STRYKER ESSX MICRODEBRIDER SYSTEM

K073633 · Stryker Ireland Ltd., Instruments Division · ERL · Aug 26, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K073633
• Device Name: STRYKER ESSX MICRODEBRIDER SYSTEM
• Applicant: Stryker Ireland Ltd., Instruments Division
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Aug 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ESSx Microdebrider System is intended for the cutting and removal of soft and osseous tissue in general ENT encompassing the areas of Sinus, Nasopharyngeal /Laryngeal and Head and Neck procedures, such as the following: Sinus: - ethmoidectory/sphenoethmoidectomy - polypectomy - septoplasty - antrostomy - endoscopic DCR - frontal sinus drill-out - frontal sinus trephination - septal spurs removal - trans-sphenoidal procedures Nasopharyngeal/laryngeal: - adenoidectomy - laryngeal lesion debulking - laryngeal polypectomy - tracheal procedures - tonsillectomy Head & Neck: - soft tissue shaving - rhinoplasty - removal of fatty tissue in the maxillary and mandibular regions of the face

Device Story

Stryker ESSx Microdebrider System is a powered surgical instrument for ENT procedures. System components include console, footswitch, handpiece, irrigation cassette, and disposable shaver accessories. Device operates via electric motor providing power to removable rotating surgical cutting tools. Used in clinical settings by physicians for cutting/removing soft and osseous tissue. Output is mechanical tissue resection; healthcare provider controls device via footswitch to perform precise tissue removal. Benefits include efficient tissue debridement and access in complex anatomical regions like sinuses and laryngeal structures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Powered surgical instrument system consisting of console, footswitch, handpiece, irrigation cassette, and disposable shaver accessories. Operates via electric motor for rotating cutting tools. Designed for ENT surgical applications.

Indications for Use

Indicated for patients requiring soft or osseous tissue removal during general ENT procedures, including sinus, nasopharyngeal, laryngeal, and head and neck surgeries. No specific age or gender contraindications provided.

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

• Stryker Hummer IV MicroDebrider (K011381)
• Medtronic XPS 3000 (K041523)
• Gyrus Diego Powered Dissector and Drill (K020594)

Submission Summary (Full Text)

{0}------------------------------------------------

K073633

4100 E. Milham Avenue
Kalamazoo. MI 49001
t: 269 323 7700 f: 800 965 6505
www.stryker.com

# AUG 2 6 2008

# struk er

Instruments

# 510(k) Summary

| Device Sponsor: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>(p) 269-323-7700<br>(f) 269-324-5412 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 1811755 |
| Trade Name: | Stryker ESSx Microdebrider System |
| Common Name: | Surgical ENT Drill with accessories |
| Classification Name: | Ear, nose and throat (electric or pneumatic) surgical drill (ERL)<br>Ear, Nose and Throat Bur (EQJ)<br>Blade, Saw, General and Plastic Surgery, Surgical (GFA) |
| Equivalent to: | K011381 Stryker Hummer IV MicroDebrider<br>K041523 Medtronic XPS 3000<br>K020594 Gyrus Diego Powered Dissector and Drill |
| Device Description: | The Stryker ESSx Microdebrider System is a powered instrument<br>system consisting of a console, footswitch, handpiece, irrigation cassette,<br>and a variety of disposable shaver accessories. |
| Indications for Use: | The Stryker ESSx Microdebrider System is an electrically operated surgical<br>instrument system. The electric motor provides power to operate removable<br>rotating surgical cutting tools intended for the cutting and removal of soft and<br>osseous tissue in general ENT encompassing the areas of Sinus,<br>Nasopharyngeal /Laryngeal and Head and Neck procedures, such as the<br>following:<br>Sinus:<br>- ethmoidectomy/sphenoethmoidectomy<br>- polypectomy<br>- septoplasty |

- septoplasty
antrostomy
-

.

- endoscopic DCR
- frontal sinus drill-out
- frontal sinus trephination - septal spurs removal
- trans-sphenoidal procedures

.

·

Page 1 of 2

{1}------------------------------------------------

# Nasopharyngeal/laryngeal:

- adenoidectomy
- laryngeal lesion debulking
- laryngeal polypectomy
- tracheal procedures
- tonsillectomy

# Head & Neck:

- soft tissue shaving
- rhinoplasty
- removal of fatty tissue in the maxillary and mandibular regions of the face

| Substantial Equivalence<br>(SE) Rational: | The Stryker ESSx Microdebrider System has the same intended use as the<br>Medtronic XPS 3000 and Gyrus Diego Powered Dissector and Drill.<br>This device and the predicate devices have the same technological<br>characteristics, the same operating principles, use the same patient<br>contacting materials and have similar performance characteristics. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker ESSx<br>Microdebrider System is substantially equivalent to legally marketed devices. |

Submitted by:

Colette O'Connor Regulatory Specialist

Colette O'Hara (

Signature

Date submitted:

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are black and the background is white. There is a registered trademark symbol in the upper right corner of the word. The word appears to be a logo for the Stryker Corporation, a medical technology company.

Carrigtwohill Business & Tcchnology Park, Carrigtwohill, Co. Cork. Ireland t: [phone] f: [phone] www.stryker.com

Instruments

August 21st, 2008

ATTN: K073633 Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Document mail Center (HFZ-401), 9200 Corporate Boulevard, Rockville, MD 20850, USA

# Subject: K073633, Stryker ESSx System

Dear Mr. Nandkumar,

The following information is being provided per your request of August 20th 2008. The indications for use statement section of the 510K summary sheet has been revised as requested.

Can you please confirm that you have received this response via e-mail [e-mail] or by fax to 011 353 21 4532961.

Sincerely,

Colette O'Connor 21 Aug 08
Colette O'Connor, Regulatory Specialist

olette O'Connor, Regulatory Specialist

{3}------------------------------------------------

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 stylized eagle or bird symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 2 6 2008

Stryker® Instruments c/o Liz Walsh Carrigtwohill Business & Technology Park, Carrigtwohill, Co. Cork, Ireland

Re: K073633

Trade/Device Name: Stryker ESSx Microdebrider System Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: II Product Code: ERL Dated: July 16, 2008 Received: July 21, 2008

Dear Ms. Walsh:

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 -Liz Walsh

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Malvina B. Egleston, und

Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# KO 73633

Page 1 of 1

#### 510(K) Number (if known):

Device Name: Stryker ESSx Microdebrider System

#### Indications for Use

The ESSx Microdebrider System is intended for the cutting and removal of soft and osseous tissue in general ENT encompassing the areas of Sinus, Nasopharyngeal /Laryngeal and Head and Neck procedures, such as the following:

Sinus:

- ethmoidectory/sphenoethmoidectomy
- polypectomy
- septoplasty
- antrostomy
- endoscopic DCR
- frontal sinus drill-out
- frontal sinus trephination
- septal spurs removal
- trans-sphenoidal procedures

## Nasopharyngeal/laryngeal:

- adenoidectomy
- laryngeal lesion debulking
- laryngeal polypectomy
- tracheal procedures
- tonsillectomy

## Head & Neck:

- soft tissue shaving
- rhinoplasty
- removal of fatty tissue in the maxillary and mandibular regions of the face

Prescription Use X (Part 21 CFR 801 Subpart D) and/or

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Analote

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
7363

510(k) Number