(14 days)
Glide is to be used exclusively for exoprosthetic fittings of the upper limb.
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)
This document describes the Glide device, an electromyography (EMG) electrode and control system for upper limb prostheses, and its comparison to a predicate device for FDA 510(k) clearance.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics (like sensitivity, specificity, accuracy, or specific thresholds for latency, signal-to-noise ratio). Instead, it relies on demonstrating compliance with recognized performance standards and successful completion of internal verification and validation testing, implying that passing these tests constitutes meeting the acceptance criteria for safety and effectiveness.
General Performance and Acceptance Status: The Glide device passed all internal testing regimens and relevant performance standards.
| Acceptance Criteria (Implied by Testing) | Reported Device Performance |
|---|---|
| Compliance with IEC/EN 60601-1 (2012/2020) General Requirements for Basic Safety and Essential Performance | Passed |
| Compliance with IEC 60601-1-11 (2015/2020) Home Healthcare Environment Requirements | Passed |
| Compliance with IEC 60601-1-2 (2015/2021) Electromagnetic Compatibility | Passed |
| Successful Installation of Core2 | Pass |
| Successful Patient Use of UI | Pass |
| Successful Practitioner Use of UI | Pass |
| Successful Patient Use of Prosthetic Component | Pass |
| Acceptable Battery Life | Pass |
| Acceptable Performance with Region Specific Noise | Pass |
| Successful Installation and Use of IBT Electrodes | Pass |
| Acceptable Lifetime and Reliability | Pass |
| Successful Packaging Drop Test | Pass |
| Software Verification and Validation (V&V) | Passed Internal Testing Regimen |
| Design Verification and Validation (V&V) | Passed Internal Testing Regimen |
| Usability Testing | Passed Internal Testing Regimen |
Note regarding predicate device comparison: For software V&V and Design V&V, the document states "As with any device, the predicate would also have been tested to determine if user and device requirements are met. There is no publicly available information on the same." This indicates the comparison is based on the expectation that the predicate met similar internal standards, rather than direct public data.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for any specific performance tests (e.g., number of users, number of devices tested, or duration of tests). It generally refers to "Internal Testing Regimen" and "Validation testing on Glide."
The data provenance is internal, from Infinite Biomedical Technologies, LLC. No country of origin of the data is specified beyond the manufacturer's location (Baltimore, MD, USA). The studies appear to be prospective in nature, performing tests on the Glide device to gather data for submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for testing. The validation tests (e.g., "Patient Use of UI," "Practitioner Use of UI") imply user testing, but details on how success was evaluated or if independent experts were involved in defining successful outcomes are not provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating test results. The implication is that internal teams and standard testing procedures determined pass/fail outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study or any studies evaluating the effect size quantifying human reader improvement with or without AI assistance. The Glide device is an EMG control system for prostheses, not an AI diagnostic imaging tool that would typically involve human "readers."
6. Standalone Performance Study
The information provided focuses on the standalone performance of the Glide system (algorithm and hardware together) through various verification and validation tests and compliance with performance standards. The results listed in the "Performance Data" section (e.g., "Installation of Core2," "Battery Life," "Lifetime and Reliability Testing") are all indicative of standalone algorithmic and system performance. The "IBT Control Application" runs on an iPad OS platform, and its software verification and validation is part of the standalone performance assessment.
7. Type of Ground Truth Used
The ground truth used for the tests appears to be based on device functionality and compliance with engineering/performance standards. For example:
- Engineering specifications: (e.g., successful installation, battery life, lifetime and reliability)
- User interaction/usability: (e.g., UI use by patient and practitioner, patient use of prosthetic component)
- Regulatory standards: (e.g., IEC/EN 60601 series for safety, essential performance, EMC).
- Physical testing: (e.g., packaging drop test).
The ground truth is not related to expert consensus, pathology, or outcomes data in a clinical diagnostic sense, but rather to the successful and safe operation of the medical device as per its design and intended use.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. The Glide device functions as a real-time control system for prostheses, processing electromyography (EMG) signals. While such systems may involve machine learning or signal processing algorithms, the document focuses on the performance verification of the final device, rather than the training phase of any underlying algorithms. It states that "Glide processes inputs from two to eight electrodes to drive a prosthesis into multiple movements without the use of traditional triggers and/or calibration," and uses "vector summation control." This implies a deterministic or rule-based control scheme, or a pre-trained model where the training details are not elaborated.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not described.
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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.
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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
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OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
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)
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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 |
| Damini@i-biomed.com |
3. DEVICE INFORMATION
| Trade Name | Glide |
|---|---|
| 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.
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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 BiomedicalTechnologies, LLC | Ottobock HealthcareProduct GmbH | Predicate DeviceComparison |
|---|---|---|---|
| Trade Name | Glide | Axon Bus Prostheticsystem | |
| System | |||
| Indications for Use | Glide is to be usedexclusively forexoprosthetic fittings ofthe upper limbs. | The Axon BusProsthetic System isto be usedexclusively forexoprosthetic fittingsof the upper limbs. | Same1 |
| Power Source included? | No | Yes | Differs2 |
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| Manufacturer | Infinite BiomedicalTechnologies, LLC | Ottobock HealthcareProduct GmbH | Predicate DeviceComparison |
|---|---|---|---|
| Trade Name | Glide | Axon Bus Prostheticsystem | |
| Terminal device (Hand,Wrist or Elbow) included? | No | Yes | Differs 3 |
| Wireless communication | Bluetooth® | Bluetooth® | Same |
| Clinical Software Tool | YesIBT Control Application | YesAxon Soft | Similar6 |
| Software/Firmware/ MicroprocessorControl? | 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 partCompatible withindustry 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 /suction socket | Suspension arms /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.
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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 DeviceGlide System | Predicate Device (K123795)Axon Bus Prosthetic System |
|---|---|---|
| Indications forUse | Glide is to be used exclusivelyfor exoprosthetic fittings of theupper limbs. | The Axon Bus ProstheticSystem is to be usedexclusively for exoprostheticfittings 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 DeviceGlide | PredicateAxon-Br | |
|---|---|---|
| D | Compatible with multiple | Michela |
| Subject Device | Predicate Device (K123795) | |
|---|---|---|
| Component | Glide | Axon-Bus Prosthetic System |
| Terminal device | Compatible with multipleprosthetic componentsincluding Michelangelo Hand | Michelangelo Hand |
| Passive wrist flexion device | Compatible with multipleprosthetic componentsthat include passive wristflexion within the device. | AxonFlexion Adapter |
| Passive wrist rotation device | Compatible with multipleprosthetic componentsincluding AxonRotation | AxonRotation Adapter |
| Passive elbow joint | Compatible with multipleprosthetic componentsincluding AxonArm | AxonArm |
| Battery | Compatible with multipleprosthetic powering systemsincluding AxonEnergyIntegral | AxonEnergy Integral |
| Charger | N/A | AxonCharge |
| Processing unit | Core2 Controller | Axon Master |
| EMG electrode | IBT Electrode V2 | Cased Electrode(PN:13E200=60) |
| Adjustment software | IBT Control Application | AxonSoft |
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| Component | Subject DeviceGlide | Predicate Device (K123795)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 apower source called AxonEnergy Integral. |
|---|---|
| Discussion: | Glide draws power from the prosthesis batteries and hence does notinclude a specific power source. Similar to other prosthetic components,Glide is designed to work with all industry standard battery systems. Asa result, this difference in inclusion of a power source has no impact onthe safety or effectiveness profile of the system. |
3. Terminal Device
| Description & Comparison: | Glide is compatible with multiple prosthetic components including thoseof the predicate device. The predicate device is compatible with onlyspecific prosthetic components. |
|---|---|
| Discussion: | Glide is designed to be compatible with all industry standard prostheticcomponents. They can be broadly classified into 3 main categories –analog, motor and digital – hands, wrists and elbows. IBT has runverification and validations on each category of devices to confirm thesafety and effectiveness of the same. |
| Further, the subject device outputs analog, digital, and motor signals tocontrol prosthetic components. In comparison, the predicate deviceoutputs only digital signals. However, the subject device has beendesigned and adequately verified and validated to be compatible with allindustry standard analog, motor and digital prosthetic components of |
not a concern.
hands, wrists, and elbows. Therefore, the difference in output signals is
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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
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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 thepredicate device. The control options include use of sustained electrodesignal with proportional range, ability to adjust the working range of thesignal, use of fast vs slow contraction signals, co-contraction basedcontrol and four channel control.The predicate device allows for use of the above control schemes withonly up to 3 electrodes; however, Glide applies the above controlschemes for up to 8 electrodes using vector summation control.Adjustment to the settings of the control scheme is performed throughthe IBT Control Application in Glide which is like the AxonSoft software inthe predicate device. Both systems run the control scheme throughfirmware programmed on a microprocessor. |
|---|---|
| Discussion | Glide expands the control options provided by the predicate device foruse with up to 8 electrodes through a vector summation method. Thenative functionality is similar and is only presented to the user visually ina different manner that also allows for the function to be applied to upto 8 electrodes. Since the native functionality is similar in both systems,and has been verified and validated thoroughly, there is no additionalsafety or effectiveness concern.Both the subject device and the predicate device allowclinicians to view EMG signals and adjust signal thresholds. However,each software app is proprietary to its own device system. The subjectdevice IBT Control application locally stores device configuration andcontrol option settings. It does not store any Personal IdentifiableInformation (PII) Data, nor does it connect to the internet. It hasundergone extensive software verification and validation. Therefore, thisdifference in the app is minor and not a concern.Both systems run the control scheme through firmware programmed ona microprocessor. The microprocessor used and the firmware it runs isproprietary to its own device system. However, the same control schemeis implemented in the firmware of both the subject and predicate device.The subject has undergone extensive software verification and |
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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.
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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 DeviceGlide | Comparison to Predicate DeviceAxon-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.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)Axon-Bus Prosthetic System |
|---|---|---|---|---|
| Safety | IEC/EN 60601-1 | Medical electrical equipmentPart 1: General requirements for basic safety and essential performance | IEC 60601-1:2005,IEC 60601 1:2005/AMD1:2012,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,IEC 60601-1-11:2015/AMD1:2020 for use in conjunction with IEC 60601-1:2005,IEC 60601-1:2005/AMD1:2012,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.
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| 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.
§ 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).