Wave Electrode (AE02-60); Wave Electrode (AE02-50)
Device Facts
| Record ID | K242326 |
|---|---|
| Device Name | Wave Electrode (AE02-60); Wave Electrode (AE02-50) |
| Applicant | Bionit Labs Srl |
| Product Code | GXY · Neurology |
| Decision Date | Jan 2, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1320 |
| Device Class | Class 2 |
Indications for Use
The Wave Electrode is to be used exclusively for external prosthetic fittings of the upper limbs.
Device Story
Wave Electrode is an active analog cutaneous electrode for detecting surface electromyographic (EMG) signals to control myoelectric prosthetic hands. It detects electrical potentials from residual muscles on an amputated limb; processes and amplifies signals; and transmits an analog output (0-5V) proportional to muscle contraction to the prosthetic hand's electronic board. Used in professional healthcare facilities and home settings; operated by prosthetists during assembly and by patients during daily use. The device is integrated into the prosthetic system and requires no additional battery. It provides real-time control of prosthetic hand opening/closing. Benefits include non-invasive control of prosthetic devices for amputees.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-23).
Technological Characteristics
Active analog electrode; dimensions 27x18x8 mm; materials ABS and AISI316L; frequency bandwidth 90-450 Hz; power 6-8.4 V DC, 2 mA. Features notch filter (50 Hz for AE02-50, 60 Hz for AE02-60). Standalone analog component; no software or firmware. Sterilization not specified.
Indications for Use
Indicated for adults with mono- or bilateral upper limb amputations (transradial level or higher) requiring external prosthetic fittings.
Regulatory Classification
Identification
A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Predicate Devices
Submission Summary (Full Text)
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January 2, 2025
BionIT Labs Srl Aventaggiato Matteo Co-Founder & COO Via Cracovia 1 Soleto, LE 73010 Italy
Re: K242326
Trade/Device Name: Wave Electrode (AE02-60); Wave Electrode (AE02-50) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY, IQZ Dated: July 30, 2024 Received: August 6, 2024
Dear Aventaggiato Matteo:
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.
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"
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(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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
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Sincerely,
# Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K242326
Device Name
Wave Electrode (AE02-60); Wave Electrode (AE02-50)
Indications for Use (Describe)
The Wave Electrode is to be used exclusively for external prosthetic fittings of the upper limbs.
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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Image /page/4/Picture/0 description: The image is a logo for Bionit Labs. The logo features a stylized human figure inside a circle, next to the words "BIONIT LABS" in bold, black letters. Below the company name is the tagline "TURNING DISABILITIES INTO NEW POSSIBILITIES" in a smaller, blue font.
# Traditional 510(k) Summary Wave Electrode - K242326
# 1. SUBMITTER INFORMATION
| Manufacturer: | BionIT Labs Srl<br>Via Cracovia 1<br>73010 - Soleto (LE)<br>ITALY |
|----------------------|-------------------------------------------------------------------|
| Contact Person: | Matteo Aventaggiato |
| Contact Information: | m.aventaggiato@bionitlabs.com<br>+39 393 4425 000 |
| Date Prepared: | 02/01/2025 |
| Revision | 4 |
# 2. DEVICE IDENTIFICATION
| Trade/Proprietary Name: | Wave Electrode |
|--------------------------|------------------------------------------------------------------|
| Common/Usual Name: | Cutaneous electrode for External Upper Limb<br>Prosthetic System |
| Model name | AE02-50 and AE02-60 |
| Classification Name: | Cutaneous electrode |
| Regulation Number: | 21 CFR 882.1320 |
| Product Code: | GXY |
| Subsequent Product Code: | IQZ |
| Device Class: | Class II |
| Classification Panel: | Neurology |
# 3. LEGALLY MARKETED PREDICATE DEVICE
| 510k number | Predicate Device | Device name | Manufacturer |
|-------------|------------------|--------------------------------------|-----------------------------------------|
| K220002 | I - Primary | Dexus Prosthetics System | Zhejiang Qiangnao<br>Technology Co.,Ltd |
| K223738 | II - Secondary | Alpha Control Liner System<br>(ACLS) | Coapt, LLC |
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Image /page/5/Picture/0 description: The image is a logo for BionIT Labs. The logo features a stylized image of the Vitruvian Man on the left. To the right of the image is the text "BIONIT LABS" in a bold, sans-serif font. Below the company name is the tagline "TURNING DISABILITIES INTO NEW POSSIBILITIES" in a smaller, sans-serif font.
# 4. DEVICE DESCRIPTION
Wave Electrode is an active analogue electrode for detecting any surface electromyographic signals, used for controlling prosthetic devices. It is compact and low-power, ensuring an accurate and fast reading of muscle electrical potentials generated voluntarily by the user. It also provides a real-time output signal proportional to the detected muscle activation.
Therefore,
Through the Wave Electrode it is possible to non-invasively detect the electrical signal produced by the residual muscles on the patient's amputated limb (unilateral amputees, starting from a transradial amputation level) and send an electrical signal to the electronic board of the prosthetic hand with a proportional width to the detected contraction.
Wave Electrode is only compatible with the Adam's Hand that, according to the Requlation Number 890.3420, are classified as class I medical device.
Wave Electrode is available in two different models:
- . Mod. AE02-50, with notch filter centred on the 50 Hz frequency;
- . Mod. AE02-60, with notch filter centred on the 60 Hz frequency
# 5. INDICATION FOR USE
The Wave Electrode is to be used exclusively for external prosthetic fittings of the upper limbs.
# 6. COMPARISON TO PREDICATE DEVICE
The following table compares the Wave Electrode to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials used, and performance. The comparison of the devices provides more detailed information reqarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or efficacy based on the similarities to the predicate devices.
| Elements of<br>Comparison | Subject Device | Predicate Device<br>I | Predicate Device<br>II | Comparison<br>Verdict |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BionIT Labs Srl | Zhejiang Qiangnao<br>Technology Co.,Ltd | Coapt, LLC<br>Contract Manufacturer:<br>WillowWood Global LLC | |
| Trade Name | Wave Electrode | Dexus Prosthetic<br>System | Alpha Control Liner<br>System | |
| Models | AE02-50, AE02-60 | MSL1, MSR1 | | |
| 510(k) Number | K242326 | K220002 | K223738 | - |
| Classification<br>Name | Cutaneous electrode | Cutaneous electrode | Cutaneous electrode | same |
| Classification<br>Product<br>Code | GXY | GXY | GXY | same |
| Product device<br>Classification | II | II | II | same |
| Subsequent<br>Product<br>Code | IQZ | IQZ | IQZ | same |
| Intended Use /<br>Indications | The Wave Electrode<br>is to be used | The Dexus<br>Prosthetic System is | The Alpha Control Liner<br>System is to be used | same |
| | | | | |
| for Use | exclusively for<br>external prosthetic<br>fittings of the upper<br>limbs. | to be used<br>exclusively for<br>external prosthetic<br>fittings of the upper<br>limbs. | exclusively for<br>exoprosthetic fittings of<br>the upper limbs. | |
| Target group | The Wave Electrode<br>is designed to be<br>used by ADULTS<br>wearing mono- or<br>bilateral<br>amputations. | Dexus Prosthetic<br>System is suitable<br>for upper limb<br>disabled groups for<br>upper limb<br>amputees. | The Alpha Control Liner<br>System is suitable for<br>unilateral or bilateral<br>amputations. | same |
| Principle of<br>operation | Detect, process, and<br>transmit<br>physiological signals<br>for use with a<br>prosthesis and<br>controls the terminal<br>device. | Detect, process, and<br>transmit<br>physiological signals<br>for use with a<br>prosthesis and<br>controls the terminal<br>device. | The Alpha Control Liner<br>System is an interface<br>solution designed to<br>provide the Complete<br>Control System Gen2with<br>amputee muscle<br>contraction signals needed<br>for the pattern recognition<br>algorithms. | same |
| Environment of<br>Use | Professional<br>healthcare facility<br>and home use | Professional<br>healthcare facility<br>and home use | Professional healthcare<br>facility and home use | same |
| Assembling<br>procedure | Components are<br>assembled by a<br>prosthetist | Components are<br>assembled<br>by a prosthetist | The components of the<br>Alpha Control Liner<br>System are assembled by<br>a prosthetist according to<br>the individual needs of<br>the amputee. | same |
| Technological Characteristics - System | | | | |
| Signal<br>acquisition | EMG signals | EMG signals | EMG signals | same |
| Output signal | The output is an<br>analog signal with<br>0-5V dynamics,<br>proportional to the<br>instantaneous<br>envelope of the<br>EMG signal | The output is an<br>analog signal of the<br>EMG signal | The output is an analog<br>and or digital signal of the<br>EMG signal | Same of<br>predicate I<br>Negligible<br>differences<br>for predicate<br>II |
| Principle of<br>operation | Detect the EMG<br>signal, process it,<br>provide it as output<br>to an electronic<br>system that drives<br>the opening/closing<br>of a myoelectric<br>prosthetic hand; this<br>system can be<br>integrated into the<br>hand itself (as in the<br>case of Adam's<br>Hand) | Detect the EMG<br>signal, process it,<br>provide it as output<br>to an electronic<br>system that drives<br>the opening/closing<br>of a myoelectric<br>prosthetic hand; this<br>system can be<br>integrated into the<br>hand itself (as in the<br>case of Dexus<br>prosthetic hand) | Detect the EMG signal,<br>process it, provide it as<br>output to an electronic<br>system that drives the<br>opening/closing of a<br>myoelectric prosthetic<br>hand; this system can be<br>external as in the case by<br>Coapt Gen 2. | Same of<br>predicate I<br>Negligible<br>differences<br>for predicate<br>II |
| | present in the upper<br>limb prosthetic<br>system. | | and does not require an<br>additional battery. | |
| Power<br>Requirements | 6 - 8.4 V (DC)<br>2 mA | - | 5.3–16.8 VDC<br>115 mA at 7.4 V | Similar (1)<br>The range of<br>the subject<br>device is<br>included in<br>the predicate<br>device II |
| Software<br>Control tools | No | Yes | Yes<br>Complete Control Room<br>Software | Different (2)<br>The subject<br>device does<br>not use any<br>software tool<br>to control the<br>signal. |
| Terminal device<br>(e.g., Hand,<br>wrist, or elbow)<br>included? | No | Yes | No | Similar/same<br>(3)<br>The subject<br>device does<br>not include<br>prosthetic<br>limbs as the<br>predicate II<br>device. |
| Wireless<br>Communication<br>for electrode | No | No | No | Same |
| | Technological Characteristics - Electrode | | | |
| Dimensions | 27 x 18 x 8 mm | 34.5 x 16 x 11.5 mm | - | Similar (1) |
| Operating<br>temperature | 0°C - 40°C | 0°C - 40°C | - | Same of the<br>predicate l<br>device. |
| Contact<br>materials | ABS<br>AISI316L | Polycarbonate:<br>PC2858,<br>Thermoplastic<br>Elastomer:<br>TM5ADT and Metal<br>Pieces<br>(Copper gold plated):<br>C1SQIN | Electrodes: Stainless Steel<br>316L<br>Liner: Tri-block copolymer<br>gel | Similar (4)<br>Additional<br>Biocompatibi<br>lity testing<br>performed |
| Frequency<br>bandwidth | 90 - 450 Hz | 80 - 500 Hz | - | Similar (1)<br>The range of<br>the subject<br>device is<br>included<br>in<br>the predicate<br>device I |
| | Safety and Performance Testing | | | |
| Electrical Safety | IEC 60601-1<br>IEC 60601-1-11 | IEC 60601-1<br>IEC 60601-1-11 | IEC 60601-1 | same |
| EMC<br>Compatibility | IEC 60601-1-2 | IEC 60601-1-2 | - | Same |
| | ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23 | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | The subject<br>device has<br>been tested<br>according to<br>the state of<br>art of the<br>biocompatibil<br>ity standard. |
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Image /page/6/Picture/0 description: The image shows the logo for BionIT Labs. The logo features a stylized human figure inside a circle and square on the left. To the right of the figure, the text "BIONIT LABS" is written in a bold, sans-serif font. Below the company name, a light blue rectangle contains the text "TURNING DISABILITIES INTO NEW POSSIBILITIES".
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Image /page/7/Picture/0 description: The image is a logo for BionIT Labs. The logo features a stylized human figure inside a circle, followed by the text "BIONIT LABS" in bold, black letters. Below the text is a blue rectangle with the words "TURNING DISABILITIES INTO NEW POSSIBILITIES" in white letters.
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Image /page/8/Picture/0 description: The image shows the logo for Bionit Labs. The logo features a stylized image of a human figure inside of a circle on the left. To the right of the image is the text "BIONIT LABS" in a bold, sans-serif font. Below the company name is the text "TURNING DISABILITIES INTO NEW POSSIBILITIES" in a smaller font.
Given that the Wave Electrode is intended to acquire the surface EMG signals, filter and amplify them analogically and input them to the electronics of the myoelectic hand present in the prosthesis in which the electrodes are integrated, and acknowledging a few distinctions among the devices, it can be affirmed that the subject device is substantially equivalent to the predicate devices.
(1) Although the power requirements, dimensions, and frequency bandwidth of the subject device are slightly different from the predicate devices, all of them meet the requirements of safety and performance standards IEC 60601-1. So, the differences between the predicate devices and the subject device will not affect the safety and effectiveness of the subject device.
(2) The subject device communicates directly with the upper limb prosthetic systems.
Wave Electrode is an analog device and has no on-board programmable electronics (FW and or PEMS).
The subject device cannot lead to risks resulting from programmable electronics malfunctioning than the predicates .
(3) The subject device does not include prosthetic limbs.
Performance tests have showcased the compatibility of the Wave Electrode with only Adam's Hand prosthetic limb that can be utilized in conjunction with it.
(4) Although the contact materials of the subject device are different from the predicate devices, all the materials that in NORMAL USE come into contact to the PATIENT meet the requirements of ISO 10993 series standards. So, the differences between the predicate device and the subject devices will not affect the safety and effectiveness of the subject device.
(5) Although the subject device, the predicate device I (primary), and the predicate device II (secondary) use slightly different versions of the test standards, the subject device is in compliance with the state of art standards. So, the differences between the predicate devices and the subject device will not affect the safety and effectiveness of the subject device. The ISO 10993- 23 specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation, this specifies was included in the ISO 10993- 10.
# 7. NON-CLINICAL PERFORMANCE DATA
Considering that the Wave Electrode is intended to be used in conjunction with "Adam's Hand({" prosthetic hand, the safety of the electrodes have been demonstrated through the tests performed on the whole system (Electrodes + "Adam's Hand(B)" prosthetic hand)
- . Electrical safety test according to IEC 60601-1 and IEC 60601-1-11 standards
- . Electromagnetic compatibility test according to IEC 60601-1-2 standard
The Wave Electrode does not require an additional battery beyond the one present in the upper limb prosthetic system, and not included any software.
Wave Electrode has been directly evaluated for the biological safety to exclude the toxicological concerns, by an accredited laboratory as following:
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Image /page/9/Picture/0 description: The image shows the logo for BionIT Labs. The logo features a stylized human figure inside a circle on the left. To the right of the figure is the text "BIONIT LABS" in bold, black letters. Below the text is a blue rectangle with the words "TURNING DISABILITIES INTO NEW POSSIBILITIES" in white letters.
- Cytotoxicity testing per ISO 10993-5 .
- . Skin irritation testing per ISO 10993-10
- . Sensitization testing per ISO 10993-23
The Wave Electrode was also tested internally to ensure that it meets design specifications & requirements and operates as intended when is used in conjunction with "Adam's Hand®" prosthetic hand.
# 8. CLINICAL PERFORMANCE DATA
No human clinical testing was required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy for the use of the nonclinical testing detailed in this submission supports the substantial equivalence of the device.
# 9. STATEMENT OF SUBSTANTIAL EQUIVALENCE
The technological characteristics, features, specifications, mode of operation, and intended use of Wave Electrode are substantially equivalent to the electrodes included in the Dexus Prosthetics System and the electrode Alpha Control Liner System (ACLS) quoted above.
The differences between the subject device and primary predicate device do not raise new issues of safety or effectiveness. Thus, the subject device is substantially equivalent to the already placed on the US market primary predicate device K220002.
