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510(k) Data Aggregation
(86 days)
Premier North America Inc.
The NUNA LUX is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.
The NUNA LUX is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles. NUNA LUX is a battery-operated device that uses low power light spectrum at red and infrared, at wavelength of 808 ±5nm, 620 ±5nm emitting optical power in a uniform distribution. The NUNA LUX incorporates a near-infrared LED light source within the optimum Therapeutic Optical Window at 808 nm, optimized for Low Level Light Therapy, and a red LED light source at 620 nm. An optical lens that diffuses the light to produce narrowband, divergent distribution across an 8 cm2 treatment area. The energy output of the 808 nm and 620 nm wavelengths is 62.5 mW/cm2 which produces a beneficial treatment for full-face wrinkles.
The provided document is a 510(k) summary for the NUNA LUX (NUNL528) device, which is an Over-the-Counter (OTC) light-based device intended for treating full-face wrinkles. It primarily focuses on demonstrating substantial equivalence to a predicate device (LYMA Laser, K210823) through non-clinical testing. Crucially, this document does not contain information about a clinical study with acceptance criteria for device performance related to efficacy (e.g., wrinkle reduction) or a multi-reader multi-case (MRMC) comparative effectiveness study.
Therefore, I cannot provide a table of acceptance criteria for device performance based on clinical efficacy or details about human reader improvement with AI. The information below reflects what is available in the document regarding safety and general performance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this document primarily addresses safety and general device performance through non-clinical testing for substantial equivalence, the "acceptance criteria" are implied by conformity to specific international consensus standards. The "reported device performance" is the confirmation that these standards were met. There are no quantitative efficacy performance metrics provided for wrinkle reduction from a clinical study.
| Acceptance Criteria (Implied by standard conformity) | Reported Device Performance |
|---|---|
| Electrical Safety: Conformity to ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010(R)2012 (Cons. Text) [Incl. AMD2:2021] | Device conforms to this standard. |
| EMC (Electromagnetic Compatibility): Conformity to IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION | Device conforms to this standard. |
| Additional Safety (Home healthcare environment): Conformity to IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION | Device conforms to this standard. |
| Photobiological Safety: Conformity to IEC 62471 First edition 2006-07 | Device conforms to this standard. |
| Laser Product Safety: Conformity to IEC 60825-1 Edition 2.0 2007-03 | Device conforms to this standard. |
| Biocompatibility (Cytotoxicity): Conformity to ISO 10993-5 Third edition 2009-06-01 | Device conforms to this standard. |
| Biocompatibility (Skin Sensitization): Conformity to ISO 10993-10 Fourth edition 2021-11 | Device conforms to this standard. |
| Biocompatibility (Irritation): Conformity to ISO 10993-23 First edition 2021-01 | Device conforms to this standard. |
| Performance (Skin Temperature): No specific standard or quantitative criterion provided, but "Skin Temperature Testing" was performed. | Testing was conducted, results are not detailed but presumably acceptable. |
| Performance (LED Wavelength and Power Density): No specific standard or quantitative criterion provided, but "LED Wavelength And Power Density Testing" was performed. | Testing was conducted, results are not detailed but presumably acceptable. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical testing (lab bench testing) rather than a clinical study with a test set of human subjects. Therefore, the concept of "sample size for the test set" as typically applied to clinical data or patients does not apply here. The testing involved the device in a laboratory setting to verify compliance with safety and performance standards. No information on data provenance relating to human subjects is provided as no human subject data was discussed.
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 section is not applicable. The document details non-clinical laboratory testing against international consensus standards, not a clinical study involving expert assessment of patient data (e.g., for ground truth on disease or condition).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. There was no clinical test set requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not reported in this document. This device is an OTC light-based device; there is no AI component or human reader interpretation involved in its intended use as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The NUNA LUX is a physical light-based device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing described, the "ground truth" was established by international consensus standards for electrical safety, EMC, photobiological safety, laser safety, and biocompatibility. The device's performance was compared against the requirements specified in these standards.
8. The sample size for the training set
This section is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established
This section is not applicable as there was no training set.
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(75 days)
Premier North America Inc.
BLU TOTALE is an over the counter phototherapy device for use in dermatology for the treatment of mild to moderate acne.
BLU TOTALE is a battery-operated device that uses low power light spectrum at blue LED, at wavelength of 415 ±15nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode (LED) device for the treatment of acne designed for home-use.
The provided text is a 510(k) summary for the BLU TOTALE device (Model: ENEOB852), an over-the-counter phototherapy device for treating mild to moderate acne. This document describes the device, its intended use, and its substantial equivalence to a predicate device (Sapphire, K172555).
However, the document does not contain any information regarding acceptance criteria, performance studies (clinical or otherwise), sample sizes, ground truth establishment, or expert involvement related to demonstrating the device's efficacy for treating acne. The "Non-clinical Testing" section only lists various safety and performance bench tests conducted to conform to international standards (e.g., electrical safety, EMC, biocompatibility, photobiological safety), and does not report on clinical efficacy.
Therefore,Based on the provided text, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because:
1. No clinical efficacy acceptance criteria or corresponding performance claims are present. The document focuses on demonstrating substantial equivalence to a predicate device through shared specifications and conformance to safety and electrical standards. There are no tables of acceptance criteria for treatment efficacy or reported clinical performance metrics in the provided text.
2. No study proving clinical efficacy is described. The "Non-clinical Testing" section details laboratory bench tests for safety (electrical, EMC, photobiological, biocompatibility) and basic device performance (pyrogen, skin temperature, LED wavelength/power density). It does not describe any study (retrospective, prospective, standalone, or MRMC) that evaluates the device's effectiveness in treating acne on human subjects.
Without information on a clinical study or stated performance criteria related to the device's indicated use for acne treatment, it is impossible to answer the specific questions below.
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(550 days)
Premier North America Inc.
The Avologi Gel Primer is intended to be used with Luminice device to improve skin conductivity.
The Avologi Gel Primer is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.
This document describes the Avologi Gel Primer (Model: Av25), an electroconductive gel intended for use with the Luminice device to improve skin conductivity. The submission demonstrates substantial equivalence to the predicate device, NuFACE Gel Primer (K161654), through performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Parameter) | Predicate Device (NuFACE Gel Primer - K161654) | Avologi Gel Primer (Av25) Performance | Comparison |
|---|---|---|---|
| Regulation Number | 21CFR 882.1275 | 21CFR 882.1275 | SE (Substantially Equivalent) |
| Regulation Name | Electroconductive Media | Electroconductive Media | SE |
| Regulatory Class | Class II | Class II | SE |
| Product Code | GYB | GYB | SE |
| Regulation Medical Specialty | Neurology | Neurology | SE |
| Intended Use | To be used with NuFACE microcurrent devices to improve skin conductivity. | To be used with Luminice device to improve skin conductivity. | SE |
| Use | Over-the-Counter cosmetic use | Over-the-Counter cosmetic use | SE |
| Environment of use | Home | Home | SE |
| Target population | Adults 18 years of age or older | Adults 18 years of age or older | SE |
| Where used | Topically on intact skin | Topically on intact skin | SE |
| Sterilization | Non-sterile | Non-sterile | SE |
| Color | Colorless | Colorless | SE |
| Appearance | Clear | Clear | SE |
| Odour | Odourless | Odourless | SE |
| Volume | 2 fl.oz. and 5 fl.oz. tube | 3.38 fl.oz. | Note 1 (Difference in packaging, does not affect performance) |
| Weight(g) | Not publicly available | 170 - 200 | Note 1 (Difference in packaging, does not affect performance) |
| Specific gravity | Not publicly available | 0.900 - 1.100 | SE |
| Viscosity(cps) | Not publicly available | 30000-80000 | Note 1 (Difference, does not affect performance) |
| pH | 6.0-7.0 | 5.0-7.0 | Note 1 (Difference, does not affect performance) |
| Biocompatibility | Complies with ISO 10993-5 and ISO 10993-10 | Complies with ISO 10993-5 and ISO 10993-10 (and ISO 10993-23) | SE |
| Chemical Safety | Non-OSHA PEL | Non-OSHA PEL | SE |
| Conductive material | Salt (Magnesium Sulfate) | Salt (Magnesium Sulfate) | SE |
| Impedance | Not publicly available | 154 Ω ± 10% | SE (Note 2 - acceptable based on performance study) |
| Shelf-life | Not publicly available | 3 years | Note 2 (acceptable based on real-time stability testing) |
| Conductivity (mS/cm) | 2-5 | 3.38 | Note 3 (similar to predicate, higher than some cleared devices, which is more conductive) |
| Microbiological growth (Total Aerobic Microbial Count) |
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(57 days)
Premier North America Inc.
Luminice is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
Luminice is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. Four (4) stainless steel electrodes, fixed on the Luminice device main body, deliver low level electrical impulses (microcurrent) to targeted locations on the body. The Luminice should be used with 510(k) clearance electroconductive media gel, and it's compatible with NuFACE Gel Primer cleared under K161654.
The provided text is a 510(k) summary for the Luminice device, stating its substantial equivalence to a predicate device (NuBODY Skin Toning Device, K171588). However, this document does not contain any information about acceptance criteria, device performance results from a study, sample sizes, data provenance, expert involvement for ground truth, or MRMC studies.
The document primarily focuses on:
- Device Description: What the Luminice device is, its intended use (body skin stimulation for over-the-counter cosmetic use), and its technical specifications.
- Substantial Equivalence Comparison: A detailed comparison of the Luminice device with its predicate device (NuBODY Skin Toning Device) across various characteristics like regulation number, class, product code, intended use, anatomical sites, technological characteristics, basic unit characteristics, and output specifications.
- Non-clinical Testing: A list of international consensus standards (electrical safety, EMC, additional safety, biocompatibility, software validation) to which the Luminice device has been tested and conformed.
- Conclusion: The device is substantially equivalent to the predicate device based on similar intended uses and technological characteristics.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.
The document only states that the device has passed certain non-clinical tests (electrical safety, EMC, biocompatibility, software validation) according to specific standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 10993-5, etc.). These standards define test methods and acceptance limits for specific safety and performance aspects, but the results of these tests (the reported device performance against specific numerical acceptance criteria) are not detailed here. The document also does not mention any clinical studies or studies involving human subjects, nor does it refer to multi-reader multi-case (MRMC) studies or standalone algorithm performance studies. The ground truth establishment methods for any such studies are consequently also not available.
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(28 days)
Premier North America Inc.
ENEO TOTALE is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
ENEO TOTALE is a battery-operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode(LED) device for the treatment of periorbital wrinkles designed for home-use.
This document describes the 510(k) summary for the ENEO TOTALE device, which is indicated for the treatment of periorbital wrinkles.
1. Table of Acceptance Criteria and Reported Device Performance
The device is cleared based on demonstrating substantial equivalence to a predicate device (Avologi ENEO K181659). The "acceptance criteria" here are that the new device's specifications and performance do not raise new questions of safety or effectiveness compared to the predicate.
| Feature / Criteria | Predicate Device (Avologi ENEO K181659) | New Device (ENEO TOTALE) | Assessment / Performance |
|---|---|---|---|
| Product Code | OHS | OHS | Same |
| Class | 2 | 2 | Same |
| Applicant | Premier North America Inc | Premier North America Inc | Same |
| Indications for Use | Treatment of periorbital wrinkles | Treatment of periorbital wrinkles | Same |
| Handheld | Yes | Yes | Same |
| Target Population | Individuals with periorbital lines and wrinkles | Individuals with periorbital lines and wrinkles | Same |
| Location for Use | OTC | OTC | Same |
| Materials | ABS and stainless steel | ABS and stainless steel | Same |
| Visible LCD | No | Yes | New feature, but re-evaluated for safety/effectiveness (Note 1) |
| Wavelengths | 633 ±5nm, 830 ±5nm | 633 ±5nm, 830 ±5nm | Same |
| Waveform | Constant | Constant | Same |
| Light Source | Light emitting diode (LED) | Light emitting diode (LED) | Same |
| Visible Light LEDs | Yes | Yes | Same |
| Energy Source | 24 LEDs (12x 633nm, 12x 830nm) over 15cm² | 24 LEDs (12x 633nm, 12x 830nm) over 15cm² | Same |
| Energy Level (633nm) | 69mW/cm² | 69mW/cm² | Same |
| Energy Level (830nm) | 55mW/cm² | 56mW/cm² | Subtle difference, no new safety/effectiveness issues (Note 2) |
| Therapeutic Temperature Range | 41±2°C / 105.8±35.6°F | 41±2°C / 105.8±35.6°F | Same |
| Power Supply | Adaptor: 100~240V AC 50/60Hz 2.4A; Lithium battery: 3.75Vdc, 3000 mAh | Adaptor: 100~240V AC 50/60Hz 2.4A; Lithium battery: 3.75Vdc, 3000 mAh | Same |
| Handpiece Charging Method | In Charging cradle | In Charging cradle | Same |
| Initial Treatment Course | 3 times/week for 15-20 min/session, for 1 month | 3 times/week for 15-20 min/session, for 1 month | Same |
| Maintenance Regime | Once a week for 15-20 minutes | Once a week for 15-20 minutes | Same |
| Anatomical Sites | Periorbital Area | Periorbital Area | Same |
| Standard Compliance | IEC60601-1, IEC60601-1-2, IEC60601-1-11, IEC62471 | IEC60601-1, IEC60601-1-2, IEC60601-1-11, IEC62471 | Same |
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | Same |
| Software Validation | N/A (implied by predicate clearance) | Tested and validated per FDA guidance for software in medical devices | New specific testing for the LCD feature. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify human clinical trials or a specific "test set" in the context of diagnostic performance. The device is a physical therapy device. The testing conducted was non-clinical focusing on electrical safety, EMC, photobiological safety, and biocompatibility, as well as software validation. Therefore, there is no information on sample size or data provenance related to human subjects for a "test set."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a non-clinical submission focused on device safety and performance criteria against engineering and biocompatibility standards, not diagnostic or treatment efficacy evaluation requiring expert ground truth on patient data.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not describe an MRMC study. The submission is for a physical device for wrinkle reduction and relies on demonstrating substantial equivalence to a predicate device through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a light therapy device, not an AI algorithm requiring standalone performance evaluation in the described context. The "software validation" mentioned refers to the proper functioning of the device's internal software, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission are established international consensus standards (e.g., IEC, ISO standards for electrical safety, EMC, biocompatibility) and FDA guidance for software validation. The device's performance against these standards constitutes the "ground truth" in this context.
8. The Sample Size for the Training Set
Not applicable, as this is not a submission for an AI/ML algorithm or a diagnostic device requiring a "training set" of data in that sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated above. The "ground truth" for the device's development and testing was based on engineering specifications and adherence to recognized safety and performance standards.
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(31 days)
Premier North America Inc.
Avologi ENEO is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Avologi ENEO is a battery operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633±5nm, 830±5nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode(LED) device for the treatment of periorbital wrinkles designed for home-use.
The provided text describes the 510(k) premarket notification for the Avologi ENEO device, which is an over-the-counter light-emitting diode (LED) device for the treatment of periorbital wrinkles. However, the submission explicitly states that "Clinical data was not including in this submission." This means there is no study presented in this document that proves the device meets specific acceptance criteria based on clinical performance.
Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical testing and comparison of technical specifications.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent due to the nature of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical study was conducted for this 510(k) submission to demonstrate performance against specific clinical acceptance criteria, such a table cannot be provided from this document. The "acceptance criteria" here refers to the device meeting various safety and technical standards for substantial equivalence.
| Acceptance Criteria (Non-Clinical Standards) | Reported Device Performance (Compliance) |
|---|---|
| Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (AAMI / ANSI ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R) 2012 And A2:2010/(R)2012) | Complies |
| Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Test (IEC 60601-1-2 Edition 4.0 2014-02) | Complies |
| Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment (IEC 60601-1-11 Edition 2.0 2015-01) | Complies |
| Photobiological Safety of Lamps and Lamp Systems (IEC 62471 First Edition 2006-07) | Complies |
| Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) | Complies |
| Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity (ISO 10993-5:2009/(R)2014) | Complies |
| Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10 Third Edition 2010-08-01) | Complies |
Note: The performance reported is compliance with the listed standards, not clinical effectiveness for wrinkle reduction, as no clinical study was presented.
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set data from human subjects was used for this submission. The "test set" in this context refers to the device itself being tested against non-clinical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical study with a "ground truth" established by experts was performed or included in this submission.
4. Adjudication method for the test set
Not applicable. No clinical study requiring adjudication was performed or included in this 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
Not applicable. This device is an LED therapy device, not an AI-assisted diagnostic or interpretive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established as no clinical study was conducted. The "ground truth" for the non-clinical tests would be the specifications and requirements of the various international standards.
8. The sample size for the training set
Not applicable. This device does not use an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use an algorithm that requires a training set.
Summary of the Document's Conclusion:
The 510(k) submission for Avologi ENEO establishes substantial equivalence based on:
- Non-clinical bench tests: Verifying the device met design specifications and complied with electrical safety, EMC, home healthcare, photobiological safety, and biocompatibility standards (ISO 10993 suite).
- Comparison to predicate devices: Demonstrating similar indications for use, product code, device class, technology (LED, wavelengths, energy density, temperature), materials, and use environment (OTC, handheld, for periorbital wrinkles).
The submission explicitly states that no clinical performance data was included. Therefore, the acceptance criteria and study proving performance in the traditional sense of clinical efficacy are not detailed in this document. The "proof" of meeting acceptance criteria is through compliance with recognized technical and safety standards and demonstration of substantial equivalence to existing legally marketed devices.
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