(84 days)
Not Found
No
The device description and performance studies focus on mechanical, electrical, and functional aspects of a microdebrider with monopolar coagulation. There is no mention of AI, ML, image processing, or data analysis for decision-making or control.
Yes
The device is intended for cutting, coagulation, and removal of tissue in general ENT procedures (Tonsillectomy and Adenoidectomy), which are surgical interventions treating medical conditions.
No
Explanation: The DTAD is described as a device for "cutting, coagulation, and removal of tissue" and its function is described as a "microdebrider blade with a built-in motor." These functions are therapeutic, not diagnostic.
No
The device description clearly outlines a physical medical device with hardware components including a blade, motor, batteries, cables, and a housing. It also describes mechanical and electrical functions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting, coagulation, and removal of tissue in general ENT procedures," specifically "Tonsillectomy and Adenoidectomy." This describes a surgical procedure performed on the patient's body.
- Device Description: The description details a surgical tool with a blade, motor, and monopolar coagulation capability. It interacts directly with tissue within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health.
This device is clearly designed for use in vivo (within the living body) during a surgical procedure, not for testing samples in vitro (in a lab setting).
N/A
Intended Use / Indications for Use
The DTAD is intended for cutting, coagulation, and removal of tissue in general ENT procedures.
Specific indications include: Tonsillectomy and Adenoidectomy.
Product codes (comma separated list FDA assigned to the subject device)
ERL
Device Description
The DTAD (Disposable Tonsil and Adenoid Device) is a disposable microdebrider blade with a built-in motor that will plug into the users electrosurgical generator. The sole energy application mode is Monopolar coagulation. The monopolar use will require a return electrode for the generator. The cutting performance is the same as the current Gyrus ACMI Diego® tonsil and adenoid blades cleared under K034004, with the addition of monopolar coagulation. The monopolar effect is completely dependent upon the generator used and its settings, which is the same as the other monopolar predicates.
The device will be a single-use battery operated microdebrider with monopolar capability. A button will activate the blade oscillation and the standard OR electrosurgical unit footswitch will power the monopolar effect. A nosecone will allow the tip to rotate 90° left or right. The blade will be provided at a 40° bend for adenoids with the capability of being reduced to 15° for tonsillectomies. The blade angle is flexible, and the design allows the blade to be bent between 0° and 50°,
The microdebrider device will include a monopolar cable that connects to a separate standard operating room electrosurgical generator. A standard suction tube will be attached to the suction port and a clip will attach the tubing to the cable. Two batteries, provided with a three year shelf life from the manufacturer, will be provided in the DTAD cable to power the blade oscillation. The battery leads connect internally to the PCB in the housing which connects to the oscillation switch and motor. When the handpiece button is pressed, power is sent to the motor which oscillates a gear which in turn oscillates the inner blade gear at approximately 3500 rpm. The monopolar lead from the cable is connected directly to the outer blade and is powered by the electrosurgical generator footswitch.
For user convenience the package will also include a disposable stylet for declogging if needed. The stylet is the same as the one provided in the current Diego® tubeset package (K034004). The device packaging is similar to the predicate Diego blades and disposables, and the devices are not labeled as non-pyrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Nose, Throat
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical / Preclinical Performance: Evidence of safety and effectiveness was obtained from two primary areas:
- non-clinical (electrical, mechanical, functional, stability) performance testing
- preclinical (bench tissue, animal) evaluations and testing
Non-clinical: Basic safety and performance testing was performed in accordance with IEC 60601-1 and IEC 60601-2-2. In addition, verification and comparison bench studies were conducted to evaluate the mechanical and functional performance. Specifically, test results in the following areas were provided: functionality, RF isolation, tip vibration, fluid ingress, battery and blade endurance, cable and connector pull force, monopolar effect, strain relief strength, suction and clog performance, blade flex capability, ability of the cutting edge to resist damage, blade torque, generator compatibility, and operational temperature.
Stability: Representative samples were subjected to accelerated and real time ageing to confirm that the device maintains functionality and continues to meet their specifications over time. The results of the accelerated age testing demonstrate that the device will be stable for the stated shelf-life. In addition, real time age testing will confirm the results of the accelerated age testing. Representative samples were also subjected to ship testing.
Preclinical: Evidence obtained from preclinical bench tissue (ex vivo) and animal (in vivo) studies demonstrate that the DTAD performs substantially equivalent to the predicate devices in relevant aspects associated with usability, cutting, coagulation, and removal of tissue.
Bench tissue - evaluated ex vivo using bovine tissue:
- Thermal margin
- Thermal impact
- Visual comparison of coagulation
Animal - evaluated in vivo using porcine models:
- Cut, coagulation, and suction
- Ergonomics
- Usability aspects such as device setup, tip rotation, and tip malleability
- Overall design confidence
Key results: Testing demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate devices. No clinical testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K034004, K091223, K082568, K083415
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Gyrus ACMI DTAD Gyrus ACMI, Inc.
Traditional 510(k) Notification June 2012
Page 1 of 6
510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. DTAD
AUG 30 2012
General Information
Manufacturer:
Gyrus ENT, L.L.C. (subsidiary of Gyrus ACMI, Inc.) 2925 Appling Road Bartlett , TN 38113 Phone: 1-800-262-3540 Fax: 1-901-373-0237
Establishment Registration Number:
510(k) Submitter:
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Classification Name:
1037007
Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104
3003790304
Dolan Mills, RAC Specialist, Regulatory Affairs
June 6, 2012
Electrosurgical Cutting & Coagulation Device and Accessories, ENT Electric or Pneumatic Surgical Drill Class 2
21 CFR 878.4400 GEI General and Plastic Surgery Panel
21 CFR 874.4250 ERL Ear, Nose, Throat
Gyrus ACMI DTAD
Project Name:
ﻏ
1
Gyrus ACMI DTAD Gyrus ACMI, Inc. 121678
Traditional 510(k) Notification June 2012
Page 2 of 6
Trade Name(s):
Generic/Common Name:
Disposable Tonsil and Adenoid Device (DTAD)
Electrical Surgical Drill / Shaver or Electrosurgical cutting and coagulation device and accessories
Predicate Devices
| Gyrus ACMI Inc. Diego® RF Powered Dissector & Drill System: | K034004 |
|---|---|
| Covidien / ValleyLab Suction Coagulator: | K091223 |
| Bovie SEER: | K082568 |
| Peak TnA Plasmablade: | K083415 |
Device Description and Technological Characteristics
The DTAD (Disposable Tonsil and Adenoid Device) is a disposable microdebrider blade with a built-in motor that will plug into the users electrosurgical generator. The sole energy application mode is Monopolar coagulation. The monopolar use will require a return electrode for the generator. The cutting performance is the same as the current Gyrus ACMI Diego® tonsil and adenoid blades cleared under K034004, with the addition of monopolar coagulation. The monopolar effect is completely dependent upon the generator used and its settings, which is the same as the other monopolar predicates.
The device will be a single-use battery operated microdebrider with monopolar capability. A button will activate the blade oscillation and the standard OR electrosurgical unit footswitch will power the monopolar effect. A nosecone will allow the tip to rotate 90° left or right. The blade will be provided at a 40° bend for adenoids with the capability of being reduced to 15° for tonsillectomies. The blade angle is flexible, and the design allows the blade to be bent between 0° and 50°,
The microdebrider device will include a monopolar cable that connects to a separate standard operating room electrosurgical generator. A standard suction tube will be attached to the suction port and a clip will attach the tubing to the cable. Two batteries, provided with a three year shelf life from the manufacturer, will be provided in the DTAD cable to power the blade oscillation. The battery leads connect internally to the PCB in the housing which connects to the oscillation switch and motor. When the handpiece button is pressed, power is sent to the motor which oscillates a gear which in turn oscillates the inner blade gear at approximately 3500 rpm. The monopolar lead from the cable is connected directly to the outer blade and is powered by the electrosurgical generator footswitch.
For user convenience the package will also include a disposable stylet for declogging if needed. The stylet is the same as the one provided in the current Diego® tubeset
2
Gyrus ACMI DTAD Gyrus ACMI, Inc. K121678
Traditional 510(k) Notification June 2012
Page 3 of 6
package (K034004). The device packaging is similar to the predicate Diego blades and disposables, and the devices are not labeled as non-pyrogenic.
Material
The DTAD uses patient-contacting materials that are utilized in the predicate devices. as well as other legally marketed devices manufactured by Gyrus ACMI.
The composition of the DTAD is similar to the devices within the previously cleared predicate, Diego® RF Powered Dissector and Drill System, K034004. The handle and RF cable are not patient-contacting materials, and therefore no biocompatibility testing is warranted for those materials. The composition of the patient contacting shaver blade portion is similar to the devices cleared under K034004. The silicone material used as an RF insulator is the same material used in the disposable Gyrus ACMI Plasmacision devices tied to K041285. These devices are used in a similar manner, for the same procedures, manufactured in the same value stream, and are subjected to the same EtO sterilization cycle and process as the DTAD.
The DTAD is classified in accordance with ISO 10993-1, as an external communicating, tissue/bone/dentin device for limited exposure (