(129 days)
The DOUBLEFLO system represents an arthroscopy system using fluid from saline bags (0.9% NaCl). This arthroscopy system is 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 DOUBLEFLO system (pump) contains as a main component a microprocessor-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 pump has to be used with the following tube sets: DAY TUBE Set, Patient Tube Set, Inflow Tube Set, Outflow Tube Set.
The provided text is a 510(k) summary for the DOUBLEFLO system, an arthroscopy system. It describes the device, its intended use, a comparison with a predicate device, and performance data used to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study information based only on the provided text. Many of the requested fields are not applicable or not explicitly stated in this type of FDA submission.
Acceptance Criteria and Device Performance
The provided document describes various performance tests rather than specific acceptance criteria with numerical targets. The "Results" column largely states that the device "demonstrated to be substantially equivalent to the predicate device." Therefore, numerical acceptance criteria are inferred from the predicate device's performance or general safety/effectiveness standards.
| Test Category | Acceptance Criteria (Implied/Standard) | Reported Device Performance |
|---|---|---|
| Software | Conformity with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304 standard (Medical Device Software - Life Cycle Process) for a "moderate" level of concern. Software should perform as intended, without directly or indirectly causing minor injury. | Software was developed, tested, and verified according to specified FDA guidance and IEC 62304. Unit, integration, system, and verification tests were performed. Overall software validation report confirmed conformity with user needs and intended use. Demonstrated intended performance without raising new safety/effectiveness questions. |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility. | The device complies with IEC 60601-1 and IEC 60601-1-2. Evaluation and testing demonstrated substantial equivalence to the predicate device. |
| Biocompatibility | Compliance with FDA Guidance Document: Use of International Standard ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 for externally communicating devices in indirect contact with tissue/bone for a limited time ( |
§ 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.