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510(k) Data Aggregation
(341 days)
The Clareblend Probes are intended to provide light to the body.
Clareblend Probe (Red-631) is generally indicated for the treatment of superficial, benign vascular and pigmented lesions
Clareblend Probe (Blue-415) is generally indicated for the treatment of dermatological conditions and specially indicated for the treatment of mild to moderate inflammatory acne vulgaris.
Clareblend Probe (IR-830) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffiess; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The Clareblend Probes are hand held devices that utilizes Light Emitting Diodes to provide LED light to the body. The hand hold device contains the power supply. The probe will be simply activated by an alternote action ON/OFF pushbutton switch which is located on the top of the probe. The probe when activated anplies full power (100% duty cycle). The OFF button is provided for the user to immediately remove all power to the probes. The probe housing is 100% machined aluminum and has a recessed clear lexanowindow. The device delivers the light to the skin as it moves over the skin. The output is pre-tuned to one wavele. gth a narrow spectral bandwidth. The output wavelength of Red is 631 +/- 4nm, IR is 830 +/- 5mm and Blue is 415 +/- 5nm.
The provided FDA 510(k) Summary for Clareblend LED Probes (K073022) does not contain information about a study with acceptance criteria and reported device performance in the typical sense of a clinical or analytical study.
This document describes a substantial equivalence determination, meaning the device was deemed equivalent to already-marketed predicate devices. For this type of submission, extensive new clinical performance data is often not required if the new device's technological characteristics and intended use are very similar to established devices.
Therefore, many of the requested details about acceptance criteria, study sizes, expert involvement, and ground truth are not applicable (N/A) for this particular document and submission type.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Technological Characteristics: | |
| - Wavelength output matching predicate devices. | - Red: 631 +/- 4nm |
| - IR: 830 +/- 5nm | |
| - Blue: 415 +/- 5nm | |
| - Device type: Hand-held, LED-based. | - Hand-held device utilizing Light Emitting Diodes. |
| - Power supply, ON/OFF switch, 100% duty cycle. | - Contains power supply, "alternote action ON/OFF pushbutton switch," applies full power (100% duty cycle). |
| - Housing material and design. | - 100% machined aluminum, recessed clear lexan window. |
| Intended Use: | |
| - Be equivalent to the indications for use of predicate devices: | - Clareblend Probe (Red-631): Treatment of superficial, benign vascular and pigmented lesions. (Equivalent to Omnilux Revive in scope, although Omnilux Revive has more general indications). |
| - Clareblend Probe (Blue-415): Treatment of dermatological conditions, specifically mild to moderate inflammatory acne vulgaris. (Equivalent to Omnilux Blue). | |
| - Clareblend Probe (IR-830): Temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness; promoting relaxation of muscle tissue; temporarily increasing local blood circulation. (Equivalent to Omnilux Plus). | |
| Safety and Effectiveness: | |
| - No significant differences in safety or effectiveness compared to predicate devices. | - "The intended use and technological characteristics of the Clareblend Probes are virtually identical to the intended use and technological characteristics of the listed equivalent devices. Any differences between the Clareblend Probes and the equivalent devices have no significant influence on safety or effectiveness of the Clareblend Probes product." |
- "no significant differences exist between this system and the predicate systems quoted, therefore, the Clareblend Probes do not impose any new safety or effectiveness concerns." |
Study Details (Not Applicable/Information Not Provided for this type of Submission)
- Sample size used for the test set and the data provenance: N/A. This 510(k) relies on substantial equivalence and does not describe a clinical performance study with a test set of data. The "test" was a comparison to predicate devices, not a new data collection.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment for a test set is not described as no new clinical study data evaluation is referenced.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. No test set requiring adjudication is described.
- 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: N/A. This device is not an AI-assisted diagnostic tool; it's a therapeutic LED light probe. No MRMC study was conducted or mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an algorithm or AI device. Its performance is inherent in its physical properties (wavelength, power) and intended biological effect.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. For a substantial equivalence claim, the "ground truth" implicitly refers to the established safety and effectiveness profiles of the identified predicate devices (Omnilux Blue K030883, Omnilux Revive K030426, Omnilux Plus K043317).
- The sample size for the training set: N/A. There is no mention of a training set as this is not an AI/ML device.
- How the ground truth for the training set was established: N/A. Not applicable as no training set is described.
In summary: The provided document is a 510(k) summary for a device seeking clearance based on substantial equivalence to existing predicate devices. It focuses on demonstrating that the new device's technological characteristics and intended uses are "virtually identical" and pose "no new safety or effectiveness concerns" compared to the predicates. It does not detail new clinical trials or performance studies with specific acceptance criteria beyond the comparison to the predicate devices' established performance and safety profiles.
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