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 prostatectorny, transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, 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 surgical procedures involving the vaporization, ablation, 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 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 tube, a quiding 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.

As an accessory the sterile device recognition cable is enclosed. The cable enables the use of the Gyrus ACMI PK Superpulse System (K100816) with the Olympus HF Electrosurgical Resection and Vaporization Electrodes.

AI/ML Overview

This 510(k) summary describes a submission for HF (High-Frequency) Electrosurgical Resection and Vaporization Electrodes. The document asserts substantial equivalence to predicate devices, rather than presenting a study to prove performance against specific acceptance criteria. Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not available in the provided text.

Here's what can be inferred or explicitly stated from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission, not a de novo or PMA where specific performance criteria are typically established and tested against. The implicit acceptance criterion is "substantial equivalence" to the predicate devices in terms of intended use, design, and material specifications, implying similar safety and effectiveness.
Reported Device Performance: Not reported in a quantitative manner. The document states: "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." This is a qualitative claim of similarity, not a measurement of performance against specific metrics.

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

Sample Size: Not applicable. No "test set" in the context of performance measurement is described, as the submission relies on substantial equivalence to existing predicate devices.
Data Provenance: Not applicable. No new performance data is presented.

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

Number of Experts: Not applicable. Ground truth establishment for device performance is not described.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. No performance test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

MRMC Study: No, an MRMC comparative effectiveness study was not done or reported. This document is a 510(k) summary for electrocautery electrodes, not an AI or diagnostic imaging device that would typically involve such studies.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

Standalone Study: No, a standalone performance study (relevant for AI/software devices) was not done or reported. This device is a surgical instrument.

7. The Type of Ground Truth Used:

Type of Ground Truth: Not applicable. The submission is based on substantial equivalence to predicate devices, not on proving new performance against an independent ground truth. The "ground truth" here is essentially the established safety and efficacy of the predicate devices.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

Ground Truth Establishment for Training Set: Not applicable.

Summary of what the document does provide:

Device Identification: HF Electrosurgical Resection and Vaporization Electrode Series, for use with the Gyrus ACMI PK® PlasmaKinetic Superpulse System.
Intended Use/Indications for Use: Detailed descriptions for both the HF-Resection Electrodes and the HF-Resection Electrode for Plasma Vaporization, covering endoscopic urological surgical procedures (resection, ablation, removal of soft tissue, hemostasis) in specific locations (prostate, bladder, bladder neck) and specific conditions (BPH, bladder cancer, tumors, lesions, neoplasms). They are intended for use in an irrigated environment and are not for treating cancer of the prostate.
Predicate Devices:
- For HF Resection Electrodes: K100275 (Olympus WA22302D, WA22503D, WA22306D, WA22507D, WA22521C, WA22523C, WA22351C, WA22355C)
- For HF Resection Button Electrode for Plasma Vaporization: K100275 (Olympus WA22557C)
Conclusion: The manufacturer concludes that the new devices do not incorporate any significant changes that could affect the safety or effectiveness, thus asserting substantial equivalence to the predicate devices. The FDA agrees with this finding and clears the devices for market.

Summary

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510(k) SUMMARY

Date Prepared: September 7, 2010

K102781

, l

JAN 1 1 2011

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:	HF Electrosurgical Resection and Vaporization Electrode Series,for use with the Gyrus ACMI PK® PlasmaKinetic Superpulse System
Common Name:	Electrosurgical Cutting & Coagulation & AccessoriesElectrode, Electrosurgical, Active, Urological
Regulation Number:	21 CFR 878.440021 CFR 876.430021 CFR 876.1500
Regulation Name:	Electrosurgical cutting and coagulation and accessoriesEndoscopic electrosurgical unit and accessories
Regulatory Class:	II
Product Code:	FAS, GEI, FJL
Classification Panel:	General and Plastic Surgery, Gastroenterology, and Urology

Section 3 Predicate Device Information

Predicate Devices for HF Resection Electrodes (Type H281)

510(k)	Device Name	Manufacturer
K100275	WA22302D, WA22503D,WA22306D, WA22507D,WA22521C, WA22523C,WA22351C, WA22355C	Olympus

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Predicate Devices for HF Resection Button Electrode for Plasma Vaporization (Type H281)

510(k)	Device Name	ManufacturerA CONTRACT CALL PROPERTY
A BREAL A BREAL A B A B A A A A A A A A A A A A K100275	WA22557C	Olympus

Section 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.

Section 5 Indications for Use

Section 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.

Section 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an emblem featuring a stylized image of an eagle or bird with three wing-like shapes. The emblem is rendered in black and white.

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. Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance 3500 Corporate Parkway, P.O. Box 610 Center Valley, Pennsylvania 18034-0610

JAN 1 1 2011

Re: K102781

Trade/Device Name: HF-Resection Electrode Series (Models WA22602D, WA22603D, WA22606D, WA22607D, WA22621C, WA22623C, WA22632D, WA22651C, WA22655C) HF-Resection Electrode for Plasma Vaporization (Model WA22657C) Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS, GEI Dated: December 9, 2010 Received: December 13, 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 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.

: 上一篇:

and the state of the state of the states of the states

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Page 2 - Ms. Stacy Abbatiello Kluesner, M.S., RAC

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.

ff 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/ReportalProblem/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,

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

K102781

510(k) Number (if known):

JAN 1 1 2011

Device Name: HF-Resection Electrode Series

Model Numbers: WA22602D, WA22603D, WA222606D, WA22607D, WA22621C, WA 22623C, WA22632D WA22651C, WA22655C

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 prostatectorny, transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, 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)

(Division of Surgical, Orthopedic, Orthopedic,
Division of Surgical, Orthopedic, Division of Surges
and Restorative Devices and Restorative Devices

K102781

510(k) Number -

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510(k) Number (if known):

Device Name: HF- Resection Electrode for Plasma Vaporization

JAN 1 1 2011

Model Number: WA22657C

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 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.

AND/OR

Prescription Use ✔ (Part 21 CFR 801 Subpart D)

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)

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, and Restorative Devices

K102781 510(k) Number .

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).