(18 days)
No
The summary describes a radio frequency bipolar electrosurgical device and its electrodes, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML information.
Yes
The device is described as an electrosurgical system "intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required," which directly refers to treating medical conditions.
No
Explanation: The device is intended for surgical procedures, specifically for ablation or removal of soft tissue and hemostasis, not for diagnosing conditions.
No
The device description explicitly states it is a "radio frequency bipolar electrosurgical device system" and includes "sterile, disposable electrodes," indicating it is a hardware-based medical device with physical components, 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 clearly states it's for "urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required." This describes a surgical device used in vivo (within the body) for treatment.
- Device Description: It's described as a "radio frequency bipolar electrosurgical device system" and "sterile, disposable electrodes." These are typical components of surgical equipment, not devices used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to diagnose diseases or conditions by examining samples.
Therefore, the Gyrus Endourology System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Gyrus Endourology System, when used with a Gyrus Axipolar Resectoscope Electrode, is a radio frequency bipolar electrosurgical device system intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indications where the system can be used are in transurethral prostatectorny (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors and in cystodiathermy.
Product codes
78 FJL, 78 FJC, 78 FAS, 78 KNS
Device Description
The Axipolar Resectoscope Electrode devices described in this 510(k) are sterile, disposable electrodes designed for use with the Gyrus Endourology System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, bladder, bladder neck
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)
Reference Device(s)
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)
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Gyrus has provided certification of compliance to 21 CFR 820.30 design Control requirements, and Risk Analysis procedures.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
K994166" platl
Gyrus Medical Limited Document No. 814278 Gyrus Axipolar Resectoscope Electrode (ARE) Special 510(k) Premarket Notification: Device Modification December 3, 1999
DEC 27 1999
SECTION 9
510(k) SUMMARY
1. Name Of Device
| Trade name: | Gyrus Endourology System: Axipolar Resectoscope
Electrode | | | | |
|----------------------|----------------------------------------------------------------------|--|--|--|--|
| Common name: | Electrosurgical Generator System | | | | |
| Classification name: | Endoscopic Electrosurgical Unit and Accessories
(21 CFR 876.4300) | | | | |
2. Equivalence
| Device | Premarket Notification |
|---|---|
| Gyrus Axipolar Resectoscope Electrode | K990628 |
3. Device Description
The Axipolar Resectoscope Electrode devices described in this 510(k) are sterile, disposable electrodes designed for use with the Gyrus Endourology System.
4. Indicated Use
The Gyrus Endourology System is intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indications where the system can be used are in transurethral prostatectorny (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors and in cystodiathermy.
Safety & Performance 5.
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Gyrus has provided certification of compliance to 21 CFR 820.30 design Control requirements, and Risk Analysis procedures.
6. Summary
By virtue of design, materials, function and indicated use, the Gyrus Endourology System Axipolar Resectoscope Electrode is substantially equivalent to similar devices currently marketed in the USA.
7. Regulatory Contact
Please direct any questions regarding this submission to:
David Kay Director, Regulatory Affairs & Quality Assurance Gyrus Medical Limited, Fortran Road, St Mellons, Cardiff, CF3 0LT, UK Tel: +44 (029) 20 776300 Fax: +44 (029) 20 776301
1
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized human figures.
DEC 27 1999
Mr. David Kay Director, Regulatory Affairs and Quality Assurance Gyrus Medical Limited Fortran Road St. Mellons Cardiff CF3 OLT UNITED KINGDOM
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K994166 Gyrus Endourology Electrosurgical System: Axipolar Resectoscope Electrode Dated: December 3, 1999 Received: December 9, 1999 Requiatory Class: II 21 CFR §876.1500/Procodes: 78 FJL; 78 FJC; 21 CFR §876.4300/Procodes: 78 FAS; 78 KNS
Dear Mr. Kay:
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 legally marketed predicate 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 requirements, 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 the Electronic Product 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 Compiiance 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/dsma/dsmamain.html".
Sincerely yours.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
of ___________________________________________________________________________________________________________________________________________________________________________ Page 1
510(k) Number (if known): K99466
Device Name: Gyrus Axipolar Resectoscope Electrode
Indications for Use:
The Gyrus Endourology System, when used with a Gyrus Axipolar Resectoscope Electrode, is a radio frequency bipolar electrosurgical device system intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indications where the system can be used are in transurethral prostatectorny (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors and in cystodiathermy.
(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 | |
|---|---|
| ---------------------- | ----------------------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K994166 |
|---|---|
| --------------- | --------- |
Gyrus Medical Limited Gyrus Axipolar Resectoscope Electrode (ARE)