(50 days)
1,064nm:
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, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
595 nm:
General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangioma, spider angioma, poikiloderma of civatte, and benign cutaneous lesions, such as warts, scars, striae, psoriasis and the treatment of benign epidermal pigmented lesions. Treatment of inflammatory acne vulgaris.
Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
Podiatry: Treatment of benign cutaneous lesions, such as warts.
The Vbeam Prima Laser system is designed as a transportable device that delivers laser energy at wavelengths of 595 nm (pulse-dye) or 1064 nm (Nd: YAG). The device is comprised of a main console, power supply, controlled electronics, firmware, software, cooling system, and handpieces. There is also an internal calibration port with an internal meter located in the system. The handpiece offers a set of distance gauges available in the following spot ranges: 3-7 mm, 11-15 mm, and 3 X 10 mm. The user selects treatment settings, such as fluence, number of pulses, and spot size selection via a color touch screen. The handpiece incorporates a Dynamic Cooling Device (DCD) into its handpiece that is designed to cool the skin surface during treatment, which consists of an electrically controlled spray nozzle, cryogen reservoir canister and an electronic control circuitry. The Vbeam Prima Laser System also offers an optional EverCool Delivery System Handpiece for skin cooling during treatment.
The Vbeam Prima Laser System (K183452) is a laser surgical instrument. As stated in section 9, "no clinical studies were needed to support this 510(k) Premarket Notification." Therefore, no specific acceptance criteria or "study that proves the device meets the acceptance criteria" in terms of clinical performance are provided in the document.
The document focuses on demonstrating substantial equivalence to predicate devices (Candela Vbeam Prima Laser System (K180593) and Candela GentleMAX Family of Pulse Dye Laser Systems (K140122)) through non-clinical performance data.
Here's a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since no clinical acceptance criteria or performance metrics were reported for this specific 510(k), this table cannot be populated as requested. The document emphasizes equivalence to predicate devices based on:
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Electrical Safety Standards Adherence: | |
| IEC 60825-1 | Compliant |
| IEC 60601-1-2 | Compliant |
| IEC 60601-1 | Compliant |
| IEC 60601-2-22 | Compliant |
| Biocompatibility: | Established based on predicate devices and ISO 10993-5 and ISO 10993-10 testing results. |
| Software Verification & Validation: | Testing results found acceptable for software release, performed per FDA guidance. |
| Technological Characteristics Similarity: | Same design, operating principles, intended use, calibration port, wavelengths, laser medium, delivery systems, cooling system, user display screen as predicate (K180593), with changes to power supply, electronics, firmware, and software. |
| Operating Principles Similarity: | Same repetition rate, range of spot sizes as predicate. |
| Minor Differences in Parameters: | Input voltage, pulse duration, and pulse energy are similar to predicates and do not raise new safety or effectiveness questions. |
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 no clinical human subject test set was used for this 510(k) submission. Performance data primarily comes from engineering and software testing.
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, as no clinical human subject test set requiring expert ground truth assessment was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical human subject test set was conducted.
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, as the device is a laser system, not an AI diagnostic tool, and no clinical studies, including MRMC studies, were performed for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies with a defined ground truth were provided in this 510(k). The "ground truth" for the non-clinical performance data would be adherence to established engineering and software standards.
8. The sample size for the training set
Not applicable, as no machine learning algorithm was evaluated, and therefore no training set was used.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.