(84 days)
No
The summary describes a physical patch and liquid used as an accessory to laser tattoo removal. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as an accessory to laser tattoo removal procedures and does not directly treat or diagnose a disease or condition itself.
No
The device is indicated for use as an accessory to laser tattoo removal procedures, not for the purpose of diagnosing a medical condition or disease. It is used during the treatment, not for assessing or identifying a problem.
No
The device description explicitly states it consists of physical components: a dual-layer medical-grade silicone transparent film and an optical clearing agent (OCA).
Based on the provided information, the DESCRIBE PFD Patch is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's an "accessory to laser tattoo removal procedures." This is a therapeutic/procedural use, not a diagnostic one.
- Device Description: The description details a physical patch and a liquid (perfluorodecalin) applied to the skin during a procedure. It doesn't involve analyzing samples from the body (like blood, urine, tissue) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The DESCRIBE PFD Patch does not fit this definition.
N/A
Intended Use / Indications for Use
The DESCRIBE PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using 532, 694, 755, and 1064 nm standard Q-Switched (QS) lasers and 532, 755, 785, and 1064 nm standard picosecond lasers in Fitzpatrick Skin Type I-III patients.
Product codes
PKO
Device Description
The DESCRIBE® PFD 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 (FluoroMed, LLC).
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
Bench performance testing was conducted in order to confirm that the optical transparency of the DESCRIBE® PFD Patch and its optical clearing agent PFD are unchanged after exposure to standard, commercially available lasers. Briefly, the patch and PFD were exposed to the highest available laser intensities at multiple wavelengths (Q-switched 532, 694, 755 and 1064 nm lasers, as well as 532, 755, 785, and 1064 nm picosecond lasers). The exposed patches and their unexposed controls, as well as the respective associated PFD, were then analyzed using UV/V/S/NIR spectroscopy. No optical changes were observed within the precision of the instrument, demonstrating optical stability of the patch and the OCA after laser exposure. This testing verified that the Patch is optically suitable for use with Q-switched 532, 694, 755 and 1064 nm lasers and 532, 755, 785, and 1064 nm picosecond lasers.
Gas chromatography and mass spectrometry (GC/MS) testing was also conducted on the OCA after exposure to the same set of lasers outlined above. This testing confirmed that no chemical changes to the PFD occurred after laser exposure within the precision of the instrument.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized caduceus. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 29, 2017
Merz North America, Inc. Misty D'Ottavio Director, Regulatory Affairs 6501 Six Forks Road Raleigh, North Carolina 27615
Re: K172689
Trade/Device Name: DESCRIBE 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: September 5, 2017 Received: September 6, 2017
Dear Misty D'Ottavio:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@Ida.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S3
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
DESCRIBE PFD PATCH
Indications for Use (Describe)
The DESCRIBE PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using 532, 694, 755, and 1064 nm standard Q-Switched (QS) lasers and 532, 755, 785, and 1064 nm standard picosecond lasers in Fitzpatrick Skin Type I-III patients.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Merz North America's DESCRIBE PFD Patch
Submitted by:
Merz North America, Inc. 6501 Six Forks Road Raleigh, NC 27615 Phone: (919) 582-8000
Contact Person:
Misty D'Ottavio Director of Regulatory Affairs 6501 Six Forks Road Raleigh, NC 27615 Phone: (919) 582-8107 Fax: (919) 882-8962
Date Prepared: September 5, 2017 Trade Name: DESCRIBE® 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 Regulation: 21 C.F.R. § 878.4810 Product Code: PKO Classification Panel: General and Plastic Surgery Predicate Device: DeScribe Transparent PFD Patch (K150212) Indications for Use:
The DESCRIBE PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using 532, 694, 755, and 1064 nm standard Q-Switched (QS) lasers and 532, 755, 785, and 1064 nm standard picosecond lasers in Fitzpatrick Skin Type I-III patients.
Technological Characteristics
The DESCRIBE® PFD Patch consists of two components: a dual-layer medicalgrade 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
4
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 (FluoroMed, LLC).
Performance Data
Bench performance testing was conducted in support of the additional wavelength indications and is described below. It was our expectation that after exposure to the additional lasers and wavelengths, no optical changes to either the patch or the OCA (PFD) would be observed, and that the PFD would remain chemically unchanged after said exposure. In all instances, the DESCRIBE® PFD Patch functioned as intended and results observed were as expected.
Performance Testing- Bench
Bench performance testing was conducted in order to confirm that the optical transparency of the DESCRIBE® PFD Patch and its optical clearing agent PFD are unchanged after exposure to standard, commercially available lasers. Briefly, the patch and PFD were exposed to the highest available laser intensities at multiple wavelengths (Q-switched 532, 694, 755 and 1064 nm lasers, as well as 532, 755, 785, and 1064 nm picosecond lasers). The exposed patches and their unexposed controls, as well as the respective associated PFD, were then analyzed using UV/V/S/NIR spectroscopy. No optical changes were observed within the precision of the instrument, demonstrating optical stability of the patch and the OCA after laser exposure. This testing verified that the Patch is optically suitable for use with Q-switched 532, 694, 755 and 1064 nm lasers and 532, 755, 785, and 1064 nm picosecond lasers.
Gas chromatography and mass spectrometry (GC/MS) testing was also conducted on the OCA after exposure to the same set of lasers outlined above. This testing confirmed that no chemical changes to the PFD occurred after laser exposure within the precision of the instrument.
Stability Data
Three-year stability tests
Merz wishes to amend the declared shelf life from 2 years to 3 years based on the attached real-time aging test protocol and reports. Briefly, twenty samples of the Patch from identical lots manufactured in 2014 were placed in storage; after 3 years,
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fourteen patches were tested for package burst testing and bubble emission leak testing (Bubble and Burst Nonporous Packing Validation GLP Test as per ISO 11607, Nelson Laboratory Standard Test Protocol STP07170). For burst testing, test articles were conditioned for a minimum of 24 hours at 23 ± 2℃ and 50 ± 5% relative humidity (RH). The packages were then attached to the T.M. Electronics package tester by adhesive package ports and pressurized at a constant rate until they burst. For bubble emission leak testing, a probe was attached to a package then the test article was completely immersed in the fluid. Next, the package was pressurized to a minimum of 10 inches H1,0 and inspected for evidence of bubble emission originating from the package or seals. All Nonporous Packaging Validation test method acceptance criteria were met.
Additionally, a representative sample Patch from the above batch was used to test three parameters to confirm stability after 3 years. Visual verification was conducted to ensure the product remained properly sealed. Additionally, the heat seal was visually verified via measurement to ensure a width of no less than approximately 5 mm. Finally, the product weight was measured both before and after evaporative removal of the perfluorodecalin to verify that 1.8 mL + 30% - 10% had remained in the pouch. All acceptance criteria were met and thus the product was deemed to have successfully passed 3-year real time aging testing.
Substantial Equivalence
The DESCRIBE PFD Patch is as safe and effective as the predicate device (DeScribe Patch, ON Light Science, K150212) as the two devices are identical. They have the same intended uses and similar indications, technological characteristics, and principles of operation. This submission contains bench studies in which the Patch was exposed to the highest energy fluence at a number of laser wavelengths (Q-switched 532, 694, 755 and 1064 nm lasers and 532, 755, 785 and 1064 nm picosecond lasers), including the wavelength currently contained in the indication (specifically, a 755nm Q-Switched Alexandrite laser).
A key feature of the Patch is that it is completely optically transparent to all dermatological lasers. Hence, it does not absorb or attenuate laser light any more than a sheet of glass. The bench studies contained within this application show that upon measuring the optical absorption spectra of both the patch and liquid PFD with a UV/Visible Spectrometer, the patch is transparent at all of the wavelengths tested. We
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conclude that since no light is absorbed at any of the new wavelengths of interest, the Patch has been demonstrated to be formally clinically suitable for use at these laser wavelengths (Q-switched 532, 694, 755 and 1064 nm lasers and 532, 755, 785 and 1064 nm picosecond lasers). Thus, the DESCRIBE PFD Patch, with the amended indication including additional laser wavelengths, is substantially equivalent to the original cleared device.
Conclusions
The DESCRIBE PFD Patch with its revised indication statement is as safe and effective as the predicate device. Performance testing as described above has been conducted to support these claims.