(120 days)
Not Found
No
The document describes a radio-frequency electrosurgical generator with controls for temperature, energy, power, and waveform. It mentions readouts for various parameters but does not include any language related to AI, ML, image processing, or data-driven decision making.
Yes
The device is described as a system for ablation, resection, and coagulation of soft tissue, and hemostasis of blood vessels in head and neck surgery, which are therapeutic interventions.
No
The device description clearly states its intended use for ablation, resection, coagulation, and hemostasis of soft tissue and blood vessels. These are all therapeutic and surgical interventions, not diagnostic procedures. While it has readouts for parameters like impedance and temperature, these are for monitoring the delivery of therapy, not for diagnosing a condition.
No
The device description clearly outlines hardware components such as a generator with controls, connectors, and accessories like electrodes, cables, and a footswitch. This is not a software-only device.
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 "ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery". This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device description details a generator that delivers energy (monopolar and bipolar) through electrodes to perform surgical actions on tissue. This is consistent with a surgical device, not a device that analyzes samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVD devices are designed to examine specimens in vitro (outside the body) to provide information about a patient's health status.
This device is a surgical electrosurgical system used for treating conditions directly within the patient's body.
N/A
Intended Use / Indications for Use
The Gyrus G3 System is intended for use for ablation. resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery coagulation of soft tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
The Bipolar Generator section of the G3 RF Workstation is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including:
- Adenoidectomy .
- Cysts .
- Head, Neck, Oral, and Sinus Surgery
- Mastoidectomy
- Myringotomy with effective Hemorrhage Control
- Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal
- Polypectomy, and Laryngeal Lesion Debulking
- Neck Mass
- Papilloma Keloids
- Submucosal Palatal Shrinkage
- Tonsillectorny
- Traditional Uvulopalatoplasty (RAUP)
- Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring
- Uvulopaiatopharyngoplasty (UPPP)
- Parotidectomy
- Radical Neck Disection
The Gyrus Somnoplasty TCRF Generator section of the G3 RF Workstation with the Temperature Controlled Radio-frequency (Somnoplasty®) Electrodes is indicated for coagulation of soft tissue including:
The coagulation of enlarged tonsils in patients 13 years of age and older; the reduction of the incidence of airway obstructions, e.g., base of tongue, soft palate, etc., in patients suffering from UARS or OSAS: tissue coagulation in the inferior turbinates; and tissue coagulation in the uvula/soft palate which may reduce the severity of snoring in some individuals.
The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment and familiar with potential complications that may arise during or following fead and Neck surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Gyrus G3 System Generator has two principal modes of operation:
- The monopolar mode has controls for maximum temperature and energy delivered. The unit has readouts for total energy delivered, impedance. temperature for two thermocouples and time of energy delivery.
- -The bipolar mode has controls for output waveform type and power. The unit has readouts for set power and waveform.
Connectors on the front panel include the monopolar connector for active electrode and dispersive electrode and separate dual bipolar connectors for PlasmaCision electrodes and bipolar instruments. The foot pedal is connected on the back panel.
Accessories included with the generator are the electrodes, connector cable, footswitch and a power cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, blood vessels in otorhinolaryngology (Head and Neck), Adenoid, Cysts, Sinus, Mastoid, Myringotomy, Nasal Airway, Nasopharyngeal / Laryngeal, Tracheal, Laryngeal, Neck, Papilloma, Palatal, Tonsil, Uvula/Soft Palate, Parotid, enlarged tonsils, base of tongue, inferior turbinates
Indicated Patient Age Range
patients 13 years of age and older
Intended User / Care Setting
qualified medical personnel trained in the use of electrosurgery.
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)
Performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.
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.
K021777 (G2 Radio-frequency Workstation & Accessories)
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
Gyrus Medical, Cardiff, UK 11 May 2004
SEP 1 0 2004
510(k) Premarket Notification Gyrus G3 Generator System & Accessories
Page 1 of (2)
510(k) Summary of Safety and Effectiveness
Gyrus G3 System (Generator & Accessories)
| Submitted by: | Gyrus Medical Ltd
Fortran Road
St Mellons,
Cardiff CF30LT
UK |
|------------------------|---------------------------------------------------------------------------------------|
| Contact Person: | Andrew Dzimitrowicz
Quality Manager |
| Telephone: | +44 29 20 776 349 |
| Facsimile: | +44 29 20 776 591 |
| Date Summary Prepared: | 11 th May 2004 |
| Name of the Device: | |
| Proprietary Name: | Gyrus G3 System (Generator & Accessories) |
| Project Name: | G3 |
| Common/Usual Name: | Electrosurgical Generator and Accessories |
| Classification Name: | Electrosurgical Cutting & Coagulation Device and
Accessories (per 21 CFR 878.4400) |
| Brand Name: | Not yet assigned |
| Predicate Devices: | K021777 (G2 Radio-frequency Workstation &
Accessories) |
1
Page 2 of (2)
Gyrus Medical, Cardiff, UK 11 May 2004
510(k) Premarket Notification Gyrus G3 Generator System & Accessories
Description:
The Gyrus G3 System Generator has two principal modes of operation:
- The monopolar mode has controls for maximum temperature and energy delivered. The unit has readouts for total energy delivered, impedance. temperature for two thermocouples and time of energy delivery.
- -The bipolar mode has controls for output waveform type and power. The unit has readouts for set power and waveform.
Connectors on the front panel include the monopolar connector for active electrode and dispersive electrode and separate dual bipolar connectors for PlasmaCision electrodes and bipolar instruments. The foot pedal is connected on the back panel.
Accessories included with the generator are the electrodes, connector cable, footswitch and a power cable.
Statement of Intended Use:
The Gyrus G3 System is intended for use for ablation. resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery coagulation of soft tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
The Gyrus G3 System has been carefully compared to Comparison to Predicate Devices: legally marketed devices with respect to intended use technological and characteristics. In addition. performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
SEP 1 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Andrew Dzimitrowicz Director of RA/QA Gyrus Medical Ltd. Fortran Road, St. Mellons Cardiff United Kingdom CF3 OLT
Re: K041285
Trade/Device Name: Gyrus G3 Radio-Frequency Workstation and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 13, 2004 Received: July 16, 2004
Dear Mr. Dzimitrowicz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to commerce proc to ritly 20, 1978, as excerdance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costherior (110) that as nevice, subject to the general controls provisions of the Act. The 1 ou may, mererore, mainer of the Act include requirements for annual registration, listing of general controls provision 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 If your device 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 r reaso be actived a determination that your device complies with other requirements of the Act that I Dr has Intacted and regulations administered by other Federal agencies. You must or unly with all 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 CI It Fat 80 77, accems (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. Andrew Dzimitrowicz
This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter will anow you've begin finding of substantial equivalence of your device to a legally premailed 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 If you desire spocents acrive ice 3 at (301) 594-4659. 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 other general mionnal 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,
Miriam C. Provost
for
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Gyrus Medical, Cardiff, UK 11 May 2004
510(k) Premarket Notification Gyrus G3 Generator System & Accessories
Indications for Use
510(k) Number (if known):
Not Yet Assigned
Device Name:
Gyrus G3 Radio-frequency workstation & Accessories
Indications For Use:
y modulation @ 1.000000
The Bipolar Generator section of the G3 RF Workstation is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including:
- Adenoidectomy .
- Cysts .
- Head, Neck, Oral, and Sinus Surgery
- Mastoidectomy
- Myringotomy with effective Hemorrhage Control
- Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal
- Polypectomy, and Laryngeal Lesion Debulking
- Neck Mass
- Papilloma Keloids
- Submucosal Palatal Shrinkage
- Tonsillectorny
- Traditional Uvulopalatoplasty (RAUP)
- Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring
- Uvulopaiatopharyngoplasty (UPPP)
- Parotidectomy
- Radical Neck Disection
The Gyrus Somnoplasty TCRF Generator section of the G3 RF Workstation with the Temperature Controlled Radio-frequency (Somnoplasty®) Electrodes is indicated for coagulation of soft tissue including:
The coagulation of enlarged tonsils in patients 13 years of age and older; the reduction of the incidence of airway obstructions, e.g., base of tongue, soft palate, etc., in patients suffering from UARS or OSAS: tissue coagulation in the inferior turbinates; and tissue coagulation in the uvula/soft palate which may reduce the severity of snoring in some individuals.
The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment and familiar with potential complications that may arise during or following fead and Neck surgery.
Contraindications for Use:
There are no known absolute contraindications to the use of radio-frequency surgery. The use of the Gyrus G3 Radio-frequency Workstation is contraindicated when, in the judgement of the physician, electross urgal procedures would be contrary to the best interests of the patient. The use of the system is also contraindicated for patients with heart pacemakers or other active device implants.
Prescription Use X (Per 21 CFR 801.109) OH
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Muriam C. Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K041285