(91 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 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), 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, 7-11 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's acceptance criteria and the study proving it meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety and EMC | Compliance with recognized standards: | The device passed the required testing and is in full compliance with the following standards: |
| - IEC 60825-1 | - IEC 60825-1: Safety of Laser Products – Part 1: Equipment classification and requirements | |
| - IEC 60601-1-2 | - IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for safety - collateral standard: electromagnetic compatibility (EMC)requirements and test | |
| - IEC 60601-1 | - IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance | |
| - IEC 60601-2-22 | - IEC 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | |
| Biocompatibility | Established based on predicate devices and ISO standards. | Biocompatibility was established based on predicate devices and the results of ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) series of testing. |
| Software Verification & Validation | Acceptable for software release according to FDA guidance. | Software verification and validation testing was conducted, and the results demonstrated that testing results were found acceptable for software release. Software testing was performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." |
| Bench Testing (Cooling Performance) | DCD handpiece and Evercool handpiece produce similar cooling results. | A bench study was conducted to confirm that the DCD handpiece and Evercool handpiece can produce similar cooling results. (The document does not provide specific performance metrics, but states "confirm that the DCD handpiece and Evercool handpiece can produce similar cooling results," implying the criterion was met.) |
| Clinical Testing | Not needed due to similarity to predicate devices. | Based on the similarities of the device specifications, intended use, and indications for use between the Vbeam Prima Laser System and its predicate devices, no clinical studies were needed to support this 510(k) Premarket Notification. The safety and effectiveness are established by substantial equivalence to previously cleared devices. |
2. Sample Size Used for the Test Set and Data Provenance
Since no clinical studies were conducted for the Vbeam Prima Laser System due to its substantial equivalence to predicate devices, there isn't a "test set" in the traditional sense for clinical performance.
- Electrical Safety and EMC: Testing was conducted on the device itself (Epic Pro 940, implicitly the Vbeam Prima or a prototype). This involved laboratory testing, not human subjects or patient data.
- Biocompatibility: Testing was on materials of the device, according to ISO 10993 standards. This is laboratory testing.
- Software Verification & Validation: Testing was on the software of the device. This is internal software testing.
- Bench Testing (Cooling Performance): Testing was on the DCD and Evercool handpieces. This is laboratory testing.
Therefore, there is no human subject data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as no clinical studies were performed. The "ground truth" for the device's safety and effectiveness was established by its compliance with recognized standards and its technological similarity to legally marketed predicate devices, which had previously demonstrated safety and effectiveness through their own studies and clinical use.
4. Adjudication Method for the Test Set
Not applicable, as no clinical studies were performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as no clinical studies were performed. The Vbeam Prima Laser System is a physical medical device (laser system), not an AI algorithm that assists human readers.
6. Standalone (Algorithm Only) Performance
Not applicable, as the Vbeam Prima Laser System is a physical medical device, not an AI algorithm. Its performance is evaluated through engineering and biocompatibility testing, not AI algorithm standalone performance.
7. Type of Ground Truth Used
The "ground truth" for the Vbeam Prima Laser System's safety and effectiveness relies on:
- Compliance with recognized international standards for electrical safety, electromagnetic compatibility, and biocompatibility.
- Demonstrated equivalence of technological characteristics and intended use to predicate devices that have an established history of safe and effective use.
8. Sample Size for the Training Set
Not applicable, as this is a physical medical device, not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is a physical medical device, not an AI 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.