The PicoSure™ workstation is a high-powered, laser system that delivers energy in the 755-nm wavelength. Same as its predicates, the PicoSure™ workstation is intended for tattoos and benign pigmented lesions removal. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed.

AI/ML Overview

The provided document is a 510(k) summary for the PicoSure™ workstation, a laser surgical instrument for tattoo and benign pigmented lesion removal. It describes the device's intended use, technological characteristics, and performance data from non-clinical and clinical studies. However, the document does not explicitly state predefined acceptance criteria for the clinical studies nor detailed quantitative results against such criteria. It provides a general statement of "safety and effectiveness" and "high level of overall tattoo clearance." Therefore, some of the requested information cannot be fully extracted or will be based on inference.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative acceptance criteria for clinical effectiveness. It broadly states the device was found "safe and effective, with high level of overall tattoo clearance." For safety, it states "All treatment arms had a comparable safety profile. None of the events were classified as adverse device reaction. No serious or unexpected adverse events were reported."

Acceptance Criteria (Inferred from study goals)	Reported Device Performance
Effectiveness (Tattoo Clearance)	- "High level of overall tattoo clearance" - "Demonstrated more significant % of highest clearance score than control device in controlled studies"
Safety (Adverse Events)	- "Comparable safety profile" across treatment arms - No adverse device reactions - No serious or unexpected adverse events - Majority of AEs were mild, no severe AEs - Most common AEs: pain and blistering
User Satisfaction	- "Extreme" physician satisfaction (physician evaluation) - Subject satisfaction surveyed and analyzed (no specific results provided)

2. Sample Size and Data Provenance for Test Set

Sample Size (Clinical Studies): Not explicitly stated. The document mentions "Three clinical studies (two controlled and one uncontrolled)," but does not provide the number of subjects or lesions included in these studies.
Data Provenance: Not explicitly stated. The document does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of clinical trials for device approval, it is highly likely the studies were prospective.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The evaluation of tattoo clearance was done by "evaluation of before-and-after photos and calculation the % of tattoo clearance." Physician satisfaction was also surveyed. It can be inferred that treating physicians or other qualified medical personnel were involved in these assessments, but their specific qualifications (e.g., dermatologists, years of experience) are not provided.

4. Adjudication Method for Test Set

Adjudication Method: Not explicitly stated. The document mentions "evaluation before-and-after photos and calculation the % of tattoo clearance." It does not describe any specific adjudication process like 2+1 or 3+1 for discrepancies in evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: Not explicitly mentioned. The clinical studies involved "two controlled studies" where the device "demonstrated more significant % of highest clearance score than control device." This suggests a comparison between the PicoSure™ workstation and a control (likely another laser device or a sham treatment). However, it does not describe a setting where human readers interpret images with and without AI assistance. The PicoSure™ workstation itself is a laser device, not an AI for image interpretation. Therefore, a traditional MRMC study comparing human readers with and without AI assistance is not applicable in this context.
Effect Size of Human Readers with AI vs. without AI: Not applicable, as this is not an AI-based diagnostic/interpretive device.

6. Standalone (Algorithm Only) Performance

Standalone Performance: Not applicable. The PicoSure™ workstation is a physical laser device for treatment, not an algorithm for standalone diagnostic performance.

7. Type of Ground Truth Used

Type of Ground Truth: The effectiveness was assessed by "evaluation before-and-after photos and calculation the % of tattoo clearance." For safety, "Treatment-emergent adverse events were recorded and evaluated." This indicates that clinical assessment (visual clearance from photos) and reported adverse events/clinical observations served as the ground truth for effectiveness and safety, respectively. There is no mention of pathology or outcomes data beyond the clinical observations.

8. Sample Size for Training Set

Sample Size for Training Set: Not applicable. The PicoSure™ workstation is a physical laser device, not a machine learning model that requires a training set. The clinical studies mentioned are for validation of the device's safety and efficacy, not for training an algorithm.

9. How Ground Truth for Training Set was Established

How Ground Truth for Training Set was Established: Not applicable, as there is no training set for a machine learning model.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked slightly offset from each other. Above the profiles is a design element resembling a wing or feather. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 23, 2016

Cynosure, Incorporated Ms. Irina Kulinets Vice President of Regulatory Affairs and Quality Systems 5 Carlisle Road, Westford, Massachusetts, 01886

Re: K121346 Trade/Device Name: Picosure™ workstation 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: GEX Dated: November 8, 2012 Received: November 9, 2012

Dear Ms. Kulinets:

This letter corrects our substantially equivalent letter of November 27, 2012.

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 vour 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

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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 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/ResourcesforYou/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 -A

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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Indications for Use

510(k) Number (if known) K121346

Device Name Picosure™ workstation

Indications for Use (Describe)

The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal.

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

510(K) Owner:	CYNOSURE, INC.5 Carlisle RoadWestford, MA 01886Telephone: 978-256-4200Fax: 978 256 6556
Contact:	Irina KulinetsVP of Regulatory Affairs and Quality SystemsCYNOSURE, INC.5 Carlisle RoadWestford, MA 01886
Submitter:	Connie HoySVP of Regulatory Affairs and Quality SystemsCYNOSURE, INC.5 Carlisle RoadWestford, MA 01886
Manufacturer:	CYNOSURE, INC.5 Carlisle RoadWestford, MA 01886
Date Prepared:	March 29, 2016
Trade name:	PicoSureTM workstation
Common name:	Powered Laser Surgical Instrument (Laserfor Surgery and Dermatology)
Classification name:	21 CFR 878.4810
Product Code(s):	GEX (Laser Surgical Instrument for Use in General andPlastic Surgery and in Dermatology)
Classification:	Class II

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Review Panel:

General & Plastic Surgery

Predicate Devices (Claiming Substantial Equivalence):

K992814 Cynosure Accolade/Accolade II Laser K103118 HOYA ConBio RevLite

Summary Description of the Device:

Intended Use / Indications for Use:

The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal.

Technological Characteristics:

The PicoSure™ workstation contains equivalent basic technology, components and patient-contact materials as the FDA cleared Cynosure Accolade/Accolade II laser (K992814 and K072868). The fundamental scientific technology of the PicoSure™ workstation is substantially equivalent to the FDA cleared Cynosure Accolade/Accolade II laser (K992814 and K072868).

Performance Standards:

This device conforms to the Laser Performance Standard (21 CFR 1040). No additional performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.

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Performance Data: Non-clinical testing

Performance (bench and animal) testing summaries are included in this submission. Bench testing included:

. Design verification which includes software and hardware verification
Design validation which includes software and hardware validation .
. Production verification which includes in-process inspection and test

Animal data has been used to establish the device safety. A study examined the effect of the PicoSure™ workstation in an animal model (porcine study).

Performance Data: Clinical testing

Three clinical studies (two controlled and one uncontrolled) were presented in the submission to confirm safety and effectiveness of the device in the tattoo removal. Number of treatments varied in the studies from 4 to 10 sessions. The device effectiveness in removal tattoos was assessed by the evaluation before-and-after photos and calculation the % of tattoo clearance at the end of study for each treatment area. Subject and physician satisfaction with the treatment results was also surveyed and analyzed.

The device safety was evaluated by the incidence, timing, severity of treatment-emergent adverse events were categorized and summarized.

The device was found to be safe and effective, with high level of overall tattoo clearance and "extreme," physician satisfaction (physician evaluation) and, additionally, demonstrated more significant % of highest clearance score than control device in controlled studies.

Treatment-emergent adverse events were recorded and evaluated in all studies. All treatment arms had a comparable safety profile. None of the events were classified as adverse device reaction. No serious or unexpected adverse events were reported. The majority of reported adverse events across the studies were of mild severity; no severe adverse events were reported in any group. The most common reactions were pain and blistering.

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Substantial Equivalence:

The Cynosure PicoSure™ workstation is as safe and effective as its predicate devices currently cleared for the same indications. The Cynosure PicoSure™ workstation is substantially equivalent to the predicate device(s) as shown in the table below and does not does not raise any additional questions of safety and effectiveness. Substantial Equivalence Table is provided below.

	Proposed Device	Predicate Device	Predicate Device
510(k) #		K992814	K103118
Company	CYNOSURE, INC.	CYNOSURE, INC.	HOYA ConBio
Name	Cynosure PicoSure™workstation	CynosureAccolade	RevLite
Laser Type	Flashlamp excited Q-switched alexandrite	Flashlamp excited Q-switched alexandrite	Flashlamp excited Q-switched alexandrite
Nominal Wavelength	755nm	755nm	532 nm, 585 nm 650 nm,& 1064 nm
Energy per pulse	0.2 J/cm2	0.57 J/cm2	0.85 J/cm2
Maximum AverageFluence	6.37 J/cm2	7.5 J/cm2	12 J/ cm² (1064nm)5 J/ cm² (532nm)10 J/ cm² (585nm)6 J/ cm²(650 nm)1.2 J/ cm² (532Lite)
Rate	Single pulse, or 1, 2.5,5, or 10 pulse(s) persecond (Hz)	Single pulse, or 1,2,5,or 10 pulse(s) persecond (Hz)	Single & double pulse, 1,2, 5, & 10 Hz pulses persecond
Pulse Width	450ps - 900ps	45-75 ns	5-20 ns
Spot Sizes	Zoom 2-6 mm,Fixed 2, 3, 4, 6, 8, 10mm	Fixed2.4, 3, 4 mm	Fixed 2 - 8 mm (varies bywavelength)

Device Comparison Table - Substantial Equivalence

Conclusion:

PicoSure™ workstation is as safe and efficient as its predicate devices.

Regulation Number and Section

§ 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.