(15 days)
The Quanta System Polysurge Diode Laser Family, including the Polysurge808, Polysurge940, Polysurge980, Polysurge1064, Polysurge1320, Polysurge1470 and Polysurge1950 (and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
The Polysurge Diode Laser System includes seven models: Polysurge808, Polysurge940, Polysurge980, Polysurge1064, Polysurge1320, Polysurge1470 and Polysurge1950 with different wavelengths and laser power. The Polysurge Diode Laser Family is designed with 5 major subsystems: (1) an external structure; (2) power electronics; (3) display with control electronics; (4) the laser system with an opto-mechanical block and (5) the cooling system. In addition to the five subsystems, the Polysurge Diode Laser Family incorporates several safety features, including a remote interlock, an emergency red push button and a key switch. The external accessories include separate optical fibers and hand pieces for dental, dermatological and surgical applications, or for endovascular applications.
This 510(k) summary for the Quanta System Polysurge Diode Laser Family does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the manner one might expect for a diagnostic or AI-driven device.
Instead, this document focuses on establishing substantial equivalence to predicate devices. For medical devices that are not significantly different from devices already legally marketed (predicate devices), the FDA’s 510(k) pathway allows market clearance withoutrequiring new clinical trials to demonstrate safety and effectiveness from scratch.
This means the "study that proves the device meets the acceptance criteria" is implicitly the demonstration that the new device is as safe and effective as the predicate devices, which were themselves proven safe and effective through prior regulatory processes. The acceptance criteria are therefore aligned with the performance and safety characteristics of those predicate devices.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Implicit - Derived from Predicate Devices): The Quanta System Polysurge Diode Laser Family must demonstrate clinical performance (vaporization, incision, excision, ablation, cutting, hemostasis, coagulation of soft tissue, etc.) across various medical specialties and for specific applications, comparable to the predicate devices. The safety profile must also be comparable.
Reported Device Performance:
The document does not provide specific quantitative performance metrics for the Quanta System Polysurge Diode Laser Family. Instead, it relies on the principle of substantial equivalence, stating:
"The Quanta System Polysurge Diode Laser Family is as safe and effective as the predicate devices. The Polysurge Diode Laser Family has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Polysurge Diode Laser Family and its predicate devices raise no new issues of safety or effectiveness. Thus, the Polysurge Diode Laser Family is substantially equivalent."
The performance is "reported" by defining its intended uses and indications for use across multiple wavelengths and medical specialties, implying that it performs these functions equivalently to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| The device must be safe and effective for its intended uses and indications, demonstrating comparable clinical outcomes (e.g., efficacy in vaporization, incision, excision, ablation, cutting, hemostasis, coagulation of soft tissue, and specific applications across various medical specialties) as the predicate devices. This includes ensuring the stated wavelengths and power outputs achieve the clinical effects without new safety concerns. | The document asserts: "The Quanta System Polysurge Diode Laser Family is as safe and effective as the predicate devices. The Polysurge Diode Laser Family has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Polysurge Diode Laser Family and its predicate devices raise no new issues of safety or effectiveness. Thus, the Polysurge Diode Laser Family is substantially equivalent." |
The device's performance is therefore implicitly deemed satisfactory based on the established safety and efficacy of the predicate devices. The vast list of indications for use (spanning multiple pages) serves as the "reported performance" by demonstrating the broad range of applications for which equivalence is claimed. |
| Must meet the clinical performance standards set by the predicate devices: - Quanta System Diode Medical Laser Family (K072034) - INTERmedic Diode Laser Family (K053540) - Dornier Medilase D Family Laser (K070536) - Biolitec 150W Ceralas D 980nm Diode Laser (K072106) - Trimedyne Optilase PL100 Nd:YAG Laser (K932883) - CoolTouch LC215 Nd:YAG Laser (K072424) - Biolitec 15W Ceralas D 1470nm Diode (K073063) - Biolitec 50W Ceralas D 1950nm Diode (K072682) | The device's performance is argued to be "substantially equivalent" to these specific predicate devices. The document highlights that the new device shares "the same intended uses and similar indications, technological characteristics, and principles of operation." |
| Ensure that any "minor technological differences" (e.g., variations in specific wavelengths or power outputs within the family) do not introduce any new safety or effectiveness concerns compared to the predicate devices. | The submission explicitly states: "The minor technological differences between the Polysurge Diode Laser Family and its predicate devices raise no new issues of safety or effectiveness." This implies that the sponsor presented evidence (e.g., bench testing, engineering analysis) to FDA to demonstrate that these differences do not negatively impact safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study or a test set with a specific sample size in the context of proving the device meets acceptance criteria for a new clinical performance claim. The evidence provided is primarily based on a comparison to predicate devices, focusing on technological characteristics and intended uses.
Therefore, details such as data provenance (country of origin, retrospective/prospective) are not provided because a dedicated clinical study for this 510(k) submission is not presented.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. Since no new clinical study (test set) is described, there's no mention of experts establishing a ground truth for a test set. The "ground truth" for the device's safety and effectiveness is implicitly established by the regulatory clearance of the predicate devices.
4. Adjudication Method
Not applicable, as no new clinical study (test set) is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study would typically be performed for diagnostic imaging devices to assess the impact of AI on human readers. The Quanta System Polysurge Diode Laser Family is a surgical laser, and its clearance is based on substantial equivalence, not an MRMC study.
6. Standalone Performance
The concept of "standalone performance" for a surgical laser would refer to its inherent ability to perform the stated functions (vaporization, cutting, etc.) as an algorithm-only device would for AI. While the laser itself is a standalone device in operation, the document doesn't provide specific performance metrics from standalone testing in the way an AI algorithm's standalone performance might be reported (e.g., sensitivity, specificity). Its "standalone performance" is implicitly that it functions as described and comparable to predicate devices.
7. Type of Ground Truth Used
The "ground truth" for the safety and effectiveness of the Quanta System Polysurge Diode Laser Family is the prior regulatory clearance and established safety/effectiveness of the predicate devices. This is explicitly stated in the substantial equivalence claim. There is no mention of pathology, outcomes data, or expert consensus being used to establish a new ground truth for this submission, as it leverages the existing regulatory history of similar devices.
8. Sample Size for the Training Set
Not applicable. This device is a surgical laser, not an AI/machine learning model, so there is no training set in the context of data used to train an algorithm.
9. How Ground Truth for the Training Set Was Established
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.