(87 days)
The Dornier Diode Laser family, Medilas™ D Fibertom Laser ("Medilas D"), Medilas™ D SkinPulse™ ("SkinPulse") and Medilas D SkinPulse™ S ("SkinPulse S"), with ITT Light Guide or Light Guide with bare fiber (fiber diameter 400μm) are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranqing in total volume from 28-85cc.
The Dornier Diode Laser family, Medilas™ D Fibertom Laser ("Medilas D"), Medilas™ D SkinPulse™ ("SkinPulse") and Medilas D SkinPulse™ S ("SkinPulse S"), are intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, gastroscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without a handpiece). The SkinPulse™ and SkinPulse™ S lasers are also for use for the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.
The Dornier Diode Laser Family includes: Medilas™ D Fibertom Laser System ("Medilas D"), Medilas™ D SkinPulse™ Laser System ("SkinPulse"), and Medilas™ D SkinPulse™ S Laser System ("SkinPulse S"). These are diode lasers.
The provided text is a 510(k) summary for the Dornier Diode Laser Family. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. Critically, this document describes regulatory aspects and indications for use, but it does not contain any information about acceptance criteria or studies proving device performance against such criteria.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone) because this information is not present in the provided text.
The document primarily focuses on:
- Substantial Equivalence: Asserting that the Dornier Diode Laser Family is substantially equivalent to previously cleared predicate devices based on technological characteristics and overall performance.
- Indications for Use: Expanding the indications for use to include the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH).
- Device Description: Listing the different models within the Dornier Diode Laser Family.
- Regulatory Information: Submitter's contact, device classification, and FDA communication.
There are no performance metrics, study designs, or data presented that would allow me to populate the requested table or answer the questions about how the device meets acceptance criteria.
§ 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.