(197 days)
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No
The summary describes a laser device for surgical cutting and coagulation, with performance metrics focused on penetration depth. There is no mention of AI, ML, image processing, or data-driven decision-making.
Yes.
The device's intended use clearly states it "provide[s] power to cut or coagulate tissues" and mentions "interstitial laser coagulation," which are therapeutic actions. It also lists various anatomical sites for its application.
No
This device is described as a surgical instrument that provides power to cut or coagulate tissues, and a laser for interstitial laser coagulation, indicating a therapeutic rather than diagnostic function.
No
The device description explicitly mentions a "laser" and "diffusing fiberoptic," which are hardware components. The performance studies also focus on the physical effects of the laser on tissue.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "general surgical instrument" used to "cut or coagulate tissues" and provide "interstitial laser coagulation." This describes a device used on the patient's body for therapeutic or surgical purposes.
- Device Description: The description focuses on the laser and fiberoptic for delivering energy to tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body), such as blood, urine, tissue biopsies, etc. The device's function is directly applied to the patient's tissue.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's function is clearly surgical and therapeutic, not diagnostic.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
When used as a general surgical instrument, the laser is able to provide power to cut or coagulate tissues.
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
Invitro and exvivo testing was conducted to establish equivalence to predicate devices in terms of safety and efficacy and to characterize the performance of the laser system using different types of fiber optics.
When used as a general surgical instrument, the laser is able to provide power to cut or coagulate tissues. The table below shows the penetration depth in porcine tissues (invitro) as a function of time and exposure to diode laser power. Penetration depths for other types of tissues are not presented in the table below, however tissues with similar coloration will result in similar penetration depths. For gynecological application in which it is desired to treat highly vascular endometrial tissue, liver can be used as a reference.
Key Metrics
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Predicate Device(s)
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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.
0
Section K : Summary of Safety and Effectiveness
Invitro and exvivo testing was conducted to establish equivalence to predicate devices in terms of safety and efficacy and to characterize the performance of the laser system using different types of fiber optics.
When used as a general surgical instrument, the laser is able to provide power to cut or coagulate tissues. The table below shows the penetration depth in porcine tissues (invitro) as a function of time and exposure to diode laser power. Penetration depths for other types of tissues are not presented in the table below, however tissues with similar coloration will result in similar penetration depths. For gynecological application in which it is desired to treat highly vascular endometrial tissue, liver can be used as a reference.
| Exposure
| Power/Time | Penetration Depth (mm) | ||
|---|---|---|---|
| Liver | Kidney | Heart | |
| 5 Watts / 1 sec | 1.73±0.20 | 1.75±0.34 | 1.77±0.37 |
| 5 Watts / 2 sec | 2.48±0.73 | 2.29±0.31 | 2.19±0.62 |
| 5 Watts / 5 sec | 3.37±0.64 | 3.31±0.39 | 3.03±0.72 |
| 10 Watts / 1 sec | 2.26±0.47 | 1.90±0.35 | 2.25±0.62 |
| 10 Watts / 2 sec | 3.30±0.59 | 2.36±0.27 | 2.16±0.35 |
| 10 Watts / 5 sec | 4.34±0.78 | 3.65±0.54 | 2.89±0.34 |
| 15 Watts / 1 sec | 2.35±0.45 | 2.60±0.35 | 2.16±0.32 |
| 15 Watts / 2 sec | 3.61±0.50 | 3.17±0.38 | 2.58±0.34 |
| 20 Watts / 1 sec | 2.99±0.48 | 2.64±0.50 | 1.99±0.36 |
| 20 Watts / 2 sec | 3.27±1.34 | 2.98±0.77 | 3.48±0.79 |
| 25 Watts / 1 sec | 2.81±1.13 | 2.24±0.53 | 2.96±0.83 |
| 25 Watts / 2 sec | 3.65±0.72 | 3.17±1.04 | 2.81±0.44 |
When used as a coagulating device, the Indigo laser in conjunction with a diffusing fiberoptic provides interstitial laser coagulation. The process of interstitial laser coagulation relies on quickly elevating tissue to a temperature range (Appox. 60 to 100°C) where tissue necrosis rapidly occurs, but below temperatures at which carbonization begins. Lesion sizes vary according to diffuser length and variation of tissue conditions.
2/6/97 GYN-SumSE