(34 days)
The ClearTouch Lite is intended to provide phototherapeutic light to the body. The ClearTouch Lite is generally indicated to treat dermatological conditions. The ClearTouch Lite is specifically indicated to treat mild and moderate inflammatory acne, which includes pustular inflammatory acne in patients with Fitzpatrick skin types I-VI.
The ClearTouch Lite™ is a pulsed-light, manually controlled system designed to deliver light in a sequence of pulses to treat mild and moderate inflammatory acne.
The provided text is a 510(k) summary for the Radiancy ClearTouch Lite™ Acne Clearance System (K060411). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data for the new device. As such, much of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment is not available in this document.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document states that the new device has "similar technical characteristics" and "the same intended use and the same indications for use" as the predicate. It also mentions a "minor difference" in energy delivery (lower intensity pulses in sequence vs. a single pulse) which does not raise new safety and effectiveness issues. However, specific quantitative acceptance criteria for acne treatment effectiveness (e.g., percentage reduction in lesions, success rates) and how the ClearTouch Lite performed against these criteria are not provided.
| Acceptance Criteria (Not explicitly stated for the new device) | Reported Device Performance (Not explicitly stated for the new device) |
|---|---|
| Likely related to reduction in mild to moderate inflammatory acne, similar to predicate device performance, but no quantitative figures are given. | Implied to be equivalent to the predicate device's performance for treating mild to moderate inflammatory acne, pustular inflammatory acne, in Fitzpatrick skin types I-VI. |
2. Sample Size Used for the Test Set and Data Provenance
Not available. This 510(k) summary does not describe a new clinical trial for the ClearTouch Lite. It relies on the substantial equivalence to a previously cleared device (K032205, K051268). Therefore, there is no mention of a test set, its sample size, or data provenance for the ClearTouch Lite itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not available. As no new test set is described, there's no information on experts or ground truth establishment for it.
4. Adjudication Method for the Test Set
Not available. No test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe an MRMC study. It's a 510(k) for a physical medical device (pulsed light system), not typically an AI/software device that would undergo MRMC comparative effectiveness studies in the context of human reader improvement with AI assistance.
6. If a Standalone Performance Study Was Done
No, not explicitly for the ClearTouch Lite. The submission hinges on substantial equivalence to a predicate device (Radiancy Acne System with ClearTouch™ Light Unit Assembly) which had already demonstrated its safety and effectiveness. The focus is on the minor technical difference (sequence of lower intensity pulses vs. single pulse) not raising new issues. There's no description of a separate, standalone clinical performance study specifically for the ClearTouch Lite in this document.
7. The Type of Ground Truth Used
Not available/Applicable. Since no new clinical performance study for the ClearTouch Lite itself is presented, there's no discussion of ground truth establishment. For the predicate device, it would presumably involve clinical assessment of acne lesions and potentially photographic evidence, but this is not detailed for the ClearTouch Lite's submission.
8. The Sample Size for the Training Set
Not applicable. This device is a pulsed light system, not an AI/machine learning algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, the concept of a training set and its ground truth in this context is not relevant for this type of medical device submission.
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510(k) SUMMARY
Radiancy (Israel) Ltd. Radiancy ClearTouch Lite™ Acne Clearance System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Manufacturer: | Radiancy (Israel) Ltd.9 Gan Rave StreetIndustrial ParkYavneIsrael |
|---|---|
| Telephone: | +972-8-9438010 |
| Facsimile: | +972-8-9438020 |
| Contact Person: | Margaret FourteDirector, Clinical and Regulatory AffairsRadiancy, Inc.40 Ramland RoadOrangeburg, NY 10972Telephone: (845) 398-1647Facsimile: (845) 398-1648Email: margaret@radiancy.com |
|---|---|
| Date Prepared: | February 15, 2006 |
Name of Device and Name/Address of Sponsor
| Trade/Proprietary Name: | Radiancy ClearTouch Lite™ Acne Clearance System |
|---|---|
| Common Name: | Pulsed Light System and Light Unit Assembly |
| Classification Name: | Laser surgical instrument for use in general and plastic surgeryand in dermatology (21 C.F.R. § 878.4810) |
| Manufacturing Facility: | Radiancy (Israel) Ltd. |
|---|---|
| 9 Gan Rave Street | |
| Industrial Park | |
| Yavne, Israel |
| Establishment | |
|---|---|
| Registration Number: | 9616256 |
| Owner/operator number: | 9040071 |
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Predicate Devices
Radiancy Acne System with ClearTouch™ Light Unit Assembly (K032205, K051268)
Device Description
The ClearTouch Lite™ is a pulsed-light, manually controlled system designed to deliver light in a sequence of pulses to treat mild and moderate inflammatory acne.
Intended Use / Indications for Use
The ClearTouch Lite is intended to provide phototherapeutic light to the body. The ClearTouch Lite is generally indicated to treat dermatological conditions. The ClearTouch Lite is specifically indicated to treat mild and moderate inflammatory acne, which includes pustular inflammatory acne in patients with Fitzpatrick skin types I-VI.
Technological Characteristics
The ClearTouch Lite that is the subject of this 510(k) notice is similar to the predicate device already cleared to provide phototherapeutic light to the body, except that the ClearTouch Lite xenon lamp emits lower energy intensity pulses compared to the predicate device delivery of similar energy in a single pulse.
Substantial Equivalence
The Radiancy ClearTouch Lite Acne Clearance System has the same intended use and the same indications for use, principles of operation and similar technical characteristics as the Radiancy Acne System with ClearTouch Light Unit Assembly predicate, which has already been cleared by FDA. The cleared Radiancy Acne System predicate and the ClearTouch Lite are generally indicated to treat dermatological conditions, The ClearTouch Lite and the Radiancy Acne System are specifically indicated to treat mild and moderate inflammatory acne, which includes pustular inflammatory acne in patients with Fitzpatrick skin types I-VI. The minor difference between the Radiancy ClearTouch Lite delivery of a fixed sequence of lower intensity pulses and the predicate delivery of a single pulse does not raise any new issues of safety and effectiveness. Thus, the Radiancy ClearTouch Lite is substantially equivalent to the predicate.
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2006
Radiancy, Ltd. c/o Radiancy, Inc. Ms. Margaret Fourte Director, Clinical and Regulatory Affairs 40 Ramland Road South - Suite 10 Orangeburg, New York 10962
Re: K060411
Trade/Device Name: Radiancy Clear Touch Life™ Acne Clearance 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: February 15, 2006 Received: February 16, 2006
Dear Ms. Fourte:
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
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Page 2 – Ms. Margaret Fourte
comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, 110, and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality 35stems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declosis our device as described in your Section 510(k) I his letter will anow you to oegin manteinig your antial equivalence of your device to a legally premarket nothleation: The PDA maing of backannal 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 If you desire specific at 10-10-1015. Also, please note the regulation entitled, Colliation of Other of Obinphalled as (21 transmit (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response 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
Sincercly vours.
el Malle
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosurc
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Page 1 of 1 Indication for Use Form
510(k) Number (if known): K060411
Device Name:
Radiancy ClearTouch Lite™ Acne Clearance System
Indications for Use:
The Radiancy ClearTouch Lite Acne Clearance System (ClearTouch Lite) is intended to provide phototherapeutic light to the body. The ClearTouch Lite is thehded to treat dermatological conditions. The ClearTouch Lite is gecifically indicated to treat mild and moderate inflammatory acres, which includes pustular inflammatory acne in patients with Fitzpatrick skin types I-VI.
Prescription Use X
OR
Over-The-Counter Use (Per 21 C.F.R. 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
QMdl
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number_KO6041
§ 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.