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510(k) Data Aggregation
(90 days)
Intended for use with electric stimulation therapy devices, such as TENS and EMS. Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode and the skin.
Conductive Gel can be used with any of dozens of stimulating devices that are legally sold, to reduce the impedance between the skin and the stimulating device. It consists of Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2% and Triclosan: 0.05%. And the Purified water used as the solvent, the Carbopol as a gel forming material, the Glycerin as a Moisturizing, the Sodium hydroxide as a Buffering and the Triclosan as a preservative. The Conductive Gel is used on intact skin surfaces. The entire surface of Conductive Gel is very conductive, smeared evenly on the stimulation device, so that the current is evenly distributed. The gel is to be generously applied to the area where an electrode will be used. The gel can be washed off the skin after use.
This document describes the validation of a "Conductive Gel" medical device. Here's a breakdown of the acceptance criteria and the study conducted to prove it:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Purpose of the Test | Reference Standard | Acceptance Criteria | Test Results |
|---|---|---|---|---|
| In vitro Cytotoxicity Test | Determine if the target device extract is cytotoxic | ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Non-cytotoxicity to L929 cells | Pass |
| Skin Sensitization Test | Evaluate skin sensitization after topical applications | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Frequency of positive challenge results in sample extract and Negative control animals are 0%, Positive control is 100% | Pass |
| Skin Irritation Test | Evaluate skin irritation after single topical applications | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Negligible irritation in a rabbit skin single exposure test | Pass |
| Usability Study | Study how usability will be performed | IEC 62366-1 Edition 1.0 2015-02, Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)] | The subject device can meet the usability goal of IEC 62366-1 standards | Pass |
| Shelf Life Test | Study if performance meets 2-year shelf life requirements | ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices; Guidance document for the "Shelf Life of Medical Devices" issued in April 1991 | All items (Exterior, Package, pH, Impedance and conductivity) tested on both before and after aging samples meet the performance required | Pass |
Additional Performance Data from Comparison to Predicate Device:
| Item | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Impedance (at 1 MHz) | ≤ 500 Ω | ≤ 500 Ω |
| pH | 7.0 - 7.5 | 6.5 - 7.5 |
| Percent Concentration of Ingredients | Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2%, Triclosan: 0.05% | Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2%, Triclosan: 0.05% |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for each non-clinical test (cytotoxicity, sensitization, irritation, usability, shelf life). However, it refers to standard biological evaluation and aging test methods (ISO 10993-5, ISO 10993-10, IEC 62366-1, ASTM F1980-16), which inherently define sample sizes for their respective procedures, typically involving animal models for biological tests or specific numbers of units for usability/shelf life.
- Data Provenance: The studies were identified as "lab bench testing." The location of these labs or the country of origin for the data is not specified beyond the submitter's and correspondent's addresses (China). The tests are non-clinical, meaning they were not conducted on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as the validation is based on non-clinical (lab bench) testing against established standards, not on expert consensus or human reader performance.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the validation is based on objective lab bench testing against predefined acceptance criteria, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a conductive gel, which is a physical product, not an AI or software device that would involve human readers or comparative effectiveness studies with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As mentioned, this is a physical medical device (conductive gel), not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established scientific and regulatory standards and their defined criteria.
- For biological tests (cytotoxicity, sensitization, irritation), the ground truth is whether the device elicits a toxic or adverse biological response as determined by standardized in-vitro and in-vivo (animal) models.
- For usability, the ground truth is compliance with IEC 62366-1 usability engineering principles.
- For shelf life, the ground truth is the maintenance of specified physical and chemical properties (like pH, impedance, conductivity, exterior, package integrity) over the declared shelf life based on accelerated aging models.
- For material composition, the ground truth is the precise percentage concentration of each ingredient.
- For impedance and pH, the ground truth is the measured value compared to the specified range or limit.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, there is no training set for this type of device.
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(321 days)
The TOPTENS-01 can be used for the Symptomatic relief of chronic intractable pain, Post traumatic pain adjunctive treatment, Post-surgical pain adjunctive treatment.
The proposed device is transcutaneous electrical nerve stimulator for pain relief. this is a device used to apply an electrical current to electrodes on a patient's skin to treat pain. It only has one model: TOPTENS-01. TOPTENS-01 is mainly composed: host, built-in power supply, output lead and electrode. TOPTENS-01 power supply is DC4.5V, using built-in removable 3 AAA batteries. TOPTENS-01 comes with 2 independent output channels (A&B). Users can be adjust independently the two output channels Intensity by pressing the Left and right sides Intensity adjustment key. LCD screen display the remaining stimulation time in the top left corner. The default stimulation time is 30 minutes. TOPTENS-01 has 9 types stimulation modes: Mode1, Mode2, Mode 3, Mode 4, Mode 5, Mode6, Mode 7, Mode 8, Mode 9.
This is a 510(k) premarket notification for a medical device called the Transcutaneous Electrical Nerve Stimulator (TOPTENS-01) manufactured by Top-Rank Health Care Co., Ltd. The document aims to demonstrate that the TOPTENS-01 device is substantially equivalent to a legally marketed predicate device (K152374, also a Transcutaneous Electrical Nerve Stimulator).
This document does not contain acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy. Instead, it demonstrates substantial equivalence based on a comparison to a predicate device, focusing on technical specifications and safety standards.
Therefore, many of the requested sections (acceptance criteria related to clinical performance, sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, and ground truth types) are not applicable or cannot be extracted from this specific 510(k) summary, as these types of studies were not conducted or reported for this submission.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
This document does not establish performance acceptance criteria in terms of clinical outcomes or accuracy. Instead, it demonstrates substantial equivalence based on compliance with harmonized electrical safety and EMC standards, and a comparison of the device's technical specifications to a predicate device. The "performance" being evaluated is its adherence to these standards and the similarity of its operational parameters to the predicate.
| Acceptance Criteria Category (from 510(k) Summary) | Description of Criteria / Standard | Reported Device Performance and Compliance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1: Medical electrical equipment Part 1: General Requirements For Basic Safety And Essential Performance; and IEC 60601-2-10: Medical electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators. | The device complies with IEC 60601-1 and IEC 60601-2-10. The 510(k) states: "The new device passed Safety testing, so these differences will not cause any safety and effectiveness issues." (Difference 4). "The pulse parameters meet the maximum current density <2mA/cm² And the maximum average power density <0.25W/cm² safety standard requirements, and passed the safety test." (Difference 6). "But they all meet the safety standard requirements of maximum current density < 2mA/cm² and maximum average power density <0.25W/cm², and the new device has passed the safety test." (Difference 7). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic disturbances-Requirements and tests. | The device complies with IEC 60601-1-2. "The EMC property meets the requirements." (Section 6) |
| Home Healthcare Environment | Compliance with IEC 60601-1-11:2015: Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. | The device complies with IEC 60601-1-11:2015. (Section 6) |
| Additional Safety Standards | Compliance with ANSI/AAMI/ES 60601-1: 2005/(R)2012 and A1:2012, C1:2009/(r)2012 and a2:2010/(r)2012. | The device complies with ANSI/AAMI/ES 60601-1. (Section 6) |
| Functional Equivalence | Substantial equivalence in intended use, principle of operation, and performance specifications to the predicate device K152374. | The document provides detailed comparisons (Table 3 and Table 4) highlighting similarities in product code, regulation, indications for use, principle of operation, type of use, user interface, number of output channels, anatomical locations, regulated voltage, software control, automatic shut-off features, and display indications. Differences (e.g., power source, synchronous/alternating output, time range, dimensions, max output voltage/current, pulse parameters) were individually assessed and argued not to raise new questions of safety or effectiveness, often by referencing successful safety testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for clinical data. This 510(k) submission does not include clinical studies.
- For non-clinical (engineering/safety) tests: No specific "sample size" is mentioned for these tests, as they are typically performed on a limited number of manufactured units to verify design compliance with standards. The provenance of this non-clinical testing data is implied to be from the manufacturer (Top-Rank Health Care Co., Ltd. in China) or a certified testing laboratory. The tests are prospective in the sense that they were performed on the device after its manufacture.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set or ground truth established by experts is mentioned in this 510(k) submission, as no clinical studies were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware and does not perform diagnostic algorithms in a standalone capacity that would require this type of evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For non-clinical tests: The "ground truth" for the non-clinical tests (electrical safety, EMC, etc.) is the adherence to the specified international and national standards (e.g., IEC 60601-x series). These standards define measurable parameters and acceptable limits.
- For clinical performance: No clinical ground truth was used as no clinical testing was performed or submitted. The statement of "Substantial Equivalence" relies on the device being technologically similar and equally safe and effective to the predicate device.
8. The sample size for the training set
- Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator and does not utilize a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
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