(89 days)
The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including:
- urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery.
- urology; general surgery; gastroenterology; thoracic & pulmonary surgery; E.N.T. surgery; podiatry; orthopaedics; dermatology and plastic surgery and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.
The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with accessories are indicated for use in the performance of specific surgical applications in urology, urinary lithotripsy, arthroscopy/orthopaedics, discectomy, E.N.T. surgery, gynecological surgery/gynecology, general surgery, gastroenterology, thoracic and pulmonary surgery, dermatology and plastic surgery, podiatry, and limited indications in neurosurgery and ophthalmology as follows: [Specific indications for each medical specialty and laser type are listed in detail in the document].
The Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers that are the subject of this Premarket Notification 510(k) submission are comprised of the following functional components:
- a laser console;
- control and display panel;
- a fiber port for delivery systems;
- system microprocessor control electronics;
- a covered footswitch or handswitch;
- operating software;
- an optional remote control unit;
- a variety of fiber optic delivery devices with accessories.
The Lumenis delivery devices that are the subject of this Premarket Notification 510(k) submission are comprised of all or some (depending on the product configuration) of the following functional components:
- laser connector;
- handpiece;
- probe tube;
- probe tip;
- fiber optic cable.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Modified Lumenis VersaPulse PowerSuite Surgical Lasers:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary statement does not include explicit, quantifiable acceptance criteria or performance metrics for the modified device. Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices.
Therefore, the table below will reflect the nature of the information provided, which is a claim of substantial equivalence for intended use, indications for use, design, and functional features.
| Acceptance Criterion (Implicit from Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Intended Use: Functionally equivalent to predicate devices. | The Modified Lumenis VersaPulse PowerSuite Surgical Lasers share the same intended use as the currently marketed and predicate surgical lasers. |
| Indications for Use: Equivalent to predicate devices. | The Modified Lumenis VersaPulse PowerSuite Surgical Lasers share the same indications for use as the currently marketed and predicate surgical lasers. |
| Design Features: Similar to predicate devices. | The Modified Lumenis VersaPulse PowerSuite Surgical Lasers have similar design features as the currently marketed and predicate surgical lasers. |
| Functional Features: Similar to predicate devices. | The Modified Lumenis VersaPulse PowerSuite Surgical Lasers have similar functional features as the currently marketed and predicate surgical lasers. |
| Safety and Effectiveness: Equivalent to predicate devices. | Safety and effectiveness information was provided to demonstrate that the modified devices are safe and effective when used as indicated, implicitly equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on the concept of substantial equivalence, meaning that new clinical studies with test sets are generally not required if the device is sufficiently similar to legally marketed predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document does not describe a clinical study with a test set requiring ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable as the document does not describe a clinical study with a test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this document. The submission is for a surgical laser system, which is a physical medical device, not an AI or imaging diagnostic tool that would typically undergo MRMC studies. The concept of "human readers improving with AI vs. without AI assistance" does not apply to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm-only performance study was not done. This device is a laser surgical system, which inherently requires human-in-the-loop operation by a trained medical professional.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically understood in studies validating diagnostic or AI devices (e.g., pathology, outcomes data) is not directly applicable here. For this 510(k) submission, the "ground truth" for demonstrating safety and effectiveness implicitly relies on:
- Established safety and efficacy of the predicate devices: The primary argument is that because the modified device is substantially equivalent to predicate devices that have already been deemed safe and effective, the modified device also meets these criteria.
- Engineering and performance testing: While not detailed in this summary, the submission would have included technical performance data demonstrating that the laser meets its specifications and operates safely within expected parameters (e.g., power output, wavelength, pulse duration). This testing serves as the "ground truth" for the device's physical performance, but not in the clinical diagnostic sense.
8. The Sample Size for the Training Set
This information is not applicable. This document describes a surgical laser device, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device.
§ 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.