(117 days)
755 nm:
The PicoSure workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.
532 nm:
The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I-III.
The PicoSure™ 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 755 nm handpiece, an optional 532 nm Laser Delivery System can replace the 755 nm handpiece at the distal end of the articulated arm. This 532 nm Laser Delivery System converts the 755 nm laser energy into a 532 nm wavelength and is available in multiple spot sizes.
The provided document describes the Cynosure PicoSure™ Workstation with 532 nm Laser Delivery System (K143105) for tattoo removal. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with specific thresholds for device performance. Instead, it describes a comparative clinical study where the PicoSure device was deemed "as effective as" a predicate device (RevLite Q-Switched Nd:YAG Laser System K133254) based on a qualitative scoring scale.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Effectiveness in tattoo removal comparable to predicate device | Mean score of 3.8/6 overall efficacy for PicoSure, compared to 3.7/6 overall efficacy for the predicate device (RevLite). The study concluded that "PicoSure to be as effective as the predicate device RevLite." |
| Safety (absence of serious adverse events) | "There were no deaths, serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported in this study." |
| Software Verification and Validation | "Software verification and validation testing to support the 532 nm Laser Delivery System was successfully completed." (No specific metrics provided for this, but implies it met internal acceptance criteria for functionality and reliability). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 18 subjects with a total of 23 tattoos.
- Data Provenance: Not explicitly stated, but clinical trials for FDA submissions are typically conducted in the US or in countries with comparable regulatory standards. The document doesn't specify if it was retrospective or prospective, but clinical studies for regulatory approval are generally prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Three (3) blinded reviewers.
- Qualifications of Experts: Not specified in the document.
4. Adjudication Method for the Test Set
- Adjudication Method: "Mean scores for all three evaluators were calculated per subject to determine overall mean scores." This indicates that the scores from the three reviewers were averaged. It's not a 2+1 or 3+1 method, but rather a direct averaging.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study involving AI assistance was not done. This study solely compared the PicoSure device to a predicate laser device (RevLite) in the context of human-conducted laser treatments. AI assistance is not mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. The device in question is a laser system, not an AI algorithm. The performance evaluation was for the laser system's ability to remove tattoos when operated by humans.
7. The Type of Ground Truth Used
- Ground Truth Type: Expert consensus based on a "6 point categorical efficacy scoring scale" applied to photographs. This is a form of clinical assessment/subjective evaluation.
8. The Sample Size for the Training Set
- Not applicable. The device is a physical laser system, not a machine learning algorithm that requires a training set in the conventional sense. The "training" for this device would be its engineering design, development, and manufacturing processes, which are informed by scientific principles and prior knowledge of laser-tissue interaction, not a data training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As explained above, this is a physical device, not an AI/ML algorithm that uses a training set with established ground truth.
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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 the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2016
Cynosure, Inc. Ms. Kelli McMillan Regulatory Affairs Specialist 5 Carlisle Road. Westford, Massachusetts, 01886
Re: K143105
Trade/Device Name: Picosure™ Workstation with 532 nm Laser Delivery System 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: January 20, 2015 Received: January 21, 2015
Dear Ms. McMillan:
This letter corrects our substantially equivalent letter of February 23, 2015.
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. Isting 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
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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 (OS) 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) K141305
Device Name
Picosure™ Workstation with 532 nm Laser Delivery System
Indications for Use (Describe)
755 nm:
The PicoSure workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.
532 nm:
The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I-III.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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PicoSure™ Workstation 510(k) Summary K143105
| 807.92(a)(1) Submitter Information | |
|---|---|
| Applicant | Cynosure, Inc |
| Address | 5 Carlisle Road |
| Westford, MA 01886 | |
| Phone Number | (781) 993-2454 |
| Fax Number | (978) 256-6556 |
| Establishment Registration Number | 1222993 |
| Contact Person | Connie Hoy |
| Preparation Date | April 4, 2016 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | PicoSure Workstation with 532 nm Laser Delivery System |
| Common or Usual Name | Medical Laser System |
| 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 K140719 | |
| RevLite Q-Switched Nd:YAG Laser System K133254 | |
| 807.92(a){4) Device Description | |
| The PicoSure™ 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 755 nm | |
| handpiece, an optional 532 nm Laser Delivery System can | |
| replace the 755 nm handpiece at the distal end of the | |
| articulated arm. This 532 nm Laser Delivery System | |
| converts the 755 nm laser energy into a 532 nm | |
| wavelength and is available in multiple spot sizes. | |
| 807.92(a)(5) Intended Use of the Device | |
| 755 nm: | |
| The PicoSure workstation is indicated for tattoo and benign | |
| pigmented lesions removal. The PicoSure workstation with the | |
| 3mm and 6mm handpieces and the Focus Array are indicated for | |
| the treatment of acne scars and wrinkles in Skin Types I-IV. | |
| 532 nm: | |
| The PicoSure 532 nm Laser Delivery System is indicated for | |
| tattoo removal. | |
| The modifications to the device have not changed the | |
| indications for use for the 755 nm wavelength. |
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PicoSure™ Workstation
| 807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to the Predicate | ||||
|---|---|---|---|---|
| Laser Type | PicoSure™ Workstation (KPending) Alexandrite | PicoSure Workstation (K140719) Alexandrite | RevLite (K133254) Nd:YAG | |
| Frequency doubled 1064 nm solid state laser | ||||
| Wavelength | 532 nm | 755 nm | 1064 nm/532 nm | |
| Maximum Average Fluence | 1.4 J/cm² | 6.37 J/cm² | 12 J/cm² @ 1064 nm5 J/cm² @ 532 nm | |
| Repetition Rate | 1, 2.5, 5, 10 Hz | Single, 1, 2.5, 5, 10 Hz | Single shot, 1, 2, 5, 10 Hz | |
| Pulse Duration | 450ps-900 ps | 450ps-900ps | ≤ 20 ns | |
| Spot Sizes (mm) | Fixed 1.5-3.5 mm | Zoom 2-6 mm, Fixed 2, 3, 4, 6, 8, 10 mm | 2-8.5 mm, 0.1 mm increments | |
| 807.92(b)(1) Non-clinical tests submitted | Software verification and validation testing to support the 532 nm Laser Delivery System was successfully completed. | |||
| 807.92(b)(2) Clinical tests submitted | The study was performed using 18 subjects with a total of 23 tattoos. Subjects were ages 24 - 47. Subjects received 2 to 7 treatments every 6weeks (+/- 2 weeks). Subjects were divided into two groups and treated exclusively with PicoSure or the tattoo was split into two treatmentareas and treated with PicoSure and the predicate device. Three blinded reviewers performed an evaluation of photographs using a 6 pointcategorical efficacy scoring scale as well as rating the clearance of individual colors present in the tattoo. Mean scores for all three evaluatorswere calculated per subject to determine overall mean scores. The results of the blinded evaluation were subjects treated with PicoSure wererated 3.8/6 overall mean score, showing the PicoSure to be as effective as the predicate device RevLite, rated 3.7/6 overall mean score. Therewere no deaths, serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported in this study. The primary objectives ofthe study were to assess overall treatment efficacy through blinded photographic evaluation using a 6 point scale to grade improvement, assesssafety of the PicoSure laser through the recording of side effects during the course of the study and compare efficacy of the PicoSure laser to thepredicate device in a subset of patients, have been met. | |||
| 807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted | Testing confirmed that the PicoSure workstation with the 532 nm Laser Delivery System is safe and effective in the removal of tattoos. |
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§ 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.