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510(k) Data Aggregation
(461 days)
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.
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.
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.
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