(149 days)
Not Found
No
The summary describes a surgical system with mechanical and electrical components for cutting, coagulation, and tissue removal. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as being "intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue" in various medical procedures, which are therapeutic actions to treat medical conditions.
No
Explanation: The device description states its intended use is for "cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue" during surgical procedures. This describes therapeutic intervention, not diagnosis.
No
The device description explicitly lists multiple hardware components including a power console, footswitch, handpiece, suction pump, disposable accessories, and interchangeable burrs/blades. The performance studies also detail testing of electrical, mechanical, and functional aspects of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system for cutting, coagulation, drilling, debriding, and removal of bone and tissue during various ENT, Sinus, Nasopharyngeal, Laryngeal, and Head & Neck procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device description details a system with a power console, handpiece, burrs/blades, and suction, all components used for physical manipulation and removal of tissue within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment. The device acts directly on the patient's tissue in situ.
IVD devices are used to perform tests outside the body on samples taken from the body. This device is used inside the body during surgical procedures.
N/A
Intended Use / Indications for Use
The system, including Image Guided Surgery compatibility, and optional Suction console, is intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus / Rhinology, Nasopharyngeal / Laryngology, and Head & Neck procedures.
Specific procedures and applications would include: Sinus / Rhinology:
- FESS (Functional Endoscopic Sinus Surgery)
- Including Endoscopic approaches to: Polypectomy, Ethmoidectomy, Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy
- Septal Spur removal
- Endoscopic DCR
- Trans-sphenoidal procedures specifically to create access through the sinuses to the Fituitary, Skull base, and CSF leak repair
- Turbinate Reduction / Turbinoplasty
- Including sub mucosal resection
Nasopharyngeal / Laryngeal:
- Adenoidectomy / Tonsillectomy
- Laryngeal procedures for Recurrent respiratory papilloma, Lesion de-bulking, Polypectomy
Head & Neck:
- Soft tissue shaving
Product codes
GEI, ERL, JCX, HAW, EQJ, FSM
Device Description
The DIEGO ELITE system is the second generation of the RF Diego® system cleared under K034004. The second generation system offers many improvements over the previous system. The DIEGO ELITE includes a power console with touchscreen, footswitch, reusable handpiece, image guided surgery compatibility, an optional powered suction pump, single use disposable accessories and interchangeable burrs / blades and electrosurgical blades. This second generation device adds monopolar capability, disposable sensing technology, improved blades. improved fluid pathway, a more durable reusable handpiece, a premium tubeset with a declog feature and IGS connector, and a powered suction pump that is an optional accessory that can be used to replace the standard facility suction.
The DIEGO ELITE console is a reusable, non-sterile electrosurgical generator and electrical drill system that features monopolar and bipolar cutting and coagulation modes. The maximum output power is 40 W. The console controls operational and performance aspects of the reusable motor module (MDU) handpiece and the suction module.
The front side of the console features a touch screen interface that displays the connection status of accessories. It is also used to show and modify the output settings, such as mode, output power, speed, and irrigation. The front panel has a socket for the MDU, a socket for a neutral electrode, and a socket for the footswitch. The front of the console has a power switch. The console recognizes which accessories and peripherals are connected and displays default settings and any needed warning indicators. After default settings are loaded, the user may adjust settings as desired. The touch screen also has a menu button that controls various functions and settings.
The side panel offers a peristaltic irrigation pump and irrigant sensing section. The irrigation line is loaded through an air bubble sensor section and then through the irrigation pump. The sensing section identifies when the irrigation line is empty and displays a warning on the touch screen.
The rear panel offers a channel and clamping mechanism to load the console onto a standard IV pole. The rear panel also contains the mains disconnect, grounding post, connection socket for the optional powered suction pump, service port, and back panel labeling. Ventilation holes are in the rear and bottom panel.
The DIEGO ELITE includes an optional suction module that connects to the main controller and can replace the standard facility suction system. The suction system can only be used with the main console.
Application Modes:
Microdebrider only:
- Variable or Constant Speed - selected by user
- Rotation of inner blade - Oscillate, Forward
Monopolar Coagulation:
- Crest Factor (CF): 4.3
- CF is a description of the waveform
- 390kHz damped sinusoid, every 36 kHz
Bipolar Coagulation:
- Crest Factor (CF): 2.1 at rated load
- CF is a description of the waveform
- Carrier Frequency: 470 KHz
The DIEGO ELITE handpiece consists of the non-sterile reusable MDU (reusable portion of the handpiece), the sterile disposable blade / burr, and the sterile disposable suction tube connector. The entire fluid pathway is contained in the disposable sections. All electrosurgical leads are contained within the MDU and the monopolar and bipolar disposable blades. The MDU is connected to the console for control. the irrigation tube line is connected through the pump and then the irrigant source. The suction tube is connected to either the facility standard suction, or the optional powered suction pump via a fluid collection canister. The monopolar or bipolar effect is limited to the disposable blade tip, and activation is controlled by the surgeon by pressing a coag button on the top of the blade nosecone.
The system footswitch connects to the console and is used to control microdebridement only. The footswitch also offers a toggle switch on either side of the pedal that can toggle the shaver blade cutting window open or closed when the blade is stopped.
The system blades and burrs are offered in similar working lengths and geometries as the predicate Gyrus ACMI Diego® system, and they include a capacitor that is used to determine the disposable "family" to which it belongs and establish the proper default settings and features that go along with that family.
Image Guided Surgery (IGS) instrumentation / array allows the blades and burrs to be tracked in real time in the surgical field. IGS compatibility is accomplished by moving the connector from the predicate Diego® Starlink handpiece to the top of the premium tubeset connector. This allows for the elimination of an additional handpiece for IGS. The IGS connector (boss) and assembled MDU handpiece is functionally equivalent to the predicate Starlink handpiece, and it will continue to accept the BrainLab AG IGS equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ENT, Sinus / Rhinology, Nasopharyngeal / Laryngology, and Head & Neck
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
Performance tests were executed to ensure that the system functioned as intended and met design specifications. The following non-clinical and preclinical tests, and usability studies were conducted:
Non-Clinical / Preclinical Performance: Evidence of safety and effectiveness was obtained from two primary areas:
- non-clinical (electrical, mechanical, functional, biocompatibility, stability) performance testing
- preclinical (bench tissue, cadaver, 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. Testing included: tip vibration, torque strength, endurance, dynamic seal integrity, force testing, reliability, leak testing, ship testing, baseline performance testing, age testing, joint strength, environmental conditioning, durability, aspiration, RF isolation, and many other applicable tests.
Stability: Representative samples were subjected to accelerated aging to confirm that the device maintains functionality and continues to meet 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 environmental conditioning and ship testing.
Preclinical: Evidence obtained from preclinical bench tissue (ex vivo) and animal (in vivo) studies demonstrate that the system performs substantially equivalent to the predicate devices in relevant aspects associated with usability, cutting, coagulation, and removal of tissue. For simulated use and bench testing, the selected tissue medium was confirmed to be appropriate for testing based on surgeon input. Sample impedance levels were also investigated and confirmed as appropriate.
Bench tissue - evaluated ex vivo using bovine tissue:
- Thermal margin
- Thermal impact
- Visual comparison of coagulation
Cadaver - evaluated in vivo:
- Cut, coagulation, tissue removal, and suction
- Ergonomics
- Usability aspects such as device setup, tip rotation, and tip malleability
- Overall design confidence
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 performs as well as or better than the predicate devices. No clinical testing was conducted. The use of Electrosurgical Cutting and Coagulation Devices / Microdebriders has been documented in published literature and indicates safe and effective use for the target procedures and expected patient populations.
Key Metrics
Not Found
Predicate Device(s)
K034004, K030343, K944602, K121678, K011725
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Traditional 510(k) Notification November 2012
510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. DIEGO ELITE
5 2013 APR
General Information
Manufacturer:
Gyrus ENT, L.L.C. (a subsidiary of Gyrus ACMI, Inc., an Olympus company) 2925 Appling Road Bartlett , TN 38113 Phone: 1-800-262-3540 Fax: 1-901-373-0237
Southborough, MA 01772-2104
Establishment Registration Number:
510(k) Submitter:
Establishment Registration Number:
Contact Person:
Dolan Mills Specialist, Regulatory Affairs
3003790304
Gyrus ACMI, Inc.
136 Turnpike Rd.
1037007
Date Prepared:
November 6, 2012
Device Description
Classification Name:
ENT Electric or Pneumatic Surgical Drill Electrosurgical Cutting & Coagulation Device and Accessories Class 2
| Electrosurgical System
21 CFR 878.4400
General and Plastic Surgery
Panel
GEI | Drill System
21 CFR 874.4250
Ear, Nose, Throat
ERL | Suction Pump
21 CFR 878.4780
General and Plastic Surgery
Panel
JCX |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------|
| Stereotaxic Instrument | Bur, Ear, Nose & Throat | Tray, Surgical Instrument |
| 21 CFR 882.4560 | 21 CFR 874.4140 | 21 CFR 878.4800 |
| Neurology | Ear, Nose & Throat | General & Plastic Surgery |
| HAW | EQJ | FSM |
1
Traditional 510(k) Notification November 2012
Project Name:
Trade Name(s):
Generic/Common Name:
EPS. PKD2 System / Bullitt (09-016)
DIEGO ELITE
Electrical Surgical Drill / Shaver or Electrosurgical cutting and coagulation device and accessories, Suction Pump, Stereotaxic Instrument, Burs, Instrument Tray
Predicate Devices
| Gyrus ACMI Diego® RF Powered Dissector & Drill System: | K034004 |
|---|---|
| Gyrus ACMI Diego® Starlink with IGS | K030343 |
| Covidien ValleyLab Force FX | K944602 |
| Gyrus ACMI DTAD | K121678 |
| Olympus KV-5 Powered Suction Pump | K011725 |
Product Description
The DIEGO ELITE system is the second generation of the RF Diego® system cleared under K034004. The second generation system offers many improvements over the previous system. The DIEGO ELITE includes a power console with touchscreen, footswitch, reusable handpiece, image guided surgery compatibility, an optional powered suction pump, single use disposable accessories and interchangeable burrs / blades and electrosurgical blades. This second generation device adds monopolar capability, disposable sensing technology, improved blades. improved fluid pathway, a more durable reusable handpiece, a premium tubeset with a declog feature and IGS connector, and a powered suction pump that is an optional accessory that can be used to replace the standard facility suction.
Technological Characteristics
The DIEGO ELITE console is a reusable, non-sterile electrosurgical generator and electrical drill system that features monopolar and bipolar cutting and coagulation modes. The maximum output power is 40 W. The console controls operational and performance aspects of the reusable motor module (MDU) handpiece and the suction module.
The front side of the console features a touch screen interface that displays the connection status of accessories. It is also used to show and modify the output settings, such as mode, output power, speed, and irrigation. The front panel has a socket for the MDU, a socket for a neutral electrode, and a socket for the footswitch. The front of the console has a power switch. The console recognizes which
2
Traditional 510{k) Notification November 2012
accessories and peripherals are connected and displays default settings and any needed warning indicators. After default settings are loaded, the user may adjust settings as desired. The touch screen also has a menu button that controls various functions and settings.
The side panel offers a peristaltic irrigation pump and irrigant sensing section. The irrigation line is loaded through an air bubble sensor section and then through the irrigation pump. The sensing section identifies when the irrigation line is empty and displays a warning on the touch screen.
The rear panel offers a channel and clamping mechanism to load the console onto a standard IV pole. The rear panel also contains the mains disconnect, grounding post, connection socket for the optional powered suction pump, service port, and back panel labeling. Ventilation holes are in the rear and bottom panel.
The DIEGO ELITE includes an optional suction module that connects to the main controller and can replace the standard facility suction system. The suction system can only be used with the main console.
Application Modes:
Microdebrider only:
- o Variable or Constant Speed - selected by user
- . Rotation of inner blade - Oscillate, Forward
Monopolar Coagulation:
- . Crest Factor (CF): 4.3
- · CF is a description of the waveform
- t 390kHz damped sinusoid, everv 36 kHz
Bipolar Coagulation:
- . Crest Factor (CF): 2.1 at rated load
- o CF is a description of the waveform
- . Carrier Frequency: 470 KHz
The DIEGO ELITE handpiece consists of the non-sterile reusable MDU (reusable portion of the handpiece), the sterile disposable blade / burr, and the sterile disposable suction tube connector. The entire fluid pathway is contained in the disposable sections. All electrosurgical leads are contained within the MDU and the monopolar and bipolar disposable blades. The MDU is connected to the console for control. the irrigation tube line is connected through the pump and then the irrigant source. The suction tube is connected to either the facility standard suction, or the optional powered suction pump via a fluid collection canister. The monopolar or bipolar effect is limited to the disposable blade tip, and activation is controlled by the surgeon by pressing a coag button on the top of the blade nosecone.
3
Traditional 510{k) Notification November 2012
The system footswitch connects to the console and is used to control microdebridement only. The footswitch also offers a toggle switch on either side of the pedal that can toggle the shaver blade cutting window open or closed when the blade is stopped.
The system blades and burrs are offered in similar working lengths and geometries as the predicate Gyrus ACMI Diego® system, and they include a capacitor that is used to determine the disposable "family" to which it belongs and establish the proper default settings and features that go along with that family.
Image Guided Surgery (IGS) instrumentation / array allows the blades and burrs to be tracked in real time in the surgical field. IGS compatibility is accomplished by moving the connector from the predicate Diego® Starlink handpiece to the top of the premium tubeset connector. This allows for the elimination of an additional handpiece for IGS. The IGS connector (boss) and assembled MDU handpiece is functionally equivalent to the predicate Starlink handpiece, and it will continue to accept the BrainLab AG IGS equipment.
Material
The DIEGO ELITE uses similar patient-contacting materials that are utilized in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI.
The DIEGO ELITE patient contacting items are classified in accordance with ISO 10993-1, as an external communicating, tissue/bone/dentin device for limited exposure (