(55 days)
The LILY device is indicated for muscle conditioning to stimulate healty muscles.
The device is not intended to be used in conjunction with therapy or treatment of medical disease or medical conditions of any kind.
The device is intended to be operated by a trained professional who is present to monitor treatment.
The DEKA LILY device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via electrodes incorporated in an EMS applicator connected to the main unit.
The delivery of the electrical energy is controlled by a footswitch.
The DEKA LIL Y is provided with an applicator to perform EMS (Electrical Muscle Stimulation).
The applicator is provided with two different tips: Large and Medium, used to treat areas having different sizes, which include 3 stainless-steel equidistant electrodes.
The Applicator is directly applied on the area to be treated and moved by the operator across the skin.
The overall weight is approximately 62 kg and the sizes 47cm x 56cm x 106cm (L x W x H).
Electrical requirements: 115V, 50/60Hz, 2300VA.
Here's a breakdown of the acceptance criteria and study information for the DEKA LILY device, based on the provided FDA 510(k) summary:
Important Note: The provided document is a 510(k) summary for a Powered Muscle Stimulator (DEKA LILY). For this type of device, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily focused on safety and electrical performance to demonstrate substantial equivalence to a predicate device, rather than diagnostic accuracy or clinical efficacy studies that would typically involve AI/ML models. Therefore, many of the questions related to AI/ML model evaluation (e.g., ground truth, expert adjudication, MRMC studies) are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
For the DEKA LILY, acceptance criteria are generally defined by compliance with recognized electrical safety and performance standards for muscle stimulators, and a comparison to a legally marketed predicate device.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (DEKA LILY) | Comparison to Predicate (Legend Pro DMA) | Comment on Acceptance |
|---|---|---|---|---|
| Electrical Safety | ANSI AAMI ES60601-1 | Compliant | N/A (Standard Compliance) | Met |
| IEC 60601-1-2 (EMC) | Compliant | N/A (Standard Compliance) | Met | |
| IEC 60601-2-10 | Compliant | N/A (Standard Compliance) | Met | |
| Patient Leakage Current - Normal Condition | Limit: < 100 µA (FDA Guidance), Standard Limits | 0.1 µA | Predicate: 1.5 µA | Met (Compliant) |
| Patient Leakage Current - Single Fault Condition | Limit: < 500 µA (FDA Guidance), Standard Limits | 2 µA | Predicate: 40 µA | Met (Compliant) |
| Functional/Output Specs | Waveform | Biphasic | Identical | Met |
| Shape | Rectangular | Identical | Met | |
| Max Output Voltage | 60V@500Ω, 200V@2kΩ, 360V@10kΩ | Identical | Met | |
| Max Output Current | 120mA@500Ω, 100mA@2kΩ, 36mA@10kΩ | Identical | Met | |
| Pulse Width | 25 to 400 µs | Predicate: 20 to 400 µs | Almost Identical | |
| Frequency | 0.78, 1.56, 3.13, 6.25, 12.5 Hz | Identical | Met | |
| Net Charge @ 500 ohms | 0µC (biphasic, symmetrical) | Identical | Met | |
| Max Phase Charge | 24 µC @ 500Ω @12.5 Hz | Identical | Met | |
| Max Current Density | 1.1mA/cm² @ 500Ω | Identical | Met | |
| Max Power Density | 0.0044mW/cm² @500Ω | Identical | Met | |
| Software | Verification & Validation | Conducted according to FDA guidance | Predicate: Yes | Met (Compliant) |
| Biocompatibility | ISO 10993-1 | Performed according to FDA guidance | N/A (Standard Compliance) | Met |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the studies cited are primarily non-clinical electrical safety and performance testing, and engineering comparisons to a predicate device. There is no "test set" of patient data in the context of an AI/ML model for diagnostic performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for an AI/ML model is not relevant here. The "ground truth" for this device's performance is adherence to recognized industry standards for electrical safety and functional output.
4. Adjudication Method for the Test Set
Not applicable. There is no test set requiring adjudication in the context of this 510(k).
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
Not applicable. This device is a powered muscle stimulator, not an AI-assisted diagnostic tool. No human reader studies (MRMC) were conducted or are relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not feature a standalone algorithm or AI component in the sense of image analysis or diagnostic support. Performance is evaluated based on its physical and electrical characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering specifications and measurements: Direct measurement of electrical outputs (voltage, current, pulse width, frequency, leakage current).
- Compliance with international and national standards: Adherence to IEC 60601 series for medical electrical equipment safety and essential performance, and FDA guidance for powered muscle stimulators.
- Substantial equivalence to a legally marketed predicate device: Demonstrating that differences do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML training set for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML training set for this device.
In summary, the provided document details a 510(k) clearance for a medical device that operates on established electrical stimulation principles. The "acceptance criteria" and "studies" are focused on demonstrating that the new device is electrically safe, performs within expected parameters for its intended use, and is substantially equivalent to existing predicate devices, according to relevant industry standards and FDA guidance. This is distinct from the detailed performance evaluations required for AI/ML-driven diagnostic devices.
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December 19, 2023
El.En. S.p.A. Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, Fl 50141 Italy
Re: K233470
Trade/Device Name: DEKA LIL Y Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 25, 2023 Received: October 25, 2023
Dear Paolo Peruzzi:
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.
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 OHT5: Office of Neurological and Physical Medicine Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K233470
Device Name DEKA LILY
Indications for Use (Describe)
The LILY device is indicated for muscle conditioning to stimulate healty muscles.
The device is not intended to be used in conjunction with therapy or treatment of medical disease or medical conditions of any kind.
The device is intended to be operated by a trained professional who is present to monitor treatment.
| 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
LILY
Submitter:
El.En. S.p.A.
Via Baldanzese, 17
50041 Calenzano (FI), Italy
Contact:
Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it
Date Summary Prepared:
December 19, 2023
Device Trade Name:
DEKA LILY
Manufacturer:
DEKA M.E.L.A. srl
Via Baldanzese, 17
50041 Calenzano (FI), Italy
Common Name:
Electro Muscle Stimulator
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Regulation Number:
21 CFR 890.5850
Regulation Name:
Powered Muscle Stimulator
Regulatory Class:
Class II
Product Code:
NGX
Predicate Devices:
Legend Pro DMA (K200545)
Device Description:
The DEKA LILY device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via electrodes incorporated in an EMS applicator connected to the main unit.
The delivery of the electrical energy is controlled by a footswitch.
The DEKA LIL Y is provided with an applicator to perform EMS (Electrical Muscle Stimulation).
The applicator is provided with two different tips: Large and Medium, used to treat areas having different sizes, which include 3 stainless-steel equidistant electrodes.
The Applicator is directly applied on the area to be treated and moved by the operator across the skin.
The overall weight is approximately 62 kg and the sizes 47cm x 56cm x 106cm (L x W x H).
Electrical requirements: 115V, 50/60Hz, 2300VA.
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Intended Use:
The LILY device is indicated for muscle conditioning to stimulate healthy muscles.
The device is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind.
The device is intended to be operated by a trained professional who is present to monitor treatment.
Comparison with the Predicate Device:
| Device Trade Name | Predicate Device | ||
|---|---|---|---|
| Subject Device | K200545 | Comment | |
| LILY | Legend Pro DMA | ||
| Product Code | NGX | NGX | |
| Type of Use | Prescription Use (Part 21 CFR 801 Subpart D) | Prescription Use (Part 21 CFR 801 Subpart D) | Identical |
| Mechanism of Action | Muscle contraction by electrical pulsing | Muscle contraction by electrical pulsing | Identical |
| Indications for use | The LILY device is indicated for muscleconditioning to stimulate healthy muscles.The device is not intended to be used inconjunction with therapy or treatment of medicaldisease or medical conditions of any kind.The device is intended to be operated by atrained professional who is present to monitortreatment. | Legend Pro DMA is intended for muscleconditioning to stimulate healthy muscles.Legend Pro DMA is not intended to be used inconjunction with therapy or treatment of medicaldiseases or medical conditions.Legend Pro DMA is intended to be operated by atrained professional who is present to monitortreatment. | Identical |
| Predicate Device | |||
| Device Trade Name | Subject Device | K200545 | Comment |
| LILY | Legend Pro DMA | ||
| Mode of Operation | Application of transcutaneous electrical musclestimulation (EMS) through skin contactelectrodes | Application of transcutaneous electrical musclestimulation (EMS) through skin contactelectrodes | Identical |
| Mode of application | Metal (Stainless steel) electrodes in the SystemApplicator emit electric energy to the skin whilethe system applicator is rolled across thetreatment area | Metal (Stainless steel) electrodes in the SystemApplicator emit electric energy to the skin whilethe system applicator is rolled across thetreatment area | Identical |
| Basic Unit Characteristics | |||
| Dimensions | 47cm x 56cm x 106cm | 45 x 110 x 45 cm | Differences do notaffect safety andeffectiveness ofthe device, as thesubject iscompliant withrequirements ofIEC 60601-1 andIEC 60601-2-10Standards |
| Weight: | ~ 62 Kg | ~30 Kg; | Differences do notaffect safety andeffectiveness ofthe device, as thesubject iscompliant withrequirements of |
| Device Trade Name | Subject Device | Predicate Device | Comment |
| LILY | K200545Legend Pro DMA | IEC 60601-1 andIEC 60601-2-10Standards | |
| Power Source(s) | 115V, 50/60Hz | 110-240 V, 50-60 Hz | Differences do notaffect safety andeffectiveness ofthe device, as thesubject iscompliant withrequirements ofIEC 60601-1 andIEC 60601-2-10Standards |
| Method of line current isolation | Medical Power Supply, Transformer in outputstage | Medical Power Supply, Transformer in outputstage | Identical |
| Patient Leakage Current - NormalCondition (μΑ) | 0.1 μA | 1.5 μΑ | Different.Value reported forthe subject deviceis in compliancewith the limit of100uA set out inFDA's "GuidanceDocument forPowered MuscleStimulator 510(k)"and with IEC60601-1 and IEC |
| Device Trade Name | Subject DeviceLILY | Predicate DeviceK200545Legend Pro DMA | Comment |
| 60601-2-10Standards | |||
| Patient Leakage Current - SingleFault Condition (μΑ) | 2 μΑ | 40 μΑ | DifferentValue reported forthe subject deviceis in compliancewith the limit of500uA set out inFDA's "GuidanceDocument forPowered MuscleStimulator 510(k)"and with IEC60601-1 and IEC60601-2-10Standards |
| Number of output modes | 1 | 1 | Identical |
| Number of Output channels | 1 | 1 | Identical |
| Synchronous or alternating | Single output channel | Single output channel | Identical |
| Method of Channel Isolation | Single output channel | Single output channel | Identical |
| Device Trade Name | Subject DeviceLILY | Predicate DeviceK200545Legend Pro DMA | Comment |
| Regulated Current or RegulatedVoltage (output signals only) | Voltage | Voltage | Identical |
| Software/Firmware/MicroprocessorControl | Yes | Yes | Identical |
| Automatic Overload Trip | No | No | Identical |
| Automatic No-Load Trip | No | No | Identical |
| Automatic Shut Off | Yes, On/off switch | Yes, On/off switch | Identical |
| Patient Override Control | No | Yes | Differences do notaffect safety andeffectiveness ofthe device, as thesubject iscompliant withrequirements ofIEC 60601-1 andIEC 60601-2-10Standards |
| Indicator Display | Yes | Yes | Identical |
| On/Off Status | Yes | Yes | Identical |
| Device Trade Name | Subject DeviceLILY | Predicate DeviceK200545Legend Pro DMA | Comment |
| Low Battery | N/A | N/A | Identical |
| Voltage/Current level | Voltage | Voltage | Identical |
| Timer Range (minutes) | 1-30 minutes | 1-99 min | Differences do notaffect safety andeffectiveness ofthe device, as thesubject iscompliant withrequirements ofIEC 60601-1 andIEC 60601-2-10Standards |
| Compliance with 21 CFR 898 | Yes | Yes | Identical |
| Housing Material | Metal, Plastics | Metal, Plastics | Identical |
| Output Specifications | |||
| Waveform | Biphasic | Biphasic | Identical |
| Shape | Rectangular | Rectangular | Identical |
| Device Trade Name | Subject DeviceLILY | Predicate DeviceK200545Legend Pro DMA | Comment |
| Maximum output voltage(± 10%) | 60V @500Ω3.95VRMS@500Ω200V @2kΩ12.3VRMS @2kΩ360V@10kΩ17.6VRMS@10kΩ | 60V @500Ω3.95VRMS @500Ω200V @2kΩ12.3VRMS @2kΩ360V@10kΩ17.6VRMS@10kΩ | Identical |
| Maximum outputcurrent (± 10%) | 120mA@500 Ω100mA@2 kΩ36mA@10 kΩ | 120mA@500 Ω100mA@2 kΩ36mA@10 kΩ | Identical |
| Pulse Width (μs) | 25 to 400 μs | 20 to 400 μs | Almost identical.Differences do notaffect safety andefficacy of thedevice |
| Frequency (Hz) | 0.78, 1.56, 3.13, 6.25, 12.5 Hz | 0.78, 1.56, 3.13, 6.25, 12.5 Hz | Identical |
| Net Charge @ 500 ohms(µC/pulse)] | 0μC @ 500Ωbiphasic waveformZero net charge is achieved by using | 0μC @ 500Ωbiphasic waveformZero net charge is achieved by using | Identical |
| Device Trade Name | Subject Device | Predicate DeviceK200545 | Comment |
| LILY | Legend Pro DMA | ||
| symmetrical biphasic waveforms | symmetrical biphasic waveforms | ||
| Maximum Phase Charge (µC) | 24 µC @ 500Ω @12.5 Hz | 24 µC @ 500Ω @12.5 Hz | Identical |
| Maximum Current Density(mA/cm2) | 1.mA/cm² @ 500Ω | 1.1 mA/cm² @ 500Ω | Identical |
| Maximum Power Density(mW/cm2) | 0.0044mW/cm² @500Ω | 0.0044mW/cm² @500Ω | Identical |
| Burst Mode (i.e., pulse trains)a. Pulses per burst | N/A no burst mode | N/A no burst mode | Identical |
| b. Bursts per secondc. Burst duration (seconds)d. Duty Cycle [Line (b) x Line (c)] | |||
| ON time | 30 minutes | Not Publicly available | N/A |
| OFF time | 5 minutes | Not Publicly available s | N/A |
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Clinical Performance Data:
None
Non-Clinical Performance Data:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the DEKA LIL Y device, according to the following standards:
ANSI AAMI ES60601-1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Software Validation and Verification Testing
Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
Biocompatibility evaluation
Biocompatibility evaluation was performed according to the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Additional non-clinical testing conducted
Additional tests were conducted on the DEKA LILY device, according to the following standards:
IEC 60601-2-10 - Medical electrical equipment - Part 2-10: Particular requirements for basic safety and essential performance of nerve and muscle stimulators.
Conclusion:
Based on the comparison of indications for use and the technological characteristics, DEKA LIL Y is deemed to be substantially equivalent to the predicate device for the proposed indications for use.
Additional Information:
None
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).