(251 days)
The DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets 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 INFLOW/OUTFLOW 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 accessories / shaver systems. The pump has to be used with the following tube sets: DOUBLEFLO DAY TUBE SET, DOUBLEFLO PATIENT TUBE SET, DOUBLEFLO INFLOW TUBE SET, DOUBLEFLO OUTFLOW TUBE SET.
This document is a 510(k) Premarket Notification for a medical device called the "DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets." It concerns a pump used in arthroscopic procedures.
It is crucial to understand that this document does NOT describe the acceptance criteria and study proving a device meets those criteria for an AI/ML-driven medical device.
Instead, this is a traditional 510(k) summary for a physical medical device (a pump). The "software" mentioned refers to the embedded software controlling the pump's mechanical functions, not an AI/ML algorithm that interprets medical data (like images) or assists in diagnosis/treatment decisions.
Therefore, the requested information about acceptance criteria for an AI/ML device, sample sizes for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML is not applicable to this document.
The document discusses performance in terms of safety and effectiveness of the traditional medical device (the pump and its accessories/tubing sets), primarily through:
- Software verification and validation: Ensuring the pump's control software functions correctly and safely.
- Acceptance Criteria (Implied for Software): Software performs as intended, no anomalies, compliant with relevant standards (IEC 62304, FDA guidance for software in medical devices).
- Reported Performance (Software): Unit, integration, system, and validation tests performed; successfully covers RFID-related requirements; software considered "moderate" level of concern.
- Electrical safety and electromagnetic compatibility (EMC): Ensuring the device operates safely in its electromagnetic environment.
- Acceptance Criteria: Compliance with IEC 60601-1 and IEC 60601-1-2 standards.
- Reported Performance: Complies with recognized standards, demonstrated substantial equivalence.
- Biocompatibility testing: Ensuring the tubing sets are safe for contact with the body.
- Acceptance Criteria: Compliance with ISO 10993 series standards and FDA guidance.
- Reported Performance: Tests performed (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogenicity), met requirements, demonstrated substantial equivalence.
- Sterilization validation: Ensuring the tubing sets can be effectively sterilized.
- Acceptance Criteria: Compliance with ISO 11135, ISO 14937, ISO 10993-7. Residual EO/ECH limits met. SAL of 10^-6. Package integrity confirmed.
- Reported Performance: Validation performed, met requirements, demonstrated substantial equivalence.
- Bench Performance Testing: Functional and usability tests of the pump and tubing sets (e.g., leak, tensile strength, accelerated aging).
- Acceptance Criteria (Implied): Device performs as intended for fluid distension, irrigation, and suction; tubing sets maintain integrity over shelf life.
- Reported Performance: Tests performed, demonstrated substantial equivalence.
In summary, this document is not about an AI/ML device, and thus cannot provide the specific details requested for such a system. The performance data provided relates to the physical and software functionalities of a medical pump, not an AI's analytical or diagnostic capabilities.
§ 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.