The SCENAR Cutaneous Electrode Family with SCENAR TENS devices is indicated for relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain.

Device Description

The SCENAR Cutaneous Electrode Family is intended to be used with electrostimulation devices produced by RITM OKB ZAO as external add-on electrode accessories. The SCENAR Cutaneous Electrode Family does not contain any electrical components. Electrodes are made of stainless steel, brass with silver plated, ABS plastic and fluoroplastic placed in ABS plastic case. The electrodes are connected to electrostimulator by wiring through a connector cable.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is a 510(k) submission for a medical device accessory and the "study" described is a substantial equivalence comparison rather than a clinical trial in the traditional sense.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a predicate device. This means the new device (SCENAR Cutaneous Electrode Family) should have similar technological characteristics and indications for use, and perform at least as safely and effectively as the predicate. The performance evaluation focuses on direct comparison of physical and technical specifications rather than clinical outcomes.

Parameter	Acceptance Criteria (based on predicate INTERX5000)	Reported Device Performance (SCENAR Cutaneous Electrode Family)
Type of electrodes	classic – coaxial bipolarcomb – multipoint bipolarsmall circular – coaxial bipolar	small – coaxial bipolarcomb – multipoint bipolarpoint – coaxial bipolar
Dimensions (without cable)	classic – ~ 80x40x20 mmcomb – ~ 80x40x20 mmsmall circular – ~ Ø16x130 mm	small – 45x37x22 mmcomb – 55x37x22 mmpoint – Ø11x117 mm
Weight (whole electrode)	data not available	small – 0.028 kgcomb – 0.040 kgpoint – 0.022 kg
Cable length	data not available	small – 910 mmcomb – 905 mmpoint – 907 mm
Compliance with Standards	Not explicitly stated as "acceptance criteria," but implicit for a predicate.	Complies with 21 CFR 898.12 (patient lead wires and electrodes), IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 (safety and EMC).
Intended Use	Relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain.	Relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain.

Key Finding: The report asserts that differences in dimensions are "minor" and do not affect the Indications for Use or Fundamental scientific technology. The devices meet relevant electrical safety and EMC standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not describe a clinical "test set" with human subjects or a specified number of devices tested for performance comparison. Instead, the comparison is based on the published specifications of an existing predicate device (InterX5000 optional external electrode accessories) and the specifications of the new SCENAR Cutaneous Electrode Family.
Data Provenance: This is not a study involving patient data. The data provenance is from the manufacturer's internal specifications and publicly available information (published data) for the predicate device. The information originates from Russia (RITM OKB ZAO) for the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study that establishes ground truth through expert consensus on clinical cases. The "ground truth" for this submission are the technical specifications and safety standards.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is a technical comparison, not a clinical study involving case assessment.

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 transcutaneous electrical nerve stimulator electrode family, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a passive accessory (an electrode) and does not involve an algorithm or standalone performance in the sense of AI or automated diagnostic systems. The electrodes have no power or software on their own.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" here is the technical specifications and safety standards for transcutaneous electrical nerve stimulator electrodes. The comparison is made against the established characteristics of the legally marketed predicate device (InterX5000 optional external electrode accessories) and relevant international safety and EMC standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and FDA regulations (21 CFR 898.12).

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore, no training set is relevant.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI model, no ground truth needed to be established for one.

Summary

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Закрытое акционерное общество "ОКБ "РИТМ" RITM OKB ZAO JUL 1 1 2014

ЗАО "ОКБ "РИТМ", ул.Петровская, 99. г.Таганрог, Россия, 347900 Тел./факс: (8634) 62-31-79 E-mail: medsc@scenar.com.ru RITM OKB ZAO Petrovskaya St., 99 Taganrog, Russia, 347900 Tel./fax: (8634) 62-31-79 E-mail: medso@scenar.com.ru

പ്രദിപ്പിച്ച

510(k) Summary

Submitter Information:

RITM OKB ZAO Address: 99, Petrovskaya str., Taganrog, Russia, 347900 Phone/fax: +7 (8634) 623-179 Contact person: Larisa Shpungina Date of Summary Preparation: May 19, 2014

Trade Name:

SCENAR (SCELAP, ENISAR, IPENS) Cutaneous Electrode Family

Common Name: Transcutaneous Electrical Nerve Stimulator

Classification Name:

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (21 CFR 882.5890, PRODUCT CODE GZJ)

Predicate Device:

SCENAR (K092117) InterX5000 (K042912)

Description:

The SCENAR Cutaneous Electrode Family is intended to be used with electrostimulation devices produced by RITM OKB ZAO as external add-on electrode accessories.

Purpose

Purpose of SCENAR transcutaneous electrostimulator (K092117) is completely specified. SCENAR transcutaneous electrostimulators and SCENAR Cutaneous Electrode Family are designed for delivering general non-invasive treatment via human skin areas for relief and management of chronic and acute pain, as adjunctive treatment in the management of postsurgical and post-traumatic pain.

SCENAR devices and SCENAR Cutaneous Electrode Family can be used:

at home on a doctor's prescription to relief pain after various injuries and traumas;
by medical professionals in medical and prophylactic institutions - as an independent remedy as well as combined with other treatments.

Action: How it works

SCENAR devices generate low and medium frequency bipolar electric pulses. The shape of the pulses dynamically varies with changing electrophysiological characteristics of the skin. The SCENAR Cutaneous Electrode Family has no power unless it is connected to transcutaneous electrostimulator. The SCENAR Cutaneous Electrode Family is placed

May 19, 2014

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directly onto unbroken skin and does not use any conductive gels. These electrodes serve as complement to the device and allow influencing the special or hard-to-get-to parts of the body in comparison with built-in electrode.

The small electrode facilitates to influence parts with difficult relief -ulnar and wrist joints, feet etc. and also while using in pediatrics.

The comb electrode facilitates to influence pubis, axilla and other hairy parts of the skin. The point electrode allows carrying out condensed influence to reflexogenic points of extremities and ears.

List of produced devices

The SCENAR Cutaneous Electrode Family produced by RITM OKB ZAO is listed in the Table 1. The Electrodes are united into array since their purpose, application, mechanism of action, utilized materials, basic technical characteristics, functionality and manufacturing processes are similar.

Table 1

Electrode Model
Small electrode
Comb electrode
Point electrode

Specifications

Specifications of SCENAR Cutaneous Electrode Family are given in Table 2.

Table	2
-------	---

Parameter	Small electrode	Comb electrode	Point electrode
Type of electrodes	coaxial bipolar	multipoint bipolar	coaxial bipolar
Dimensions(without cable)	not more than50x40x25 mm	not more than60x40x25 mm	not more than$⌀$ 15x120 mm
Weight(whole electrode)	not more than 0.04 kg	not more than 0.05 kg	not more than 0.04 kg
Cable length	(900 ± 100) mm

Design Description

The SCENAR Cutaneous Electrode Family does not contain any electrical components. Electrodes are made of stainless steel, brass with silver plated, ABS plastic and fluoroplastic placed in ABS plastic case. The electrodes are connected to electrostimulator by wiring through a connector cable.

The cable is a two conductor cable using two single wires tinned with copper.

The connector is medically recognized and cannot be plugged into an AC socket.

Materials

Stainless steel, brass with silver plated, ABS, fluoroplastic - electrodes, ABS - case.

Power supply

The SCENAR Cutaneous Electrode Family does not contain power supply.

Sterilization

The SCENAR Cutaneous Electrode Family is intended to be used non-sterile.

Software

The SCENAR Cutaneous Electrode Family does not contain any software/firmware.

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Indications for Use

Substantial Equivalence Comparison

The performance comparison of SCENAR Cutaneous Electrode Family and INTERX5000 optional external electrode accessories is given in Table 3.

Performance testing was conducted to characterize the performance of the SCENAR Cutaneous Electrode Family as compared to published data of predicate devices InterX5000 optional external electrode accessories.

Parameter	SCENAR CutaneousElectrode Family	InterX5000 optional externalelectrode accessories
Type ofelectrodes	small – coaxial bipolarcomb – multipoint bipolarpoint – coaxial bipolar	classic – coaxial bipolarcomb – multipoint bipolarsmall circular – coaxial bipolar
Dimensions(withoutcable)	small – 45x37x22 mmcomb – 55x37x22 mmpoint – Ø11x117 mm	classic – ~ 80x40x20 mmcomb – ~ 80x40x20 mmsmall circular – ~ Ø16x130 mm
Weight(wholeelectrode)	small – 0.028 kgcomb – 0.040 kgpoint – 0.022 kg	data not available
Cable length	small – 910 mmcomb – 905 mmpoint – 907 mm	data not available

Table0
------------	--

The differences in dimensions of the subject and predicate devices are minor because:

the dimensions of the electrode's part contacting the skin differ unsignificantly (2-5 mm). These dimensions are approximately determined by the purpose of the electrode and their minor deviations do not affect the Indications for Use and Fundamental scientific technology of the proposed electrodes;
the third dimension (length) of the electrode has been determined considering ergonomics. This dimension as well as the shape of the electrode body can influence only the comfort of performing manipulations with the electrode, and maybe, the way the electrode is held.

SCENAR Cutaneous Electrode Family complies with performance standard requirements (21 CFR 898.12) relating to patient lead wires and electrodes.

RITM OKB ZAO has received test reports certifying that SCENAR Cutaneous Electrode Family was tested and found to be in conformity with IEC 60601-1, IEC 60601-2-10 and IEC 60601-1-2 international safety and EMC standards.

The test reports have been provided as part of this premarket notification. Test results of SCENAR devices with add-on electrodes (SCENAR Cutaneous Electrode Family) are given in the test reports.

Conclusions

The devices have intended use and technological characteristics that are substantially equivalent to those of the predicate device InterX5000 (K042912) (optional external electrode accessories) and SCENAR (K092117).

The test reports contained in this submission demonstrate that the submitted models are equivalent to the safety and effectiveness as that of the cleared devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gbl) Silver Spring, MD 20993-0002

July 11, 2014

Ritm Okb Zao Larisa Shpungina Certification and Licensing Engineer 99. Petrovskaya Str., Taganrog. 347900. Russia

Re: K131513

Trade/Device Name: SCENAR Cutancous Electrode Family Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutancous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ, GXY Dated: May 19, 2014 Received: June 11, 2014

Dear Ms. Shpungina:

We have reviewed your Section 510(k) premarket notification of intent to market the device relerenced 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. 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 I hat 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 or any i each statutes and regainments. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Larisa Shpungina

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K131513

Device Name

SCENAR (SCELAP, ENISAR, IPENS) Cutaneous Electrode Family

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Date: 2014.07.11 11:51:26 -04'00'

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Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).