(104 days)
The fiber optic laser delivery system is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fiber optic laser delivery system is intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is 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. It is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho:YAG, Nd:YAG, 1.44YAG, and Diode Lasers (635-1900nm) with peak and continuous power from 1-200W. Core size 230um- 45W, 365um- 113W, 400um-135W, 600um- 200W, 800um-200W, and 1000um-200W.
The fiber optic laser delivery system contains the same components and design as the already cleared CeramOptec MegaBeam optical fibers and the Biolitec radial emitting shaped fiber optic delivery system. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath. The fibers distal tip can be several configurations and the fiber can be used with handpieces.
The provided text is a 510(k) summary for a medical device called the "Fiberoptic Laser Delivery System." This document is a premarket notification to the FDA, demonstrating substantial equivalence to already legally marketed predicate devices, rather than a study proving the device meets acceptance criteria through performance testing.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable or explicitly stated as not performed in this type of submission. The submission relies on the established performance of the predicate devices for substantial equivalence.
Here's the information that can be extracted or deduced from the provided text, with clarifications where the requested information is not available:
1. A table of acceptance criteria and the reported device performance
The submission does not present specific acceptance criteria with quantitative performance values for the new device, nor does it report new performance data as a study was not conducted. Instead, it claims substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it matches that of the predicate devices.
| Feature / Characteristic | Acceptance Criteria (from Predicate Device) | Reported Device Performance (Fiberoptic Fabrications) |
|---|---|---|
| Intended Use | Delivery of laser light to soft tissue in contact and non-contact mode during surgical procedures, including via endoscopes. Intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector. Indicated for general surgical applications (incision, excision, vaporization, ablation, hemostasis, coagulation), endoscopic applications (incision, excision, dissection, tumor/lesion removal, tissue vaporization, hemostasis, coagulation), and lithotripsy with compatible lasers. Specified compatible lasers (Argon, KTP/532, Ho:YAG, Nd:YAG, 1.44YAG, Diode Lasers (635-1900nm)) with peak and continuous power from 1-200W, and specific core size power ratings. | Matches predicate device's intended use and indications. |
| Fiber Material | Flexible fiber, Quartz glass | Flexible fiber, Quartz glass |
| Core Diameter | 200 - 1000 µm | 200 - 1000 µm |
| Proximal End | SMA 905 connector or SMA 905 compatible connector, HGM connector or other | SMA 905 connector or SMA 905 compatible connector |
| Sterility | Sterile | Sterile |
| Distal End | Shaped fibers, side fibers, hand pieces (flat, orb, cone, chisel, radial) | Shaped fibers, side fibers, hand pieces (flat, orb, cone, chisel, or radial) |
| Maximum Recommended Power | Core size-specific (e.g., 230um-45W, 365um-113W, 400um-135W, 600um-200W, 800um-200W, 1000um-200W) | Core size-specific (e.g., 230um-45W, 365um-113W, 400um-135W, 600um-200W, 800um-200W, 1000um-200W) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. No performance testing on a test set for the new device was conducted or reported.
- Data Provenance: Not applicable. The submission relies on the established performance of predicate devices, not new data from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No new test set was created, and thus no experts were used to establish ground truth for this submission. The "ground truth" for the device's acceptable performance is derived from the established safety and effectiveness of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set was used.
5. 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
- Not applicable. This device is a laser delivery system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices (CeramOptec MegaBeam Fiber Optic Laser Delivery Systems and Biolitec Radial Emitting shaped fiber optic delivery system). This is based on their regulatory clearances and presumably, their own prior performance data and clinical use.
8. The sample size for the training set
- Not applicable. This is a physical device, not a machine learning algorithm. No training set was used.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.