(364 days)
The Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris.
The Soundskin Phototherapy System is a visible light source of high spectral purity, it provides uniform illumination of red light and blue light within the same lamp housing. The output is pre-tuned to one wavelength for each light, with a narrow spectral handwidth of 635 +/-5nm for red light and an output of 435 +/- 5nm bandwidth for blue light. The light output is 2460 mW ner sa cm of the treatment area with a lamp efficiency of 95% of the nutput. This compares with laser outputs which are approximately 2300-2500 mW per sq cm of area covered when measured in joules the output can average between 15 and 600 per sq cm. We have supplied technical data sheets and charts for the information requested.
The Soundskin system is in three parts, the hase unit contains the power supply and electronic control unit, the programme is electronic timed through mechanical relays instead of software for simplicity und reliability. The red light runs for 10 minutes then changes to blue light for 10 minutes, at the end of the 20 minute cycle it automatically shuts off. There is a separate mains supply switch attached to the base unit and a single on off switch on the lamp housing everything is uutomatic operation. A three part arm attached to the base unit supports the lamp housing, the head is attached to the end of the arm with a multifunctional positioning for natient treatment. The automatic controlled electronics operate from a single reset button on the lamp housing for easy access.
The provided text does NOT contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.
Instead, the document is a 510(k) summary for the Soundskin Phototherapy System, asserting substantial equivalence to a predicate device (Lumenis Clearlight K013623).
Here's what can be extracted based on the prompt's requested information, with significant gaps for the criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Visible Light Source: High spectral purity, uniform illumination. Red Light Output: 635 +/- 5nm wavelength, narrow spectral bandwidth. Blue Light Output: 435 +/- 5nm bandwidth. Light Output (Intensity): 2460 mW per sq cm of treatment area. Lamp Efficiency: 95% of output. Timer: Electronic timed (mechanical relays), red light for 10 minutes, then blue light for 10 minutes, automatic shut-off after 20 minutes. Safety/Effectiveness Claim: "no significant differences exist between this system and the predicate system quoted. Therefore, the Soundskin Phototherapy System raises no new issues of safety and the clinical trials prove the effectiveness is the same." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: The document states "clinical trials prove the effectiveness is the same," implying clinical data was used, but details on location (country of origin), whether it was retrospective or prospective, or specific data used for this device's pre-market submission versus the predicate's trials are not provided.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- This device is a phototherapy system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is a standalone phototherapy system; it does not involve an algorithm separate from human-in-the-loop performance in the sense of a diagnostic or decision-support AI. Its performance is inherent to its physical light emission and timing mechanisms. No separate "algorithm-only" performance study is described beyond its physical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that "clinical trials" (likely referencing the predicate device's trials, or trials that directly compare this device to the predicate) were used to demonstrate effectiveness. The ultimate ground truth would likely involve clinical outcomes data related to the reduction of moderate inflammatory Acne Vulgaris.
8. The sample size for the training set:
- Not applicable as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/machine learning device.
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JAN 8 2005 K040103 1/2
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1 8 20BHC International Ltd.
Smart Peel"" Skin Exfoliation Technology
Derma - Light Coloured Light Therapy
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510(k) Summary of safety and Effectiveness for the Soundskin Phototherapy System
This 510(k) Summary of safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92
General Information 1.
Submitter
Contact Person
BHC International Ltd 18 Stapledon Road Orton Southgate Peterborough PE2 6TD United Kingdom
Michael Breen 400 Lathrop Avenue Suite 200 River Forest IL 60305 USA Tel: 708 366 6626 Fax: 708 366 5655
Summary Preparation Date
Wednesday, 20 October 2004
- Names
Device Name:
Classification Name
Soundskin Phototherapy System
Laser Instrument, Surgical Powered Product Code: GEX Panel: 79
- Predicate Devices
The Soundskin Phototherapy System is substantially equivalent to the Lumenis Clearlight (K013623)
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40103 2/2
BHC International Ltd.
Smart Peel ™ Skin Exfoliation Technology
Derma - Light Coloured Light Therapy
Image /page/1/Picture/5 description: The image shows a black and white logo of a globe. The text "World Leaders of Innovative Technology" is written in a circular fashion around the top of the globe. The text "Skin Resurfacing & Rejuvenation Equipment" is written in a circular fashion around the bottom of the globe. The globe itself is a wireframe design, with the continents shown in solid black.
4. Device Description
The Soundskin Phototherapy System is a visible light source of high spectral purity, it provides uniform illumination of red light and blue light within the same lamp housing. The output is pre-tuned to one wavelength for each light, with a narrow spectral handwidth of 635 +/-5nm for red light and an output of 435 +/- 5nm bandwidth for blue light. The light output is 2460 mW ner sa cm of the treatment area with a lamp efficiency of 95% of the nutput. This compares with laser outputs which are approximately 2300-2500 mW per sq cm of area covered when measured in joules the output can average between 15 and 600 per sq cm. We have supplied technical data sheets and charts for the information requested.
The Soundskin system is in three parts, the hase unit contains the power supply and electronic control unit, the programme is electronic timed through mechanical relays instead of software for simplicity und reliability. The red light runs for 10 minutes then changes to blue light for 10 minutes, at the end of the 20 minute cycle it automatically shuts off. There is a separate mains supply switch attached to the base unit and a single on off switch on the lamp housing everything is uutomatic operation. A three part arm attached to the base unit supports the lamp housing, the head is attached to the end of the arm with a multifunctional positioning for natient treatment. The automatic controlled electronics operate from a single reset button on the lamp housing for easy access.
-
న్ Indications for use
The Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris. -
Performance duta ().
Based upon an analysis of the overall performance characteristics for the Soundskin Light device, BHC. International believes that no significant differences exist hetween this system and the predicate system quoted. Therefore, the Soundskin Phototherapy System raises no new issues of safety and the clinical trials prove the effectiveness is the same.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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JAN 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BHC International Ltd. c/o Mr. Michael Breen 400 Lathrop Avenue, Suite 200 River Forest, Illinois 60305
Re: K040103 Trade/Device Name: Soundskin Phototherapy System 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: December 21, 2004 Received: December 22, 2004
Dear Mr. Breen:
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 may or babyer to de 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. Michael Breen
This letter will allow you to begin marketing your device as described in your Section 510(k) I ma letter will and 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,
Muriam 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
Soundskin Phototherapy System
Indications for use
The Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris.
Prescription Use X Yes AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
No
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUF ON ANOTHER I'AGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K040103
§ 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.