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.

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.

AI/ML Overview

The provided document is a 510(k) summary for electrosurgical resection and vaporization electrodes and does not contain any information about acceptance criteria, device performance metrics, or details of a study that proves the device meets specific criteria.

The document primarily focuses on:

General Information: Applicant, official correspondent, manufacturer.
Device Identification: Device name, common name, regulation number, regulation name, regulatory class, product code, classification panel.
Predicate Device Information: Lists predicate devices used for comparison.
Device Description: Explains the components and variations of the electrodes.
Indications for Use: Details the intended uses for the HF-Resection Electrodes and the HF-Resection Electrode for Plasma Vaporization.
Comparison of Technological Characteristics: States that the devices are "basically identical to the predicate devices in intended use, design and material specifications."
Conclusion: Concludes that there are no significant changes affecting safety or effectiveness compared to predicate devices.
FDA Correspondence: Official letter from the FDA determining substantial equivalence.

Without this information in the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader studies.

Therefore, for your request:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not specified in the provided text.
Reported Device Performance: Not specified in the provided text.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No test set or study data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

No test set or ground truth establishment is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No test set or adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study is mentioned. This device is an electrosurgical tool, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This device is an electrosurgical tool, not an algorithm. No standalone performance study is mentioned or relevant in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

No ground truth is mentioned as no study evaluating diagnostic or interpretive performance is discussed.

8. The sample size for the training set:

No training set is mentioned.

9. How the ground truth for the training set was established:

No training set or ground truth for a training set is mentioned.

Summary

{0}------------------------------------------------

K100275

'JUL - 1 2010

510(k) SUMMARY

General Information Section 1

• Applicant	Olympus Winter & Ibe GmbHKuehnstrasse 61 * 22045 Hamburg * GermanyEstablishment Registration No: 9610773
• Official Correspondent	Stacy Abbatiello Kluesner, M.S., RACRegulatory Affairs & Quality AssuranceOlympus America Inc.3500 Corporate ParkwayPO Box 610Center Valley, PA 18034-0610Phone: 484-896-5405FAX: 484-896-7128Email: Stacy.Kluesner@Olympus.comEstablishment Registration No.: 2429304
• Manufacturer	Olympus Winter and Ibe GmbHKuehnstrasse 61 * 22045 Hamburg * GermanyEstablishment Registration No.: 9610773

Section 2_ Device Identification_

Device Name:	Electrosurgical Resection and Vaporization Electrode Series
Common Name:	Electrosurgical Cutting & Coagulation Device & AccessoriesElectrode, Electrosurgical, Active, Urological
Regulation Number:	21 CFR 878.440021 CFR 876.430021 CFR 876.1500
Regulation Name:	Electrosurgical cutting and coagulation device and accessoriesEndoscopic electrosurgical unit and accessoriesResectoscopeResectoscope Working Element
Regulatory Class:	II
Product Code:	FAS, GEI, FJL, FDC
Classification Panel	General and Plastic SurgeryGastroenterology 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, HFResection 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 VaporizationElectrode and VaporTome Resection Electrode	Gyrus ACMI
K994166	Gyrus Axipolar Resectoscope Electrode	Gyrus ACMI
K030185	Gyrus PlasmaKinetic Superpulse System	Gyrus Inc

Device Description ব

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

{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

Regulation Number and Section

§ 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).