(55 days)
Not Found
No
The description focuses on standard electrical muscle stimulation technology and does not mention any AI or ML components.
No.
The device's intended use explicitly states: "The device is not intended to be used in conjunction with therapy or treatment of medical disease or medical conditions of any kind."
No
Explanation: The "Intended Use / Indications for Use" states that the device is "indicated for muscle conditioning to stimulate healthy muscles" and "is not intended to be used in conjunction with therapy or treatment of medical disease or medical conditions of any kind." This indicates it's for muscle stimulation, not for diagnosing medical conditions.
No
The device description explicitly details hardware components including a main unit, electrodes, an EMS applicator, a footswitch, and physical dimensions and weight, indicating it is not software-only.
Based on the provided information, the LILY device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "muscle conditioning to stimulate healthy muscles." This is a physical function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device uses electrical pulses delivered via electrodes applied to the skin. This is a form of physical stimulation, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or physiological states through the analysis of these samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The LILY device's function falls outside of this definition.
N/A
Intended Use / Indications for 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 disease or medical conditions of any kind.
The device is intended to be operated by a trained professional who is present to monitor treatment.
Product codes (comma separated list FDA assigned to the subject device)
NGX
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 LILY 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional who is present to monitor treatment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
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"
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.
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
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
5
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.
6
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 muscle | ||
| conditioning to stimulate healthy 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. | Legend Pro DMA is intended for muscle | ||
| conditioning to stimulate healthy muscles. | |||
| Legend Pro DMA is not intended to be used in | |||
| conjunction with therapy or treatment of medical | |||
| diseases or medical conditions. | |||
| Legend Pro DMA is intended to be operated by a | |||
| trained professional who is present to monitor | |||
| treatment. | Identical | ||
| Predicate Device | |||
| Device Trade Name | Subject Device | K200545 | Comment |
| LILY | Legend Pro DMA | ||
| Mode of Operation | Application of transcutaneous electrical muscle | ||
| stimulation (EMS) through skin contact | |||
| electrodes | Application of transcutaneous electrical muscle | ||
| stimulation (EMS) through skin contact | |||
| electrodes | Identical | ||
| Mode of application | Metal (Stainless steel) electrodes in the System | ||
| Applicator emit electric energy to the skin while | |||
| the system applicator is rolled across the | |||
| treatment area | Metal (Stainless steel) electrodes in the System | ||
| Applicator emit electric energy to the skin while | |||
| the system applicator is rolled across the | |||
| treatment area | Identical | ||
| Basic Unit Characteristics | |||
| Dimensions | 47cm x 56cm x 106cm | 45 x 110 x 45 cm | Differences do not |
| affect safety and | |||
| effectiveness of | |||
| the device, as the | |||
| subject is | |||
| compliant with | |||
| requirements of | |||
| IEC 60601-1 and | |||
| IEC 60601-2-10 | |||
| Standards | |||
| Weight: | ~ 62 Kg | ~30 Kg; | Differences do not |
| affect safety and | |||
| effectiveness of | |||
| the device, as the | |||
| subject is | |||
| compliant with | |||
| requirements of | |||
| Device Trade Name | Subject Device | Predicate Device | Comment |
| LILY | K200545 | ||
| Legend Pro DMA | IEC 60601-1 and | ||
| IEC 60601-2-10 | |||
| Standards | |||
| Power Source(s) | 115V, 50/60Hz | 110-240 V, 50-60 Hz | Differences do not |
| affect safety and | |||
| effectiveness of | |||
| the device, as the | |||
| subject is | |||
| compliant with | |||
| requirements of | |||
| IEC 60601-1 and | |||
| IEC 60601-2-10 | |||
| Standards | |||
| Method of line current isolation | Medical Power Supply, Transformer in output | ||
| stage | Medical Power Supply, Transformer in output | ||
| stage | Identical | ||
| Patient Leakage Current - Normal | |||
| Condition (μΑ) | 0.1 μA | 1.5 μΑ | Different. |
| Value reported for | |||
| the subject device | |||
| is in compliance | |||
| with the limit of | |||
| 100uA set out in | |||
| FDA's "Guidance | |||
| Document for | |||
| Powered Muscle | |||
| Stimulator 510(k)" | |||
| and with IEC | |||
| 60601-1 and IEC | |||
| Device Trade Name | Subject Device | ||
| LILY | Predicate Device | ||
| K200545 | |||
| Legend Pro DMA | Comment | ||
| 60601-2-10 | |||
| Standards | |||
| Patient Leakage Current - Single | |||
| Fault Condition (μΑ) | 2 μΑ | 40 μΑ | Different |
| Value reported for | |||
| the subject device | |||
| is in compliance | |||
| with the limit of | |||
| 500uA set out in | |||
| FDA's "Guidance | |||
| Document for | |||
| Powered Muscle | |||
| Stimulator 510(k)" | |||
| and with IEC | |||
| 60601-1 and IEC | |||
| 60601-2-10 | |||
| Standards | |||
| 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 Device | ||
| LILY | Predicate Device | ||
| K200545 | |||
| Legend Pro DMA | Comment | ||
| Regulated Current or Regulated | |||
| Voltage (output signals only) | Voltage | Voltage | Identical |
| Software/Firmware/Microprocessor | |||
| Control | 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 not |
| affect safety and | |||
| effectiveness of | |||
| the device, as the | |||
| subject is | |||
| compliant with | |||
| requirements of | |||
| IEC 60601-1 and | |||
| IEC 60601-2-10 | |||
| Standards | |||
| Indicator Display | Yes | Yes | Identical |
| On/Off Status | Yes | Yes | Identical |
| Device Trade Name | Subject Device | ||
| LILY | Predicate Device | ||
| K200545 | |||
| Legend 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 not |
| affect safety and | |||
| effectiveness of | |||
| the device, as the | |||
| subject is | |||
| compliant with | |||
| requirements of | |||
| IEC 60601-1 and | |||
| IEC 60601-2-10 | |||
| Standards | |||
| 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 Device | ||
| LILY | Predicate Device | ||
| K200545 | |||
| Legend Pro DMA | Comment | ||
| Maximum output voltage | |||
| (± 10%) | 60V @500Ω | ||
| 3.95VRMS@500Ω | |||
| 200V @2kΩ | |||
| 12.3VRMS @2kΩ | |||
| 360V@10kΩ | |||
| 17.6VRMS@10kΩ | 60V @500Ω | ||
| 3.95VRMS @500Ω | |||
| 200V @2kΩ | |||
| 12.3VRMS @2kΩ | |||
| 360V@10kΩ | |||
| 17.6VRMS@10kΩ | Identical | ||
| Maximum output | |||
| current (± 10%) | 120mA@500 Ω | ||
| 100mA@2 kΩ | |||
| 36mA@10 kΩ | 120mA@500 Ω | ||
| 100mA@2 kΩ | |||
| 36mA@10 kΩ | Identical | ||
| Pulse Width (μs) | 25 to 400 μs | 20 to 400 μs | Almost identical. |
| Differences do not | |||
| affect safety and | |||
| efficacy of the | |||
| device | |||
| 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 @ 500Ω | ||
| biphasic waveform | |||
| Zero net charge is achieved by using | 0μC @ 500Ω | ||
| biphasic waveform | |||
| Zero net charge is achieved by using | Identical | ||
| Device Trade Name | Subject Device | Predicate Device | |
| K200545 | 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 second | |||
| c. 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 |
7
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10
11
12
13
14
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