(105 days)
eBeam CO2 Laser System are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), general surgery ,gynecology,podiary,dental and otorhinolaryngology
Dermatology, Plastic Surgery and General Surgery procedures including but not limited to:
Laser skin resurfacing
Treatment of furrows and wrinkles
Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation.
Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
Blepharoplasty
Site preparation for hair transplants
Dental procedure including but not limited to -
Periodontal procedures such as - gingivectomy, removal of hyperplasias gingivoplasty (incision and excision);
Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign /malignant lesion ablation, operculectomy and homeostasis
Podiatry procedures including but not limited to -
Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.
Otorhinolaryngology (ENT) procedures including but not limited to -
Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.
Gynecology
Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia.
This device is for prescription use only.
The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device.
eBeam CO2 Laser System is an intelligent sealed-off CO2 laser. eBeam CO2 Laser System delivers laser energy to the treatment site via a 7-joint spring-balanced articulated arm in which mirrors reflect the laser beam along the axis of arms to enter the output device- the specially designed handpiece.
eBeam CO2 Laser System can produce a laser beam with a wavelength of 10.6 m which is effective on all soft tissues, thus it can be used in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic(dermatology and plastic surgery), general surgery, gynecology, podiatry, dental and otorhinolaryngology.
eBeam CO2 Laser System consists of control system, user interface, power supply, laser emission and delivery system, cooling system, safety features and handpieces (including scanning handpiece and normal handpiece).
The provided text describes a 510(k) submission for the "eBeam CO2 Laser System." This submission focuses on demonstrating substantial equivalence to a predicate device and does not involve a study to prove the device meets specific performance acceptance criteria in the way a diagnostic AI/ML device would. Instead, the "acceptance criteria" are based on compliance with established safety standards and the device's functional similarity to the predicate.
Therefore, many of the requested categories (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment, training set size) are not applicable to this type of regulatory submission and device.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on regulatory submission) | Reported Device Performance (as per submission) |
|---|---|
| Safety Standards Compliance: | |
| IEC 60825-1: 2007 (Laser products safety) | Complies |
| IEC 60601-2-22: 2007 (Diagnostic/therapeutic laser safety) | Complies |
| IEC 60601-1:1988+A1:1991+A2:1995 (General safety) | Complies |
| IEC60601-1-2:2001+A1:2004 (EMC requirements) | Complies |
| European Medical Directive 93/42/EEC | Complies |
| US Federal Performance Standards 21 CFR 1002.10 (21CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products) | Complies |
| Quality System Compliance: | |
| Part 820 - Quality System Regulation | Passed ISO9001 and ISO13485 System Certification |
| Functional Equivalence to Predicate Device: | |
| Same Indications for Use | Shares the same Indications for Use as predicate (SLIM Evolution Family of CO2 Laser, K063001) |
| Similar design features | Similar design features to predicate |
| Similar functional features | Similar functional features to predicate |
| Equivalent wavelengths (10.6 m) | Equivalent wavelengths to predicate |
| Used for same indicated surgical procedures | Used for same indicated surgical procedures as predicate |
2. Sample size used for the test set and the data provenance
Not applicable. This device is a surgical laser system, not a diagnostic AI/ML system requiring a test set of data. The "testing" referred to in the document is non-clinical laboratory testing of the device's engineering specifications and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no "test set" or "ground truth" in the context of expert review of data for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. This is not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device's regulatory acceptance is its adherence to international safety standards and its functional equivalence to a legally marketed predicate device, confirmed through non-clinical laboratory testing.
8. The sample size for the training set
Not applicable. This device does not use an AI/ML training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.