(33 days)
The Tuta Healthcare Pty. Limited Arthroscopy Flushing set (80.601) is a gravity system for fluid management during arthroscopic procedures. During these procedures, the fluid is used to (1) distend the site, enabling good visibility and (2) flush it continuously to clear debris (loose bodies or cartilage fragments away).
The Tuta Healthcare Arthroscopy Flushing set is designed to provide controlled Irrigation to a joint during arthroscopic procedures. action of the hand pump help to remove blood, tissue debris, loose bodies and foreign matter from the joint cavity. The click clamps are used to block the flow of fluid.
The provided text describes a 510(k) summary for Tuta's Arthroscopic Flushing Device. However, it does not contain information regarding a study, acceptance criteria, or device performance metrics.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
- If a standalone performance study was done.
- 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 is a 510(k) premarket notification for an Arthroscopy Flushing Set, focusing on establishing substantial equivalence to a legally marketed predicate device (Edwards Orthopedic Division, Baxter Healthcare Irrigation Set K883300). The 510(k) process primarily demonstrates that a new device is as safe and effective as a predicate device, often without requiring new clinical studies if the technology and intended use are similar. The information provided confirms the device name, manufacturer, intended use, and substantial equivalence to a predicate device, as well as the FDA's clearance letter.
§ 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.