Search Results

The RIWO Drive with small motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions.

Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation.

Indications and Fields of Application:

For therapy with endoscopic accessories:

• · in arthroscopy, e.g. for meniscus resection, removal of soft tissue, as well as intra-articular severing or abrasion of osseous tissue, e.g. ACL or shoulder procedures.
• thoracic surgery, e.g. for removing hematomas .
• sinus surgery (ENT), e.g. for removing polyps or cysts.In cases, bone structures are . removed or trimmed.
• spine surgery (arthroscopic micro disectomy (AMD), spinal endoscopsy) e.g. removal of . pathological tissue.

The RIWO Drive Generator is designed to efficiently drive and control different motor handles. The handle functions are controlled by a footswitch.

The motor handle is a tubular system. The modular system consists of:

• motor unit
• · motor housing
• · suction adapter (8563.111) And/Or suction /irrigation adapter (8563.311)

The suction and irrigation stream are controlled by slide valves. The motor handle is connected to the RIWO Drive 2302 by a removable cable.

The provided text describes the RIWO Drive System 2302 with small motor handles, an ENT electric surgical drill. However, the document does not contain any performance data from a specific study that would allow for an evaluation of acceptance criteria and reported device performance in the manner requested.

Here's a breakdown of the information that is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The document mentions that the devices "are designed and tested to assure their safety and effectiveness when used according to the instructions manual," but it does not specify quantitative performance metrics or thresholds for acceptance.
• Reported Device Performance: Not reported. The document states "Performance Data: The RIWO Drive Generator with the motor handles were tested according to the standards IEC601-1 and UL2601-1." However, the results of these tests (e.g., speed accuracy, torque, safety parameter measurements) are not provided.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable/not provided for performance testing results.
• Data Provenance: Not applicable/not provided for performance testing results.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not applicable. No clinical or diagnostic performance study is described that would require expert-established ground truth.
• Qualifications: Not applicable.

4. Adjudication Method:

• Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical tests performed were not performed."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• Standalone Study: Not applicable. This device is a surgical tool, not an AI algorithm. Its performance is intrinsic to its mechanical and electrical function, not an algorithm's output.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable. No clinical or diagnostic performance study is described. The "ground truth" for this type of device would typically be its adherence to engineering specifications and safety standards.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. There is no AI component or machine learning model that would require a training set.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth Establishment: Not applicable.

Summary of Device Information Provided:

• Device Name: RIWO Drive System 2302 with small motor handles.
• Intended Use: Driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions, with simultaneous suction and optional irrigation.
• Technological Characteristics: Four speed settings, continuous digital display, automatic adaptation of speed/torque, acoustic and optical alarms, footswitch control, 360° motor handle rotation, modular construction, variable irrigation control, watertight, lightweight, detachable cable, BF insulation.
• Safety/Performance Testing: Tested according to IEC601-1 and UL2601-1, which are general electrical medical equipment safety standards. The results of these tests are not provided.
• Clinical Tests: "Clinical tests performed were not performed."
• Substantial Equivalence: Claimed to be substantially equivalent to existing devices from Richard Wolf, Stryker, Xomed, and Karl Storz, based on posing the "same type of questions about safety or effectiveness" and new technological characteristics not diminishing safety or effectiveness.

In conclusion, while the document adequately describes the device and its intended use, it does not provide any specific performance data or studies that detail acceptance criteria and how the device performed against those criteria. The focus of this 510(k) summary is on substantial equivalence to predicate devices and adherence to general safety standards, rather than proving efficacy or detailed performance metrics through specific studies.

Ask a specific question about this device