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510(k) Data Aggregation
(233 days)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
The subject device (Model: FM-B2403) is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg. 4 channels that effectively transfer 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 24 modes of operations. The electrode pads are cleared by FDA, and 510(k) number is K092546 for the electrode pads. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. The electrode pads are composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient (age ≥ 18) multiple application use. Its output waveform is provided 24 programs and 20 adjustable intensity levels. The LCD screen shows the information of program, level, operating time and channel.
This document is a 510(k) Premarket Notification for a TENS & EMS Device (Model FM-B2403). It outlines the device's characteristics and demonstrates its substantial equivalence to a predicate device (HIVOX OTC Electrical Stimulator, Model SEM44).
It's important to note that this document does not describe a study involving an algorithm or AI. Instead, it focuses on the physical and electrical specifications of a medical device (a TENS and EMS stimulator) and compares them directly to a legally marketed predicate device to establish substantial equivalence for regulatory clearance. Therefore, many of the requested details about acceptance criteria for an AI/algorithm-based device and its study will not be present in this type of submission.
However, I can extract the information relevant to this specific device's acceptance strategy, which relies on demonstrating substantial equivalence to a predicate device through non-clinical testing of its physical and electrical parameters.
Here's a breakdown of the available information based on your request, adapted to the context of this traditional medical device submission:
1. A table of acceptance criteria and the reported device performance
For this type of device, the "acceptance criteria" are not framed as performance metrics against a clinical ground truth for an algorithm. Instead, they are the technical specifications and safety standards measured against the predicate device's characteristics and recognized industry standards. The "reported device performance" is essentially its measured engineering specifications.
The table in Section 7.1 and 7.2 of the 510(k) Summary serves this purpose. The "SE" column indicates "Substantially Equivalent," implying that the subject device's performance (its measured characteristics) meets the criteria for substantial equivalence to the predicate.
| Contents (Acceptance Criteria / Parameter to be met) | Subject Device (Reported Device Performance) | Predicate Device (Target for equivalence) | SE (Outcome of Meeting Criteria) |
|---|---|---|---|
| Basic Characteristic | |||
| Trade Name | TENS & EMS Device | HIVOX OTC Electrical Stimulator | SE |
| Device Model | FM-B2403 | SEM44 | / (Not a direct SE comparison, just identifies) |
| Regulatory Information | 882.5890, 890.5850 | 882.5890, 890.5850 | / (Indicates equivalent regulatory classification) |
| Classification | Class II | Class II | / |
| Product code | NUH, NGX | NUH, NGX | / |
| Panel | Physical Medicine; Neurology | Neurology; Physical Medicine | / |
| OTC/RX | OTC | OTC | / |
| Intended Use | (Identical descriptions for TENS and EMS) | (Identical descriptions for TENS and EMS) | SE |
| Apply parts of the body | Shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom | Shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom | SE |
| Power Source | Built-in 3.7V lithium battery | Batteries, 3x1.5V AAA | SE (Functionally equivalent despite different battery type) |
| Number of Output Modes | TENS:19, EMS:5 | TENS: 15 EMS: 35 | SE (Different numbers, but still acceptable for equivalence) |
| Number of Output Channels | 4 | 2 | SE (More channels is not considered a disadvantage for equivalence) |
| Synchronous or Alternating | Synchronous | Synchronous | SE |
| Method of Channel Isolation | By electrical circuit and software | By electrical circuit and software | SE |
| Regulated Current or Regulated Voltage | Regulated voltage control | Regulated voltage control | SE |
| Software/Firmware/Microprocessor Control? | Yes | Yes | SE |
| Automatic Overload Trip? | No | Yes | SE (Difference noted, but deemed non-critical for substantial equivalence) |
| Automatic No-Load Trip? | No | Yes | SE (Difference noted, but deemed non-critical for substantial equivalence) |
| Automatic Shut Off? | Yes | Yes | SE |
| Patient Override Control? | Yes | Yes | SE |
| Indicator Display? | Yes | Yes | SE |
| Timer Range (minutes) | 10-80 | 5-100 | / (Acceptable range difference for equivalence) |
| Compliance with Voluntary Standards? | ANSI/AAMI/ES 60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11, ISO10993-5, ISO10993-10 | IEC60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11, ISO10993-5, ISO10993-10 | SE |
| Compliance* with 21 CFR 898? | Yes | Yes | SE |
| Weight(g) | 82 g | 89 g (including belt clip, without batteries), 123 g (including belt clip and batteries) | SE |
| Dimensions (mm) [D x W H] | 1106015 | 132 x 63 x 29.5 mm (including belt clip) | SE |
| Housing Materials and Construction | ABS | ABS | SE |
| Output Parameters | (Comparison to Predicate and often to a second predicate for broader range acceptance) | ||
| Waveform | biphasic | biphasic | SE |
| Shape | Square | Square / Rectangular (Second Predicate) | SE |
| Maximum Output Voltage (volts) (+/- 10%) | 97.6@500Ω, 135@2KΩ, 157@10KΩ | 100volts peak-peak±10%@500Ω, 180volts peak-peak±10%@2kΩ, 250volts peak-peak±10%@10KΩ; 62@500Ω (Second Pred.) | SE |
| Maximum Output Current (mA) (+/- 10%) | 195.2@500Ω, 67.5@2KΩ, 15.7@10KΩ | 200mA peak-peak±10% @500Ω, 90mA peak-peak±10% @2kΩ, 25mA peak-peak±10% @10kΩ; 124@500Ω, 37.6@2KΩ (Second Pred.) | SE |
| Pulse Duration (µsec) | 90µS | 50-450µS; 100µS (Second Pred.) | SE |
| Frequency† (Hz) [or Rate† (pps)] | < 90.9Hz | 1-150Hz; 61Hz (Second Pred.) | SE |
| Net Charge (micro coulombs (µC) per pulse) | 0.001@500Ω | 0.001@500Ω; 0 (Second Pred.) | SE |
| Maximum Phase Charge, (µC) | 15.5@500Ω | 45@500Ω; 17.92µC (Second Pred.) | SE |
| Maximum Current Density(mA/cm2) | 0.1192@500Ω | 0.667@500Ω; 9.95 mA/cm² (Second Pred.) | SE |
| Maximum Power Density(mW/cm2) | 0.176@500Ω | 4.6@500Ω; 2.7 (Second Pred.) | SE |
| Pulses per burst | 2 | 3; Not publicly available (Second Pred.) | SE |
| Bursts per second | 1/30 | 2/60; Not publicly available (Second Pred.) | SE |
| Burst duration (ms) | 45 | 36; Not publicly available (Second Pred.) | SE |
| Duty Cycle: Line (b) x Line (%) | 0.016 | 36ms/390ms; Not publicly available (Second Pred.) | SE |
| ON Time (seconds) | 1 | 2; Not publicly available (Second Pred.) | SE |
| OFF Time (seconds) | 1 | 2; Not publicly available (Second Pred.) | SE |
| Standard/Guidance Document Referenced | As listed | As listed; Not publicly available (Second Pred.) | SE |
2. Sample sized used for the test set and the data provenance
This document describes a medical device, not an AI/ML algorithm. Therefore, there is no "test set" in the context of diagnostic performance evaluation with patient data. The "testing" refers to engineering and electrical performance testing of the device itself.
- Sample Size: Not applicable in the sense of patient data. The testing would typically involve a specific number of manufactured devices, but this is not detailed in the summary as it's part of the manufacturer's internal quality control and verification activities to ensure each device meets specifications.
- Data Provenance: The device is manufactured by Shenzhen Jianfeng Electronic Technology Co., Ltd. in China. The testing data would be generated from their internal labs or third-party testing facilities engaged by the manufacturer, verifying the device's electro-physical properties against the stated specifications and international standards (e.g., IEC 60601 series). This is prospective testing of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of medical device submission. Ground truth, in this context, relates to clinical diagnoses or outcomes, which are not evaluated for this device's substantial equivalence. The "ground truth" for this device is its adherence to engineering specifications and safety standards as measured by accredited test methods, performed by qualified engineers and technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical datasets, particularly for image-based diagnostic AI, where human expert consensus is needed to define a true positive/negative. This process is not part of a regulatory submission for a TENS/EMS device.
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 not an AI or imaging diagnostic tool, so no MRMC study or AI assistance evaluation was performed. The device delivers electrical stimulation for pain relief and muscle performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device, not an algorithm. Its performance is evaluated based on its electrical output parameters, safety, and physical characteristics.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's clearance is its compliance with established electrical and safety standards (e.g., IEC 60601 series, ISO 10993 for biocompatibility) and its functional equivalence to a legally marketed predicate device. This is determined through:
- Measured Electrical Output Parameters: Verification that its output voltage, current, pulse duration, frequency, etc., fall within acceptable ranges and are comparable to the predicate device.
- Safety Testing: Demonstrating compliance with electrical safety (e.g., against electric shock hazards, EMC), mechanical safety, and biocompatibility standards.
- Performance Verification: Ensuring the device operates as intended for TENS and EMS functionalities.
This is fundamentally different from a clinical "ground truth" derived from patient outcomes or expert diagnoses.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set is involved.
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