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LaserDock is indicated to hold laser fibers and prevent any unwanted laser emissions from escaping LaserDock. The LaserDock is designed for use with Ho:YAG ("HolmiumDock"), Nd:YAG, CO2 ("CO2Dock", OmniDock"), and KTP ("KTPDock") laser systems when laser fibers are deployed.

The LaserDock is a sterile holster accessory to be used with surgical lasers and fiber optic laser energy delivery devices (laser fibers). The LaserDock can be marketed under the following brand names (HolmiumDock, CO2Dock, OmniDock, or KTPDock). During a clinical procedure, when the laser fiber is not deployed in the patient, insertion into the LaserDock provides a sterile and secure holster for temporarily protecting the laser fiber. The sterility of the laser fiber is maintained by the sterile LaserDock.

The LaserDock is a single use sterile device comprising of an inner medical grade silicone tube, a clamp for securing the laser fiber in place, and a clam shell housing to protect the inner silicone tubing. When not in use, the laser fiber is held securely within the sterile medical grade silicone tubing by a twist clamp. Upon insertion of the laser fiber into the Laserdock, accidental discharging of laser energy is prevented from escaping the LaserDock and injuring or burning users and patients or creating potential fire hazards within the sterile field or outside of the sterile field.

This document describes the validation of the "LaserDock" device, which is designed to hold laser fibers and prevent unwanted laser emissions. The study aims to demonstrate substantial equivalence to a previously cleared device (K152636) and ensure the safety and effectiveness of the updated device.

1. Table of Acceptance Criteria and Reported Device Performance:

• 200–500 um fiber: 5 lb/f
• 500–1000 um fiber: 2–5 lb/f
• 1–2.1 mm fiber: 2–5 lb/f
  (Based on largest force parameter (5lb/f) for KTP green light 180 moxy fiber and smallest force parameter (1lb/f) for 200um fiber, and maximum grip users can get with a wet glove (0.7lb/f). | All pull testing passed for both the predicate and proposed LaserDock according to the specified force parameters for different fiber diameters. |
  | Accidental Laser Fiber Suppression | Containment material shows no visual signs of exposure stress after 10 seconds of direct laser energy exposure at maximum power. Outer shell shows no heat transfer. | Containment material showed no visual signs of exposure stress after being exposed to each of the four wavelengths (532nm, 980nm, 1064nm, 2100nm) at maximum power (30W, 180W, 100W, 100W respectively) and 10-second exposure times. The outer shell did not have any heat transferred to it. |
  | Primary Ignition (ISO 11810-1:2005) | Material classified as Class I1 (does not ignite after 10 seconds of focused laser contact). | All samples were classified as Class I1 material (material does not ignite after 10 seconds of focused laser contact), indicating it is safe and does not present a risk as a primary ignition source. |
  | Secondary Ignition (ISO 11810-2:2007) | Material classified as Class SI1 (material does not ignite after 10 seconds of focused laser contact, and gauze does not ignite after 10 seconds of energy contact). | All samples were classified as Class SI1 material (material does not ignite after 10 seconds of focused laser contact, and gauze does not ignite after 10 seconds of energy contact), indicating it is safe and does not present a risk as a secondary ignition source. |
  | Penetration (ISO 11810-1:2005 & 11810-2:2007) | Material classified as Class P1 (no penetration observed after 10 seconds of focused laser contact). | All samples were classified as Class P1 material (no penetration observed after 10 seconds of focused laser contact), indicating it is safe and does not present a risk for penetration. |

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of number of devices. Instead, performance testing was conducted on "samples" of the LaserDock device. For each test (sterility, biocompatibility, fiber securement, laser suppression, ignition, penetration), "all samples" were tested or "validation testing was performed initially" or "testing was performed using CO2." The exact number of units subjected to each specific test is not provided beyond these general statements.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It describes laboratory-based performance testing of the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This documentation describes performance testing of a physical device, not an AI or diagnostic system that relies on expert interpretation for ground truth. Therefore, there were no experts used to establish ground truth in this context. The "ground truth" is defined by the physical properties and performance characteristics of the material and design as measured by established engineering and safety standards.

4. Adjudication Method for the Test Set:

• Not applicable as this is performance testing of a physical device against engineering and safety standards, not a diagnostic task requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance:

• Not applicable. This is not an AI-assisted diagnostic device, but a physical accessory for laser systems.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance is the device's inherent physical performance as tested.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• The ground truth for this device's performance is established by engineering standards and physical measurements based on:
  • Sterilization Validation (e.g., achieving SAL 10⁻⁶)
  • Biocompatibility Standards (e.g., ISO recognized tests for cytotoxicity, irritation, sensitization, pyrogenicity)
  • Mechanical Force Testing (e.g., pull force in lb/f)
  • Laser Energy Containment and Thermal Dissipation (e.g., visual inspection for stress, absence of heat transfer)
  • Fire Safety and Penetration Standards (e.g., ISO 11810-1:2005, ISO 11810-2:2007 classifications)

8. The Sample Size for the Training Set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. No training set was used.

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