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.

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.

AI/ML Overview

This is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria.

The provided text describes a 510(k) submission for the I-RUNE (I-200 L) Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (K102598 / Hi-Dow Model JQ-5C) through comparison of technological characteristics and performance properties.

Here's an analysis of the acceptance criteria and the study based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission appear to be based on demonstrating "substantial equivalence" to the predicate device, specifically regarding output specifications and compliance with relevant safety standards. The "reported device performance" is the measured output of the I-RUNE (I-200L).

Acceptance Criteria (Predicate Device K102598 Performance)	Reported Device Performance (I-200L)	Outcome
Max Voltage over 10k, V: 84	71	Met (Lower is generally safer)
Max Current over 10k, mA: 8.4	7.1	Met (Lower is generally safer)
Max Voltage over 2k, V: 85	59	Met (Lower is generally safer)
Max Current over 2k, mA: 42.5	29.5	Met (Lower is generally safer)
Max Voltage over 500, V: 62.4	45	Met (Lower is generally safer)
Max Current over 500, mA: 124.8	90	Met (Lower is generally safer)
Pulse Width, μ seconds: 100	10~160 (Range includes predicate)	Met (Range encompasses predicate value)
Pulse Period, msec: 16.3~781	8.4~187 (Range overlaps with predicate)	Met (Range overlaps and is within acceptable TENS parameters)
Max Pulse Frequency, Hz: 61.3	110 (Higher than predicate)	Met (Tolerances for TENS frequency can vary; FDA deemed acceptable)
Max Charge per Phase over 500Ω, μC: 17.92	9.49	Met (Lower is generally safer)
Max Current Density over 500Ω, mA/cm²: 9.92	0.15	Met (Significantly lower, which is safer)
Max Average Power Density over 500Ω, mW/cm²: 2.72	0.51	Met (Significantly lower, which is safer)
Compliance to EN 60601-1 and EN 60601-1-2	Achieved	Met
Software verification according to FDA guidance	Conducted	Met

The Study Proving Acceptance Criteria:

The primary "study" presented here is a pre-clinical comparison study demonstrating the technical equivalence of the I-RUNE (I-200L) to the predicate device (K102598) based on quantifiable output specifications and compliance with recognized standards.

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

Sample Size: This is not applicable in the traditional sense of a clinical trial. The "test set" here refers to the measurement and evaluation of the device's output specifications and its compliance with standards. It's a single device or a small sample representing the manufactured product.
Data Provenance: The data comes from the manufacturer (Medirune Co., Ltd.) in Korea, through their internal testing and verification processes. This is retrospective in the context of the 510(k) submission, as the tests would have been performed prior to submission.

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

Not applicable. This is not a study requiring expert readers or interpretation of clinical images/data. The "ground truth" for the output specifications is derived from objective measurements, and for standard compliance, it's determined by testing against the requirements of the standards (e.g., in a certified lab).

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication is mentioned or required for this type of technical performance comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices where human readers interpret medical images with and without AI assistance. This device is a therapeutic device (TENS) for pain relief, and its approval pathway relies on demonstrating substantial equivalence in technical performance and safety, not on improving human reader performance.

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

No, a "standalone algorithm only" performance study is not applicable here. The device itself is a standalone TENS unit. The assessment is on the device's physical and electrical output and its compliance with safety standards, not on an algorithm's performance in isolation.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is:

Objective Measurement Data: For electrical output specifications (voltage, current, pulse width, frequency, charge, density, power density).
Standard Requirements: For compliance with international safety standards (EN 60601-1, EN 60601-1-2) and FDA software guidance.

8. The Sample Size for the Training Set

Not applicable specific to this type of device and submission. There is no "training set" in the context of machine learning or AI algorithm development mentioned. The device's design and manufacturing processes are iteratively developed, but not through a formal "training set" like an AI model.

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

Not applicable. As there's no stated "training set" in the context of AI, there's no mention of how its ground truth was established for this submission. The device's design and performance parameters are established through engineering principles, relevant standards, and comparison to existing legally marketed devices.

Summary

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K122410

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 descriptionTrade Name(s):Classification Name:Panel:Product Code & Regulation:	I Rune (I-200L)Transcutaneous electrical nerve stimulator for pain reliefneurologyNUH / 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

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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	10~160	100
Pulse Period, msec	8.4~187	16.3~781
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

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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

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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

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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:_ I-RUNE (I-200 L)

Indications For Use:

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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).