(189 days)
Dornier ThermaFocus 3600000
Not Found
No
The summary describes a simple fiber optic device for laser delivery and does not mention any AI/ML terms or capabilities.
Yes
The device is used for "soft tissue contact and coagulation," which directly relates to treating a medical condition and is thus therapeutic.
No
The device is described as being for "soft tissue contact and coagulation," which are therapeutic actions, not diagnostic.
No
The device description explicitly states it is a "Cylindrically Diffusing Sterile Disposable Fiber," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "soft tissue contact and coagulation". This describes a therapeutic or surgical application, not a diagnostic test performed on samples outside the body.
- Device Description: The description "Cylindrically Diffusing Sterile Disposable Fiber" points to a physical tool used in a medical procedure.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used directly on soft tissue for therapeutic effect.
N/A
Intended Use / Indications for Use
The Cylindrically Diffusing Fiber is intended for soft tissue contact and coagulation for all cleared LaserSonics Nd: YAG soft tissue applications.
Product codes
Not Found
Device Description
Cylindrically Diffusing Fiber
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Dornier ThermaFocus 3600000 Fiber
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
AUG 21 1996
SUMMARY OF SAFETY AND EFFECTIVENESS 2.
Heraeus Surgical, Inc. Premarket Notification for Cylindrically Diffusing Fiber
1
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
2
SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2
HE CHE = = = = = = = = = =
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.
.
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.
3
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.