DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE

K034004 · Gyrus Ent LLC · ERL · Mar 3, 2004 · Ear, Nose, Throat

Device Facts

• Record ID: K034004
• Device Name: DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
• Applicant: Gyrus Ent LLC
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Mar 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diego RF Powered Dissector and Drill System's intended use is the cutting and tissue in general ENT, Head & Neck, and otoneurologic procedures. Sinus applications include: ethmoidectorny/sphenoethmoidectomy . polypectomy . septoplasty and . procedures such as . the removal of septal spurs . antrostomy, . frontal sinus trephination and irrigation . frontal sinus drill-out . . endoscopic DCR 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) . removal of fatty (adipose) tissue (lipodebridement) in the maxillary and ● mandibular regions of the face acoustic neuroma removal . Otology procedures would include - · mastoidectomy . mastoidotomy

Device Story

System consists of console and handpieces with RF blades; provides powered dissection and RF coagulation. Used in ENT, head/neck, and otoneurologic procedures. Operated by physicians in clinical settings. Console provides power to handpieces; RF blades enable simultaneous tissue removal and coagulation. Output is mechanical tissue resection and RF-based hemostasis. Benefits include reduced need for separate instruments for cutting and coagulation, potentially improving procedural efficiency.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics and intended use to legally marketed predicate devices.

Technological Characteristics

System includes console and handpieces with RF blades. Energy source: RF (Radiofrequency). Power output: 10W default, 40W maximum. Functions: Powered tissue dissection and RF coagulation. Connectivity: Handpiece-to-console interface. Sterilization: Not specified.

Indications for Use

Indicated for cutting and tissue removal in general ENT, Head & Neck, and otoneurologic procedures, including sinus, nasopharyngeal, laryngeal, and otology surgeries. Contraindications not specified.

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

• Diego Powered Dissector and Drill System (K020594)
• Smith & Nephew Dyonics® ElectroBlade™ Arthroscopy System (K994365, K012314, K031675)
• Gyrus ENT Plasmacision (K021777)
• Arthrocare ENTec Coblator Surgery System (K030108)
• Surgitron IEC II (K001986)

Submission Summary (Full Text)

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510(k) Summary - K 034004
Diego™ RF Powered Dissector and Drill System
Date Revised February 19, 2004

| MAR - 3 2004 | 510(k) Summary |
|--------------------------|---------------------------------------------------------------------------|
| Submitter's Name | Gyrus ENT LLC |
| Submitter's Address | 2925 Appling Road,<br>Bartlett, TN 38133 |
| Submitter's Phone Number | [phone] |
| Contact Person | Alicia E. Farage |
| Date Revised: | February 19, 2004 |
| Proprietary Name: | Diego™ RF Dissector and Drill System |
| Common Name: | Electrical Surgical Drill/Shaver |
| Classification Name: | Ear, Nose and Throat electric or pneumatic<br>surgical drill (§ 874.4250) |
| Classification | Class II |
| Classification Panel | Ear, Nose, Throat |
| Device Product Code | 77 ERL |

KO34004

### Subject Device Description

The new Diego RF Powered Dissector and Drill System Console is identical to the console cleared in 510(k) # 020594 (3.08.02). However an additional panel was added to operate the current handpieces with new RF blades that can provide coagulation in addition to powered dissection. Other than coagulation during procedures, there are no new indications for use.

### Applicable 510(k)s - Predicate Devices

| Device | Manufacturer | FDA Clearance |
|----------------------------------------------------------------|------------------------------------------------------------------|-------------------------------|
| Diego Powered Dissector and Drill<br>System | Gyrus ENT LLC<br>Bartlett, TN 38133 | K020594 |
| Smith & Nephew Dyonics®<br>ElectroBlade™ Arthroscopy<br>System | Smith & Nephew, Inc.<br>Endoscopy Division<br>Andover, MD 001810 | K994365<br>K012314<br>K031675 |
| Gyrus ENT Plasmacision | Gyrus ENT LLC<br>Bartlett, TN 38133 | K021777 |
| Arthrocare ENTec Coblator<br>Surgery System | Arthocare Corporation<br>Sunnyvale, CA 94085 | K030108 |
| Surgitron IEC II | Ellman International<br>Hewlett, NY 11557 | K001986 |

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#### 510(k) Summary - K 034004 Diego™ RF Powered Dissector and Drill System Date Revised February 19, 2004

### Subject Device Intended Use

The Diego RF Powered Dissector and Drill System's intended use is the cutting and The Dlego KF Fowered Bissector and Brill Cycleme in a broneurologic procedures.

Sinus applications include:

- ethmoidectorny/sphenoethmoidectomy .
- polypectomy .
- septoplasty and .
- procedures such as .
- the removal of septal spurs .
- antrostomy, .
- frontal sinus trephination and irrigation .
- frontal sinus drill-out .
- . endoscopic DCR
- 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) .
- removal 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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### Comparison Chart of Power Ratings

## Diego RF Powered Dissector and Drill System

Vs.

# Gyrus ENT Plasmacision vs. Arthrocare ENTec Coblation Plastma Surgery vs. Ellman Surgitron IEC

| | Diego RF<br>Gyus ENT<br>(K034004) | Gyrus ENT<br>Plasmacision<br>(K021777) | Arthrocare ENTec<br>Coblation Plastma<br>Surgery (K030108) | Ellman Surgitron IEC<br>(K001986) |
|-------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use | General ENT, Head &<br>Neck, and<br>Otoneurologic<br>Procedures | General ENT, Head &<br>Neck, and<br>Otoneurologic<br>Procedures | General ENT<br>Procedures | General ENT Procedures |
| Functions | Tissue Removal and<br>RF Coagulation | Tissue Removal and RF<br>Coagulation | Ablation, Resection and<br>Coagulation of Soft<br>Tissue and Hemostasis<br>of Blood Vessels | Resection, Ablation, and<br>Coagulation of Soft<br>Tissues and Hemostasis<br>of Blood Vessels |
| Default Power<br>Rating | 10 Watts | 30 Watts | 284 Watts | Cut 100 Watts<br>Cut/Coag 75 Watts<br>Hemo 35 Watts<br>Fulgurate 35 Watts<br>Bipolar 40 Watts |
| Maximun<br>Power Rating | 40 Watts | 40 Watts | 284 Watts | 100 Watts |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wing feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2004

Gyrus ENT c/o Alicia E. Farage Manager Clinical/Regulatory Affairs 2925 Appling Road Bartlett, TN 38133

Re: K034004

Trade/Device Name: Diego™ RF Powered Dissector and Drill System Regulation Number: 21 CFR 874.4250 Regulation Name: ENT electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: December 22, 2003 Received: December 24, 2003

Dear Ms. Farage:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate for togenty the enactment date of the Medical Device Amendments, or to commerce print to May 20, 1978, the excordance with the provisions of the Federal Food, Drug. devices that nave been receasined in assere approval of a premarket approval application (PMA). and Costietic Act (Tec) that to not requent to the general controls provisions of the Act. The You may, dicierole, market the act include requirements for annual registration, listing of general controls provisions of and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassified (600 world) in Existing major regulations affecting your device can may be subject to subject to successions, Title 21, Parts 800 to 898. In addition, FDA may ov round in ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I reast of advised that I Dr F instantes a vour device complics with other requirements of the Act mat I DT has made a actern administered by other Federal agencies. You must of any Federal statutes and regulations , including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirement; anie (21 CFR Part 807), laboralle (21 OFR Part 820); and if applicable, the clectronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 - Alicia E. Farage

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Ahalye 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

Enclosure

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Food and Drug Administration 1 ood and Brug Administration - Diego™ RF Powered Dissector and Drill System December 22, 2003

K034004

#### Indications for Use:

510(k) Number:

Device Name:

.

Diego™ RF Powered Dissector and Drill System

### Indications for Use:

indications for Soci The Diego R. Fowere and tissue in general ENT, Head & Neck, and otoneurologic procedures.

Sinus applications would embody:

- applications in the most moidectorny, polypectorny, septoplasty and .
- procedures such as endoscopic DCR antrostomy frontal sinus trephination and irrigation frontal sinus drill-out trans-spehnoidal procedures septal spurs removal

Nasõpharyngeal/laryngeal procedures would comprise:

adenoidectomy laryngeal polypectomy tonsillectomy

laryngeal lesion de-bulking tracheal procedures

Head & Neck procedures would encompass:

soft tissue shaving

rhinoplasty (narrowing of the bony vault & revision of the bony pyramid) removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular regions of the face acoustic neuroma removal

Otology procedures would include:

mastoidectomy

mastoidotomy.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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