(183 days)
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Evolve HPD Multiwavelength 980/ 1470 Diode Laser (up to 150W) is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the saphenous veins in patients with superficial vein reflux. The Multiwavelength laser is further indicated for laser assisted lipolysis. Power from 151W to 200W is indicated in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH).
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Arthroscopy
Gastroenterology
General Surgery, Dermatology, Plastic Surgery and Podiatry
Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities
Urology
Gynecology
Neurosurgery
Cardiac Surgery
Pulmonary Surgery
Dental Applications
Powers from 151W to 200W
The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser contains the same basic components as the cleared Ceralas 150W 980/ 1470mm Diode Laser (K090164). The purpose of this submission is to increase the energy from 150W to 200W for application in the vaporization of the prostate to treat Benign Prostatic Hyperplasia. (BPH)
The provided text is a 510(k) summary for the Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices and expanding the power range for a specific indication. The document does not contain the level of detail typically found in a clinical study report that would establish specific acceptance criteria and detailed performance metrics.
Therefore, many of the requested fields cannot be directly extracted or inferred from this document. However, based on the information provided, here's what can be answered:
Acceptance Criteria and Device Performance:
The document states that the device complies with several voluntary consensus standards, implying that meeting these standards served as acceptance criteria for certain aspects (e.g., electrical safety, electromagnetic compatibility, biocompatibility).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with 21 C.F.R. §§ 1040.10 & 1040.11 (Performance Standards for Light-Emitting Products) | Device complies |
| Compliance with ANSI/AAMI ES1 (Medical Electrical Equipment - Part 1: General Requirements for Safety – Collateral Standard: Essential Performance Requirements of Medical Electrical Equipment and Medical Electrical Systems) | Device complies |
| Compliance with IEC 601-2-22 (Medical electrical equipment — Part 2-22: Particular requirements for the safety of surgical, cosmetic, therapeutic and diagnostic laser equipment) | Device complies |
| Compliance with EN 60825-1 (Safety of laser products — Part 1: Equipment classification and requirements) | Device complies |
| Compliance with ANSI/AAMI/ISO 10993-7 (Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals) | Device complies |
| Demonstrated safety and effectiveness for power increase from 150W to 200W for vaporization of the prostate to treat BPH (Substantial Equivalence) | "Published clinical data supplied quantifies ablation rates on a per Watt basis for a 980nm laser versus a 1470nm laser, which together with studies using 200W 980nm lasers on human cadaver prostates and 50W 1470nm lasers on prostates of patients with bladder outlet obstruction along with its predicate devices support the conclusion that the device is safe and effective and substantially equivalent to its predicate devices." |
Study Details:
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Sample size used for the test set and the data provenance:
- The document mentions "studies using 200W 980nm lasers on human cadaver prostates" and "50W 1470nm lasers on prostates of patients with bladder outlet obstruction." However, specific sample sizes for these studies are not provided.
- Provenance: "human cadaver prostates" and "prostates of patients." The country of origin is not specified but given it's a US FDA submission, US data is implied or preferred, but not explicitly stated.
- Retrospective or prospective: Not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document refers to "published clinical data" and "studies," but doesn't detail the methodology for establishing ground truth within those studies.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This device is a surgical laser, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a surgical laser, and its performance is inherently tied to its use by a human in a surgical setting. Therefore, a "standalone algorithm only" performance study is not applicable. The "performance data" refers to the physical effects of the laser (ablation rates).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the ablation studies on prostates, the "ground truth" would likely involve objective measurements of tissue ablation, such as volume of tissue removed, depth of penetration, or other physical/histological evaluations of the treated tissue. The document does not explicitly state the specific type of measurement.
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The sample size for the training set:
- The document primarily relies on "published clinical data" and studies on cadaver/patient prostates. There is no mention of a "training set" in the context of an algorithm or AI model, as this is a hardware device.
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How the ground truth for the training set was established:
- As there is no "training set" in the context of an AI model for this hardware device, this question is not applicable. The "ground truth" related to the laser's physical performance (e.g., ablation rates) would be established through direct measurement and observation in experiments.
§ 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.