(359 days)
The ZEOS AQUA VISION Pump is an arthroscopy pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during arthroscopy procedures.
The ZEOS AQUA VISION pump is a micro-processor controlled pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend cavities and provides fluid aspiration for arthroscopic procedures. The pump connects via cable to various interfaces. The pump can be connected to various shaver systems.
The provided text describes the 510(k) premarket notification for the ZEOS AQUA VISION PUMP and tube, which is an arthroscopy pump system. The document focuses on demonstrating substantial equivalence to a predicate device (FMS VUE Fluid Management & Tissue Debridement System) through various non-clinical performance tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format of a typical performance study. Instead, it states compliance with recognized standards and guidelines as the acceptance criteria for each test category. The reported device performance is that the device meets these standards and demonstrated substantial equivalence to the predicate device.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical safety and electromagnetic compatibility (EMC) | Compliance with IEC 60601-1 and IEC 60601-1-2 standards | Evaluation and testing demonstrated substantial equivalence to the predicate device. |
| Biocompatibility testing | Compliance with FDA Guidance "Use of International Standard ISO 10993, Biological evaluation of medical Devices Part 1" and ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11. | Cytotoxicity, Sensitization, Irritation, and Acute systemic toxicity tests were performed and demonstrated substantial equivalence to the predicate device. |
| Software Verification and Validation Testing | Compliance with FDA guidance "General Principles of Software Validation" and IEC 62304 | Evaluation and testing demonstrated substantially equivalent performance to the identified predicate device. |
| Sterilization Validation | Compliance with ISO 11135, ISO 11135-1, ISO 14937, and ISO 10993-7 for sterilization and residuals. | Validation demonstrated substantial equivalence to the identified predicate devices. Residual ethylene oxide (EO) |
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.