(34 days)
The Dermillume Red HR1000 infrared lamp is intended for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarity increase local blood circulation.
The Dermillume Red HR1000 lamp is a compact light source that delivers high intensity narrow band red and near infrared light to the skin surface. The light sources are narrow bandwidth LEDs mounted in an array to give even and safe illumination of skin surfaces. The principal parts of the lamp are a light unit, positioning arm and firmware timer to control duration of exposure.
The Dermillume Red HR1000 infrared lamp is intended for therapeutic use. The provided text, however, focuses on a 510(k) summary for substantial equivalence to predicate devices, rather than a study proving specific acceptance criteria related to its therapeutic efficacy.
Therefore, the response below reflects the information available regarding the performance data provided for demonstrating substantial equivalence, which is a regulatory pathway, not a clinical efficacy study with acceptance criteria in the traditional sense of a clinical trial.
Here's the breakdown based on the provided document:
1. Table of "Acceptance Criteria" and Reported Device Performance
It's important to clarify that this 510(k) summary doesn't present "acceptance criteria" in the typical sense of a clinical study (e.g., target RMSE, sensitivity, specificity for a diagnostic device). Instead, the performance data provided is to demonstrate substantial equivalence to predicate devices. The "criteria" are implicit in proving comparability.
| Acceptance "Criteria" (Implicit for Substantial Equivalence) | Reported Device Performance (Dermillume Red HR1000) |
|---|---|
| Irradiance at practicable distance from skin surface | Comparable with cited predicate lamps. The device performs similarly to existing, legally marketed infrared therapy lamps in terms of energy delivery to the skin surface. |
| Mode of operation, technology, and general principles | Same as the predicate lamps. This indicates functional and technological similarity to established devices. |
| Safety profile | No significant adverse reactions observed in clinical studies using this technology. The device is considered safe based on existing knowledge and absence of new safety concerns compared to predicate devices. |
| Efficacy | Efficacious. The efficacy is indirectly supported by its substantial equivalence to predicate devices that are considered effective for their intended use. The 510(k) process doesn't require a new clinical efficacy study if substantial equivalence can be demonstrated. It is intended for relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains, and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation. |
| Spectral output | Substantially equivalent to predicate lamps. |
| Operating principles | Substantially equivalent to predicate lamps. |
| General and specific indications for use | Substantially equivalent to predicate lamps. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention a "test set" or a sample size for a clinical study to evaluate the device's therapeutic efficacy. The performance data discussed is from "bench testing" to compare the irradiance. Data provenance is not specified beyond being "bench testing." This is typical for a 510(k) where the primary goal is often to demonstrate equivalence, not necessarily de novo clinical efficacy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. The text does not describe a clinical study requiring ground truth established by experts.
4. Adjudication Method for the Test Set
Not Applicable. There is no mention of a clinical study or associated adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The provided text does not describe an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human readers interpret results.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This device is an infrared therapy lamp, not an algorithm. The concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant here.
7. The Type of Ground Truth Used
Not Applicable. The document does not describe a clinical study that would require a "ground truth" (e.g., pathology, outcomes data). The performance data cited is for "bench testing" to compare irradiance.
8. The Sample Size for the Training Set
Not Applicable. This is an infrared therapy lamp, not an AI/ML algorithm that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As above, this is not an AI/ML algorithm.
{0}------------------------------------------------
510(k) Summary 2.
510(k) Summary
| Applicant & Submitter: | Care Electronics, Inc. |
|---|---|
| Address: | 4700 Sterling Dr., Suite DBoulder, CO 80301 |
| Phone: | 303-444-2273 |
| Fax: | 303-447-3502 |
| Contact Person: | Thomas Moody |
| Preparation Date: | 6/21/05 |
| Lamp Submitted: | Dermillume Red Lamp |
| Proprietary Name: | Dermillume Red |
| Common Name: | Infrared Therapy Lamp |
| Classification: | Lamp, Infrared; Class II Product code: ILY |
| Predicate Lamps: | Biolight PCD (K011355), Biobeam (K042813), AnodyneTherapy Systems (K931261), PremIR 818 (K042532),Dermillume Pro1000 (K043575) |
| Lamp Description: | The Dermillume Red HR1000 lamp is a compact light sourcethat delivers high intensity narrow band red and near infraredlight to the skin surface. The light sources are narrowbandwidth LEDs mounted in an array to give even and safeillumination of skin surfaces. |
| The principal parts of the lamp are a light unit, positioning armand firmware timer to control duration of exposure. | |
| Intended Use: | The Dermillume Red HR1000 infrared lamp is intended for therelaxation of muscles and relief of muscle spasms, temporaryrelief of minor muscle and joint aches, pains and stiffness,temporary relief of minor pain and stiffness associated witharthritis, and to temporarily increase local blood circulation. |
{1}------------------------------------------------
Care Electronics, Inc.
Dermillume Red 501(k) Submission
051681
510(k) Summary, contd.
The performance data obtained from bench testing of the Performance Data: Dermillume lamp substantiates that the irradiance at a practicable distance from the skin surface is comparable with the cited predicated lamps.
The mode of operation, technology and general principles of this lamp are the same as the predicate lamps.
There are no significant adverse reactions observed in clinical studies using this technology. The lamp is safe and efficacious.
The Dermillume Red HR1000 infrared lamp is substantially Substantial Equivalence: equivalent to the cited predicate lamps for spectral output, mode of operation, operating principals as well as general and specific indications for use. Although there are some differences in the source of the emitted light and output intensity, these differences are minor and do not raise new questions of safety or efficacy.
The Dermillume Red HR1000 infrared lamp is substantially equivalent.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, representing healing and medicine. The caduceus is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2005
Mr. Thomas O. Moody President Care Electronics, Inc. 4700 Sterling Drive, Suite D Boulder. Colorado 80301
Re: K051681
Trade/Device Name: Dermillume Red, model HR 1000 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: July 8, 2005 Received: July 12, 2005
Dear Mr. Moody:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
Page 2- Mr. Thomas O. Moody
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stypt Rlvodlee
Mark N. Melkerson, MS Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K051681
Lamp Name: Dermillume Red, model HR1000
Indications for Use: The Dermillume Red HR1000 infrared lamp is intended for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarity increase local blood circulation.
Prescription Use . Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use Yes (21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Lamp Evaluation (ODE)
Styt Rurda
ign-Off (Division Division of General, Restorative, and Neurologica! Devices
510(k) Number K051681
§ 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.