(28 days)
Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory to the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:
- Arthroscopy,
- . Urology,
- Lithotripsy,
- Pulmonology,
- . Gastroenterology,
- Gynecology,
- ENT,
- General Surgery.
The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H RFID Laser Fibers (K121938) to include a fiber with a reduced outer diameter. The fiber core and cladding for the subject device are made from silica.
This document is a 510(k) premarket notification for a medical device called "Dornier Medilas H RFID Laser Fiber." It is a request for clearance from the FDA to market a modified laser fiber. The document evaluates the new device against previously cleared predicate devices to demonstrate substantial equivalence, rather than establishing acceptance criteria and conducting a study to prove device performance against those criteria in the context of an AI/algorithm-based diagnostic device.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance cannot be provided from this particular document, as it pertains to a different type of device and regulatory submission.
The document contains information primarily related to:
- Device Name: Dornier Medilas H RFID Laser Fiber
- Intended Use/Indications for Use: Used as an accessory to the Dornier Medilas H Holmium Laser for cutting, vaporization, ablation, and coagulation of soft tissue in various medical specialties.
- Technological Characteristics: Similar to predicate devices, made from silica, manufactured and tested in the identical fashion. The key modification is a "reduced outer diameter" of the fiber.
- Performance Data (Nonclinical functional testing):
- Power transmission testing
- Durability Stress Testing
- Eccentricity Testing
- Visual Inspections
- These methods were the same as used for the cleared predicate.
- Substantial Equivalence Claim: The device has the same intended use/indications for use, technological characteristics, and principles of operation as predicate devices. The minor difference in outer diameter does not raise new safety or effectiveness concerns, and performance data demonstrates substantial equivalence.
§ 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.