(23 days)
Quanta System Surgical Laser Fibers are intended to be used in conjunction with any cleared surgical laser manufactured by Quanta System equipped with SMA 905 or SMA 906 or compatible connector.
Quanta System Surgical Laser Fibers are indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode (with a compatible laser marketed for use in the desired application).
Quanta System Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/ otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.
Quanta System Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 mm to 2100 om, with pulsed and continuous wave (CW) emission mode.
Quanta System Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho;YAG, Nd;YAG, Tm:YAG pulsed and continuous wave CW laser devices.
Quanta System Surgical Laser Fibers may be used in surgical specialty or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.
The Quanta System Surgical Laser Fibers are a family of medical devices. The Quanta System Surgical Laser Fibers are a Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes.
The Quanta System Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetraffluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) in length and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and various core diameter sizes (150, 200, 272, 365, 400, 550, 600, 800 and 1000 microns) are offered.
The provided document is a 510(k) summary for Quanta System Surgical Laser Fibers, which details a submission for modifications to an already cleared device (K131473). The key aspect of this submission is a change to the labeling information regarding reprocessing instructions.
Therefore, the primary study conducted and the acceptance criteria are related to the validation of these new reprocessing instructions to ensure the modified device remains safe and effective, similar to the original device. The document states: "In addition to the performance data provided for the unmodified device (K131473), the modified device reprocessing instructions have been validated."
Since this is a modification to reprocessing instructions for a physical laser fiber, the "acceptance criteria" discussed are likely performance metrics for the fiber after reprocessing, rather than, for example, diagnostic algorithm performance metrics (like sensitivity/specificity) which would be relevant for an AI-powered diagnostic device.
Based on the provided text, a detailed table of acceptance criteria and reported device performance from a specific study directly addressing the modified reprocessing instructions is not explicitly provided in a quantifiable format. However, we can infer the nature of the evaluation.
Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided document for some points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred for Reprocessing Validation) | Reported Device Performance (Inferred from "Validated") |
|---|---|
| Sterility/Cleanliness: Fibers must be sterile or effectively clean after reprocessing according to manufacturer's instructions. | Reprocessing instructions have been "validated," implying that post-reprocessing fibers meet sterility and cleanliness requirements. Specific quantitative outcomes (e.g., bioburden reduction, endotoxin levels) are not provided in this summary. |
| Functional Integrity: Fibers must maintain their structural and functional integrity (e.g., optical transmission, mechanical strength) after multiple reprocessing cycles. | Reprocessing instructions have been "validated," implying that fibers remain functional and structurally sound after reprocessing. Specific quantitative outcomes (e.g., optical power loss, tensile strength, number of reprocessing cycles tested) are not provided. |
| Material Compatibility: Materials must not degrade or leach harmful substances due to reprocessing agents or methods. | Reprocessing instructions have been "validated," implying material compatibility is maintained. No specific details on material degradation or leaching. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used to validate the reprocessing instructions.
- Sample Size: Not specified.
- Data Provenance: Not specified. This would typically be from laboratory testing and potentially in-house or third-party validation studies. It's prospective in the sense that the new instructions are tested.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information is generally not applicable for the validation of reprocessing instructions of a physical device. Ground truth for reprocessing validation typically involves laboratory measurements and established sterility/cleanliness standards rather than expert clinical consensus or interpretation.
4. Adjudication Method
Not applicable for reprocessing validation. Adjudication methods like 2+1 or 3+1 are used for expert review of images or clinical cases, not for laboratory testing of device reprocessing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of data. The Quanta System Surgical Laser Fibers are a physical surgical tool; their reprocessing instructions do not involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. This device is a physical surgical fiber, not an algorithm, and does not have standalone algorithmic performance.
7. Type of Ground Truth Used
The ground truth for reprocessing validation would be based on:
- Established Performance Standards: Industry standards (e.g., ISO, AAMI) for sterility, bioburden reduction, cleaning efficacy, and material compatibility.
- Laboratory Measurements: Direct quantifiable measurements of microbial load, optical transmission, mechanical properties, and material integrity after reprocessing.
8. Sample Size for the Training Set
Not applicable. Reprocessing validation does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no training set. The "ground truth" for validation would be established through adherence to scientific principles of sterilization/disinfection and performance testing protocols.
Summary of Study:
The "study" referenced in this 510(k) summary is the validation of the modified device reprocessing instructions. While specific details of the validation study (e.g., protocols, sample sizes, quantitative results) are not provided in this summary document, the FDA's clearance implies that such a study was performed and demonstrated "substantial equivalence" of the modified device to the predicate (K131473). This validation would have focused on ensuring that the new reprocessing steps maintain the device's original performance, safety, and effectiveness, particularly concerning sterility, functional integrity, and material compatibility over its intended lifespan. The phrase "the modified device reprocessing instructions have been validated" serves as the key statement indicating that the necessary tests were conducted and met the required performance standards.
§ 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.