DESCRIBE PFD Patch

K172689 · Merz North America, Inc. · PKO · Nov 29, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K172689
• Device Name: DESCRIBE PFD Patch
• Applicant: Merz North America, Inc.
• Product Code: PKO · General, Plastic Surgery
• Decision Date: Nov 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2

Intended 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.

Device Story

The DESCRIBE PFD Patch is a sterile, dual-layer silicone film containing perfluorodecalin (PFD) optical clearing agent; used as an accessory during laser tattoo removal. The patch is applied to the patient's skin; the PFD liquid fills the space between the skin and the patch, providing optical clearing. The device is transparent to laser light, allowing the laser beam to pass through to the tattoo pigment without attenuation. It is used in a clinical setting by a physician or trained professional. The patch facilitates multiple laser passes by reducing the scattering of laser light, potentially allowing for faster treatment and improved clinical outcomes. The device is disposable and intended for single use.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included UV/Vis/NIR spectroscopy to verify optical transparency and stability of the patch and PFD after exposure to Q-switched (532, 694, 755, 1064 nm) and picosecond (532, 755, 785, 1064 nm) lasers. GC/MS testing confirmed no chemical changes to the PFD after laser exposure. Three-year real-time aging studies were conducted per ISO 11607, including package burst and bubble emission leak testing.

Technological Characteristics

Dual-layer medical-grade silicone film (low-friction upper layer, tacky lower layer) and sterile, high-purity perfluorodecalin (PFD) optical clearing agent. Optically transparent to dermatological lasers. Shelf life validated to 3 years via real-time aging and ISO 11607 package integrity testing.

Indications for Use

Indicated for Fitzpatrick Skin Type I-III patients undergoing laser tattoo removal using specified Q-Switched (532, 694, 755, 1064 nm) or picosecond (532, 755, 785, 1064 nm) lasers.

Regulatory Classification

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.

Predicate Devices

• DeScribe Transparent PFD Patch (K150212)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K172689

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: [phone]

# Contact Person:

Misty D'Ottavio Director of Regulatory Affairs 6501 Six Forks Road Raleigh, NC 27615 Phone: [phone] Fax: [phone]

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

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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.