(300 days)
The Dornier Thulio Laser is intended for minimally-invasive stone fragmentation, surgical tissue preparation such as cutting, ablation, coagulation and vaporization, in the following medical specialties: Urology a) Lithotripsy - Endoscopic fragmentation and pulverization of urethral, ureteral, bladder and renal stones - b) Benign Prostatic Hyperplasia (BPH) - c) Urethral Strictures - d) Bladder Neck Incision of the Prostate (BNI) e) Superficial and invasive bladder, urethral and ureteral tumors
The Dornier Thulio is a compact, mobile, diode pumped Thulium, pulsed, single wavelength surgical laser with a wavelength of 2013 nm. The Dornier Thulio laser is comprised two functional components: (1) a laser console and (2) a dual pedal footswitch (wired or wireless). The laser console emits laser radiation which is transmitted to the application site by a sterile fiber optic delivery system (fiber cable) with a SMA 905 connector. A graphic control panel regulates and displays the operating parameters, application modes, time functions, system status and messages to the user. The control panel consists of a display with integrated touch screen panel applications to control the functions of the laser. Laser energy is transmitted by depressing a foot pedals, both the wired and wireless models, are water-proof and explosion-proof. The Dornier Thulio laser also has the same principles of operation as other currently available medical lasers (switch on the device, set energy, set frequency, set laser mode, connect the lightguide, prepare the footswitch, activate the laser device). The laser energy is transmitted via the use of a laser fiber connected to the Thulio laser.
The Dornier Thulio Laser, a Thulium-doped YAG laser operating at 2013 nm, was evaluated against established performance criteria primarily through non-clinical bench testing and literature review to demonstrate its substantial equivalence to predicate devices, especially the Lumenis Pulse™ 100H/120H (K170121).
Here's a breakdown of the acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The direct acceptance criteria with specific numerical targets are not explicitly stated as "acceptance criteria" in the provided text. Instead, the evaluation focuses on demonstrating comparability and equivalence to known predicate and reference devices regarding clinical functions. Therefore, the "acceptance criteria" are implied to be achieving comparable performance to the predicate/reference devices in key urological applications.
| Acceptance Criterion (Implied) | Reported Device Performance (Dornier Thulio Laser) |
|---|---|
| Similar Pressure Generation (Lithotripsy) | Produced similar pressure in almost all investigated settings compared to Medilas H Solvo 35 Ho:YAG. Comparable risk profile for laser lithotripsy. |
| Comparable Dusting Performance (Lithotripsy) | Dusting performance proved to be comparable to Medilas H Solvo 35 Ho:YAG laser device at similar settings. |
| Similar Fragmentation Efficiency (Lithotripsy) | Fragmentation efficiency was similar to Ho:YAG lasers (specifically Medilas H Solvo 35 Ho:YAG). |
| Comparable Retropulsion Force (Lithotripsy) | When compared to Medilas H Solvo 35 Ho:YAG at the same settings, both devices gave comparable values with a slight tendency towards lower retropulsion forces with the Dornier Thulio. |
| Comparable Tissue Cutting and Coagulation Performance | Enucleation performance rated comparable to high-power Ho:YAG (Dornier Medilas H140) and low-power Ho:YAG (Dornier Medilas H Solvo 35). |
| Compliance with Safety and Performance Standards | Evaluated according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC60601-1-6. |
| Software Verification and Validation | Performed in accordance with FDA Guidance for Industry and FDA Staff. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact "sample sizes" in terms of number of cases or experimental repetitions for the non-clinical bench testing mentioned. The descriptions refer to "in-vitro experiments" and "a study" for lithotripsy and cutting/coagulation.
- Data Provenance: The studies were non-clinical bench tests (in-vitro experiments). Therefore, there is no country of origin for human data, as no human or animal subjects were involved. The provenance is laboratory-based testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. As the studies were non-clinical bench tests (in-vitro), the concept of "experts establishing ground truth for a test set" in a clinical sense does not directly apply. The 'ground truth' for these tests would be the physical measurements and observations made during the bench testing, with the comparison being against established performance characteristics of the reference Ho:YAG lasers.
4. Adjudication Method for the Test Set
Since the studies were non-clinical bench tests focusing on physical properties and performance metrics (pressure, dusting, fragmentation, retropulsion, enucleation), an adjudication method as typically applied to human-read medical imaging or clinical outcomes (e.g., 2+1, 3+1 consensus) is not applicable or described. The results would likely be based on direct measurements and quantitative analysis of the physical parameters.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The studies described are non-clinical bench tests comparing the physical effects of the Dornier Thulio Laser to other laser devices. There is no mention of human readers or AI assistance.
6. Standalone (Algorithm Only) Performance
This question is not applicable to this device. The Dornier Thulio Laser is a physical surgical laser device, not an AI algorithm or software. Its performance is inherent to its hardware and operational parameters, not a standalone algorithm.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance studies was primarily based on:
- Physical measurements and quantitative analysis of laser effects in an in-vitro (bench test) environment (e.g., pressure produced, fragmentation efficiency, retropulsion force, tissue cutting/coagulation depth/area).
- Comparison against the known and established performance characteristics of the predicate and reference Ho:YAG lasers (Medilas H Solvo 35 and Medilas H140), which serve as the "ground truth" for what is considered acceptable or comparable performance in the field.
8. Sample Size for the Training Set
This information is not applicable as the Dornier Thulio Laser is a hardware device (surgical laser) and not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device does not use a training set.
§ 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.