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.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested. The document is a 510(k) summary for the DEKA SIMON device, primarily focused on establishing substantial equivalence to a predicate device (DEKA PHYSIQ, K202079).

It discusses the device's technical specifications and how they compare to the predicate, and lists the types of performance data submitted (Electrical safety and electromagnetic compatibility, Software Validation and Verification Testing) and the standards followed. However, it does not provide:

A table of acceptance criteria and reported device performance specifically for a clinical or performance study.
Sample size used for a test set.
Data provenance (country of origin, retrospective/prospective).
Number of experts or their qualifications.
Adjudication method.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
Results from a standalone (algorithm only) performance study.
Type of ground truth used.
Sample size for a training set.
How ground truth for the training set was established.

The "Performance Data" section solely lists the types of engineering and software tests conducted for safety and essential performance, not clinical or performance studies for effectiveness. The conclusion states that the device is "as safe, as effective, and performs as well as the legally marketed predicate device (K202079)" based on technological characteristics and indication for use comparison, implying that no separate clinical performance study was deemed necessary for demonstrating substantial equivalence for this particular modification (a Special 510(k)).

Summary

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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

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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

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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)

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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)

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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

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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/DCpower supply units, controller and user interfaceincluding an LCD touch screen. The delivery ofthe electrical energy is controlled by a Start/Stopbutton positioned on the front panel.The System support the following components:• LCD display touch screen• Buzzer• 24V AC/DC power supply• Controller• FansThe System operates while connected to thehandpiece.	The PHYSIQ System with consists of AC/DCpower supply units, controller and user interfaceincluding an LCD touch screen. The delivery ofthe electrical energy is controlled by a Start/Stopbutton positioned on the front panel.The System support the following components:• LCD display touch screen• Buzzer• 24V AC/DC power supply• Controller• FansThe System operates while connected to thehandpiece.	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 productcode 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 modefor:• Prevention or retardation of disuse atrophy	The indications foruse are a subset ofthe predicatedevice, the changedoes not affect
Device Trade Name	Subject DeviceSIMON	Predicate DeviceK202079PHYSIQ	Comment
	• Relaxation of muscle spasms• Increasing local blood circulation• Immediate postsurgical stimulation of calfmuscles 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 calfmuscles to prevent venous thrombosisand in TENS mode for:• Symptomatic relief and management ofchronic, intractable pain• Post-surgical acute pain• Post-traumatic acute pain	safety and efficacy
Basic Unit Characteristics
	The DEKA SIMON device consists of thefollowing components:	The PHYSIQ System consists of the followingcomponents:	Identical
ComponentsConsole	• Console (including controller, power supplyunits and all needed electronic boards), and userinterface including an LCD touch screen.• Four Applicators connected to the console via acable.	• Console (including controller, power supplyunits and all needed electronic boards), and userinterface including an LCD touch screen.• Four Applicators connected to the console via acable.
Device Trade Name	Subject Device	Predicate Device	Comment
	SIMON	K202079PHYSIQ
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
PerformanceSpecifications:ComponentsConsole	Main Line Frequency(nominal)50/60HzInput Voltage (nominal)115-230VACInput Current (rms)7A max	Main Line Frequency(nominal)50-60HzInput Voltage (nominal)115-230VACInput Current (rms)9A max	Similar, changes do not affect safety and effectiveness of the device
Device Trade Name	Subject DeviceSIMON	Predicate DeviceK202079PHYSIQ	Comment
Method of line current isolation	AC/DC isolation	AC/DC isolation	Identical
Electrical Type	Type BF	Type BF	Identical
Patient Leakage Current - NormalCondition (μΑ)	<100uA patient leakage	<100uA patient leakage	Identical
Patient Leakage Current - SingleFault Condition (μΑ)	<500uA line leakage	<500uA line leakage	Identical
Number of output modes	1	2	Change does notaffect safety andeffectiveness ofthe device. (TENSmode 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 RegulatedVoltage (output signals only)	Regulated voltage on all channels with currentlimit	Regulated voltage on all channels with currentlimit	Identical
Device Trade Name	Subject DeviceSIMON	Predicate DeviceK202079PHYSIQ	Comment
Software/Firmware/MicroprocessorControl	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,changes do notaffect safety andeffectiveness ofthe device
Device Trade Name	Subject DeviceSIMON	Predicate DeviceK202079PHYSIQ	Comment
Compliance with 21 CFR 898	Yes	Yes	Identical
Compliance with 21 CFR 890.5850(IPF)	Yes	Yes	Identical
Housing Material	Delrin	Delrin	Identical
Output Specifications
Waveform	Symmetrical BiphasicWaveform	Symmetrical BiphasicWaveform	Identical
Pulse Shape	Rectangular	Rectangular	Identical
Maximum output voltage(± 10%)	50V @500Ω50V @2kΩ50V @ 10kΩ	50V@500Ω50V@2kΩ50V @ 10kΩ	Identical
Maximum outputcurrent (± 10%)	100mA@500 Ω25mA@2 kΩ5mA@10 kΩ	100mA@500 Ω25mA@2 kΩ5mA@10 kΩ	Identical
Pulse Width (µs)	25 to 400 µs	25 to 400 µs	Identical
Device Trade Name	Subject DeviceSIMON	Predicate DeviceK202079PHYSIQ	Comment
Frequency (Hz)	3 to 200 Hz	3 to 200 Hz	Identical
Net Charge @ 500 ohms(µC/pulse)]	0μC @ 500Ω	0μC @ 500Ω	Identical
Maximum Phase Charge (μC)	40 μC @ 500Ω	40 μC @ 500Ω	Identical
Maximum Current Density(mA/cm2)	1.mA/cm² @ 500Ω	1.1 mA/cm² @ 500Ω	Almost identical,changes do notaffect safety andeffectiveness ofthe device.Specification is incompliance withIEC 60601-2-10standard
Maximum Power Density(mW/cm2)]	6.35mW/cm² @500Ω	6.4mW/cm² @500Ω	Almost identical,changes do notaffect safety andeffectiveness ofthe device.Specification is incompliance withIEC 60601-2-10standard
Burst Mode (i.e., pulse trains)	Yes:	Yes:	Identical
		Predicate Device
Device Trade Name	Subject Device	K202079	Comment
	SIMON	PHYSIQ
a. Pulses per burst	a. 3 - 200	a. 3 - 200
b. Bursts per second	b. 1	b. 1
c. Burst duration (seconds)	c. 0.2-60 s	c. 0.2-60 s
d. Duty Cycle [Line (b) x Line (c)]	d. Time on / off	d. Time on / off
ON time	0.2 – 60 s	0.2 – 60 s	Identical
OFF time	0.5 - 60 s	0.5 - 60 s	Identical
Treatment Time (min) -	Up to 60 min	Up to 60 min	Identical
Output intensity levels	1 to 50	1 to 50	Identical

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The DEKA SIMON device has a subset of the above mentioned predicate device, with same principle of operation and same performances.

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Performance Data:

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and 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 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"

Conclusion:

Based on the comparison of indications for use and the technological characteristics, we can conclude that the DEKA SIMON device is as safe, as effective, and performs as well as the legally marketed predicate device (K202079)

Additional Information:

None.

Regulation Number and Section

§ 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).