LogoFDA 510(k) Search
K Number
K150997
Device Name
RUBY STAR
Manufacturer
BISON MEDICAL CO., LTD
Date Cleared
2015-12-22

(251 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
K990902
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

RUBY STAR Laser Q -switched 694mm Ruby laser system is indicated for cutting, vaporization, and ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.

Device Description

RUBY STAR Q-switched laser system are emitting a beam of coherent light at 694nm with 25-30ns Pulse width, and 0.1 - 200j/cm2 Energy fluence via 7-Articulated arm and consist of

    • An articulated arm delivery systems terminated in a hand piece.
    • Electronic power supply and interface circuitry
    • Optical chamber with laser rod and cavity optics with cooling system.
    • LCD color touch screen with foot pedal switch.
      Laser energy produced is delivered to the Tissue by means of an articulated arm.
      The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch.
AI/ML Overview

The provided document is an FDA 510(k) summary for the "RUBY STAR" laser system. Unfortunately, it states that "Clinical and Non-Clinical performance test data was not provided in this submission."

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria. The document explicitly mentions the absence of such data in point 6, "Performance test."

However, I can extract other relevant information from the document:

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

  • Acceptance Criteria: Not explicitly stated as performance metrics in the document. The submission relies on substantial equivalence to a predicate device and compliance with general safety standards.
  • Reported Device Performance: No clinical or non-clinical performance test data was provided in the submission. The device is described as emitting a beam of coherent light at 694nm with 25-30ns Pulse width, and 0.1 - 200j/cm2 Energy fluence. These are technical specifications, not performance outcomes against acceptance criteria.

2. Sample sized used for the test set and the data provenance:

  • Sample Size: Not applicable, as no performance test data was provided.
  • Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable, as no performance test data was provided.

4. Adjudication method for the test set:

  • Not applicable, as no performance test data was provided.

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, as no performance test data was provided. The device is a laser system, not an AI-assisted diagnostic tool.

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

  • No standalone performance study was done, as no performance test data was provided. The device is a laser system, not an algorithm.

7. The type of ground truth used:

  • Not applicable, as no performance test data was provided.

8. The sample size for the training set:

  • Not applicable, as no performance test data was provided and the device is not an AI/machine learning model that typically requires a training set.

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

  • Not applicable.

Additional information from the document:

  • Predicate Device: K990902 MLT R694 Medical laser Technologies. The submission claims substantial equivalence based on characteristics such as Design, Construction, Energy, Repetition rate, Cooling System, and Intended use of wave length 694nm.
  • Standards Complied With: The device was manufactured in accordance with IEC60601-1 (general requirements for basic safety and essential performance), IEC60601-1-2 (EMC test), IEC60601-2-22 (particular requirements for safety of diagnostic and therapeutic laser), and IEC60825-1 (equipment classification and requirement). This indicates compliance with safety and electrical standards, not necessarily clinical performance.
  • Intended Use: Cutting, Vaporization, Ablation of Soft Tissue, including Tattoo Removal and treatment of Benign Pigmented Lesions.

§ 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.