(149 days)
The Wave Electrode is to be used exclusively for external prosthetic fittings of the upper limbs.
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. 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
This document is a 510(k) Premarket Notification from BionIT Labs Srl for their Wave Electrode (AE02-60; AE02-50) devices, seeking clearance from the FDA. The document focuses on demonstrating substantial equivalence to predicate devices, and therefore does not contain acceptance criteria or performance studies in the way you might expect for a novel device or AI/ML algorithm.
Here's an analysis based on the provided text, highlighting what is present and what is absent regarding your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance statistics. Instead, it relies on demonstrating compliance with recognized electrical safety, EMC, and biocompatibility standards, and functional compatibility with a specific prosthetic hand. The performance is assessed by meeting these standards and ensuring the device operates as intended alongside the "Adam's Hand®" prosthetic hand.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The non-clinical performance data refers to "internal testing" and testing by "an accredited laboratory," but specifics on sample sizes, types of data (e.g., specific scenarios, duration), provenance, or study design are omitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided as there is no mention of a ground truth established by experts in the context of diagnostic or interpretive performance for an AI/ML algorithm. The device is a cutaneous electrode for EMG signal detection, and its performance is evaluated against engineering and biological safety standards, not against an expert-derived ground truth for an interpretation task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. As explained above, there's no mention of a ground truth derived from expert adjudication for interpretive tasks.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done or mentioned. This type of study is typically relevant for AI/ML-driven diagnostic or interpretive devices that assist human readers. The Wave Electrode is a hardware device for signal acquisition, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm-only performance study was done or mentioned. The device itself is hardware. The document states it is an "analog device and has no on-board programmable electronics (FW and or PEMS)."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the nature of the device (cutaneous electrode), the "ground truth" implicitly refers to:
- Engineering specifications and recognized standards: Performance is measured against criteria for electrical safety (IEC 60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993 series).
- Intended function: The ability to "detect, process, and transmit physiological signals" and operate as intended "in conjunction with 'Adam's Hand®' prosthetic hand."
There is no mention of ground truth related to medical diagnoses, pathology, or outcomes data, as these are not relevant to the function of a cutaneous EMG electrode.
8. The sample size for the training set
This information is not applicable/not provided. The Wave Electrode is described as an analog device without programmable electronics or software. Therefore, there is no AI/ML algorithm that would require a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as point 8.
{0}------------------------------------------------
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"
{1}------------------------------------------------
(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).
{2}------------------------------------------------
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
{3}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
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 SrlVia Cracovia 173010 - Soleto (LE)ITALY |
|---|---|
| Contact Person: | Matteo Aventaggiato |
| Contact Information: | m.aventaggiato@bionitlabs.com+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 LimbProsthetic 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 QiangnaoTechnology Co.,Ltd |
| K223738 | II - Secondary | Alpha Control Liner System(ACLS) | Coapt, LLC |
{5}------------------------------------------------
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 ofComparison | Subject Device | Predicate DeviceI | Predicate DeviceII | ComparisonVerdict |
|---|---|---|---|---|
| Manufacturer | BionIT Labs Srl | Zhejiang QiangnaoTechnology Co.,Ltd | Coapt, LLCContract Manufacturer:WillowWood Global LLC | |
| Trade Name | Wave Electrode | Dexus ProstheticSystem | Alpha Control LinerSystem | |
| Models | AE02-50, AE02-60 | MSL1, MSR1 | ||
| 510(k) Number | K242326 | K220002 | K223738 | - |
| ClassificationName | Cutaneous electrode | Cutaneous electrode | Cutaneous electrode | same |
| ClassificationProductCode | GXY | GXY | GXY | same |
| Product deviceClassification | II | II | II | same |
| SubsequentProductCode | IQZ | IQZ | IQZ | same |
| Intended Use /Indications | The Wave Electrodeis to be used | The DexusProsthetic System is | The Alpha Control LinerSystem is to be used | same |
| for Use | exclusively forexternal prostheticfittings of the upperlimbs. | to be usedexclusively forexternal prostheticfittings of the upperlimbs. | exclusively forexoprosthetic fittings ofthe upper limbs. | |
| Target group | The Wave Electrodeis designed to beused by ADULTSwearing mono- orbilateralamputations. | Dexus ProstheticSystem is suitablefor upper limbdisabled groups forupper limbamputees. | The Alpha Control LinerSystem is suitable forunilateral or bilateralamputations. | same |
| Principle ofoperation | Detect, process, andtransmitphysiological signalsfor use with aprosthesis andcontrols the terminaldevice. | Detect, process, andtransmitphysiological signalsfor use with aprosthesis andcontrols the terminaldevice. | The Alpha Control LinerSystem is an interfacesolution designed toprovide the CompleteControl System Gen2withamputee musclecontraction signals neededfor the pattern recognitionalgorithms. | same |
| Environment ofUse | Professionalhealthcare facilityand home use | Professionalhealthcare facilityand home use | Professional healthcarefacility and home use | same |
| Assemblingprocedure | Components areassembled by aprosthetist | Components areassembledby a prosthetist | The components of theAlpha Control LinerSystem are assembled bya prosthetist according tothe individual needs ofthe amputee. | same |
| Technological Characteristics - System | ||||
| Signalacquisition | EMG signals | EMG signals | EMG signals | same |
| Output signal | The output is ananalog signal with0-5V dynamics,proportional to theinstantaneousenvelope of theEMG signal | The output is ananalog signal of theEMG signal | The output is an analogand or digital signal of theEMG signal | Same ofpredicate INegligibledifferencesfor predicateII |
| Principle ofoperation | Detect the EMGsignal, process it,provide it as outputto an electronicsystem that drivesthe opening/closingof a myoelectricprosthetic hand; thissystem can beintegrated into thehand itself (as in thecase of Adam'sHand) | Detect the EMGsignal, process it,provide it as outputto an electronicsystem that drivesthe opening/closingof a myoelectricprosthetic hand; thissystem can beintegrated into thehand itself (as in thecase of Dexusprosthetic hand) | Detect the EMG signal,process it, provide it asoutput to an electronicsystem that drives theopening/closing of amyoelectric prosthetichand; this system can beexternal as in the case byCoapt Gen 2. | Same ofpredicate INegligibledifferencesfor predicateII |
| present in the upperlimb prostheticsystem. | and does not require anadditional battery. | |||
| PowerRequirements | 6 - 8.4 V (DC)2 mA | - | 5.3–16.8 VDC115 mA at 7.4 V | Similar (1)The range ofthe subjectdevice isincluded inthe predicatedevice II |
| SoftwareControl tools | No | Yes | YesComplete Control RoomSoftware | Different (2)The subjectdevice doesnot use anysoftware toolto control thesignal. |
| Terminal device(e.g., Hand,wrist, or elbow)included? | No | Yes | No | Similar/same(3)The subjectdevice doesnot includeprostheticlimbs as thepredicate IIdevice. |
| WirelessCommunicationfor 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) |
| Operatingtemperature | 0°C - 40°C | 0°C - 40°C | - | Same of thepredicate ldevice. |
| Contactmaterials | ABSAISI316L | Polycarbonate:PC2858,ThermoplasticElastomer:TM5ADT and MetalPieces(Copper gold plated):C1SQIN | Electrodes: Stainless Steel316LLiner: Tri-block copolymergel | Similar (4)AdditionalBiocompatibility testingperformed |
| Frequencybandwidth | 90 - 450 Hz | 80 - 500 Hz | - | Similar (1)The range ofthe subjectdevice isincludedinthe predicatedevice I |
| Safety and Performance Testing | ||||
| Electrical Safety | IEC 60601-1IEC 60601-1-11 | IEC 60601-1IEC 60601-1-11 | IEC 60601-1 | same |
| EMCCompatibility | IEC 60601-1-2 | IEC 60601-1-2 | - | Same |
| ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | The subjectdevice hasbeen testedaccording tothe state ofart of thebiocompatibility standard. |
{6}------------------------------------------------
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".
{7}------------------------------------------------
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.
{8}------------------------------------------------
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:
{9}------------------------------------------------
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.
§ 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).