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, 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.

Device Description

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. 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 tip angle from 12° - 30° tips. The design of the HF cable plugs fits Olympus electrosurgical generators with Universal Socket. 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

This document is a 510(k) Premarket Notification from the FDA regarding Olympus Winter & Ibe GmbH's Resection Electrodes with HF cable. It describes the device, its intended use, and its equivalence to a predicate device.

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

The document does not explicitly present a table of "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as this is a traditional medical device (electrodes) rather than a diagnostic device or AI algorithm with such measures. Instead, the acceptance criteria are based on demonstrating comparable safety and effectiveness to the predicate device through various non-clinical performance and safety tests, and compliance with relevant standards.

Here's a summary of the performed tests as evidence of meeting safety and effectiveness requirements:

Acceptance Criteria / Test Category	Test Performed	Reported Device Performance/Conclusion
Mechanical Performance	- Mechanical compatibility	Demonstrated compatibility.
	- Detaching force of electrode	Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion.
	- Lifetime connection/disconnection of the electrodes	Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion.
	- Compression and tension between guiding sheets and contact part	Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion.
	- Detaching force of the cable from ESG410	Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion.
Resection/Coagulation Performance	- Duration of single activation in combination with a HF generator	Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion.
Transport Tests	- Communication with a HF generator	Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion.
	- Electrode pull back to proximal stop	Not explicitly stated as pass/fail, but implied to be acceptable as part of overall positive conclusion.
Usability/User Interface	- Manual assembly of the system	Tested and implied to be acceptable.
	- Visual inspection of the generator display	Tested and implied to be acceptable.
Electrical Safety	- AAMI/ANSI ES 60601-1:2005 + A1:2012, C1:2009 and A2:2010 (General requirements for safety and essential performance)	Devices tested according to listed standards. Implied compliance as part of overall positive conclusion ("The performance data support the safety and effectiveness of the subject device...").
	- AAMI/ANSI/IEC 60601-2-2 2017 (Particular requirements for High Frequency Surgical Equipment)	Devices tested according to listed standards. Implied compliance as part of overall positive conclusion.
	- IEC 60601-2-18:2009 (Particular requirements for endoscopic equipment)	Devices tested according to listed standards. Implied compliance as part of overall positive conclusion.
Sterilization & Packaging	- Sterilization according to ISO 11135:2014	EtO sterilization cycle validated. Sterility assurance level (SAL) of 10^-6^ reached. EtO residuals within limits.
	- Packaging conforms with ISO 11607-1:2019	Subject device passed simulated shipping distribution and associated packaging integrity testing per ASTM D4169:2016, ASTM F88, ASTM F1929, and ASTM F2096.
Biocompatibility	- Evaluation in accordance with ISO-10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010), irritation (ISO 10993-10:2010), acute systemic toxicity (ISO10993-11:2017), and material-mediated pyrogenicity (ISO10993-11:2017).	Successfully tested for biocompatibility. Patient contact materials (stainless steel, elastosil (glue), ceramic, loctite 4303 (glue), PTFE, PtIr, tungsten) have been successfully tested.

The study concluded that "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."

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

The document describes non-clinical performance and safety testing. It does not refer to "test sets" in the context of patient data. The samples for testing would be units of the device itself (electrodes and cables). The specific number of devices tested for each non-clinical test (e.g., how many electrodes were subjected to lifetime connection/disconnection tests) is not explicitly stated in this summary.

The provenance of this data is from regulatory submissions to the FDA, originating from the manufacturer, Olympus Winter & Ibe GmbH, which is located in Hamburg, Germany. The tests are non-clinical (laboratory/bench tests), not clinical studies; therefore, terms like retrospective/prospective or country of origin of patient data are not applicable.

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 as the document describes non-clinical testing for a traditional medical device (electrosurgical electrodes and cables), not a diagnostic device or AI algorithm requiring expert-established ground truth from patient data.

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 for the reasons stated above. The device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system.

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

This is not applicable for the reasons stated above. The device is a physical electrosurgical electrode and cable, not an algorithm.

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

For the non-clinical tests conducted, the "ground truth" or reference for evaluating performance is typically defined by:

Engineering specifications and design requirements: For mechanical, electrical, and functional performance.
Applicable national and international standards: For electrical safety (e.g., IEC 60601 series), sterilization (ISO 11135), packaging (ISO 11607-1, ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and biocompatibility (ISO 10993 series).
Comparison to the predicate device: The goal is to demonstrate that the subject device is substantially equivalent in terms of safety and effectiveness to the legally marketed predicate device.

8. The sample size for the training set

This is not applicable. The device is a traditional medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

Summary

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August 3, 2021

Olympus Winter & Ibe GmbH % Christina Flores Manager, Regulatory Affairs Olympus Surgical Technologies America 118 Turnpike Road Southborough, Massachusetts 01772

Re: K210651

Trade/Device Name: Resection Electrodes with HF cable Regulation Number: 21 CFR 884.1690 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS, HIH, FJL Dated: July 16, 2021 Received: July 20, 2021

Dear Christina Flores:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K210651

Device Name

Resection Electrodes with HF cable (WA22702S, WA22705S, WA22706S, WA22707S, WA22721S, WA22723S, WA227328, WA22737S, WA22739S, WA22751S, WA22755S, WA22760S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S)

Indications for Use (Describe)

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)

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Indications for Use

510(k) Number (if known)

K210651

Device Name

Resection Electrodes with HF cable (WA47705S, WA47707S, WA47721S, WA47723S, WA47732S, WA47737S, WA47738S, WA47739S, WA47751S, WA47755S, WA47760S, WA47740S, WA47741S, WA47741S, WA47742S, 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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510(k) Summary

1. Submitter Information

Submitter Address:	Olympus Winter & Ibe GmbH
	Kuehnstr. 61
	22045 Hamburg
	Germany

Contact person:	Christina Flores, RAC
	Regulatory Affairs Manager
	Olympus Surgical Technologies America
	800 West Park Drive
	Westborough, MA 01581
	Phone: (508) 808-3341
	Email: christina.flores@olympus.com

August 3, 2021 Date prepared:

2. Device Information

Trade Name:	Resection Electrodes with HF cable
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

Model numbers:

WA22702S, WA22703S, WA22705S, WA22706S, WA22707S, WA22721S, WA22723S, WA22732S, WA22737S, WA22738S, WA22739S, WA22751S, WA22755S, WA22760S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S

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

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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.
K171965	Resection Electrodes withHF cable	WA22702S, WA22703S,WA22705S, WA22706S,WA22707S, WA22721S,WA22723S, WA22732S,WA22737S, WA22738S,WA22739S, WA22751S,WA22755S, WA22760S,WA22766S, WA22740S,WA22741S, WA22742S,WA22743S, WA22744S,WA47705S, WA47706S,WA47707S, WA47721S,WA47723S, WA47732S,WA47737S, WA47738S,WA47739S, WA47751S,WA47755S, WA47760S,WA47766S, WA47740S,WA47741S, WA47742S,WA47743S, WA47744S	FAS / 876.4300FJL / 876.1500HIH / 884.1690

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

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4. Product 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 tip angle from 12° - 30° tips. The design of the HF cable plugs fits Olympus electrosurgical generators with Universal Socket.

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.

5. Indications for Use

Resection Electrodes with HF cable for use in Urology

Article no .: WA22702S, WA22703S, WA22706S, WA22706S, WA22707S, WA22721S, WA22723S, WA22732S, WA22737S, WA22738S, WA22739S, WA22751S, WA22755S, WA22760S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S

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

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.

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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 -

The subject and predicate devices have the same indications for use statements.

6. Comparison of Technological characteristics

The following table compares the technological characteristics of the subject and predicate devices:

Device & PredicateDevice(s):	K210651	K171965
Indication (anatomicalsite)	Gynecological and Urological	Gynecological and Urological
Mode of ablation	Bipolar (resection in saline)	Bipolar (resection in saline)
Irrigation solution	Saline	Saline
Length	261.8 - 336.7 mm	261.8 – 336.7 mm
Compatible scope shaftdiameter	24 Fr	24 Fr
Electrode Active tipshapes	Loop, band, needle, roller, button	Loop, band, needle, roller, button
Electrode Active tipdesigns	12° - 30° angles	12° - 30° angles
Patient ContactMaterials	stainless steel, elastosil (glue),ceramic, loctite 4303 (glue), PTFE,PtIr, tungsten	Stainless steel, Al2O3, PTFE (colors),PtIr
Stabilizing tubediameter	4.1 mm	4.1 mm
Sterilization andPackaging Materials	Provided sterile (EtO), Tyvek/BlisterPET	Provided sterile (EtO), Tyvek/BlisterPET
HF Cables packagedwith the subject device	Yes	Yes
Shelf life	3 years	3 years
Compatible generator(s)	Current Olympus electrosurgicalgenerators with UNIVERSALsocket [ESG-400 (K141225 andK203682), ESG-410 (K203277)]as well as future ESG-generationswith UNIVERSAL socket	ESG-400 (K141225 and pendingK203682)

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

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. 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
트 Used in combination with a resectoscope system
. 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 outer dimensions
I Design changes of the electrodes and cables 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, with the exception of the compatibility to the Olympus electrosurgical generators with UNIVERSAL socket. 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. Summary of Non-Clinical Performance Testing

The following tests were conducted to demonstrate the compatibility to Olympus HF generators that have UNIVERSAL socket to the instructions for use of the resection electrodes:

Mechanical performance:

Mechanical compatibility ●
Detaching force of electrode ●
Lifetime connection/disconnection of the electrodes
Compression and tension between guiding sheets and contact part
. Detaching force of the cable from ESG410

Resection/Coagulation performance:

Duration of single activation in combination with a HF generator
Transport tests:
Communication with a HF generator ●
Electrode pull back to proximal stop .

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In addition, tests to evaluate manual assembly of the system and visual inspection of the generator display were conducted.

Electrical Safety was tested according to the following standards:

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 60601-2-22017	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.

Sterilization is performed according to ISO 11135:2014 and packaging conforms with ISO 11607-1: 2019. 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.

The subject device passed the simulated shipping distribution and associated packaging integrity testing conducted per ASTM D4169:2016, ASTM F88, ASTM F1929, and ASTM F2096.

The biocompatibility was evaluated in accordance with ISO-10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010), irritation (ISO 10993-10:2010), acute systemic toxicity (ISO10993-11:2017), and material-mediated pyrogenicity (ISO10993-11:2017).

8. 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).