(83 days)
Not Found
K# 952681
No
The description focuses on mechanical cutting action, irrigation/vacuum options, and powered instrumentation technology, with no mention of AI or ML.
Yes.
The device is used for surgical procedures (plastic, reconstructive, and aesthetic surgery of the Head and Neck) to achieve biological or therapeutic effects, such as tissue removal and minimizing trauma, which falls under the definition of a therapeutic device.
No
The device description indicates it is a surgical tool used for tissue removal, not for diagnosing conditions.
No
The device description explicitly states it consists of "instrumentation which power disposable irrigated cutters and burs," indicating it is a hardware system with accessories, not software only.
Based on the provided text, the Stryker Hummer II MicroDebrider system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The intended use and device description clearly state that the Hummer II MicroDebrider system is used for surgical procedures on the Head and Neck, involving the removal of tissue directly from the patient's body.
- The device description focuses on surgical tools and their function. It describes cutters, burs, irrigation, vacuum, and powered instrumentation for tissue removal, which are characteristic of surgical devices, not diagnostic tests performed on samples.
- There is no mention of analyzing biological samples. The text does not describe any process of collecting, preparing, or analyzing blood, urine, tissue samples, or any other bodily fluid or material for diagnostic purposes.
Therefore, the Stryker Hummer II MicroDebrider system is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Hummer II MicroDebrider system, is to be utilized for endoscopic or open plastic, reconstructive, and aesthetic surgery of the Head and Neck.
When using the Stryker Hummer II MicroDebrider system, the surgeon has the ability to choose either open or endoscopic viewing and the option to utilize irrigation or vacuum as the surgeon deems necessary. The precise cutting action of the Hummer II Shaver blades allow the surgeon to achieve desired tissue removal, thus minimizing unwanted contour lines, skin discoloration and patient trauma.
Product codes (comma separated list FDA assigned to the subject device)
77 ERL
Device Description
The Stryker Hummer II MicroDebrider System, consisting of instrumentation which power disposable irrigated cutters and burs, is used in Endoscopic or open plastic, reconstructive and aesthetic surgery of the Head and Neck.
The disposable cutters, burs and tubing sets employed as accessories with the Stryker Hummer II MicroDebrider system, are provided sterile, for single use only, and are validated to an SAL of 10-6. The materials of construction, cutting action, speed of rotation, availability of suction/irrigation and tip configuration are equivalent to Linvatec blades and or the Xomed shaver system, and patient contact materials are demonstrated to be biocompatible per ISO standard 10993. The accessory devices offer no new safety or effectiveness concerns.
The powered instrumentation technology utilized in the device is equivalent to existing marketed devices and is currently cleared for use in Functional Endoscopic Sinus Surgery under K# 952681. This instrumentation is designed to meet TEC 601-1 electrical standards, as well as UL and CSA requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Not Found
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.)
Not Found
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.
Not Found
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.
K# 952681
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.
0
Image /page/0/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black against a white background. The word appears to be a logo or brand name.
FIXOSCULY
2590 Walsh Avenus Santa Clara, CA 95031 (408) 567 2179 ( 800 ) (408) 567 25.77 177
Devicc Name:
Classification Name: Common and Usual Name Proprietary Name:
Surgical ENT Drill 874.4250, Class II Electrical Surgical Shaver Stryker Hummer II MicroDebrider System
I
Device Sponsor: Stryker Endoscopy
2590 Walsh Ave. તે રેણે રે જે જે જેવી સુરત કરવામાં આવે છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એ તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસ Santa Clara, CA I/DA Registration No. 2936485
SAFETY AND EFFECTIVENESS SUMMARY:
The Stryker Hummer II MicroDebrider System, consisting of instrumentation which power disposable irrigated cutters and burs, is used in Endoscopic or open plastic, reconstructive and acsthetic surgery of the Head and Neck.
The disposable cutters, burs and tubing sets employed as accessories with the Stryker Hummer II MicroDebrider system, are provided sterile, for single use only, and are validated to an SAL of 10-6. The materials of construction, cutting action, speed of rotation, availability of suction/irrigation and tip configuration are equivalent to Linvatec blades and or the Xomed shaver system, and patient contact materials are demonstrated to be biocompatible per ISO standard 10993. The accessory devices offer no new safety or effectiveness concerns.
The powered instrumentation technology utilized in the device is equivalent to existing marketed devices and is currently cleared for use in Functional Endoscopic Sinus Surgery under K# 952681. This instrumentation is designed to meet TEC 601-1 clectrical standards, as well as UL and CSA requirements.
The Stryker Hummer II MicroDebrider system does not raise any new safety or effectiveness concerns when compared to, and is therefore equivalent to, the Linvatec and Xomed shaver systems.
Carlos Gonzalez
Carlos Gonzalez VP, Regulatory Affairs and Quality Assurance
Image /page/0/Picture/16 description: The image contains a handwritten sequence of digits and a letter. The sequence starts with the letter 'K', followed by the numbers 9, 7, 2, 5, 8, and 4. The handwriting style appears cursive and slightly slanted. The numbers are written in a connected manner.
Vice President of Regulators and Onalily Vesti res.
CARIOS CONZALI
OCT - 1 1997
1
Image /page/1/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized depiction of three human figures or abstract shapes arranged vertically. The figures are rendered in a simple, flowing line style, creating a sense of movement or connection. The text "DEPARTMENT OF HEALTH" is arranged vertically along the left side of the logo.
ublic Hearth Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - I
Carlos Gonzalez Vice President, Regulatory Affairs Stryker Endoscopy 2590 Walsh Avenue Santa Clara, CA 95051
Re: K972584 Stryker Hummer II MicroDebrider System Dated: July 7, 1997 Received: July 10, 1997 Regulatory Class: II 21 CFR 874.4250/Procode: 77 ERL
Dear Mr. Gonzalez:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h.7liau Yu
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Page __ 1
510(k) Number (if known):_K # 972584
Device Name: Stryker Hummer II MicroDebrider
Indications For Use:
The Stryker Hummer II MicroDebrider system, is to be utilized for endoscopic or
es and Neck The Stryker Hummer if MicroDebnoer system, is to a see and Neck.
open plastic, reconstructive, and aesthetic surgery of the Head and Neck.
When using the Stryker Hummer II MicroDebrider system, the surgeon has the
continued the street the survey desenie viewing and the option to utilize When using the Stryker Hummen in MicroDebiading and the option to utilize
ability to choose either open or endoscopic viewing and the opense cutting ability to choose either open of enodscope viewing and the precise cutting
irrigation or vacuum as the surgeon deems necessary. The precise cutting irrigation or vacuum as the surgeon deenls necessary.
action of the Hummer II Shaver blades allow the surgeon to achieve desired action of the Hummer II Shaver blades anow the surgoon in
tissue removal, thus minimizing unwanted contour lines, skin discoloration and patient trauma.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number