(197 days)
When used as a general surgical instrument, the laser is able to provide power to cut or coagulate tissues.
The Indigo laser in conjunction with a diffusing fiberoptic provides interstitial laser coagulation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the K963081 device, presented in the requested format:
Acceptance Criteria and Device Performance Study (K963081)
This submission describes the performance characteristics of a laser system as a general surgical instrument for cutting or coagulating tissues. The study focuses on quantifying penetration depth in various porcine tissues under different power and exposure settings.
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state pre-defined acceptance criteria. Instead, it presents the reported device performance as measured penetration depths in different porcine tissues. If acceptance criteria were to be inferred, they would likely revolve around the laser's ability to consistently achieve specific penetration depths for cutting/coagulating, or to demonstrate comparable performance to predicate devices (though specific predicate performance isn't detailed here).
| Exposure Power/Time | Anticipated/Targeted Performance (Acceptance Criteria - Inferred/Not Explicit) | Reported Device Performance (Penetration Depth in mm, Mean ± Std Dev) |
|---|---|---|
| Liver | Kidney | |
| 5 Watts / 1 sec | N/A (Performance demonstrated) | N/A (Performance demonstrated) |
| 5 Watts / 2 sec | N/A (Performance demonstrated) | N/A (Performance demonstrated) |
| 5 Watts / 5 sec | N/A (Performance demonstrated) | N/A (Performance demonstrated) |
| 10 Watts / 1 sec | N/A (Performance demonstrated) | N/A (Performance demonstrated) |
| 10 Watts / 2 sec | N/A (Performance demonstrated) | N/A (Performance demonstrated) |
| 10 Watts / 5 sec | N/A (Performance demonstrated) | N/A (Performance demonstrated) |
| 15 Watts / 1 sec | N/A (Performance demonstrated) | N/A (Performance demonstrated) |
| 15 Watts / 2 sec | N/A (Performance demonstrated) | N/A (Performance demonstrated) |
| 20 Watts / 1 sec | N/A (Performance demonstrated) | N/A (Performance demonstrated) |
| 20 Watts / 2 sec | N/A (Performance demonstrated) | N/A (Performance demonstrated) |
| 25 Watts / 1 sec | N/A (Performance demonstrated) | N/A (Performance demonstrated) |
| 25 Watts / 2 sec | N/A (Performance demonstrated) | N/A (Performance demonstrated) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The sample size for each data point (e.g., number of tissue samples tested for each power/time setting) is not explicitly stated. The reported "mean ± standard deviation" implies multiple measurements were taken for each condition.
- Data Provenance:
- Origin: Porcine tissues (animal origin).
- Study Type: Invitro and exvivo testing. This means the tests were conducted on biological materials outside of their normal biological context (e.g., excised organs in a lab).
- Retrospective/Prospective: The study described is inherently prospective as it involves controlled experimental conditions to characterize the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. The "ground truth" (penetration depth) in this study is a direct physical measurement. It does not rely on expert interpretation or consensus.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Penetration depth is a quantitative measurement, not subject to subjective adjudication. The standard deviation reported suggests variability in measurement or tissue properties, but not a need for expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This study is focused on the physical performance characteristics of a laser device, not on the interpretative performance of human readers or AI algorithms.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a laser system, not an algorithm. Its performance is measured directly, not through an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: The ground truth is direct physical measurement of penetration depth in biological tissue samples.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI study that involves training data. The study describes experimental characterization of a physical device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set mentioned or implied in this submission.
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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.
| ExposurePower/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
§ 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.