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

Gynecology: Electrodes 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 nonconducting irrigation fluid.

Specific intended use Gynecology:

-Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
-Lysis of intrauterine septa
-Endometrial ablation

Device Description

The Olympus Resection Electrodes that are subject to this submission are either monopolar or for application in saline. The main difference between monopolar electrosurgery and electrosurgery in saline is that while in monopolar electrosurgery a neutral electrode is required, whereas in electrosurgery in saline the (neutral) return electrode is part of the surgical device.

Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporisation and cutting.

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 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.

All subject Resection Electrodes are single-use electrodes and are delivered sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for Olympus Winter & Ibe Gmbh's electrodes. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove a device meets specific acceptance criteria in the typical sense of algorithm performance metrics.

Therefore, many of the requested sections about acceptance criteria and study design for performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission. The document primarily details the device's technical specifications, indications for use, and a comparison to predicate devices based on safety and effectiveness, rather than a clinical performance study with numerical acceptance criteria.

However, I can extract information related to the safety and material performance testing mentioned in the document.

1. Table of acceptance criteria and the reported device performance

The document does not provide specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the device's clinical efficacy in the way an AI or diagnostic device submission might. Instead, the "acceptance criteria" are implied by adherence to recognized international standards for various non-clinical tests. The reported "performance" is that these tests were conducted and the device complied with the requirements of these standards, supporting its safety and effectiveness.

Category	Acceptance Criteria (Implied by Standards Adherence)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1 and FDA guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'' for tests including: Cytotoxicity, Irritation, Sensitization, Chemical Analysis, and Biological-toxicological evaluation. The implied acceptance is that the device materials are biocompatible and do not pose unacceptable biological risks to the patient.	All biocompatibility testing has been conducted according to the specified standards and guidance. The different technological characteristics (patient contacting materials) were tested and "do not affect the safety and effectiveness of the subject devices."
Electrical Safety	Compliance with: - AAMI/ANSI ES 60601-1:2005 + A1:2012, C1:2009 and A2:2010 (Medical Electrical Equipment - Part 1.1 General requirements for safety and essential performance). - AAMI/ANSI/IEC 60601-2-2 2009 (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). - IEC 60601-2-18:2009 (Medical Electrical Equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment). The implied acceptance is that the device is electrically safe for its intended use.	Electrical Safety was tested according to the listed standards.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 and IEC 60601-2-2 for the resectoscope system. The implied acceptance is that the device, as part of the system, operates without causing or being unduly affected by electromagnetic disturbances.	EMC testing was conducted for the resectoscope system (not standalone electrodes). It was demonstrated that "the compatible resectoscope system complies with all requirements of IEC 60601-1-2 and IEC 60601-2-2." It is assumed that since electrodes are made of similar conductive materials and contain no electrical components, they will not affect the electrical properties of the system.
Thermal Safety	Compliance with AAMI/ANSVIEC 60601-2-2 2009 (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). The implied acceptance is that the device does not reach unsafe temperatures during operation.	Tested according to AAMI/ANSVIEC 60601-2-2 2009.
Sterilization	Compliance with ISO 11135 for the EtO sterilization cycle and conformity with AAMI ANSI ISO 11607-1:2006 for packaging. A Sterility Assurance Level (SAL) of 10-6 must be reached. EtO residuals must be within limits.	Sterilization is performed according to ISO 11135 and packaging conforms with AAMI ANSI ISO 11607-1:2006. The EtO sterilization cycle has been validated, and an SAL of 10-6 was reached. EtO residuals are within limits.
Shelf Life	Adequate performance and package integrity over the declared shelf life.	Shelf life testing was conducted, including performance testing and package integrity testing, to support a shelf life of 5 years.
Performance Testing Bench	Mechanical and electrical performance, resection/coagulation effectiveness, durability, and transport/packaging integrity. Implied acceptance is that the devices perform their intended functional tasks reliably and safely.	Conducted tests include mechanical and electrical performance testing, resection/coagulation testing, durability testing, and transport/packaging testing. (No specific numerical results or thresholds provided, but the statement indicates compliance was achieved to support substantial equivalence).

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

This document describes non-clinical performance and safety testing. It does not refer to a "test set" in the context of diagnostic performance or AI model evaluation. The tests mentioned (biocompatibility, electrical safety, thermal safety, sterilization, shelf life, bench testing) were conducted on device samples to ensure compliance with standards. The sample sizes for these engineering and materials tests are not specified in the summary but would be determined by the specific test protocols for each standard. Data provenance is not applicable as it is laboratory testing for device characteristics, not patient data.

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 testing described. "Ground truth" in the context of expert consensus on medical images or diagnoses is not a component of this submission for an electrosurgical device. The ground truth for the performance tests would be the established scientific and engineering principles and the requirements defined within the referenced international standards.

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

Not applicable. This concept applies to human reader studies or similar diagnostic performance evaluations, which were not part of this 510(k) submission.

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

Not applicable. This is a premarket notification for electrosurgical electrodes, not an AI-assisted diagnostic device. No MRMC study or AI component is mentioned.

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

Not applicable. This device does not involve an algorithm.

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

The "ground truth" for this submission is based on adherence to recognized international standards and engineering principles. For example:

Biocompatibility: Defined by ISO 10993-1.
Electrical Safety: Defined by AAMI/ANSI ES 60601-1, AAMI/ANSI/IEC 60601-2-2, IEC 60601-2-18.
EMC: Defined by IEC 60601-1-2 and IEC 60601-2-2.
Sterilization: Defined by ISO 11135 and AAMI ANSI ISO 11607-1:2006.
Thermal Safety: Defined by AAMI/ANSVIEC 60601-2-2.
Functional Performance: Evaluated against design specifications and predicate device performance.

There is also a "Clinical Evaluation" mentioned, which was a "comprehensive literature review" rather than new clinical data or expert consensus on cases.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. It's a medical device, and the testing outlined is for manufacturing, material properties, and safety.

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

Not applicable, as there is no "training set" for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms a wing-like shape above them.

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

October 26, 2015

Olympus Winter & Ibe Gmbh % Graham Baillie Manager, Regulatory Affairs Gyrus Acmi, Inc. 136 Turnpike Rd. Southborough, Massachusetts 01772

Re: K152092

Trade/Device Name:

Electrodes for resection in saline (WA22302S, WA22306S, WA22332S. WA22351S. WA22355S. WA22503S. WA22507S, WA22521S, WA22523S, WA22537S, WA22538S, WA22539S, WA22557S, WA22558S, and WA22559S)

Monopolar Electrodes (WA22201S, WA22202S, WA22203S, WA22210S, WA22211S, WA22221S, WA22222S, WABD09MS, WABD10MS, WACL21MS, WACL27MS, WACL28MS, WALP03MS, WALP04MS, WALP06MS, WALP08MS, WALP13MS, WALP14MS, WALP31MS, WALP35MS, WAND18MS, WAND20MS, WARL16MS, WARL23MS, WARL33MS, WARN25MS)

Slim Resection Electrodes (WA47050S, WA47051S, WA47052S, WA47053S, WA47054S, WA47055S, WA47056S)

Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: FAS, FJL, HIH Dated: July 27, 2015 Received: July 28, 2015

Dear Graham Baillie:

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).

{1}------------------------------------------------

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.

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 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 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 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.

for

Sincerely yours.

Herbert P. Lerner -S

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

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Page 3 - Graham Baillie

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known)

K152092

Device Name

Electrodes for resection in saline (WA22302S, WA22306S, WA22351S, WA22355S, WA22503S, WA22507S, WA22521S, WA22533S, WA22538S, WA22538S, WA22557S, WA22558S, and WA22559S)

Indications for Use (Describe)

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

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

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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."

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

{4}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K152092

Device Name

Monopolar Electrodes (WA22202S, WA22203S, WA22210S, WA22211S, WA2221S, WA22222S, WABD09MS, WABD10MS, WACL21MS, WACL28MS, WACL28MS, WALP03MS, WALP06MS, WALP06MS, WALP13MS, WALP14MS, WALP31MS, WALP35MS, WAND18MS, WAND20MS, WARL16MS, WARL33MS, WARL33MS, WARN25MS)

Indications for Use (Describe) General intended use

Urology

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

Gynecology

Electrodes 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 non-conducting irrigation fluid.

The following products are not intended to be used in gynecology: WA22202S, WA22222S, WABD10MS, WALP06MS, WALP08MS

Specific intended use

Gynecology

Transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
Lysis of intrauterine septa
Endometrial ablation

The following products are not intended to be used in gynecology: WA22203S, WA22222S, WABD10MS, WALP06MS, WALP08MS

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."

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

{5}------------------------------------------------

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

Indications for Use

510(k) Number (if known)

K152092

Device Name

Slim Resection Electrodes (WA47051S, WA47052S, WA47052S, WA47054S, WA47055S, WA47056S)

Indications for Use (Describe) General intended use

Urology

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

The following product is not intended to be used in urology: WA47056S

Gynecology

Specific intended use

Gynecology

Transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
Lysis of intrauterine septa
Endometrial ablation

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

	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."

{6}------------------------------------------------

510(k) Summary of Safety and Effectiveness

1. General Information

Manufacturer:	Olympus Winter & Ibe GmbHKuehnstr. 6122045 HamburgGermany
Establishment Registration Number:	9610773
Official Correspondent:	Graham A.L. BaillieManager, Regulatory AffairsGyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104Phone: 508.804.2738Fax: 508. 804.2624Email: Graham.baillie@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
Proprietary/Trade Name:	Electrodes for resection in saline (WA22302S, WA22306S,WA22332S, WA22351S, WA22355S, WA22503S,WA22507S, WA22521S, WA22523S, WA22537S,WA22538S, WA22539S, WA22557S, WA22558S, andWA22559S),
	Monopolar Electrodes (WA22201S, WA22202S,WA22203S, WA22210S, WA22211S, WA22221S,WA22222S, WABD09MS, WABD10MS, WACL21MS,WACL27MS, WACL28MS, WALP03MS, WALP04MS,

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WALP06MS, WALP08MS, WALP13MS, WALP14MS, WALP31MS, WALP35MS, WAND18MS, WAND20MS, WARL16MS, WARL23MS, WARL33MS, WARN25MS)

Slim Resection Electrodes (WA47050S, WA47051S, WA47052S, WA47053S, WA47054S, WA47055S, WA47056S)

3. Predicate Devices

For each electrode model the respective predicate device was chosen from the following predicate 510(k)s:

510(k)No.	Name	Predicate Model No.	Product code /Reg No.
K897003	OlympusHysteroresectoscope	A2184, A2189, A2193, A4516	HIH / 884.1690
K903323	Resectoscope Loops	A2183S, A2184S, A2185S, A2189S, A2193S, A2195S, A2203S, A2204S, A2205S, A4513S, A4514S, A4515S, A4513US, A4514US	KNS / 876.4300
K931764	HF Resection Electrode,Loop w/runnerHyster/Acces	A2186, A2228	HIH / 884.1690
K954488	Roller Electrode	A2158S	HIH / 884.1690
K931763	HF-Resection Electrode,Loop w/runnerHyster/Acces	A2186	FAS / 876.4300FJL / 876.1500
K100275	Resection Button Electrodefor Plasma Vaporization,HF-Resection ElectrodeLoops and Band	WA22302D, WA22306D, WA22332D, WA22351C, WA22355C, WA22503D, WA22507D, WA22521C, WA22523C, WA22537D, WA22538C, WA22539D, WA22557C, WA22558C	FAS / 876.4300GEI / 878.4400

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

No reference devices were used in this submission.

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4. Product Description

Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporisation and cutting.

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 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.

1. Subject electrodes for Hystero-Resectoscope System with 4mm Telescope (OES Pro)
	1.1 Monopolar electrodes standard length
WA22201S	HF-resection electrode, loop 24 Fr., 0.35 wire, 12°/16°
WA22210S	HF-resection electrode, loop, 24 – 28 Fr., 0.2 wire, 12°/16°
WALP03MS	HF-resection electrode, loop 24 Fr., 0.35 wire, 12° - 30°
WALP04MS	HF-resection electrode, loop, 24 – 28 Fr., 0.2 wire, 12° - 30°
WARN25MS	HF-resection electrode, loop with runner, 24 Fr., 12° - 30°
WALP13MS	HF-resection electrode, angled loop, 24 - 28 Fr., 0.35 wire, 12° - 30°
WALP14MS	HF-resection electrode, angled loop, 24-28 Fr., 0.2 wire, 12° - 30°
WARL16MS	HF-resection electrode, roller, 24 - 28 Fr., 12° - 30°
WARL23MS	HF-resection electrode, large roller, 24 - 28 Fr., 12° - 30°
WACL27MS	HF-resection electrode, cylinder, 24 - 28 Fr., 12° - 30°
WAND18MS	HF-resection electrode, needle 90°, 24 - 28 Fr., 12°/16°
WAND20MS	HF-resection electrode, angled needle, 24 - 28 Fr., 12° - 30°
WACL21MS	HF-resection electrode, cylinder with grooves, 24 - 28 Fr., 12° - 30°
WA22211S	HF-resection electrode, loop with runner, 24 Fr., 12°/16°
WA22221S	HF-resection electrode, band 24 Fr., 12°/16°
WABD09MS	HF-resection electrode, band 24 Fr., 12° - 30°
WACL28MS	HF-resection electrode, cylinder with spikes, 24 - 28 Fr., 12° - 30°
	1.2 Electrodes for resection in saline - standard length (Urology only)
WA22302S	HF-resection electrode, loop, 24 Fr., 0.2 wire, standard, 12°/16°
WA22503S	HF-resection electrode, large loop, 24 Fr., 0.2 wire, 12°/16°
WA22306S	HF-resection electrode, loop, 24 Fr., 0.2 wire, standard, 12° - 30°
WA22507S	HF-resection electrode, large loop, 24 Fr., 0.2 wire, 12° - 30°
WA22521S	HF-resection electrode, band, 24 Fr., standard, 12°/16°

WA22523S	HF-resection electrode, band, 24 Fr., standard, 12° - 30°
WA22332S	HF-resection electrode, angled loop, 24 Fr., 0.2 wire, standard, 12° - 30°
WA22351S	HF-resection electrode, roller, 24 Fr., 12° - 30°
WA22355S	HF-resection electrode, angled needle, 24 Fr., 12° - 30°
WA22557S	HF-resection electrode, button, 24 Fr., 12° - 30°
2. Subject electrodes for long Resectoscope OES Pro with 4mm Telescope
2.1 Monopolar electrodes long
WALP31MS	HF-resection electrode, long loop, 24 Fr., 12°
WARL33MS	HF-resection electrode, long roller, 24 - 28 Fr., 12° - 30°
WALP35MS	HF-resection electrode, long angled loop, 24 - 28 Fr., 12° - 30°
2.2 Electrodes for resection in saline - long (Urology only)
WA22537S	HF-resection electrode, long loop, 24 Fr., 0.2 wire, standard, 12°
WA22538S	HF-resection electrode, long roller, 24 Fr., 12° - 30°
WA22539S	HF-resection electrode, long angled loop , 24 Fr., 0.2 wire, standard, 12° - 30°
3. Subject electrodes for Hystero-Resectoscope System with 3mm Telescope
3.1 Monopolar slim electrodes standard length
WA47050S	HF-resection electrode, loop, 22.5 Fr., 0.35 wire, 12°
WA47051S	HF-resection electrode, angled loop, 22.5 Fr., 0.35 wire, 12°
WA47052S	HF-resection electrode, roller, 22.5 Fr., 12° and 30°
WA47053S	HF-resection electrode, cylinder, 22.5 Fr., 12° and 30°
WA47054S	HF-resection electrode, angled needle, 22.5 Fr., 12°
WA47055S	HF-resection electrode, cylinder with grooves, 22.5 Fr., 12° and 30°
WA47056S	HF-resection electrode, cylinder with spikes, 22.5 Fr., 12° and 30° (gyn only)
4. Subject electrodes for urology-only
4.1 Monopolar electrodes standard length (Urology only)
WA22202S	HF-resection electrode, loop 26 Fr., 0.35 wire, 12°/16°
WA22203S	HF-resection electrode, loop 28 Fr., 0.35 wire, 12°/16°
WA22222S	HF-resection electrode, band 26 Fr., 12°/16°
WABD10MS	HF-resection electrode, band 26 Fr., 12° - 30°
WALP06MS	HF-resection electrode, loop 26 Fr., 0.35 wire, 12° - 30°
WALP08MS	HF-resection electrode, loop 28 Fr., 0.35 wire, 12° - 30°
4.2 Electrodes for resection in saline - standard length (Urology only)
WA22558S	HF-resection electrode, TUEB angled loop , 24 Fr., 12° - 30°
WA22559S	HF-resection electrode, TUEB loop, 24 Fr., 12° - 30°

All subject Resection Electrodes are single-use electrodes and are delivered sterile.

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5. Indications for Use

The subject device resection electrodes have essentially the same intended use as the predicate resection electrodes (K897003, K903323, K931764, K954488, or K100275, respectively).

Subject Monopolar Electrodes

(WA22201S, WA22202S, WA22203S, WA22210S, WA22211S, WA22221S, WA2222S, WABD09MS, WABD10MS, WACL21MS, WACL27MS, WACL28MS, WALP03MS, WALP04MS, WALP06MS, WALP08MS, WALP13MS, WALP14MS, WALP31MS, WALP35MS, WAND18MS,

{10}------------------------------------------------

WAND20MS, WARL16MS, WARL23MS, WARL33MS, WARN25MS)

General intended use

Urology

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

Gynecology

Electrodes 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 nonconducting irrigation fluid.

The following products are not intended to be used in gynecology: WA22202S, WA22203S, WA22222S, WABD10MS, WALP06MS, WALP08MS

Specific intended use

Gynecology

-Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
-Lysis of intrauterine septa
-Endometrial ablation

The following products are not intended to be used in gynecology: WA22202S, WA22203S, WA22222S, WABD10MS, WALP06MS, WALP08MS

Subject Electrodes for Resection in Saline

(WA22302S, WA22306S, WA22332S, WA22351S, WA22355S, WA22503S, WA22507S, WA22521S, WA22523S, WA22537S, WA22538S, WA22539S, WA22557S, WA22558S, WA22559S)

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

Slim Electrodes

(WA47050S, WA47051S, WA47052S, WA47053S, WA47054S, WA47055S, WA47056S)

General intended use

Urology

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

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The following product is not intended to be used in urology: WA47056S

Gynecology

Electrodes 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 nonconducting irrigation fluid.

Specific intended use

Gynecology

Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium
Lysis of intrauterine septa -
-Endometrial ablation

6. Comparison of Technological characteristics

At a high level, the subject and predicate devices are based on similar technological principles with similar elements:

. 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)
Used in combination with a resectoscope system
I Like the predicate electrodes, the subject device resection electrode series features loops, bands, needles, rollers, and a button as active tip shapes
. Utilizing either monopolar mode of ablation or for resection in saline (dependent on model)
Respectively identical or similar outer dimensions
. Design changes of the electrodes are minor and do not negatively impact safety or effectiveness of the subject devices
. 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. The primary technological differences between the subject and predicate devices are related to the patient contacting materials. These minor differences, however, do not raise different questions of safety or effectiveness. As demonstrated in the non-clinical testing (e.g., biocompatibility), the different technological characteristics do not affect the safety and effectiveness of the subject devices.

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7. Performance Data

The following performance data was provided in support of the substantial equivalence determination. All standards applied are FDA recognized international standards.

Biocompatibility testing

All biocompatibility testing has been conducted according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. Additionally, the FDA guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'' was followed.

Testing included the following tests:

Cytotoxicity -
Irritation -
Sensitization -
Chemical Analysis -
Biological-toxicological evaluation -

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 was conducted for the resectoscope system, but not for the standalone Resection Electrodes. EMC testing demonstrates that the compatible resectoscope system complies with all requirements of IEC 60601-1-2 and IEC 60601-2-2. Since all resection electrodes are made of similar conductive materials, there is no reason to expect that different electrodes would affect the electrical properties of the resectoscope system. They do not contain

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any electrical components that can be influenced by electromagnetic emission as well as electrostatic discharge.

Thermal Safety

Tested according to AAMI/ANSVIEC 60601-2-2 2009, 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.

Clinical Evaluation

Clinical and animal studies were not necessary.

A clinical evaluation has been conducted containing a comprehensive literature review.

Software

Not applicable as the Resection Electrodes do not contain any software.

Performance Testing Bench

Conducted tests include mechanical and electrical performance testing. resection/coagulation testing, durability testing, and transport/packaging testing.

8. 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 was conducted, including performance testing and package integrity testing, to support a shelf life of 5 years for the resection electrodes.

9. Conclusion

The performance data support the safety of the device and demonstrate that the subject devices comply with the intended use as specified.

In summary, we believe the Resection Electrodes are substantially equivalent with the predicate devices with respect to the general design approach, function, and the intended use. The Resection Electrodes raise no new concerns of safety or effectiveness when compared 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).