(37 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of a surgical drill system, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as an XPS Drill System primarily intended for surgical procedures involving controlled incision or removal of bone, which indicates it's a surgical tool rather than a therapeutic device.
No
The device description indicates it is a surgical tool for controlled incision or removal of bone, not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a console, electric motor, handpieces, and foot pedal, indicating it is a physical medical device system, not software-only.
Based on the provided information, the XPS Drill System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a surgical drill system with a console, motor, handpieces, and foot pedal. This is consistent with a surgical tool, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on sample analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The XPS Drill System's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
The XPS Drill System is primarily intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck.
The XPS Drill System is intended for the controlled incision or remov al of bone in the ear, nose, throat and other areas of the head and neck.
Product codes
77ERL, 79GEY
Device Description
The XPS Drill System is made up of a console, electric motor, exchangable handpieces, foot pedal and accessories as described below. It has the ability to operate one handpiece and incorporates irrigation capability. The handpiece speed range is 0 - 90,000 RPM and the stall torque is 3.5 oz-in.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear, nose, throat and other areas of the 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 21 1998
Image /page/0/Picture/1 description: The image shows the word "XOMED" in a bold, sans-serif font. To the right of the word is a registered trademark symbol, followed by a circular design with a cross-like shape inside. The cross is made up of four arrow-like shapes pointing towards the center of the circle. The overall design is simple and clean, with a focus on the brand name and logo.
510k Summary XPS Drill System
1.0 Date Prepared
September 10, 1998
2.0 Submitter (Contact)
David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532
3.0 Device Name
Proprietary Name: XPS Drill System Electric Surgical Drill System Common Name: ENT electric or pneumatic surgical drill Classification Name:
4.0 Device Classification
Currently marketed products of this type have been classified by the Ear, Nose and Throat Panel as follows:
| ENT electric or pneumatic surgical drill | 77ERL | Class II | 874.4250 |
|---|---|---|---|
| Surgical Instrument Motors and accessories | 79GEY | Class I* | 878.4820 |
| * exempted from premarket notification. |
રુ:0 Device Description
The XPS Drill System is made up of a console, electric motor, exchangable handpieces, foot pedal and accessories as described below. It has the ability to operate one handpiece and incorporates irrigation capability. The handpiece speed range is 0 - 90,000 RPM and the stall torque is 3.5 oz-in.
NOTE: There is no software involved with the operation of this device.
1
Revised 10/13/98
Intended Use 6.0
The XPS Drill System is primarily intended for the controlled incision or removal of bonc in the ear, nose, throat and other areas of the head and neck.
7.0 Substantial Equivalence
The new XPS Drill System is the same drill system that was previously cleared by K904850 Xomed now intends to market this system for ENT and Head and Neck surgery. In so doing, we have made some minor changes to the labeling, i.e. the instruction manual and the console None of these changes are significant and are typical of any ENT drill. As an ENT drill, the XPS Drill System is also substantially equivalent to the MPS Powerforma currently marketed by Xomed (K960853). Information from the MPS Powerforma manual was used in modifying the Micro Motors manual for the proposed XPS Drill.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
David M. Timlin Manager, Regulatory Affairs Xomed Surgical Products, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216
Re:
K983224 Xomed XPS Drill System Dated: September 10, 1998 Received: September 14, 1998 Regulatory class: II 21 CFR 874.4250/Procode: 77 ERL
Dear Mr. Timlin:
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, 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 (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 requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product 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 vitn diagnostic devices), please contact the Office of Compliance at (301) 5944613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Complianced (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/cdr/dsmaldsmamain.html".
Sincerely yours,
William Yin
Lillian Yin, Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Revised 10/13/98
510(k) Number (if known): __ K983224 Device Name: XPS Drill System__ Indications for Usc:
The XPS Drill System is intended for the controlled incision or renoval of bone in the ear, nose, throat and other areas of the head and neck.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use A (Per 21 CFR 801.109)
Oi
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Formal 1-2-96)
Samil A. Sezern
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
49