The UNIDRIVE® S III ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpieces. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.

Device Description

The UNIDRIVE S III ENT is a motorized surgical device system used for the excision, ablation, removal or transection of bones/tissues during head, neck, ENT, or otoneurological surgical procedures. The system components include a control unit used in conjunction with the High-Speed Micro Motor that houses the high-speed handpieces and DrillCut-X® II Shaver handpieces. The modifications made to the UNIDRIVE® S III ENT system is the addition of the DrillCut-X® II-35 and DrillCut-X® II-35 N Shaver handpieces. Additional accessories used with the UNIDRIVE S III ENT system include the shaver blades, sinus burrs and the sinus burr 35k.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the UNIDRIVE S III ENT system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study for a new AI/CAD device. Therefore, many of the requested criteria related to AI/CAD system performance, such as human reader improvement with AI assistance, sample sizes for AI training/test sets, expert qualifications for ground truth, and adjudication methods, are not applicable or findable in this document.

However, I can extract the information relevant to the device's technical performance and the non-clinical testing performed to demonstrate its acceptance criteria.

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

The document doesn't present acceptance criteria in a quantitative table with specific performance metrics for the device itself (like accuracy, sensitivity, specificity for an AI system). Instead, its acceptance appears to be based on adherence to recognized consensus standards and successful completion of specific non-clinical tests to demonstrate safety and effectiveness, and substantial equivalence to a predicate device.

Here's a summary of the non-clinical performance data provided, which serves as the "acceptance criteria" through compliance:

Acceptance Criteria Category (Testing Type)	Reported Device Performance / Compliance
Electrical Safety Testing	Passed, certified to be Class I protection against electrical shock.
EMC Testing	Passed.
Consensus Standards Compliance	Follows FDA recognized consensus standards: • IEC 60601-1 • IEC 60601-1-2 • ISO 14971 • ISO 10993
Cleaning and Sterilization Validations (for patient-contacting components)	Conducted, complies with: • ANSI/AAMI ST81:2004/(R) 2010 • ANSI/AAMI ST79: 2010/A4:2013 • AAMI TIR 12:2010 • ANSI/AAMI/ISO 17665-1:2006 • ANSI/AAMI/ISO 17665-2:2009 • AAMI TIR 39:2009
Bench Testing (to meet design specifications)	Performed, specifically "Inspection of rotation speed and torque". Bench testing demonstrated substantial equivalence to the predicate device.
Risk Evaluation on Modification	Conducted, concluded that differences do not raise new questions of safety and effectiveness.
Biological Evaluation	Conducted, summarized.

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

Not applicable. This device is a surgical drill system, not an AI/CAD system evaluated on patient data. The "test set" here refers to the device itself undergoing various engineering and biological safety tests. No patient data or associated provenance is mentioned.

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)

Not applicable. Ground truth in the context of AI/CAD systems usually refers to verified diagnoses or findings from medical images. For this surgical device, "ground truth" would be established by engineering standards, material science, and biological safety standards, which are inherent to the testing methodologies used. The document does not specify the number or qualifications of experts involved in the direct testing of the device, beyond implying qualified personnel conducting the tests and regulatory bodies reviewing the submissions.

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

Not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations for establishing ground truth in AI/CAD image analysis studies. This document discusses mechanical, electrical, and biological testing of a surgical device.

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. An MRMC study is relevant for AI/CAD systems that assist human interpretation of medical images. This document describes a surgical drill system.

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

Not applicable. This device is a surgical hardware system, not an AI algorithm. Its performance is inherent to its mechanical and electrical function.

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

The "ground truth" for this device's acceptance is established by engineering standards, material science, and biological safety standards, as demonstrated through the various non-clinical tests (electrical safety, EMC, cleaning/sterilization validity, rotation speed/torque inspection, biological evaluation) and compliance with national and international standards (IEC, ISO, ANSI/AAMI).

8. The sample size for the training set

Not applicable. This document describes a hardware device, not an AI algorithm that requires a training set.

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

Not applicable. As noted above, this is not an AI/CAD algorithm.

Summary

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October 22, 2020

Karl Storz Endoscopy-America, Inc. Alita McElroy Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245

Re: K200318

Trade/Device Name: UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: July 21, 2020 Received: July 23, 2020

Dear Alita McElroy:

We have reviewed vour 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/cfpmr/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.

Joyce C. Lin-S

for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200318

Device Name UNIDRIVE S III ENT

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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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.

K200318 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

Submitter:	KARL STORZ Endoscopy-America, Inc.2151 E. Grand AvenueEI Segundo, CA 90245
Contact:	Alita McElroyRegulatory Affairs SpecialistPhone: (424) 218-8376Fax: (424) 218-8519
Date of Preparation:	October 22, 2020
Type of 510(k)Submission:	Traditional
DeviceIdentification:	Trade Name: UNIDRIVE S III ENTClassification Name: Drill, Surgical, ENT (Electric OrPneumatic) Including Handpiece
Regulatory Class:	II
Product Code:	ERL
Regulation:	21 CFR 874.4250 (Ear, nose and throat electric or pneumaticsurgical drill)
Predicate Device(s):	Predicate Device: UNIDRIVE S III ENT (K150969)The predicate device has not been subject to a design-relatedrecall.
Device Description:	The UNIDRIVE S III ENT is a motorized surgical devicesystem used for the excision, ablation, removal or transectionof bones/tissues during head, neck, ENT, or otoneurologicalsurgical procedures. The system components include a controlunit used in conjunction with the High-Speed Micro Motor thathouses the high-speed handpieces and DrillCut-X® II Shaverhandpieces.The modifications made to the UNIDRIVE® S III ENT systemis the addition of the DrillCut-X® II-35 and DrillCut-X® II-35N Shaver handpieces. Additional accessories used with theUNIDRIVE S III ENT system include the shaver blades, sinusburrs and the sinus burr 35k.
Intended Use:	The UNIDRIVE S III ENT system consists of an active controlunit used in conjunction with the High-Speed Micro Motor andDrillCut-X® II Shaver handpieces. The system is intended foruse by qualified surgeons to provide controlled cutting,drilling, debriding, sawing, and shaving for the ablation,excision, removal, or transection of tissue or bone during head,neck, ENT, or otoneurological surgical procedures.
Indications For Use:	The UNIDRIVE S III ENT system consists of an active controlunit used in conjunction with the High-Speed Micro Motor andDrillCut-X® II Shaver handpieces. The system is intended foruse by qualified surgeons to provide controlled cutting,drilling, debriding, sawing, and shaving for the ablation,excision, removal, or transection of tissue or bone during head,neck, ENT, or otoneurological surgical procedures.
TechnologicalCharacteristics:	The UNIDRIVE S III ENT is a modification of andsubstantially equivalent to the UNIDRIVE S III ENT(K150969) in terms of its indication for use, principle ofoperation, patient-contacting materials and reprocessingmethods.The subject device includes the addition of the DrillCut-X® II-35 and DrillCut-X® II-35 N Shaver handpieces that have amaximum rotational speed of 35,000 RPM in comparison withthe shaver handpieces of the predicate device that have amaximum rotational speed of 12,000 RPM.
Non-ClinicalPerformance Data:	The device has been tested and passed the electrical safetytesting and EMC testing, which is certified to be Class Iprotection against electrical shock.The UNIDRIVE S III ENT system follows the FDArecognized consensus standards and is tested according to thefollowing standards:• IEC 60601-1• IEC 60601-1-2• ISO 14971• ISO 10993

	Cleaning and sterilization validations were conducted forpatient-contacting components. The reprocessing datasubmitted complies with the following standards:ANSI/AAMI ST81:2004/(R) 2010 ANSI/AAMI ST79: 2010/A4:2013 AAMI TIR 12:2010 ANSI/AAMI/ISO 17665-1:2006 ANSI/AAMI/ISO 17665-2:2009 AAMI TIR 39:2009 The following bench testing was performed to ensure that theUNIDRIVE S III ENT system meets its design specification Inspection of rotation speed and torque Bench testing demonstrated substantial equivalence to thepredicate device.
ClinicalPerformance Data:	Clinical testing was not required to demonstrate the substantialequivalence to the predicate device. Non-clinical bench testingwas sufficient to assess safety and effectiveness and toestablish the substantial equivalence of the modifications.
SubstantialEquivalence:	The conclusions drawn from the nonclinical test such as therisk evaluation on the modification of the system, biologicalevaluation summary, cleaning and sterilization summarydemonstrated that the subject device is as safe and as effectiveas the predicate device. Both systems also comply withidentical standards and safety testing, where applicable.As such, we concluded that the substantial equivalence of thesubject and the predicate device has been met, and thedifferences between the subject and predicate do not raise newquestions of safety and effectiveness.

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Image /page/4/Picture/0 description: The image displays the logo for "STORZ KARL STORZ – ENDOSKOPE". The word "STORZ" is written in large, bold, blue letters. Below it, the words "KARL STORZ – ENDOSKOPE" are written in smaller, blue letters. The logo appears to be for a medical company.

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Image /page/5/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, in smaller blue letters, is the phrase "KARL STORZ - ENDOSKOPE".

Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.