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510(k) Data Aggregation
(245 days)
Brehna, 06796
Germany
Re: K250047
Trade/Device Name: bite away two
Regulation Number: 21 CFR 890.5740
Common or Usual Name:** Powered Heating Pad
Classification Name: Pad, Heating, Powered (21 CFR 890.5740
2 | Yes |
Page 8
| Product Code | IRT | IRT | Yes |
|---|---|---|---|
| CFR Section | 890.5740 | ||
| 890.5740 | Yes |
VII.
The bite away® two is indicated for use to provide temporary relief of the pain and itching resulting from insect stings and bites such as bees, wasps and mosquitoes.
The mibeTec bite away® two device is a light weight, portable, handheld, battery powered, user-operated device that produces mild heat for direct contact with the affected areas of the skin. The heat is initiated by the user through the activation of the unit by depressing a non-locking button. The device is provided with two (2) side-by-side buttons. The user has the choice of a short 3 second heat treatment or a 5 second heat treatment depending on which button is depressed. The activation of the unit is signified with the illumination of an LED light and an audible chirp through the use of an electronic buzzer. An audible error message is activated when there is a user error. The device is not connected to the user as the user is in complete control of the heat treatment and as such, self-delivers the heat treatment to themselves by contacting the device to their own anatomy / treatment site. As in any user-controlled heat therapy, the user determines the tolerance to such delivered heat and applies and removes the heat treatment per their own tolerance; thereby virtually alleviating the risks of inadvertent overheating of the skin. The short duration of treatment time of 3 and 5 seconds and the small surface area of the heated ceramic plate that contacts the patient further alleviates risk of overheating the skin as the device automatically stops heating the element after 3 or 5 seconds; limiting the maximum amount of heat to be delivered to the site.
The mibeTec bite away® two device utilizes two AAA batteries (1.5 volts each) that power a MOSFET that heats a 7mm ceramic disc to approx. 51C +/- 1% when activated by the user through the use of one of the two electro-mechanical NOC (normal open contact) buttons (3 seconds or 5 seconds of heating). The device consists of a few major components: a hard plastic outer case, a printed circuit board, two activation buttons, two AAA batteries, and a heated ceramic plate that contacts the patient.
N/A
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(216 days)
|
| RegulatoryNumber | 21 CFR 890.5290(b)21 CFR 890.5740
| 21 CFR 890.529021 CFR 890.5740
The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
The Caerus Active System is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) and thermal exchange therapy. The Active System includes general use wraps and therapy is delivered with single-use OrthoPods, sold separately.
The Caerus Avenue8 device is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) therapy and electronic heat.
The provided text is a 510(k) summary for the Caerus Active System and Avenue8, seeking substantial equivalence to predicate devices. It describes performance data and a clinical study conducted.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that non-clinical performance testing and a clinical study were conducted to verify device performance and satisfy special controls. However, it does not explicitly state specific acceptance criteria values (e.g., "The device must achieve X% pain reduction to be considered effective") and then report the results against those criteria in a tabular format. Instead, it reports outcomes from the clinical study and compliance with standards.
We can infer "performance" from the clinical study's outcome in terms of pain reduction effect.
| Acceptance Criteria (Implied from Clinical Study Goal) | Reported Device Performance (Active System + SOC group) |
|---|---|
| Significant pain reduction compared to Standard of Care (SOC) alone | 36% reduction in pain (compared to 10% reduction in SOC group) using the Mankowski scale over 2 weeks. |
| Low incidence of adverse events and no serious adverse events | 3.3% minor complications (4 out of 120 participants), distributed equally between groups, with no serious or unanticipated adverse events. |
2. Sample Size Used for the Test Set and Data Provenance
The text describes a clinical study which serves as the "test set" for demonstrating clinical performance.
- Sample Size: 120 patients enrolled.
- 48 in the Active System (Shortwave Diathermy + Heating Therapy) group.
- 43 in the SOC group. (Note: The sum of these two groups is 91, not 120. There's a discrepancy in the provided numbers, as 120 is the total. This could imply other groups or just a rounding/reporting discrepancy. Assuming the reported group sizes are correct for the Active System and SOC groups, the remaining 29 participants are unaccounted for in this specific breakdown).
- Data Provenance: Not specified, neither country of origin nor retrospective/prospective. However, a clinical study implies prospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. For a clinical study measuring pain, the "ground truth" is typically the patient's self-reported pain score (Mankowski scale in this case), not an expert consensus on interpreting data like images. Therefore, expert consensus in the traditional sense (e.g., radiologists interpreting images) is not applicable here.
4. Adjudication Method for the Test Set
- This information is not applicable as the "ground truth" is patient-reported pain scores, not adjudicated data. There's no mention of an adjudication process for these scores.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This device involves direct patient treatment and pain measurement, not interpretation of data by multiple human readers (e.g., radiologists) with or without AI assistance. The study described is a clinical trial comparing the device's efficacy against standard of care.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. The device (Active System) is a physical medical device that delivers therapy, not a standalone AI algorithm for diagnosis or interpretation. The clinical study evaluates the device's performance as a treatment.
7. The Type of Ground Truth Used
- The "ground truth" for the clinical study was patient-reported pain assessment scores, specifically using the Mankowski scale, measuring the change from baseline at the end of 2 weeks.
8. The Sample Size for the Training Set
- This information is not applicable or not provided. This document describes a medical device for treatment, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The clinical study serves to validate the device's effectiveness, not to train an algorithm. There is no mention of an algorithm or AI component that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable or not provided as there is no "training set" in the context of an AI/ML algorithm for this device.
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(197 days)
|
| Regulatory Number: | 1) 21 CFR 882.58902) 21 CFR 890.5740
This home used device is designed to be used for adult and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.
The FT-810R with a remote controller is a self-adhesive TENS device with 15 adjustable intensity level for pain relief. Moreover, it also provides a heat function which can be used in conjunction with the TENS function. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective non-pharmacological method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS self-treatment regime.
TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear and must be replaced when they stop providing sufficient contact or the main device no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.
The provided text is a 510(k) summary for the Hivox Biotek Inc. Heating TENS (FT-810R) device. It details the device's characteristics, its comparison to predicate devices, and the non-clinical tests performed to demonstrate substantial equivalence. However, it explicitly states that "No clinical test data was used to support the decision of substantial equivalence."
Therefore, I cannot provide information on acceptance criteria based on human performance, nor can I describe a study that proves the device meets such criteria, because no clinical efficacy or human performance studies were conducted or presented for this 510(k) clearance. The clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices through engineering and safety testing.
The document focuses on non-clinical testing to ensure the device meets predefined acceptance criteria for safety and performance, primarily in comparison to its predicate devices.
Here's an analysis of the provided information, addressing your points where possible, and explicitly stating where information is not available:
1. A table of acceptance criteria and the reported device performance
The document mentions that "All the test results demonstrate the subject device, Heating TENS (FT-810R), meets the requirements of its pre-defined acceptance criteria and intended use, and its substantially equivalent to the predicate device." However, it does not explicitly list the specific quantitative acceptance criteria or the reported performance for each criterion in a consolidated table. Instead, it lists the types of non-clinical tests performed and implies that the device passed them by stating it "meets the requirements."
The "Table 1 – Comparison to Predicate Devices and Reference Device" does show comparisons of various technical specifications (e.g., maximum temperatureetting, output voltage, current, pulse width, frequency, maximum phase charge, maximum current density, maximum power density, etc.). While these are comparative performance metrics, they are not presented as explicit "acceptance criteria" with a target value + achieved value in the way you might see for clinical performance. The acceptance here is that it falls within a similar, safe, and effective range as the predicate devices.
For example, we can infer acceptance based on the comparison table:
| Comparison Item | Implied Acceptance Criterion | Reported Device Performance (FT-810R) |
|---|---|---|
| Functional Equivalence | The device's function and design (electrical stimulation and heat) should be comparable to predicate devices. | Identical to predicate device. |
| Power Source | Must use a similar power source to predicate devices. | 3.7 V Lithium-ion battery (identical to Predicate #2, similar to Predicate #1 "Rechargeable battery"). |
| Maximum Temperature Setting | Must operate at or below predicate device temperature settings for safety (e.g., 43℃). | 43℃ (Identical to predicate device). |
| Safety Standards Compliance | Must comply with relevant electrical safety, EMC, usability, and biocompatibility standards (e.g., ANSI/AAMI ES60601-1, IEC 60601 series, ISO 10993 series). | Compliant with ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993-5, ISO 10993-10, 21 CFR 898. |
| Output Waveform | Should be similar to predicate devices (e.g., Biphasic, Symmetrical, Rectangular shape). | Biphasic, Symmetrical, Rectangular (identical to predicate device). |
| Maximum Output Voltage (@ 500 Ω) | Voltage profile should be within a safe and effective range comparable to predicate devices. | 72 Vp-p (@ 500 Ω). (Predicate #1: 100 Vp-p, Predicate #2: 72 Vp-p. "No significant differences would raise concern in safety or effectiveness"). |
| Maximum Output Current (@ 500 Ω) | Current profile should be within a safe and effective range comparable to predicate devices. | 144 mAp-p (@ 500 Ω). (Predicate #1: 200 mAp-p, Predicate #2: 144 mAp-p. "No significant differences would raise concern in safety or effectiveness"). |
| Maximum Phase Charge (@ 500 Ω) | Safety margin relative to predicate devices. | 21.6 µC (@ 500 Ω). ("much lower than Predicate device #1 [45 µC]. The differences would not raise concern in safety or effectiveness from predicate device"). |
| Maximum Averaged Current (@ 500 Ω) | Safety margin relative to predicate devices. | 9.04 mA (@ 500 Ω). ("No significant differences would raise concern in safety or effectiveness"). |
| Maximum Current Density (@ 500 Ω) | Max current density should be below safety limits (e.g., 2mA/cm² per IEC 60601-2-10). | 1.01 mA/cm² (@ 500 Ω). ("lower than 2mA/cm² which meets the requirement of IEC 60601-2-10"). |
| Maximum Power Density (@ 500 Ω) | Max power density should be below safety limits (e.g., 0.25 W/cm²). | 0.055 W/cm² (@ 500 Ω). ("< 0.25W/cm²"). |
| Wireless Communication | If applicable, wireless features should meet relevant standards (e.g., FCC Part 15). | Meets FCC Part 15 (identical to reference device). |
| Shelf Life | Device maintains performance over its defined shelf life. | (Passed ASTM F1980-16, results not detailed). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify a "sample size" in terms of patient data or clinical images, as no clinical studies were performed. The "test set" here refers to the device units themselves that underwent non-clinical testing. The number of physical units tested is not specified (e.g., "N=3 devices passed electrical safety testing").
- Data Provenance: The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Hivox Biotek Inc.) or their contracted labs, primarily in Taiwan (R.O.C.) as indicated by their address. The studies conducted were non-clinical performance and safety tests, not retrospective or prospective patient data studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there was no test set involving human data or expert review for establishing "ground truth" (e.g., diagnostic labels, disease presence/absence). The ground truth for the non-clinical tests would be the established engineering and safety standards (e.g., IEC 60601 series, ISO 10993 series).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as no human expert review or adjudication of data (e.g., medical images) was involved in this 510(k) submission.
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
- No MRMC comparative effectiveness study was done. The device cleared is a hardware-based TENS/EMS device with heating function, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable as the device is not an algorithm for diagnosis or interpretation. Its performance is evaluated based on its physical, electrical, and thermal outputs meeting specified safety and performance requirements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical tests was adherence to recognized consensus standards and/or guidance documents (e.g., ASTM F1980-16 for shelf life, ISO 10993 for biocompatibility, IEC 62304 for software validation, ANSI/AAMI ES60601-1 and related IEC 60601 series for electrical safety and EMC). These standards define the acceptable limits and performance characteristics for such medical devices.
8. The sample size for the training set
- This is not applicable as the device is not an AI/Machine Learning algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
- This is not applicable as there was no training set for an AI/ML algorithm.
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(88 days)
701B, HK-701C Regulatory Class: II Product Code: NUH, NGX, IRT Regulation Number: 882.5890, 890.5850, 890.5740
Health Expert Electronic Stimulator
Model: EM59-1, EM59-2
Requlation Number: 882.5890, 890.5850, 890.5740
PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (mode 4-6): 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.
Heating: This function is designed to be used for temporary relief of minor aches and pains.
Ems Foot Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS), Powered Muscle Stimulator (PMS) and heating qualities.
Ems Foot Stimulator has 6 modes (PMS mode 13, TENS mode 46), which can give certain electrical pulse through 6 pcs of electrode Pad placed on the body to help users to enjoy body stimulation. There are 2 big electrode pads in foot conductive area for feet placed on the main unit to help users to enjoy sole stimulation. And a heating belt can provide heating treatment on waist area.
The main unit has the operating elements of Power on/off switch, ON/OFF Switch, Display screen, 2 Mode Selection keys, 2 Intensity Selection keys and a time setting key.
The LCD display screen can show selected mode, output intensity of body and sole, heating level and time remaining of an application mode.
The remote controller has a ON/OFF Switch to control the EMS/ TENS treatment, a ON/OFF switch to control heating treatment, 2 mode selection keys, 2 intensity selection keys, 2 heating adjust keys and a time setting key.
The heating belt and foot conductive pad can only warm the waist and foot rang 30 to 41 degree C The Heating adjust keys on remote controller can help user to adjust the temperature for warming the waist and foot simultaneously. The heating time is same as the treatment time you selected. The heating and stimulation can be applied simultaneously.
There are 4 models, model HK701, HK701A, and HK701C, all the four models include a main unit and many accessories. The main unit of the four models are the same, the difference is only the accessories included in the package, so the function is a little different.
This document is a 510(k) summary for the Ems Foot Stimulator, a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) device. The purpose of this summary is to demonstrate substantial equivalence to previously cleared devices, not to present a study proving the device meets a specific set of acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria and a detailed study proving performance is not directly available in this type of submission.
Based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific acceptance criteria in a quantifiable table for clinical performance (e.g., sensitivity, specificity for a diagnostic device or a specific clinical outcome for a therapeutic device) nor does it report device performance against such criteria. Instead, it demonstrates substantial equivalence to predicate devices through technical comparisons and compliance with recognized standards.
The document lists performance characteristics for the subject device and predicate devices for comparison. These are not acceptance criteria in the sense of a clinical outcome, but rather technical specifications and safety parameters.
| Element of Comparison | Subject Device (Ems Foot Stimulator) | Primary Predicate Device (K203574) | Secondary Predicate Device (K190783) | Remark |
|---|---|---|---|---|
| Intended Use | PMS (stimulate healthy muscles), TENS (temporary pain relief), Heating (temporary minor aches/pains) | TENS (temporary pain relief), EMS (stimulate healthy muscles), SH (temporary minor aches/pains) | PMS (stimulate healthy muscles), TENS (temporary pain relief) | Same |
| Power Source | Adaptor Input: 100-240Vac, Output: DC12V-3A | Rechargeable battery | Adaptor Input: 100-240Vac, Output: 5Vdc, 2A | Similar (Note 1) |
| Function and Design | Electrical stimulation and heat | Electrical stimulation and heat | Electrical stimulation and heat | Same |
| Heating Setting | Adjustable | Low and high | Adjustable | Same |
| Output Patterns | Electrical stimulation only, Heat only, Electrical stimulation + heat simultaneously | Electrical stimulation only, Heat only, Electrical stimulation + heat simultaneously | Not public available | Same |
| Method of Line Current Isolation | Type BF Applied Part | N/A (internal power source) | Type BF Applied Part | Same |
| Patient Leakage Current (NC) | AC: 54.5μA, DC: 0.5μA | 6.0 μΑ | AC: 54.5μA, DC: 0.5μA | Same |
| Patient Leakage Current (SFC) | AC: 120.0μA, DC: 0.6μA | 5.6 μΑ | AC: 120.0μA, DC: 0.6μA | Same |
| Average DC current through electrodes (no pulses) | < 0.01μA | Not public available | < 0.01μA | Same |
| Number of Output Channel | 2 | 2 | 2 | Same |
| Number of Output Modes | 6 | Model EM 59-2: TENS: 15, EMS: 35 | 25 | Similar (Note 2) |
| Heating Temperature Range | 30-41°C | SH: 1, Max temp setting 43°C | 30-40°C | Similar (Note 2) |
| Output Intensity Level | TENS: 99 steps, EMS: 99 steps, Heating: 6 levels | TENS: 0 to 50, EMS: 0 to 50, SH: LOW to HI | 99 steps | Similar (Note 2) |
| Timer Range | 15min, 20min, 25min, 30min | 5 to 100 minutes adjustable | 25 to 60 min | Similar (Note 2) |
| Maximum Output Voltage @ 500Ω | 44V ± 10% | 50V ± 20% | 44V ± 10% | Same |
| Maximum Output Voltage @ 2KΩ | 80V ± 10% | 90V ± 20% | 80V ± 10% | Same |
| Maximum Output Voltage @ 10KΩ | 112V ± 10% | 125V ± 20% | 112V ± 10% | Same |
| Maximum Output Current @ 500Ω | 88mA ± 10% | 100mA ± 20% | 88mA ± 10% | Same |
| Maximum Output Current @ 2KΩ | 40mA ± 10% | 45mA ± 20% | 40mA ± 10% | Same |
| Maximum Output Current @ 10KΩ | 11.2mA ± 10% | 12.5mA ± 20% | 11.2mA ± 10% | Same |
| Pulse Duration | 120μs | 50 to 450 | 120μs | Same |
| Pulse frequency | 77.3Hz | 1 to 150 | 77.3Hz | Same |
| Net Charge (per pulse) @ 500Ω | 0µC | 0µC | 0µC | Same |
| Maximum Phase Charge @ 500Ω | 10.56μC | 45μC | 10.56μC | Same |
| Maximum Average Current @ 500Ω | 1.63mA | 13.5 mA | 1.63mA | Same |
| Maximum Current Density (r.m.s) @ 500Ω | 5.5 mA/cm2 | 0.667mA/cm2 | 0.0326 mA/cm2 | Different (Note 2) |
| Maximum Average Power Density @ 500Ω | 0.0000831mW/cm2 | 0.0046 W/cm2 | 0.0000266mW/cm2 | Different (Note 2) |
| Biocompatibility | Compliance with ISO10993-5 and ISO10993-10 requirements | ISO 10993-5, ISO 10993-10 | Compliance with ISO10993-5 and ISO10993-10 requirements | Same |
| Electrical Safety | IEC 60601-1, IEC 60601-2-10 | ES 60601-1, IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | Same |
| EMC | 60601-1-2 | IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
Note 1: The power source difference from predicate devices is addressed by compliance with IEC 60601-1, asserting no safety/effectiveness issue.
Note 2: Differences in "number of output modes," "heating temperature," "output intensity level," "timer range," "maximum current density," and "maximum average power density" are addressed by passing safety tests complying with FDA-recognized consensus standards, asserting no adverse impact on safety/effectiveness.
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical study was performed." (page 6). Therefore, there is no test set or clinical data provenance in the context of a clinical trial for device efficacy. Performance data provided are from non-clinical tests (biocompatibility, electrical safety, EMC, usability, software V&V). These tests were likely conducted on a representative sample of the manufactured device. Specific sample sizes for these engineering tests are not provided in this summary. The data provenance for non-clinical tests is generally from internal testing or certified external labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study was performed and thus no "ground truth" was established based on expert assessment for a clinical test set.
4. Adjudication method for the test set
Not applicable, as no clinical study was performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was performed."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a physical medical device (TENS/PMS unit), not an algorithm or AI. Standalone performance as typically described for AI/software devices is not applicable. The performance demonstrated is through non-clinical bench testing and compliance with electrical, safety, and biocompatibility standards.
7. The type of ground truth used
For the non-clinical tests performed:
- Biocompatibility: Ground truth is established by standards like ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), where the "truth" is whether the materials elicit an adverse biological response.
- Electrical safety and EMC: Ground truth is established by compliance with international standards such as IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, and IEC 60601-1-2.
- Usability Testing: Ground truth is established by compliance with standards like IEC 62366-1 and IEC 60601-1-6.
- Software Verification and Validation Testing: Ground truth is established by FDA's guidance for software in medical devices, assuring that the software functions as intended and does not lead to minor injury.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device that requires a training set and ground truth for training.
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(121 days)
Santee, California 92071
Re: K220514
Trade/Device Name: bite away® neo Regulation Number: 21 CFR 890.5740
Name: | Heating pad |
| Classification Name: | Powered Heating Pad (21 CFR 890.5740
predicate device (K160943) share the design feature of being over-the-counter (OTC) devices under 21 CFR 890.5740
|
| CFR Section | 890.5740
| 890.5740
The bite away® neo is indicated for use to provide temporary relief of the pain and itching from insect stings and bites such as bees, wasps and mosquitoes.
The bite away® neo device is a light weight, portable, hand-held, battery powered, user- operated device that produces mild heat for direct contact with the affected areas of the skin. The heat is initiated by the user through the activation of the unit by depressing a non-locking button. The device is provided with two (2) side-by-side buttons. The user has the choice of a short 3 second heat treatment or a 5 second heat treatment depending on which button is depressed. The activation of the unit is signified with the illumination of an LED light and an audible chirp through the use of an electronic buzzer. An audible alarm is activated when there is a user error. The device is not connected to the user as the user is in complete control of the heat treatment and as such, self-delivers the heat treatment to themselves by contacting the device to their own anatomy / treatment site. The short duration of 3 and 5 seconds of heating the device's heated ceramic plate that contacts the patient further alleviates risk of overheating the skin as the device automatically stops heating the element after 3 or 5 seconds; limiting the maximum amount of heat to be delivered to the site.
The bite away® neo device utilizes two AA batteries (1.5 volts each) that power a resistor that heats a 7mm ceramic disc to approximately 50°C when activated by the user through the use of one of the two electro-mechanical NOC (normal open contact) buttons (3 seconds of heating). The device consists of a few major components: a hard plastic outer case, a printed circuit board, an activation button. AA batteries, and a heated ceramic plate that contacts the printed circuit board consists of the following components: electro-mechanical NOC buttons, microcontroller with programmed firmware, MOSFET transistor heating element, ceramic pad, resistors, coils, capacitor, thermistor temperature sensor and buzzer. The bite away® neo device is approximately 7 inches long and weighs approximately 40 grams.
This document is a 510(k) Premarket Notification from MibeTec, GmbH to the FDA for their device, the bite away® neo. The device is a powered heating pad intended for the temporary relief of pain and itching from insect stings and bites.
Since this document is a 510(k) submission, the study performed is a non-clinical performance study to demonstrate substantial equivalence to a predicate device, not a comparative effectiveness study with human readers (MRMC study) or a standalone algorithm performance study. The core of this submission is comparison to a predicate device and demonstration that the new device is as safe and effective.
Here's an breakdown of the requested information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds for clinical efficacy in this document, as this is a 510(k) submission demonstrating substantial equivalence based primarily on non-clinical performance and design characteristics, rather than de novo clinical efficacy trials. The implicit acceptance criterion is that the device is as safe and effective as the predicate device and meets relevant safety and performance standards.
The document demonstrates this by:
- Identical Indications for Use: The bite away® neo and the predicate device (Riemser Bite Away, K160943) are indicated for the same purpose.
- Similar Design Principles: Both are user-operated, hand-held, battery-powered, reusable devices that deliver mild heat to the skin via a ceramic disc.
- Compliance with Safety Standards: The device underwent and passed electrical safety, EMC, software verification/validation, and usability testing according to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62366, IEC 60601-1-6) and FDA guidance for biocompatibility (ISO 10993-1).
Table of Acceptance Criteria (Implicit) and Reported Device Performance:
| Acceptance Criterion (Implicitly Met) | Reported Device Performance (vs. Predicate K160943) |
|---|---|
| Indications for Use Equivalence | Identical: Both devices are indicated for temporary relief of pain and itching from insect stings and bites (bees, wasps, mosquitoes). The difference in claim of "increasing localized blood flow" for the predicate is stated to not affect safety or efficacy. |
| Intended Use Equivalence | Identical: Delivery of mild heat to the skin/dermis. |
| Temperature Profile Equivalence | Similar Temperature Range: Subject device: 50 - 53°C (device surface); Predicate: 50 - 53°C (device surface). Max skin surface temp for subject: 48.6°C. Rationale: Identical temperature range, no additional risks. |
| Energy Transfer Mechanism Equivalence | Identical: Both use a heated ceramic disc. |
| Power Source Equivalence | Identical: Both use AA Batteries (3 volts DC). |
| Operator Control / Application Method Equivalence | Identical: Hand-held, user-operated, applied directly to the insect bite, user in complete control of heat treatment. |
| Biocompatibility | Compliant: Patient contact polymers and ceramics evaluated against ISO 10993-1, including Cytotoxicity, Sensitization, and Irritation. |
| Electrical Safety & Electromagnetic Compatibility (EMC) | Compliant: Tested against IEC 60601-1 (MOD), IEC 60601-1-2, and IEC 60601-1-11. |
| Software Verification and Validation | Compliant: Tested following FDA Guidance for "moderate" level of concern software; complies with IEC 62366 (implied). |
| Usability | Compliant: Tested against IEC 60601-1-6. |
| Risk Mitigation (Differences from Predicate) | Reduced Heating Time: Subject device has 3 and 5 seconds vs. predicate's 3 and 6 seconds. Rationale: "Greater safety with less heating time." Smaller Heated Area (7mm vs 9mm): Rationale: "Small disc size delivers heat to less surface area; reducing risk. User can apply to multiple areas for more surface area treatments." These differences are argued to enhance safety. |
| Material & Component Similarities | Hard plastic outer case, LED light, audible signal, microprocessor. |
| Regulatory Classification Equivalence | Identical: Powered Heating Pad, Class II, Product Code IRT, CFR Section 890.5740, OTC Use. |
2. Sample Size for the Test Set and Data Provenance
The document explicitly states: "No clinical studies were performed to support safety or effectiveness of the subject device."
Therefore, there is no "test set" in the traditional sense of a clinical data set used to prove efficacy. The "testing" refers to non-clinical bench testing (biocompatibility, electrical safety, software validation, usability) against established standards. The data provenance is from laboratory testing and engineering analysis conducted by the manufacturer, MibeTec, GmbH (Germany), as part of their premarket notification submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. As no clinical studies were performed, there was no "ground truth" derived from expert consensus on medical images or patient outcomes. The "ground truth" for the non-clinical tests is adherence to engineering and safety standards, which are defined by international bodies and regulatory agencies like the FDA. The experts involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at the manufacturer and the testing laboratories.
4. Adjudication Method for the Test Set
N/A. There was no clinical test set requiring adjudication. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in clinical image interpretation studies or clinical trials, which were not conducted here.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical studies were performed to support safety or effectiveness of the subject device." Therefore, no MRMC study was conducted, and no effect size for human readers improving with or without AI assistance is provided. (Note: This device is a heating pad, not an AI-powered diagnostic tool, so an MRMC study would generally not be applicable in this context).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
N/A. This device is a powered heating pad, not an AI algorithm. There is no software or algorithm whose performance is being evaluated in a standalone manner. The software mentioned is for the device's internal control (e.g., heating duration, temperature regulation), verified as "moderate" level of concern.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is established through:
- Engineering and Safety Standards: Compliance with international standards (IEC 60601 series, ISO 10993, IEC 62366).
- Predicate Device Equivalence: The legally marketed predicate device (K160943) serves as the primary benchmark for demonstrating safety and effectiveness. The premise of a 510(k) is that if the new device is substantially equivalent to a legally marketed predicate, it is considered safe and effective.
8. The Sample Size for the Training Set
N/A. As this is not an AI/machine learning device, there is no "training set" in the conventional sense. The device's design (e.g., microcontroller firmware) would be developed and refined through engineering iterations, but not trained on a distinct dataset like an AI model.
9. How the Ground Truth for the Training Set Was Established
N/A. See #8.
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(148 days)
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| Regulation Number: | 1) 882.58902) 890.58503) 890.5740
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| Regulation Number: | 1) 882.58902) 890.58503) 890.5740
The WL-2405K+ is a digital electrical and heat stimulator for active treatment application as the following:
TENS can be used for the following applications:
- For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.
EMS can be used for the following applications:
- For healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
Heat Mode:
- Heat can be used for temporary relief of minor aches and pains.
Well-Life OTC TENS/EMS/Heating Stimulator Device, Model no. WL-2405K* provides a combination of transcutaneous electrical nerve stimulation (TENS) for temporary relief of pain associated with sore and aching muscles due to strain from exercise, normal household chores and work related activities, Electrical Muscle Stimulator (EMS) can be used to stimulate healthy muscles in order to facilitate muscle performance, relax muscle spasms, prevent or retard disuse atrophy, reeducate muscles and to maintain or increase the range of motion, Heat can be used in warming the muscle for soothing comfort.
The stimulator generates the output current specified as the input of controller. The output port transmits the output current & heat to the electrode, which is attached to the user's skin ; ; with the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back, upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities, and to be used to stimulate healthy muscle in order to improve and facilitate muscle performance.
The device includes several operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached and detached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS/EMS and heat. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43°C.
For the heating cycle, the temperature will get to 43 degree Celsius in 130 seconds after turning on the heating mode, and when it reaches 43 degree Celsius then it will cool down to body temperature for 20 seconds, then back to 43 degree Celsius for 20 seconds , the cycle will continue for 15 minutes.
The device could be operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature. Channel 1 can provide electrical stimulation signal, such as TENS/EMS, and it can only be performed by connecting an electrode and wire dedicated to electrical stimulation. Channel 2 can provide heat treatment, and it can only be carried out by connecting heat-exclusive electrode and wires. The exclusive accessories used for electrical stimulation or thermotherapy are marked by color to prevent misuse by the user. If you accidentally use it incorrectly, there will be a protective mechanism in the device to prevent it from operating and causing harm.
Based on the provided text, the device in question is the "Well-Life TENS/EMS/Heating Stimulator (Model: WL-2405K+)". This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical acceptance criteria through a clinical study with detailed performance metrics.
Therefore, much of the information typically requested for demonstrating device performance against acceptance criteria in a clinical study (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or not provided in this type of submission. This summary primarily relies on non-clinical testing (bench testing, usability, biocompatibility, electrical safety, shelf life, software validation) and direct comparison to predicate devices, asserting equivalence in safety and effectiveness.
Here's a breakdown of what can be extracted and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the standards the device claims to meet and the performance benchmarks of the predicate devices. However, explicit numerical acceptance criteria and direct performance results are primarily presented for non-clinical tests rather than clinical outcomes.
| Criteria Category / Parameter | Acceptance Criteria (Implied/Standard) | Reported Device Performance (as stated in Non-Clinical Testing Summary or Comparison) |
|---|---|---|
| Usability | Compliance with IEC/EN 60601-1-6:2016 & IEC/EN 62366:2016 | Meets the usability requirement as defined in the verification & validation test report. |
| Biocompatibility | Compliance with ISO 10993-1, -5, -10, -12 (Cytotoxicity, Sensitization, Irritation, Sample Prep) | Patient contacting components (electrode) are the same as a cleared predicate (K082065) and are in compliance with listed ISO 10993 standards. |
| Electromagnetic Compatibility & Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-11, ANSI/AAMI ES 60601-1, and Li-ion safety. Results meet IEC 60601-1 standard: Ed 3. | Results meet the requirement of IEC 60601-1 standard: Ed 3. |
| Performance (Electrical Stimulator) | Compliance with IEC 60601-2-10 | Result meets the requirement of IEC 60601-2-10. |
| Shelf Life | Adequacy of shelf life per FDA-2020-D-0957 & ASTM F1980-16 | Regarded as 2 years. |
| Software Validation | Compliance with "General Principles of Software Validation" (11/05/2005) guidance | Representative sample WL-2405K+ chosen for systematic assessment; required test reports provided. |
| Heating Temperature (Maximum) | Max 43°C (matching primary predicate) | 43°C reached in 130 seconds, cycle continues for 15 minutes. |
| Heating Temperature (Low) | Specific value (e.g., 41°C of predicate) | Subject device: 42°C. Deemed substantially equivalent as difference from predicate's 41°C is minor. |
| Output Voltage (Vp, ±20%) | For 500Ω, 2KΩ, 10KΩ loads (compared to predicates) | Lower than primary predicate (e.g., 40V@500Ω vs 50V@500Ω), but deemed substantially equivalent. Same as secondary predicate. |
| Output Current (mAp, ±20%) | For 500Ω, 2KΩ, 10KΩ loads (compared to predicates) | Lower than primary predicate (e.g., 80mA@500Ω vs 100mA@500Ω), but deemed substantially equivalent. Same as secondary predicate. |
| Pulse Width (μs) | Compared to predicates | 50 to 300 μs (Primary predicate: 50 to 450 μs; Secondary predicate: 50 to 300 μs). Deemed substantially equivalent based on safety and effectiveness. |
| Frequency (Hz) | Compared to predicates | 1 to 100 Hz (Primary predicate: 1 to 150 Hz; Secondary predicate: 1 to 100 Hz). Deemed substantially equivalent based on safety and effectiveness. |
| Maximum Phase Charge (μC @ 500Ω) | Compared to predicates | TENS/EMS: 260(max) (Primary predicate: 45; Secondary predicate: 260(max)). Deemed substantially equivalent based on safety and effectiveness. |
| Maximum Current Density (mA/cm² @ 500Ω) | Compared to predicates | TENS Mode: 0.067; EMS Mode: 0.058 (Primary predicate: 0.667; Secondary predicate: TENS: 0.203, EMS: 0.095). Deemed substantially equivalent based on safety and effectiveness. |
| Maximum Power Density (W/cm² @ 500Ω) | Compared to predicates | TENS Mode: 0.0027; EMS Mode: 0.0023 (Primary predicate: 0.0046; Secondary predicate: TENS: 0.0081, EMS: 0.0038). Deemed substantially equivalent based on safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. No clinical test set data is provided or mentioned as being used for substantial equivalence. The "test sets" mentioned refer to non-clinical bench testing.
- Data Provenance: Not applicable for clinical data. For non-clinical tests, tests were conducted at an "accredited test laboratory" (location not specified beyond Taiwan for the manufacturer).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. No external "experts" were used to establish ground truth as no clinical test set requiring human interpretation for ground truth was performed or presented. The "ground truth" for the non-clinical tests is based on the specifications of the standards (e.g., IEC, ISO, ASTM).
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set involved human readers or ground truth requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document explicitly states: "No clinical test data was used to support substantial equivalence." (Page 10, Section 9.1). Therefore, no MRMC study was performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical stimulator, not an AI algorithm. Its performance is related to its electrical and heating outputs and physical characteristics.
7. The Type of Ground Truth Used
- For Non-Clinical Tests: The "ground truth" is established by adherence to recognized voluntary consensus standards (e.g., IEC 60601-1, IEC 60601-2-10, ISO 10993 series, ASTM F1980-16, FDA guidances for software and shelf life). These standards define the acceptable range or performance for various parameters.
- For Substantial Equivalence: The primary "ground truth" is the performance and indications of the legally marketed predicate devices. The claim is that the subject device is similar enough in terms of safety and effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set for an algorithm.
Summary of the Study:
The "study" that proves the device meets the acceptance criteria is primarily a non-clinical evaluation documented in the "Non-Clinical Testing Summary" (Section 9) and a comparison to predicate devices for substantial equivalence (Section 10). The manufacturer performed:
- Usability Testing: To meet IEC/EN 60601-1-6 and IEC/EN 62366 standards.
- Biocompatibility Testing: Covering cytotoxicity, sensitization, and irritation, in compliance with ISO 10993 standards. It leverages the fact that the electrode is identical to one cleared in a predicate device.
- Electromagnetic Compatibility and Electrical Safety Testing: To meet IEC 60601-1, IEC 60601-1-11, and ANSI/AAMI ES 60601-1 standards, and Li-ion battery safety.
- Performance Testing: To meet the IEC 60601-2-10 standard for nerve and muscle stimulators.
- Shelf Life Testing: Following FDA guidance and ASTM F1980-16.
- Software Validation: Following FDA guidance on software for medical devices.
The entire submission is geared towards demonstrating substantial equivalence to existing predicate devices (HIVOX OTC Electrical Stimulator K203574 and Otc combo tens/ems system K172809) based on these non-clinical tests and a detailed comparison of technical specifications, rather than new clinical trials with patient outcomes. The premise of a 510(k) is that if a new device is as safe and effective as a legally marketed predicate device, it does not require a new PMA (Premarket Approval) process which typically involves extensive clinical data.
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(93 days)
890.5850 |
| | 3) 890.5740
HIVOX OTC Electrical Stimulator, EM59-1
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
SH: This function is designed to be used for temporary relief of minor aches and pains.
HIVOX OTC Electrical Stimulator, EM59-2
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
SH: This function is designed to be used for temporary relief of minor aches and pains.
HIVOX OTC Electrical Stimulators, EM59-1 and EM59-2, fall into the electrostimulation device category.
EM59-1 provides two basic functions, TENS and SH; EM59-2 provides three basic functions, TENS, EMS and SH:
(1) Electrical stimulation of nerve tracts (TENS)
(2) Electrical stimulation of muscle tissue (EMS)
(3) Superficial heat (SH)
Both two models feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general wellbeing, pain relief, maintaining physical fitness, relaxation, muscle revitalisation and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.
The size of the self-adhesive electrode gel pad is 45x45 mm supplied by Shaoxing DL Healthcare Co., Ltd. It is an OTC medical device cleared by FDA under K182111. On the other hand, the electrode made by PET, sponge, PCB and protect cases is designed by HIVOX BIOTEK INC.
The provided text describes the 510(k) summary for the HIVOX OTC Electrical Stimulator (EM59-1, EM59-2). This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain information about acceptance criteria and studies demonstrating device performance for an AI/ML powered device, as the device described is an electrical stimulator, not an AI/ML product.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types) because it is not present in the provided document.
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(143 days)
Santee, California 92071
Re: K160943
Trade/Device Name: Bite Away Regulation Number: 21 CFR 890.5740
ESTABLISHMENT REGISTRATION NUMBER 3007770022
DEVICE CLASSIFICATION AND PRODUCT CODE
As shown in 21CFR 890.5740
devices under 21 CFR 890.5500 while the Hontech Li's Itch Stopper (K963824) is 510(k) exempt under 21 CFR 890.5740
| 890.5740
The Bite Away is indicated for use to provide temporary relief of the pain and itching from insect stings and bites such as bees, wasps and mosquitoes by temporarily increasing localized blood flow.
The Riemser Pharma Bite Away device is a light weight, portable, hand held, battery powered, user-operated device that produces mild heat for direct contact with the affected areas of the skin. The heat is initiated by the user through the activation of the unit by depressing a non-locking button. The device is provided with two (2) side-by-side buttons. The user has the choice of a short 3 second heat treatment or a 6 second heat treatment depending on which button is depressed. The activation of the unit is signified with the illumination of an LED light and an audible chirp through the use of an electronic buzzer. An audible alarm is activated when there is a user error. The device is not connected to the user as the user is in complete control of the heat treatment and as such, self-delivers the heat treatment to themselves by contacting the device to their own anatomy / treatment site. The short duration of 3 and 6 seconds of heating the device's heated ceramic plate that contacts the patient further alleviates risk of overheating the skin as the device automatically stops heating the element after 3 or 6 seconds; limiting the maximum amount of heat to be delivered to the site.
The Riemser Pharma Bite Away device utilizes two AA batteries (1.5 volts each) that power a resistor that heats a 9mm ceramic disc to 51.5℃ +/- 1% when activated by the user through the use of one of the two electro-mechanical NOC (normal open contact) buttons (3 seconds or 6 seconds of heating). The device consists of a few major components: a hard plastic outer case, a printed circuit board, an activation button, AA batteries, and a heated ceramic plate that contacts the patient. The printed circuit board consists of the following components: electro-mechanical NOC buttons, microcontroller with programmed firmware, MOSFET transistor heating element, ceramic pad, resistors, coils, capacitor, thermistor temperature sensor and buzzer.
The Riemser Pharma Bite Away device is approximately 6 inches long and weighs approximately 25 grams. The Bite Away device is provided in 2 shapes, both of which are identical in every way except for the shape. One product is an elongated configuration called "Cobra" and the other configuration is an oblong configuration called "Mouse". Although these products have different shapes and names, the products are identical in every way to include raw materials, subcomponents, electronic circuits, electronic components, and imbedded software code, fabrication processes, etc., and only differs in the shape of the outer case (elongated Cobra model versus the oblong Mouse model).
This document describes the marketing authorization for the "Bite Away" device, a powered heating pad intended for temporary relief of pain and itching from insect stings and bites. The study provided focuses on clinical data to support the device's indications for use.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" is not explicitly defined as a numeric threshold in the document for the clinical study's primary endpoint. Rather, the study aims to demonstrate a statistically significant reduction in pain, itching (pruritus), and swelling as measured by a Visual Analog Scale (VAS) after using the Bite Away device. The reported performance shows significant improvement across these metrics.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Primary Endpoint: Statistically significant reduction in VAS scores for swelling, pain, and pruritus after treatment. | Swelling: Mean VAS score decreased from 4 (prior) to 2 (2-5 min post-treatment) and 1 (10 min post-treatment) (p < 0.0001). |
| Pain: Mean VAS score decreased from 6 (prior) to 2 (2 min post-treatment), 1 (5 min post-treatment), and 0 (10 min post-treatment) (p < 0.0001). | |
| Pruritus: Mean VAS score decreased from 5 (prior) to 2 (2 min post-treatment) and 0 (5 and 10 min post-treatment) (p < 0.0001). | |
| Safety: No mention of specific safety acceptance criteria, but generally implied to be safe for its intended use. | Not explicitly quantified in this section directly, but device safety is typically assessed through adverse event reporting which is not detailed here. The clinical study is a "single arm, open label" which might not be designed to extensively assess comparative safety but rather efficacy in a real-world setting. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: 146 subjects
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It is a prospective, single-arm, open-label clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The study utilized a Visual Analog Scale (VAS) for pain, swelling, and pruritus. This is a subjective patient-reported outcome. Therefore, there were no external "experts" used to establish a ground truth in the traditional sense (e.g., radiologist opinions). The "ground truth" was the subjects' own reported experience via the VAS scores.
4. Adjudication Method for the Test Set
Since the "ground truth" was based on patient-reported VAS scores, there was no adjudication method described for external review of these subjective reports.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done. The device (Bite Away) is a direct treatment device, not an AI-powered diagnostic or assistive tool for human readers. The study evaluates the device's direct therapeutic effect on patients.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Bite Away" is a physical device, not an algorithm. Therefore, the concept of a "standalone" algorithmic performance study does not apply to this device. The clinical study evaluates the device's performance when used by a human (user-operated).
7. The Type of Ground Truth Used
The ground truth used was patient-reported outcomes (PROs) via a Visual Analog Scale (VAS) for pain, swelling, and pruritus.
8. The Sample Size for the Training Set
Not applicable. This device does not involve an AI algorithm that requires a training set. The clinical study evaluates the device's performance in a direct therapeutic context.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI algorithm being developed or evaluated, there is no training set or ground truth establishment for a training set.
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(180 days)
Unit B Tempe, AZ 85283
Re: K142228 Trade/Device Name: Heated Eye Pad Regulation Number: 21 CFR 890.5740
The Heated Eye Pad ophthalmic warmer is a powered heating pad for the application of localized heat therapy. Use for treatment when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, Blepharitis, Stye, or Chalazia.
Not Found
The provided document is an FDA 510(k) clearance letter for a device called "Heated Eye Pad." This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The content is a regulatory clearance stating that the device is "substantially equivalent" to legally marketed predicate devices. It outlines:
- The device name, regulation number, regulatory class, and product code.
- General controls provisions of the Act that apply.
- Contact information for further guidance.
- Indications for Use: The Heated Eye Pad is a powered heating pad for localized heat therapy, recommended for conditions like Meibomian Gland Dysfunction (MGD), Dry Eye, Blepharitis, Stye, or Chalazia, and is approved for Over-The-Counter use.
Therefore, I cannot fulfill your request for information on acceptance criteria and device performance studies based on the provided text. The document is strictly a regulatory clearance, not a technical report detailing performance studies.
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(232 days)
Avenue, Suite L San Diego, CA, 92126
Re: K133981
Trade Name: Avacen 100 Regulation Number: 21 CFR 890.5740
| 890.5740 |
|---|
| FDA Reg |
The AVACEN 100 is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffiess; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied.
The AVACEN 100 consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN 100 is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN 100 for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.
The provided text does not describe a study involving acceptance criteria for device performance in the context of an AI/ML algorithm. Instead, it is an FDA 510(k) summary for a medical device called "AVACEN 100," which is a heat therapy system.
This document focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Anpan FIR Heat Therapy Systems) for regulatory clearance. It outlines the device description, indications for use, comparison with the predicate device, and compliance with nonclinical safety standards (electrical safety, electromagnetic compatibility, and biocompatibility).
Therefore, I cannot provide the requested information about acceptance criteria, device performance from a study, sample sizes, ground truth establishment, or multi-reader multi-case studies, as none of this pertains to the content of the provided document. The device in question is a physical heat therapy system, not an AI/ML algorithm.
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