The DragonFly™ Surgical Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.

Device Description

The DragonFly™ Surgical Drill System consists of a small surgical power tool (handpiece); a battery powered footswitch for control of speed and direction; various cutting instruments (burs); angled adaptors to adjust the angle between the handpiece and the bur; and a sterilization tray. Accessories include a battery charger and a battery replacement kit.

AI/ML Overview

This document describes the DragonFly Surgical Drill System, a surgical power tool for light drilling of bones in procedures like stapedotomy or ossiculoplasty.

Here's an analysis of the acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets for each performance metric, as might be seen for AI/Software-as-a-Medical-Device (SaMD) assessments. Instead, it describes performance verification and validation studies by comparing the device against predicate devices and demonstrating compliance with relevant standards. The "acceptance criteria" are implied by successful completion of these tests and comparable or superior performance to predicates.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Functionality After Repeated Autoclave Cycles	Maintain normal specifications (not more than 15% decline in RPM and/or magnet strength, no discernable increase in vibration) for a minimum of 100 autoclave cycles.	13 handpieces subjected to 270 autoclave cycles. First handpiece failed at 130 cycles, last failed after 270 cycles.
Drill Speed (RPM)	Consistent speed, within normal specifications.	Average maximum RPM at t=0 was 9,535; at t=100 was 9,563. Highest RPM achieved was 9,840. (Note: Predicate devices have max 12,000 RPM, but DragonFly's lower RPM was deemed acceptable by surgeons in bench testing).
Simulated Use (After Autoclave)	No issues related to intended performance.	No issues reported after 100 autoclave cycles.
User's Understanding of IFU	Users successfully determine how to use the device.	Users successfully read IFU and determined how to turn on/off, charge, assemble, perform startup, and evaluate functional characteristics.
User's Ability to Determine Performance Failure	Users successfully recognize failures in essential performance.	Users successfully recognized failures in essential performance.
Software Detection of Essential Performance	Software successfully detects failure, displays alarm, and shuts down system.	Foot control software successfully detected failure, displayed alarm, and shut down.
Biocompatibility	Pass ISO 10993-1 tests (Intracutaneous Irritation, Acute Systemic Injection, Mem Elution L-929 Mouse Fibroblast Cells, Guinea Pig Sensitization).	Representative burs passed all listed ISO 10993-1 tests.
Software Safety Level	Classified as moderate level of concern (FDA guidance) and Risk Class A (IEC 62366), with verification and validation complete.	Software classified as moderate level of concern and Risk Class A. Verification and validation conducted.
Electrical Safety	Certified according to IEC 60601-1 and related standards.	Certified according to IEC 60601-1-2 and ANSI/AAMI ES60601-1:2005/(R) 2012, CSA CAN/CSAC22.2 NO. 60601-1:14, IEC 60601-1 Edition 3.1 (2012) / EN 60601-1 (2006) + A11 + A1 + A12.
Cleaning and Reprocessing	Validation of cleaning and steam autoclavability.	Cleaning validation (radioactive and protein markers) and steam autoclavability validation performed by external labs.
Shelf-life (Burs)	Validated for 3 years.	Gamma irradiated burs validated for a 3-year shelf-life.
Handling and Bur Runout (Comparison to Predicate)	At least as good as or better than predicate devices.	Tested in parallel with Xomed Skeeter Drill and OSSEOSTAP; confirmed handling and bur runout were at least as good or better.
Surgical Evaluation (Comparison to Predicate)	Comparable to or better than predicate devices in operation, handling, cutting performance, and precision suitable for intended use.	Evaluated by 15 otologic surgeons in temporal bone labs, deemed at least as good as predicate Xomed Skeeter drill. Board-certified otolaryngologist compared to OSSEOSTAP and Skeeter, scored 20 characteristics, deemed comparable or better, and suitable for intended use.
Magnetic Latching Mechanism	Average axial force to remove bur: adequate. Lateral force to stall bur: adequate. Minimum lateral force to disarticulate bur: adequate.	Average axial force of 1.1 lb. required to remove a bur. Lateral force of 0.24 lbs required to stall a 2.3mm cutting bur. Minimum lateral force of 1.2 lb. required to disarticulate a bur.
Magnetic Drive Mechanism	Capable of transferring adequate torque.	Capable of transferring a minimum of 0.45 in-oz of torque.
Movable Outer Bur Guard	No new risks created, desirable, safe, and adequate for intended use.	No new risks created. Surgeon feedback indicated it was desirable, safe, and adequate.

2. Sample Size Used for the Test Set and Data Provenance

Functionality after repeated autoclave cycles: 13 handpieces.
Biocompatibility: Representative burs were tested.
Bench Testing and Surgical Evaluation of Performance:
- Comparison of handling and bur runout: Not explicitly stated beyond "The DragonFly Surgical Drill system was tested in parallel with the predicate device".
- Temporal bone labs evaluation: 15 Otologic surgeons.
- Comparison by board-certified otolaryngologist: One board-certified otolaryngologist.
Data Provenance: Not explicitly stated as retrospective or prospective or country of origin in the provided text. However, temporal bone labs and surgeon evaluations suggest a prospective, controlled testing environment, likely in the US where the submitter is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Autoclave/Drill Speed/Simulated Use/Usability: While the tests involve "users" and "surgeons," the "ground truth" here is objective performance metrics (RPM, presence of issues) and user feedback on usability, rather than diagnostic "ground truth" like in imaging studies.
Surgical Evaluation:
- 15 Otologic surgeons: These surgeons were "familiar with and had used the predicate Xomed Skeeter drill." This implies clinical expertise in oto-laryngology. Their specific years of experience are not stated.
- 1 board certified otolaryngologist: Performed surgical procedures on human temporal bone and provided comparative scores for 20 performance characteristics. This qualification establishes significant clinical expertise.

4. Adjudication Method for the Test Set

For the surgical evaluations:
- The 15 otologic surgeons provided individual feedback and generally "deemed" the DragonFly as "at least as good as" the predicate. This suggests consensus-based or individual assessments rather than a formal pre-defined adjudication method (like 2+1 or 3+1).
- The single board-certified otolaryngologist provided comparative scores for 20 characteristics. This was a direct comparison by a single expert.
For other performance tests (autoclave cycles, biocompatibility, electrical safety, etc.), the adjudication involves meeting predefined engineering specifications and regulatory standards, evaluated through testing rather than expert medical adjudication.

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

No, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed. This device is a surgical drill system, a hardware device, not an AI/SaMD diagnostic tool. The "readers" here are surgeons evaluating the physical device's performance, not interpreting medical images or data with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, this question is not applicable. The device is a surgical drill system; it is not an algorithm or AI. It requires a human operator (surgeon).

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, clinical outcomes) doesn't directly apply in the same way to a surgical tool. Instead, the "truth" is established through:

Objective Performance Metrics: RPM, autoclave cycle durability, force measurements (for magnetic latching/drive), biocompatibility test results, electrical safety certifications, shelf-life validation.
Expert Clinical Opinion/Comparative Assessment: Direct subjective evaluation and comparison by qualified otologic surgeons and a board-certified otolaryngologist during bench testing and temporal bone labs, confirming the device's suitability and comparable performance to established predicates.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device; there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a hardware device; there is no "training set" with associated "ground truth."

Summary

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

August 25, 2016

Grace Medical, Inc. c/o Mr. Dave Yungvirt, CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, NJ 07041

Re: K161376

Trade/Device Name: DragonFly Surgical Drill System 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: August 8, 2016 Received: August 10, 2016

Dear Mr. Yungvirt:

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161376

Device Name

DragonFlyTM Surgical Drill System

Indications for Use (Describe)

The DragonFly™ Surgical Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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FORM FDA 3881 (8/14)

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PSC Publishing Services (301) 443-6740
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510(k) Summary

Date Prepared:	Aug 25th, 2016
Submitter:	Grace Medical, Inc.8500 Wolf Lake Drive, Suite 110Memphis, TN 38133 USA
Contact Person:	William GrahamDirector RA/QEmail: bgraham@eaglevis.comTelephone: 901-386-0990Fax: 901-386-0950
Device Name:Proprietary Name:	DragonFly™ Surgical Drill System
Common Name(s):	Electrical surgical drill, ENT drill burs
Classification Name:	Drill, Surgical, ENT (electric or pneumatic) including handpiece(21 CFR 874.4250, Product Code ERL) Class IIBur, Ear, Nose and Throat(21 CFR 874.4140, Product Code EQJ), Class I

Primary Predicate Device: OSSEOSTAP Microdrill, FDA Clearance K143492

Predicate Device(s):

Device	Classification	Manufacturer
Skeeter Ultra-Lite Oto-Tool Drill(Accessory of K041523)	874.4250, ERL, Class IIDrill, Surgical, ENT (electric orpneumatic) including handpiece(21 CFR 874.4250, ProductCode ERL)	Medtronic Xomed, Inc.
OSSEOSTAP Microdrill	874.4250, ERL Class IIDrill, Surgical, ENT (electric orpneumatic) including handpiece(21 CFR 874.4250, ProductCode ERL)	Shenzhen Medical

510(k) Summary DragonFly™ Surgical Drill System Page 1 of 7

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Device Description

Principles of Operation

The footswitch serves as the power control system and is used to control direction (Forward and Reverse) and handpiece speed (proportional to pedal position). Energy is supplied by rechargeable batteries contained within the footswitch. The handpiece contains a dc motor with a cylindrical magnet mounted to the drive shaft. It has an integrated handpiece power cable that connects to the footswitch cable via a push/pull Lemo connector. Interchangeable angled adaptors (15, 25, or 35 degrees) hold the cutting tool or bur in proper relation to the handpiece. A combination of friction and magnetic attraction keep the bur in place.

Unique Features

InvisiDrive™ - Transfer of power from the handpiece to the cutting tool is achieved via a magnetic drive system termed InvisiDrive™. More specifically, a transversely magnet mounted to the motor shaft magnetically links to a similar magnet mounted to the drive shaft of the bur. This creates a magnetic gear that requires no physical contact between motor and cutting tool.

BurShield™ - Some cutting tools have a sliding external guard termed BurShield™ which can be positioned to partially or completely shield the bur in order to protect tissue or packing material from coming into contact with the bur.

Sterilization Overview

The handpiece with cable, angled adaptors, and sterilization tray are autoclavable and intended for use in the sterile field. They should be thoroughly cleaned and sterilized before use. The sterilization tray is designed to hold (3) angled adaptors and the handpiece with cable. Burs are provided sterile and labeled for single use only. The footswitch with cable and the battery charger are located outside of the sterile field.

Service Life

The handpiece is designed to function within normal specifications (not more than a 15% decline in RPM and/or magnet strength, and no discernable increase in vibration.) for a minimum of 100 autoclave cvcles (134°C, 18 minutes hold). Beyond this point, the handpiece speed and power may begin to decline. The user must visually inspect the handpiece and cable, angled adaptors, and sterilization tray after each use. Replace components that appear to be chipped or damaged. Test the system for Essential Performance prior to each use, as identified in the quick start up guide on page 4. Return for service in the event of a performance failure. Items to be returned must be reprocessed in accordance with APPENDIX A. With proper charging and care, the rechargeable 1.2 volt NiMH batteries may be used for up to one year, after initial use.

Indications For Use:

The DragonFlyTM Surgical Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.

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SUBSTANTIAL EQUIVALENCE DISCUSSION

Predicate Devices: The primary predicate device is the BienAire Drill. A secondary predicate device is the Skeeter Drill. The Skeeter Drill is listed as a secondary predicate because it features equivalent Indications for Use Statement, size, control/power supply, and bur offerings.

Characteristic	Predicate Devices		Candidate Device
	Skeeter Ultra-Lite Oto-toolDrill Medtronic Xomed, Inc.(Accessory of K041523)	OSSEOSTAP MicrodrillBien-Air Surgery SAK143492	DragonFlyTM Surgical DrillSystem Candidate Device
1. Intended Use	Intended for the incisionand removal of soft andhard tissue or bone ingeneralotorhinolaryngology, headand neck, andotoneurological surgery.	Intended for the lightdrilling of bones as part ofsurgical operations suchas stapedotomy orossiculoplasty.	The DragonFlyTM SurgicalDrill System has beendesigned for the lightdrilling of bones as partof surgical operationssuch as stapedotomy orossiculoplasty.
2. Control Unit	Foot pedal	Foot pedal	Foot pedal
3. Energy Source	Electrical (batteries)	Electrical (batteries)	Electrical (batteries)
4. Rotation Speed	Max. 12,000 rpm	Max. 12,000 rpm	Max. 9,800 rpm (Note 1)
5. Steam AutoclavableHandpieces	Yes	Yes	Yes
6. Direct PatientContact Materials	Stainless Steel, diamond,and medical polymer	Stainless Steel, diamond,and carbide	Stainless Steel, diamond,and medical polymer(Note 2)
7. Burs Biocompatible	Yes	Yes	Yes
8. Chucking Mechanism	Mechanical Latch	Mechanical Latch	Magnetic Latch (Note 3)
9. Bur DriveMechanism	Mechanical Drive	Mechanical Drive	Magnetic Drive (Note 4)
10. Movable outer bur	No	No	Yes (Note 5)

Summary of Technological Characteristics:

Note 1: The lower RPM of DragonFly has been shown to be acceptable in temporal bone lab bench testing.

Note 2: Stainless steel, diamond, and Medical polymers used for patient contact meet the requirements as set forth in ISO 10993

Note 3: Testing has shown the following in regards to the magnetic latching mechanism.

An average axial force of 1.1 lb. is required to remove a bur from the angled adaptor.
A lateral force of 0.24 lbs is required to stall a 2.3mm cutting bur.
A minimum lateral force of 1.2 lb. is required to disarticulate a bur from the angled adaptor.

Note 4: The magnetic drive is capable of transferring a minimum of .45 in-oz of torque

Note 5: No new risks have been created as a result of the movable outer bur guard

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The technological characteristics of the DragonFly™ Surgical Drill System are comparable to those of the predicate devices in the following ways.

1. Intended Use The intended use for the Osseostap Microdrill is the same as for the subject device. The intended use for the Skeeter is equivalent to the subject device.
1. Control Unit The control unit in both predicate devices and the subject device is a foot pedal controller.
1. Energy Source The energy source for both predicate devices and the subject device is electrical (batteries).
1. Steam Autoclavable Handpiece Both predicate devices offer a reusable, steam autoclavable handpiece. The subject device also offers a reusable, steam autoclavable handpiece.
1. Direct Patient Contact Materials Both predicate devices offer diamond impregnated stainless steel cutting tools. The subject device also offers diamond impregnated stainless cutting tools.
1. Biocompatibility Both predicate devices offer biocompatible cutting tools. The subject device also offers biocompatible cutting tools.

The technological characteristics of the DragonFly™ Surgical Drill System differ from those of the predicate devices in the following ways.

1. A Magnetic Drive Mechanism is used to transfer rotational energy to the bur. The predicate devices utilize a mechanical gear for this purpose. Surgeon feedback from bench testing and use in temporal bone labs indicated that the torque was adequate for the intended use.
1. A magnetic latching mechanism in conjunction with an angled adaptor is used to hold the bur in place. The predicate devices use a mechanical latching mechanism. Surgeon feedback from bench testing and use in temporal bone labs indicated that bur stability and latching strength was adequate for the intended use.
1. A sliding bur external bur guard is utilized which provides the user with the option to shield varying amounts of the rotating bur. The predicate devices utilize a fixed external bur guard that does not shield any portion of the bur tip. Surgeon feedback from bench testing and use in temporal bone labs indicated that a sliding bur guard was desirable, safe, and adequate for the intended use.
1. The DragonFly drill has a maximum rotation speed of 9,800 rpm. The RPM for both the Skeeter and Osseotap drills is listed at 12,000 rpm. Surgeon feedback from bench testing and use in temporal bone labs indicated that the DragonFly drill speed was deemed adequate for the intended use.

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Performance Data:

A. Functionality after repeated autoclave cycles

The DragonFly™ Surgical Drill System handpiece is duty rated for 100 repeated autoclave cycles. Thirteen handpieces were subjected to 270 autoclave cycles (134C, 18 minute hold, 20 minute cool down) and tested functionally at defined intervals. The first handpiece failed, due to a decline in simulated use, at 130 autoclave cvcles. The last handpiece failed simulated use and RPM after 270 autoclave cycles.

1. Drill Speed in RPM

The speed of the handpiece motor, measured in rotation per minute (RPM) was consistent for all samples between autoclave cvcles. The average maximum RPM for all 13 samples at t=0 was 9,535, while the average maximum RPM at t=100 was 9,563. The highest RPM achieved in testing was 9840 RPM.

1. Simulated Use
  The simulated use testing of each handpiece after 100 autoclave cvcles revealed no issues related to the intended performance of the DragonFly™ handpiece.

B. Usability

1. User's understanding of the IFU
  Users were able to read successfully the MicroDrill IFU and successfully determine how to turn the device on and off, charge the device, assemble handpiece components, perform startup procedures, and recognize and correctly evaluate important functional characteristics and essential performance of the device.
1. User/s ability to determine failure of essential performance by observation:
  Users were able to successfully recognize failures in the essential performance of the handpiece.
1. Software detection of essential performance
  The foot control software was successfully able to detect failure of essential performance, display the appropriate alarm, and shut down the system.

C. Biocompatibility

Biocompatibility of the DragonFly™ Surgical Drill System was evaluated according to ISO

10993-1. The system's burs are in direct contact with bone or tissue for a limited duration. Representative burs were tested and passed the following tests:

· ISO Intracutaneous Irritation Test
· ISO Acute Systemic Injection Test
· ISO Mem Elution L-929 Mouse Fibroblast Cells
· ISO Guinea Pig Sensitization

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D. Software

The software that controls the micro-controller in the DragonFly™ Foot Pedal has been classified as a moderate level of concern in accordance with the FDA guidance Document "Guidance for the content of premarket submissions for software contained in medical devices issued on May 11, 2005" and Risk Class A in accordance with IEC 62366. Software verification and validation have been conducted.

E. Electrical Safety

The electrical safety of the Dragonfly™ Surgical Drill System has been certified according to IEC 60601-1

1. IEC 60601-1-2 Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance. Collateral Standard: Electromagnetic Compatibility, and
1. ANSI/AAMI ES60601-1:2005/(R) 2012, CSA CAN/CSA-C22.2 NO. 60601-1:14,

IEC 60601-1 Edition 3.1 (2012), IEC 60601-1 Edition 3.1 (2012) / EN 60601-1 (2006)

A11 + A1 + A12

F. Cleaning and Reprocessing

Cleaning validation of the DragonFly™ Surgical Drill System components has been validated by an external lab using radioactive and protein markers. Steam autoclavability including drying has also been validated by an external lab.

G. Shelf-life

The Shelf-Life of the gamma irradiated burs has been validated for a period of 3 years.

H. Bench Testing and Surgical Evaluation of Performance.

The DragonFly Surgical Drill system was tested in parallel with the predicate device Xomed Skeeter Drill to confirm that handling and bur runout were at least as good or better.

The DragonFly Surgical Drill system was tested in parallel with the predicate device OSSEOSTAP to confirm that handling and bur runout were at least as good or better.

The DragonFly Surgical Drill system was evaluated at temporal bone labs by fifteen Otologic surgeons who were familiar with and had used the predicate Xomed Skeeter drill. A variety of Otologic surgical procedures were conducted and the DragonFly Surgical Drill was deemed to be at least as good as the predicate device in regards to operation and handling, cutting performance, and precision.

A board certified otolaryngologist compared the predicate OSSEOSTAP and Skeeter drills to the DragonFly Surgical Drill by performing surgical procedures on human temporal bone. Twenty performance characteristics were scored and the total average scores compared. The DragonFly Surgical Drill System performed comparably to or better than the predicate devices and the Surgeon deemed the DragonFly Surgical Drill as suitable for its intended use.

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I. Mechanical testing

Magnetic Drive System Magnet Selection, Testing, and Inspection. ●
Magnetic Drive System Design and Effects of Autoclave and Aging on the . System.
Mechanical Testing of Components and Component Interactions. ●
Power Supply Testing ●
Footswitch Testing .
Age Reliability Testing .
Handpiece Heating .

Summary and Conclusions:

Based upon comparative analysis and testing the DragonFly Surgical Drill system was found to have a safety and effectiveness profile, technological characteristics, and indications for use that are similar to the predicate devices.

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.