(71 days)
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No
The description focuses on a motorized laser beam deflection system with pre-set patterns and parameters controlled by the operator via an LCD panel. There is no mention of adaptive learning, data analysis for decision making, or any other characteristic typically associated with AI/ML.
Yes
The device is indicated for medical procedures such as incision, excision, coagulation, vaporization, and ablation, which are therapeutic actions performed on a patient's soft tissue.
No
Explanation: The document describes the device as a CO2 accessory for a laser, indicated for soft tissue incision, excision, coagulation, vaporization, and ablation. These are all treatment functions, not diagnostic ones. There is no mention of the device being used to detect, identify, or monitor conditions.
No
The device description explicitly states it is a "motorized, laser beam deflection system" and includes a "CO2 handpiece and LCD control panel interface," indicating it is a hardware accessory with physical components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Sharplan Lasers, Inc. Silktouch XJ Scanner Accessory is a surgical accessory that uses a CO2 laser to directly interact with soft tissue for procedures like incision, excision, and vaporization. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states surgical procedures on soft tissue for various medical specialties. There is no mention of analyzing samples or providing diagnostic information.
Therefore, this device falls under the category of a surgical laser accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sharplan Lasers, Inc. Silktouch XJ Scanner Accessory is a CO2 accessory for a Sharplan Laser (models 60, 80, and 150 x)). It is indicated for soft tissue incision, excision, coagulation, vaporization, and ablation for the following indications: General/Thoracic Surgery, Neurosurgery, Otolaryngology, Dental Surgery (soft tissue only), Gynecology, Podiatry, Plastic Surgery/Dermatology, and Genito-Urinary Surgery.
Product codes
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Device Description
The Sharplan Lasers, Inc. Silktouch XJ Scanner CO2 Laser Accessory is a motorized, laser beam deflection system that is attached to a Sharplan CO2 laser articulating arm. The device redirects a focused laser beam from moving mirrors, within a specified pattern scan area. Similar to the common surgeon's technique of manually scanning a focused beam over a treatment area, the constantly moving beam of the Silktouch XJ Scanner limits the time of laser exposure on tissue while providing sufficient power density for tissue vaporization at low average power levels. This device features a CO2 handpiece and LCD control panel interface which allows the operator to select or change the various patterns and treatment parameters. This accessory does not defeat or over-ride the safety or control mechanisms which are integral to CO2 laser system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Soft tissue
Indicated Patient Age Range
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Intended User / Care Setting
Surgeon
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Physical testing of the device has demonstrated that it is similar both in function and performance to its predicate devices. No new indications were sought in this premarket notification and no clinical data was presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Coherent Computerized Pattern Generator and the Sharplan SwiftLase (aka SilkTouch) Flashscanner. K946304, K941312
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/0 description: The image shows the logo for Sharplan Lasers, Inc. The logo consists of a circular graphic on the left, with three triangular shapes cut out of it. To the right of the graphic is the word "SHARPLAN" in large, bold, sans-serif letters. Below "SHARPLAN" is the text "LASERS, INC." in smaller letters.
K60880
MAY 1 0 1996
510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. Silktouch XJ Scanner CO2 Laser Accessory
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the Sharplan Lasers, Inc. Silktouch XJ Scanner is based on a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Coherent Computerized Pattern Generator and the Sharplan SwiftLase (aka SilkTouch) CO2 Flashscanner.
- 1 . Sharplan Lasers, Inc. l Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs Updated: October, 1995. 1-800-394-2000, ext. 531
- Model: Sharplan Lasers, Inc. Silktouch XJ Scanner CO2 Laser Accessory 2.
- Predicate Devices: 3. The Coherent Computerized Pattern Generator and the Sharplan SwiftLase (aka SilkTouch) Flashscanner.
- 4 . Description: The Sharplan Lasers, Inc. Silktouch XJ Scanner CO2 Laser Accessory is a motorized, laser beam deflection system that is attached to a Sharplan CO2 laser articulating arm. The device redirects a focused laser beam from moving mirrors, within a specified pattern scan area. Similar to the common surgeon's technique of manually scanning a focused beam over a treatment area, the constantly moving beam of the Silktouch XJ Scanner limits the time of laser exposure on tissue while providing sufficient power density for tissue vaporization at low average power levels. This device features a CO2 handpiece and LCD control panel interface which allows the operator to select or change the various patterns and treatment parameters. This accessory does not defeat or over-ride the safety or control mechanisms which are integral to CO2 laser system.
- 5 . The Sharplan Lasers, Inc. Silktouch XJ Scanner Accessory is substantially equivalent to the following devices: Coherent Computerized Pattern Generator and the Sharplan SwiftLase (aka SilkTouch) Scanner ( K946304 and K941312, respectively). It is a CO2 accessory for a Sharplan Laser (models 60, 80, and 150 x)). It is indicated for soft tissue incision, excision, coagulation, vaporization, and ablation for the following indications: General/Thoracic Surgery, Neurosurgery, Otolaryngology, Dental Surgery (soft tissue only), Gynecology, Podiatry, Plastic Surgery/Dermatology, and Genito-Urinary Surgery.
No new indications were sought in this premarker notification and no clinical data was presented.
1
510(k) Summary of Safety and Effectiveness (continued) Sharplan Lasers, Inc. Silktouch XJ Scanner C(2 Laser Accessory
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- From a clinical performance perspective, the aforementioned devices produce a similar therapeutic output in terms of laser spot size and patterns. Regarding the technological characteristics, while are not identical, physical testing of the device has demonstrated that it is similar both in function and performance to its predivate devices. Sharplan Lasers, Inc. believes that none of the modifications made to the device raise any issues pertaining to its safety or efficacy.
- Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.