
Wrist or Elbow) included? | No | Yes | Differs |
| Wireless communication | Bluetooth® | Bluetooth® | Same |
| Clinical Software Tool | Yes
Element Application | Yes
AxonSoft | Similar |
| Software/Firmware/
Microprocessor Control? | Yes | Yes | Similar |
| Input Voltage | 5 to 10 VDC | 11.1 VDC | Differs |
| Output Signal | 0-5 V analog | 0-5 V analog | Same |
| Processing Unit | | | |
| Processing Unit
(L x W x H) | Signal Processing
Box
38 x 23 x 8 mm | AxonMaster
53 x 28 x 9 mm | Similar |
| Control options | None | Multiple | Differs |
| Signal Smoothing | Yes | No | Differs |
| Electrode | | | |
| Electrode
(L x W x H) | IBT Electrode
29 x 17 x 7 | Electrode
27 x 18 x 9.5 mm | Similar |
| Temperature range (use) | -10°C to 50°C | -15°C to 60°C | Similar |
| Housing Material | Plastics (ABS/PC
Blend) | Plastics (ASA) | Similar |
| Contact Area | Titanium (Grade 1) | Titanium (Grade 1) | Same |
| Bonding Agent | Cyanoacrylate | Cyanoacrylate | Same |
| Signal processing | Digital | Analog | Differs |
| Frequency Bandwidth | 90 - 500 Hz | 90 - 450 Hz | Similar |
| Adjustment | Digital gain 1-7 | Potentiometer 1-7 | Differs |
| Installation | suspension arms /
suction socket | suspension arms /
suction socket | Same |
Table 1: Technological Summary
7. Substantial Equivalence Discussion
IBT believes that its Element system with IBT Electrodes is substantially equivalent to specific parts of the Ottobock Axon-Bus Prosthetic System (K123795). A comparison of intended use, indications for use, technology, and performance is provided herein to support this determination. For instances where technological differences are identified, additional discussion describes how these differences do not raise
5
Image /page/5/Picture/0 description: The image shows a red infinity symbol against a black background. The symbol is centered in the frame and is the only object in the image. The red color of the symbol contrasts with the black background, making it stand out.
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.
Intended Use and Indications for Use
Both the subject device and the predicate device aim to detect, process, and transmit physiological signals (detected via surface electrodes), providing them to a downstream prosthetic device. Both products are prescription use devices, intended to be installed by a prosthetist or trained clinician.
From a clinical perspective, the Element system with IBT Electrodes is intended to be used with upper limb exoprosthetic fittings, exclusively. This clinical usage profile is identical to the predicate device.
| Characteristic | Subject Device | Predicate Device (K123795) |
|---|---|---|
| Element System with IBT Electrodes | Axon-Bus Prosthesis System | |
| Intended Use | Detect, process, and transmit | |
| physiological signals for use with a | ||
| prosthesis | Same as subject device | |
| Indications for Use | The Element system is intended to be | |
| used exclusively for myoelectric | ||
| exoprosthetic fittings of the upper limb. | The Axon-Bus Prosthetic System is to be | |
| used exclusively for exoprosthetic fittings | ||
| of the upper limbs. |
Table 2. Intended Use and Indications for Use
Minor differences in the written text do not affect the meaning (in other words, they are semantics).
Technology
The Element system contains a subset of components within the Axon-Bus Prosthetic System (K123795), as delineated in Table 3.
| Component | Subject Device | Predicate Device (K123795) |
|---|---|---|
| Element System | Axon-Bus Prosthesis System | |
| Terminal device | N/A | Michelangelo Hand |
| Passive wrist flexion device | N/A | AxonFlexion Adapter |
| Passive wrist rotation device | N/A | AxonRotation Adapter |
| Passive elbow joint | N/A | AxonArm |
| Battery | N/A | AxonEnergy Integral |
| Charger | N/A | AxonCharge |
| Processing unit | Signal Processing Box | AxonMaster |
| EMG electrode | IBT Electrode | Electrode |
| Adjustment software | Software Application | AxonSoft |
| Prosthetic glove | N/A | AxonSkin |
Table 3: System Components
IBT is only claiming equivalence to the predicate's components that are comparable to or part of the Element system. Based upon a technical review of both systems, IBT has identified the following technical differences:
6
Image /page/6/Picture/0 description: The image shows a red infinity symbol against a black background. The symbol is centered in the frame and appears to be illuminated, as the red color is vibrant. The infinity symbol is a mathematical symbol representing the concept of limitless or endless.
- Digital Signal Processing ●
- Digital Gain Adjustment Software
- Signal Smoothing
- Control Options
- Terminal Options
- . Battery Characteristics
- Electrode Materials
- Electrode Size
- . Software
These areas are described and discussed herein.
Digital Signal Processing
Description & Comparison: The IBT Electrodes digitize the signals at the electrode site using an analog front end (AFE) chip. The AFE samples the raw EMG signals with a high-resolution ADC. By digitizing the signal near the site of the electrode contacts, this system architecture reduces the potential for external noise sources to corrupt the EMG signals. The predicate Axon-Bus Prosthetic System Electrodes only use analog components in its design.
Discussion: Digital signal processing was incorporated to reduce noise corruption and allow for further signal processing downstream. These low-power components also are protected throughout the circuit layout with appropriate ESD protective components. The deviation does not result in any additional risk to the user. Both subject and predicate devices need meet electrical safety and electromagnetic compatibility to requirements.
Digital Gain Adjustment Software
| Description & Comparison: | The Element system allows for wireless adjustments of gain and further
signal processing at the downstream Signal Processing Box. Specifically,
the Signal Processing Box includes a microcontroller that communicates
with the electrodes, processes the EMG signals, and outputs envelope
EMG signals to connected prosthetic components. The Signal Processing
Box contains a Bluetooth module, which allows the controller to
communicate with a software application developed in Java called the
Element Application. The user (clinician) can visualize EMG signals and
adjust electrode gains through this mechanism. The predicate Axon-Bus
Prosthetic System Electrode has a gain that can be adjusted through a
potentiometer on the back of the electrode. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Discussion: | Access to the gain adjustment can be difficult to reach for prosthetists
and, often times, they must create holes in the exterior shell and socket
of the prosthesis to enable access to the gain adjustment, creating high
stress areas in the material as well as making the prosthesis vulnerable to
debris and liquids. The Element system does not have a physical
manipulator to adjust the gains. Instead, the adjustments can all be made |
through the Element Application software. Verification and Validation tests were conducted to ensure that the Element System's gain
7
Image /page/7/Picture/0 description: The image shows a red infinity symbol against a black background. The symbol is centered in the image and is the only object present. The red color of the symbol contrasts sharply with the black background, making it stand out. The infinity symbol is a mathematical symbol representing the concept of infinity.
adjustment method resulted in an equivalent signal output to the predicate device.
Although the methodology is different, both systems contain a mechanism to adjust the signal gain.
| Signal Smoothing | |
|---|---|
| Description & Comparison: | The Element system includes functionality to change the smoothness of the EMG signal. This feature is adjusted through the Element Application . The smoothing function increases the stability of the EMG signal at the cost of responsiveness. The higher smoothness allows for users to control their signal amplitude more steadily if they have trouble maintaining extended signals. A lower smoothness allows the user to achieve triggers for degree-of-freedom switching more easily. The smoothness function does have limits to ensure that the reduced responsiveness does not significantly impede the performance of the electrodes when used with a prosthetic device (see draft instructions for use). Default settings can be used to mimic similar signal qualities of the predicate device. The predicate device does not include a smoothing feature in the design, however other electrodes on the market include this functionality. 1 |
| Discussion: | The smoothness function is a feature to aid prosthetists in making adjustments unique to the individual, similar to how the predicate device provides various control options depending on the type of signals generated by the patient/end user. The risks involved in this customization step are no different between subject and predicate devices. |
| Control Options | |
| Description & Comparison: | Complete prosthetic systems typically contain a set of "control options" that allow modification of the way a user would operate the prosthetic device. This may include "first-over" versus "differential" activation of a degree of freedom or an option to reverse input directions. It may also specify if inputs besides EMG are used in the prosthesis. The Axon-Bus Prosthetic System (predicate under K123795) contains this functionality, whereas the subject Element system does not. |
| Discussion: | Element does not provide control mechanisms for the downstream prosthetic system; the output of the Element system is similar to that of the predicate device EMG Electrode, which provides filtered signals to the prosthesis based on user inputs. Therefore, the device has inherently simpler operation than the predicate. This deviation does not raise any additional concerns with respect to risk to the user. |
| Terminal Options | |
| Description & Comparison: | The Element system does not include a terminal device, passive wrist flexion/extension devices, or an elbow joint. These options are available on the predicate device. Instead, the Element system outputs its signal |
1 For example, the Triad Electrodes from Motion Control, Inc. have a smoothness functionality from Motion Control is part of a Class I, 510(k) exempt component.
8
| 8 | ||
|---|---|---|
infinite biomedical technologies
through industry-standard 3-pin kidney shaped connectors, with an output range exactly the same as other similar electrode devices on the market (including the predicate system's electrode).
- Discussion: Both subject and predicate devices need to ensure that the output signal is transferrable to a downstream component. The subject device does this through industry-standard connections. If this specification is met, then the subject device does not introduce new or different questions of safety or effectiveness.
- Battery Characteristics Description & Comparison: The Element system does not include a battery and has an input voltage range of 5-10 V. The predicate device uses a rechargeable 11.1 V Li-lon Battery Pack. This difference is thought to be due to voltage requirements in the Axon-Bus Prosthetic System's Michelangelo Hand, which requires higher voltage than other terminal devices on the market.
- Discussion: The input voltage range of the Element system is similar to most electrodes currently sold on the market today. The Element system is only intended to be compatible with a separately sold battery, FlexCell, which is rated at a nominal voltage of 7.4V. This battery system is compatible with most upper limb prosthetic terminal devices on the market. This difference in voltage requirements has no impact on the safety or effectiveness profile.
- Electrode Materials Description & Comparison: The housing of the IBT Electrode is manufactured with a PC-ABS blend, whereas the predicate device housing uses ASA. Both products utilize titanium grade 1 electrode contact material. The type of contact, duration of contact, and cleaning profiles are identical.
- Discussion: Both subject and predicate devices have patient contacting materials that experience the same use scenarios. The risk of a tissue response to the material used is equivalent, and both products are tested to the applicable parts of ISO 10993.
- Electrode Size 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 Element system with IBT Electrodes can maintain a sealed socket with a small form factor.
- The smaller electrode size could impact installation (maintaining suction) Discussion: and performance (signal detection). Neither aspect is unique or representative of a new/different question of safety or effectiveness. Testing demonstrated equivalent performance.
- Software Description & Comparison: The Element system includes embedded system software within the microprocessor of the Signal Processing Unit and a separate software application. The predicate device also has a software application (AxonSoft) and embedded software within the Axon Master and
9
Image /page/9/Picture/0 description: The image shows a red infinity symbol against a black background. The symbol is centered in the image and is the only object present. The red color of the symbol contrasts with the black background, making it stand out.
infinite biomedical technologies
Michaelangelo hand. The Element's software application is used for viewing signals, gain adjustment, and adjusting smoothness of the EMG signal, whereas the predicate device's software application is used to change control options, adjust the parameters of the control options, and view signals. The Element's embedded software is used to process the digital signals (filtering, gain adjustment, smoothness), whereas the embedded software in the predicate device is responsible for both lowlevel and high-level control functions for the prosthetic hand.
Discussion:
The differing features of the Element system's software application and embedded software do not introduce new/different safety or efficacy concerns.
8. Performance Data
The Element system with IBT Electrodes was tested to ensure its safety and effectiveness. The following Performance Standards were used for performance testing of the Element system:
| Category | No | Title | Version | Comparison to Predicate
Device Axon-Bus
(K123795) |
|----------|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------|
| Safety | IEC/EN 60601-1 | Medical electrical equipment
Part 1: General requirements
for basic safety and essential
performance | 2012
(IEC)/2006
(EN) | Equivalent |
| | IEC 60601-1-11 | General requirements for basic
safety and essential
performance - Collateral
Standard: Requirements for
medical electrical equipment
and medical electrical systems
used in the home healthcare
environment | 2010 | Predicate was not tested to
this standard |
10
Image /page/10/Picture/0 description: The image shows a red infinity symbol against a black background. The symbol is horizontally oriented and centered in the frame. The red color of the symbol contrasts sharply with the black background, making it stand out. The infinity symbol is smooth and symmetrical.
infinite biomedical technologies
| Category | No | Title | Version | Comparison to Predicate
Device Axon-Bus
(K123795) |
|----------------------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------------------|
| Electromagnetic
Compatibility | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | 2007 | Equivalent |
| Biocompatibility | ISO 10993-1 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process | 2009 | Equivalent |
| Biocompatibility | ISO 10993-5 | Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity | 2009 | Equivalent |
| Biocompatibility | ISO 10993-10 | Biological evaluation of medical devices Part 10: Test for irritation and skin sensitization | 2009 | Equivalent |
The Element system with IBT Electrodes 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 following validation testing was performed on the device:
| Test Name | Result |
|---|---|
| Compatibility with IBT Electrodes | Pass |
| Simulated installation of Element | Pass |
| Simulated Use of Element Software and | |
| Electrode Placement | Pass |
| Simulated Use with Commonly used Prosthetic | |
| Components | Pass |
| Lifetime and Reliability Testing | Pass |
| Testing Report Summary | Pass |
| Signal Performance during Simulated Use | Pass |
| Simulated battery life with Element | Pass |
| Simulated use with Region Specific Noise | Pass |
| Packaging Drop Test | Pass |
| Simulated Installation of IBT Electrodes | Pass |
| Simulated Seal | Pass |
| Simulated Cleaning | Pass |
11
Image /page/11/Picture/0 description: The image shows a red infinity symbol against a black background. The infinity symbol is a mathematical symbol representing the concept of infinity. It is shaped like a figure eight on its side. The red color of the symbol contrasts with the black background, making it stand out.
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 | |
| requirements for basic safety and essential | |||
| performance | 2012 (IEC) | ||
| IEC 62133 | Secondary cells and batteries containing alkaline | ||
| or other non-acid electrolytes - Safety | |||
| requirements for portable sealed secondary cells, | |||
| and for batteries made from them, for use in | |||
| portable applications | 2002 (1st edition) | ||
| Transportation | UN38.3 | Transportation Testing for Lithium Batteries | ST/SG/AC.10/11/Rev.5/Amend.1 |
| & | |||
| 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 |
9. Conclusions
Based upon the discussion provided herein and the supporting data, IBT believes its Element system with IBT Electrodes are as safe and as effective as the predicate device (Axon-Bus K123795) for its intended use, making it substantially equivalent to a legally marketed predicate device.