(150 days)
The O-pel laser and families of probe delivery devices are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including Arthroscopy, Urology, ENT, Dermatology, Plastic Surgery, General Surgery, Gastroenterology, Thoracic and Pulmonary and Gynecology.
The O-pel laser is an infrared laser system with an output wavelength of approximately 2μm. The O-pel laser and families of probe delivery devices (O-pel laser system) have an Intended Use of cutting and coagulating tissue, specifically incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue. The O-pel laser system is comprised of the following components:
-a laser console
-control and display panel;
-a fiber port for delivery systems;
-a footswitch:
-a variety of fiber optic (probe) delivery devices
The provided text is a 510(k) summary for the O-pel Laser and families of probe delivery devices. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, indications for use, design features, and functional features.
Crucially, the document explicitly states: "Substantial equivalence was not based upon clinical performance." This means that a clinical study designed to test the device's performance against pre-defined acceptance criteria was not conducted or presented in this submission. Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them.
The sections you asked for, such as sample size, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, are all related to clinical performance studies, which were not part of this 510(k) submission.
The document does include information on non-clinical performance data, primarily related to safety and compatibility:
- Electromagnetic Compatibility: Tested to IEC 60601-1-2: 2007 and found to comply.
- Electrical Safety: Tested to IEC 60601-1: 2007 and found to comply.
- Laser Safety: Tested to IEC 60601-2-22 and IEC 60825-1 and found to comply.
- Coexistence: Tested to FDA Guidance, "Radio Frequency Wireless Technology in Medical Devices" (August 14, 2013) and found to comply.
- Biocompatibility:
- Tests performed: ISO 10993-5 (in vitro cytotoxicity) and ANSI/AAMI/ISO 10993-7 (ethylene oxide sterilization residues).
- Evaluation conducted per FDA draft guidance document, "Use of International Standard ISO 10993. Biological Evaluation of medical devices Part 1: Evaluation and Testing" (April 23, 2013).
However, these are safety and engineering performance tests, not clinical efficacy or effectiveness studies with acceptance criteria in the sense of demonstrating how well the device performs a specific clinical task in a patient population.
§ 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.