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K Number
K171079
Device Name
Q-Switched Nd:YAG Laser System
Manufacturer
IDS, Ltd.
Date Cleared
2017-08-01

(112 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Q10 Q-Switched Nd: YAG Laser System is indicated for incision, ablation and vaporization of soft tissue for general dermatology.

1064nm wavelength in Q-switched mode:

  • Removal of dark ink (black, blue and brown) tattoos
  • Treatment of nevus of Ota
  • Treatment of common nevus
  • Removal or lightening of unwanted hair
  • Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064nm wavelength in non Q-switched mode:

  • Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9, and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin
  • Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins
  • Coagulation and hemostasis of soft tissue
  • Treatment of wrinkles
  • Treatment of mild to moderate inflammatory acne vulgaris

532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650mm with the optional 585nm and 650nm dye hand-piece):

  • Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
  • Treatment of vascular lesions including, but not limited to:
  • port wine birthmarks
  • telangiectasias
  • spider angioma
  • cherry angioma
  • spider nevus
  • Treatment of pigmented lesions including, but not limited to:
  • café-au-lait birthmarks
  • solar lentigines
  • senile lentigines
  • Becker's nevus
  • freckles
  • common nevus
  • nevus spilus
  • Treatment of seborrheic keratosis
  • Treatment of post inflammatory hyperpigmentation
  • Skin resurfacing procedures for the treatment of acne scars and wrinkles
Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a laser surgical instrument, and as such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for a novel AI or diagnostic device. Therefore, a direct response to your detailed questions regarding acceptance criteria and study design (as might be found for a new diagnostic algorithm) is not present in the provided document.

However, I can extract the relevant information from the document and explain why other requested details are not applicable here.

Here's a breakdown based on the provided text:

Pertaining to the Device:

  • Trade/Device Name: Q-Switched Nd:YAG Laser System / IDS Model Q10 Q-Switched Nd: YAG Laser
  • 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

Analysis of your specific questions:

  1. A table of acceptance criteria and the reported device performance:

    • Not Applicable. This document is a 510(k) summary, which establishes substantial equivalence, not novel performance against specific acceptance criteria for a new diagnostic device. The device is a physical laser system, not an AI or diagnostic tool that would have performance metrics like sensitivity, specificity, or AUC against a ground truth. Its performance is inherent in its physical specifications and intended use, which are deemed equivalent to a predicate. The "Indications for Use" section outlines what the device is cleared to do, not its diagnostic performance.

  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • Not Applicable. As this is a 510(k) for a physical laser device, it doesn't typically involve a "test set" in the context of evaluating an AI or diagnostic algorithm. Clinical data to support the indications may have been generated, but the specific details of a test set, its size, and provenance are not outlined in this 510(k) clearance letter. The FDA's review for substantial equivalence generally focuses on technological characteristics, safety, and effectiveness compared to a predicate, which might include relying on established literature or predicate device's safety record rather than a new clinical study with a "test set" for performance evaluation.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

    • Not Applicable. There is no "ground truth" establishment in the context of evaluating a diagnostic algorithm mentioned. The effectiveness of the laser for its stated indications (e.g., "removal of dark ink tattoos," "treatment of wrinkles") is generally supported by the predicate device's history and the understanding of laser-tissue interaction for these applications.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not Applicable. No test set requiring expert adjudication is discussed in this document.

  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:

    • Not Applicable. This is a physical laser device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant here.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not Applicable. This device is not an algorithm.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Not Applicable. As explained, the concept of "ground truth" as applied to evaluating a diagnostic algorithm doesn't apply to this type of device and submission. Efficacy is generally demonstrated by clinical observations and comparisons to predicate devices over time, rather than a single "ground truth" metric.

  8. The sample size for the training set:

    • Not Applicable. Training sets are relevant for machine learning algorithms, which this device is not.

  9. How the ground truth for the training set was established:

    • Not Applicable. This device does not have a training set or associated ground truth.

In summary, the provided document is a 510(k) clearance letter for a Q-Switched Nd:YAG Laser System, indicating that the FDA has determined it is substantially equivalent to legally marketed predicate devices. The nature of this submission (a physical device, not a diagnostic or AI product) means that the requested details regarding acceptance criteria, test/training sets, ground truth, and expert evaluations in the context of diagnostic performance are not applicable or provided within this type of regulatory document.

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Image /page/0/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, arranged in a way that they resemble a bird in flight. The profiles are depicted in a simple, line-art style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 1, 2017

IDS, Ltd. % Alexander Henderson Official Correspondent, IDS BraunSolutions 970 South Dawson Way Unit 14 Aurora, Colorado 80012-3827

Re: K171079

Trade/Device Name: Q-Switched Nd:YAG 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 2, 2017 Received: May 5, 2017

Dear Alexander Henderson:

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

{1}------------------------------------------------

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 devicerelated 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,

Jennifer R. Stevenson -S3

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) K171079

Device Name

IDS Model Q10 Q-Switched Nd: YAG Laser

Indications for Use (Describe)

The Q10 Q-Switched Nd: YAG Laser System is indicated for incision, ablation and vaporization of soft tissue for general dermatology.

1064nm wavelength in Q-switched mode:

  • Removal of dark ink (black, blue and brown) tattoos
  • Treatment of nevus of Ota
  • Treatment of common nevus
  • Removal or lightening of unwanted hair
  • Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064nm wavelength in non Q-switched mode:

  • Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9, and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin

  • Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains,

hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins

  • Coagulation and hemostasis of soft tissue
  • Treatment of wrinkles
  • Treatment of mild to moderate inflammatory acne vulgaris

532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650mm with the optional 585nm and 650nm dye hand-piece):

  • Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
  • Treatment of vascular lesions including, but not limited to:
  • port wine birthmarks
  • telangiectasias
  • spider angioma
  • cherry angioma
  • spider nevus
  • Treatment of pigmented lesions including, but not limited to:
  • café-au-lait birthmarks
  • solar lentigines
  • senile lentigines
  • Becker's nevus
  • freckles
  • common nevus
  • nevus spilus
  • Treatment of seborrheic keratosis
  • Treatment of post inflammatory hyperpigmentation
  • Skin resurfacing procedures for the treatment of acne scars and wrinkles

{3}------------------------------------------------

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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§ 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.