(461 days)
Not Found
No
The device description and summary of performance studies do not mention any AI or ML capabilities. The device is described as a TENS unit with programmed electrical pulses and multiple modes of operation, which are typical features of non-AI/ML TENS devices.
Yes
The device is described as a "portable pain reliever offering TENS" and is indicated for the "temporary relief of pain associated with sore and aching muscles," which aligns with the definition of a therapeutic device.
No
The device is described as a pain reliever using TENS for symptomatic relief, not for diagnosing a condition or disease.
No
The device description explicitly states it is a "portable pain reliever offering TENS" and transfers electrical pulses through "electrode adhesive pads," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a portable pain reliever offering TENS (Transcutaneous Electrical Nerve Stimulation). TENS is a physical therapy modality, not a method for diagnosing conditions.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
I-RUNE (I-200 L) is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
I-RUNE (I-200 L) is a portable pain reliever offering TENS.
The channel that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 7modes of operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back neck, upper extremities (arm), and lower extremities (leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
| Submitter Information: | Medirune Co., Ltd.
3-206,207 Medical Device Industrial Complex,
Taejang-dong, Wonju-si, Gangwon-do, Korea (220-120) |
|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho-Kyun Sin |
| Date Summary Prepared: | Apr 25, 2013 |
| Device description
Trade Name(s):
Classification Name:
Panel:
Product Code & Regulation: | I Rune (I-200L)
Transcutaneous electrical nerve stimulator for pain relief
neurology
NUH / 882.5890 |
Predicate Device Information K102598 / Hi-Dow Model JQ-5C NOV 1 2 2013
Device Description:
I-RUNE (I-200 L) is a portable pain reliever offering TENS.
The channel that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 7modes of operation.
Intended Use:
I-RUNE (I-200 L) is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in its intended use and technological characteristics, including:
-
- indications for use
-
- technological characteristics
-
- performance properties
1
Comparison of Output Specification
| Comparison | New device
(I-200L) | K102598
(JQ-5C) |
|----------------------------------------------|------------------------|--------------------|
| Max Voltage over 10k, V | 71 | 84 |
| Max Current over 10k, mA | 7.1 | 8.4 |
| Max Voltage over 2k, V | 59 | 85 |
| Max Current over 2k, mA | 29.5 | 42.5 |
| Max Voltage over 500, V | 45 | 62.4 |
| Max Current over 500, mA | 90 | 124.8 |
| Pulse Width, μ seconds | 10160 | 100 |187 | 16.3~781 |
| Pulse Period, msec | 8.4
| Max Pulse Frequency, Hz | 110 | 61.3 |
| Max Charge per Phase over 500Ω, μC | 9.49 | 17.92 |
| Max Current Density over 500Ω , mA/cm² | 0.15 | 9.92 |
| Max Average Power Density over 500Ω , mW/cm² | 0.51 | 2.72 |
Summary of non-clinical testing:
Compliance to EN 60601-1, and EN 60601-1 -2 requirement. In addition to the compliance of voluntary standards, the software verification has been conducted according to the FDA software guidance
Conclusion
Based on the information provided in this summary we conclude that this device is ' substantially equivalent to the predicate device K102598
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2013
- Medirune Co. Ltd c/o Yang, Ho Dong Onbix Corporation 821 Samil Plaza 837-26 Yeuksam-Dong Gangnam-Gu, Seoul, 135-768 Republic of Korea
Re: K122410
Trade/Device Name: I-Rune (1-200L) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Regulatory Class: Class II Product Code: NUH Dated: October 30, 2013 Received: November 6, 2013
Dear Yang, Ho Dong:
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
3
Page 2 - Yang, Ho Dong
or any Federal statutes and regulations administered by other Federal agencies. You must 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:_ I-RUNE (I-200 L)
Indications For Use:
I-RUNE (1-200 L) is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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