(53 days)
Intended use is to communicate the laser beam of a CO2 surgical laser to the target site for the incision, excision, ablation, or photocoagulation of soft tissue. Representative examples of indications for use:
Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization; vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts.
Dermatology – port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratosis, actinic keratosis and actinic cheilitis.
Dentistry/Oral Surgery – gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors
General Surgery - hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of deciditus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cyto-reduction for metastatic disease; many dermatological procedures.
Laparoscopic surgery – vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy.
Otorhinolaryngology - lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsillectomy, removal of vocal cord papillomas, nodules, and polyps.
Podiatry – plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment
Orthopedic - menisectomy, chondromalacia ablation, partial synovectomy, lateral release, PMMA removal
These tips are short, hollow lightpipes of alumina ceramic or stainless steel that provide a variety of spot sizes to target tissue when utilized in a mating laser handpiece.
The provided text describes a 510(k) submission for the LightScalpel family of handpiece tips for CO2 surgical lasers. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily due to a change in the sterilization method.
Here's an analysis of the acceptance criteria and supporting study based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization to 10⁻⁶ SAL (Sterility Assurance Level) | Validation of sterilization parameters required for obtaining 10⁻⁶ SAL utilizing radiation sterilization was provided. |
| Identical construction and performance to predicate device | The devices are described as "identical to the predicate products, utilizing the same specifications, materials and methods." |
| No new indications for use sought beyond predicate device | "No new indications for use are sought beyond those associated with the predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated in the provided text. The nonclinical performance data refers to "validation of sterilization parameters," which would involve a specific number of sterilization cycles and tests, but the exact sample size (e.g., number of test units) is not given.
- Data Provenance: The nature of the study (sterilization validation) suggests a controlled laboratory setting. The origin (e.g., country) of the tests or where the validation was performed is not mentioned. It is an internal study conducted by the manufacturer to support their 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission does not involve clinical data or expert evaluation of device performance in a diagnostic or treatment context that would require expert-established ground truth. The primary focus is on sterilization efficacy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of adjudication, as the study is a nonclinical validation of sterilization rather than an assessment of subjective interpretations.
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:
- No. An MRMC study was not done. The device is a surgical laser handpiece tip, not an AI-assisted diagnostic or treatment system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The device is a physical medical instrument, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the sterilization validation would be a predetermined sterility assurance level (SAL), specifically 10⁻⁶ SAL. This is an objective, quantitative standard. The validation demonstrates that the chosen sterilization process consistently achieves this sterility level under defined conditions.
8. The sample size for the training set:
- Not applicable. This is a nonclinical validation study for a physical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for a machine learning model.
§ 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.