(372 days)
The 800 Series Surgical Laser Systems and Accessories are intended for use in cutting, coagulating and vaporizing prostatic tissues during treatment of benign prostatic hyperplasia (BPH) in men 50 years of age or older with prostatic volumes of 60cc or less. Ablation and hemostasis are performed with Nd: Y AG wavelength (1064 nm). Vaporization is performed with the KTP wavelength (532 nm). Specific indications include: laser prostatectomy, visual laser ablation of the prostate (VLAP), obstructive voiding symptoms, obstructive prostatic adenoma, prostatic enlargement, prostatic adenoma and bladder outlet obstruction due to BPH. The device is not intended to treat prostate cancer.
The Orion Series Surgical Laser Systems and Accessories are intended for use in cutting, coagulating and vaporizing prostatic tissues during treatment of benign prostatic hyperplasia (BPH) in men 50 years of age or older with prostatic volumes of 60cc or less. Ablation and hemostasis are performed with Nd: YAG wavelength (1064 nm). -Vaporization is performed with the KTP wavelength (532 nm). Specific indications include: laser prostatectomy, visual laser ablation of the prostate (VLAP), obstructive voiding symptoms, obstructive prostatic adenoma, prostatic enlargement, prostatic adenoma and bladder outlet obstruction due to BPH. The device is not intended to treat prostate cancer.
The Laserscope KTP/Nd: YAG Surgical Laser Systems lasing medium is an yttrium aluminum garnet (YAG rod) that has been doped with a small amount of the element neodymium (Nd). In this system, the electrons of the Nd atoms become excited and release photons of a characteristic wavelength. The light energy that is emitted from this source has a wavelength of 1064 nm which is in the infrared portion of the spectrum.
The KTP/532 laser utilizes the same lasing medium as the Nd: YAG laser. In this system, the infrared beam produced by Nd: Y AG source is passed through a second crystal made from potassium titanyl phosphate (KTP), The KTP crystal converts some of the infrared light in the green portion of the spectrum. The wavelength of this light is 532 nm. The process that converts the infrared light to the visible ereen light requires two photons of infrared light to produce one photon of green light. This conversion process halves the wavelength, or doubles the frequency, so the wavelength of the KTP beam is exactly half that of the Nd: YAG beam. Thus, KTP is not a laser crystal, rather it is a frequency doubling crystal.
Laserscope's line of Angled Delivery Devices have side-firing capabilities for use in contact and non-contact procedures. The devices come in a variety of configurations (length, fiber core diameters, coaxial capability, etc.). The devices are available with either a Laserscope proprietary SmartConnector or a standard SMA-905 connector, facilitating use with either Laserscope or SMA-905 compatible lasers. The SmartConnector versions can transmit both the 532 and 1064 wavelengths.
The provided text focuses on regulatory submissions and approvals for the Laserscope KTP/Nd: YAG Surgical Laser System and Angled Delivery Devices. It establishes substantial equivalence to predicate devices and outlines indications for use. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria with performance metrics, sample sizes, expert involvement, or adjudication methods.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about the study, as this information is not present in the provided document.
The document primarily states:
- Performance Standards: The device conforms to federal regulations and performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. This refers to general safety and performance standards for laser products, not specific clinical acceptance criteria for BPH treatment.
- Comparison with Predicate Device: The device is deemed "substantially equivalent" to predicate devices (K912538, K933880, K920589, K924644) regarding indications for use, materials, method of operation, and physical construction. This allows for 510(k) clearance based on the predicate's established safety and effectiveness, rather than requiring a detailed new clinical study to meet specific performance acceptance criteria.
- Safety and Effectiveness: "Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale." This is a regulatory conclusion based on substantial equivalence, not a summary of a specific study meeting predefined acceptance criteria.
Without a clinical study section in the provided text detailing performance metrics, sample sizes, expert reviews, or ground truth establishment, I cannot populate the requested information.
§ 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.