Glide (91000-GL-X)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 15, 2024 Infinite Biomedical Technology LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K240884 Trade/Device Name: Glide (91000-GL-X) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: March 29, 2024 Received: April 1, 2024 Dear Prithul Bom: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Heather L. Dean -S Heather Dean, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices {2}------------------------------------------------ OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Submission Number (if known) K240884 Device Name Glide Indications for Use (Describe) | Glide is to be used exclusively for exoprosthetic fittings of the upper limb | |------------------------------------------------------------------------------| |------------------------------------------------------------------------------| Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {4}------------------------------------------------ Image /page/4/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) Summary Glide ## 1. SUBMITTER'S INFORMATION | Name/Manufacturer | Infinite Biomedical Technologies, LLC | |-------------------|---------------------------------------------| | Address | 8 Market Pl, Suite 500, Baltimore, MD 21202 | | Phone Number | (443) 451-7175 | | Fax Number | (443) 451-7179 | | Contact Person | Rahul Kaliki, PhD, Chief Executive Officer | | Date Prepared | February 13, 2024 | ## 2. CORRESPONDENT CONTACT | Contact Person | Damini Agarwal | |----------------|---------------------------------------| | Company | Infinite Biomedical Technologies, LLC | | Email | Damini@i-biomed.com | ### 3. DEVICE INFORMATION | Trade Name | <b>Glide</b> | |-------------------------|------------------------------------------------| | 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) | #### 4. PREDICATE DEVICE INFORMATION | Device Name | Axon-Bus Prosthetic System | |-----------------------------|------------------------------------------------| | Common Name | Powered, External Upper Limb Prosthetic System | | Device Manufacturer | Otto Bock Healthcare Product GmbH | | Classification Name | Cutaneous Electrode (21 CFR § 882.1320) | | Classification Product Code | GXY (Electrode, Cutaneous) | | 510(k) Number | K123795 | ### 5. REFERENCE DEVICE INFORMATION | Device Name | Element System with IBT Electrodes | |----------------------------------|------------------------------------------------| | Common Name | Powered, External Upper Limb Prosthetic System | | Device Manufacturer | Infinite Biomedical Technologies, LLC | | Classification Name | Cutaneous Electrode (21 CFR § 882.1320) | | Classification Product Code | GXY (Electrode, Cutaneous) | | 510(k) Number | K173571 | | C. INDICATIONS FOR USE STATEMENT | | ## 6. INDICATIONS FOR USE STATEMENT Glide is to be used exclusively for exoprosthetic fittings of the upper limb. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a red infinity symbol against a black background. The symbol is horizontally oriented and centered in the frame. To the right of the black background is a vertical gray bar. #### 7. DEVICE DESCRIPTION Glide is a surface electromyography (EMG) electrode and control system intended to be used with an upper limb prosthesis. Glide detects surface EMG signals using IBT Electrodes V2 placed on the user's skin. These signals are processed by Glide and are used to drive the upper limb prosthesis. Glide is compatible with industry standard domes. Glide does not have any direct skin contacting parts. Glide is compatible with most hands, wrists, and elbows that accept industry standard inputs. Glide accepts power from the prosthesis batteries and outputs control signals to hands, wrists, and other prosthetic components. The components of Glide are assembled into the prosthesis by a certified prosthetist or trained technician according to the individual needs of the amputee. Glide is a reusable single patient use device. Glide does not replace or modify any functionality of connected prosthetic components. Adjustments to the Glide components can be performed through Bluetooth data transfer using the IBT Control Application. The IBT Control Application runs on the iPad OS platform and allows the prosthetist to adjust the settings of the system, such as assignment of input filtered signal to prosthesis movements, adjustment of gains, etc. Glide components: - Core2 Controller (90010) - Output Cable (90020-XX) - IBT Remote Dome Electrodes (upto 8) - Electrode Cables - IBT Control Application - Core2 Fabrication Kit (94001) - Documentation - Dome Fabrication Kit (optional) #### 8. PRINCIPLES OF OPERATION FOR GLIDE Glide is an alternate to the two-site direct control methods used in commercially available prosthesis control systems. Glide processes inputs from two to eight electrodes to drive a prosthesis into multiple movements without the use of traditional triggers and/or calibration. Glide uses similar control options as that of the predicate device and enables the use of those control options for more than 3 electrodes. #### 9. Comparison of Technological Characteristics Table 1 provides a summary of technological characteristics of the product in comparison to the predicate device. | Manufacturer | Infinite Biomedical<br>Technologies, LLC | Ottobock Healthcare<br>Product GmbH | Predicate Device<br>Comparison | |------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------| | Trade Name | Glide | Axon Bus Prosthetic<br>system | | | System | | | | | Indications for Use | Glide is to be used<br>exclusively for<br>exoprosthetic fittings of<br>the upper limbs. | The Axon Bus<br>Prosthetic System is<br>to be used<br>exclusively for<br>exoprosthetic fittings<br>of the upper limbs. | Same1 | | Power Source included? | No | Yes | Differs2 | {6}------------------------------------------------ Image /page/6/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. | Manufacturer | Infinite Biomedical<br>Technologies, LLC | Ottobock Healthcare<br>Product GmbH | Predicate Device<br>Comparison | |-----------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------|--------------------------------| | Trade Name | Glide | Axon Bus Prosthetic<br>system | | | Terminal device (Hand,<br>Wrist or Elbow) included? | No | Yes | Differs 3 | | Wireless communication | Bluetooth® | Bluetooth® | Same | | Clinical Software Tool | Yes<br>IBT Control Application | Yes<br>Axon Soft | Similar6 | | Software/<br>Firmware/ Microprocessor<br>Control? | Yes | Yes | Similar6 | | Power Input Voltage | 7.4 - 16 VDC | 11.1 VDC | Differs 4 | | Output Signal | Analog and Digital | Digital | Similar3 | | Control Unit | | | | | Processing Unit | Core2 Controller | Axon Master | | | (L x W x H) | 59 x 27.8 x 9.8mm | 53 x 25 x 9 mm | Similar7 | | Weight | 10g | 15g | Similar7 | | Control options | Multiple | Multiple | Similar6 | | Electrode | | | | | Electrode | IBT Electrode V2 | Electrode | | | (L x W x H) | 26.8 x 14.8 x 7.5mm | 27 x 18 x 9.5 mm | Similar5 | | Temperature range (use) | -10° to 60°C | -15° to 60°C | Similar5 | | Type | Remote | Cased | Differs5 | | Housing Material | Nylon12 (PA12) | Plastics (ASA) | Differs5 | | Contact Area | No skin contacting part<br>Compatible with<br>industry standard domes | Titanium (Grade 1) | Differs5 | | Number | Up to 8 | Up to 2 | Differs5 | | Bonding Agent | Cyanoacrylate | Cyanoacrylate | Same | | Signal processing | Digital | Analog | Differs5 | | Frequency Bandwidth | 90 - 300 Hz | 90 – 450 Hz | Similar5 | | Adjustment | Digital Gain 1-10 | Analog Gain 1 - 7 | Differs5 | | Installation | Suspension arms /<br>suction socket | Suspension arms /<br>suction socket | Same | ### Table 1: Technological Summary ## 10. Substantial Equivalence Discussion IBT believes that Glide is substantially equivalent to specific parts of Ottobock's Axon-Bus Prosthetic System (K123795). 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 below 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. Glide also uses the Element System with IBT Electrodes (K173571) as the reference device. This is because IBT Electrodes V2 uses similar digital signal processing as the reference device. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a red infinity symbol against a black background. The symbol is centered in the frame and is the primary focus of the image. 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. #### 1. Indications for Use Both the subject device, the predicate device are intended to be used exclusively for exoprosthetic fittings of upper limbs. Both products are prescription-use devices, intended by a certified prosthetist or trained technician. | Characteristic | Subject Device<br>Glide System | Predicate Device (K123795)<br>Axon Bus Prosthetic System | |------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | Glide is to be used exclusively<br>for exoprosthetic fittings of the<br>upper limbs. | The Axon Bus Prosthetic<br>System is to be used<br>exclusively for exoprosthetic<br>fittings of the upper limbs. | ## Technology Glide contains similar components to the Axon Bus Prosthetic System (K123795), as delineated in Table 3. Table 3: System Components | | Subject Device<br>Glide | Predicate<br>Axon-Br | |---|--------------------------|----------------------| | D | Compatible with multiple | Michela | | | Subject Device | Predicate Device (K123795) | |-------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------| | Component | Glide | Axon-Bus Prosthetic System | | Terminal device | Compatible with multiple<br>prosthetic components<br>including Michelangelo Hand | Michelangelo Hand | | Passive wrist flexion device | Compatible with multiple<br>prosthetic components<br>that include passive wrist<br>flexion within the device. | AxonFlexion Adapter | | Passive wrist rotation device | Compatible with multiple<br>prosthetic components<br>including AxonRotation | AxonRotation Adapter | | Passive elbow joint | Compatible with multiple<br>prosthetic components<br>including AxonArm | AxonArm | | Battery | Compatible with multiple<br>prosthetic powering systems<br>including AxonEnergy<br>Integral | AxonEnergy Integral | | Charger | N/A | AxonCharge | | Processing unit | Core2 Controller | Axon Master | | EMG electrode | IBT Electrode V2 | Cased Electrode<br>(PN:13E200=60) | | Adjustment software | IBT Control Application | AxonSoft | {8}------------------------------------------------ Image /page/8/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 glowing. The infinity symbol is a mathematical symbol representing the concept of infinity, which is something that is limitless or endless. There is a gray bar on the right side of the image. | Component | Subject Device<br>Glide | Predicate Device (K123795)<br>Axon-Bus Prosthetic System | |------------------|-------------------------|----------------------------------------------------------| | Prosthetic glove | N/A | AxonSkin | Based upon a technical review of both systems, IBT has identified the following technical differences: - Power Source - Terminal Devices - Power Input voltage - . Electrode Features These areas are described and discussed herein. #### 2. Power Source | Description & Comparison: | Glide does not include a power source. The predicate device includes a<br>power source called AxonEnergy Integral. | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Discussion: | Glide draws power from the prosthesis batteries and hence does not<br>include a specific power source. Similar to other prosthetic components,<br>Glide is designed to work with all industry standard battery systems. As<br>a result, this difference in inclusion of a power source has no impact on<br>the safety or effectiveness profile of the system. | ## 3. Terminal Device | Description & Comparison: | Glide is compatible with multiple prosthetic components including those<br>of the predicate device. The predicate device is compatible with only<br>specific prosthetic components. | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Discussion: | Glide is designed to be compatible with all industry standard prosthetic<br>components. They can be broadly classified into 3 main categories –<br>analog, motor and digital – hands, wrists and elbows. IBT has run<br>verification and validations on each category of devices to confirm the<br>safety and effectiveness of the same. | | | Further, the subject device outputs analog, digital, and motor signals to<br>control prosthetic components. In comparison, the predicate device<br>outputs only digital signals. However, the subject device has been<br>designed and adequately verified and validated to be compatible with all<br>industry standard analog, motor and digital prosthetic components of | not a concern. hands, wrists, and elbows. Therefore, the difference in output signals is {9}------------------------------------------------ Image /page/9/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. #### Power Input Voltage 4. Description & Comparison: The Glide has an input voltage range of 7.4 – 16V DC. The predicate device has an input voltage of 11.1VDC. Discussion: The input voltage range of Glide matches that of industry standard prosthesis powering systems. Since Glide draws power from the prosthesis, Glide has been tested to an input voltage range that matches that of industry standard prosthesis powering systems. The predicate device draws power from only a single power source and as a result, it is rated such. Additionally, Glide is also compatible with the power source of the predicate device. This difference in input voltage has no impact on the safety or effectiveness profile; especially since it was tested as part of the 60601 testing for Glide. #### 5. Electrode Features Description & Comparison: Glide includes up to 8, remote-style electrodes with digital gains and signal processing. The Glide system does not have any skin contacting part and is compatible with industry standard skin contacting domes. Alternatively, the Axon-Bus Prosthetic system uses up to 3, cased-style electrodes with analog gains and a skin contacting part made up of titanium. Additionally, Glide includes electrodes that have a L x W x H of 26.8 x 14.8 x 7.5mm whereas the predicate device uses electrode with dimensions of 27 x 18 x 9.5 mm. Also, electrodes in Glide are tested from -10° to 60°C whereas the predicate device electrodes are tested from -15° to 60°C. Moreover, Glide has a frequency bandwidth of 90 - 300 Hz, whereas the predicate device has a frequency bandwidth of 90 – 450 Hz. Glide is designed to use up to 8 electrodes, and the safety and Discussion: effectiveness of 8 electrodes is like that of 1 electrode. Moreover, due to compatibility with industry standard domes, Glide itself does not have any skin contacting parts, and thus the safety and effectiveness is comparable to that of cased electrodes of the predicate device. Additionally, Glide uses digital gains and signal processing similar to that of the reference device (K173571) which offers no difference in the safety and effectiveness profile of the electrode. > Moreover, Glide uses electrodes that have similar dimensions than that of the predicate system, in fact they are smaller to not add additional weight or bulk to the prosthesis. The same has been verified and validated and hence is not a concern. > Electrodes in Glide have been tested to the latest 60601 standards for safety testing, which also includes testing at the specified temperature {10}------------------------------------------------ Image /page/10/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 infinity symbol is a mathematical symbol representing the concept of infinity. range. Since Glide passed all 60601 testing successfully, the minor difference in temperature does not present a safety or efficacy concern. Glide and the predicate device use similar bandwidths for the electrodes. The 90 – 350 Hz range captures the bulk of EMG signals, and since neither Glide nor the predicate device use frequency dependent signal features, the minor difference in bandwidth does not result in any safety and efficacy concerns. This is further evidenced by the extensive verification and validation testing performed on Glide. In addition to the technical differences, IBT has also identified a key technical similarity in the control options offered by both systems. It is described and discussed herein. #### 6. Control Options: | Description & Comparison: | Glide provides various control options to the user, similar to that of the<br>predicate device. The control options include use of sustained electrode<br>signal with proportional range, ability to adjust the working range of the<br>signal, use of fast vs slow contraction signals, co-contraction based<br>control and four channel control.<br><br>The predicate device allows for use of the above control schemes with<br>only up to 3 electrodes; however, Glide applies the above control<br>schemes for up to 8 electrodes using vector summation control.<br>Adjustment to the settings of the control scheme is performed through<br>the IBT Control Application in Glide which is like the AxonSoft software in<br>the predicate device. Both systems run the control scheme through<br>firmware programmed on a microprocessor. | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Discussion | Glide expands the control options provided by the predicate device for<br>use with up to 8 electrodes through a vector summation method. The<br>native functionality is similar and is only presented to the user visually in<br>a different manner that also allows for the function to be applied to up<br>to 8 electrodes. Since the native functionality is similar in both systems,<br>and has been verified and validated thoroughly, there is no additional<br>safety or effectiveness concern.<br><br>Both the subject device and the predicate device allow<br>clinicians to view EMG signals and adjust signal thresholds. However,<br>each software app is proprietary to its own device system. The subject<br>device IBT Control application locally stores device configuration and<br>control option settings. It does not store any Personal Identifiable<br>Information (PII) Data, nor does it connect to the internet. It has<br>undergone extensive software verification and validation. Therefore, this<br>difference in the app is minor and not a concern.<br><br>Both systems run the control scheme through firmware programmed on<br>a microprocessor. The microprocessor used and the firmware it runs is<br>proprietary to its own device system. However, the same control scheme<br>is implemented in the firmware of both the subject and predicate device.<br>The subject has undergone extensive software verification and | {11}------------------------------------------------ Image /page/11/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 glowing slightly. The infinity symbol is a mathematical symbol representing the concept of limitless or endless. validation. Therefore, this difference in the firmware/microprocessor is minor and is not a concern. ## 7. Control Unit: Description & Comparison: Glide has a processing unit with L x W x H of 59 x 27.8 x 9.8mm whereas the predicate device processing unit has L x W x H of 53 x 25 x 9 mm. Additionally, the Glide control unit has a weight of 10g and the predicate device control unit has a weight of 15g. - Discussion The dimensions of both the subject and the predicate device processing units are similar, in fact, the volume of Glide is lesser than the volume of the predicate device to not add additional weight or bulk to the prosthesis. The same has been verified and validated and hence is not a concern. Similarly, the weight of both the subject and the predicate device are similar, in fact, the weight of Glide is lesser than the weight of the predicate device to not add additional weight or bulk to the prosthesis. The same has been verified and validated and hence is not a concern. {12}------------------------------------------------ Image /page/12/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 infinity symbol is a mathematical symbol representing the concept of endlessness or limitlessness. ## 11. Performance Data IBT has conducted performance tests to demonstrate the safety and effectiveness of Glide, as compared to the predicate device (see Table below) | Performance Test | Subject Device<br>Glide | Comparison to Predicate Device<br>Axon-Bus Prosthetic System (K123795) | |-----------------------------|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Software V&V and Design V&V | Passed Internal Testing Regimen | As with any device, the predicate would also have been tested to determine if user and device requirements are met.<br>There is no publicly available information on the same. | Glide was tested to ensure its safety and effectiveness. The following Performance Standards were used for performance testing of Glide: | Category | No | Title | Version | Comparison to Predicate Device (K123795)<br>Axon-Bus Prosthetic System | |--------------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------| | Safety | IEC/EN 60601-1 | Medical electrical equipment<br>Part 1: General requirements for basic safety and essential performance | IEC 60601-1:2005,<br>IEC 60601 1:2005/AMD1:2012,<br>IEC 60601-1:2005/AMD2:2020 | Predicate was tested to 2005 standards | | Safety | 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 | IEC 60601-1-11:2015,<br>IEC 60601-1-11:2015/AMD1:2020 for use in conjunction with IEC 60601-1:2005,<br>IEC 60601-1:2005/AMD1:2012,<br>IEC 60601-1:2005/AMD2:2020 | Predicate was not tested to this standard | | Electro-magnetic 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 | EN 60601-1-2:2015+A1:2021, | Predicate was tested to 2007 standards | Glide also underwent design verification and validation, software verification 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 Glide. {13}------------------------------------------------ Image /page/13/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. | Test Name | Result | |----------------------------------------|--------| | Installation of Core2 | Pass | | IBT Use of UI | Pass | | Practitioner Use of UI | Pass | | Patient Use of UI | Pass | | Patient use of prosthetic component | Pass | | Battery Life | Pass | | Use with region specific noise | Pass | | Installation and use of IBT electrodes | Pass | | Lifetime and Reliability Testing | Pass | | Packaging Drop Test | Pass | ### Validation testing on Glide ## 12. Conclusions Based upon the discussion provided herein and the supporting data, IBT believes that Glide, is as safe and effective as the predicate device (Axon Bus Prosthetic System, K123795) for its intended use, making it substantially equivalent to a legally marketed predicate device.