(20 days)
Not Found
Not Found
No
The summary describes a mechanical surgical bur and does not mention any software, algorithms, or data processing related to AI or ML.
No.
The device is described as a surgical bur intended for incising or removing bone, which suggests a surgical tool rather than a device for treating a disease or condition. Its function is to perform a surgical action, not to provide therapy.
No
The device is described as a surgical tool ("incising or removing bone"), not as a device used to identify or analyze a medical condition.
No
The device description clearly states it is a physical bur with a cutting tip, flexible shank, and outer cannula, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "incising or removing bone in the ear, nose, or throat area" using a surgical drill. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical cutting tool used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to perform surgical procedures directly on the body.
N/A
Intended Use / Indications for Use
The XPS Curved Bur is intended for use in an ear, nose, and throat electric or pneumatic surgical drill for incising or removing bone in the ear, nose, or throat area, and is an accessory to the XPS 3000 System.
Product codes
77EQJ
Device Description
The XPS Curved Bur consists of a cutting tip connected to a flexible bur shank which is surrounded by a stationary outer cannula. The flexible shank and cutting tip are rotated by a surgical drill motor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear, nose, or throat area
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4140 Ear, nose, and throat bur.
(a)
Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
AUG 1 2 2004
510(k) Summary
Date Prepared 1.0
June 25, 2004
Submitter (Contact) 2.0
Martin D. Sargent Regulatory Affairs Manager Medtronic Xomed Jacksonville, FL (904) 279-7586
Device Name 3.0
| Proprietary Name: | XPS Curved Bur (the tradename has not been finalized at this time) |
|---|---|
| Common Name(s): | ENT bur |
| Classification Name(s): | Ear, nose, and throat bur |
Device Classification 4.0
| Classification Name: | Ear, nose, and throat bur |
|---|---|
| Procode: | 77EQJ |
| Class I | 21 CFR § 874.4140 |
Device Description 5.0
The XPS Curved Bur consists of a cutting tip connected to a flexible bur shank which is surrounded by a stationary outer cannula. The flexible shank and cutting tip are rotated by a surgical drill motor.
Indications for Use 6.0
The XPS Curved Bur is intended for use in an ear, nose, and throat electric or pneumatic surgical drill for incising or removing bone in the ear, nose, or throat area, and is an accessory to the XPS 3000 System.
1
510(k) Summary (continued)
Substantial Equivalence 7.0
The proposed XPS Curved Bur is substantially equivalent in operating principle, technology, overall I ne proportion, and cuting surface materials to ENT Burs as described in 21 CFR § 874.4140. acolEh, railetter, and new safety or efficacy issues associated with the proposed device.
| Characteristic | ENT Bur
(21 CFR § 874.4140) | XPS Curved Bur
(This submission) |
|------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|
| Intended Use /
Indications for use | Incising or removing bone in
the ear, nose, or throat area | Incising or removing bone in
the ear, nose, or throat area |
| For use with a surgical drill
per 21 CRF § 874.4140 | Yes | Yes |
| Maximum rotational speed | 80,000 RPM | 80,000 RPM |
| Bur guard integrated into design
or available as an accessory | Yes | Yes |
| Direct patient contacting
materials (Burs / Blades) | Stainless Steel and
medical polymer | Stainless Steel, 6/6 nylon
thread, and medical polymer |
| Blades / burs biocompatible | Yes | Yes |
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration Rockville MD 20857
AUG 1 2 2004
Medtronic Xomed, Inc. c/o Mr. Jefffrey D. Rongero Underwriters Laboratories, Inc. 12 Laboratory Dr. Research Triangle Park, NC 27709
Re: K041985
Trade/Device Name: XPS Curved Bur Regulation Number: 21 CFR 874.4140 Regulation Name: ENT Bur Regulatory Class: Class I Product Codc: 77 EQJ Dated: July 21, 2004 Received: July 23, 2004
Dear Ms. Rongero:
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 for doo ourselve in 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 r va may a 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 I hat 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 or any I ederal 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.
3
Page 2 - Mr. Jeffrey Rongero
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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A képi korentthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): XPS Curved Bur Device Name: Indications for Use:
The XPS Curved Bur is intended for use in an ear, nose, and throat electric or pneumatic surgical dirill for The XPS Curved Bur is meetided for use mail cal, nose, and is an accessory to the XPS 3000 System.
incising or removing bone in the ear, nose, or throat area, and is an acces
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Page 1 of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K041985
Prescription Use
(Per 21 CFR 801.109)
ਹੈ 8