(75 days)
The CyberScan Device is intended for use for all cleared Heraeus LaserSonics CO2 soft tissue surgical applications.(K955734)
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The provided text is a Summary of Safety and Effectiveness for the CyberScan Device System (K970017). It states that the device is substantially equivalent to a predicate device (ParaScan Dosimeter Device, K955734).
However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given input. The document focuses on regulatory classification, indications for use, and a comparison to a predicate device for substantial equivalence, rather than detailing performance studies and their results.
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SUMMARY OF SAFETY AND EFFECTIVENESS
CYBERSCAN DEVICE SYSTEM
REGULAROY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Nidek Incorporated 47651 Westinghouse Drive Fremont, CA. 94539-7474 Phone: (510)226-5700 (800) 223-9044 (510) 2265750 Fax:
DEVICE TRADE NAME
CyberScan Device
DEVICE COMMON NAME
Scanning Laser Delivery System
DEVICE CLASSIFICATION:
CO2 laser systems have been classified as Class II (79 GEX) medical devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels. To the best of our knowledge, scanning laser delivery systems have not been classified.
PERFORMANCE STANDARDS:
The ParaScan Dosimeter Device complies with 21 CFR 1040.10 and 1040.11. FDA regulations for medical laser products, as applicable.
INDICATIONS FOR USE STATEMENT
The CyberScan Device is intended for use for all cleared Heraeus LaserSonics CO2 soft tissue surgical applications.(K955734)
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COMPARISON WITH PREDICATE DEVICE:
The CyberScan Device is substantially equivalent to the ParaScan Dosimeter Device manufactured by Heraeus Surgical.(K955734)
The risks and benefits of the CyberScan are comparable to the predicate device when used for similar clinical applications.
Since the CyberScan Device is substantially equivalent with respect to indication for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510 (k) guidelines. Safety and effectiveness are reasonable assured, therefore justifying 510 (k) clearance.
§ 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.