(28 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard EMS technology and hardware components.
Yes
The device is intended for various medical applications, including the prevention of disuse atrophy, increasing range of motion, muscle re-education, relaxation of muscle spasms, increasing local blood circulation, and preventing venous thrombosis, all of which are therapeutic purposes.
No
The DEKA SIMON device employs Electrical Muscle Stimulation (EMS) for therapeutic purposes such as preventing atrophy, increasing range of motion, and muscle re-education, rather than for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as an AC/DC power supply unit, EMS driving electronic board, CPU controller, user interface with LCD touch screen, and EMS applicators with cables.
Based on the provided information, the DEKA SIMON device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to applying electrical stimulation to the body for therapeutic purposes (muscle stimulation, circulation, etc.). These are all in vivo applications, meaning they are performed on a living organism.
- Device Description: The device description details components related to electrical stimulation and user interface, not components typically found in IVD devices (which analyze biological samples).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements associated with in vitro testing.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. The DEKA SIMON's function is to directly interact with the body through electrical stimulation.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
IPF
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.
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
Not Found
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)
Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the DEKA SIMON device, according to the following standards:
- AAMI/ANSI ES60601-1- Medical 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.
- IEC 60601-2-10 - Medical electrical equipment - Part 2-10: Particular requirements for basic safety and essential performance of nerve and muscle stimulators.
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".
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
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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)
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)
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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 | ||
| power supply units, controller and user interface | |||
| including an LCD touch screen. The delivery of | |||
| the electrical energy is controlled by a Start/Stop | |||
| button positioned on the front panel. | |||
| The System support the following components: | |||
| • LCD display touch screen | |||
| • Buzzer | |||
| • 24V AC/DC power supply | |||
| • Controller | |||
| • Fans | |||
| The System operates while connected to the | |||
| handpiece. | The PHYSIQ System with consists of AC/DC | ||
| power supply units, controller and user interface | |||
| including an LCD touch screen. The delivery of | |||
| the electrical energy is controlled by a Start/Stop | |||
| button positioned on the front panel. | |||
| The System support the following components: | |||
| • LCD display touch screen | |||
| • Buzzer | |||
| • 24V AC/DC power supply | |||
| • Controller | |||
| • Fans | |||
| The System operates while connected to the | |||
| 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 |
| code is identical | |||
| Rx/OTC | Rx only | Rx only | Identical |
| Indications for use | The DEKA SIMON device is intended for | ||
| • Prevention or retardation of disuse atrophy | |||
| • Maintaining or increasing range of motion | |||
| • Muscle re-education | The PHYSIQ device is intended in EMS mode | ||
| for: | |||
| • Prevention or retardation of disuse atrophy | The indications for | ||
| use are a subset of | |||
| the predicate | |||
| device, the change | |||
| does not affect | |||
| Device Trade Name | Subject Device | ||
| SIMON | Predicate Device | ||
| K202079 | |||
| PHYSIQ | Comment | ||
| • Relaxation of muscle spasms | |||
| • Increasing local blood circulation | |||
| • Immediate postsurgical stimulation of calf | |||
| muscles to prevent venous thrombosis | • 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 | |||
| and in TENS mode for: | |||
| • Symptomatic relief and management of | |||
| chronic, intractable pain | |||
| • Post-surgical acute pain | |||
| • Post-traumatic acute pain | safety and efficacy | ||
| Basic Unit Characteristics | |||
| The DEKA SIMON device consists of the | |||
| following components: | The PHYSIQ System consists of the following | ||
| components: | Identical | ||
| Components | |||
| Console | • Console (including controller, power supply | ||
| units and all needed electronic boards), and user | |||
| interface including an LCD touch screen. | |||
| • Four Applicators connected to the console via a | |||
| cable. | • Console (including controller, power supply | ||
| units and all needed electronic boards), and user | |||
| interface including an LCD touch screen. | |||
| • Four Applicators connected to the console via a | |||
| cable. | |||
| Device Trade Name | Subject Device | Predicate Device | Comment |
| SIMON | K202079 | ||
| 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 | |||
| Specifications: | |||
| Components | |||
| Console | Main Line Frequency | ||
| (nominal) | |||
| 50/60Hz | |||
| Input Voltage (nominal) | |||
| 115-230VAC | |||
| Input Current (rms) | |||
| 7A max | Main Line Frequency | ||
| (nominal) | |||
| 50-60Hz | |||
| Input Voltage (nominal) | |||
| 115-230VAC | |||
| Input Current (rms) | |||
| 9A max | Similar, changes do not affect safety and effectiveness of the device | ||
| Device Trade Name | Subject Device | ||
| SIMON | Predicate Device | ||
| K202079 | |||
| 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 | |||
| Condition (μΑ) |