The Diego Elite Drill is intended for cutting, drilling, and removal of bone, and soft and hard tissue in general ENT, and Otoneurologic procedures when used in conjunction with the Diego Elite console.

Specific procedures would include Mastoid Neurotology (Mastoidotomy) and Stapes procedures.

Device Description

The Diego Elite Drill is similar to the drills associated with the predicate Diego® RF Powered Dissector and Drill System cleared under K034004. The Diego Elite Drill is the next generation drill and it is functionally equivalent to the predicate Gyrus ACMI product and other predicates.

The proposed Drill and accessories are to be used only in conjunction with the Diego Elite system (K123429) for Otologic procedures. The Diego Elite system original submission did not include an Otologic drill, and the predicate (K034004) is not compatible with the Diego Elite system.

Accessories include straight and angled attachments, an irrigation clip, various burrs, an irrigation tubeset, a cleaning kit, and a cleaning / sterilization tray. The drill base plugs into the existing Diego Elite console and is activated by the existing Diego Elite footswitch. The drill base and the straight and angled attachments, and irrigation clip are provided non-sterile and are reusable. The burrs and tubeset are provided sterile and are single-use. The cleaning kit is provided non-sterile and is single-use.

AI/ML Overview

This document describes the premarket notification for the "Diego Elite Drill" (K152744), a surgical drill intended for ENT and Otoneurologic procedures. The submission claims substantial equivalence to existing predicate devices.

Here's an analysis of the acceptance criteria and study data:

Acceptance Criteria and Device Performance

The acceptance criteria for the "Diego Elite Drill" are primarily based on simulated use testing and preclinical evaluations to demonstrate substantial equivalence to predicate devices, focusing on functionality, usability, and safety. There are no explicit quantitative performance metrics like sensitivity, specificity, or AUC provided in the context of diagnostic accuracy, as this is a surgical device. Instead, performance is evaluated through surgeon feedback against predefined usability criteria.

Acceptance Criteria Category	Specific Metric / Criterion	Acceptance Threshold	Reported Device Performance
Simulated Use Testing (Phacon Temporal Bone)	Average Rating for Set-up	< 2.5 (Score: 1-Exceeds, 2-Meets, 3-Nearly Meets, 4-Does Not Meet)	1.7
	Average Rating for Ergonomics	< 2.5	2.0
	Average Rating for Performance	< 2.5	2.0
Feasibility DVS Study (Cadaver Heads)	Average Rating for Set-up	< 2.3 (Score: 1-Exceeds, 2-Meets, 3-Does Not Meet)	1.6
	Average Rating for Ergonomics	< 2.3	1.7
	Average Rating for Performance	< 2.3	1.5
Biocompatibility	Cytotoxicity Testing	Passing Results	Passing Results
	Sensitization Testing	Passing Results	Passing Results
	Irritation Testing	Passing Results	Passing Results
Electrical Safety	Compliance with IEC 60601-1	Compliance demonstrated	Complies with applicable clauses of IEC 60601-1
Sterilization Assurance Level	Ethylene Oxide Sterilization	10⁻⁶ (standard for medical devices, document states 10⁻⁹ for burrs and tubeset)	10⁻⁹ (for burrs and tubeset)
Shelf-Life	Functionality over time	Maintain functionality & meet specifications for stated shelf-life	Accelerated aging supports initial one-year shelf life
General Functional & Mechanical Performance	Tip vibration, noise, torque strength, endurance, force, reliability, leak, ship testing, baseline performance, age, joint strength, environmental conditioning, durability	Met design specifications	Met design specifications; testing conducted

Study Details

Sample size used for the test set and the data provenance:
- Simulated Use Testing (Phacon Temporal Bone Analog):
  - Sample Size: 5 ENT surgeons.
  - Data Provenance: Not specified, but likely within the US, given the FDA submission. The study is prospective, involving surgeons evaluating the device in a controlled simulated environment.
- Feasibility DVS Study (Cadaver Heads):
  - Sample Size: 10 ENT surgeons.
  - Data Provenance: Not specified, but likely within the US. The study is prospective, involving surgeons evaluating the device on cadaver heads.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For this type of surgical device, the "ground truth" for performance is established by the expert opinion and experience of the participating surgeons (5 ENT surgeons for simulated use, 10 ENT surgeons for DVS study). Their feedback on usability, ergonomics, and performance against the stated indications for use serves as the basis for assessing the device's acceptable performance compared to predicate devices.
- Qualifications of Experts: All participants were "ENT surgeons." Specific years of experience are not detailed in the provided summary.
Adjudication method for the test set:
- Surgeons provided individual scores/feedback which were then averaged to reach a collective assessment against predetermined acceptance thresholds. There is no mention of a separate adjudication panel or consensus process beyond the collective average.
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:
- No, an MRMC comparative effectiveness study was not done. This is a surgical device, not an AI-assisted diagnostic tool, so this type of study is not applicable. The comparison made is between the new device and predicate devices in terms of general performance and safety, primarily through surgeon feedback.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a "standalone" algorithm-only performance study was not done. This device is a manual surgical tool that requires human operation; its performance is inherently tied to human interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance relies on expert opinion and feedback from ENT surgeons during simulated use studies. This is qualitative and subjective data collected through surveys, assessing aspects like usability, ergonomics, and performance in cutting/drilling tissue.
- For biocompatibility and electrical safety, the "ground truth" is adherence to established international standards (ISO, IEC) and passing results on specific laboratory tests.
The sample size for the training set:
- The document does not describe a "training set" in the context of machine learning or AI. This is a medical device subject to bench testing, biocompatibility, and human factors (usability) assessments. The device's design and development would have involved iterative testing and refinement, but this isn't analogous to an AI training set.
How the ground truth for the training set was established:
- As there is no "training set" in the AI/ML sense, this question is not applicable. The device's performance characteristics (e.g., torque, vibration, cutting ability) are established through engineering design specifications and verified through bench testing, guided by an understanding of surgical requirements and risk analysis.

Summary

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

June 10, 2016

Gyrus Acmi, Inc. Mr. Dolan Mills Sr. Specialist, Regulatory Affairs 136 Turnpike Road Southborough, MA 01772

Re: K152744

Trade/Device Name: Diego Elite Drill 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: May 11, 2016 Received: May 12, 2016

Dear Mr. Mills:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 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.

Sincerely yours.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K152744

Device Name Diego Elite Drill

Indications for Use (Describe)

Specific procedures would include Mastoid Neurotology (Mastoidotomy) and Stapes procedures.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Diego Elite Drill

General Information

Manufacturer and 510(k) Submitter:	Gyrus ACMI, Inc., an Olympus company136 Turnpike RoadSouthborough, MA 01772-2104Phone: 1-800-262-3540Fax: 1-901-373-0260
Establishment Registration Number:	3003790304
Manufacturing Site:	2925 Appling RoadBartlett , TN 38113Phone: 1-800-262-3540Fax: 1-901-373-0260
Establishment Registration Number:	1037007
Contact Person:	Dolan MillsSenior Specialist, Regulatory Affairs
Date Prepared:	September 22, 2015

Device Description

Classification Name:

ENT Electric or Pneumatic Surgical Drill

Drill System	Bur, Ear, Nose & Throat	Tray, Surgical Instrument
21 CFR 874.4250	21 CFR 874.4140	21 CFR 878.4800
Ear, Nose, Throat	Ear, Nose & Throat	General & Plastic Surgery
ERL	EQJ	FSM

Regulatory Class Regulation Number Review Panel Product Code

Project Name:

Class 2 21 CFR 874.4250 Ear, Nose, & Throat Panel ERL

Diego Elite Drill (12-002), High Speed Drill

Trade Name(s):

Diego Elite Drill

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Generic/Common Name:

Electrical Surgical Drill / Shaver Burs, Instrument Tray

Predicate Devices

Gyrus ACMI Diego® RF Powered Dissector & Drill System:	K034004
Reference Predicates:
Medtronic Midas Rex:	K081277
Gyrus ACMI Diego Elite System:	K123429

The Gyrus ACMI predicate has not been subject to a design-related recall.

Product Description

Technological Characteristics

The Drill system is used in the same general way as the predicate RF Diego drills (K034004) and Diego Elite system handpieces (K123429). A reusable drill base connects to the existing Diego Elite console, is recognized by a unique Diego Elite Drill software version, and differentiated from other possible Diego Elite handpiece options. A reusable tip guard, 1 of 5 interchangeable attachments, is connected to the drill; each tip is detected by the drill hardware/software based on its intended use (Mastoid vs. Stapes), and default performance settings (speed, irrigation) are then displayed by the console on the graphical user interface. A disposable burr is then loaded into the drill/guard and locked in to place for use. The total assembly creates a variable speed drill.

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A new sterile disposable tubeset delivers irrigation via the existing Diego Elite console pump to the operative site through either a guard-attachable clip or a separate suction / irrigation instrument (sold separately). The new tubeset also provides suction capabilities and is compatible with standard OR suction and the existing Diego Elite Suction Module (K123429). The existing Diego Elite footswitch connects to the console and is used to start and stop the drill operation.

Material

The Diego Elite Drill uses the same patient-contacting materials that are utilized in the predicate devices (K123429, K034004), as well as other legally marketed devices manufactured by Gyrus ACMI.

The patient contacting items are classified in accordance with ISO 10993-1, as an external communicating, tissue/bone/dentin device for limited exposure (<24hrs.). ISO10993-1 and FDA Blue Book memo #G95-1 guidelines recommend that these direct patient contact parts have supporting data for cytotoxicity, sensitization and irritation. Full biocompatibility testing (Cytotoxicity, sensitization, and irritation) to ISO10993-1 for the device category for any material differences was completed and is available for patient contacting materials.

The battery of testing included the following tests:

Cytotoxicity
Sensitization
Irritation ●

Based on the material assessment, patient contacting materials were evaluated as comparable to the predicate or tested in accordance with ISO 10993-1, with passing results.

Intended Use / Indications

Specific procedures would include Mastoid/Neurotology (Mastoidectomy / Mastoidotomy) and Stapes procedures.

Compliance to Standards

The design of the Diego Elite Drill complies with the following standards:

IEC 60601-1, 2005

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ISO 10993-1 (2009), 5 (2009), 7 (2008), 10 (2010), Biological Evaluation of Medical Devices

ISO 14971:2012, Risk Analysis

ISO 15223-1:2012, Medical Devices - Symbols to be used

ISO 17665-1:2006. Sterilization of Health Care Products. Moist Heat

ISO 11135:2014, Sterilization of Health Care Products, EO Validation

ISO 11138: 2006, Sterilization of health care products: Biological Indicators

ISO 11607-1:2006, Packaging for Terminally Sterilized Medical Devices

ISO 11607-2:2006, Packaging for Terminally Sterilized Medical Devices

ISO 11737-1:2006, Sterilization of Medical Devices - Microbiological Methods

ISO 11737-2:2009, Sterilization of Medical Devices - Microbiological Methods

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971. The design verification tests were identified and performed as a result of risk analysis assessment.

Electrical safety

Electrical safety testing was conducted on the device complies with the applicable clauses of IEC 60601-1.

Summary of Sterilization and Shelf Life Discussion

The Drill base and drill components are provided non-sterile and are reusable. The console and footswitch are to be wiped down with cleaning / disinfecting wipes after use. The drill is not in the fluid or suction pathway, and any contamination it receives will be through indirect means from handling and as the disposables are removed. The drill is to be cleaned and reprocessed according to the validated procedure provided in the instruction manual.

The burrs and tubeset are provided sterile for single-use. They are sterilized using Ethylene Oxide, using a cycle validated in accordance with ISO 11135 to provide a sterility assurance level of 10-9.

The Shelf Life period for the disposable items was determined through an analysis of the shelf-life stability of the materials used in the design of the devices, as well as an analysis of the packaging materials and processes used with other Gyrus ACMI devices. Accelerated shelf-life studies were conducted to support an initial one year shelf life, with real time testing in process to confirm an initial one year expiration date. Additional studies (accelerated and real time) are planned to support a five-year expiration date in the future.

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Summary of Performance Testing

Performance tests were executed to ensure that the system functioned as intended and met design specifications. The following non-clinical and preclinical tests, and usability studies, were conducted:

Non-Clinical / Preclinical Performance

Evidence of safety and effectiveness was obtained from two primary areas:

1. non-clinical (electrical, mechanical, functional, biocompatibility, stability) performance testing
1. preclinical (simulated use) evaluations and testing

Non-clinical: Basic safety and performance testing was performed in accordance with IEC standards. In addition, verification and comparison bench studies were conducted to evaluate the mechanical and functional performance. Testing included: tip vibration, noise, torque strength, endurance, force testing, reliability, leak testing, ship testing, baseline performance testing, age testing, joint strength, environmental conditioning, durability, and other applicable tests.

Stability: Representative sterile samples were subjected to accelerated aging to confirm that the disposable devices maintain functionality and continue to meet specifications over time. The results of the accelerated age testing demonstrate that the device will be stable for the stated shelf-life. In addition, real time age testing will confirm the results of the accelerated age testing. Representative samples were also subjected to environmental conditioning and ship testing.

Preclinical: Evidence obtained from preclinical simulated use studies demonstrate that the system performs substantially equivalent to the predicate device in relevant aspects associated with usability, cutting, drilling, and removal of tissue. For simulated use testing, the selected test medium (PHACON temporal bone analog) was confirmed to be appropriate for testing based on surgeon input. Testing included:

-Usability aspects such as device setup
Overall design confidence -
Ergonomics and Control -
Performance -

The simulated use testing established substantial equivalence with the predicate device for the intended use based on an assessment of non-clinical performance data, as per 807.92(b). The simulated use testing included feedback from five ENT surgeons using a PHACON temporal bone simulator for simulation of mastoidectomy / mastoidotomy and stapedectomy procedures, and a feasibility DVS study with ten ENT surgeons in which cadaver heads were used in a controlled cadaver lab to perform mastoid and middle ear procedures. The surgeons were asked a series of

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questions related to the procedures being simulated and in comparison to the predicate device.

The simulated use testing results were considered passing according to defined acceptance criteria in relation to the expectations of the user for the device type (average score of less than (but not equal to) 2.5 must be achieved for each of the three test sections (Set-up, Ergonomics, Performance)) tested across the surgeon evaluation base. Score options: 1 - Exceeds Expectations; 2 - Meets Expectations; 3 - Nearly Meets Expectations; 4 -Does Not Meet Expectations. The subject device scores were as follows:

Set-up: 1.7
Ergonomics: 2.0
Performance: 2.0 ●

The feasibility DVS study results were considered passing according to our acceptance criteria in relation to the expectations of the user for the device type (average score of less than (but not equal to) 2.3 must be achieved for each of the sections (Set-up, Ergonomics, Performance)) tested across the surgeon evaluation base. The individual survey responses show that in total all procedures were performed satisfactorily with the new device. Score options: 1 - Exceeds Expectations; 2 - Meets Expectations; 3 - Does not Meet Expectations. The subject device scores were as follows:

Set-up: 1.6
Ergonomics: 1.7
Performance: 1.5 ●

Testing demonstrated that the device performs substantially equivalent to the main predicate device in relation to the stated indications, and is as safe and effective, and performs as well as or better than the legally marketed predicate.

No clinical testing was conducted. The use of Electric Drills has been documented in published literature and indicates safe and effective use for the target procedures and expected patient populations.

Substantial Equivalence

The Diego Elite Drill utilizes the same console to cut, drill, and remove tissue as that used in the Diego Elite System cleared under K123429.

The Diego Elite Drill operates as a drill in a similar manner as the predicate drills and burrs found in the currently marketed Diego® RF Dissector and Drill System cleared under K034004. The Diego Elite Drill disposable tubeset and burrs are similar to the predicate devices physically and in their methods of operation. The tubeset continues

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to be bifurcated, offering saline irrigation to the surgical site, and suction away from the surgical site.

The Diego Elite Drill uses the same patient-contacting materials in similar quantities that are utilized in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI.

Conclusion

The performance of the Diego Elite Drill was compared against the known performance characteristics of the predicate device. Testing demonstrated that the performance requirements were met, and that the Diego Elite Drill exhibited comparable performance characteristics to the predicate.

In summary, the Diego Elite Drill is substantially equivalent to the predicate device and presents no new questions of safety or efficacy.

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.