← Product Code [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL) · K080052 # STRYKER ESSX WITH NAVIGATION MOUNT (K080052) _Stryker Corp. · ERL · Oct 2, 2008 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K080052 ## Device Facts - **Applicant:** Stryker Corp. - **Product Code:** [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL.md) - **Decision Date:** Oct 2, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4250 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use The Stryker ESSx with Navigation Mount is to be utilized for Functional Endoscopic Sinus Surgery (FESS) for the incision of soft and osseous tissue in the sinus cavities, open plastic, reconstructive and aesthetic surgery of the Head and Neck. When used in conjunction with the Stryker Navigation/Tracker System, the device will enhance the surgeon's ability to localize anatomical landmarks (intraoperatively). ## Device Story Stryker ESSx with Navigation Mount is an electric, high-speed surgical ENT drill system comprising a motor handpiece, hoses, and various cutting attachments. Used in clinical settings for FESS and head/neck surgeries. Integrates with FDA-cleared Stryker Navigation/Tracker Systems to provide intraoperative localization of anatomical landmarks. Navigation serves as secondary verification to visual confirmation via endoscope. Surgeon operates device to perform tissue incision; navigation output assists in spatial orientation during procedures. Benefits include enhanced surgical precision and landmark localization. ## Clinical Evidence No clinical data provided; substantial equivalence is based on technological comparison and intended use. ## Technological Characteristics Electric, high-speed surgical ENT drill system. Includes handpiece, hoses, and cutting accessories. Features a navigation mount for integration with Stryker Navigation/Tracker Systems. Operates as a powered surgical instrument. ## Regulatory 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 System ([K011381](/device/K011381.md)) - Diego Powered Dissector Handpiece with Starlink Image Guided Adapter Mounting Interface ([K030343](/device/K030343.md)) - XPS 3000 System ([K041523](/device/K041523.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Kodoos2_ # OCT 0 2 2008 : 4400 E. Milham Avenue t: 269 323 7700 1: 800 965 G505 ww.stryker.com . . . : : : # rige. I og men stryker stryker 14.20 1 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Instruments | 510(k) Summary | | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Sponsor: | Stryker Instruments
4100 E. Milham Avenue
Kalamazoo, MI 49001
(p) 269-323-7700 ext4233
(f) 269-324-5412 | | Registration No.: | 1811755 | | Trade Name: | Stryker ESSx with Navigation Mount | | Common Name: | Surgical ENT Drill with Accessories | | Classification Name: | Drill, Surgical, ENT (electric or pneumatic) including Handpiece | | Equivalent to: | K011381 Stryker Hummer IV MicroDebrider System
K030343 Diego Powered Dissector Handpiece with Starlink Image Guided Adapter Mounting Interface
K041523 XPS 3000 System | | Device Description: | The Stryker ESSx with Navigation Mount is an electric, high-speed instrument system consisting of a motor (handpiece), hoses, and a variety of attachments and cutting accessories. The handpiece will operate with FDA cleared Stryker Navigation Systems. The Navigation feature will serve as a secondary verification to the tips position which is obtained through visual means typically with use of an endoscope. | | Indications for Use: | The Stryker ESSx with Navigation Mount is to be utilized for Functional Endoscopic Sinus Surgery (FESS) for the incision of soft and osseous tissue in the sinus cavities, open plastic, reconstructive and aesthetic surgery of the Head and Neck. When used in conjunction with the Stryker Navigation/Tracker System, the device will enhance the surgeon's ability to localize anatomical landmarks (intraoperatively). | | Substantial Equivalence (SE) Rational: | The Stryker ESSx with Navigation Mount has the same intended use, technological characteristics and navigated operating mechanism as compared to the predicate devices: the Diego Powered Dissector Handpiece with Starlink Image Guided Adapter Mounting Interface (K030343) and the Xomed XPS 3000 System (K041523). The Stryker ESSx with Navigation Mount has the same intended use as the Stryker Hummer IV MicroDebrider System (K011381). | | Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker ESSx with Navigation Mount is substantially equivalent to legally marketed devices. | | Page 1 of 2 | | : Page It of 2 . {1}------------------------------------------------ Submitted by: 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 Valerie Franck Senior Regulatory Affairs Representative : : : : : Image /page/1/Picture/2 description: The image shows a signature that reads "Colorit Parre" in cursive handwriting. The signature is underlined with a horizontal line. Below the signature is the word "Signature" in a smaller font size. . 11. 11. 11. 11:10 PM 9/30/08_ : : . Date submitted: : . 1 . Page 2 of 2 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## OCT 02 2008 Stryker Corp. c/o Valerie Franck 4100 East Milham Ave. Kalamazoo, MI 49001 Re: K080052 Trade/Device Name: Stryker ESSx with Navigation Mount Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose and Throat (electric or pneumatic) surgical drill Regulatory Class: Class II Product Code: ERL Dated: September 12, 2008 Received: September 15, 2008 Dear Ms. Franck: 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 gencral 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. {3}------------------------------------------------ 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, M. B. Egerlino, mD Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(K) Number (if known): 080052 Page 1 of 1 Device Name: Stryker ESSx with Navigation Mount #### Indications for Use The Stryker ESSx with Navigation Mount is to be utilized for Functional Endoscopic Sinus Surgery (FESS) for the incision of soft and osseous tissue in the sinus cavities, open plastic, reconstructive and aesthetic surgery of the Head and Neck. When used in conjunction with the Stryker Navigation/Tracker System, the device will enhance the surgeon's ability to localize anatomical landmarks (intraoperatively). Prescription Use × (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) x Prescription Use (Per 21 CFR 801.109) Sein Machen (Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises 2057 510(k) Number. --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K080052](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K080052) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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