(71 days)
INTENDED USE
The device Litho DK30 including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.
INDICATIONS FOR USE
The device Litho DK30 including a fiber optic delivery system is insurgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones in medical specialties including, but not limited to:
- Urology
- · Gastroenterology
- Arthroscopy
- Neurosurgery
- Pulmonary
- Gynecology
- ENT
- Dermatology
- Plastic Surgery
- General Surgery
The modified device Litho DK30 is a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). This Special 510(k) of the modified device Litho DK30 is submitted due to Device Modifications of the already cleared device Litho (K091909): Litho DK30 is the desktop version of the already cleared device Litho (K09109). Both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 um. The device Litho including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for device modifications (Litho DK30) to an already cleared device (Litho). It focuses on demonstrating substantial equivalence to the predicate device due to minor modifications that do not change the fundamental scientific technology or intended use.
This is a regulatory submission for device modifications, not a study evaluating performance against specific acceptance criteria. The device is a "Laser surgical instrument for use in general and plastic surgery and in dermatology," and the modifications are primarily mechanical, electrical and software changes to create a desktop version of an existing device.
Therefore, I cannot provide the requested information as it is not present in the given text.
§ 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.