DIEGO POWERED DISSECTOR AND DRILL SYSTEM

K020594 · Gyrus Ent LLC · ERL · Mar 8, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K020594
• Device Name: DIEGO POWERED DISSECTOR AND DRILL SYSTEM
• Applicant: Gyrus Ent LLC
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Mar 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diego Powered Dissector and Drill System's intended use is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures. Sinus applications would embody ethmoidectomy/sphenoethmoidectomy, polypectomy, septoplasty, and procedures such as the removal of septal spurs, antrostomy, frontal sinus trephination and irrigation, frontal sinus drill-out, endoscopic DCR and trans-spehnoidal procedures. Nasopharyngeal/laryngeal procedures would comprise adenoidectorny, laryngeal lesion de-bulking, laryngeal polypectomy, tracheal procedures, and tonsillectomy. Head & neck procedures would encompass soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular regions of the face, and acoustic neuroma removal. Otology procedures would include mastoidectomy and mastoidotomy.

Device Story

Powered surgical system for ENT, head/neck, and otoneurologic procedures; comprises console, footswitch, irrigation pump, and handpieces. Inputs: user-selected operating mode (forward, reverse, oscillate) and speed via footswitch. Console processes inputs via 8-bit microprocessor to control handpiece motor speed; provides digital speed indication. Outputs: mechanical rotation/oscillation of burs or blades for cutting/removing bone and soft tissue. Used in OR by surgeons. Integrated irrigation pump manages fluid delivery. System benefits include precise tissue/bone removal during complex procedures like mastoidectomy or rhinoplasty. Safety/effectiveness supported by compliance with electrical/EMC standards (UL 2601-1, IEC 60601 series).

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Stainless steel nosecone, aluminum housing. Power: Electric. Modes: Forward, reverse, oscillate. Speeds: Up to 18,000 rpm (sinus) and 44,000 rpm (otologic). Connectivity: Console-based with footswitch. Sterilization: Autoclave or EO. Standards: UL 2601-1, CSA 22.2 No. 601, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 61000-4-2/3/4/5, IEC 529, ISO 10993-1, EN 55011 Class B.

Indications for Use

Indicated for patients undergoing general ENT, head and neck, and otoneurologic surgical procedures requiring bone or tissue cutting and removal. Includes sinus, nasopharyngeal, laryngeal, and otologic procedures.

Regulatory Classification

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.

Predicate Devices

• Turbo 7000 Shaver/Drill System (K020594)

Submission Summary (Full Text)

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KO 20594

Food and Drug Administration 510(k) Notification - Diego™ Powered Dissector and Drill System February 21, 2002

MAR 8 2002

## 510(k) Summary of Safety and Effectiveness

| Trade Name:<br>Common Name:<br>Classification Name: | Diego Dissector and Drill System<br>Electrical Surgical Drill/Shaver<br>Ear, Nose and Throat electric or pneumatic surgical<br>drill (§ 874.4250) |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Greg Sredin<br>Sr. Regulatory Affairs Specialist<br>Gyrus ENT LLC<br>2925 Appling Road<br>Bartlett, TN 38133 |
| Telephone:<br>Telefax: | [phone]<br>[phone] |
| Date Prepared: | February 21, 2002 |

The Diego Powered Dissector and Drill System's intended use is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures. Sinus applications would embody ethmoidectomy/sphenoethmoidectomy, polypectomy, septoplasty, and procedures such as the removal of septal spurs, antrostomy, frontal sinus trephination and irrigation, frontal sinus drill-out, endoscopic DCR and trans-spehnoidal procedures. Nasopharyngeal/laryngeal procedures would comprise adenoidectorny, laryngeal lesion de-bulking, laryngeal polypectomy, tracheal procedures, and tonsillectomy. Head & neck procedures would encompass soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular regions of the face, and acoustic neuroma removal. Otology procedures would include mastoidectomy and mastoidotomy.

The Diego Powered Dissector and Drill system that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate device. The intended uses are substantially equivalent to the described predicate Turbo 7000 System. The Diego Powered Dissector and Drill system is designed to meet UL 2601-1 including Australian deviations, CSA 22.2 No. 601, IEC 601-1-1 (EN 60601-1), IEC 601-1-2 (EN 60601-1-2), IEC 601-1-4 (EN 60601-1-2), IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 529, ISO 10993-1, EN 55011. Class B.

The Diego Powered Dissector and Drill System is substantially equivalent to the Turbo 7000 System and difference of the processors that control the units should not affect the safety or effectiveness of the device.

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Comparison Chart

**vs**

## vs.
Turbo 7000 Shaver/Drill Syster

# Console, Footswitch, and Irrigation Pump

| | Diego Powered Dissector and Drill System | Turbo 7000 Shaver Drill System |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | General ENT, Head and Neck, and Otoneurologic Procedures | General ENT, Head and Neck, and Otoneurologic Procedures |
| Driver Configuration<br>Operating Modes | Console with separate footswitch<br>Forward, Reverse, Oscillate | Console with separate footswitch<br>Forward, Reverse, Oscillate |
| Operating Speeds | Up to 18,000 rpm for sinus surgery and<br>up to 44,000 rpm for otologic,<br>otoneurologic, and acoustic neuroma<br>procedures | Up to 7,000 rpm for sinus surgery and<br>up to 44,000 rpm for otologic,<br>otoneurologic, and acoustic neuroma<br>procedures |
| Speed Indication | Digital | Digital |
| Footswitch | Electric | Electric |
| Irrigation Pump | Yes, integrated into console | Yes, integrated into console |
| Number of Handpieces supported | 4 | 5 |
| | Diego, Stapes, and Viper Straight and<br>Angled | Turbo 7000, Enhanced ESSential<br>Shaver, Stapes, and Viper Straight and<br>Angled |
| Processor Control | 8-bit Microprocessor, Re-<br>programmable (Factory Only) | FPGA (Field Programmable Gate<br>Array) chip. Not re-programmable |
| | Diego Powered Dissector and Drill System | Turbo 7000 Shaver Drill System |
| Intended Use | General ENT, Head and Neck, and Otoneurologic Procedures | General ENT, Head and Neck, and Otoneurologic Procedures<br>Enhanced ESSential Shaver and Stapes |
| Material of Housing | Diego - Stainless Steel Nosecone and Aluminum Housing<br>Viper Handpiece - Stainless Steel Nosecone and Aluminum Housing | - Stainless Steel<br>Viper Handpiece - Stainless Steel Nosecone and Aluminum Housing<br>Turbo 7000 – Aluminum with Stainless Steel Sleeve |
| Suction Capability | Yes for Shaver Handpiece<br>No for Drill Handpiece | Yes for Shaver Handpiece<br>No for Drill Handpiece |
| Irrigation Capability | Yes, with the exception of the Stapes Drill Handpiece | Yes, with the exception of the Stapes Drill Handpiece |
| Chucking Mechanism | Diego is Spring Loaded and able to chuck in multiple positions. The Viper handpieces utilize locking rings and the Stapes uses a collet to secure the burrs | Spring Loaded; ESSential Shaver and Turbo 7000 Shaver Blades/Burrs are able to chuck in multiple positions.<br>The Viper handpieces utilize locking rings and the Stapes uses a collet to secure the burrs |
| Sterilization Method | Autoclave or EO | Autoclave or EO |

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Handpieces

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three horizontal lines that curve downwards, resembling a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 8 2002

Gyrus ENT LLC c/o Gregory Sredin Sr. Regulatory Affairs Specialist 2925 Appling Road Bartlett, TN 38133

Re: K020594

Trade/Device Name: Diego™ Powered Dissector and Drill System Regulation Number: 21 CFR 874.4250 Regulation Name: ENT Pneumatic or Electric Drill Regulatory Class: Class II Product Code: ERL Dated: February 21, 2002 Received: February 22, 2002

Dear:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Food and Drug Administration 510(k) Notification -- Diego™ Powered Dissector and Drill System February 21, 2002

KU20594

510(k) Number: Device Name:

Diego™ Powered Dissector and Drill System

### Indications for Use:

The Diego Powered Dissector and Drill System's intended use is the cutting and The Dlego Powered Dissociol and Bhil System. Beath and otoneurologic procedures.

Sinus applications would embody:

- ethmoidectory/sphenoethmoidectomy .
- polypectomy .
- septoplasty and .
- procedures such as .
- antrostomy ●
- endoscopic DCR .
- frontal sinus drill-out .
- frontal sinus trephination and irrigation ●
- septal spurs removal .
- trans-spehnoidal procedures .

Nasopharyngeal/laryngeal procedures would comprise:

- adenoidectomy .
- laryngeal lesion de-bulking .
- laryngeal polypectomy .
- tracheal procedures ●
- tonsillectomy .

Head & Neck procedures would encompass:

- soft tissue shaving .
- rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) .
- minopial of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face
- acoustic neuroma removal .

Otology procedures would include:

- mastoidectomy ●
- mastoidotomy. .

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### Food and Drug Administration 510(k) Notification - Diego™ Powered Dissector and Drill System February 21, 2002

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
|----------------------|---|
| Counter | |
| (Per 21 CFR 801.109) | |

OR

Over-the-

(Optional Format 1-2-96)

are

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number

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