DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE

K030343 · Gyrus Ent LLC · HAW · May 2, 2003 · Neurology

Device Facts

• Record ID: K030343
• Device Name: DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE
• Applicant: Gyrus Ent LLC
• Product Code: HAW · Neurology
• Decision Date: May 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Diego Powered Dissector and Drill System equipped with an image guided surgery system 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 . 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) . 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

Diego Powered Dissector and Drill System modified with Starlink Image Guided Adapter mounting interface; allows integration with BrainLAB VectorVision and Kolibri Image-Guided Surgery (IGS) systems. Device enables real-time tracking of dissector blades and burs within surgical field. Used by surgeons in OR for ENT, Head & Neck, and otoneurologic procedures. Provides visual feedback via IGS system to assist in precise bone/tissue removal; enhances surgical navigation; improves procedural accuracy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered dissector and drill handpiece; includes mechanical mounting interface (Starlink Adapter) for external IGS system tracking sensors. Device is a modification of existing cleared handpiece (K020594).

Indications for Use

Indicated for patients undergoing ENT, Head & Neck, and otoneurologic procedures requiring cutting and removal of bone and tissue, including sinus, nasopharyngeal, laryngeal, and otology surgeries.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Diego Powered Dissector and Drill System (K020594)

Reference Devices

• BrainLAB VectorVision IGS System (K003589)
• BrainLAB Kolibri IGS System (K014256)

Submission Summary (Full Text)

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1630343

Food and Druq Administration

January 31, 2003

510(k) Notification – Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece

#### MAY = 2 2003 510(k) Summary

| Submitter's Name:<br>Submitter's Address:<br>Submitter's Telephone Number: | Gyrus ENT LLC<br>2925 Appling Road, Bartlett, TN 38133<br>901.373.0200 |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Gregory Sredin |
| Date Summary Prepared: | January 31, 2003 |
| Proprietary Name: | Diego™ Powered Dissector Handpiece<br>with Starlink™ Image Guided Adapter<br>Mounting Interface |
| Common Name: | Instrument, Stereotaxic |
| Classification Name: | Instrument, Stereotaxic |
| Classification | Class II |
| Classification Panel: | Neurology |
| Device Product Code | HAW |

# Subject Device Description

The Diego Powered Dissector and Drill System Handpiece, cleared under 510(k) K020594, has been modified to accept the BrainLAB VectorVision (K003589) and Kolibri (K014256) Image-Guided Surgery System Instrument Adapter that will allow the Dissector blades and burs to be tracked in real time in the surgical field.

# Applicable 510(k)'s

| Manufacturer | Submission Name | FDA Clearance |
|--------------|----------------------------|---------------|
| BrainLAB AG | Kolibri IGS System | K014256 |
| BrainLAB AG | Vectorvision2 IGS System | K003589 |

# Subject Device Intended Use

The intended use of the Diego Powered Dissector and Drill System equipped with an image guided surgery system is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.

Sinus applications would embody:

- ethmoidectomy/sphenoethmoidectomy .

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K030343

### Food and Drug Administration

January 31, 2003

510(k) Notification – Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece

- 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) .
- 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "HUMAN SERVICES • USA" and "DEPARTMENT OF" arranged around the top and bottom of the circle, respectively. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, with flowing lines suggesting movement or progress.

MAY - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gregory Sredin Senior Regulatory Affairs Specialist Gyrus ENT LLC 2925 Appling Road Bartlett, Tennessee 38133

Re: K030343

Trade/Device Name: Diego™ Powered Dissector Handpiece with Starlink™ Image Guided Adapter Mounting Interface

Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 21, 2003 Received: February 3, 2003

Dear Mr. Sredin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 - Mr. Gregory Sredin

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]. 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) you may obtain. 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,

Miriam a. Provost

(W Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Food and Drug Administration

January 31, 2003 510(k) Notification – Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece

#### Ko30343 510(k) Number:

Device Name: Diego™ Powered Dissector and Drill System Handpiece with Image Guided Surgery System Interface,

Indications for Use:

The intended use of the Diego Powered Dissector and Drill System is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.

Sinus applications would embody:

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

Nasopharyngeal/laryngeal procedures would comprise:

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

Otology procedures would include:

- mastoidectomy .
- mastoidotomy. ●
- 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 ●

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number K030343

Prescription Use
(Per 21 CFR 801.109) X

OR

Over-the-Counter

(Optional Format 1-2-96)