(90 days)
K#914197, K#924120, K#924160, K#931070, K#932272, K#901365
914520, 914521, 909128, 923991
No
The summary describes a laser system and its thermal effects, with no mention of AI, ML, image processing, or data-driven algorithms. The performance studies focus on temperature profiles and tissue coagulation depths, not algorithmic performance.
No
The description indicates the device is a Near-infrared Diode Laser System and mentions its use for thermal coagulation in tissues, comparing it to other surgical laser systems and scalpels. This points to a surgical or ablative function, which is a therapeutic rather than a diagnostic purpose.
No
Explanation: The provided text describes a "Near-infrared Diode Laser System" used for surgical purposes, as evidenced by its comparison to a surgical scalpel and Nd:YAG laser systems for their thermal effects on tissue. There is no information in the provided text to suggest it is used for diagnostic purposes.
No
The device description explicitly states "Near-infrared Diode Laser System," which is a hardware device. The performance studies also describe laboratory bench top studies involving temperature profiles of a scalpel tip used with a diode laser, further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: This section is "Not Found," which is a strong indicator that the device's purpose is not related to in vitro diagnostic testing.
- Device Description: The device is described as a "Near-infrared Diode Laser System." Laser systems are typically used for therapeutic or surgical procedures, not for analyzing samples outside the body.
- Performance Studies: The performance studies described involve comparing temperature profiles and depths of thermal coagulation in rabbit tissues. These are studies related to the device's interaction with biological tissue, consistent with a surgical or therapeutic device, not an IVD.
- Predicate and Reference Devices: The listed predicate and reference devices are surgical laser systems, scalpels, and other surgical tools. This further supports the conclusion that the device is intended for surgical or therapeutic use.
IVD devices are designed to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description and studies provided for this device do not align with this purpose.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The SDL diode laser system has the same operating characteristics as the diode laser system offered by Diomedics Inc with respect to power output, operating parameters and operating controls and indicators. The SDL diode laser system incorporates touch pad controls for setting of operating parameters, uses identical input power (110 VAC) as the Diomed 25W diode laser system offered by Diomedics Inc. (The Woodlands, TX).
The SDL diode laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems. This is identical to the connector system used by Diomedics (The Woodlands, TX). The delivery system which will be used with the SDL diode laser system will be able to directly attach to the fiberoptic connector system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Laboratory bench top studies were performed to compare temperature profiles of a NEOS Alloy Scalpel tip with respect to the use with a diode laser or a 1.06u Nd:YAG laser system. Temperature plots were made at typical power settings of 3.5 and 6.5 watts. The maximum temperatures obtained using both laser devices were equivalent. These studies support the belief that the NEOS family of fiberoptic delivery systems and the Bipolar Dissector can be used with a variety of sources of energy (i.e. - many different laser wavelengths) due to their surface coatings which makes these devices true heat sources independent of input laser wavelength.
In 1993, Judy et al reported a study in which comparisons of the depths of thermal coagulation in rabbit tissues obtained with a diode laser and a 1.06u Nd:YAG laser using contact fibers. Results of this study support the equivalency of tissue thermal effects obtained with the diode and Nd: YAG lasers in a contact mode; and support the use of the diode laser as an alternative medical device.
Key Metrics
Not Found
Predicate Device(s)
NEOS Alloy Scalpel (K#914197), Fiber Cap (K#924120), Hybrid Surgical Device (K#924160), Closed End (K#931070), Closed End/Electrocautery (K#932272), Bipolar Dissector (K#901365)
Reference Device(s)
Diomed" 25, 25W surgical diode laser system (K#s 914520, 914521), ZOE Nd: YAG laser system (K#s 909128, 923991)
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
Summary of Safety and Effectiveness V.
Summary of 21 CFR 807.87
A. Device Name:
-
- Proprietary Name:
K960905
- Proprietary Name:
JUN - 3 1996
SDL Diode Laser System and Associated Fiberoptic Delivery Systems
- Common Name:
Near-infrared Diode Laser System
- B. Establishment Registration Number:
SLT-J, Ltd. has not yet registered as a medical device establishment with the FDA. The company intends to complete all regulatory filings prior to introducing the SDL diode laser system into interstate commerce.
Address all correspondence to: Mr. Michael D. Johnson iohnson + associates -5848 Price Road Milford, OH 45150 513-248-8804
- C. Device Classification:
Diode surgical laser systems are currently considered Class II medical devices subject to pre-market notification provisions for many surgical applications.
Although not formally classified, diode surgical laser delivery systems typically have been regulated as Class II devices.
1
Electrosurgery handpieces (pencils, electrodes) are considered Class II 79 GEI [21 CFR 878.4400]. SLT-J, Ltd. anticipates these accessory devices would receive the same classification if such energy delivery systems were officially classified.
D. Compliance With Standards
The SDL diode laser conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. Certification reports will be submitted to CDRH certifying compliance with this standard and are currently in preparation and will be submitted by SLT-J, Ltd. prior to commercial distribution of this product.
E. Labeling
Product labels comply with 21 CFR 1040.10 and 1040.11 as applicable. An Operator's Manual for the SDL diode laser system is currently in preparation. A draft Operator's Manual is included in this submission (See Attachments).
Product labels comply with 21 CFR 801 as applicable for ... accessory devices. Copies of the proposed text for these package labels are located in Section IV of this submission.
F. Statement of Equivalence
In the opinion of SLT-J, Ltd., the SDL diode laser system, when used with any of the following fiberoptic delivery systems:
NEOS Alloy Scalpel (K#914197) LCA, Inc. (Cincinnati, OH)
2
Fiber Cap (K#924120) LCA, Inc. (Cincinnati, OH)
Hybrid Surgical Device (K#924160) LCA, Inc. (Cincinnati, OH)
Closed End (K#931070) LCA, Inc. (Cincinnati, OH)
Closed End/Electrocautery (K#932272) LCA, Inc. (Cincinnati, OH)
Bipolar Dissector (K#901365) LCA, Inc. (Cincinnati, OH)
is substantially equivalent to the use of any of the abovementioned devices when used with any of the following medical devices which are used as a laser (energy) source:
Diomed" 25, 25W surgical diode laser system (K#s 914520, 914521), Diomedics Inc. (The Woodlands, TX)
ZOE Nd: YAG laser system (K#s 909128, 923991), LCA, Inc. (Cincinnati, OH)
Section III of this submission provides information in support of this equivalence claim.
This belief of equivalence is based upon the following facts:
-
- The SDL diode laser system has the same operating characteristics as the diode laser system offered by Diomedics Inc with respect to power output, operating parameters and operating controls and indicators. The SDL diode laser system incorporates touch pad controls
3
for setting of operating parameters, uses identical input power (110 VAC) as the Diomed 25W diode laser system offered by Diomedics Inc. (The Woodlands, TX).
-
- The SDL diode laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems. This is identical to the connector system used by Diomedics (The Woodlands, TX). The delivery system which will be used with the SDL diode laser system will be able to directly attach to the fiberoptic connector system.
-
- Due to the technologies used in the manufacturing of the NEOS family of fiberoptic delivery systems as well as the Bipolar Dissector, the laser system used with these products is not a dependent variable to achieve a desired tissue effect. The particular surface treatment used on the NEOS Alloy Scalpel, Fiber Cap, Hybrid Surgical Device and the Bipolar Dissector, provide a product which completely absorbs the laser energy, thus converting laser light energy into thermal energy, regardless of the wavelength of the laser light source.
The Closed End and Closed End/Electrocautery fiberoptic delivery systems use swaged stainless steel hypo tubing to convert light energy transmitted through the fiberoptics into thermal energy, again regardless of the wavelength of the laser light source.
Laboratory bench top studies were performed to compare temperature profiles of a NEOS Alloy Scalpel tip with respect to the use with a diode laser or a 1.06u Nd:YAG laser system. Temperature plots were made at typical power settings of 3.5 and 6.5 watts. The maximum temperatures obtained using both laser devices were equivalent. These studies support the belief that the NEOS family of fiberoptic delivery systems and the
4
Bipolar Dissector can be used with a variety of sources of energy (i.e. - many different laser wavelengths) due to their surface coatings which makes these devices true heat sources independent of input laser wavelength.
In 1993, Judy et al reported a study in which comparisons of the depths of thermal coagulation in rabbit tissues obtained with a diode laser and a 1.06u Nd:YAG laser using contact fibers. Results of this study support the equivalency of tissue thermal effects obtained with the diode and Nd: YAG lasers in a contact mode; and support the use of the diode laser as an alternative medical device.
-
- The SDL diode laser system can be operated by either a footswitch or a fingerswitch. This technology is equivalent to, and has been offered since 1990 on Nd:YAG laser systems offered by Surgical Laser Technologies (The Oaks, PA) and LCA (Cincinnati, OH). This allows the operator to select between either footswitch or fingerswitch control of the fiberoptic delivery system.
5
Bibliography
Absten GT, Joffe SN. Lasers in Medicine - An Introductory Guide. 2nd ed. London: Chapman and Hall, Ltd, 1989.
Dixon, JA. Surgical Applications of Lasers. 2nd ed. Chicago: Year Book Medical Publishers, Inc, 1987.
Joffe SN, Oguro Y. Advances in Nd:YAG Laser Surgery. New York: Springer-Verlag, 1988.
Joffe, SN. Lasers in General Surgery. Baltimore, Maryland: Williams & Wilkins, 1989.
Judy MM, Matthews JL, Aronoff BL, Hults DF. Soft Tissue Studies With 805nm Diode Laser Radiation: Thermal Effects With Contact Tips and Comparison With Effects of 1064nm Nd: YAG Laser Radiation. Lasers in Surgery and Medicine, 13:528-536 (1993).