(186 days)
The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including: Oropharangeal / Dental Surgery, General Surgery, Endonasal Surgery, Podiatry, and Dermatology and Plastic Surgery.
The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers are comprised of the following main components: Main console containing the major electrical components, including: A Control/ Display Panel, A 1064 nm treatment laser (solid state Nd: YAG laser rod) with flashlamp and associated light regulation components and electronics; A 630 -680 nm (red) aiming beam diode laser; A Delivery device fiber-optic connector port; A Remote interlock connector (External door interlock connector); A Connector ports for the footswitch and power cord; A Accessory holder (attached to the rear of the main console); Footswitch; Medical grade power cord; Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue: Guide Tip -No Standoff, Guide Tip With Standoff; Delivery Devices for Contact with Breached Surfaces (Previously Cleared in K011423): Optical Fibers, Handpieces, Handpiece Tips; Accessories: Safety Glasses, Tools: Optical Fiber Striper, Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).
This K083616 submission is for a Traditional 510(k) for PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (K083616) does not contain specific acceptance criteria or detailed device performance metrics in a manner typical for medical device studies evaluating diagnostic accuracy or algorithmic performance. This is a 510(k) summary for a laser device, and its primary purpose is to demonstrate substantial equivalence to predicate devices, not to present a rigorous performance study of a new diagnostic algorithm.
The core claim is that the device is "substantially equivalent" to existing predicate devices. This means that the device is considered as safe and effective as a legally marketed device without requiring a new PMA. The "performance" in this context is the general functionality and intended use, which is deemed equivalent to the predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Lumenis VersaPulse PowerSuite, Incisive InPulse Dental Laser) | Shared "same or similar indications for use, device operation, overall technical and functional capabilities." |
| Safety Profile Equivalent to Predicates | Not explicitly detailed, but implied by substantial equivalence claim. |
| Effectiveness Profile Equivalent to Predicates | Not explicitly detailed, but implied by substantial equivalence claim. |
| Compliance with General Controls | Not detailed; this is an FDA requirement for all devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable/not provided. This submission is for a laser surgical instrument, not a device that relies on a "test set" of data for performance evaluation in the way a diagnostic algorithm would.
- Data Provenance: Not applicable/not provided for performance evaluation. The submission relies on a comparison to predicate devices and their established safety and effectiveness.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable/not provided. This type of expert assessment for ground truth is specific to studies evaluating diagnostic accuracy or image interpretation, which is not the nature of this device submission.
4. Adjudication Method for the Test Set:
- Not applicable/not provided.
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/not provided. This is a laser surgical instrument, not an AI-powered diagnostic device that involves human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable/not provided. The device is a surgical laser, not an algorithm.
7. The Type of Ground Truth Used:
- Not applicable/not provided in the context of a "ground truth" for a performance study. The "truth" in this submission relies on the established safety and effectiveness of the predicate devices for their stated indications.
8. The Sample Size for the Training Set:
- Not applicable/not provided. There is no AI algorithm being trained for this device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/not provided.
Summary of Device and Acceptance Criteria (from the provided text):
The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers are 1064 nm Nd:YAG lasers intended for surgical procedures involving ablation, vaporization, incision, and coagulation of soft tissue across various medical specialties (general & cosmetic dentistry, ENT, dermatology & plastic surgery, general surgery, endonasal surgery, podiatry).
The acceptance criteria for this 510(k) submission are implicitly tied to the FDA's "substantial equivalence" determination. This means the device must demonstrate that it is as safe and effective as legally marketed predicate devices. The "study" to prove this is the comparison of the new device's characteristics and intended uses to those of the predicate devices.
The submission lists the following as proof of shared characteristics:
- Identical indications for use (as extensively listed in the "Indications for Use" section).
- Similar design features.
- Similar functional features.
- Similar device operation.
- Similar overall technical and functional capabilities.
The FDA's decision to clear the device (K083616) on June 12, 2009, signifies that they found these comparisons sufficient to deem the PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers substantially equivalent to the identified predicate devices (Lumenis VersaPulse PowerSuite and Incisive InPulse Dental Laser).
§ 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.