(34 days)
The ATL Family of CO2 Medical Laser Systems (and the delivery accessories that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Dermatology, Plastic Surgery and General Surgery procedures including but not limited to -
- A Treatment of furrows and wrinkles
- A Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation,
- A Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
- A Blepharoplasty
- V Site preparation for hair transplants
Dental procedure including but not limited to
- ア Periodontal procedures such as - gingivectomy, removal of hyperplasias, gingivonlasty (incision and excision)
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Oral Surgery procedures such as - aphous ulcer excision, frenectorny, benignimalignant 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 - - ア Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucae vulgares, choanal atresia, LAUP and papillomatosis polyps.
Gynecology - V Treatment of condyloma acuminata, cervical intracpithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasja.
The ATL Family of CO2 Medical Laser Systems is a microprocessor-controlled CO2 laser system using a sealed laser tube providing either 15 watts maximum power (ATL-150) or 25 watts maximum power (ATL-250).
The ATL Family of CO2 Medical Laser Systems is intended to be used to deliver 10.6um CO2 light energy in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties.
The ATL Farnily of CO2 Medical Laser Systems covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.
This 510(k) summary (K083918) for the ATL Family of CO2 Medical Laser Systems indicates that no clinical studies were required or performed to demonstrate substantial equivalence or meet acceptance criteria. The submission relies entirely on non-clinical testing and comparison to a predicate device.
Therefore, many of the requested details cannot be provided as they pertain to clinical studies.
Here's the breakdown of what can be extracted from the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific acceptance criteria in terms of performance metrics (sensitivity, specificity, etc.) for the device. Instead, acceptance is based on adherence to recognized standards and verification through laboratory testing that the device met its design specifications and was substantially equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with International and US Standards (Safety, EMC, QMS) | The device "met all design specifications" and complied with: |
| - IEC 60825-1: 2007 | |
| - IEC 60601-2-22:2007 | |
| - IEC 60601-1:1988+A1:1991+A2:1995 | |
| - IEC60601-1-2:2001+A1:2004 | |
| - European Medical Directive 93/42/EEC | |
| - US Federal Performance Standards 21 CFR 1002.10 requirements | |
| - Part 820 - Quality System Regulation | |
| - ISO9001 and ISO13485 System Certification | |
| Substantial Equivalence to Predicate Device | "Laboratory testing was conducted to validate and verify that the proposed device... was substantially equivalent to the predicate device." The device shares "same indications for use and safety compliance, similar design features, functional features." |
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. No clinical test set was used. "No Clinical Information is required."
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. No clinical test set or ground truth established by experts for clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
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. No AI component. No MRMC study was done. This is a medical laser system, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical laser system, not an algorithm. Performance was evaluated based on meeting design specifications and safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical performance. For non-clinical validation, the "ground truth" was adherence to established engineering standards and design specifications, verified through laboratory testing.
8. The sample size for the training set
- Not applicable. No training set was used as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. No training set.
§ 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.