(26 days)
Surgical Laser Fibers are intended to be used in conjunction with cleared surgical lasers equipped with SMA 905 or SMA 906 or compatible connector.
Surgical Laser Fibers are indicated for use in general surgical applications for: incision, excision, vaporization, ablation, haemostasis or coagulation of soft tissue in a contact or non-contact mode (with a compatible laser marketed for use in the desired application).
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.
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.
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.
Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.
Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode.
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.
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, contraindications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.
The Surgical Laser Fibers are a Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue. The Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetrafluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) long and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations (flat and ball shaped) and several core diameter sizes (from 200 to 1000 microns) are offered.
The provided text is a 510(k) premarket notification for "Surgical Laser Fibers" (K180158). This document primarily focuses on establishing substantial equivalence to a predicate device and does not describe a study proving the device meets specific acceptance criteria in the way a diagnostic algorithm or predictive model would.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present quantitative acceptance criteria or device performance data in the typical sense of a diagnostic or predictive device. Instead, it relies on demonstrating compliance with recognized consensus standards and "substantial equivalence" to a predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Sterilization | Complies with EN 556-1:2006, ISO 11135-1:2007, ISO 11138-2:2006, EN ISO 17665:2006 (for moist heat sterilization). |
| Biocompatibility | Complies with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010. Materials are unchanged from predicate, assumed biocompatible. |
| Packaging & Labeling | Complies with ISO 15223-1:2012, EN 1041:2008, ISO 11607-1:2006, ISO 11607-2:2006. |
| Risk Management | Complies with ISO 14971:2007. |
| Microbiological Methods | Complies with ISO 11737-1:2006. |
| Fiber Optic Connectors | Complies with IEC 61754-22:2005. |
| Intended Use & Technological Characteristics | Stated as having the "same intended use and the same technological characteristics" as the predicate device (K160513). |
2. Sample Size for Test Set and Data Provenance
Not applicable. This device is a surgical tool, not a diagnostic or AI-driven system that would typically have a "test set" in the context of algorithm performance. The "testing" involved compliance with established medical device standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, in the sense of expert consensus on medical findings, is not relevant for this type of device submission. Compliance with standards is typically assessed by engineers and regulatory experts.
4. Adjudication Method
Not applicable. There is no adjudication method described as this is not a study involving human interpretation of data for diagnosis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The device is a surgical laser fiber, not an AI-assisted diagnostic tool. Therefore, there's no concept of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is its compliance with internationally recognized consensus standards for medical device safety, performance, sterilization, biocompatibility, and packaging. The claim of "substantial equivalence" to a predicate device (K160513) also serves as a form of "ground truth" regarding its safety and effectiveness profile.
8. Sample Size for Training Set
Not applicable. This is not an AI/ML device trained on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Study/Evidence Provided:
The "study" or evidence provided in this 510(k) submission is primarily a declarative statement of compliance with consensus standards and a comparison to a legally marketed predicate device. The manufacturer asserts that the modified device (K180158) is "substantially equivalent" to its predicate (K160513) because:
- It has the same intended use.
- It has the same technological characteristics.
- Any minor labeling differences do not raise new questions of safety or effectiveness.
- The device (both predicate and subject) complies with a comprehensive list of recognized international and European standards covering aspects like sterility, biocompatibility, packaging, risk management, and fiber optic connector specifications.
Therefore, the "proof" the device meets acceptance criteria lies in its adherence to these established standards and its demonstrated equivalence to a previously cleared device. There are no clinical trials, diagnostic performance metrics, or expert consensus reviews detailed in this document for this specific 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.