(105 days)
The MicroPower Hand Piece: Medium Speed Drill, Saggital saw, Reciprocating saw, and Oscillating saw functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.
The MicroPower Hand Piece: Medium Speed Drill, Saggital saw. Reciprocating saw, and Oscillating saw device description is identical to the MicroChoice product line cleared in the original submission except for the modifications which have been detailed in Section 9 of this submission. These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised.
The MicroPower hand pieces are electric and based upon the existing Microchoice hand piece platform cleared under K971059. Both are pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A cord connects the hand pieces to the controllers that supply power to the device. The hand pieces have a lever that is used to actuate the device. The drills use a wide variety of bur guards, attachments, drill bits and burs. The saws use a wide variety of blades. The MicroPower drill and saws will use the same burs and blades that the current Microchoice hand pieces use.
This document is a 510(k) summary for a medical device (MicroPower Hand Piece) and does not contain the detailed information required to describe acceptance criteria and associated studies as requested. The 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, rather than a full demonstration of safety and effectiveness through detailed performance studies with acceptance criteria.
Therefore, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth.
- Adjudication method for the test set.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone (algorithm only) performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document states: "The changes made to the Universal Drive System have been tested to assure that the proposed modifications do not raise any new issues regarding safety and effectiveness." However, it does not detail what these tests were, what the specific acceptance criteria were, or the performance results. The focus of this submission is on the "substantial equivalence" of the new device to a predicate device (Universal Drive System, K971059) rather than a detailed performance study against pre-defined acceptance criteria for novel claims.
§ 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.