Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)

• K Number: K230990
• Device Name: Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
• Manufacturer: Candela Corporation
• Date Cleared: 2023-06-01 ( 56 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K183452 , K050673

Intended Use

Vbeam Prima is indicated for the following:
595 nm

• General Surgery:
• Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
• Dermatology/Plastic Surgery:
  o For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars. striae and Psoriasis and the treatment of wrinkles.
• Treatment of Benign Epidermal Pigmented Lesions.
• Treatment of Inflammatory Acne Vulgaris.
• Gynecology:
  o Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
• Podiatry:
  o Treatment of benign cutaneous lesions, such as warts.
• Pediatric Population
  o Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas

1064 nm
The Vbeam Prima laser system is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus lakes, leg veins, and poikiloderma of Civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café-au-lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, peri-ocular and peri-oral wrinkles.

Vbeam Perfecta is indicated for the following:
595 nm

• General Surgery:
• Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
• Dermatology/Plastic Surgery:
  o For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and Psoriasis and the treatment of wrinkles.
• Treatment of Benign Epidermal Pigmented Lesions.
• Treatment of Inflammatory Acne Vulgaris.
• Gynecology:
  o Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
• Podiatry:
  o Treatment of benign cutaneous lesions, such as warts.
• Pediatric Population
  Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas

Device Description

The Candela Vbeam Family of Pulsed Dye Lasers includes both the Vbeam Prima and Vbeam Perfecta Laser Systems.
The Vbeam Prima Laser System has been previously cleared for both port wine stains, and hemangiomas under K183452.
The Vbeam Perfecta (Candela Family of Pulse Laser Systems) has been previously cleared for both port wine stains, and hemangiomas under K050673.
This 510(k) Premarket Notification is to expand the indications for use for the Candela Vbeam Family of Pulsed Dye Lasers for the Vbeam Prima Laser System and Vbeam Perfecta to include the pediatric population for treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas for the 595 nm wavelength. There is no new technology being introduced than what has been previously cleared Vbeam Prima Laser System under its predicate K183452 and Vbeam Perfecta under its predicate K050673.

AI/ML Overview

The provided text from the FDA 510(k) summary (K230990 for Candela Vbeam Family of Pulsed Dye Lasers) does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it details the substantial equivalence determination for an expanded indication (treatment of cutaneous capillary malformations and infantile/congenital hemangiomas in the pediatric population) for devices (Vbeam Prima and Vbeam Perfecta) that were previously cleared.

The 510(k) summary states that:

• There are no new technologies being introduced.
• The device is identical in design, function, and intended use to its previously cleared Vbeam Prima Laser System (K183452) and Vbeam Perfecta (K050673) predicates.
• The expanded indications do not raise any new concerns of safety or effectiveness.

Therefore, the performance data provided relies on:

1. Bench testing: "based on the established testing previously cleared under Vbeam Prima Laser System under its predicate K183452 and Vbeam Perfecta under its predicate K050673. There are no changes in the design therefore the subject Candela Vbeam of Pulsed Dye Lasers is based on the established performance testing of the device's predicates." This implies that prior acceptance criteria for the predicate devices are considered met for the new device due to identical design. No specific quantitative acceptance criteria or results from this bench testing are provided in the document.

2. Clinical Performance: A systematic literature search was conducted to support the expanded pediatric indications. This is not a direct study proving the device meets an acceptance criterion "for the device itself," but rather a review of existing clinical evidence to support the safety and effectiveness of the treatment method (Vbeam 595-nm PDL) for the expanded indications.

Given this, I cannot fill in a table of acceptance criteria and reported device performance directly from this document, as the document explicitly states there are no changes to the device itself and it relies on the predicate's established performance. The "performance data" presented for the new indication is effectively a literature review.

However, I can extract information related to the clinical literature review used to support the new indication:

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

• Acceptance Criteria for Device (Implied): The device (Vbeam Prima and Vbeam Perfecta) must perform identically to its predicate devices, as no design changes were made. The performance is assessed on the safety and effectiveness of the 595-nm PDL for the target conditions based on existing literature. No specific quantitative performance metrics (e.g., laser fluence accuracy, pulse stability) are provided in this summary for the "acceptance criteria" of the device itself for this 510(k) submission, as it relies on the prior clearance of the predicate.
• Reported Device Performance (from literature review): The studies reviewed "support the intended indications for use of the Vbeam 595-nm PDL to treat cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas in the pediatric population." Details on specific outcome measures (e.g., percentage improvement in lesion appearance, adverse event rates) from these studies are not summarized or quantified in this 510(k) document, only that the literature generally supports the use.

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

• Test Set (Literature Review): A total of 33 articles were identified.
  • Total Patients: 7,725
  • Pediatric Patients (Hemangioma): 5,692 (4,782 IH, 910 congenital)
  • Pediatric & Adult Patients (PWS/Capillary Malformation): 1,354 pediatric and 679 pediatric and adult.
• Data Provenance: The studies were conducted globally, specifically listed as from the USA, UK, Europe, and Asia (including China, Japan, Taiwan, India, and the Middle East). The studies included randomized controlled, prospective, open label, evaluator-blinded clinical trials, or retrospective evaluator-blinded studies. The data is retrospective in the sense that it relies on previously published research.

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

• This information is not provided in the 510(k) summary. The ground truth for the efficacy and safety of the treatment would have been established by the methods within each of the 33 individual published studies (e.g., clinical assessment by dermatologists, photographic evaluation, patient-reported outcomes). The 510(k) summary only reviews the conclusions of these studies.

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

• This information is not provided as it's a literature review, not a de novo clinical study with a central adjudication panel. Adjudication methods would vary by individual study.

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 performed or referenced in this document. This submission is for a laser device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a laser device for treatment, not an algorithm.

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

• The ground truth for the effectiveness of the treatment, as drawn from the literature review, is based on clinical outcomes data reported in peer-reviewed articles. This would typically include assessments of lesion clearance/improvement, photographic documentation, and safety outcomes (adverse events). Specific types of ground truth would vary by individual study design (e.g., some studies might use standardized scales for improvement, others might rely on subjective expert assessment).

8. The sample size for the training set:

• Not applicable. This is a laser device, not a machine learning algorithm requiring a "training set." The clinical literature review serves as the evidentiary basis for the expanded indication.

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

• Not applicable. As above, no training set for a machine learning model is involved.

Regulation Number and Section

§ 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.