(60 days)
Sense System with IBT Electrodes is to be used exclusively for external prosthetic fittings of upper limbs.
The Sense System is a surface electromyography (EMG) electrode system designed to enhance control of upper limb prosthetic devices. The Sense System detects EMG signals using the IBT Electrodes (previously approved by the FDA under 510k, K173571). The electrode signals are then processed using a pattern recognition algorithm and translated to output signals that are standardized to be compatible with an array of connected prosthetic devices, such as hands, wrists or elbows. The Sense System does not replace or modify any functionality of connected prosthetic components.
The Sense System is compatible with most hands, wrists, and elbows that accept industry standard signals. It is typically sold with three-port kidney-style output connectors; however, alternative connectors may be used to ensure compatibility with other components. The Sense System accepts power from IBT's FlexCell Battery system and outputs control signals to hands, wrists, and other prosthetic components. The Sense System is installed in the prosthesis by a trained prosthetist and connected to prosthetic components selected to meet the needs of the individual user.
Sense System components:
- IBT Electrodes (up to 8)
- Signal Processing Box
- User Interface Software
- Fabrication dummies for electrodes and processing box
The provided text describes a 510(k) premarket notification for the "Sense System with IBT Electrodes." It focuses on demonstrating substantial equivalence to a predicate device ("COMPLETE CONTROL System") rather than providing detailed acceptance criteria and a study dedicated to proving the device meets those criteria in the way typically found for an AI/ML medical device's performance claims.
The document primarily addresses the technological characteristics, performance, and safety of the Sense System in comparison to a predicate device to establish substantial equivalence for regulatory clearance. It doesn't present a study aimed at validating distinct performance metrics against specific, predefined numerical acceptance criteria for an AI model's accuracy, sensitivity, or specificity.
However, based on the information provided, we can infer some "acceptance criteria" through the lens of safety and effectiveness equivalence, and summarize the supporting "study" as a series of verification and validation tests.
Here's an attempt to structure the answer based on your request, while acknowledging the limitations of the provided text for a typical AI/ML performance study description:
Device: Sense System with IBT Electrodes
Purpose of the "Study" (Verification & Validation Testing): To demonstrate the safety and effectiveness of the Sense System with IBT Electrodes and its substantial equivalence to the legally marketed predicate device, the COMPLETE CONTROL System (K162891).
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly tied to demonstrating the new device performs as safely and effectively as the predicate, and does not raise new or different questions of safety and effectiveness. The "reported device performance" is the outcome of various tests and comparisons confirming this equivalence. Specific quantitative performance metrics for a pattern recognition algorithm's accuracy (e.g., control accuracy rates) are not detailed in this document.
| Feature / Category | Implied Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Indications for Use | Same as predicate: "exclusively for external prosthetic fittings of upper limbs" and "prescription use". | Identical indications for use and prescription use. Minor semantic differences in wording. (Table 2) |
| Technological Characteristics | Demonstrate no new or different questions of safety/effectiveness despite differences from predicate (Wireless Communication, Input Voltage, Output Signals, Calibration Method, Electrode Material, Suction Seal Compatibility) | Detailed discussion provided arguing that differences do not impact safety or effectiveness. (Pages 6-8) |
| Wireless Communication | Safe and Stable; passes FCC requirements; no additional safety risks over predicate. | Uses Bluetooth®, identical to previously approved Element system (K123759), tested extensively and found stable, passed FCC requirements. (Page 6) |
| Input Voltage Compatibility | Compatible with intended power source (FlexCell battery); no impact on safety/effectiveness. | Range of 5-10V, compatible with 7.4V FlexCell battery and other systems; no impact on safety/effectiveness. (Page 6) |
| Output Signals | Compatible with industry standard prosthetic components; similar functionality to predicate's outputs. | 0-5V analog, 0-3.3V digital, 0-8.2V motor signals. Tested for compatibility; similar to predicate's output standards. (Page 7) |
| Calibration Method | Safe and effective; no additional risks to patient safety. | PC-based User Interface for calibration, allowing more user options and pre-prosthetic practice. No additional risks. (Page 7) |
| Electrode Material & Biocompatibility | Safe, biocompatible, no increase in skin irritation or patient risks. | Titanium contacts (no nickel), plastic biocompatible. Passed biocompatibility tests. (Page 7) |
| Software Verification & Validation | Software meets design requirements and provides safe/effective operation. | "Passed Internal Testing Regimen," includes Software V&V and Design V&V. (Page 8) |
| Electrical Safety Standards | Compliance with relevant IEC standards for medical electrical equipment. | Certified to IEC/EN 60601-1 (2012/2006) and IEC 60601-1-11 (2010). (Page 8) |
| Electromagnetic Compatibility | Compliance with relevant IEC standards. | Certified to IEC 60601-1-2 (2007). (Page 8) |
| Design Verification & Validation Tests | Successfully demonstrate intended use safely and effectively. | All listed tests (Simulated installation, User Interface Use (IBT, Practitioner, Patient), Simulated Use with Prosthetic Components, Lifetime and Reliability, Battery Life, Packaging Drop Test) passed. (Page 9) |
| FlexCell Battery Testing | Safe and effective; compliance with relevant safety and transportation standards. | Passed all listed tests (Major Component, V&V Test Plans, Charger Update V&V) and certified to IEC 60601-1, IEC 62133, and UN38.3. (Page 10) |
2. Sample Size and Data Provenance
The document does not specify a "sample size" in the context of a dataset for an AI model's performance evaluation (e.g., number of patient cases). Instead, it refers to various engineering and functional tests.
- Test Set Sample Size: Not applicable in the context of a test set for an AI model's performance on patient data. The tests described are functional, electrical safety, usability, and design verification tests.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing appears to be internal validation and verification, simulating use and testing components as per regulatory standards. No country of origin for specific "data" (apart from the manufacturer being in Baltimore, Maryland, USA) relating to patient cases is mentioned.
3. Number of Experts and Qualifications for Ground Truth
The document does not describe a process for establishing ground truth through expert review of patient data, as would be typical for an AI diagnostic device. The "ground truth" for this device's performance appears to be established by engineering specifications, safety standards, and functional requirements. For the "Practitioner Use of UI" and "Patient Use of UI" tests, it can be inferred that prosthetists and patients were involved, but the number and their specific qualifications for establishing ground truth are not detailed.
4. Adjudication Method for the Test Set
Not applicable. The tests described are engineering and functional validation, not clinical review of cases requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this document. The device is a control system for prosthetics, where the "human-in-the-loop" is the user of the prosthetic. The document does not evaluate how human readers (e.g., radiologists interpreting images) improve with AI assistance.
6. Standalone (Algorithm Only) Performance
The sense system is described as using a "pattern recognition algorithm" to process EMG signals (Page 4). However, the document does not report standalone performance metrics (e.g., accuracy, sensitivity, specificity) for this algorithm in isolation. The evaluation focuses on the entire "Sense System" as a functional unit to ensure safety and effectiveness for controlling prosthetic devices.
7. Type of Ground Truth Used
The "ground truth" for this device's clearance is based on:
- Engineering specifications and design requirements.
- International standards for medical electrical equipment (IEC/EN 60601 series) and battery safety (IEC 62133, UN38.3).
- Functional performance (e.g., proper signal output, compatibility with prosthetic components).
- Usability testing, which would involve observing user interaction with the system.
It is not based on expert consensus on patient cases, pathology, or outcomes data in the typical sense of a diagnostic AI device.
8. Sample Size for the Training Set
Not applicable. The document does not describe the specifics of the pattern recognition algorithm's training, including its training data size. The focus is on the integrated system's safety and effectiveness.
9. How the Ground Truth for the Training Set Was Established
Not applicable. The document does not provide details on the training process or ground truth establishment for the internal pattern recognition algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Infinite Biomedical Technologies, LLC Rahul Kaliki CEO 8 Market Place, Suite 500 Baltimore, Maryland 21202
Re: K182112
Trade/Device Name: Sense System with IBT Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY, IQZ Dated: August 2, 2018 Received: August 6, 2018
Dear Rahul Kaliki:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (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
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Indications for Use
510(k) Number (if known) K182112
Device Name Sense System with IBT Electrodes
Indications for Use (Describe)
Sense System with IBT Electrodes is to be used exclusively for external prosthetic fittings of upper limbs.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/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 a mathematical symbol representing the concept of endlessness or limitlessness.
510(k) Summary Sense System
1. SUBMITTER'S INFORMATION
| Name/Manufacturer | Infinite Biomedical Technologies, LLC |
|---|---|
| Address | 8 Market Pl, Suite 500, Baltimore, MD 21202 |
| Phone Number | (443) 451-7175 |
| Fax Number | (443) 451-7179 |
| Contact Person | Rahul Kaliki, PhD, Chief Executive Officer |
| Date Prepared | August 1, 2018 |
2. DEVICE INFORMATION
| Trade Name | Sense System with IBT Electrodes |
|---|---|
| Common Name | Powered, External Upper Limb Prosthetic System |
| Classification | Cutaneous Electrode (21 CFR § 882.1320) |
| Product Code | GXY (Electrode, Cutaneous) |
| Subsequent Product Code | IQZ (Hand, External Limb, Component, Powered) |
PREDICATE DEVICE INFORMATION 3.
| Device Name | COMPLETE CONTROL System |
|---|---|
| 510(k) Number | K162891 |
4. REFERENCE DEVICE INFORMATION
| Device Name | Element System with IBT Electrodes |
|---|---|
| 510(k) Number | K173571 |
5. INDICATIONS FOR USE STATEMENT
Sense System with IBT Electrodes is to be used exclusively for external prosthetic fittings of upper limbs.
6. DEVICE DESCRIPTION
The Sense System is a surface electromyography (EMG) electrode system designed to enhance control of upper limb prosthetic devices. The Sense System detects EMG signals using the IBT Electrodes (previously approved by the FDA under 510k, K173571). The electrode signals are then processed using a pattern recognition algorithm and translated to output signals that are standardized to be compatible with an array of connected prosthetic devices, such as hands, wrists or elbows. The Sense System does not replace or modify any functionality of connected prosthetic components.
The Sense System is compatible with most hands, wrists, and elbows that accept industry standard signals. It is typically sold with three-port kidney-style output connectors; however, alternative connectors may be used to ensure compatibility with other components. The Sense System accepts power from IBT's FlexCell Battery system and outputs control signals to hands, wrists, and other prosthetic components. The Sense System is installed in the prosthesis by a trained prosthetist and connected to prosthetic components selected to meet the needs of the individual user.
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Sense System components:
- IBT Electrodes (up to 8)
- Signal Processing Box
- User Interface Software
- . Fabrication dummies for electrodes and processing box
7. TECHNOLOGICAL CHARACTERISTICS
Table 1 provides a summary of technological characteristics of the product in comparison to the predicate device as well as in comparison to the reference device.
Table 1: Technological Summary
| Manufacturer | Infinite BiomedicalTechnologies, LLC | Coapt, LLC | DeviceComparison | Reference Device -Infinite BiomedicalTechnologies LLC | ReferenceDeviceComparison |
|---|---|---|---|---|---|
| Trade Name | Sense System withIBT Electrodes | COMPLETE CONTROLSystem | Element Systemwith IBT Electrodes | ||
| System | |||||
| Power Sourceincluded? | No | No | Same | No | Same |
| Terminal device(Hand, Wrist orElbow) included? | No | No | Same | No | Same |
| Wirelesscommunication | Bluetooth® | RF Transmitter,CompleteCommunicator21.8 x 69.2 x 16.1mm | Differs | Bluetooth® | Same |
| Clinical SoftwareTool | YesUser InterfaceApplication | YesCompleteControlroom | Similar | YesUser InterfaceApplication | Similar |
| Software/Firmware/ MicroprocessorControl? | Yes | Yes | Similar | Yes | Similar |
| Input Voltage | 5 to 10 VDC | 5.3-16.8 VDC | Differs | 5 to 10 VDC | Same |
| Output Signal | 0-5V analog, 0-3.3Vdigital and 0-8.2Vmotor | Analog, motor(ranges unknown) | Unknown | 0-5V analog | Similar |
| Processing Unit | |||||
| Processing Unit | Processing Box | Complete Controller | Processing Box | ||
| (L x W x H) | 59 x 27.8 x 9.8mm | 66.1 x 25.9 x 13.5mm | Similar | 38 x 23 x 8 mm | Similar |
| Control options | Pattern Recognition | Pattern Recognition | Same | None | Differs |
| Input button | None | Complete Calibrate27.6 x 17.8 x 11.7mm | Differs | None | Same |
| Electrode | |||||
| Electrode /Amplifier | IBT Electrode | Complete Co-Amp47.8 x 21.4 x 9.6 mm+ Cables and metaldomes | IBT Electrode | ||
| (L x W x H) | 29 x 17 x 7 | 47.8 x 21.4 x 9.6 mm+ Cables and metaldomes | Similar | 29 x 17 x 7 | Same |
| Temperaturerange | -10°C to 50°C | 0°C to 35°C | Differs | -10°C to 50°C | Same |
| infinite biomedical technologies | |||||
| Manufacturer | Infinite BiomedicalTechnologies, LLC | Coapt, LLC | DeviceComparison | Reference Device -Infinite BiomedicalTechnologies LLC | ReferenceDeviceComparison |
| Trade Name | Sense System withIBT Electrodes | COMPLETE CONTROLSystem | Device Comparison | Element Systemwith IBT Electrodes | Reference Device Comparison |
| Housing Material | Plastics (ABS/PCBlend) | Unknown | Unknown | Plastics (ABS/PCBlend) | Same |
| Contact Area | Titanium (Grade 1) | Stainless Steel orgold plated | Differs | Titanium (Grade 1) | Same |
| Bonding Agent | Cyanoacrylate | Unknown | Unknown | Cyanoacrylate | Same |
| Signal processing | Digital | Digital | Same | Digital | Same |
| FrequencyBandwidth | 90 - 500 Hz | Unknown | Unknown | 90 - 500 Hz | Same |
| Adjustment | Digital gain 1-7 | Digital gain | Similar | Digital gain 1-7 | Same |
| Installation | suspension arms /suction socket | suspension arms /suction socket | Same | suspension arms /suction socket | Same |
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8. Substantial Equivalence Discussion
The Sense system with IBT Electrodes is substantially equivalent to the Coapt COMPLETE CONTROL System (K162891). A comparison of the indications for use, technology, and performance is provided herein to support this determination. For instances where technological differences are identified in the previous section, additional discussion describes how these differences do not raise new or different questions of safety and effectiveness. When appropriate, performance data is cited to provide evidence that the subject device is as safe and as effective as the legally marketed predicate device.
The Sense System with IBT Electrodes also uses the Electrodes (K173571) as the reference device. This is because the Bluetooth module and communication protocol, the Ul framework, the electrodes used as well as the recommended power supply are identical to those in the Element System with the IBT Electrode which was previously cleared under K173571.
Indications for Use
Both the subject device and the predicate device are intended to be used exclusively for external prosthetic fittings of upper limbs. Both products are prescription use devices, intended by a prosthetist or trained clinician.
Table 2. Indications for Use
| Characteristic | Subject Device | Predicate Device (K162891) |
|---|---|---|
| Sense System | COMPLETE CONTROL System | |
| Indications for Use | The Sense System is to be usedexclusively for external prosthetic fittingsof upper limbs. | The COMPLETE CONTROL System is to beused exclusively for external prostheticfittings of the upper limbs. |
Minor differences in the written text do not affect the meaning (in other words, they are semantics).
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Technology
The Sense System contains similar components as the COMPLETE CONTROL System (K162891), as delineated in Table 3.
| Component | Subject DeviceSense System | Predicate Device (K162891)COMPLETE CONTROL System |
|---|---|---|
| Processing unit | Signal Processing Box | Complete Controller |
| EMG electrode | IBT Electrode | Complete Co-amp, with cablingand domes |
| Adjustment software | User Interface Application | Complete Controlroom |
| Input Button | Not needed | Complete Calibrate |
| Communication | Use internal | Complete Communicator |
Table 3: System Components
Based upon a technical review of both systems, IBT has identified the following technical differences:
- Wireless Communication ●
- Input Voltage
- Output Signals
- Calibration Method
- . Electrode Material and Suction Seal Compatibility
These areas are described and discussed herein.
Wireless Communication
| Wireless Communication Description & Comparison: | |
|---|---|
| The Sense signal processing box communicates with the user interface viaBluetooth® to update the pattern recognition classifier and otherparameters. The predicate uses a non-Bluetooth®-based RF wirelesstechnology to do the same. | |
| Wireless Communication Discussion: | |
| Wireless communication with the user interface is not related to usersafety. The use of Bluetooth® in the Sense system does not introduce anyadditional safety risks over the predicate device. In fact, the SenseSystem Bluetooth® communication is identical to the previouslyapproved Element system (K123759), has been tested extensively andfound to be stable. Additionally, the Bluetooth® module has passed FCCrequirements. | |
| Input Voltage Description & Comparison: | |
| The Sense System has an input voltage range of 5-10 V. The predicatedevice has an input range of 5.3-16.8 V. | |
| Input Voltage Discussion: | |
| The input voltage range of the Sense System is similar to most electrodesand controllers currently sold on the market today. The Sense System isonly intended to be compatible with a separately sold battery, FlexCell,which is rated at a nominal voltage of 7.4V. Many other battery systemsare also rated at this voltage. This difference in voltage requirements hasno impact on the safety or effectiveness profile; furthermore, compatiblecomponents are listed for customers. | |
| Output Signals | |
| Description & Comparison: | The processing box determines what type of signal the Sense Systemoutputs. Sense has a great variety of outputs, which include 0-5V analog,0-3.3V digital, and 0-8.2V motor signals, all based on compatibility testingwith a range of prosthetic components. The COMPLETE CONTROL systemdoes not specifically list the output types, but based on the list ofcompatible components provided, the system likely have similar analogand motor inputs. |
| Discussion: | The two systems share a similar list of compatible components, andtherefore must have similar output standards. Majority of componentslisted are compatible with the industry standard 5V output analogelectrode. Those that are motor driven have been tested throughverifications. Therefore, the outputs of Sense and COMPLETE CONTROLare likely similar. Additionally, both systems use industry standardconnection types. |
| Calibration Method | |
| Description & Comparison: | The Sense System offers users the option to calibrate their patternrecognition algorithm through a user interface. The option of a PC pre-installed with the software is available to reduce the burden on thepatient and their practitioner. The predicate device offers an input buttonconnected to the controller that activates a prosthesis-guided calibrationsession. The PC-based GUI is provided as a back-up only for use bypractitioners. |
| Discussion: | IBT developed the user interface as the main form of calibration in orderto allow users more options for their control, including the ability tocalibrate only one movement in the classifier Additionally, the userinterface provides the option to practice control pre-prosthetically witha virtual arm, allowing patients to practice control before the finalprosthesis is completed. The calibration methodology used in the Sensesystem does not introduce any additional risks related to patient safety. |
| Electrode Material | |
| Description & Comparison: | The Sense System includes 8 active, encased electrodes which digitizesthe signals on board and communicates with the processing box. Thecontacts are titanium and the plastic is biocompatible. Alternatively, theCOMPLETE CONTROL system uses commercially available electrodedome contacts which are typically stainless steel. These are the onlycomponents to interface with the skin; signals are processed remotely inthe Complete Co-amp. |
| Discussion: | The IBT Electrodes were designed to be self-contained through earlydigitization and be easily replaceable in case of damage. Additionally, allmaterials were selected with reduction of skin irritation in mind. Thetitanium contacts do not contain nickel, which is a common skin allergy.The electrodes have been tested for and successfully passedbiocompatibility. Differences in material and size do not increase risks tothe patient. |
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infinite biomedical technologies
Description & Comparison: A specific requirement for certain prosthetic applications is to include electrodes capable of maintaining suction on the patient's limb when the prosthesis is donned. The Sense system with IBT Electrodes can be fabricated into a suction seal socket. The predicate device uses domed electrodes which need to be individually fabricated into a suction socket. Discussion: The electrode size could impact installation (maintaining suction) and performance (signal detection). Neither aspect is unique or representative of a new/different question of safety or effectiveness.
9. Performance Data
IBT has conducted performance tests to demonstrate the safety and effectiveness of the Sense system with IBT Electrodes, compared to the predicate device (see Table below)
| Performance Test | Subject DeviceSense System with IBT Electrodes | Comparison to Predicate DeviceComplete Control System (K162891) |
|---|---|---|
| Software V&V and Design V&V | Passed Internal Testing Regimen | As with any device, predicate would alsobe tested to determine if user and devicerequirements are met. |
The Sense System was tested to ensure its safety and effectiveness. The following Performance Standards were used for performance testing on Sense and the IBT Electrodes:
| Category | No | Title | Version | Comparison to PredicateDevice (K162891)COMPLETE CONTROLSystem |
|---|---|---|---|---|
| Safety | IEC/EN 60601-1 | Medical electrical equipmentPart 1: General requirementsfor basic safety and essentialperformance | 2012(IEC)/2006(EN) | Similar - predicate wastested to 2007 standards |
| IEC 60601-1-11 | General requirements for basicsafety and essentialperformance - CollateralStandard: Requirements formedical electrical equipmentand medical electrical systemsused in the home healthcareenvironment | 2010 | Predicate was not tested tothis standard | |
| ElectromagneticCompatibility | IEC 60601-1-2 | Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirementsand tests | 2007 | Equivalent |
The IBT Electrodes have been previously cleared by the FDA under K173571.
The Sense System also underwent design verification and validation, software verification and validation, and usability testing to demonstrate its ability to achieve its intended use safely and effectively. The tables below outline the validation testing that was performed on Sense with IBT Electrodes.
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infinite biomedical technologies
| Test Name | Result |
|---|---|
| Simulated installation of Sense | Pass |
| IBT Use of UI | Pass |
| Practitioner Use of UI | Pass |
| Patient Use of UI | Pass |
| Simulated Use with Prosthetic Components | Pass |
| Lifetime and Reliability Testing | Pass |
| Battery Life | Pass |
| Packaging Drop Test | Pass |
Validation testing on Sense with IBT Electrodes
The FlexCell battery was also tested to ensure its safety and effectiveness. The following Performance Standards were used for performance testing of the FlexCell battery:
| Category | No | Title | Version |
|---|---|---|---|
| Safety | IEC 60601-1 | Medical electrical equipment Part 1: Generalrequirements for basic safety and essentialperformance | 2012 (IEC) |
| IEC 62133 | Secondary cells and batteries containing alkalineor other non-acid electrolytes - Safetyrequirements for portable sealed secondary cells,and for batteries made from them, for use inportable 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 |
10. Conclusions
Based upon the discussion provided herein and the supporting data, IBT believes that the Sense System, which includes Sense, the IBT Electrodes, and the UI Application, is as safe and as effective as the predicate device (COMPLETE CONTROL System, K162891) for its intended use, making it substantially equivalent to a legally marketed predicate device.
§ 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).