(150 days)
Not Found
No
The document describes standard electrosurgical electrodes for urological procedures and makes no mention of AI or ML technology.
Yes
The device is designed for surgical procedures like resection, ablation, and vaporization of soft tissue to treat conditions such as benign prostatic hyperplasia and bladder tumors, which are therapeutic interventions.
No
Explanation: The device is described as an instrument series for surgical procedures involving resection, ablation, or removal of soft tissue and hemostasis, not for diagnosing conditions.
No
The device description clearly outlines physical components such as an active tip, insulator, guiding tube, telescope clip, and arm (shaft), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside of the body (in vitro).
- Device Function: The description clearly states that these devices are used during endoscopic urological surgical procedures to resect, ablate, remove, or vaporize soft tissue within the body. They are directly interacting with the patient's tissues during surgery.
Therefore, based on the intended use and device description, this is a surgical instrument used in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HF-Resection Electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostatis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used for are transurethral resection in saline (TURis), transurethral prostatectorny, transurethral resection of the prostate (TURP) for benign prostatic hypertplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used to treating cancer of the prostate.
The HF-Resection Electrode for Plasma Vaporization is a bipolar instrument designed and intended for use in urological procedures involving the vaporization, ablation, coagulation, cutting, removal of soft tissue and coagulation where hemostatis is required. The specific soft tissue indications include use in the prostate, bladder neck. The specific treatment indications include benign prostate hyperplasia BPH, bladder cancer, tumors, lesions and neoplasms. The specific urological indications include transurethral electrovaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used to treating cancer of the prostate.
Product codes (comma separated list FDA assigned to the subject device)
FAS, GEI, FJL, FDC
Device Description
The HF-Resection Electrodes and HF Resection Button Electrode for Plasma Vaporization consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft).
The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons.
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): 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.
K903233, K994166, K030194, K973820, K030185
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
§ 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
'JUL - 1 2010
510(k) SUMMARY
General Information Section 1
| • Applicant | Olympus Winter & Ibe GmbH
Kuehnstrasse 61 * 22045 Hamburg * Germany
Establishment Registration No: 9610773 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Official Correspondent | Stacy Abbatiello Kluesner, M.S., RAC
Regulatory Affairs & Quality Assurance
Olympus America Inc.
3500 Corporate Parkway
PO Box 610
Center Valley, PA 18034-0610
Phone: 484-896-5405
FAX: 484-896-7128
Email: Stacy.Kluesner@Olympus.com
Establishment Registration No.: 2429304 |
| • Manufacturer | Olympus Winter and Ibe GmbH
Kuehnstrasse 61 * 22045 Hamburg * Germany
Establishment Registration No.: 9610773 |
Section 2_ Device Identification_
| Device Name: | Electrosurgical Resection and Vaporization Electrode Series |
|---|---|
| Common Name: | Electrosurgical Cutting & Coagulation Device & Accessories |
| Electrode, Electrosurgical, Active, Urological | |
| Regulation Number: | 21 CFR 878.4400 |
| 21 CFR 876.4300 | |
| 21 CFR 876.1500 | |
| Regulation Name: | Electrosurgical cutting and coagulation device and accessories |
| Endoscopic electrosurgical unit and accessories | |
| Resectoscope | |
| Resectoscope Working Element | |
| Regulatory Class: | II |
| Product Code: | FAS, GEI, FJL, FDC |
| Classification Panel | General and Plastic Surgery |
| Gastroenterology and urology |
1
Predicate Device Information 3
Predicate Devices for HF Resection Electrodes
| 510(k) | Device Name | Manufacturer |
|---|---|---|
| K903233 | Resectoscope Loops | Olympus |
| K994166 | Gyrus Axipolar Resectoscope Electrode | Gyrus ACMI |
| K030194 | Electrosurgical Unit and its associated accessories, HF | |
| Resection Electrode | Olympus |
Predicate Devices for HF Resection Button Electrode for Plasma Vaporization
| 510(k) | Device Name | Manufacturer |
|---|---|---|
| K903233 | Resectoscope Loops | Olympus |
| K973820 | CIRCON ACMI USA Elite System VaporTrode Vaporization | |
| Electrode and VaporTome Resection Electrode | Gyrus ACMI | |
| K994166 | Gyrus Axipolar Resectoscope Electrode | Gyrus ACMI |
| K030185 | Gyrus PlasmaKinetic Superpulse System | Gyrus Inc |
Device Description ব
The HF-Resection Electrodes and HF Resection Button Electrode for Plasma Vaporization consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft).
The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons.
5 Indications for Use
The HF-Resection Electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostatis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used for are transurethral resection in saline (TURis), transurethral prostatectorny, transurethral resection of the prostate (TURP) for benign prostatic hypertplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used to treating cancer of the prostate.
The HF-Resection Electrode for Plasma Vaporization is a bipolar instrument designed and intended for use in urological procedures involving the vaporization, ablation, coagulation, cutting, removal of soft tissue and coagulation where hemostatis is required. The specific soft tissue indications include use in the prostate, bladder neck. The specific treatment indications include benign prostate hyperplasia BPH, bladder cancer, tumors, lesions and neoplasms. The specific urological indications include transurethral electrovaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an
2
irrigated environment. These devices are not intended to be used to treating cancer of the prostate.
6 Comparison of Technological Characteristics
The HF Resection Electrodes and the HF Resection Button Electrode for Plasma Vaporization are basically identical to the predicate devices in intended use, design and material specifications.
7 Conclusion
When compared to the predicate devices, HF Resection Electrodes and the HF Resection Button Electrode for Plasma Vaporization do not incorporate any significant changes that could affect the safety or effectiveness of the device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Olympus Winter & Ibe GmbH % Olympus America Inc. Stacy Abbatiello Kluesner, M.S., RAC 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610
FJUL -1 2010
Re: K100275
Trade/Device Name: HF-Resection Electrode for Plasma Vaporization, Model WA22557C HF-Resection Electrode Series, Models WA22301D, WA22302D, WA22503D, WA22305D, WA22306D, WA22507D, WA22537D, WA22521C, WA22523C, WA22331D, WA22332D, WA22538C, WA22539D, WA22351C, WA22438C, WA22355C, WA22351A, WA22355A, WA22558C Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS, GEI Dated: January 29, 2010 Received: February 1, 2010
Dear Ms. Abbatiello Kluesner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
4
Page 2 - Stacy Abbatiello Kluesner, M.S., RAC
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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark A. Milburn
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: HF- Resection Electrode Series
Model Numbers:
WA22301D, WA22302D, WA22503D, WA22305D, WA222306D, WA22507D, WA22537D, WA22521C, WA22523C, WA22331D, WA22332D, WA22538C, WA22539D, WA22351C, WA22438C, WA22355C, WA22351A, WA22355A, WA22558C
Indications For Use:
The HF-Resection Electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostatis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis), transurethral prostatectomy, transurethral resection of the prostate (TURP) for benign prostatic hypertplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment.
These devices are not intended to be used to treating cancer of the prostate.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
yfffff
Divis Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K100275
6
Indications for Use
510(k) Number (if known):
Device Name: HF- Resection Electrode for Plasma Vaporization
Model Number: WA22557C
Indications For Use:
The HF-Resection Electrode for Plasma Vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving the vaporization, ablation, coagulation, cutting, removal of soft tissue and coagulation where hemostatis is required. The specific soft tissue indications include use in the prostate, bladder and bladder neck. The specific treatment indications include benign prostate hyperplasia BPH, bladder cancer, tumors, lesions and neoplasms. The specific urological indications include transurethral electrovaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment.
These devices are not intended to be used in treating cancer of the prostate.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
Page 1 of 1
510(k) Number K100275