(56 days)
Not Found
NOT APPLICABLE
No
The 510(k) summary describes a tissue removal system and does not mention any AI or ML components or capabilities.
Yes
The device is used for the removal of soft tissue and bone in the ear, nose & throat, which is a therapeutic intervention.
No
The 'Intended Use / Indications for Use' states "For the removal of soft tissue and bone...", which indicates a therapeutic or surgical function, not a diagnostic one. There is no mention of identifying, detecting, or measuring a condition.
No
The device description explicitly states "Promex ENT Tissue Removal System," which strongly implies a physical system for tissue removal, not a software-only device. The intended use also describes a physical action ("removal of soft tissue and bone").
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the removal of soft tissue and bone in the ear, nose & throat." This describes a surgical or procedural device used directly on a patient's body, not a test performed on samples taken from the body (like blood, urine, or tissue samples).
- Device Description: The description "Promex ENT Tissue Removal System" further supports the idea of a surgical tool.
- Lack of IVD Indicators: There is no mention of analyzing samples, performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically remove tissue and bone, which is a therapeutic or procedural action, not a diagnostic one.
N/A
Intended Use / Indications for Use
For the removal of soft tissue and bone in the ear, nose & throat.
Product codes
77 ERL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear, nose & throat
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)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 1997
Joseph L. Mark Vice President Promex, Inc. 1125 Brookside Ave., Suite G500 Indianapolis, IN 46202
K972865 Re:
Promex ENT Tissue Removal System Dated: July 31, 1997 Received: August 4, 1997 Regulatory class: II 21 CFR 874.4250/Procode: 77 ERL
Dear Mr. Mark:
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 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 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,
hJliau 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
1
Page_1 of I
91128 510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________ Promex ENT Tissue Removal System
Indications For Use:
For the removal of soft tissue and bone in the ear, nose & throat.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segmon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
Ω(k) Number _
/ )
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
..
(Optional Format 1-2-96)
EN
II