(268 days)
Not Found
No
The document describes a surgical instrument system with navigation capabilities, but there is no mention of AI or ML in the intended use, device description, or other sections. The navigation feature is described as a secondary verification tool, not an AI/ML-driven analysis.
No
The device is described as an instrument system for surgical procedures, focusing on tissue incision and anatomical localization through navigation, rather than a treatment or therapeutic intervention itself.
No
The device is an electric, high-speed instrument system used for surgical cutting (incision) of tissue. Its navigation feature helps localize anatomical landmarks intraoperatively, which assists in the surgical procedure rather than diagnosing a condition.
No
The device description explicitly states it is an "electric, high-speed instrument system consisting of a motor (handpiece), hoses, and a variety of attachments and cutting accessories," which are hardware components.
Based on the provided information, the Stryker ESSx with Navigation Mount is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for cutting soft and osseous tissue within the body (sinus cavities, head and neck). IVDs are used to examine specimens outside the body to provide information about a patient's health.
- Device Description: The device is described as an electric, high-speed instrument system with a motor, hoses, attachments, and cutting accessories. This is consistent with a surgical tool, not a diagnostic test.
- Lack of Diagnostic Function: The device's function is to perform surgical procedures and, when used with navigation, to help the surgeon localize anatomical landmarks during the procedure. It does not analyze biological samples or provide diagnostic information about a patient's condition.
Therefore, the Stryker ESSx with Navigation Mount is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
ERL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus cavities, Head and Neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
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.(b)
Classification. Class II.
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| 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. |
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Submitted by:
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Valerie Franck Senior Regulatory Affairs Representative
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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.
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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), 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
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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.