(83 days)
Not Found
No
The document describes a standard radiofrequency electrosurgical system and does not mention any AI or ML components or functionalities.
Yes
The device is used for cutting, removing, and coagulating tissues, including procedures for snoring and turbinate shrinkage, which are therapeutic interventions.
No
Explanation: The device is described as an electrosurgical system for cutting, removing, and coagulating tissues, not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a radio frequency electrosurgical generator, footswitch, fingerswitch, various instruments (scissors, forceps, probe), electrical cables, and potentially a peristaltic pump. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for surgical procedures involving cutting, removal, coagulation, and thermal ablation of tissues within the body. This is a therapeutic and surgical device, not a diagnostic one.
- Device Description: The description details an electrosurgical generator, instruments like scissors and forceps, and accessories for delivering radiofrequency energy to tissues. This aligns with surgical tools, not diagnostic tests.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to diagnose diseases or conditions.
Therefore, the Xomed ENT RF system is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Xomed ENT RF system is for use by qualified surgeons familiar with radiofrequency electrosurgery techniques. The system produces monopolar and bipolar cutting and coagulation, and may provide fluid irrigation.
Indications in general surgery are for cutting, removal, and coagulation of tissues.
Indications in otorhinolaryngology (ENT) are for cutting, removal, and coagulation of tissues and for the destruction of tissue by thermal ablation in ENT procedures including, but not limited to snoring procedures, submucosal palatal and turbinate shrinkage, and traditional uvulopalatoplasty.
Product codes (comma separated list FDA assigned to the subject device)
97GEI
Device Description
The Xomed ENT RF System consists of a radio frequency electrosurgical generator with a footswitch and/or fingerswitch to activate the generator RF output, various scissors, forceps, and probe electrosurgical instruments, and accessories including electrical cables to attach various electrosurgical instruments.
The system may be provided with an RF output current indicator, and a built-in peristaltic pump and associated footswitch for fluid irrigation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons familiar with radiofrequency electrosurgery techniques
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
DEC - 9 1999
510(k) Summary
K99 3112
1.0 Date Prepared
September 16, 1999
2.0 Submitter (Contact)
Martin D. Sargent Xomed Surgical Products Jacksonville, FL (904) 279-7586
3.0 Device Name
Proprietary Name: Common Name(s): Classification Name(s): Xomed ENT RF System Electrosurgical system Device, Electrosurgical, Cutting & Coagulation & Accessories
5.0 Device Classification
Device, Electrosurgical, Cutting & Coagulation & Accessories: 21 CFR 878.4400 Procode 97GEI Class II
6.0 Device Description
The Xomed ENT RF System consists of a radio frequency electrosurgical generator with a footswitch and/or fingerswitch to activate the generator RF output, various scissors, forceps, and probe electrosurgical instruments, and accessories including electrical cables to attach various electrosurgical instruments.
The system may be provided with an RF output current indicator, and a built-in peristaltic pump and associated footswitch for fluid irrigation.
1
Intended Use 7.0
The Xomed ENT RF system is for use by qualified surgeons familiar with radiofrequency electrosurgery techniques. The system produces monopolar and bipolar cutting and coagulation, and may provide fluid irrigation.
Indications in general surgery are for cutting, removal, and coagulation of tissues.
Indications in otorhinolaryngology (ENT) are for cutting, removal, and coagulation of tissues and for the destruction of tissue by thermal ablation in ENT procedures including, but not limited to snoring procedures, submucosal palatal and turbinate shrinkage, and traditional uvulopalatoplasty.
8.0 Substantial Equivalence
The Xomed ENT RF system is substantially equivalent to the Surgitron IEC marketed by Ellman (K990146 and K980177) in its intended use, materials, and overall design.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human figures, representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 1999
Mr. Martin D. Sargent Senior Regulatory Affairs Specialist Xomed Surgical Products 6743 Southpoint Drive North Jacksonville, Florida 32216
Re: K993112 Trade Name: Xomed ENT RF System Regulatory Class: II Product Code: GEI Dated: September 16, 1999 Received: September 17, 1999
Dear Mr. Sargent:
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 (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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Martin D. Sargent
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) 594-4595. 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.
Sincerely, yours,
Stpt Rhodes
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
12993112 510(k) Number (if known):_ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:
The Xomed ENT RF system is for use by qualified surgeons familiar with radiofrequency electrosurgery techniques. The system produces monopolar and bipolar cutting and coagulation, and may provide fluid irrigation.
Indications in general surgery are for cutting, removal, and coagulation of tissues.
Indications in otorhinolaryngology (ENT) are for cutting, removal, and coagulation of tissues and for the destruction of tissue by thermal ablation in ENT procedures including, but not limited to snoring procedures, submucosal palatal and turbinate shrinkage, and traditional uvulopalatoplasty.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
A.S. Rurch
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K953112
Prescription Use
(Per 21 CFR 801.109)
Or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)