(318 days)
No
The description mentions the pulse shape dynamically varying with skin characteristics, but this is described as a direct response to physiological changes, not as a learned or intelligent adaptation based on AI/ML algorithms. There is no mention of AI, ML, training data, or complex algorithms typically associated with AI/ML.
Yes
The device is intended for "relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain," which are therapeutic claims.
No
The device description and intended use clearly state that it is for relief and management of pain and is an electrostimulator, not a device for diagnosing medical conditions.
No
The device description explicitly states it has a case, built-in electrode, battery cover, and printed circuit board, indicating it is a hardware device that delivers electrical pulses.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain." This describes a therapeutic device that interacts with the body to treat a condition, not a device that analyzes samples from the body to provide diagnostic information.
- Device Description: The description details a "transcutaneous electrostimulator" that delivers electric pulses through the skin. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is clearly therapeutic.
N/A
Intended Use / 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.
Product codes
GZJ
Device Description
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 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.
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.
Materials: Stainless steel - electrode, ABS - case.
Power supply: Alkaline batteries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human skin areas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
- at home on a doctor's prescription
- medical professionals in medical and prophylactic institutions
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)
Evaluation tests have been performed to support the determination of substantial equivalence. The results of these tests demonstrate that technological characteristics and performance of SCENAR devices are substantially equivalent to those of InterX5000.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
InterX5000 (K042912)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/2 description: The image shows the text 'K092117' enclosed in a partial circle. The text is in a simple, sans-serif font and is horizontally centered. The circle begins above the 'K' and ends after the last digit, suggesting an identifier or code within a circular marking.
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 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 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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Image /page/1/Picture/2 description: The image shows the text "K092117" inside of an oval shape. The text is in a simple, sans-serif font and is centered within the oval. The oval is outlined in black and appears to be hand-drawn.
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-SCENAR
CHANS-01-SCENAR-M |
|-------------------------------------------------------------|----------------------------|--------------------------------------|
| Supply voltage | 4.0 to 6.4 V | 9 V |
| Maximum supply
current | not more than 650 mA | not more than 85 mA |
| Amplitude of the
stimulating pulse at
a 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 Output
RMS 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 Output
RMS 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 V | |
| SCENAR-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 mA | |
| SCENAR-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 Hz | |
| SCENAR-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 kg | |
| SCENAR-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 mm | |
| SCENAR-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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Image /page/3/Picture/2 description: The image shows the text 'K092117' inside of an oval shape. The text is centered within the oval. The oval is outlined in black.
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
5
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)
i.
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