Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.

Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.

The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system.

Specific indications:

transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
lysis of intrauterine septa -
endometrial ablation -

Device Description

The subject HF-Resection Electrodes 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 accompanying HF cables consist of two lantern plugs on the instrument side and one generator plug on the generator side.

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 electrodes have a shaft diameter of 24 Fr. range in length from 261.8-336.7mm, and range in compatibility with telescopes with a direction of view of 12° - 30°. The design of the HF cable plugs vary depending on which electrosurgical generator they are compatible with.

All subject Resection Electrodes are single-use electrodes and are delivered sterile. All subject Resection Electrodes are provided with a single-use, sterile cable to connect the electrode to the generator.

AI/ML Overview

The provided document is a 510(k) summary for Olympus Winter & Ibe GmbH's Resection Electrodes with HF cable (K171965). This is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through a standalone clinical study involving acceptance criteria as typically understood for new major medical devices or AI algorithms.

Therefore, the acceptance criteria and study information typically requested for AI/ML performance are not present in this type of submission. This device is an accessory to electrosurgical units, and its substantial equivalence is primarily demonstrated through comparisons to predicate devices in terms of design, materials, indications for use, and adherence to recognized electrical safety and sterilization standards.

Here's how to interpret the available information against your request:

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

This document does not present "acceptance criteria" for device performance in the typical sense of a clinical outcome or diagnostic accuracy. Instead, it relies on demonstrating compliance with recognized standards and equivalence to a predicate device. The "reported device performance" refers to its ability to meet these standards and exhibit similar characteristics to the predicate.

Acceptance Criteria	Reported Device Performance
Electrical Safety	Complies with AAMI/ANSI ES 60601-1:2005 + A1:2012, C1:2009 and A2:2010; AAMI/ANSI/IEC 60601-2-2:2009; IEC 60601-2-18:2009
Electromagnetic Compatibility (EMC)	Not applicable, as the device doesn't contain electrical components that can be influenced by electromagnetic emission or electrostatic discharge.
Sterilization	Complies with ISO 11135, achieving a Sterility Assurance Level (SAL) of 10^-6 for EtO sterilization. EtO residuals are within limits.
Shelf Life	Validated for 3 years, including package integrity testing in accordance with ISO 11607-1:2006.
Biocompatibility	Patient-contacting materials are identical to the predicate (K152092) and previously successfully tested for biocompatibility.
Substantial Equivalence to Predicate	Design, manufacturing, materials, and technological principles are similar to or identical to the predicate device (K152092), with minor differences not negatively impacting safety or effectiveness.

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

This information is not applicable and therefore not provided in the 510(k) summary. The submission focuses on engineering and bench testing, not clinical performance data that would involve a "test set" in the context of AI/ML or clinical trials. The performance data relies on testing previously reviewed and deemed acceptable in K152092.

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)

This is not applicable to the type of device and submission. There is no "ground truth" to be established by clinical experts for the electrical safety, sterilization, or shelf-life testing of these electrodes.

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

This is not applicable for the reasons stated above.

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

This is not applicable. This is a medical device accessory, not an AI/ML diagnostic or assistive tool.

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

This is not applicable. This is a physical medical device, not an algorithm.

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

For the technical aspects (electrical safety, sterilization, shelf life), the "ground truth" is adherence to established international and national standards (e.g., ISO, AAMI/ANSI IEC standards) and validated engineering test results. For substantial equivalence, the "ground truth" is the previously cleared predicate device (K152092) and its established safety and effectiveness.

8. The sample size for the training set

This is not applicable. There is no software algorithm or AI model being trained for this device.

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

This is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 28, 2017

Olympus Winter & Ibe GmbH % Dolan Mills Sr. Specialist, Regulatory Affairs Gyrus ACMI. Inc. 136 Turnpike Road Southborough, MA 01772

Re: K171965

Trade/Device Name: Resection Electrodes with HF cable (WA22702S, WA22703S, WA22706S, WA22707S, WA22721S, WA22723S, WA22732S, WA22751S, WA22755S, WA22760S, WA22737S, WA22738S, WA22739S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S, WA22705S, WA22602S, WA22603S, WA22606S, WA22607S, WA22621S, WA22623S, WA22632S, WA22651S, WA22655S, WA22657S, WA22637S, WA22638S, WA22639S, WA22666S, WA22640S, WA22641S, WA22642S, WA22643S, WA22644S, WA22605S, WA47705S, WA47706S, WA47707S, WA47721S, WA47723S, WA47732S, WA47737S, WA47738S, WA47739S, WA47751S, WA47755S, WA47760S, WA47766S, WA47740S, WA47741S, WA47742S, WA47743S, WA47744S) Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: FAS, FJL, HIH Dated: June 29, 2017

Dear Dolan Mills:

Received: June 30, 2017

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

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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.

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 devicerelated 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Charles Viviano -S

For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171965

Device Name

Resection Electrodes with HF cable (WA22703S, WA22706S, WA22701S, WA2272SS, WA22732S, WA22732S, WA22751S, WA22751S, WA22760S, WA22737S, WA22739S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S, WA22705S, WA22602S, WA22603S, WA22606S, WA22621S, WA22621S, WA22635, WA22651S, WA22655S, WA22657S, WA22637S, WA22638S, WA22639S, WA22666S, WA22640S, WA22641S, WA22642S, WA22644S, WA22605S)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171965 Device Name Resection Electrodes with HF cable (WA47705S, WA47707S, WA47721S, WA47723S, WA47732S, WA47737S, WA47738S, WA47739S, WA47751S, WA47755S, WA47760S, WA47740S, WA47740S, WA47741S, WA4742S,

WA47743S, WA47744S)

Indications for Use (Describe)

Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.

The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system.

Specific indications:

transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
lysis of intrauterine septa
endometrial ablation

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K171965

510(k) Summary of Safety and Effectiveness September 22, 2017

1. General Information

Manufacturer:	Olympus Winter & Ibe GmbHKuehnstr. 6122045 HamburgGermanyEstablishment Registration Number: 9610773
Official Correspondent:	Dolan MillsSr. Specialist, Regulatory AffairsGyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104Phone: 901.373.0236Fax: 901.373-0220Email: dolan.mills@olympus-osta.com
EstablishmentRegistration No	3003790304

2. Device Identification

Common Name:	- Electrode, Electrosurgical, active, urological
Regulation Number:	876.4300
Classification	- Endoscopic electrosurgical unit and accessories
Device Class:	II
Product Code:	FAS / HIH / FJL
Review Panel:	Gastroenterology / Urology / Obstetrics / Gynecology
Proprietary/Trade Name:	Resection Electrodes with HF cable

Model numbers:

WA22702S, WA22703S, WA22705S, WA22706S, WA22707S, WA22721S, WA22723S, WA22732S, WA22737S, WA22738S, WA22739S, WA22751S, WA22755S, WA22760S, WA22602S, WA22603S, WA22605S, WA22606S, WA22607S, WA22621S, WA22623S, WA22632S, WA22637S, WA22638S,

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WA22639S, WA22651S, WA22655S, WA22657S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S, WA22666S, WA22640S, WA22641S, WA22642S, WA22643S, WA22644S

WA47705S, WA47706S, WA47707S, WA47721S, WA47723S, WA47732S, WA47737S, WA47738S, WA47739S, WA47751S, WA47755S, WA47760S, WA47766S, WA47740S, WA47741S, WA47742S, WA47743S, WA47744S

3. Predicate Devices

The predicate device was chosen from the following predicate 510(k):

510(k)No.	Name	Predicate Model No.	Product code /Reg No.
K152092	Resection Electrodes	WA22302S, WA22503S,WA22306S, WA22507S,WA22521S, WA22523S,WA22332S, WA22351S,WA22355S, WA22557S,WA22537S, WA22538S,WA22539S, WA22566S,WA22540S, WA22541S,WA22542S, WA22543S,WA22544S, WA22305S	FAS / 876.4300FJL / 876.1500HIH / 884.1690

These predicates have not been subject to a design-related recall.

No reference devices were used in this submission.

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K171965 Page 3 of 6

The Olympus Resection Electrodes with HF cable that are subject to this submission are for application in saline. Depending on the characteristics of electrical current. which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting.

5. Indications for Use

Resection Electrodes with HF cable for use in Urology

Article no. : WA22702S. WA22703S. WA22705S. WA22706S. WA22707S. WA22721S, WA22723S, WA22732S, WA22737S, WA22738S, WA22739S, WA22751S, WA22755S, WA22760S, WA22602S, WA22603S, WA22605S, WA22606S, WA22607S, WA22621S, WA22623S, WA22632S, WA22637S, WA22638S, WA22639S, WA22651S, WA22655S, WA22657S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S, WA22666S, WA22640S, WA22641S, WA22642S, WA22643S, WA22644S

Resection Electrodes with HF cable for use in Gynecology

Article no. : WA47705S, WA47706S, WA47707S, WA47721S, WA47723S, WA47732S, WA47737S, WA47738S, WA47739S, WA47751S, WA47755S, WA47760S, WA47766S, WA47740S, WA47741S, WA47742S, WA47743S, WA47744S

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Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.

The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system.

Specific indications:

transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
lysis of intrauterine septa -
endometrial ablation -

Although the subject and predicate devices have different indications for use statements, the intended use is the same. The subject device is indicated for gynecologic applications while the predicate device is indicated for urological indications. However, when the decision-making criteria specified in the FDA guidance document, "General/Specific Intended Use," (issued November 4, 1998) are applied, the subject device indications are determined to fall within the scope of the intended use of the predicate device. The specific gynecology indications of the subject device do not represent a different intended use since there is an extensive knowledge base regarding the use of bipolar electrosurgery for gynecological applications, including the disease states listed in the specific gynecologic indications. Therefore, the intended use comparison supports substantial equivalence.

6. Comparison of Technological characteristics

At a high level. the subject and predicate devices are based on the same technological principle with the same elements:

I Resection electrodes consisting of an active (distal) tip, PTFE color code identification at the distal and proximal ends, an insulator between the electrode and electrode tube, a stabilizing (guiding) tube, and arm (shaft)
. HF cables consisting of two lantern plugs on the instrument side and one generator plug on the generator side
I Used in combination with a resectoscope system
트 Like the predicate electrodes, the subject device resection electrode series features loops, bands, needles, rollers, and a button as active tip shapes
. Resection electrodes utilizing ablation or for resection in saline (dependent on model)
I Respectively identical or similar outer dimensions

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K171965 Page 5 of 6

Design changes of the electrodes and cables are minor and do not negatively impact safety or effectiveness of the subject devices
I The same or similar materials in patient contact are used in predicate and subject device and have all been successfully tested for biocompatibility.

As stated above, the subject and predicate devices have similar design characteristics and performance specifications, with the exception of the addition of the HF cables. These minor differences, however, do not raise different questions of safety or effectiveness. As demonstrated in the non-clinical testing (e.g., electrical safety, sterilization validation, and package integrity), the different technological characteristics do not affect the safety and effectiveness of the subject devices.

7. Performance Data

The subject device electrodes, including all patient-contacting materials, are identical in design and manufacturing to the predicate device (K152092). Therefore, the current submission relies on performance testing previously reviewed and deemed acceptable in K152092.

8. Electrical safety and electromagnetic compatibility (EMC)

Electrical Safety was tested according to

AAMI/ANSI ES 60601-1:2005 + A1:2012, C1:2009and A2:2010	Medical Electrical Equipment - Part 1.1 Generalrequirements for safety and essential performance.
AAMI/ANSI/IEC 60601-2-22009	Medical Electrical Equipment - Part 2-2: ParticularRequirements for the Basic Safety And EssentialPerformance of High Frequency Surgical Equipmentand High Frequency Surgical Accessories
IEC 60601-2-18:2009	Medical electrical equipment - Part 2-18: MedicalElectrical Equipment - Part 2-18: Particularrequirements for the basic safety and essentialperformance of endoscopic equipment.

Electromagnetic compatibility (EMC) testing according to IEC 60601-1-2 and IEC 60601-2-2 is not applicable to the Resection Electrodes. They do not contain any electrical components that can be influenced by electromagnetic emission as well as electrostatic discharge. From an electromagnetic compatibility point of view, it is a metal bar that cannot be influenced at any time.

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9. Sterilization and Shelf Life

Sterilization is performed according to ISO 11135 and packaging conforms with AAMI ANSI ISO 11607-1:2006. The EtO sterilization cycle has been validated.

A sterility assurance level (SAL) of 106 was reached during validation and will be used for routine sterilization in compliance with regulations in force for sterile medical devices.

The EtO residuals are within the limits after tunnel degassing time.

Shelf Life testing, including package integrity testing in accordance with ISO 11607-1:2006, was conducted to support a shelf life of 3 years for the resection electrodes.

10. Conclusion

The performance data support the safety and effectiveness of the subject device and demonstrate that the subject device is substantially equivalent to the predicate device.

In conclusion, the Resection Electrodes with HF cable are substantially equivalent to the predicate devices.

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).