(67 days)
Not Found
No
The description focuses on mechanical components (power control unit, footswitch, handpiece, blades, burs) for cutting and removing tissue and bone. There is no mention of AI, ML, image processing, or data-driven decision making.
No
The device is used for cutting and removing bone and tissues during surgical procedures. Its purpose is to facilitate surgery, not to treat a disease or condition itself.
No
The device is described as a surgical tool for cutting and removing bone and tissues, not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a Power Control unit, footswitch, handpiece, and accessory blades and burs.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and removal of bone and tissues in ENT, otorhinolaryngology / head and neck surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a "microdebrider system" with a power control unit, footswitch, handpiece, blades, and burs. These are all components of a surgical instrument.
- 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 about a patient's health status, diagnosis, or treatment.
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
This device is intended for the cutting and removal of bone and tissues in ENT, otorhinolaryngology / head and neck surgical procedures.
Indications: Any ENT, otorhinolaryngological, or head and neck surgery requiring the incision and removal of bone or tissue, including removal and shaping of bone during rhinoplasty procedures and removal of soft tissue during plastic, reconstructive, and/or athestic surgery of the head and neck.
Product codes (comma separated list FDA assigned to the subject device)
77 ERL, 77 EQJ
Device Description
The XPS microdebrider system is composed of the Power Control unit, a footswitch and a handpiece combined with various accessory blades and burs. The XPS system and replaceable blades and burs are intended for use by health care professionals and are labeled as prescription devices. The disposable blades and burs are provided in styles and sizes to remove the various tissues and bone typically resected in ENT and Head and Neck surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ENT, otorhinolaryngology / head and neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
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.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for XOMED Surgical Products. The logo consists of the word "XOMED" in large, bold, sans-serif font, with the words "SURGICAL PRODUCTS" in a smaller font underneath. Below the words is a circular emblem with a four-pointed star inside. The logo is black and white.
Revised 8/25/97
510(k) Summary
1.0 Date Prepared June 27, 1997
SEP - 5 1997
2.0 Submitter (Contact)
David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532
3.0 Device Name
| Proprietary Name: | XPS StraightShot Microresector System and/or Sculpture
System, and various descriptive tradenames for burs and
blades as accessories for the system.) | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Common Name(s): | Electrical surgical drill, microdebrider, or microresector,
handpieces, burs and blades | |
| Classification Name: | ENT Surgical Drill | |
5.0 Device Classification
| ENT Surgical Drill | Procode: 77 ERL | Class II; 21CFR 874.4250 | Tier 1 |
|---|---|---|---|
| ENT Bur (Blade) | Procode: 77 EQJ | Class I; 21CFR 874.4140 | Tier 1 |
6.0 Device Description
The XPS microdebrider system is composed of the Power Control unit, a footswitch and a handpiece combined with various accessory blades and burs. The XPS system and replaceable blades and burs are intended for use by health care professionals and are labeled as prescription devices. The disposable blades and burs are provided in styles and sizes to remove the various tissues and bone typically resected in ENT and Head and Neck surgery.
7.0 Intended Use
This device is intended for the cutting and removal of bone and tissues in ENT, otorhinolaryngology / head and neck surgical procedures.
1
Substantial Equivalence 8.0
This submission is to obtain FDA concurrence that the specific procedures (rhinoplasty and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery of the head and neck) indicated in the proposed labeling are substantially equivalent to the current broadly stated indications for use. No other modifications or device changes are included.
The use of the XPS System for rhinoplasty is equivalent to the TreBay Microplaner handpiece, cleared via K954715, which is described as having a 4.4 mm cutting bur with a hooded tip and handpiece. Its cleared indications for use included "for removal of bone and tissues in rhinoplasty, for such procedures including nasal dorsum surgery and nasal osteotomy, and surgery for rhinoplasty".
The additional indication proposed for soft tissue removal during plastic, reconstructive, and/or aesthetic surgery of the head and neck is only identifying a specific soft tissue removal that is commonly carried out by the ENT/Head and Neck surgeon. The removal of this tissue is equivalent to the removal of any other soft tissue of the head and neck in that it raises no new issues of safety or effectiveness. In a multi-institutional experience for these indications (article of Becker, et al.), the use of powered cutting blades is found to be safe and effective for removal of such tissue.
2
Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name arranged in a circular fashion on the left side. To the right of the text is a symbol consisting of three stylized lines or strokes, which may represent a human figure or abstract design. The logo is presented in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David Timlin Manager, Regulatory Affairs XOMED Surgical Products 6743 Southpointe Drive, N. Jacksonville、FL 32216
SEP - 5 1997 Re: K972453 XPS Straight Shot Electronic or Pneumatic Surgical Drill Dated: June 27, 1997 Received: June 30, 1997 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 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. Tile 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 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 questions on the promotion 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,
William Yu, Ph.D.
Lilian Yin, Plu.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k): K972453
Device Name: Xomed (Trebay) Microdebrider / resector. XPS StraightShot. XPS Sculpture systems and accessory blades and burs
Indications for Use:
This device is intended for the cutting and removal of bone and tissues in ENT, otorhinolaryngology / head and neck surgical procedures.
Indications: Any ENT, otorhinolaryngological, or head and neck surgery requiring the incision and removal of bone or tissue, including removal and shaping of bone during rhinoplasty procedures and removal of soft tissue during plastic, reconstructive, and/or athestic surgery 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
(Per 21 CFR 801.109)
Or
Over-the-Counter Use
(Optional Format 1-2-96)
David A. Bergman
Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number