(59 days)
The Dermillume Pro1000 phototherapy lamp is intended for dermatological use by trained licensed practitioners, specifically for the treatment of mild to moderate inflammatory acne vulgaris.
The Dermillume Pro1000 device is a compact light source that delivers high intensity narrow band blue and red light to the body for the treatment of acne vulgaris. The light sources are narrow wavelength LEDs that supply a spectral output of 414 ± 5 nm (blue) and 633 ± 5 nm (red). The device supplies 20 and 10 mW/cm² for blue and red light, respectively, at 4.6 inches distance from the skin surface. The principal parts of the device are a light unit, positioning arm and firmware timer to control duration of exposure. Additional off-the-shelf electronic devices related to treatment data acquisition and storage may be supplied as user options.
The Care Electronics, Inc. Dermillume Phototherapy Device is a blue/red light acne treatment lamp (K043575).
Here's an analysis of its acceptance criteria and the supporting study, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Irradiance at 4.6 inches from skin surface (Blue Light) | 20 mW/cm² |
| Irradiance at 4.6 inches from skin surface (Red Light) | 10 mW/cm² |
| Output Wavelength (Blue Light) | 414 ± 5 nm |
| Output Wavelength (Red Light) | 633 ± 5 nm |
| Comparability to Predicate Devices (Irradiance) | Irradiance at a practicable distance (4.6") is comparable with cited predicate devices and in conformance with recommendations of current clinical studies. |
| Mode of Operation | Same as predicate devices. |
| Treatment Area | Same as predicate devices. |
| General Principles for Treatment | Same as predicate devices for the treatment of inflammatory acne vulgaris, including the reduction and elimination of P. acnes. |
| Adverse Reactions | "No significant adverse reactions observed in clinical studies using this technology." (Implies meeting an unstated threshold for acceptable safety.) |
| Efficacy | Device is stated to be "efficacious," with blue light reducing P. acnes and red light improving acne based on a recent clinical study. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "current clinical studies" and a "recent clinical acne treatment study" but does not specify the sample size for any test set from these studies. It also does not directly state the data provenance (e.g., country of origin) or whether the data was retrospective or prospective for these studies. The performance data specifically cited for Dermillume (irradiance, wavelength) comes from "bench testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document refers to "recommendations of current clinical studies" and a "recent clinical acne treatment study" but does not detail how ground truth was established within those studies or if experts were involved in a consensus process for a test set specific to this device's submission.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the device's technical specifications and its substantial equivalence to predicate devices, along with general claims of efficacy and safety supported by unnamed "clinical studies" and "this technology" broadly.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
The Dermillume Phototherapy Device is a physical light-emitting device for treatment, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply to this device.
7. The Type of Ground Truth Used
The document refers to "recommendations of current clinical studies" and a "recent clinical acne treatment study" as supporting evidence for the efficacy of blue and red light therapy. However, the specific type of ground truth used (e.g., expert consensus on clinical severity scores, photographic assessment, microbiological culture for P. acnes, patient-reported outcomes) within these clinical studies or for this device's specific validation is not detailed. For the physical parameters (irradiance, wavelength), the ground truth is based on bench testing measurements against established specifications.
8. The Sample Size for the Training Set
The document does not provide information on a training set sample size. As a non-AI device, the concept of a "training set" in the context of machine learning does not apply. The device's design is based on established scientific principles of phototherapy and comparison to existing predicate devices.
9. How the Ground Truth for the Training Set was Established
As this is not an AI device, there is no training set in the machine learning sense, and therefore no ground truth establishment for a training set. The device's design and performance claims are based on engineering specifications and the scientific understanding of phototherapy for acne, benchmarked against predicate devices and existing clinical literature.
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Care Electronics, Inc. 12/23/04
Dermillume Phototherapy Device 501(k)
.
:
K043575 1 of 2
『EB』《《 4》2005』
| 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: | 12/23/04 |
| Device Submitted: | Dermillume Phototherapeutic Lamp |
| Proprietary Name: | Dermillume |
| Common Name: | Blue/Red Light Acne Treatment Lamp |
| Classification: | Class II Laser surgical instrument for use in General and PlasticSurgery and in Dermatology. Product code: GEX |
| Predicate Devices: | ClearLight, Phototherapy System, Model Cl 420 (K013623), BLU-U, Model 4710 (K031805), Omnilux Blue (K030883), & OmniluxRed (K030426) |
| Device Description: | The Dermillume Pro1000 device is a compact light source thatdelivers high intensity narrow band blue and red light to the bodyfor the treatment of acne vulgaris. The light sources are narrowwavelength LEDs that supply a spectral output of 414 ± 5 nm(blue) and 633 ± 5 nm (red). The device supplies 20 and 10mW/cm² for blue and red light, respectively, at 4.6 inchesdistance from the skin surface.The principal parts of the device are a light unit, positioning armand firmware timer to control duration of exposure. Additional off-the-shelf electronic devices related to treatment data acquisitionand storage may be supplied as user options. |
| Intended Use: | The Dermillume Pro1000 phototherapy lamp is intended fordermatological use by trained licensed practitioners, specificallyfor the treatment of mild to moderate inflammatory acne vulgaris. |
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re Electronics, Inc.
Dermillume Phototherapy Device 501(k)
revised 2/10/2005
510(k) Summary, contd.
The performance data obtained from bench testing of the Performance Data: Dermillume device substantiates that the irradiance at a practicable distance from the skin surface (4.6") is comparable with the cited predicated devices. Additionally, the submission data demonstrates that the irradiance at the target surface is in conformance with recommendations of current clinical studies. The mode of operation, treatment area, and general principles for the treatment of inflammatory acne vulgaris with this device are the same as the predicate devices, ClearLight, Phototherapy System, Model Cl 420 (K013623), BLU-U, Model 4710 (K031805), Omnilux Blue (K030883) for the reduction and elimination of the acne-producing bacterium P. acnes. The Dermillume device combines the inflammatory acne-reducing properties of blue light with the red light improvement supported by a recent clinical acne treatment study. The output wavelength and irradiance are comparable to the predicate device, Omnilux Red (K030426). There are no significant adverse reactions observed in clinical studies using this technology. The device is safe and efficacious. The Dermillume Pro1000 phototherapeutic lamp is substantially Substantial Equivalence: equivalent to the cited predicate devices for spectral output, mode of operation, operating principals as well as general and specific indications for use. All devices emit visible light for the treatment of dermatological conditions. 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 Pro1000 phototherapeutic lamp is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2005
Mr. Thomas O. Moody President Care Electronics, Inc. 4700 Sterling Drive. Suite D Boulder, Colorado 80301
Re: K043575
Trade/Device Name: Dermillume Pro1000 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 20, 2005 Received: January 25, 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. Iisting 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.
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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/industry/support/index.html.
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Dermillume Pro1000
Indications For Use: The Dermillume Pro1000 phototherapy lamp is intended for dermatological use by trained licensed practitioners, specifically for the treatment of mild to moderate inflammatory acne vulgaris.
Prescription Use Yes (Part 21 CFR 801 Subpart D)
AND/OR
no Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K013575
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.