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510(k) Data Aggregation
(212 days)
eCO2 3D
The eCO2 3D Laser System with fractional handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
The eCO2 3D Laser System using the non-fractional handpieces (F100, F50, Zoom, and 500 micron tip) is also indicated for use in skin resurfacing and surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, and podiatry.
Dermatology & Plastic Surgery:
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- Laser skin resurfacing
- Treatment of wrinkles, rhytids and furrows
- Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.
Dermatology, Plastic Surgery & General Surgery: Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.
Podiatry:
Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares.
The eCO2 3D Laser System consists of a self-contained console, with a 10.6μm wavelength delivered through an articulated arm. The emitted laser beam is then irradiated to the treatment area through a handpiece and a tip connected to the handpiece.
The eCO2 3D is used by a trained physician for procedures requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue.
The eCO2 3D Laser System utilizes an articulated arm to generate a laser beam with a wavelength of 10.6μm by applying patented chaos scanning technology. It radiates a micro-laser beam with an aiming beam of 520nm to the surgical area. Micro laser beams are radiated onto the treatment area, generating MAC (Micro Ablative Column), which improves the skin condition as it recovers. By changing the handpiece according to various application areas, the user can change the beam spot size to optimize the treatment effect. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece tip.
The system console is the heart of the eCO2 3D Laser System and contains the Touch LCD, handpieces, system control module, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the Touch LCD. There are 4 casters in the console base that can be used when moving the system.
This FDA 510(k) clearance letter pertains to the eCO2 3D Laser System, an ablative laser, not an AI/Software as a Medical Device (SaMD). Therefore, the typical acceptance criteria and study designs associated with AI/SaMDs (such as sensitivity, specificity, MRMC studies, ground truth establishment, etc.) are not applicable to this document.
The document describes the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence, as is standard for a 510(k) submission for a physical medical device. It explicitly states: "No clinical tests were performed for this submission." This means there is no data provided within this document regarding device performance against typical AI/SaMD acceptance criteria.
However, I can extract the information that is relevant to the device's clearance and structure it to address your request as best as possible within the limitations of the provided text.
Analysis of the Provided Document for Acceptance Criteria and Study Proof:
The eCO2 3D Laser System is a physical medical device (laser system) for dermatological and surgical procedures. The 510(k) clearance process for such a device primarily relies on demonstrating substantial equivalence to predicate devices through technical characteristics, safety standards compliance, and intended use alignment, rather than performance metrics on a 'test set' as would be seen for an AI diagnostic algorithm.
Therefore, many of the requested categories (related to AI performance metrics, test sets, ground truth, and human reader studies) are explicitly not present in this document because they are not relevant to the 510(k) clearance of this type of device.
Here's a breakdown based on the provided text, indicating where information is present and where it's not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "acceptance criteria" are primarily related to safety, electrical performance, laser specifications, and functional equivalence to predicate devices. There are no performance metrics like sensitivity/specificity for a diagnostic AI.
| Acceptance Criteria (Implied from technical comparison and standards) | Reported Device Performance (from the table in 807.92(a)(6)) |
|---|---|
| Indications for Use Alignment | "See Indications for Use Above" (matches predicate and reference devices, indicating equivalent scope of use) |
| Laser Wavelength (10.6µm) | 10.6µm (=10,600 nm) (Matches predicate and reference devices) |
| Laser Medium (CO2) | CO2 (Matches predicate and reference devices) |
| Laser Transfer Method | Articulated arm with Handpiece (Matches predicate and reference devices) |
| Aiming Beam Wavelength (within acceptable range) | 520nm (Green) +/- 5nm (predicate uses 637nm, reference uses 630-650nm. This is a technical difference but deemed acceptable for substantial equivalence). |
| CO2 RF Module Maximum Power (within range of predicates) | 40Watt at Continuous Wave (Max. 30W with surgical handpiece, Max. 40W with Fractional handpiece and Bella V handpiece) (Predicate eCO2 Plus is 30W, Reference Finexel is 30/40W. The 40W capability is a new maximum for the eCO2 3D fractional handpiece, but aligns with the range of the reference device). |
| Protection against shock (CLASS I/ B-type) | CLASS I/ B-type (Matches predicate and reference devices) |
| Laser Class (CLASS IV) | CLASS IV (Matches predicate and reference devices) |
| User Interface (Touch LCD Display) | 10.1inch Touch LCD Display (Matches predicate and reference devices – "Touch LCD Display") |
| Dimensions/Weight (within acceptable manufacturing variation) | Dimensions: 391mm(W) x 581mm(L) x1931mm(H) / Weight: 45kg (These vary slightly from predicates but represent the device's physical specifications, not a performance metric). |
| Device Cooling Method (Air cooling) | Air cooling (Matches predicate and reference devices) |
| Electrical Rating (compliant) | Single Phase AC100~230V, 50Hz/60Hz (FUSE 250V/6.3A or 125V/6.3A), Power consumption: 550VA (Comparable to predicate and reference electrical specifications). |
| Compliance with recognized safety standards | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, EN ISO 14971, ISO/TR 24971, IEC 62366-1, IEC 62304, ISO 10993 series (biocompatibility), ISO 15223-1, ISO 20471, ISO 15883 series (washer disinfectors), ISO 17664-1, ISO 11607 series (packaging). (These are "acceptance criteria" and the submission implicitly confirms compliance). |
Since this is not an AI/SaMD, the following sections are Not Applicable (N/A) based on the provided document:
- Sample size used for the test set and the data provenance: N/A (No clinical test set described for performance evaluation; clearance based on substantial equivalence to predicate device specifications and non-clinical testing for safety/electrical performance).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No external 'ground truth' establishment for diagnostic performance).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No adjudication required for this type of device clearance).
- 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: N/A (Not an AI-assisted device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI algorithm).
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A (No diagnostic ground truth needed).
- The sample size for the training set: N/A (No AI training set).
- How the ground truth for the training set was established: N/A (No AI training set).
Conclusion from the Document:
The acceptance for the eCO2 3D Laser System is based on demonstrating substantial equivalence to its predicate device (Lutronic eCO2 Plus, K100610) and a reference device (SNJ Finexel, K213557). This demonstration relies on comparing technical specifications and compliance with relevant national and international safety and performance standards (as listed in 807.92(b)(1)). The document explicitly states: "No clinical tests were performed for this submission." Therefore, there is no performance study data in the context of diagnostic accuracy, human reader improvement, or algorithm-specific metrics available in this 510(k) clearance letter.
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