(80 days)
No
The device description and performance studies focus on a physical patch and an optical clearing agent used in conjunction with a laser, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
Explanation: The device is an accessory to laser tattoo removal, which is a cosmetic procedure, not a therapeutic treatment for a disease or condition. The clinical study focuses on the efficiency of laser passes and immediate post-treatment observations without indicating therapeutic benefit.
No
The device is described as an accessory to laser tattoo removal procedures, facilitating faster treatment by clearing optical pathways. It does not identify or characterize a disease, condition, or health status.
No
The device description clearly states it consists of physical components: a dual-layer medical-grade silicone transparent film and an optical clearing agent (OCA). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as an accessory to laser tattoo removal procedures. This is a therapeutic procedure performed on the patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device consists of a silicone patch and an optical clearing agent (PFD). These components are designed to interact with the skin and the laser light during the tattoo removal process. They are not used to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device's function is to facilitate the laser treatment by allowing for multiple passes in a single session, which is a procedural enhancement, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Describe® Transparent PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using a 755nm Q-Switched Alexandrite laser in Fitzpatrick Skin Type I-III patients.
Product codes
PKO
Device Description
The DeScribe Patch consists of two components: a dual-layer medical-grade silicone transparent film, and an optical clearing agent (OCA). The dual-layer silicone film is composed of a thin low-friction silicone membrane and a tacky silicone polymer layer. The low-friction silicone membrane forms the upper layer of the film. The tacky silicone polymer layer (i.e., the lower layer) contacts the patient's skin during the device's use. The OCA in the Device is sterile, high-purity perfluorodecalin (PFD), an inert, non-toxic liquid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
A prospective, randomized, single-site clinical study was conducted to investigate the safety and efficacy of rapid (≤ 5 minute) multi-pass laser treatment of tattoos using the DeScribe Transparent PFD Patch. Thirty (30) subjects received one treatment session for a single tattoo using a standard Q-switched alexandrite laser. One half of the tattoo received laser treatment through the Patch, while the other control half received conventional laser treatment only. The number of passes performed on each side was recorded, as were the type and severity of any adverse effects. In all 30 subjects, the Patch side demonstrated whitening resolution within the treatment period so that an average of 3.7 passes could be made as compared to only 1.4 on the control side. Up to 4 passes were allowed during a treatment session. Mild erythema and edema were observed immediately post treatment that were fully resolved at the 1-month follow up-visit. No serious or unanticipated adverse device effects were observed in any subject.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2015
ON Light Sciences Incorporated Ms. Marcy Moore Director of Clinical and Regulatory Affairs 131 Kelekent Lane Cary, North Carolina 27518
Re: K150212
Trade/Device Name: DeScribe® Transparent PFD Patch Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: PKO Dated: January 30, 2015 Received: January 30, 2015
Dear Ms. Moore:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name
DeScribe® Transparent PFD Patch
Indications for Use (Describe)
The Describe® Transparent PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using a 755nm Q-Switched Alexandrite laser in Fitzpatrick Skin Type I-III patients.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY
ON Light Science's DeScribe® Transparent PFD Patch
Submitted by:
ON Light Sciences, Inc. 7852 Starward Dr. Dublin, CA 94568 Phone: (925) 364-5151
Contact Person:
Marcy Moore Director of Clinical and Regulatory Affairs 131 Kelekent Ln Cary, NC 27518 Tel: (919) 455-0500 Fax: (919) 651-1001
Date Prepared: January 30, 2015
Trade Name: DeScribe® Transparent PFD Patch
Common or Usual Name: DeScribe Patch
Classification Name: Accessory to laser surgical instrument for use in general and plastic
surgery and in dermatology
Requlation: 21 C.F.R. § 878.4810
Product Code: PKO
Classification Panel: General and Plastic Surgery
Predicate Device: Thermolase Corp. Carbon black solution (K950019; K971207)
Reference Devices:
Creative Technologies, Meladine (K022807)
Palomar Q-YAG, Carbon Solution (K023967)
Intended Use / Indications for Use:
The Describe® Transparent PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using a 755nm Q-Switched Alexandrite laser in Fitzpatrick Skin Type I-III patients.
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Technoloqical Characteristics
The DeScribe Patch consists of two components: a dual-layer medical-grade silicone transparent film, and an optical clearing agent (OCA). The dual-layer silicone film is composed of a thin low-friction silicone membrane and a tacky silicone polymer layer. The low-friction silicone membrane forms the upper layer of the film. The tacky silicone polymer layer (i.e., the lower layer) contacts the patient's skin during the device's use. The OCA in the Device is sterile, high-purity perfluorodecalin (PFD), an inert, non-toxic liquid.
Performance Data
Clinical and non-clinical performance testing was conducted as described below. In all instances, the DeScribe Patch functioned as intended and results observed were as expected.
Design verification testing
Design verification testing verified the DeScribe Patch's product dimensions, as well as adhesion and chemical stability under dermatological laser exposure of both the optical clearing agent and silicone substrate.
Transit test: Conditioning and Package Performance
Transit testing was conducted to validate the ability of the package systems to protect the DeScribe Patch units from hazards typically associated with the shipping and distribution environment.
Two-year stability test
Two-year stability testing was successfully conducted. Packaging integrity was confirmed by 2-year accelerated aging testing accordance to ISO 11607.
Biocompatibility testing
Biocompatibility tests, as listed below, were conducted in accordance with ISO 10993-1. The results of those tests confirm that all patient-contact components of the device are biocompatible through compliance to the ISO 10993 standard series.
- Cytotoxicity
- . Sensitization
- Irritation or Intracutaneous reactivity
- . Systemic toxicity (acute)
- Material Mediated Pyroqen Test ●
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Human factors validation test
Human factors validation testing demonstrated that the intended users of the subject medical device can safely and effectively perform critical tasks for the intended uses in expected use environments. This validation test of the DeScribe Patch used representative device users in a simulated use environment of appropriate realism, and addressed all aspects of intended use.
Clinical Investigation
A prospective, randomized, single-site clinical study was conducted to investigate the safety and efficacy of rapid (≤ 5 minute) multi-pass laser treatment of tattoos using the DeScribe Transparent PFD Patch. Thirty (30) subjects received one treatment session for a single tattoo using a standard Q-switched alexandrite laser. One half of the tattoo received laser treatment through the Patch, while the other control half received conventional laser treatment only. The number of passes performed on each side was recorded, as were the type and severity of any adverse effects. In all 30 subjects, the Patch side demonstrated whitening resolution within the treatment period so that an average of 3.7 passes could be made as compared to only 1.4 on the control side. Up to 4 passes were allowed during a treatment session. Mild erythema and edema were observed immediately post treatment that were fully resolved at the 1-month follow up-visit. No serious or unanticipated adverse device effects were observed in any subject.
Substantial Equivalence
The DeScribe Patch is as safe and effective as the Thermolase carbon black laser accessory device. The DeScribe Patch has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device(s). The minor technological differences between the DeScribe Patch and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the DeScribe Patch is as safe and effective as the cleared Thermolase carbon black accessory. Thus, the DeScribe Patch is substantially equivalent.
Conclusions
The DeScribe Patch is as safe and effective as the predicate device. Performance testing as described above has been conducted to support these claims.