SCENAR transcutaneous electrostimulators are designed for delivering general noninvasive treatment via human skin areas for relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain. 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 device has an upper cover, case with a built-in electrode and a battery cover. All components except for the batteries are located on the printed circuit board inside the device's case. The device's controls and visual indicators are located on the upper side of its case.

AI/ML Overview

The provided document is a 510(k) Summary for the SCENAR transcutaneous electrostimulators, seeking substantial equivalence to a predicate device (InterX5000). The focus of this submission is on demonstrating the equivalence of technological characteristics and performance, not on clinical performance against specific acceptance criteria. Therefore, most of the requested information regarding clinical studies, ground truth, expert involvement, and sample sizes is not explicitly available or applicable in the provided text.

Specifically, this document describes a device for pain relief, which typically does not involve an "algorithm" in the sense of AI/image processing algorithms that would have specific performance metrics like sensitivity, specificity, or reader improvement studies. The "performance" described here refers to technical specifications and compliance with safety standards rather than clinical efficacy metrics.

Here's a breakdown of the information that can be extracted and a clear statement of what is not present:

1. A table of acceptance criteria and the reported device performance

The document does not define specific "acceptance criteria" for clinical performance. Instead, it compares the technical specifications of the SCENAR devices to the predicate device, InterX5000, and states that evaluation tests demonstrate substantial equivalence.

Parameter	Predicate Device (InterX5000) Performance	SCENAR Device Reported Performance	Acceptance Criteria (Not explicitly stated as such, but implied by comparison)
Supply Voltage	9 V	CHANS-01-SCENAR, CHANS-01-SCENAR-M: 9 V; SCENAR-1-NT (version 02): 4.0 to 6.4 V	Comparable to predicate device.
Maximum Supply Current	Data not available	CHANS-01-SCENAR, CHANS-01-SCENAR-M: not more than 85 mA; SCENAR-1-NT (version 02): not more than 650 mA	Within acceptable limits for safety and function.
Amplitude of the stimulating pulse at a standard load	not more than 450 V (measuring conditions not available)	not more than 150 V	Within an acceptable range relative to the predicate device for pain relief.
Pulse Frequency	15 to 350 Hz	CHANS-01-SCENAR, CHANS-01-SCENAR-M: 14, 60, 90, 340 Hz; SCENAR-1-NT (version 02): 15 to 350 Hz	Comparable to predicate device.
Weight	not more than 0.3 kg	CHANS-01-SCENAR, CHANS-01-SCENAR-M: not more than 0.2 kg; SCENAR-1-NT (version 02): not more than 0.4 kg	Comparable to predicate device.
Dimensions	220x60x45 mm	CHANS-01-SCENAR, CHANS-01-SCENAR-M: not more than 140x55x35 mm; SCENAR-1-NT (version 02): not more than 190x70x40 mm	Comparable to predicate device.
Safety and EMC Standards Compliance	(Implied by existing clearance of predicate)	IEC 60601-2-10:2001 + A1:2001, IEC 60601-1:1988 + A1:1991 + A2:1995, EMC: IEC 60601-1-2:2001 (ed. 2)	Full compliance with relevant international safety standards.
Software Verification	(Implied by existing clearance of predicate)	Conducted according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff- May 11, 2005"	Full compliance with FDA software guidance.

Note: The "Acceptance Criteria" column is inferred from the document's goal of demonstrating substantial equivalence to the predicate device and compliance with regulatory standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission references "evaluation tests" and "test reports" but does not detail sample sizes, types of data (e.g., patient data), or data provenance. This is typical for submissions focused on technical equivalence rather than clinical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The device is an electrostimulator for pain relief, not an diagnostic imaging or AI device that would require expert consensus for ground truth on a test set. The "tests" mentioned are likely technical and electrical performance tests conducted by engineers or testing labs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided for the same reasons as #3.

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

This information is not applicable and not provided. The SCENAR is a standalone electrostimulation device, not an AI-assisted diagnostic tool.

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

This is implicitly asserted through the demonstration of substantial equivalence in technical specifications and compliance with safety standards. The device is a "standalone" electrostimulator. There isn't an "algorithm" in the AI sense, but its fundamental operation is described as generating specific electrical pulses. The document states that the "technological characteristics and performance of SCENAR devices are substantially equivalent to those of InterX5000," which serves as the "standalone" performance assessment for regulatory purposes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the technical performance aspects, the "ground truth" would be established by validated measurement methods and engineering standards (e.g., power meters, oscilloscopes, electrical load simulators) to verify parameters like voltage, current, and frequency against the design specifications and relevant international standards (IEC 60601 series). For the pain relief indication, the document does not present clinical study data for efficacy, rather it relies on the predicate's established efficacy.

8. The sample size for the training set

This information is not applicable and not provided. The device is not based on machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established

This information is not applicable and not provided for the same reason as #8.

Summary

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Закрытое акционерное общество "ОКБ "РИТМ" RITM OKB ZAO

MAY 2 8 2010

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

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: November 11, 2009

Trade Name: SCENAR

Common Name: TENS device

Classification Name:

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF (21 CFR 882.5890, Product Code GZJ)

Predicate Device:

InterX5000 (K042912)

Device Description:

Purpose

SCENAR devices 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.

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List of produced devices

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

Table 1

Device Model and Version
SCENAR-1-NT (version 02) – Transcutaneous electrostimulator.
CHANS-01-SCENAR - Transcutaneous electrostimulator.
CHANS-01-SCENAR-M - Transcutaneous electrostimulator.

Specifications

Specifications of SCENAR devices are given in Table 2.

Table 2

Parameter	SCENAR-1-NT (version 02)	CHANS-01-SCENARCHANS-01-SCENAR-M
Supply voltage	4.0 to 6.4 V	9 V
Maximum supplycurrent	not more than 650 mA	not more than 85 mA
Amplitude of thestimulating pulse ata standard load	not more than 150 V	not more than 150 V
Pulse frequency	15 to 350 Hz	14, 60, 90, 340 Hz
Pulse Width	7 - 2000 μS	7 - 1000 μS
Maximum OutputRMS Voltage	12 V @ 500 Ω	15 V @ 500 Ω
	15 V @ 2 kΩ	20 V @ 2 kΩ
	15 V @ 10 kΩ	20 V @ 10 kΩ
Maximum OutputRMS Current	25 mA @ 500 Ω	30 mA @ 500 Ω
	8 mA @ 2 kΩ	10 mA @ 2 kΩ
	1.5 mA @ 10 kΩ	2 mA @ 10 kΩ
Weight	not more than 0.4 kg	not more than 0.2 kg
Dimensions	not more than 190x70x40 mm	not more than 140x55x35 mm

Design Description

The device has an upper cover, case with a built-in electrode and a battery cover. All components except for the batteries are located on the printed circuit board inside the device's case. The device's controls and visual indicators are located on the upper side of its case.

Materials

Stainless steel - electrode, ABS - case.

Power supply

Alkaline batteries.

Intended Use

SCENAR is indicated for:

. relief and management of chronic and acute pain
adjunctive treatment in the management of post-surgical and post-traumatic . pain.

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The comparison of SCENAR and INTERX5000 Specifications is given in Table 3.

Table 3		InterX5000
Parameter	SCENAR
Supply voltage	CHANS-01-SCENAR, CHANS-01-SCENAR-M - 9 VSCENAR-1-NT (versions 02) - 4.0 to 6.4 V	9 V
Maximum supply current	CHANS-01-SCENAR, CHANS-01-SCENAR-M - not more than 85 mASCENAR-1-NT (versions 02) – not more than 650 mA	data not available
Amplitude of the stimulating pulse at a standard load	not more than 150 V	not more than 450 V(measuring conditions not available)
Pulse frequency	CHANS-01-SCENAR, CHANS-01-SCENAR-M – 14, 60, 90, 340 HzSCENAR-1-NT (version 02) - 15 to 350 Hz	15 to 350 Hz
Weight	CHANS-01-SCENAR, CHANS-01-SCENAR-M - not more than 0.2 kgSCENAR-1-NT (versions 02) – not more than 0.4 kg	not more than 0.3 kg
Dimensions	CHANS-01-SCENAR, CHANS-01-SCENAR-M - not more than 140x55x35 mmSCENAR-1-NT (versions 02) - not more than 190x70x40 mm	220x60x45 mm

Moreover, to support our determination of substantial equivalence, evaluation tests have been performed. The results of these tests demonstrate that technological characteristics and performance of SCENAR devices are substantially equivalent to those of InterX5000. The test reports have been provided as part of this premarket notification.

The software verification has been conducted according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff- May 11, 2005.

RITM OKB ZAO has received test reports certifying that SCENAR was tested and found to be in conformity with IEC 60601-2-10:2001 + A1:2001 and IEC 60601-1:1988 + Al:1991 + A2:1995 and EMC: IEC 60601-1-2:2001 (ed. 2) international safety standards.

The test reports have been provided as part of this premarket notification.

SCENAR has received the CE Mark in the category Impulse Therapy devices type SCENAR for the devices in this submission certifying that the devices meet the EC-Directive 93/42/EEC.

The Certificate has been provided as part of this premarket notification.

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Conclusions

The devices have intended uses and technological characteristics that are substantially equivalent to those of the predicate device InterX5000 (K042912).

Verification and validation tests as well as certificates and 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/4/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and uses a serif font.

RITM OKB ZAO c/o Ms. Larisa Shpungina Certification and Licensing Engineer 99 Petrovskaya str., Taganrog, 347900 Russia

Re: K092117

MAY 2 8 2010

Trade Name(s): CHANS-01-SCENAR,

CHANS-01-SCENAR - M. SCENAR-1-NT (version 02).

Regulation Number: 21 CFR 882.5890

Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: April 08, 2010 Received: April 23, 2010

Dear Ms. Shpungina:

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. 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

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Kesia Alexander

الات Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K092117

Device Name:

CHANS-01-SCENAR, CHANS-01-SCENAR - M, SCENAR-1-NT (version 02).

Indications for Use:

For relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Aesm

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K092117

Regulation Number and Section

N/A