(73 days)
Not Found
No
The summary describes a powered surgical instrument system for tissue and bone resection, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is described as a powered instrument system for resection of soft tissue and bone in Otolaryngology surgical procedures, indicating a surgical tool rather than a therapeutic device.
No
The device is described as a powered instrument system for resection of soft tissue and bone during surgical procedures, indicating a therapeutic rather than diagnostic function.
No
The device description explicitly lists multiple hardware components including a console, handpieces, blades, burs, and a footswitch. It is described as a "combination" of existing hardware systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "resection of soft tissue and bone" during "Otolaryngology surgical procedures." This describes a surgical instrument used directly on a patient's body during a procedure.
- Device Description: The description details a "powered instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets." These are all components of a surgical tool.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens, including blood, tissue, and urine, to provide information for diagnosis, monitoring, or screening. The description of this device does not involve the analysis of biological specimens.
Therefore, the Integrated Drive/Pump System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Integrated Drive/Pump System functions as a powered instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform resection of soft tissue and bone. The field of application is Otolaryngology surgical procedures.
Product codes
77 ERL
Device Description
The Integrated Drive/Pump System is a combination of the Linvatec Universal Drive System and Hall® Irrigation System with the addition of three new handpieces used in Otolaryngology surgical procedures.
Integrated Drive/Pump System consists of an AC The powered drive/pump console, a sterilizable handpiece perforator, various blades, burs, bur guards, irrigation tubing sets, shaver adapter, and a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Testing has been done to prove safety and effectiveness of the devices.
Key Metrics
Not Found
Predicate Device(s)
K971059, K961192, K852143, K943569, K943589, K952681
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0