(36 days)
The intended use of the Xanova tips is to comprise the distal end element of a surgical CO2 laser beam delivery system for the incision, excision, ablation, or photocoagulation of soft tissue.
Representative examples of indications for use in various specialties are listed below.
Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation. of vaginal and vulvar intraepithelial neoplasia; he pes 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 tricoeptiheliomas; dermabrasion for lentigos, keratoses, actinic keratosis and actinic chleilitis.
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 decubitus ulcers and stasis ulcers; mastectomy; breast biopsy; reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures.
Otorhinolaryngology- - lymphangioma removal; turbinectomy.
Podiatry-plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment.
The Xanova Novatips constitute the disposable end element of the hollow fiber deliverv system of a CO2 surgical laser.
I'm sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) summary for laser handpiece tips and focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.
The document explicitly states: "No new indications were sought in the premarket notification and no clinical data were presented." This indicates that a study with formal acceptance criteria and proof of their fulfillment was not part of this 510(k) submission.
Therefore, I cannot populate the requested table and provide the other study-related details.
§ 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.