(8 days)
The Q-Switched Nd: YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Caf6-Au-Lait Treatment of Seborrheic Keratoses Treatment of Post Inflammatory Hyper-Pigmentation Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi Skin resurfacing procedures for the treatment of acne scars and wrinkles
The Q-Switched Nd: YAG Laser System is a new device for 510(k) submission and shares the same indications for use and safety compliance, similar design features and functional features with the predicate device.
The Q-Switched Nd:YAG Laser System (GlobalCure-SC6) delivers laser at two wavelengths of 1064nm and 532nm. The double wavelengths cause maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target. to minimize heat transfer to surrounding tissues.
The Q-Switched Nd:YAG Laser System covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Q-Switched Nd:YAG Laser System:
Based on the provided 510(k) summary, the device is a Q-Switched Nd:YAG Laser System. The submission is for a medical device and therefore the acceptance criteria are not clinical performance metrics but rather compliance with design specifications and regulatory standards.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards and Regulations) | Reported Device Performance |
|---|---|---|
| Safety and Performance | - IEC 60825-1: 2007 (Safety of laser products - Part 1: Equipment classification, requirements and user's guide) |
- IEC 60601-2-22:1995 (Medical Electrical Equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)
- IEC 60601-1:1988+A1:1991+A2:1995 (Medical Electrical Equipment - Part 1: General requirements for safety) | "Laboratory testing was conducted to validate and verify that the proposed device Q-Switched Nd: YAG Laser System (GlobalCure-SC6) met all design specifications and was substantially equivalent to the predicate device."
The submission asserts that the device is designed, tested and will be manufactured in accordance with these standards, implying it meets them. |
| Electromagnetic Compatibility (EMC) | - IEC60601-1-2:2001+A1:2004 (Medical Electrical Equipment - Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility -Requirements and tests) | "The devices also comply with European Medical Directive 93/42/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products), Part 820 - Quality System Regulation, and have passed ISO9001 and ISO13485 System Certification." |
| Regulatory Compliance | - European Medical Device Directive 93/42/EEC - US Federal Performance Standards 21 CFR 1002.10 (including 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products)
- 21 CFR Part 820 (Quality System Regulation)
- ISO9001 and ISO13485 System Certification | The document explicitly states: "The devices also comply with European Medical Directive 93/42/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products), Part 820 - Quality System Regulation, and have passed ISO9001 and ISO13485 System Certification." |
| Substantial Equivalence | Demonstrating substantial equivalence to the predicate device (Spectra VRMII, K073436) in terms of indications for use, safety, design, and functional features. | "The Q-Switched Nd: YAG Laser System shares the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device, Spectra VRMII (O-Switched Nd:YAG) (K073436)."
"In addition, a review of the predicate device demonstrates that the O-Switched Laser System is safe and effective as the predicate device as they share equivalent wavelengths, and are used to perform the same indicated surgical procedures. Therefore the proposed device is substantially equivalent (SE) to the predicate device." |
Study Information
-
Sample size used for the test set and the data provenance:
- The provided text does not mention any clinical test set involving human subjects or data. The testing discussed is non-clinical laboratory testing to verify design specifications and compliance with standards.
- The "data provenance" mentioned is compliance with international standards (IEC) and national regulations (US FDA, EU MDD).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as there is no clinical test set described in the provided document. The "ground truth" for this submission focuses on engineering specifications and regulatory compliance.
-
Adjudication method for the test set:
- This information is not applicable as there is no clinical test set described.
-
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, an MRMC comparative effectiveness study was not done. This document describes a laser system, not an AI-assisted diagnostic device, and therefore this type of study is not relevant to this submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a physical laser system, not an algorithm. The "standalone performance" refers to the device's ability to meet its technical specifications and regulatory requirements.
-
The type of ground truth used:
- For this 510(k) submission, the "ground truth" is defined by established engineering design specifications, international performance and safety standards (e.g., IEC standards), and national/regional medical device regulations (e.g., 21 CFR, MDD). The device's performance against these specifications and standards constitutes the "ground truth" for its safety and effectiveness determination via substantial equivalence.
-
The sample size for the training set:
- This information is not applicable as there is no discussion of a training set for an algorithm. The device is a physical laser system.
-
How the ground truth for the training set was established:
- This information is not applicable as there is no discussion of a training set for an algorithm.
§ 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.