(125 days)
The PicoWay laser system is indicated for the following at the specified wavelength:
532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-V.
The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240-750 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached Handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a Handpiece. The light-weight and ergonomic Handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System (up to 10 mm). The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the laser beam into the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
Here's an analysis of the acceptance criteria and study detailed in the provided text, formatted as requested:
Acceptance Criteria and Device Performance Study for PicoWay Laser System
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the clinical study. Instead, it reports specific outcomes and compares them to expectations based on predicate devices. I have inferred the implied performance goals based on the reported favorable safety profile and substantial clearance for tattoo removal, aligning with the "perfoRMS as intended" declaration.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Favorable Safety Profile | No device-related serious adverse events. Mild erythema, edema, and pinpoint bleeding observed (anticipated responses). None to moderate discomfort/pain, consistent with predicate. No adverse events in additional Resolve handpiece studies (114 subjects). |
| Substantial Clearance of Blue and Green Tattoos (785nm) | 100% of tattoos correctly identified as pre/post-treatment by 3 blinded reviewers. 83% of blue/green tattoos demonstrated at least 50% clearance compared to baseline after only 2 treatments. Investigator assessment: 83% (15/18) of blue/green tattoos achieved substantial to complete clearance. |
| Equivalent Performance to Predicate Devices (Safety & Efficacy) | Study results did not present any new types of safety questions compared to predicate devices. Histological evaluation shows effects on treated area using picosecond laser energy with Resolve handpieces are equivalent between PicoWay and PicoSure devices. |
| Electrical Safety & EMC Conformance | Conforms to IEC 60601-1, IEC 60601-1-2, IEC 62366, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1. |
| Biocompatibility | Established per ISO 10993 guidelines (based on predicate). |
| Software Verification & Validation | Testing results found acceptable for software release. |
| Bench Testing (Energy Measurements) | Met specifications. |
| Bench Testing (Resolve Handpiece efficacy)* | Clears pigment particles similarly to previously cleared Zoom handpiece. 100 pulses of PicoWay 785nm resulted in greater ink clearance than 200 pulses of another legally marketed device. Achieved ink particle fracturing/de-aggregating pigment particles in a substantially equivalent manner to other systems. |
Note: The bench testing on Resolve handpiece efficacy is an important performance indicator, even if not phrased as a "criterion" in the same way as safety or clinical clearance percentages.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 15 subjects (22 tattoos).
- Data Provenance: The document does not explicitly state the country of origin. It describes the study as a "single arm, self-controlled study," implying it was a prospective clinical trial conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: 3 blinded reviewers.
- Qualifications of Experts: Not specified. The document only states "independent review by 3 blinded reviewers."
4. Adjudication Method for the Test Set
- Method: Not explicitly described as part of an adjudication process in the traditional sense for determining "ground truth." The reviewers "correctly identified the pre and post treatment for all (100%) of the tattoos," suggesting their role was to evaluate the visibility of change rather than to establish a definitive, gold-standard diagnosis or measurement. The percentage clearance was likely based on a subjective rating scale or objective measurement method applied to the images, with the reviewers' agreement confirming the detectability of this change.
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 MRMC study was done. This study evaluated the performance of the device itself (PicoWay Laser System) and not an AI-assisted diagnostic tool or human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a laser system, not an algorithm. The clinical study evaluated the device's efficacy and safety on patients, not its performance as a standalone diagnostic tool.
7. The Type of Ground Truth Used
- For Tattoo Clearance: The "ground truth" for tattoo clearance appears to be a combination of:
- Blinded Expert Assessment: Independent review by 3 blinded reviewers who confirmed identify pre/post-treatment images.
- Quantitative/Semi-Quantitative Clinical Assessment: "At least 50% clearance compared to baseline" (how this was measured isn't detailed, but implies a scoring system).
- Investigator Assessment: "Substantial to complete clearance" assessed by the clinical investigators.
- For Safety: Clinical observation of adverse events and patient discomfort.
- For Technological Equivalence: Histological evaluation.
8. The Sample Size for the Training Set
- Not applicable. The document describes clinical studies conducted to evaluate the device, not to train a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As no training set for an AI/algorithm is discussed, this question is not relevant.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 5, 2016
Syneron Candela Corporation c/o Ms. Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103
Re: K160607
Trade/Device Name: PicoWay Laser 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: May 19, 2016 Received: May 19, 2016
Dear Ms. Hogan:
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
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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/Resourcesfor You/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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510(k) Number (if known)
Device Name
PicoWay Laser System
Indications for Use (Describe)
The PicoWay laser system is indicated for the following at the specified wavelength:
532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-V.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary PicoWay Laser System
| Submitted by: | Syneron Candela Corporation530 Boston Post RoadWayland, MA 01778-1886 |
|---|---|
| Contact Person: | Ruthie AmirGlobal Vice President of Clinical, Regulatory, and EducationTel: 508-358-7400 x330Fax: 508-358-5602 |
| Date prepared: | July 1, 2016 |
| Trade Name: | PicoWay Laser System |
| Common Name: | Dermatology Laser System |
| Classification: | Class IILaser surgical instrument for use in general and plastic surgery and indermatology (21 CFR 878.4810)Product Code GEX |
Predicate and Reference Devices:
Cynosure PicoSure™ workstation (K143105, K140719, K133364, K121346) Predicate Devices: (Primary Predicate); Syneron-Candela's PicoWay Laser System (K153527, K150326, K142372) Syneron Medical Ltd.'s Transcend System (K120510), Candela Corporation's Reference devices: GentleMAX Pro laser system (K140122, K133283, K112715), Candela Corporation's VBeam Laser System (K033461)
Intended Use / Indications for Use:
The PicoWay Laser System is indicated for the following at the specified wavelength:
532nm
Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
785nm
Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
1064nm
Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
The PicoWay Laser System is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
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Description:
The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240-750 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached Handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a Handpiece. The light-weight and ergonomic Handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System (up to 10 mm). The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the laser beam into the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
Technological Characteristics:
The PicoWay Laser System has the same intended use and similar indications for use, technological characteristics and operating principles as the Cynosure PicoSure™ workstation (K143105, K140719, K133364, K121346) and the PicoWay Laser System (K153527, K150326, K142372). The PicoWay design and components are very similar to those of the previously cleared predicates. The primary purpose of this submission is to add an additional 785 nm wavelength. For each of these device systems, the treatment Handpiece is attached to an articulating arm that is connected to the main system console. For each system, the user interface is located at the front/top of the console. For the PicoWay and predicate devices, the laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system with a Handpiece attached to the end. Treatment parameters can be adjusted according to device specifications. Each system thus consists of the articulating arm (and attached Handpiece), as well as an electrically powered system console that houses the software, user interface, and produces the laser energy. The PicoWay provides similar key design aspects, including the same or similar spot sizes, laser wavelengths, pulse width, and laser types, as its predicate devices. The frequency (repetition rate) of the PicoWay System is the same as or within the frequency range of the predicates. Further, each of the devices presents a range of spot sizes to allow the user to choose the most appropriate spot size for each patient. The wavelengths available with the PicoWay are the same as or similar to those presented by the predicates. Therefore, the minor differences do not raise any new types of safety or effectiveness questions because the PicoWay parameters are the same as or within the range of the predicates.
Performance Data:
Electrical Safety and Electromagnetic Compatibility: Electrical safety and electromagnetic compatibility (EMC) testing for the PicoWay Laser System was conducted by an independent test laboratory in accordance with IEC 60601-1, Medical equipment, Part 1: General requirements for basic safety and essential performance and - with IEC 60601-1-2, Collateral Standard: Electromagnetic Compatibility - Requirements and Tests, 3rd ed. The PicoWay System was determined to be in conformance with applicable IEC standards (IEC 62366, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1).
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Biocompatibility: The biocompatibility of the PicoWay device has also been established per ISO 10993 quidelines based on the biocompatibility of the PicoWay predicate.
Software: Software verification and validation testing was conducted and results demonstrated that testing results were found acceptable for software release.
Bench Testing: Testing verified that energy measurements met specifications. Bench testing also demonstrated that the Resolve handpieces of the PicoWay System clear pigment particles in a similar manner compared to the previously cleared Zoom handpiece. Bench testing was also conducted to evaluate the tattoo ink absorption achieved with the 785 nm handpiece of the PicoWay as compared to other legally marketed tattoo and pigmented lesions clearance devices. 100 pulses of PicoWav 785nm treatment resulted in greater ink clearance compared to 200 pulses of another legally marketed device for the treatment of pigmented lesions and tattoos. Clearance results demonstrated that the picosecond laser pulses achieve ink particle fracturing and/or de-aggregrating pigment particles in at least a substantially equivalent manner compared to other laser systems similarly cleared for tattoo clearance.
Clinical Data: Several prospective studies have been conducted to evaluate the PicoWay System, and results consistently demonstrate the favorable safety and performance profiles of the PicoWay System for its indicated uses. In support of the proposed additional wavelength in this 510(k), a single arm, self-controlled study was conducted to evaluate the safety of the PicoWay System for the previously cleared indication of tattoo removal. The clinical evaluation of 15 subjects (22 tattoos) after up to 2 treatments demonstrated that the PicoWay performs as intended and presents a favorable safety profile when used with the 785 nm wavelength. Treatments were administered following enrollment, completion of screening and obtaining informed consent from each subject. Each treatment session was 11±5 weeks) apart. Study results were evaluated at the post treatment 2 visit (10-16 weeks after the first treatment). The maiority of subjects were female. Caucasian, with a mean age of 36 years. Clinical data were available from a large majority of the treated tattoos through the third visit (post second treatment). Subjects were treated using 2-4 mm spot sizes at pulse repetition rates up to 5 Hz. Treatment with the PicoWay device using the added wavelength achieved substantial clearance of blue and green tattoos. Based on independent review by 3 blinded reviewers, the reviewers correctly identified the pre and post treatment for all (100%) of the tattoos. In addition, 83% of the blue/green tattoos demonstrated at least 50% clearance compared to baseline after only 2 treatments. In addition, investigator assessments of tattoo clearance also demonstrated that substantial to complete clearance was achieved with the PicoWay when using the added 785 nm wavelength in 83% (15/18) of the blue/green tattoos.
PicoWay treatment also demonstrated a positive safety profile, with no device related serious adverse events. Mild erythema, edema, and pinpoint bleeding following treatments were observed and considered to be anticipated responses. Treatments resulted in none to moderate discomfort/pain, consistent with the results observed with the PicoWay predicate. Therefore, the study results did not present any new types of safety questions as compared to the predicate devices.
Additional data from two separate clinical investigations of the face, an additional histology evaluation, and bench testing demonstrated the safety of the Resolve handpieces. The clinical studies together provide safety data from 114 subjects, and the investigations included both wavelengths of the Resolve handpieces (1064 nm, 532 nm). In both of the clinical studies providing
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additional safety data, there were no adverse events following PicoWay treatment throughout the course of the study and anticipated treatment-associated responses were all transient and resolved.
Histological evaluation of 19 treated areas from 9 subjects demonstrated that the effects on the treated area using picosecond laser energy using the Resolve handpieces are equivalent between the PicoWay and PicoSure devices.
Based on the clinical data, the PicoWay System with the added wavelength and Resolve handpieces performs as intended with a positive safety profile. Results were similar to the predicate devices, and further support substantial equivalence. All performance testing demonstrated that the PicoWay Laser System performs according to specifications and functions as intended.
Summary of Substantial Equivalence:
The PicoWay and the predicate devices have the same intended use with similar indications for use. The PicoWay Laser System presents the same or similar technological characteristics as its predicate devices, including the laser type, wavelengths, device design, pulse width, frequency, spot sizes and system components. Any minor differences do not present any new types of safety or effectiveness questions since the PicoWay parameters are similar to or within the range of the predicates. - Further, PicoWay performance has been demonstrated in clinical and non-clinical investigations, and results confirm the safety and performance of the device. The PicoWay device and its predicates all operate with the same mechanism of action based on selective photothermolysis of pigment particles using laser energy. Therefore, the PicoWay has the same intended use and similar indications for use, technological characteristics, and principles of operation as the predicate devices. The PicoWay is substantially equivalent to the predicate devices.
Conclusions:
Testing of the PicoWay device demonstrated that the device performs as intended with a favorable safety profile. Results in the clinical studies were similar to those reported for the predicate device, in support of substantial equivalence. The non-clinical data further support the device, and software verification and validation testing demonstrates that the PicoWay device is expected to perform as intended. The PicoWay System is substantially equivalent to the predicate devices.
§ 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.