(66 days)
No
The device description and intended use focus on mechanical components for delivering laser energy and aspiration/irrigation. There is no mention of AI or ML in the provided text, and the performance studies are based on physical testing and sterilization validation.
Yes
The device is used for "ablation, vaporization, excision, and coagulation of soft tissue," which are therapeutic medical procedures.
No
Explanation: The device is described as being used for surgical applications such as ablation, vaporization, excision, incision, and coagulation of soft tissue, and for aspiration and/or irrigation of fluid and surgical debris, which are therapeutic and procedural functions, not diagnostic ones.
No
The device description clearly lists multiple hardware components, including a handpiece assembly, optical fiber stop, aspiration needles, locking nuts, positioning trocars, and a sterilization tray. It is a physical medical device used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical applications involving the ablation, vaporization, excision, and coagulation of soft tissue, as well as aspiration and irrigation of fluid and debris. These are all procedures performed on the patient's body.
- Device Description: The description details components like needles, handpieces, and trocars, which are instruments used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (in glass, or outside the body) to analyze biological samples. This device is clearly designed for in vivo (in the living body) surgical interventions.
N/A
Intended Use / Indications for Use
The Coherent SlimLine Single Lumen Aspiration Needle Set and the Delivery Accessories that are used with them to deliver light energy are indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); arthroscopy (knee surgery); and open and endoscopic general surgery, and for aspiration and/or irrigation of fluid and/or surgical debris.
Product codes
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Device Description
The Coherent SlimLine Single Lumen Aspiration Needle Set and associated accessories are intended to be used to help deliver laser light energy from the Coherent SlimLine Family of fiber optic fibers used with the Coherent VersaPulse Family of Ho:YAG and Ho:YAG/Nd:YAG surgical lasers for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue and urinary calculi (including steinstrasse) in a variety of medical specialties.
Coherent SlimLine Single Lumen Aspiration Needle Set are comprised of the following main components:
- the handpiece assembly (with optical fiber locking nut and locking nut O-ring); .
- . the optical fiber stop;
- . aspiration needles (straight and curved needles of various lengths);
- aspiration needle locking nut (with locking nut O-ring); .
- . positioning trocars; and
- . a sterilization tray
The SlimLine Single Lumen Aspiration Needles are provided as non-sterile, ready to be sterilized devices that are either available individually or as a set of three aspiration needles in a sterilization tray.
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
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Summary of Performance Studies
Physical testing was conducted to demonstrate performance of the Coherent SlimLine Single Lumen Aspiration Needle Set in accordance with product specifications. The component materials with expected and potential patient contact were tested to demonstrate acceptable biocompatibility. Sterility testing was conducted to validate that the SlimLine Single Lumen Aspiration Needles attain a sterility assurance level (SAL) of 10-6 when sterilized in accordance with the directions provided in the Instruction Guide.
Key Metrics
Not Found
Predicate Device(s)
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
APR - 4
960417 Attachment 14 510(k) Summary Statement for the Coherent SlimLine Single Lumen Aspiration Needle Set
- I. General Information
لقابل المقابل المقابلة
تقابل المقابل الموقف الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع ال
Submitter: Coherent Medical Group 3270 West Bayshore Road Palo Alto, CA 94303
Contact Person: Anne C. Worden
Summary Preparation Date: January 25, 1996
- II. Names
Device Names: Coherent SlimLine Single Lumen Aspiration Needle Set.
Primary Classification Name: Laser Powered Surgical Instrument (and Accessories).
III. Predicate Devices
- · Suction/Irrigation Probe (with long adapter/sizing sheath, short adapter and gasket) Accessory Kit marketed by Coherent Medical, Inc. (K923575, K902990)
- LASE Surgical Kit (Model 1100 Discectomy Decompression Kit) manufactured by Clarus Medical Systems, Inc. (K913136)
IV. Product Description
The Coherent SlimLine Single Lumen Aspiration Needle Set and associated accessories are intended to be used to help deliver laser light energy from the Coherent SlimLine Family of fiber optic fibers used with the Coherent VersaPulse Family of Ho:YAG and Ho:YAG/Nd:YAG surgical lasers for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue and urinary calculi (including steinstrasse) in a variety of medical specialties.
Coherent SlimLine Single Lumen Aspiration Needle Set are comprised of the following main components:
- the handpiece assembly (with optical fiber locking nut and locking nut O-ring); .
- . the optical fiber stop;
- . aspiration needles (straight and curved needles of various lengths);
- aspiration needle locking nut (with locking nut O-ring); .
- . positioning trocars; and
- . a sterilization tray
The SlimLine Single Lumen Aspiration Needles are provided as non-sterile, ready to be sterilized devices that are either available individually or as a set of three aspiration needles in a sterilization tray.
1
V. Indications for Use
The Coherent SlimLine Single Lumen Aspiration Needle Set and the Delivery Accessories that are used with them to deliver light energy are indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); arthroscopy (knee surgery); and open and endoscopic general surgery, and for aspiration and/or irrigation of fluid and/or surgical debris.
VI. Rationale for Substantial Equivalence
The Coherent SlimLine Single Lumen Aspiration Needle Set and their delivery device accessories share the same indications for use, similar design features, components and materials, and therefore are substantially equivalent to the Suction/Irrigation Probe Accessory Kit marketed by Coherent Medical, Inc. (K923575, K902990), and to the cannulas, trocar, and trephine components included in the LASE Surgical Kit manufactured by Clarus Medical Systems, Inc. (K913136).
VII. Safety and Effectiveness Information
Physical testing was conducted to demonstrate performance of the Coherent SlimLine Single Lumen Aspiration Needle Set in accordance with product specifications. The component materials with expected and potential patient contact were tested to demonstrate acceptable biocompatibility. Sterility testing was conducted to validate that the SlimLine Single Lumen Aspiration Needles attain a sterility assurance level (SAL) of 10-6 when sterilized in accordance with the directions provided in the Instruction Guide.
VIII. Conclusion
The Coherent SlimLine Single Lumen Aspiration Needle Set was found to be substantially equivalent to the cannula, trocar and trephine components provided in the LASE Surgical Kit manufactured by Clarus Medical Systems, Inc. The Coherent SlimLine Single Lumen Aspiration Needle Set shares the same indications for use, similar design features, and similar functional features as the currently marketed Coherent Irrigation/Suction Probe Accessory Kit, and the cannula, trocar and trephine components provided in the currently marketed LASE Surgical Kit. The physical test results demonstrated that the Coherent SlimLine Single Lumen Aspiration Needle Set have acceptable performance characteristics.