SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY

{0}------------------------------------------------ ## 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 {1}------------------------------------------------ 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<br>(without cable) | not more than<br>50x40x25 mm | not more than<br>60x40x25 mm | not more than<br>$⌀$ 15x120 mm | | Weight<br>(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. {2}------------------------------------------------ #### Indications for Use 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. #### 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 Cutaneous<br>Electrode Family | InterX5000 optional external<br>electrode accessories | |----------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Type of<br>electrodes | small – coaxial bipolar<br>comb – multipoint bipolar<br>point – coaxial bipolar | classic – coaxial bipolar<br>comb – multipoint bipolar<br>small circular – coaxial bipolar | | Dimensions<br>(without<br>cable) | small – 45x37x22 mm<br>comb – 55x37x22 mm<br>point – Ø11x117 mm | classic – ~ 80x40x20 mm<br>comb – ~ 80x40x20 mm<br>small circular – ~ Ø16x130 mm | | Weight<br>(whole<br>electrode) | small – 0.028 kg<br>comb – 0.040 kg<br>point – 0.022 kg | data not available | | Cable length | small – 910 mm<br>comb – 905 mm<br>point – 907 mm | data not available | | Table<br>0 | | |------------|--| |------------|--| 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K131513 #### Device Name SCENAR (SCELAP, ENISAR, IPENS) Cutaneous Electrode Family #### Indications for Use (Describe) 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. 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' 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."