(16 days)
The MTP Unidrive® II Plus Disposable Tubing Set is intended to be utilized with the Karl Storz Unidrive® II Plus System for the controlled infusion of sterile irrigant solution during ENT endoscopic surgical surgery.
The MTP Unidrive® II Plus Disposable Tubing Set is utilized with the Karl Storz Unidrive® II Plus System. It is sold as sterile and single use device.
This 510(k) submission (K021811) for the MTP Unidrive® II Plus Disposable Tubing Set does not contain information about acceptance criteria or a study proving that the device meets those criteria.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K003994, manufactured by KSEA). Substantial equivalence means the new device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).
Here's why the requested information is not available in this document:
- Acceptance Criteria and Device Performance: The document does not specify quantitative acceptance criteria or report specific performance metrics for the MTP Unidrive® II Plus Disposable Tubing Set. The primary demonstration of safety and effectiveness relies on its similarity to the predicate device.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): Because the submission is based on substantial equivalence and not a performance study evaluating novel claims, none of these study-related details are provided. The FDA's decision is based on comparing the new device's characteristics to the predicate device, not on clinical trial data or performance testing that would typically involve such metrics.
Summary of what is provided regarding equivalence:
The "SUBSTANTIAL EQUIVALENCE TABLE FOR MTP Unidrive® II Plus DISPOSABLE TUBING SET" (page 1) details the comparative features:
| Manufacturer | MTP | KSEA (K003994) (Predicate Device) |
|---|---|---|
| Components | Irrigation tubing, roller pump tubing, tubing connectors, and an irrigation bag piercing spike | Same |
| Irrigation tubing lengths | Input: 150 cm Output: 310 cm | Same |
| Tubing, connector, & spike materials | Medical grade elastomer and plastics | Same |
| Sterile, Single Use | Yes | Same |
| Sterilization Method | Ethylene Oxide | Same |
| Packaging | Peel pouches | Same |
| Intended Use | For use with the Karl Storz Unidrive® II Plus System for the controlled infusion of sterile irrigant solution during ENT endoscopic surgical surgery | Same |
The FDA's letter (pages 2-3) confirms the "substantial equivalence determination," allowing the device to be marketed. This decision is based on the MTP device having the "same basic features and intended uses" as the predicate device (KSEA K003994). This regulatory pathway (510(k)) does not typically require extensive novel clinical performance studies if substantial equivalence can be demonstrated.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.