DEKA SIMON

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below. September 1, 2023 El.En. S.p.A. Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50141 Italy Re: K232334 Trade/Device Name: Deka Simon Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: August 2, 2023 Received: August 4, 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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, Jitendra V. Virani -S CDR Jitendra Virani, MS, MBA Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Submission Number (if known) K232334 Device Name DEKA SIMON Indications for Use (Describe) The DEKA SIMON device is intended for - · Prevention or retardation of disuse atrophy - · Maintaining or increasing range of motion - · Muscle re-education - · Relaxation of muscle spasms - · Increasing local blood circulation - · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis 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." {3}------------------------------------------------ ### 510(k) Summary # SIMON – Special 510(k) ### 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: August 2, 2023 ## Device Trade Name: DEKA SIMON ### Manufacturer: DEKA M.E.L.A. srl Via Baldanzese, 17 50041 Calenzano (FI), Italy ### Common Name: Electro Muscle Stimulator ## Regulation Number: 21 CFR 890.5850 # Regulation Name: Powered Muscle Stimulator ### Regulatory Class: Class II ### Product Code: IPF Predicate Devices: DEKA PHYSIQ (K202079) {4}------------------------------------------------ ## Device Description: The DEKA SIMON is a device provided with 4 applicators by 2 electrodes each intended to employ EMS (Electrical Muscle Stimulation) technologies for various medical applications. The DEKA SIMON consists of: - an AC/DC power supply unit, - EMS driving electronic board - CPU controller; - user interface with LCD touch screen, ● - 4 EMS applicator with interconnecting cables The modifications to the device consist of a restriction of indications for use (removal of TENS mode), a restyling of the device (chassis, cover plastics and GUI) and of modifications to the applicator (different dimensions). The indications for use of the modified device, as described in the labelling, has been restricted to those referred to EMS mode only as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since predicate device clearance and considered as minor changes. ## Intended Use: The DEKA SIMON device is intended for: - Prevention or retardation of disuse atrophy - . Maintaining or increasing range of motion - Muscle re-education - Relaxation of muscle spasms - . Increasing local blood circulation - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis {5}------------------------------------------------ ### Substantial equivalence discussion: The DEKA SIMON device is substantially equivalent to the DEKA PHYSIQ (K202079) | | | Predicate Device | | |-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Trade Name | Subject Device | K202079 | Comment | | | SIMON | PHYSIQ | | | Design | The SIMON device with consists of AC/DC<br>power supply units, controller and user interface<br>including an LCD touch screen. The delivery of<br>the electrical energy is controlled by a Start/Stop<br>button positioned on the front panel.<br>The System support the following components:<br>• LCD display touch screen<br>• Buzzer<br>• 24V AC/DC power supply<br>• Controller<br>• Fans<br>The System operates while connected to the<br>handpiece. | The PHYSIQ System with consists of AC/DC<br>power supply units, controller and user interface<br>including an LCD touch screen. The delivery of<br>the electrical energy is controlled by a Start/Stop<br>button positioned on the front panel.<br>The System support the following components:<br>• LCD display touch screen<br>• Buzzer<br>• 24V AC/DC power supply<br>• Controller<br>• Fans<br>The System operates while connected to the<br>handpiece. | Identical | | Mechanism of Action | Muscle contraction by electrical pulsing | Muscle contraction by electrical pulsing | Identical | | Class, Product Code | Class II, IPF | Class II, IPF GZJ | Principal product<br>code is identical | | Rx/OTC | Rx only | Rx only | Identical | | Indications for use | The DEKA SIMON device is intended for<br>• Prevention or retardation of disuse atrophy<br>• Maintaining or increasing range of motion<br>• Muscle re-education | The PHYSIQ device is intended in EMS mode<br>for:<br>• Prevention or retardation of disuse atrophy | The indications for<br>use are a subset of<br>the predicate<br>device, the change<br>does not affect | | Device Trade Name | Subject Device<br>SIMON | Predicate Device<br>K202079<br>PHYSIQ | Comment | | | • Relaxation of muscle spasms<br>• Increasing local blood circulation<br>• Immediate postsurgical stimulation of calf<br>muscles to prevent venous thrombosis | • Maintaining or increasing range of motion<br>• Muscle re-education<br>• Relaxation of muscle spasms<br>• Increasing local blood circulation<br>• Immediate postsurgical stimulation of calf<br>muscles to prevent venous thrombosis<br>and in TENS mode for:<br>• Symptomatic relief and management of<br>chronic, intractable pain<br>• Post-surgical acute pain<br>• Post-traumatic acute pain | safety and efficacy | | Basic Unit Characteristics | | | | | | The DEKA SIMON device consists of the<br>following components: | The PHYSIQ System consists of the following<br>components: | Identical | | Components<br>Console | • Console (including controller, power supply<br>units and all needed electronic boards), and user<br>interface including an LCD touch screen.<br>• Four Applicators connected to the console via a<br>cable. | • Console (including controller, power supply<br>units and all needed electronic boards), and user<br>interface including an LCD touch screen.<br>• Four Applicators connected to the console via a<br>cable. | | | Device Trade Name | Subject Device | Predicate Device | Comment | | | SIMON | K202079<br>PHYSIQ | | | Dimensions | | | Similar, changes do not affect safety and effectiveness of the device | | Console [W x H x D] | 41 cm x 99 cm x 88 cm | 34cm x 67cm x 90cm | | | Applicator [L x D] | 9cm x 11cm | 9cm x 9cm | | | Weight: | | | Similar, changes do not affect safety and effectiveness of the device | | Console | $\sim$ 70 Kg | 51.0 Kg | | | Applicator | 0.5 Kg | 0.5 Kg | | | Performance<br>Specifications:<br>Components<br>Console | Main Line Frequency<br>(nominal)<br>50/60Hz<br>Input Voltage (nominal)<br>115-230VAC<br>Input Current (rms)<br>7A max | Main Line Frequency<br>(nominal)<br>50-60Hz<br>Input Voltage (nominal)<br>115-230VAC<br>Input Current (rms)<br>9A max | Similar, changes do not affect safety and effectiveness of the device | | Device Trade Name | Subject Device<br>SIMON | Predicate Device<br>K202079<br>PHYSIQ | Comment | | Method of line current isolation | AC/DC isolation | AC/DC isolation | Identical | | Electrical Type | Type BF | Type BF | Identical | | Patient Leakage Current - Normal<br>Condition (μΑ) | <100uA patient leakage | <100uA patient leakage | Identical | | Patient Leakage Current - Single<br>Fault Condition (μΑ) | <500uA line leakage | <500uA line leakage | Identical | | Number of output modes | 1 | 2 | Change does not<br>affect safety and<br>effectiveness of<br>the device. (TENS<br>mode removed) | | Number of Output channels | 4 | 4 | Identical | | Synchronous or alternating | Synchronous | Synchronous | Identical | | Method of Channel Isolation | Through AC/DC and transformers | Through AC/DC and transformers | Identical | | Regulated Current or Regulated<br>Voltage (output signals only) | Regulated voltage on all channels with current<br>limit | Regulated voltage on all channels with current<br>limit | Identical | | Device Trade Name | Subject Device<br>SIMON | Predicate Device<br>K202079<br>PHYSIQ | Comment | | Software/Firmware/Microprocessor<br>Control | Yes | Yes | Identical | | Automatic Overload Trip | Yes | Yes | Identical | | Automatic No-Load Trip | Yes | Yes | Identical | | Automatic Shut Off | Yes, On/off switch | Yes, On/off switch | Identical | | Patient Override Control | Yes | Yes | Identical | | Indicator Display | Yes | Yes | Identical | | On/Off Status | Yes | Yes | Identical | | Battery | No battery | No battery | Identical | | Voltage/Current level | Yes, voltage levels | Yes, voltage levels | Identical | | Timer Range (minutes) | 1-60 minutes | 0-60 minutes | Almost identical,<br>changes do not<br>affect safety and<br>effectiveness of<br>the device | | Device Trade Name | Subject Device<br>SIMON | Predicate Device<br>K202079<br>PHYSIQ | Comment | | Compliance with 21 CFR 898 | Yes | Yes | Identical | | Compliance with 21 CFR 890.5850<br>(IPF) | Yes | Yes | Identical | | Housing Material | Delrin | Delrin | Identical | | Output Specifications | | | | | Waveform | Symmetrical Biphasic<br>Waveform | Symmetrical Biphasic<br>Waveform | Identical | | Pulse Shape | Rectangular | Rectangular | Identical | | Maximum output voltage<br>(± 10%) | 50V @500Ω<br>50V @2kΩ<br>50V @ 10kΩ | 50V@500Ω<br>50V@2kΩ<br>50V @ 10kΩ | Identical | | Maximum output<br>current (± 10%) | 100mA@500 Ω<br>25mA@2 kΩ<br>5mA@10 kΩ | 100mA@500 Ω<br>25mA@2 kΩ<br>5mA@10 kΩ | Identical | | Pulse Width (µs) | 25 to 400 µs | 25 to 400 µs | Identical | | Device Trade Name | Subject Device<br>SIMON | Predicate Device<br>K202079<br>PHYSIQ | Comment | | Frequency (Hz) | 3 to 200 Hz | 3 to 200 Hz | Identical | | Net Charge @ 500 ohms<br>(µC/pulse)] | 0μC @ 500Ω | 0μC @ 500Ω | Identical | | Maximum Phase Charge (μC) | 40 μC @ 500Ω | 40 μC @ 500Ω | Identical | | Maximum Current Density<br>(mA/cm2) | 1.mA/cm² @ 500Ω | 1.1 mA/cm² @ 500Ω | Almost identical,<br>changes do not<br>affect safety and<br>effectiveness of<br>the device.<br>Specification is in<br>compliance with<br>IEC 60601-2-10<br>standard | | Maximum Power Density<br>(mW/cm2)] | 6.35mW/cm² @500Ω | 6.4mW/cm² @500Ω | Almost identical,<br>changes do not<br>affect safety and<br>effectiveness of<br>the device.<br>Specification is in<br>compliance with<br>IEC 60601-2-10<br>standard | | Burst Mode (i.e., pulse trains) | Yes: | Yes: | Identical | | | | Predicate Device | | | Device Trade Name | Subject Device | K202079 | Comment | | | SIMON…