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 hemostasis 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 for treating cancer of the prostate.

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 hemostasis 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, The specific urological indications include transurethral and neoplasms. lesions 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.

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.

The system includes Electrodes, working elements, and an HF bipolar cable that can be connected to an electrical surgical unit.

HF Resection Electrodes (K100275) can now be used with the newly compatible electrosurgical generator, the ESG-400 (K103032). For the HF Resection Electrodes to be used with the ESG-400, an additional HF cable is needed (WA00014A). The WA00014A bipolar reusable cable is an electrosurgical accessory designed to transfer electrosurgical power to electrosurgical working elements from the electrosurgical generator ESG-400 (K103032). The cable is designed to connect the working elements WA22366A and WA22367A (K100275).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel clinical study with acceptance criteria in the typical sense of evaluating a new therapeutic or diagnostic claim. The "study" here is a set of performance tests to ensure the new device (specifically, a new cable) does not raise new safety concerns and maintains the same functionality as the predicate device.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functional Equivalence	Device functions according to its intended use (as per predicate device).	Design verification performed; results met acceptance criteria.
Electrical Safety	No new concerns regarding electrical safety when used with the new cable and electrosurgical generator.	Bench testing according to FDA-recognized consensus standards IEC 60601-1 and IEC 60601-2-2 demonstrated no new electrical safety concerns.
Risk Management	Risks are identified, assessed, and controlled to an acceptable level.	Risk analysis carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in the context of a clinical trial or a dataset for an AI model. This is a submission for a physical medical device (electrosurgical electrodes and a new cable) demonstrating equivalence, not a data-driven AI device.

Sample Size (Test Set): Not applicable in the context of a dataset; refers to the testing of the physical device components. The document implies sufficient units were tested to perform design verification, electrical safety tests, and risk analysis.
Data Provenance: Not applicable in the context of clinical data. The tests performed are bench tests and risk analyses conducted by the manufacturer, Olympus Winter & Ibe GmbH, in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. "Ground truth" in this context would refer to the established engineering and safety standards (e.g., IEC standards, ISO 14971) against which the device's performance was measured. These standards are developed by expert committees, but the specific individuals involved in this particular submission's verification of adherence to those standards are not listed.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of expert adjudication or consensus methods for evaluating the results of the bench tests or risk analysis. The results are compared directly against established engineering and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., imaging AI) to compare human reader performance with and without AI assistance. This submission is for surgical instruments, not a diagnostic or AI-assisted device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This is not an AI-driven device. The "performance" refers to the physical and electrical characteristics of the surgical electrodes and cable.

7. The Type of Ground Truth Used

The "ground truth" for this submission consists of:

Established engineering and performance specifications: The device is expected to function according to its intended use, which is defined by its design.
International Consensus Standards:
- IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
- IEC 60601-2-2: Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
- ISO 14971:2007: Medical devices – Application of risk management to medical devices.

These standards serve as the objective benchmarks against which the device's safety and performance were evaluated.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI model.

Summary

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K120418 PAGE I OF 3

JUN 2 0 2012

510(k) Summary of Safety and Effectiveness

June 20, 2012

1. General Information: Applicant:

Official Correspondent:

Manufacturer:

2. Device(s) Identification:

Device Trade Name:

Common Name:

Electrosurgical Resection and Vaporization Electrode Series Electrosurgical Cutting & Coagulation Device & Accessories Electrode, Electrosurgical, Active, Urological

Classification of the device:

Device Classification Name:

Electrosurgical, cutting & coagulation & accessories Endoscopic electrosurgical unit and accessories Resectoscope Resectoscope Working Element

Product Code: Device Classification No .:

Panel: Regulatory Status: FAS, GEI, FJL, FJC, FDC Part 876.4400, 21 CFR 876.4300, 21 CFR 876.1500

General & Plastic Surgery / Gastroenterology and Urology Class II

Olympus Winter & Ibe GmbH Kuehnstrasse 61 22045 Hamburg, Germany Registration Number: 9610773 Owner/Operator Number: 8010313

Sheri L. Musgnung Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway, PO Box 610 Center Valley, PA 18034-0610 Phone: 484-896-3147 Facsimile: (484) 896-7128 Email: Sheri.Musgnung@Olympus.com Registration No: 2429304

Olympus Winter & Ibe GmbH Kuehnstrasse 61 22045 Hamburg, Germany Registration Number: 9610773

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3. Legally Marketed Predicate Device to which Substantial Equivalence is Claimed:

Device Trade Name:	HF Electrosurgical Resection and Vaporization Electrode Series
Applicant:	Olympus Winter & Ibe GmbH
510(k) No.:	K100275
Model Nos.:	WA22301D, WA22302D, WA22503D, WA22305D, WA22306D,WA22507D, WA22537D, WA22521C, WA22523C, WA22331D,WA22332D, WA22538C, WA22539D, WA22351C, WA22438C,WA22355C, WA 22351A, WA22355A, WA22558C, WA22557C

4. Device Description:

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.

The system includes Electrodes, working elements, and an HF bipolar cable that can be connected to an electrical surgical unit.

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 hemostasis 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 hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder turnors (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.

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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.

6. Comparison of Technological Characteristics:

The HF Resection Electrodes and the HF Resection Button Electrode for Plasma vaporization are identical to the predicate devices in intended use, design and material specification. The only difference is the new cable (WA00014A) that now allows for the electrodes and working elements to be connected to the ESG-400 (K103032).

The cable is equivalent to WA00013A that allows for the electrodes and working elements to be connected to the UES-40 (K030194 and K100275). The only difference is with the plug.

7. Summary of Non-Clinical Performance Testing:

Design verification was performed to ensure the device functions according to its intended use and the results met their acceptance criteria.

Bench Testing according to the FDA-recognized consensus standards IEC 60601-1 and IEC 60601-2-2 was conducted to demonstrate that the design change does not raise any new concerns regarding electrical safety.

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007.

8. Summary of Clinical Tests Submitted or Referenced:

No clinical tests were performed or referenced in support of this Special 510(k).

9. Conclusion:

Olympus Winter & Ibe GmbH believes that the HF Electrosurgical Resection and Vaporization Electrode Series is substantially equivalent to the currently legally marketed devices. It does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.

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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 with three stripes forming its wing and body. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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. Ms. Sheri Musgnung Associate Manager RA and Clinical Monitor 3500 Corporate Parkway P.O. Box 610 Center Valley, Pennsylvania 18034-0610

JUN 2 0 2012

Re: K120418

Trade/Device Name: Electrosurgical Resection and Vaporization Electrode Series 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: May 18, 2012 Received: May 21, 2012

Dear Ms. Musgnung:

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.

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Page 2 - Ms. Sheri Musgnung

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 (OS) 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 yours,
Eunice Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ·

Device Name: HF- Resection Electrode Series

Model Numbers:

WA22301D, WA22302D, WA22503D, WA22305D, WA22306D, 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 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 for treating cancer of the prostate.

Prescription Use_

Over-The-Counter Use AND/OR

(Part 21 CFR 801 Subpart D)

(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)

(Division Sign-Off)

Page 1 of 2

Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K120418

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Indications for Use

510(k) Number (if known): _

Device Name: HF- Resection Electrode for Plasma Vaporization

Model Number: WA22557C

Indications For Use:

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)

_ and_ (Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

Page 2 of 2

510(k) Number K120418

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).