(35 days)
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No
The summary describes a mechanical surgical device (microdebrider) and does not mention any AI or ML components, image processing, or data-driven performance metrics.
No
The device is described as a surgical tool for cutting and removing bone and tissues, not for treating a disease or condition. While used by healthcare professionals, its function is mechanical removal during surgery, which is distinct from therapeutic treatment.
No
The device is described as a surgical tool for cutting and removing bone and tissues, not for diagnosing conditions.
No
The device description explicitly states it is comprised of hardware components including a Power Control unit, foot pedal, and motorized handpieces.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cutting and removal of bone and tissues during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a surgical tool (microdebrider system) used for mechanical action (cutting and removing tissue).
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue samples) to provide information about a physiological state, health, or disease. This device does not perform such analysis on specimens.
Therefore, the TreBay Microdebrider system is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for the cutting and removal of bone and tissues in ENT, otolaryngology / head and neck surgical procedures.
Product codes
77 ERL,77 EQJ
Device Description
The TreBay Microdebrider system is comprised of the Power Control unit, foot pedal and three (3) types of motorized, reusable electric handpieces that use various intercrangable cutter blades and/or bur tips. The system can operate one , two or all three handpieces (one at a time) with suction and/or irrigation, depending on the handpiece. The Microdebrider System is intended for use by health care professionals and and is labeled as a restricted device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k) Summary Trebay Microdebrider
- 1.0 Date Prepared August 16, 1996
2.0 Submitter (Contact)
David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532
3.0 Device Name
| Proprietary Name: | Trebay Microdebrider
(The product's tradename has not been finalized and may be
changed at a later date.) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name(s): | Electrical surgical shavers, electrical microdebriders, mastoid drills,
microdrill, ENT drills, handpieces and cutting blades and burs. |
| Classification Name: | ENT Surgical Drill |
4.0 Device Classification
| ENT Surgical Drill | Procode 77 ERL | Class II ; | 21 CFR 874.4250 | Tier 1 |
|---|---|---|---|---|
| ENT Bur | Procode 77 EQJ | Class I ; | 21 CFR 874.4140 | Tier 1 |
5.0 Device Description
The TreBay Microdebrider system is comprised of the Power Control unit, foot pedal and three (3) types of motorized, reusable electric handpieces that use various intercrangable cutter blades and/or bur tips. The system can operate one , two or all three handpieces (one at a time) with suction and/or irrigation, depending on the handpiece. The Microdebrider System is intended for use by health care professionals and is labeled as a restricted device.
6.0 Intended Use
This device is intended for the cutting and removal of bone and tissues in ENT, otolaryngology / head and neck surgical procedures.
7.0 Substantial Equivalence
The modified Trebay Microdebrider / XPS System that is described in this notification has the same intended use as the originally cleared device, the same technological characteristics as other ENT surgical drills currently on the market, and does not raise any new issues of safety or effectiveness.