(21 days)
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No
The document describes a mechanical accessory for a surgical laser used for focusing and steering the laser beam. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is used for incision, excision, coagulation, ablation, and vaporization of soft tissue using a surgical laser, which are all therapeutic actions.
No
The device is described as an accessory for a surgical laser, indicated for incision, excision, coagulation, ablation, and vaporization of soft tissue. Its purpose is to allow a physician to focus and steer laser beams for selective tissue treatment. This describes a therapeutic, not a diagnostic, function.
No
The device description clearly states it is an accessory for a CO2 Surgical Laser and attaches to an articulated arm and surgical microscope, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "incision, excision, coagulation, ablation, and vaporization of soft tissue" using surgical lasers. This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample of tissue or body fluid outside the body.
- Device Description: The description reinforces this by explaining it's an accessory for a surgical laser that allows a physician to "focus and steer laser beams so that when tissue is visualized, it can be selectively treated." This is a tool for performing surgery.
- Lack of IVD characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
It is indicated for incision, excision, coagulation, ablation, and vaporization of soft tissue, to be used with compatible, legally marketed surgical lasers.
Product codes
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Device Description
The Sharplan Model 713 AF Acuspot Micromanipulator is an accessory for a CO2 Surgical Laser. It attaches to the distal end of an articulated arm and connects to a surgical microscope. Its purpose is to allow a physician the ability to focus and steer laser beams so that when tissue is visualized, it can be selectively treated.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
No new indications were sought in the premarket notification and no clinical data was presented.
Based upon an analysis of the overall performance characteristics for the devices, Sharplan Lasers, Inc. believes that no significant differences exist. Furthermore, this modification raises no concerns regarding the safety or effectiveness of the Sharplan Model 713 AF Acusot Micromanipulator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Sharplan Model 712 Acuspot, Reliant UniMax Model 2000 Micromanipulator, Heraeus LaserSonics Ultraspot Micromanipulator.
Reference Device(s)
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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.
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Image /page/0/Picture/0 description: The image shows the logo for Sharplan Lasers, Inc. The logo consists of a stylized circle with three pie-shaped wedges cut out of it, followed by the company name in bold, sans-serif font. Below the company name is the number K962974 in a handwritten style.
AUG 21 1996 510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. Model 713 AF Acuspot Micromanipulator
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 Model 713 AF Acuspot Micromanipulator is based on a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Sharplan Model 712 Acuspot, the Reliant UniMax Model 2000 Micromanipulator, and the Heraeus LaserSonics Ultraspot Micromanipulator.
- 1 . Sharplan Lasers, Inc. 1 Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs/Quality Assurance July 8, 1996
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- Model: Sharplan Model 713 AF Acuspot Micromanipulator
- The Sharplan Model 712 Acuspot Micromanipulator, the 3. Predicate Devices: Reliant UniMax Model 2000 Micromanipulator, and the Heraeus LaserSonics Ultraspot Micromanipulator.
- 4 . Description: The Sharplan Model 713 AF Acuspot Micromanipulator is an accessory for a CO2 Surgical Laser. It attaches to the distal end of an articulated arm and connects to a surgical microscope. Its purpose is to allow a physician the ability to focus and steer laser beams so that when tissue is visualized, it can be selectively treated.
- 5 . The Sharplan Model 713 AF Acuspot Micromanipulator is substantially equivalent to the following devices: The Sharplan Model 712 Micromanipulator, the Reliant UniMax Model 2000, and the Heraeus LaserSonics Ultraspot Micromanipulator. It is indicated for incision, excision, coagulation, ablation, and vaporization of soft tissue, to be used with compatible, legally marketed surgical lasers.
No new indications were sought in the premarket notification and no clinical data was presented.
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510(k) Summary of Safety and Effectiveness (continued) Sharplan Lasers, Inc. Model 712 Acuspot Micromanipulator
- 6 . From a design and intended use perspective, the aforementioned devices, while are not identical, perform the same function and are of the same technology. The modification to the candidate device, involves the addition of an autofocus option. Based upon an analysis of the overall performance characteristics for the devices, Sharplan Lasers, Inc. believes that no significant differences exist. Furthermore, this modification raises no concerns regarding the safety or effectiveness of the Sharplan Model 713 AF Acusot Micromanipulator.
- This information was prepared for the sole purpose of compliance with the Advisory: 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.