(72 days)
The OmniGuide Beam Path OTO-U Fiber for CO2 Laser Systems is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissue. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry , dermatology, gynecology, gastroenterology, neurosurgery, urology and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngology, gastroscopy, colonoscopy, laproscopy, thoracoscopy, hysteroscopy and bronchoscopy.
The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.
The OmniGuide Beam Path OTO-U Fiber is a single use laser surgical instrument provided sterile for use in transmitting laser energy at 10.6 µm from a CO2 Laser System to a surgical site through an endoscope, flexible or rigid or using an accessory handpiece. It is connected to the laser system utilizing a standard ST II stainless steel fitting which is used by many laser manufacturers. The fiber has the following dimensions and composition:
| Component | Dimensions | Material | Body Contact |
|---|---|---|---|
| ST II Laser Connector | 17 mm L | Stainless Steel | No |
| Connector Insert (Ferrule) | 128μm | Die Cast Stainless Steel | No |
| RFID Wing | 1.18" W x 0.510"H x 0.512"D | Hytrel 6356 | No |
| SMA Medical Boot | 3.0 mm OD | USP Class IV Plastic | No |
| Fused Silica Core | 600 ± 15μm OD | Silica | Yes |
| Silver Coated Bore | 315 ± 10μm ID | Silver | Yes |
| Hard Clad Buffer | 630 ± 15μm OD | Fluorinated Acrylate | Yes |
| Tefzel Jacket | 1350 ± 70μm OD | Tefzel | Yes |
The device consists of an optical fiber assembly. The main functional characteristic is a Silver coating reflector that reflects and thereby contains and guides CO2 laser energy within the fiber. Silver coating is applied along the ID of the cladded fused silica core, allowing 10.6 µm laser energy to be guided along the fiber length and onto a surgical location. The fused silica core is cladded with a thin layer of Fluorinated Acrylate. The core is sheathed with a Tefzel polymer layer.
Helium gas is flowed in the core to provide cooling of the fiber as needed and to prevent contamination of the fiber core.
The fiber assembly is 1 to 2 meters long and transmits at the CO2 laser emission of 10.6 µm. The fiber can be used in single pulse mode, repeat pulse mode and CW mode. Power output is limited to 10 Watts.
The recommended distance between fiber tip and tissue is 3 mm and the recommended gas flow is less than 1 liters per minute.
The FDA medical device approval document provides information about the OmniGuide Beam Path OTO-U Fiber. However, it does not include specific details about acceptance criteria for a clinical study comparing device performance against those criteria, nor does it detail a study proving the device meets acceptance criteria in the way you've outlined for AI/ML device evaluations.
This document describes a 510(k) premarket notification for a Class II medical device (a laser surgical instrument fiber), which focuses on demonstrating substantial equivalence to previously cleared predicate devices. The review is based on non-clinical bench testing and biocompatibility assessments, rather than comparative clinical performance studies with acceptance criteria as one would typically see for AI/ML diagnostic tools.
Here's a breakdown of the information that is available and what is not available based on your request:
Information Available from the Document:
- Device Type: OmniGuide Beam Path OTO-U Fiber for CO2 Laser Systems (a laser surgical instrument accessory).
- Purpose of Submission: To expand the product offering of the OTO product line to include a more flexible modified fiber body, a silver optical reflective coating, and modify the glass configuration of the existing cleared and marketed OTO product offering. This is a modification of an existing technology, not an entirely new diagnostic or prognostic tool.
- Main Characteristic: Silver coating reflector that reflects and guides CO2 laser energy.
- Clinical Performance Data: "Clinical trials were not deemed necessary as the OTO-U is using similar technology, has the same indications for use and has the same intended use." This explicitly states that a clinical study designed to demonstrate performance against acceptance criteria was not performed because substantial equivalence was established through other means.
- Non-Clinical Bench Testing:
- Biocompatibility: Performed according to ISO 10993-1 and FDA Guidance, for an External communicating device contacting tissue/bone for a limited time (
§ 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.