(189 days)
The Cylindrically Diffusing Fiber is intended for soft tissue contact and coagulation for all cleared LaserSonics Nd: YAG soft tissue applications.
Cylindrically Diffusing Sterile Disposable Fiber
This document describes a premarket notification for a medical device, a cylindrically diffusing fiber for use with Nd:YAG lasers. However, the provided text does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets acceptance criteria.
The document primarily focuses on:
- Regulatory Information: Company name, contact, device name, classification, and regulatory authority.
- Intended Use: Soft tissue contact and coagulation for specific laser applications.
- Predicate Device Comparison: Stating equivalence to the Dornier ThermaFocus 3600000 Fiber in terms of indications, materials, operation, and construction to justify 510(k) clearance.
Therefore, I cannot answer the questions about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies because this information is not present in the provided text.
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AUG 21 1996
SUMMARY OF SAFETY AND EFFECTIVENESS 2.
Heraeus Surgical, Inc. Premarket Notification for Cylindrically Diffusing Fiber
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SUMMARY OF SAFETY AND EFFECTIVENESS LASERSONICS Nd:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER
REGULATORY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Alan Curtis,
Director Regulatory Affairs/Quality Assurance
Heraeus Surgical, Inc.
575 Cottonwood Drive
Milpitas, CA 95035-7434
Phone: (408) 954-4000
(408) 954-4326 FAX:
DEVICE TRADE NAME:
LaserSonics Nd:YAG Cylindrically Diffusing Sterile Disposable Fiber
DEVICE COMMON NAME:
Cylindrically Diffusing Fiber
Note: LaserSonics is a division of Heraeus Surgical, Inc., located at the same address.
Heraeus Surgical, Inc. Premarket Notification for Cylindrically Diffusing Fiber
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SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2
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DEVICE CLASSIFICATION:
To the best of our knowledge, laser fiberoptic delivery systems have not been classified by the FDA. The Nd:YAG laser systems on which the sterile disposable fibers are intended for use have been classified as Class II (79 GEX) Medical Devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels.
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PERFORMANCE STANDARDS:
Heraeus Surgical is unaware of any specific standards for laser fiberoptic delivery systems. The laser systems manufactured by Heraeus Surgical comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.
INDICATIONS FOR USE STATEMENT:
The Cylindrically Diffusing Fiber is intended for soft tissue contact and coagulation for all cleared LaserSonics Nd: YAG soft tissue applications.
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SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 3
COMPARISON WITH PREDICATE DEVICE:
In the opinion of Heraeus Surgical, the Cylindrically Diffusing Fiber is equivalent to the Dornier ThermaFocus 3600000 Fiber. These devices are in all aspects equivalent.
The risks and benefits of the Cylindrically Diffusing Fiber are comparable to the predicate device when used for similar clinical applications.
Since the Cylindrically Diffusing Fiber 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.