(115 days)
Intended use: In conjunction with a motorized handle (c.g. Power Stick M5/3), the POWER DRIVE ART1 2304 serves as a drive unit for Richard Wolf rotary blades/abraders for the removal of tissue during endoscopic intervention. Simultaneous evacuation (suction) allows continuous removal of the ablated tissue. In conjunction with Power Drill M1, bones can be severed or machined.
Indications and field of use: The product is used in conjunction with endoscopic accessories for the following purposes:
- . In arthroscopy, e.g. resection of the meniscus, for removing soft tissue as well as intraarticular severing or abrasion of bone tissue (e.g. ACL or shoulder applications).
- In theracte surgery, e.g. for the removal of hematomas. .
- In sinus surgery, e.g. for the removal of polyps.
- . In spinal surgery (arthroscopic microdiskectomy (AMD) for removing degenerated tissue.
The POWER DRIVE ART1 2304 is an enhanced version of our POWER CONTROL 2303, cleared in K030082. The new device has new electronics, new software, additional motor handles, tools and tool holders such as rotary blades/ abraders, saws, sagittal and reciprocal saw attachments, drill chucks, drills and surgical wires.
The POWER DRIVE ART1 2304, consisting of: generator, motor handles, tools (such as rotary blades/ abraders, sagittal and reciprocal saws, drills and surgical wires) and tool holders (such as sagittal and reciprocal saw attachments and drill chucks).
Additional features are new motor handles, some with integrated keypad as well as automatic tool recognition with the new rotary blades and abraders (via RFID technology) and a touch screen for user control.
Multiple use devices are not provided sterile; they must be startlized per their instruction before each use. Single use devices are provided sterife and designed for only one use on or in-a single patient.
Via the integrated CAN-BUS interface, the POWER CONTROL 2304 can be integrated into the R. Wolf RIWO NET SYSTEM with remote control, speech control, and touch-screen monitor.
The provided document is a 510(k) premarket notification for a medical device called "POWER DRIVE ART1 2304 with motor handles, tools and Accessories".
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria (e.g., numerical thresholds for performance metrics) or report device performance in a quantitative manner.
Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices. The core argument is that:
- The new device has same indications, equivalent design, functions, and materials as previous devices.
- New technological characteristics (electronics, software, additional handles, automatic tool recognition, touch screen) have not diminished safety or effectiveness.
- The device is designed and tested to guarantee safety and effectiveness when used according to instructions.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text as none were provided.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. No clinical tests or performance studies with a specific test set are mentioned in the document. The submission states, "No clinical tests performed."
- Data Provenance: Not applicable. As no clinical tests were performed, there is no associated data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Since no clinical tests were performed and no ground truth determination process is described, this information is not available.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical tests or ground truth adjudication methods are mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states "No clinical tests performed." Therefore, no MRMC study was conducted or reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. This device is a surgical instrument (drive unit for rotary blades/abraders, drills, etc.) and not an AI algorithm. Its performance is intrinsically tied to human operation. Therefore, a standalone performance study in the context of an algorithm is not relevant or reported.
7. Type of Ground Truth Used:
- Not applicable. As no clinical tests were performed, no ground truth was established or used in the context of device performance evaluation as would be seen in an AI/diagnostic device submission. The substantial equivalence argument relies on the inherent safety and effectiveness established for the predicate devices and the manufacturing/design process of the new device.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical medical instrument, not an AI model or software requiring a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. (See point 8 above).
§ 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.