(116 days)
The handPICO® Fraction Laser Handpiece Tip, when used with the Etherea-MX and Zye lasers at 1064 nm in picosecond mode, is indicated for:
· Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
· Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
- · Treatment of acne scars in Fitzpatrick Skin Types II-V.
· Treatment of wrinkles in Fitzpatrick Skin Types I-IV.
This 510(k) adds the handPICO® Fractional Laser Handpiece Tip, which is specifically designed for the ETHEREA MX and ZYE® LASERs manufactured by Vydence Medical Inc. The handPICO Fractional Handpiece Tip is a fractional optical element micro lens array that attaches to the handpiece. The producing 280 microbeams/cm2 and a total of 100 microbeams spaced 600 µm apart.
The provided text does not contain information about specific acceptance criteria, reported device performance metrics (numerical values for sensitivity, specificity, accuracy, etc.), or the details of a study that proves the device meets these criteria in the context of an AI/ML-driven medical device.
The document describes a 510(k) premarket notification for a HandPICO Fractional Laser Handpiece Tip, which is a hardware device, not an AI/ML software. The "Software verification and validation testing" mentioned refers to the software embedded within the medical device itself, likely for controlling the laser operation, and not a separate AI/ML component for analysis or diagnosis.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML study.
The document focuses on demonstrating substantial equivalence of the laser handpiece tip to predicate devices based on:
- Indications for Use Comparison: Showing similar indications for tattoo removal, benign pigmented lesion treatment, acne scar treatment, and wrinkle treatment.
- Technological Characteristics Comparison: Comparing aspects like laser source, wavelength, pulse width, repetition rate, spot size, and fluence, and explaining the clinical acceptability of minor differences.
- Clinical Testing Summary: A histological analysis on human participants to assess tissue changes and resolution.
- Non-Clinical Testing: Compliance with various electrical, safety, and risk management standards (e.g., IEC 60601-1, ISO 14971).
- Biocompatibility Testing: Ensuring materials in contact with patients are safe (Cytotoxicity, Sensitization, Irritation reactivity tests).
- Software Verification and Validation: For the embedded software controlling the device.
If this was an AI/ML device, the FDA submission would typically include a detailed clinical validation study with quantitative performance metrics (e.g., AUC, sensitivity, specificity) and a clear description of the ground truth generation process. This information is absent here.
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December 20, 2024
Vydence Medical Antonio Olivatto Executive Vice President, Global, Vydence Medical Rua Aldo Germano Klein, 359. CEAT Sao Carlos, SP 13573-470 Brazil
Re: K242534
Trade/Device Name: HandPICO Fractional Laser Handpiece Tip 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: August 1, 2024 Received: August 26, 2024
Dear Antonio Olivatto:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/3 description: The image shows a digital signature from "YAN FU-S". The signature includes the date and time of signing, which is December 20, 2024, at 18:53:33. The time zone offset is -05'00'. The signature indicates that the document or file has been digitally signed by YAN FU-S, ensuring its authenticity and integrity.
for Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242534
Device Name handPICO® Fraction Laser Handpiece Tip
Indications for Use (Describe)
The handPICO® Fraction Laser Handpiece Tip, when used with the Etherea-MX and Zye lasers at 1064 nm in picosecond mode, is indicated for:
· Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
· Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
- · Treatment of acne scars in Fitzpatrick Skin Types II-V.
· Treatment of wrinkles in Fitzpatrick Skin Types I-IV.
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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K242534
510(k) Summary - K242534 Preparation date: 12 December 2024
Submitter and Owner:
Vydence Medical Rua Aldo Germano Klein, 359. CEAT Sao Carlos, Brazil, 13573-470
Official Correspondent:
Jamie Owsiany, Director of Clinical Operations Hoy and Associates Regulatory Consulting Phone: 706-399-1304 Email: jamieowsiany@hoyregulatory.com
Submission Type: Traditional 510(k)
Proprietary Name: handPICO® Fractional Handpiece Tip
Device Classification Information:
Classification Name: Laser Surgical Instrument for Use in General and& Plastic Surgery and in Dermatology Regulation Number: 878.4810 Product Code: GEX Device Class: II
Primary Predicate: K191842 Quanta Discovery Pico Secondary Predicate: K191685 PicoWay Laser system with Resolve handpiece
Device Description:
This 510(k) adds the handPICO® Fractional Laser Handpiece Tip, which is specifically designed for the ETHEREA MX and ZYE® LASERs manufactured by Vydence Medical Inc. The handPICO Fractional Handpiece Tip is a fractional optical element micro lens array that attaches to the handpiece. The producing 280 microbeams/cm2 and a total of 100 microbeams spaced 600 µm apart.
Indications/Intended use:
The handPICO® Fractional Laser Handpiece Tip, when used with the Etherea-MX and Zye lasers at 1064 nm in picosecond mode, is indicated for:
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• Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
- Treatment of acne scars in Fitzpatrick Skin Types II-V.
- Treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Indications for Use Comparison:
| Subject device | Primary Predicate | Secondary Predicate | Comparison |
|---|---|---|---|
| Vydence handPICO®Fractional LaserHandpiece TipK242534 | Discovery Pico(Quanta)K191842 | PicoWay (Candela)K191685 | |
| Removal of tattoos onall skin types(Fitzpatrick skin types I-VI) with the followingtattoo colors: black, brown, green, blue andpurple. | Removal of tattoos forall skin types(Fitzpatrick skin types I-VI) to treat thefollowing tattoo colors: black, brown, green,blue and purple | Removal of tattoos forall skin types(Fitzpatrick I-VI)to treat the followingtattoo colors: black,brown, green,blue and purple. | The handPICO®Fractional LaserHandpiece Tip and theDiscovery Pico andCandela PicoWay havethe same indicationsfor use. |
| Treatment of benignpigmented lesions onFitzpatrick skin types I-IV. | Benign pigmentedlesions removal forFitzpatrick skin types I-IV. | Benign pigmentedlesions removal forFitzpatrick Skin Types I-IV. | |
| Treatment of acnescars in Fitzpatrick SkinTypes II-V. | With fractionalhandpiece, indicatedfor the treatment ofacne scars in FitzpatrickSkin Types II-V. | Treatment of acnescars in Fitzpatrick SkinTypes II-V | |
| Treatment of wrinklesin Fitzpatrick Skin TypesI-IV. | With fractionalhandpiece, indicatedfor treatment ofwrinkles in FitzpatrickSkin Types I-IV |
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| SUBJECT | PRIMARY PREDICATE | SECONDARYPREDICATE | Same/Different | |
|---|---|---|---|---|
| MANUFACTURER | Vydence Medical | Quanta | Candela | N/A |
| DEVICE MODEL | HandPICO®Fractional LaserHandpiece Tip forthe Vydence LaserFamily | PicoWay laser systemwith the ResolvehandpieceDiscovery Pico | Picoway LaserSystem with theResolve handpiece | N/A |
| 510K | This submission | K191842 | K191685 | N/A |
| CLASSIFICATION | Class II | Class II | Class II | Same |
| LASER SOURCE | Q-Switched Nd:YAG | Q-Switched Nd:YAG | Q-Switched Nd:YAG | Same |
| WAVELENGTH | 1064nm | 1064nm | 1064nm | Same |
| PULSE WIDTH | 530 ps | 450ps | 450ps | Similar; seediscussionbelow |
| REPETITION RATE(MAX) | Single pulse to 10Hz | Single pulse to 10 Hz | Up to10 Hz | Same |
| SPOT SIZE | 6x6 mm | 8mm DF and 9mmHC Fractional Round | 6x6 mm | Similar |
| FLUENCE (MAX) | 3.0 mJ/microbeam | 5.73mJ/microbeam | 2.9 mJ/microbeam | Different - seediscussionbelow |
Technological characteristics comparison:
The maximum fluence for the handPICO® fractional laser handpiece tip is 3.0 ml/microbeam, for the primary predicate is 5.73 mJ/microbeam, and for the secondary predicate is 2.9 mJ/microbeam. The fluence of the handPICO® fractional laser handpiece tip is within the range of the primary predicate and reference predicate.
The beam diameter for the handPICO® fractional laser handpiece tip is 151 mm, for the Picoway is 150 mm and for the Quanta discovery is 200 mm. The beam diameter for the handPico is within the range of the primary and reference predicates. The microbeam spacing (600 mm) for the handPico is the same as Picoway.
The pulse duration of the handPico® fractional laser handpiece tip is 530 ps, the Picoway is 450 ps and the Quanta is 450 ps. This difference of 80 ps is considered to be acceptable.
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K242534
Clinical Testing Summary:
A histological analysis was performed after treatment with the handPico® fractional laser handpiece tip. The purpose of the study was to assess histological changes after treatment at 1-, 2-, and 3 mJ at Day 0, Day 3, Day 7, Day 14, and Day 21 after treatment. Four participants were treated with the device at the stated timepoints prior to abdominoplasty.
No serious adverse events occurred and the observed histological changes resolved within three weeks of treatment.
Non Clinical Testing:
The following performance data was provided in support of the substantial equivalence determination: IEC 60601-1 Ed. 3.0 (2005) +AMD. 1 (2012) Medical electrical equipment - Part 1: General requirements for safety and essential performance
IEC 60601-1-2 Ed. 4.0 (2014) Medical electrical equipment – Part 1-2 General requirements for safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-2-22:2007 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
ISO 14971 Medical Devices - Applications of Risk Management To Medical Devices Software verification and validation testing was conducted and documentation provided as recommended by the FDA's "Guidance for the Content of Premarket Submissions Contained in Medical Devices.
Statement of Substantial Equivalence:
Vydence Medical has demonstrated that the handPICO Fractional handpiece has the same device classification, same intended use and basic technological characteristics as the predicate device.
Biocompatibility: Compliance to ISO-10993 Standard
An analysis of the biocompatibility of the materials of the Vydence laser family that have potential, or expected patient contact during use was conducted in accordance with and met the biocompatibility testing requirements per the flowchart included in FDA guidance document entitled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" effective as of September 14th, 2016.
Materials with Potential of Patient Contact
The only components with patient contact are those located at the hand piece tips where the tip of the hand pieces (or the standoffs) are placed in direct contact with the patient skin to deliver laser/light energy during the treatment. These components are sapphire crystals, aluminum 6351, and acetal.
The following biocompatibility tests were performed:
- Cytotoxicity
- Sensitization
- Irritation reactivity
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Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Conclusions Safety and Effectiveness:
The handPICO® Fractional Laser Handpiece Tip, when used with the handPICO handpiece and the Etherea MX and Zye Laser platforms, is as safe and effective as the predicate devices. The handPICO® has the same intended use and indications, similar technological characteristics, and same principle of operation as its predicate devices. Thus, the handPICO® Fractional Laser Handpiece Tip is substantially equivalent to its predicate.
§ 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.