(85 days)
Model Number 0010-2400 is a fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use.
Model Number 0010-2400 is supplied as a single-use, sterile product and is compatible with the GreenLight™ XPS Laser System. It can access the tissue in multiple planes. Model Number 0010-2400 is a liguid cooled delivery device which enables the delivery of up to 180W of power and aids in maintaining a clear environment at the fiber cap.
The provided document describes a 510(k) premarket notification for a medical device, the American Medical Systems Model Number 0010-2400 GreenLight MoXy™ Fiber Optic. This is a special 510(k) submission, indicating a modification to an already cleared device, the Fiber One (K100746). The submission focuses on demonstrating substantial equivalence to the predicate device, rather than a de novo approval.
As such, the document does not contain information related to a clinical study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement in the way one would expect for a new or significantly modified device requiring such studies. The assessment here is based on non-clinical (bench) testing and comparison of technological characteristics to the predicate device.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial. Instead, the "acceptance criteria" for this Special 510(k) are implied by demonstrating that the modified device (Model 0010-2400) maintains substantial equivalence to the predicate device (Fiber One) through non-clinical testing and comparison of specifications.
| Characteristic / "Acceptance Criteria" Metric | Predicate Device (Fiber One) Performance | Modified Device (Model 0010-2400) Performance |
|---|---|---|
| K Number | K100746 | K120870 (reference number for this submission) |
| Regulation Number | 21 CFR§878.4810 | 21 CFR§878.4810 |
| Regulation Name | Laser surgical instrument for use in general and plastic surgery and in dermatology | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Classification | Class II | Class II |
| Product Code | GEX | GEX |
| Laser System Compatibility | GreenLight XPS Laser System | GreenLight XPS Laser System |
| Endoscope/Cystoscope Compatibility | 22 to 24 Fr continuous flow | 22 to 24 Fr continuous flow |
| Saline flow | ≥0.3mL/sec | ≥0.3mL/sec |
| Fiber and Cap Assembly Outer Diameter |
§ 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.