(128 days)
755mm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure Workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV.
532mm:
The PicoSure 532mm Laser Delivery System is indicated for tattoo removal and benign pigmented lesion removal in Skin Types I - III.
1064nm:
The PicoSure 1064nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.
The PicoSureTM Workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755nm handpiece, optional 532nm Laser Delivery System and/or 1064nm Laser Delivery System can replace the 755nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755nm laser energy into a 532nm wavelength or a 1064 nm wavelength, and are available in multiple spot sizes.
Based on the provided text, the device in question is the PicoSure Workstation, a laser system used for tattoo removal, benign pigmented lesion removal, and treatment of acne scars and wrinkles. The information related to acceptance criteria and the study that proves the device meets them primarily pertains to the 532nm Delivery System for benign pigmented lesion removal in Skin Types I-III.
Here's an analysis of the provided information to address your request:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets for device performance. Instead, it describes a clinical study designed to demonstrate the safety and effectiveness of the 532nm Delivery System for benign pigmented lesions. The "acceptance criteria" here appear to be qualitative, focused on demonstrating a high level of improvement and acceptable safety profile.
Table of Performance (Inferred from Clinical Study Results):
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (532nm Delivery System for Benign Pigmented Lesions) |
|---|---|---|
| Clinical Efficacy | Significant improvement in benign pigmented lesions | 91.1% of subjects at 1-month follow-up had a score of "1 – Very Much Improved" on the Global Aesthetic Improvement Scale (GAIS). |
| Safety | Minimal, transient, and expected adverse effects | All adverse effects were transient (resolving in 2-11 days) and in the form of reddening and blistering (expected side effects from laser treatments). No serious or unexpected adverse events reported. |
Study Information:
2. Sample Size and Data Provenance
- Test Set Sample Size: 30 treatment areas (from 15 subjects).
- Data Provenance: The document does not specify the country of origin. The study was prospective as it involved treating subjects and following them up.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three.
- Qualifications of Experts: Blinded, board-certified Dermatologists. No explicit mention of years of experience.
4. Adjudication Method for the Test Set
- The clinical efficacy endpoint was evaluated "through comparison of the pre-treatment images by three blinded, board certified Dermatologists as independent reviewers." This implies a consensus-based or independent review approach, but the specific adjudication rule (e.g., majority vote, specific tie-breaking rule if opinions differed) is not detailed beyond "independent reviewers." It wasn't 2+1 or 3+1 as stated; they were independent reviewers of the images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not done. This study is a clinical trial assessing the laser device's direct performance on patients, not an AI-assisted diagnostic or assistive tool.
6. Standalone Performance (Algorithm Only)
- This is not applicable as the device is a physical laser workstation, not an AI algorithm. The reported performance is of the physical device as operated by a clinician.
7. Type of Ground Truth Used
- The ground truth for efficacy was established through expert consensus/independent review of pre-treatment and post-treatment images by board-certified Dermatologists, coupled with the clinical investigator's evaluation using the GAIS. For safety, it was the observation and reporting of adverse events during the follow-up period.
8. Sample Size for the Training Set
- This is not applicable as the PicoSure Workstation is a physical medical device (laser) and not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" for such a device would be its engineering, calibration, and manufacturing processes.
9. How Ground Truth for the Training Set Was Established
- Not applicable for the same reason as point 8. The "ground truth" for the device's design and function would be based on established medical physics principles, engineering standards, and pre-clinical testing, rather than a data-driven "ground truth" for model training.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
February 7, 2018
Cynosure, Inc Avinash Purohit Regulatory Affairs Specialist 5 Caelisle Road Westford, Massachusetts 01886
Re: K173199
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: September 28, 2017 Received: October 2, 2017
Dear Avinash Purohit:
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) 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@fda.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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Indications for Use
510(k) Number (if known) K173199
Device Name PicoSure Workstation
Indications for Use (Describe) 755mm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure Workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV.
532mm:
The PicoSure 532mm Laser Delivery System is indicated for tattoo removal and benign pigmented lesion removal in Skin Types I - III.
1064nm:
The PicoSure 1064nm Laser Delivery System 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 for the PicoSure Workstation | |
|---|---|
| 807.92(a)(1) Submitter Information | |
| Applicant | Cynosure, Inc. |
| Address | 5 Carlisle RoadWestford, MA 01886 |
| Phone Number | (978) 367-2450 |
| Fax Number | (978) 256-6556 |
| Establishment Registration Number | 1222993 |
| Contact Person | Mr. Avinash Purohit |
| Preparation Date | 28 September 2017 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | PicoSure Workstation |
| Common or Usual Name | Laser Workstation |
| Classification Name | Powered Laser Surgical Instrument |
| Classification Panel | General & Plastic Surgery |
| Regulation | 878.4810 |
| Product Code(s) | GEX |
| 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | |
| PicoSure Workstation - K160480 | |
| RevLite Q-Switched Nd:YAG Laser System - K133254 | |
| 807.92(a)(4) Device Description | |
| The PicoSureTM Workstation is a high-powered, Alexandritesystem that delivers laser energy in the 755-nm nominalwavelength. The system offers fast and efficient treatmentthrough a variety of spot sizes, fluences and repetition rates. Laseractivation is by footswitch. In addition to the 755nm handpiece,optional 532nm Laser Delivery System and/or 1064nm LaserDelivery System can replace the 755nm handpiece at the distalend of the articulated arm. These Delivery Systems convert the755nm laser energy into a 532nm wavelength or a 1064 nmwavelength, and are available in multiple spot sizes. | |
| 807.92(a)(5) Intended Use of the Device | |
| 755 nm:The PicoSure Workstation is indicated for tattoo and benignpigmented lesions removal. The PicoSure workstation with the2mm and 6mm handpieces and the Focus Array are indicated forthe treatment of acne scars and wrinkles in Skin Types I-IV. | |
| 532 nm:The PicoSure 532 nm delivery system is indicated for tattooremoval and benign pigmented lesion removal in Skin Types I-III. | |
| 1064 nm:The PicoSure 1064 nm Laser Delivery System is indicated fortattoo and benign pigmented lesions removal. |
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| 807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to the Predicate | ||||||||
|---|---|---|---|---|---|---|---|---|
| 510(k) Number | PicoSure Workstation(KPending) | PicoSure Workstation(K160480) | RevLite Q-switched Nd:YAGLaser System(K133254) | |||||
| Laser Type | Nd:YVO4 | FrequencydoubledNd:YVO4 | Alexandrite | Nd:YVO4 | FrequencydoubledNd:YVO4 | Alexandrite | Flashlamp Excited Q-SwitchedNd:YAG | |
| Wavelength(nm) | 1064 nm | 532 nm | 755 nm | 1064 nm | 532 nm | 755 nm | 1064 nm | 532 nm |
| MaximumAverageFluence (J/cm²) | 3.6 J/cm² | 1.5 J/cm² | 6.37 J/cm² | 3.6 J/cm² | 1.5 J/cm² | 6.37 J/cm² | 12 J/cm² | 5 J/cm² |
| RepetitionRate (Hz) | 1, 2.5, 5, 10 Hz | 1, 2.5, 5, 10 Hz | Single, 1, 2.5, 5,10 Hz | 1, 2.5, 5,10 Hz | 1, 2.5, 5,10 Hz | Single, 1, 2.5, 5,10 Hz | Single Shot, 1, 2, 5, 10 Hz | |
| Pulse Duration | 450-900 ps | 450-900 ps | 7 – 20 ns | |||||
| Spot Sizes(mm) | Fixed 1.4 –4.0 mm | Fixed 1.5 –3.5 mm | Zoom 2-6 mm,Fixed 6, 8, 10mm | Fixed 1.4 –4.0 mm | Fixed 1.5 –3.5 mm | Zoom 2-6 mm,Fixed 6, 8, 10mm | 2 – 8.5 mm with 0.1 mmincrements |
807.92(b)(1) Non-clinical tests submitted
For this submission, software and electrical safety testing were not necessary for the expanded indication. However, incremental software updates required testing and was completed successfully. With regard to electrical safety, the device experienced only constructional changes as part of normal maintenance, so additional testing was not required. EMC testing was still performed on two components added to improve product reliability. All changes have been analyzed and successary. There necessary. There software updates/constructional changes do not affect the safety and efficacy of the PicoSure Workstation.
807.92(b)(2) Clinical tests submitted
A prospective clinical study was conducted using 30 treatment areas (2 areas for each of the 15 subjects), both male and female, in which the removal of benign pigmented lesions was performed using the PicoSure Workstation's 532nm Delivery System. Subjects in the study were 93% female, 7% male, and were between the ages (53 – 70) years old. They were a range of Fitzpatrick Skin Types I-III. All potential subjects were evaluated against the study's inclusion criteria to determine enrollment eligibility. During the course of the study, subjects received up to 4 treatments that were 4 weeks (+/- 2) apart using the PicoSure Workstation's 532mm wavelength haser energy. These subjects were then followed up on a (1 month) timeframe to assess for any adverse patient impacts at the treatment site. The clinical efficacy endpoint was evaluated through comparison of the pre-treatment images by three blinded, board certified Dermatologists as
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independent reviewers. The clinical investigator evaluated progress via the GAIS [Global Aesthetic Improvement Scale], where 91.1% of the subjects at [1 month follow-up] had a score of "1 – Very Much Improved". The safety endpoint sought to course of the study. All adverse effects from the clinical study were transient (resolving in 2-11 days) in form of reching, and blistering. These are all expected side effects from laser treatments. The objectives of the study were met and concluded that the use of PicoSure's 532nm Delivery System is a safe and effective method for the removal of benign pigmented lesions in Skin Types I-III.
807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted
The non-clinical data demonstrates support for safety and effectiveness of the device in regards to herded for treatment conditions. The clinical study demonstration using the 532mm Delivery System operated as expected and delivered safe and effective results with minimal side effects in subjects being pigmented lesion removal in Skin Types I-III.
§ 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.