(263 days)
The PicoSure™ workstation is indicated for tattoo and benign pigmented lesion removal.
The PicoSure™ workstation operating with the 3mm or 6mm handpiee and the FOCUS lens array is indicated for the treatment of acne scars in Fitzpatrick skin types I-IV.
The PicoSure™ workstation is a high-powered, Q-switched Alexandrite system that delivers laser energy in the 755-nm wavelength. The system consists of a console that houses the power supply, control electronics and the laser. Laser energy is delivered to the skin via an articulated arm. The laser is activated using a footswitch.
The provided document describes the PicoSure™ Workstation, a laser system indicated for tattoo and benign pigmented lesion removal, and for the treatment of acne scars when operating with specific handpieces and the FOCUS lens array. The document presents two clinical studies to support the safety and effectiveness of the device for acne scar treatment. Below is an analysis of the acceptance criteria and study data based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (Acne Scars Study) |
|---|---|
| Efficacy - Improvement in Acne Scars | Mean Improvement Score (scale 0-3): 1.9 |
| Evaluator Identification Rate | Blinded Evaluators' Correct Identification of Before/After Photos: 70% of 17 subjects |
| Physician Satisfaction Rate | Non-blinded Treating Physician Overall Satisfaction: 100% (47% "satisfied", 53% "extremely satisfied") |
| Subject Satisfaction Rate | Subjects' Overall Satisfaction: 87% (53% "satisfied", 27% "extremely satisfied") |
| Safety - Tissue Response | - Immediate Post-treatment: Focal epidermal vacuolization and small foci of degenerated keratinocytes. - 7 and 15 Days Post-treatment: Intact epidermis with mild, superficial dermal lymphocytic infiltrates in peri-vascular pattern. (This indicates localized and transient tissue response, which is generally acceptable for laser procedures.) |
Note: The document does not explicitly state pre-defined acceptance criteria values for these metrics. The reported performance implies these results were considered sufficient to demonstrate substantial equivalence.
2. Sample Size and Data Provenance for the Test Set
-
Acne Scars Study (Clinical Study 1):
- Sample Size (Test Set): 17 patients completed the study, with a total of 46 acne scars treated.
- Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical study, as it describes treatment and follow-up observations.
-
Tissue Response Study (Clinical Study 2):
- Sample Size (Test Set): 3 subjects (2 on arm, 1 on leg).
- Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical study, as it describes treatment and subsequent biopsies.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
-
Acne Scars Study:
- Number of Experts: Three blinded evaluators.
- Qualifications: The specific qualifications (e.g., radiologist, years of experience) of these evaluators are not specified in the provided text. They were described as "blinded evaluators."
-
Tissue Response Study:
- Number of Experts: Not explicitly stated for establishing ground truth from biopsies, but biopsies would typically be analyzed by pathologists.
- Qualifications: Not specified.
4. Adjudication Method for the Test Set
- Acne Scars Study: The method for reaching consensus among the three blinded evaluators regarding the "before and after images" or for determining the "mean improvement score" is not explicitly detailed. It can be inferred that their evaluations were aggregated, but the specific adjudication (e.g., voting, expert consensus meeting) is not described.
- Tissue Response Study: For the biopsy analysis, an adjudication method is not detailed. Typically, a qualified pathologist would interpret the biopsies, and potentially a second opinion might be sought for complex cases, but this is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A formal MRMC comparative effectiveness study, comparing human readers with AI assistance versus without AI assistance, was not performed, nor is it applicable to this device. The PicoSure Workstation is a laser device, not an AI diagnostic or assistance tool for human readers. The study involved human evaluators assessing photographic outcomes of a treatment device.
6. Standalone Performance
- A standalone (algorithm only without human-in-the-loop performance) study was not applicable and therefore not conducted. The PicoSure Workstation is a physical laser device used for treatment, not a standalone AI algorithm.
7. Type of Ground Truth Used
- Acne Scars Study: The ground truth for effectiveness was based on:
- Expert Consensus/Opinion: Evaluations by three blinded evaluators of before/after photographs.
- Subjective Satisfaction: Non-blinded treating physician's satisfaction scores and subjects' self-reported satisfaction.
- Tissue Response Study: The ground truth for safety (tissue response) was based on Pathology via biopsies taken at various time points after treatment.
8. Sample Size for the Training Set
- The document describes clinical studies used to assess the performance of the device, not to train an AI algorithm. Therefore, a "training set" in the context of machine learning is not applicable to this device and its studies. The clinical studies served as validation for the device's efficacy and safety.
9. How the Ground Truth for the Training Set Was Established
- As a training set for an AI algorithm is not applicable, the method for establishing its ground truth is not relevant to the information provided. The "ground truth" discussed in the context of these studies refers to the outcomes measured in the clinical trials themselves by evaluators, physicians, and pathological examination.
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Image /page/0/Picture/1 description: The image is the logo for the Department of Health and Human Services (HHS). The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. Inside the circle is a symbol consisting of three stylized human profiles facing right, with flowing lines extending from the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2016
Cynosure, Inc. Ms. Connie Hoy Vice President of Regulatory Affairs 5 Carlisle Road Westford, Massachusetts, 01886
Re: K133364 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: June 15, 2014 Received: June 17, 2014
Dear Ms. Hoy:
This letter corrects our substantially equivalent letter of July 22, 2014.
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
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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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This 510(K) Summary of safety and effectiveness for the PicoSure™ workstation
is submitted in accordance with the requirements of the SMDA 1990 and following guidan concerning the organization and content of a 510(K) summary.
| Applicant: | Cynosure, Inc. | |
|---|---|---|
| Address: | 5 Carlisle RoadWestford, MA 01886USA | |
| Contact Person: | Connie Hoy, SVP of Regulatory Affairs | |
| Telephone:Email: | 1-781-993-2414choy@cynosure, com | |
| Preparation Date: | April 4, 2016 | |
| Device Trade Name: | PicoSure™ workstation | |
| Common Name: | Laser | |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878-48 | |
| Legally Marketed PredicateDevice(s): | PicoSure™ workstation (K)121346Hoya ConBio RevLite (K)103118 | |
| Description of the PicoSure™Workstation: | The PicoSure™ workstation is a high-powered, Q-switchedAlexandrite system that delivers laser energy in the 755-nmwavelength. The system consists of a console that houses thepower supply, control electronics and the laser. Laser energyis delivered to the skin via an articulated arm. The laser isactivated using a footswitch. | |
| Intended use of the PicoSure™Workstation | The PicoSure™ workstation is indicated for tattoo and benignpigmented lesion removal.The PicoSure™ workstation operating with the 3mm or 6mmhandpiee and the FOCUS lens array is indicated for thetreatment of acne scars in Fitzpatrick skin types I-IV. | |
| Performance Data: | IEC 60601-1 Medical Electrical Equipment - Part 1: GeneralRequirements for Safety | |
| IEC 60601-1-2 Medical Electrical Equipment 1-2 GeneralRequirements for basic safety and essential performance | ||
| Steam Sterilization Test Report 673257 | ||
| Software Verification and Validation Testing Report860-7012-SRV |
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Results of Clinical Study:
Two clinical studies were conducted.
One study assessed facial acne scars. In 17 patients who completed the study, a total of 46 acne scars underwent a mean of 6.3 treatments with either the 3mm or 6mm handpiece, each operated with the FOCUS lens array. Before and after photographs were evaluated by three blinded evaluators, who were able to identify correctly the before and after images in 70% of the 17 subjects. The mean improvement score (scale 0-3) was 1.9. The non-blinded treating physician reported a 100% overall satisfaction rate, scoring the improvement in 47% of subjects as "satisfied" and 53% as "extremely satisfied." Subjects reported a satisfaction rate of 87% (53% "satisfied" and 27% "extremely satisfied").
A second study was conducted on normal skin on the arm of 2 subjects and the leg of a 3rd subject to evaluate the tissue response to treatment of the FOCUS lens array. Three patients were treated with the 6mm lens with FOCUS array at 0.71J/cm2 and with the 3mm lens with FOCUS array at 2.83J/cm2. Biopsies were performed in untreated skin and in treated skin immediately post treatment, 7 days post treatment and 15 days post treatment. Treatment induced immediate focal epidermal vacuolization and small foci of degenerated keratinocytes. At days 7 and 15, skin exhibited intact epidermis with mild, superficial dermal lymphocytic infiltrates in peri-vascular pattern.
| TechnicalComparison: | Specifications | ||
|---|---|---|---|
| PicoSure™ Workstation(current submission) | PicoSure™ Workstation(previously cleared) | RevLite | |
| Laser Type | Flashlamp excited Q-switched alexandrite | Flashlamp excited Q-switched alexandrite | Flashlamp excited Q-switched Nd:YAG |
| Wavelength | 755nm | 755nm | 532 nm, 585 nm 650 nm, &1064 nm |
| Energy per pulse | 0.2 J/cm2 | 0.2 J/cm2 | 0.85 J/cm2 |
| Maximum AverageFluence | 6.37 J/cm² | 6.37 J/cm² | 12 J/cm² (1064nm)5 J/cm² (532nm)10 J/cm² (585nm)6 J/cm²(650 nm)1.2 J/cm² (532Lite) |
| Repetition Rate | Single pulse, or 1, 2.5, 5,or 10 pulse(s) per second(Hz) | Single pulse, or 1,2,5, or10 pulse(s) per second(Hz) | Single & double pulse, 1, 2,5, & 10 Hz pulses persecond |
| Pulse Width | 450ps-900ps | 450ps-900ps | 5-20 ns |
| Spot Sizes | Zoom 2-6 mm,Fixed 2, 3, 4, 6, 8, 10 mmWith FOCUS lens array:3mm 6mm | Zoom 2-6 mm,Fixed 2, 3, 4, 6, 8, 10 mm | Fixed 2 - 8 mm (varies bywavelength) |
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Conclusion:
The PicoSure Workstation is substantially equivalent to other existing laser systems in commercial distribution for use in Dermatology and Plastic Surgery.
.
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concerning the organization and content of a 510(K) summary.
| Applicant: | Cynosure, Inc. | |
|---|---|---|
| Address: | 5 Carlisle RoadWestford, MA 01886USA | |
| Contact Person: | Connie Hoy, SVP of Regulatory Affairs | |
| Telephone:Email: | 1-781-993-2414choy@cynosure, com | |
| Preparation Date: | April 4, 2016 | |
| Device Trade Name: | PicoSure™ workstation | |
| Common Name: | Laser | |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878-48 | |
| Legally MarketedDevice(s): | Predicate PicoSure™ workstation (K)121346Hoya ConBio RevLite (K)103118 | |
| Description of the PicoSure™Workstation: | The PicoSure™ workstation is a high-powered, Q-switchedAlexandrite system that delivers laser energy in the 755-nmwavelength. The system consists of a console that houses thepower supply, control electronics and the laser. Laser energyis delivered to the skin via an articulated arm. The laser isactivated using a footswitch. | |
| Intended use of the PicoSure™Workstation | The PicoSure™ workstation is indicated for tattoo and benignpigmented lesion removal. | |
| The PicoSure™ workstation operating with the 3mm or 6mmhandpiee and the FOCUS lens array is indicated for thetreatment of acne scars in Fitzpatrick skin types I-IV. | ||
| Performance Data: | IEC 60601-1 Medical Electrical Equipment - Part 1: GeneralRequirements for Safety | |
| IEC 60601-1-2 Medical Electrical Equipment 1-2 GeneralRequirements for basic safety and essential performance | ||
| Steam Sterilization Test Report 673257 | ||
| Software Verification and Validation Testing Report860-7012-SRV |
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Results of Clinical Study:
Two clinical studies were conducted.
One study assessed facial acne scars. In 17 patients who completed the study, a total of 46 acne scars underwent a mean of 6.3 treatments with either the 3mm or 6mm handpiece, each operated with the FOCUS lens array. Before and after photographs were evaluated by three blinded evaluators, who were able to identify correctly the before and after images in 70% of the 17 subiects. The mean improvement score (scale 0-3) was 1.9. The non-blinded treating physician reported a 100% overall satisfaction rate, scoring the improvement in 47% of subjects as "satisfied" and 53% as "extremely satisfied." Subjects reported a satisfaction rate of 87% (53% "satisfied" and 27% "extremely satisfied").
A second study was conducted on normal skin on the arm of 2 subjects and the leg of a 3rd subject to evaluate the tissue response to treatment of the FOCUS lens array. Three patients were treated with the 6mm lens with FOCUS array at 0.71J/cm2 and with the 3mm lens with FOCUS array at 2.83J/cm2. Biopsies were performed in untreated skin and in treated skin immediately post treatment, 7 days post treatment and 15 days post treatment. Treatment induced immediate focal epidermal vacuolization and small foci of degenerated keratinocytes. At days 7 and 15, skin exhibited intact epidermis with mild, superficial dermal lymphocytic infiltrates in peri-vascular pattern.
| TechnicalComparison: | Specifications | ||||
|---|---|---|---|---|---|
| PicoSure™ Workstation(current submission) | PicoSure™ Workstation(previously cleared) | RevLite | |||
| Laser Type | Flashlamp excited Q-switched alexandrite | Flashlamp excited Q-switched alexandrite | Flashlamp excited Q-switched Nd:YAG | ||
| Wavelength | 755nm | 755nm | 532 nm, 585 nm 650 nm, &1064 nm | ||
| Energy per pulse | 0.2 J/cm2 | 0.2 J/cm2 | 0.85 J/cm2 | ||
| Maximum AverageFluence | 6.37 J/cm² | 6.37 J/cm² | 12 J/cm² (1064nm)5 J/cm² (532nm) | ||
| 10 J/cm² (585nm) | |||||
| 6 J/cm²(650 nm) | |||||
| 1.2 J/cm² (532Lite) | |||||
| Repetition Rate | Single pulse, or 1, 2.5, 5,or 10 pulse(s) per second(Hz) | Single pulse, or 1,2,5, or10 pulse(s) per second(Hz) | Single & double pulse, 1, 2,5, & 10 Hz pulses persecond | ||
| Pulse Width | 450ps-900ps | 450ps-900ps | 5-20 ns | ||
| Spot Sizes | Zoom 2-6 mm,Fixed 2, 3, 4, 6, 8, 10 mmWith FOCUS lens array:3mm,6mm | Zoom 2-6 mm,Fixed 2, 3, 4, 6, 8, 10 mm | Fixed 2 - 8 mm (varies bywavelength) |
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Conclusion:
The PicoSure Workstation is substantially equivalent to other existing laser systems in commercial distribution for use in Dermatology and Plastic Surgery.
§ 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.