(85 days)
755 nm:
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.
532 nm:
The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I - III.
1064 nm:
The PicoSure 1064 nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.
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, optional 532 nm Laser Delivery System and/or 1064 nm Laser Delivery System can replace the 755 nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755 nm laser energy into a 532 nm wavelength or a 1064 nm wavelength and are available in multiple spot sizes.
The provided text describes a 510(k) premarket notification for the PicoSure Workstation, specifically focusing on the addition of a 1064 nm Laser Delivery System. The information necessary to fully answer all aspects of your request is not entirely present in the provided document, but I will extract what is available.
Here's a breakdown of the acceptance criteria and study information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined "acceptance criteria" in terms of specific numerical thresholds for efficacy or safety. Instead, it concludes that the device is "as effective as the predicate device" and "safe and effective."
| Acceptance Criteria Category | Specific Criteria (Implicit from study goal) | Reported Device Performance (PicoSure) | Reported Performance (Predicate RevLite) |
|---|---|---|---|
| Efficacy | Overall treatment efficacy, assessed by blinded photographic evaluation using a 6-point categorical efficacy scoring scale. | 4.1 / 6 overall mean score | 3.7 / 6 overall mean score |
| Safety | Absence of deaths, serious adverse events (SAE), or unanticipated adverse device effects (UADEs). | No deaths, SAEs, or UADEs reported | (Not specified for predicate) |
| Comparison to Predicate | Effectiveness comparable to the predicate device. | Rated 4.1/6, showing it to be as effective as the predicate which had 3.7/6. | 3.7 / 6 overall mean score |
2. Sample size used for the test set and the data provenance
- Sample Size: 66 subjects with a total of 79 tattoos.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study design indicates it was a clinical study, suggesting it was prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Three blinded reviewers.
- Qualifications of Experts: Not specified beyond being "blinded reviewers." It does not state if they were dermatologists, radiologists, or had any specific years of experience.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: "Mean scores for all three evaluators were calculated per subject to determine overall mean scores." This implies an averaging or consensus approach, rather than a specific 2+1 or 3+1 adjudication where dissenters might be reviewed by a tie-breaker.
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
- MRMC Study: This was a clinical study comparing a new device (PicoSure) to a predicate device (RevLite) for tattoo removal, not an MRMC study assessing human reader performance with or without AI assistance. Therefore, this question is not applicable to the provided information.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This device is a laser system, not an AI algorithm. Therefore, this question about "algorithm only" performance is not applicable. The study assessed the device's clinical performance in patients.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for efficacy was established by expert consensus (mean scores from three blinded reviewers) using a 6-point categorical efficacy scoring scale based on photographic evaluation.
- Safety ground truth was based on the reporting of adverse events (deaths, SAEs, UADEs).
8. The sample size for the training set
- This was a clinical study evaluating a medical device, not an AI algorithm that requires a training set. Therefore, this question is not applicable. The only "training" mentioned for the device itself would be internal engineering and development, not a data training set as understood in AI/ML contexts.
9. How the ground truth for the training set was established
- As explained above, this was not an AI algorithm study requiring a training set. Therefore, this question is not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered horizontally and appears to be part of a document header or title. The font is a serif typeface, giving it a formal and official appearance.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2016
Cynosure, Inc Ms. Amy Tannenbaum Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886
Re: K160480
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: February 19, 2016 Received: February 22, 2016
Dear Ms. Tannenbaum:
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 (reporting of medical device
{1}------------------------------------------------
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" (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.
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K160480
Device Name
PicoSure Workstation with 1064 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 2mm 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.
1064 nm:
The PicoSure 1064 nm 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
PicoSure™ Workstation 510(k) Summary KPending
| 807.92(a)(1) Submitter Information | |
|---|---|
| Applicant | Cynosure, Inc |
| Address | 5 Carlisle RoadWestford, MA 01886 |
| Phone Number | (781) 993-2454 |
| Fax Number | (978) 256-6556 |
| Establishment Registration Number | 1222993 |
| Contact Person | Amy Tannenbaum |
| Preparation Date | February 19, 2016 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | PicoSure Workstation with 532 and 1064 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 K143105RevLite Q-Switched Nd:YAG Laser System K133254 |
| 807.92(a)(4) Device Description | The PicoSure™ 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.Laser activation is by footswitch. In addition to the 755 nmhandpiece, optional 532 nm Laser Delivery System and/or1064 nm Laser Delivery System can replace the 755 nmhandpiece at the distal end of the articulated arm. TheseDelivery Systems convert the 755 nm laser energy into a532 nm wavelength or a 1064 nm wavelength and areavailable 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 the3mm 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 Laser Delivery System is indicated fortattoo removal in Skin Types I - III. | |
| 1064 nm:The PicoSure 1064 nm Laser Delivery System is indicated for |
{4}------------------------------------------------
PicoSure™ Workstation 510(k) Summary KPending
The modifications to the device have not changed the indications for use for the 755 nm or 532 nm wavelength.
{5}------------------------------------------------
PicoSure™ Workstation 510(k) Summary KPending
| 807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to the Predicate | ||||||
|---|---|---|---|---|---|---|
| PicoSure™ Workstation (KPending) | PicoSure Workstation (K143105) | RevLite (K133254) | ||||
| Laser Type | Nd:YVO4 | FrequencydoubledNd:YVO4 | Alexandrite | Frequencydoubled 1064 nmsolid state laser | Alexandrite | Nd:YAG |
| Wavelength | 1064 nm | 532 nm | 755 nm | 532 nm | 755 nm | 1064 nm/532 nm |
| MaximumAverage Fluence | 3.6 J/cm² | 1.5 J/cm² | 6.37 J/cm² | 1.5 J/cm² | 6.37 J/cm² | 12 J/cm² @ 1064 nm5 J/cm² @ 532 nm |
| Repetition Rate | 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 | Single shot,or 1, 2.5, 5,10 Hz | Single shot, 1, 2, 5, 10 Hz |
| Pulse Duration | 450 - 900 ps | 450 - 900 ps | 450 - 900 ps | ≤ 900 ps | ≤ 20 ns | |
| Spot Sizes (mm) | Fixed 1.4 – 4.0 mm | Fixed 1.5 – 3.5 mm | Zoom 2-6 mm,Fixed 6, 8, 10 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 mmincrements |
| 807.92(b)(1) Non-clinical tests submitted |
Software verification and validation testing to support the 1064 nm Laser Delivery System was successfully completed.
807.92(b)(2) Clinical tests submitted
The study was performed using 66 subjects with a total of 79 tattoos. Subjects received up to 12 treatments, one every 6 weeks (+/- 2 weeks). Subjects were divided into two groups and treated exclusively with PicoSure, or their tattoo was split into two treatments areas, and treated with PicoSure and the predicate device. Three blinded reviewers performed an evaluation of photographs using a 6 points categorical efficacy scoring scale as well as rating the cattoos. Mean scores for all three evaluators were calculated per subject to determine overall mean scores. The results of the blinded evaluation were subjects treated with PicoSure were rated 4.1/6 overall mean score, showing the PicoSure to be as effective as the predicate device RevLite, which had an average score of 3.7/6. There were no deaths, serious adverse events (SAE) or unanticipated adverse device effects (UADEs) reported in this study. The primary objectives of the study; to assess overall treatment efficacy through blinded photographic evaluation using a 6 point scale to grade improvement, assess safety of the PicoSure laser through the recording of side effects during the course of the study, and compare efficacy of the PicoSure laser to the predicate 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 and 1064 nm Laser Delivery System is safe and effective in the removal of tattoos.
§ 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.