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510(k) Data Aggregation
(426 days)
KTR-2240,KTR-2250,KTR-2610,KTR-2640,KTR-2650:(TENS, EMS, FITNESS)
TENS (Mode~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
EMS (Mode 2140): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 4150): Improvement of abdominal tone, strengthening of the abdominal muscle development of firmer abdomen.
KTR-2241,KTR-2251,KTR-2242,KTR-2252,KTR-2611,KTR-2641,KTR-2612,KTR-2612,KTR-2652: (TENS)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
The Low-frequency Multi-function physiotherapy instrument is a portable and battery powered multifunctional device. The low-frequency multi-function physiotherapy instrument (models: KTR-2240, KTR-2250, KTR-2610, KTR-2640, KTR-2650) offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulation. It has 50 operation modes, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. And the TENS (Mode 120) is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. EMS (Mode 2140) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. FITNESS (Mode 41~50) is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.
The low-frequency multi-function physiotherapy instrument (models: KTR-2241, KTR-2242, KTR-2252, KTR-2611, KTR-2641, KTR-2612, KTR-2612, KTR-2652) offering Transcutaneous Electronic Nerve Stimulator (TENS). It has 15 operation mode, and 6 automatic mode, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. The TENS (Mode 1-15) is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode.
The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit.
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
The medical device in question is a "Low-frequency Multi-function physiotherapy instrument" that functions as a Transcutaneous Electrical Nerve Stimulator (TENS), Electrical Muscle Stimulation (EMS), and/or a FITNESS device depending on the model. This is a Class II device.
The provided document describes a 510(k) submission (K200177) where the manufacturer, Shenzhen Kentro Medical Electronics Co., Ltd, aims to demonstrate substantial equivalence to previously cleared predicate devices. The study conducted to prove the device meets acceptance criteria is primarily based on nonclinical (bench) testing and comparison of technical specifications with predicate devices, rather than a clinical trial with human subjects.
Here's the detailed breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely implied by compliance with recognized electrical safety and biocompatibility standards, and by demonstrating similar technical specifications to predicate devices. The "reported device performance" is essentially the subject device's specifications and its compliance with stated standards.
| Acceptance Criteria (Implied / Standard) | Reported Device Performance (Subject Device K200177) |
|---|---|
| Electrical Safety | Complies with IEC 60601-1-11 and IEC 60601-2-10 standards. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 standard. |
| Usability | Complies with IEC 62366-1 standard. |
| Software Verification and Validation | Complies with FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices." |
| Biocompatibility (for body-contacting parts) | Electrode pads comply with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization). The electrode patches are purchased from a qualified supplier with FDA clearance (K171381). |
| Patient Leakage Current | DC: < 0.01µA (reported as NC for Normal Condition, with the value provided in the detailed comparison). While the predicate device reported DC: 0.5µA, the subject device's performance of < 0.01µA is significantly lower and better, satisfying this safety criterion. SFC (Single Fault Condition): 0.1mA (compared to 0.6µA for predicate, the 0.1mA value is acceptable). |
| Average DC current through electrodes (device ON, no pulses) | < 0.01µA |
| Number of Output Channels | 2 channels. |
| Number of Output Modes | Models KTR-2240, KTR-2250, KTR-2610, KTR-2640, KTR-2650: 50 modes. Other models (KTR-2241, etc.): 15 modes. |
| Output Intensity Level | 16 steps. |
| Synchronous or Alternating Channel | Synchronous. |
| Method of Channel Isolation | Voltage Transform Isolation. |
| Regulated Current or Voltage | Voltage Control. |
| Software/Firmware/Microprocessor Control | Yes. |
| Automatic Overload Trip | No. (Consistent with predicate devices, this is not an acceptance criterion that needs to be "Yes"). |
| Automatic No-Load Trip | No. (Consistent with predicate devices). |
| Automatic Shut Off | Yes. |
| User Override Control | Yes. |
| Indicator Display (On/Off Status, Low Battery, Voltage/Current Level) | Yes (for all listed). |
| Timer Range | 15, 30, 45 min. |
| Waveform | Pulsed, symmetric, biphasic. |
| Shape | Rectangular, with interphase interval. |
| Maximum Output Voltage @ 500Ω (various modes) | Ranges from 20.0V to 46.0V (across different modes). (Within acceptable limits compared to predicates 40-55V). "SE Note 2" indicates these differences do not raise new safety or effectiveness concerns. |
| Maximum Output Current @ 500Ω (various modes) | Ranges from 40.0mA to 92.0mA (across different modes). (Within acceptable limits compared to predicates 80-110mA). "SE Note 2" indicates these differences do not raise new safety or effectiveness concerns. |
| Pulse Duration | TENS: 120µs, EMS: 200µs, FITNESS: 200µs. |
| Pulse Frequency | TENS: (20-100) Hz, EMS: (1-15) Hz, FITNESS: (2-16) Hz. |
| Net Charge (per pulse) @ 500Ω | 0µC, Method: Balanced waveform. |
| Maximum Phase Charge @ 500Ω (various modes) | Ranges from 5.33µC to 18.40µC. (Within acceptable limits compared to predicates 12.78-19.2µC). "SE Note 2" indicates these differences do not raise new safety or effectiveness concerns. |
| Maximum Average Current @ 500Ω (various modes) | Ranges from 0.03mA to 3.20mA. (Within acceptable limits compared to predicates 1.53-1.69mA). "SE Note 2" indicates these differences do not raise new safety or effectiveness concerns. |
| Maximum Average Power Density (various modes) | Ranges from 0.0001 mW/cm² to 0.2044 mW/cm². (Within acceptable limits compared to predicates 0.056-0.08 mW/cm²). "SE Note 2" indicates these differences do not raise new safety or effectiveness concerns. |
| Maximum Average Current Density (various modes) | Ranges from 0.0010 mA/cm² to 0.1279 mA/cm². (Within acceptable limits compared to predicates 0.064-0.073 mA/cm²). "SE Note 2" indicates these differences do not raise new safety or effectiveness concerns. |
| ON Time | 0.6s. |
| OFF Time | 0.6s. |
| Environment for Operating | Temp: +5°C-+40°C; Humidity: 15%-93%RH; Atmospheric Pressure: 700hPa-1060hPa. |
| Environment for Storage | Temp: 0°C-+55°C; Humidity: 0-93%RH; Atmospheric Pressure: 700hPa-1060hPa. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a clinical test set. The submission relies on bench testing results, comparing the new device's technical specifications and compliance with standards against predicate devices and in vitro tests for biocompatibility. There is no mention of a patient-based "test set" for performance evaluation.
- Data Provenance: The data comes from nonclinical (bench) testing performed by the manufacturer, or through documentation provided by suppliers for components (e.g., electrode pads). The report does not specify the country of origin for these specific tests, but the manufacturer is based in China. The data is retrospective in the sense that it's reported after the tests were conducted, but it's not "retrospective clinical data" as no clinical trials are described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable. The ground truth, in this context, is established by international standards (IEC, ISO) for electrical safety, EMC, usability, and biocompatibility, as well as FDA guidance for software. These standards themselves are developed by expert consensus within their respective fields, but individual experts are not explicitly cited as establishing ground truth for a discrete test set in this document.
- Qualifications of Experts: Not applicable in the context of a clinical test set. The underlying expertise is embedded in the standards and regulatory guidance documents.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no clinical test set requiring expert adjudication. The "adjudication" here is the FDA's review of the submitted technical documentation and its determination of substantial equivalence based on a comparison to recognized standards and predicate devices.
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 physiotherapy instrument (TENS/EMS/FITNESS), not an AI-powered diagnostic imaging device or a device involving "human readers" or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm generating interpretations or diagnoses that would require standalone performance evaluation. Its "performance" is based on its electrical output characteristics and meeting safety standards.
7. The Type of Ground Truth Used
- The "ground truth" used is defined by adherence to international consensus standards for medical device safety and performance (e.g., IEC 60601 series, ISO 10993 series) and technical specifications that fall within the established range of legally marketed predicate devices. For biocompatibility, the ground truth is established by in vitro test results against ISO standards.
8. The Sample Size for the Training Set
- Not applicable. This device does not employ machine learning or AI that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as no training set is used.
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(428 days)
KTR-2210, KTR-2220, KTR-2230: (TENS, EMS, FITNESS)
TENS (Mode1~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 41-50): Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen.
KTR-2211, KTR-2221, KTR-2231, KTR-2212, KTR-2222, KTR-2232: (TENS)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulator (EMS) and FITNESS qualities.
Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) has 50 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body massage.
The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode.
The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit. All the accessories, including electrode pads, electrode wire, and batteries can only be changed by special person.
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
The provided text describes a 510(k) premarket notification for a Low-frequency Multi-function physiotherapy instrument. This document primarily focuses on establishing substantial equivalence to predicate devices through a comparison of technical specifications and an assessment of safety and performance testing against recognized standards. It does not detail a study involving specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity) for an AI/CADe device, as the device itself is a physiotherapy instrument, not a diagnostic imaging AI.
Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, expert qualifications, HRMC studies, standalone performance, ground truth establishment for training, etc.) are not applicable in this context.
However, I can extract the closest equivalents to acceptance criteria and reported "performance" based on the provided safety and performance tests.
Here's a breakdown of the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
For a physiotherapy instrument, "acceptance criteria" relate to meeting safety and performance standards. The "reported device performance" is that the device complies with these standards.
| Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|
| Electrical Safety: IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10 | Complies with standards |
| Electromagnetic Compatibility: IEC 60601-1-2 | Complies with standard |
| Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10 | Complies with standards (for all user-contacting materials) |
| Usability: IEC 62366-1 | Complies with standard |
| Software Verification & Validation: FDA Guidance for Pre-Market Submissions and for Software Contained in Medical Devices | Complies with FDA guidance |
| Waveform Test (Output Specifications): Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning | Complies with guidance; verifies output specifications |
| Patient Leakage Current: (e.g., < 0.01 µA) | Reported as < 0.01 µA (for Subject Device, similar to predicates) |
| Average DC current through electrodes (no pulses): (< 0.01 µA) | Reported as < 0.01 µA (for Subject Device, similar to predicates) |
| Maximum Output Voltage (e.g., @ 500 Ω, 2K Ω, 10K Ω) | 55V±10%@ 500 Ω; 75V±10% @ 2K Ω; 85V±10% @ 10K Ω |
| Maximum Output Current (e.g., @ 500 Ω, 2K Ω, 10K Ω) | 110mA±10% @ 500 Ω; 37.5mA±10% @ 2K Ω; 8.5mA±10% @ 10K Ω |
| Pulse Duration (TENS, EMS, FITNESS) | TENS: 120µs, EMS: 200µs, FITNESS: 200µs |
| Pulse frequency (TENS, EMS, FITNESS) | TENS:(20-100)Hz, EMS:(1-15)Hz, FITNESS:(2-16)Hz |
| Net Charge (per pulse) @ 500 Ω | 0µC (Balanced waveform) |
| Maximum Phase Charge @ 500 Ω | 15.97 µC |
| Maximum Average Current | 1.60mA |
| Maximum Current Density (r.m.s) @ 500 Ω | 0.064mA/cm² |
| Maximum Average Power Density | 0.08mW/cm² |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is primarily bench testing and compliance with standards, not a clinical trial with a "test set" of patients or data in the typical sense of AI/CADe validation.
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)
This information is not applicable/provided. The device is a physiotherapy instrument, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication is typically for expert review of cases in diagnostic studies, which is not relevant here.
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
This information is not applicable/provided. The device is a therapeutic physiotherapy instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is not an algorithm for standalone performance assessment in the context of diagnostic AI. The "performance" assessment is about meeting electrical, EMC, biocompatibility, and output specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's acceptable performance is defined by compliance with established international and FDA-specific standards and guidances for electrical safety, electromagnetic compatibility, biocompatibility, usability, software, and waveform output specifications. This effectively serves as the "ground truth" for its safety and effectiveness for its intended use.
8. The sample size for the training set
This information is not applicable/provided. The document does not describe a training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not applicable/provided. (See point 8)
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