(253 days)
The illumiMed device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum is intended to reduce mild to moderate acne vulgaris. Use of the combination of blue, red and near infrared regions of the spectrum is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Use of 430 ±10 nm "blue" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Use of the 660 ±10 nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs are indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase blood circulation.
Use of the accessory "38 blue LED Wand", 430 ±10 nm "blue", is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Use of the accessory "38 red/near infrared LED Wand", 660 ± 10nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs, is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature: for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase blood circulation.
Use of the accessory "240 red/near infrared LED Pad", 660 ± 10nm "red" LEDs and of the 940 ±10 mm "near infrared" LEDs, is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase blood circulation.
Use of the combination of 430 nm "blue" LEDs, 660 nm "red" LEDs and of the 940 nm "near infrared" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
The submitted device, illumiMed, is a treatment method using specific wavclengths of polychromatic energy produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and body conditions. It is an affordable, pain-free means to address a variety of dermatological concerns. The IR spectrum is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promotion the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum is intended to reduce mild to moderate acne vulgaris. Use of the combination of blue, red and near infrared regions of the spectrum is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
The control panel displays to the operator what treatment is being performed and provides the user with a choice of using the LED panels on the arm, LED attachments or both for any chosen treatment protocol.
The software component of the device controls an appropriate number of treatment protocols and each protocol can be enabled by a single action push-pad or button on the control panel. The software can be upgraded by the manufacturer.
The illumiMed device is powered by grounded 120 volt electrical power with an operator controlled on/off switch. The device is housed in a unit that is mounted on four wheels allowing it to be moved to any location desired by the operator.
The control panel has push-pads or buttons that control its operation and software functionality. The software functionally can be upgraded by the manufacturer. The device has a panel arm extension that can hold between one (1) and five (5) LED panels and can be cantilevered in any direction for LED treatment of a patient in a prone, seated or standing position. The LED panels can be combinations of LEDs at 7660 nm ("red"), y 940-950 nm (near infrared), and (430 nm ("blue"). The panels can be configured as an individual panel or in combinations up to five panels of LEDs. Accessory LED pads and wands are available for additional treatment modalities with 660 nm, 940 nm and 430 nm LED diodes.
The provided document is a 510(k) Premarket Notification for the illumiMed™ device, which is an LED phototherapy system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's effectiveness through extensive clinical trials with pre-defined acceptance criteria and detailed study results typical for novel devices or PMA applications.
Therefore, the document does not contain a detailed study with acceptance criteria and reported device performance in the way one might expect for a new clinical device undergoing rigorous efficacy testing. Instead, it relies on demonstrating that the illumiMed device shares similar technological characteristics and intended uses with existing, legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.
Here's an analysis based on the information provided, highlighting what is present and what is missing (as it's not typically required for a 510(k) submission of this nature):
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a formal table of "acceptance criteria" and "reported device performance" in the context of a clinical efficacy study. The acceptance criteria for a 510(k) submission are primarily centered around substantial equivalence to predicate devices. The "performance" described is in terms of the device's technological characteristics and its intended uses matching those of the predicates.
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (as presented in the 510(k)) |
|---|---|
| Electrical powered grounded 110 - 120 volts | Yes |
| LED diodes/infrared light wavelengths | 430, 660, 940 nm |
| Interchangeable panels/modules | Yes |
| Wand Attachment capability | Yes |
| Pad Attachment capability | Yes |
| Energy Output in Joules (430nm) | 46 J |
| Energy Output in Joules (660nm & 940nm) | 61 J |
| Energy Output in mW (430nm) | 3.5 mW |
| Energy Output in mW (660nm & 940nm) | 31 mW |
| Software component present | Yes |
| Software upgradeable | Yes |
| Action: temporary relief of minor muscle aches and pain | Yes (for 660nm & 940nm) |
| Action: improve circulation | Yes (for 660nm & 940nm) |
| Action: temporary relief from arthritis and muscle spasm | Yes (for 660nm & 940nm) |
| Action: temporary relaxation of muscle tissue | Yes (for 660nm & 940nm) |
| Action: photo-aged skin rejuvenation | Yes (for unspecified wavelengths; likely 660/940nm based on predicate comparison) |
| Action: treat dermatological conditions (mild/moderate acne vulgaris) | Yes (for 430nm, and combination 430nm, 660nm, 940nm) |
The "study" that proves the device meets "acceptance criteria" in this context is the comparison to legally marketed predicate devices and the declaration of substantial equivalence. The document explicitly states: "The performance testing and validation studies document that illumiMed is substantially equivalent to the GEX predicates... and the ILY predicate."
The following information is largely not present in this 510(k) submission because it is typically associated with a clinical trial to demonstrate efficacy, which is usually not a requirement for 510(k) substantial equivalence for devices like this light therapy system.
2. Sample sized used for the test set and the data provenance: Not applicable. This document does not describe a clinical test set from a formal study for performance evaluation, but rather a comparison of technical specifications and intended uses to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for a clinical test set is not detailed. The "ground truth" for this submission is the established performance and safety profile of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication is described.
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 phototherapy system, not an AI-assisted diagnostic device, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a treatment device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this 510(k) submission is the regulatory established safety and efficacy of the predicate devices based on their prior marketing clearance. The submission relies on the assertion that illumiMed performs "as well as the predicate devices" (Section I).
8. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable. As above, no training set or its ground truth establishment is described.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.