(99 days)
OSSEOSTAP Microdrill, K143492
No
The summary describes a mechanical surgical drill system with standard components and testing, with no mention of AI or ML capabilities.
Yes.
It is a surgical tool designed to assist in surgical operations for light drilling of bones, which can be considered a therapeutic intervention.
No
Explanation: The device is described as a surgical drill system for "light drilling of bones as part of surgical operations", which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a handpiece, footswitch, burs, angled adaptors, sterilization tray, battery charger, and battery replacement kit. The performance studies also include testing of hardware aspects like functionality after autoclave cycles, electrical safety, mechanical testing, and cleaning/reprocessing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "light drilling of bones as part of surgical operations." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical power tool with accessories for drilling bone. This is a physical tool used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not interact with specimens in this way.
The information provided clearly describes a surgical instrument used for a physical procedure, not a diagnostic test performed on samples.
N/A
Intended 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.
Product codes (comma separated list FDA assigned to the subject device)
ERL, EQJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones (as part of surgical operations such as stapedotomy or ossiculoplasty)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 2. 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.
- 2. 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.
- 3. 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.
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:
-
- IEC 60601-1-2 Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance. Collateral Standard: Electromagnetic Compatibility, and
-
- 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
OSSEOSTAP Microdrill, K143492
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures or lines that could be interpreted as human profiles or flowing shapes.
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.
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
68
3
Image /page/3/Picture/0 description: The image is a logo for Grace Medical. The logo features a light blue circle with a white letter G and a plus sign inside. Below the circle, the words "GRACE MEDICAL" are written in a sans-serif font, with the word "GRACE" in a larger font size. Below that, the words "an enteroptix company" are written in a smaller font size.
510(k) Summary
| Date Prepared: | Aug 25th, 2016 |
|---|---|
| Submitter: | Grace Medical, Inc. |
| 8500 Wolf Lake Drive, Suite 110 | |
| Memphis, TN 38133 USA | |
| Contact Person: | William Graham |
| Director RA/Q | |
| Email: bgraham@eaglevis.com | |
| Telephone: 901-386-0990 | |
| Fax: 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 II |
Bur, 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 II | |
| Drill, Surgical, ENT (electric or | ||
| pneumatic) including handpiece | ||
| (21 CFR 874.4250, Product | ||
| Code ERL) | Medtronic Xomed, Inc. | |
| OSSEOSTAP Microdrill | 874.4250, ERL Class II | |
| Drill, Surgical, ENT (electric or | ||
| pneumatic) including handpiece | ||
| (21 CFR 874.4250, Product | ||
| Code ERL) | Shenzhen Medical |
510(k) Summary DragonFly™ Surgical Drill System Page 1 of 7
4
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.
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.
5
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-tool | |||
| Drill Medtronic Xomed, Inc. | |||
| (Accessory of K041523) | OSSEOSTAP Microdrill | ||
| Bien-Air Surgery SA | |||
| K143492 | DragonFlyTM Surgical Drill | ||
| System Candidate Device | |||
| 1. Intended Use | Intended for the incision | ||
| and removal of soft and | |||
| hard tissue or bone in | |||
| general | |||
| otorhinolaryngology, head | |||
| and neck, and | |||
| otoneurological surgery. | Intended for the light | ||
| drilling of bones as part of | |||
| surgical operations such | |||
| as stapedotomy or | |||
| ossiculoplasty. | The DragonFlyTM Surgical | ||
| Drill System has been | |||
| designed for the light | |||
| drilling of bones as part | |||
| of surgical operations | |||
| such as stapedotomy or | |||
| ossiculoplasty. | |||
| 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 Autoclavable | |||
| Handpieces | Yes | Yes | Yes |
| 6. Direct Patient | |||
| Contact 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 Drive | |||
| Mechanism | 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
6
The technological characteristics of the DragonFly™ Surgical Drill System are comparable to those of the predicate devices in the following ways.
-
- 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.
-
- Control Unit The control unit in both predicate devices and the subject device is a foot pedal controller.
-
- Energy Source The energy source for both predicate devices and the subject device is electrical (batteries).
-
- Steam Autoclavable Handpiece Both predicate devices offer a reusable, steam autoclavable handpiece. The subject device also offers a reusable, steam autoclavable handpiece.
-
- Direct Patient Contact Materials Both predicate devices offer diamond impregnated stainless steel cutting tools. The subject device also offers diamond impregnated stainless cutting tools.
-
- 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.
-
- 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.
-
- 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.
-
- 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.
-
- 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.
7
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.
-
- 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.
- Simulated Use
B. Usability
-
- 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.
- User's understanding of the IFU
-
- 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.
- User/s ability to determine failure of essential performance by observation:
-
- 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.
- Software detection of essential performance
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
8
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
-
- IEC 60601-1-2 Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance. Collateral Standard: Electromagnetic Compatibility, and
-
- 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.
9
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.