Stealth Autoguide System, Midas Rex Legend Depth Stop System

K191597 · Medtronic Navigation, Inc. · HAW · Nov 1, 2019 · Neurology

Device Facts

• Record ID: K191597
• Device Name: Stealth Autoguide System, Midas Rex Legend Depth Stop System
• Applicant: Medtronic Navigation, Inc.
• Product Code: HAW · Neurology
• Decision Date: Nov 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software. The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic EEG, laser tissue ablation, etc.). The Midas Rex™ Legend™ depth stop attachment and tools are incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

Device Story

Stealth Autoguide System: robotic, electromechanical multi-jointed arm; interprets navigation tracker and surgical plan coordinates from StealthStation; positions/orients instrument holders for neurosurgical guidance. Used in OR by neurosurgeons; integrates with StealthStation navigation and 3D imaging software. Midas Rex Legend Depth Stop System: depth stop attachment and dissecting tools; used with Autoguide to create cranial access holes. System provides spatial accuracy for instrument delivery; surgeon performs final delivery through guide. Benefits: precise, image-guided instrument positioning for stereotactic procedures.

Clinical Evidence

Bench testing only. Accuracy validation performed using clinically relevant anatomical phantoms with StealthStation S7/S8. Mean positional error ≤ 2.0 mm; mean trajectory angle error ≤ 2.0 degrees. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity, material-mediated pyrogenicity, hemolysis) performed on representative attachments and tools; all results met acceptance criteria.

Technological Characteristics

Electromechanical multi-jointed arm; computer-controlled. Materials: Stainless steel, phenolic, chevron SRI grease, tool steel. Connectivity: Networked with StealthStation. Sterilization: Gamma (tools), non-sterile (attachments/accessories). Software: Integrated with StealthStation Cranial software for navigation and planning.

Indications for Use

Indicated for patients requiring stereotactic neurosurgical procedures, including stereotactic biopsy, stereotactic EEG, and laser tissue ablation, where spatial positioning of instruments is required. Also indicated for cranial surgical procedures requiring incision, cutting, removal, or drilling of soft and hard tissue to create cranial access holes.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• ROSA Brain (K151359)
• Midas Rex Legend Electric and Pneumatic Drill Systems (K170312, K163182)

Reference Devices

• iSYS1 (K131433)
• StealthStation S8 Cranial (K162309)
• Cranial Reducing Tubes (K162604)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

November 1, 2019

Medtronic Navigation, Inc. Jason Woehrle Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K191597

Trade/Device Name: Stealth Autoguide System, Midas Rex Legend Depth Stop System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, HBC, HBB, HBE Dated: September 27, 2019 Received: October 2, 2019

Dear Jason Woehrle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191597

Device Name Stealth Autoguide™ System

### Indications for Use (Describe)

The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software.

The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic EEG, laser tissue ablation, etc.).

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Indications for Use

510(k) Number (if known) K191597

Device Name Midas Rex™ Legend™ Depth Stop System

### Indications for Use (Describe)

The Midas Rex™ Legend™ depth stop attachment and tools are incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

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 [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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### 510(k) Summary June 14, 2019

- I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200
Medtronic Powered Surgical Systems 4620 N Beach Street Ft Worth, TX 76137 USA

- Contact: Jason Woehrle (Primary) Senior Regulatory Affairs Specialist Telephone Number: 949-399-1509 Fax Number: 720-890-3500
K. Elizabeth Waite (Alternate) Principal Regulatory Affairs Specialist Telephone: [phone] Fax: [phone]

- II.
Proprietary Trade Name:
Stealth Autoguide™System
Midas Rex " Legend" "Depth Stop System

#### III. Common Name:

Stealth Autoguide™ System: Stereotaxic Instrument Midas Rex " Legend " Depth Stop System: Motor, Drill, Electric, Motor, Drill, Pneumatic, Powered simple cranial drills, burrs, trephines, and their accessories

#### IV. Classification Name:

Stealth Autoguide " System: Stereotaxic Instrument (21 CFR 882.4560) Midas Rex™ Legend™ Depth Stop System: Electric cranial drill motor (21 CFR 882.4360) Pneumatic cranial drill motor (21 CFR 882.4370) Powered simple cranial drills, burrs, trephines, and their accessories (21 CFR 882.4310)

- V. Classification: Stealth Autoguide™ System: Class II Midas Rex " Legend " Depth Stop System: Class II
- VI. Product Code: Stealth Autoguide™ System: HAW Midas Rex 1 Legend " Depth Stop System: HBC, HBB, HBE

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#### VII. Product Description:

Stealth Autoguide™ System: The Stealth Autoguide System is a robotic positioning and guidance system intended to interpret navigation tracker coordinates and surgical plan coordinates from the StealthStation to robotically position and orient instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments to pre-defined plans.

Midas Rex™ Legend™ Depth Stop System: The Midas Rex™ Legend™ Depth Stop System consists of a Depth Stop Attachment and specific surgical dissecting tools that will be used in conjunction with the Stealth Autoguide System to create cranial access holes for neurosurgical procedures.

#### Indications for Use: VIII.

Stealth Autoguide "" System: The Stealth Autoguide System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (e.g., stereotactic biopsy, stereotactic EEG, laser tissue ablation, etc.).

Midas Rex "" Legend"" Depth Stop System: The Midas Rex "" Legend" depth stop attachment and tools are indicated for the incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

#### IX. Identification of Legally Marketed Devices (Predicate Devices): Stealth Autoguide "System:

Predicate: K151359 – ROSA Brain, manufactured by MEDTECH S.A Reference Devices: K131433 - iSYS1, manufactured by ISYS Reference Devices: K162309 - StealthStation S8 Cranial, manufactured by Medtronic Navigation, Inc. Reference Devices: K162604 - Cranial Reducing Tubes, manufactured by Medtronic Navigation, Inc.

# Midas Rex "" Legend "" Depth Stop System:

Predicate: K170312. K163182 – Midas Rex Legend Electric and Pneumatic Drill Systems, manufactured by Medtronic Powered Surgical Systems.

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#### X. Summary of the Technological Characteristics:

| Stealth AutoguideTM System | | |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Subject Device | Predicate Devices |
| General Description | Computer controlled<br>electromechanical multi-<br>jointed arm for use as a<br>stereotactic instrument | Predicate: ROSA Brain<br>(K151359)<br>Computer controlled<br>electromechanical multi-<br>jointed arm for use as a<br>stereotactic instrument |
| Product Code | HAW | Predicate: ROSA Brain<br>(K151359) HAW |
| Intended Use/<br>Indications for Use | The Stealth AutoguideTM<br>System is a positioning and<br>guidance system intended for<br>the spatial positioning and<br>orientation of instrument<br>holders or tool guides to be<br>used by neurosurgeons to<br>guide standard neurosurgical<br>instruments, based on a pre-<br>operative plan and feedback<br>from an image-guided<br>navigation system with three-<br>dimensional imaging software.<br>The Stealth AutoguideTM<br>System is a remotely-operated<br>positioning and guidance<br>system, indicated for any<br>neurological condition in<br>which the use of stereotactic<br>surgery may be appropriate<br>(for example, stereotactic<br>biopsy, stereotactic EEG, laser<br>tissue ablation, etc.). | Predicate: ROSA Brain<br>(K151359)<br>Intended for the spatial<br>positioning and orientation of<br>instrument holders or tool<br>guides to be used by<br>neurosurgeons to guide<br>standard neurosurgical<br>instruments (biopsy needle,<br>stimulation or recording<br>electrode, endoscope). The<br>device is indicated for any<br>neurosurgical procedure in<br>which the use of stereotactic<br>surgery may be appropriate.<br><br>Reference Device: iSYS<br>1 (K131433)<br>The iSYS 1 device is intended<br>to assist the surgeon in the<br>positioning of a needle or<br>electrode where both<br>computed tomography (CT)<br>and fluoroscopic imaging can |
| Item | Subject Device | Predicate Devices |
| | | be used for target trajectory<br>planning and intraoperative<br>tracking. The needle or<br>electrode is then manually<br>advanced by the surgeon.<br>Trajectory planning is made<br>with software that is not part<br>of the iSYS device. |
| Operating Principle | Preoperative images<br>(StealthStation)<br>Surgical planning<br>(StealthStation)<br>Patient registration<br>Guidance of instruments | Reference Device: iSYS<br>1 (K131433)<br>Preoperative images (third<br>party)<br>Surgical planning (third party)<br>Patient registration<br>Guidance of instruments |
| Localization Means | Optical markers on tool holder | Reference Device:<br>Stealth S8 Cranial (K162309)<br>Optical markers on tool holder |
| Image-Guided | Yes (on StealthStation) | Reference Device: iSYS<br>1 (K131433)<br>Yes |
| Planning Software | Compatible with:<br>S8 Cranial v1.1<br>Synergy Cranial v.3.1 | Reference Device:<br>Stealth S8 Cranial (K162309)<br>S8 Cranial v1.2 |
| System Accuracy<br>Requirement | Under representative worst-<br>case configuration, the<br>StealthStation® System with<br>Cranial Software used with<br>Stealth AutoguideTM System,<br>has demonstrated performance<br>in 3D positional accuracy with<br>a mean error ≤ 2.0 mm and in<br>trajectory angle accuracy with<br>a mean error ≤ 2.0 degrees. | Reference Device:<br>Stealth S8 Cranial (K162309)<br>Under representative worst-<br>case configuration, the<br>StealthStation® System S8<br>with StealthStationTM Cranial<br>v1.0.0 Software, has<br>demonstrated performance in<br>3D positional accuracy with a<br>mean error ≤ 2.0 mm and in<br>trajectory angle accuracy with<br>a mean error ≤ 2.0 degrees. |
| Instrumentation | Navigated Trajectory Guide<br>Tool Holders (Drill Guides,<br>Reducing Tubes)<br>Height Guides<br>Tapping Tube | Reference Device:<br>Cranial Reducing Tubes<br>(K162604)<br>Navigated Trajectory Guide<br>Tool Holders (Drill Guides,<br>Reducing Tubes |
| Item | Subject Device | Predicate Devices |
| Instrument Fixation | Special tool holders for different applications mounted to the Stealth Autoguide | Height Guides<br>Tapping Tube<br>Reference Device: iSYS<br>1 (K131433)<br>Special tool holders for different applications mounted to the device |
| Guide Position<br>Adjustment | Robotic movement | Predicate: ROSA Brain<br>(K151359)<br>Automatic (Robotized) |
| Accessories | Sterile Drapes<br>Head Frame Adapter<br>Cable Sets | Reference Device: iSYS<br>1 (K131433)<br>Sterile Drapes<br>Table Adapters<br>Cable Sets |
| Real-Time Instrument<br>Position | Yes (on StealthStation) | Reference Device: iSYS<br>1 (K131433)<br>Yes |
| Patient Registration | Optical Registration Device<br>(via StealthStation) | Reference Device:<br>Stealth S8 Cranial (K162309)<br>Optical Registration Device<br>(via StealthStation) |
| Surgeon Performs Final<br>Instrument Delivery<br>through Instrument<br>Guide | Yes | Reference Device: iSYS<br>1 (K131433)<br>Yes |

# Stealth Autoguide TM System

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| Feature/<br>Attribute | Subject<br>Devices<br>Midas<br>Rex™<br>Legend™<br>Depth<br>Stop | Electric Drill<br>Expanded Indications<br>(K170312) | Pneumatic Drill<br>Expanded Indications<br>(K163182) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HBC, HBB,<br>HBE | HBE, HBC, HRX,<br>HWE, EQJ, ERL, KFK | KFK, HBB, ERL, EQJ, HSZ,<br>GET, KFK, HBE, DWH |
| Intended Use | Incision,<br>cutting,<br>removing,<br>and drilling<br>of soft and<br>hard tissue | Incision/ cutting,<br>removal, drilling, and<br>sawing of soft and hard<br>tissue, bone, and<br>biomaterials. | Incision/ cutting, removal,<br>drilling, and sawing of soft and<br>hard tissue, bone, and<br>biomaterials. |
| Indications<br>for use | The Midas<br>Rex Legend<br>Depth Stop<br>attachment<br>and tools<br>are<br>indicated<br>for the<br>incision,<br>cutting,<br>removing,<br>and drilling<br>of soft and<br>hard tissue<br>during<br>cranial<br>surgical<br>procedures<br>with the<br>intent to<br>create a hole<br>through the<br>cranium to<br>allow<br>surgeons<br>access to<br>desired<br>surgical<br>locations<br>and/or to | The Medtronic Electric<br>Drill System is indicated<br>for the incision/cutting,<br>removal, drilling, and<br>sawing of soft and hard<br>tissue, bone, and<br>biomaterials in<br>Neurosurgical (Cranial,<br>Craniofacial) including<br>craniotomy; as well as<br>Ear, Nose and Throat<br>(ENT), Orthopedic,<br>Arthroscopic, Spinal,<br>and General Surgical<br>Procedures including<br>Maxillofacial,<br>Craniofacial and<br>Sternotomy Surgeries.<br>Additionally, the<br>Electric Drill System is<br>indicated for the<br>incision / cutting,<br>removal, drilling, and<br>sawing of soft and hard<br>tissue, bone, and<br>biomaterials during<br>open and minimally<br>invasive spine<br>procedures, which may<br>incorporate application | The Medtronic Pneumatic Drill<br>System is indicated for the<br>incision/cutting, removal,<br>drilling, and sawing of soft and<br>hard tissue, bone, and<br>biomaterials in Neurosurgical<br>(Cranial, Craniofacial)<br>including craniotomy; as well<br>as Ear, Nose and Throat (ENT),<br>Orthopedic, Arthroscopic,<br>Spinal, and General Surgical<br>Procedures including<br>Maxillofacial, Craniofacial and<br>Sternotomy Surgeries.<br>Additionally, the Pneumatic<br>Drill System is indicated for the<br>incision / cutting, removal,<br>drilling, and sawing of soft and<br>hard tissue, bone, and<br>biomaterials during open and<br>minimally invasive spine<br>procedures, which may<br>incorporate application of<br>various surgical techniques<br>during the following lumbar<br>spinal procedures:<br>• Lumbar Microdiscectomy<br>• Lumbar<br>Stenosis |
| Feature/<br>Attribute | Subject<br>Devices<br>Midas<br>Rex™<br>Legend™<br>Depth<br>Stop | Electric Drill<br>Expanded Indications<br>(K170312) | Pneumatic Drill<br>Expanded Indications<br>(K163182) |
| | facilitate<br>insertion,<br>placement<br>of other<br>surgical<br>devices<br>during such<br>procedures. | of various surgical<br>techniques during the<br>following lumbar spinal<br>procedures:<br>• Lumbar<br>Microdiscectomy<br>• Lumbar<br>Stenosis<br>Decompression<br>• Posterior<br>Lumbar<br>Interbody<br>Fusion (PLIF)<br>• Transforaminal<br>Lumbar<br>Interbody<br>Fusion (TLIF) | • Posterior Lumbar<br>Interbody Fusion (PLIF)<br>• Transforaminal<br>Lumbar Interbody<br>Fusion (TLIF)<br>• Anterior Lumbar<br>Interbody Fusion (ALIF)<br>• Direct Lateral<br>Interbody Fusion<br>(DLIF) |
| General<br>System<br>Components | Attachment,<br>Surgical<br>Dissecting<br>Tool | Electric Handpiece,<br>Attachments, Surgical<br>Dissecting Tools,<br>System Accessories | Pneumatic Handpiece,<br>Attachments, Surgical<br>Dissecting Tools, System<br>Accessories |
| Patient<br>Contacting<br>Components | Attachment<br>and Surgical<br>Dissecting<br>Tools | Attachments and<br>Surgical Dissecting<br>Tools | Attachments and Surgical<br>Dissecting Tools |
| Materials of<br>Patient<br>Contacting<br>Components | Attachment<br>- Stainless<br>Steel,<br>Phenolic,<br>Chevron | Attachments - Stainless<br>Steel, Aluminum,<br>Ceramic, Phenolic,<br>Epoxy, Chrome Coated<br>Brass, Torlon 4301 | Attachments - Stainless Steel,<br>Aluminum, Ceramic, Phenolic,<br>Epoxy, Chrome Coated Brass,<br>Polymeric |
| | SRI Grease<br>2<br>Surgical<br>Dissecting<br>Tools -Tool<br>Steel | Dissecting Tools:<br>Stainless Steel, Tool<br>Steel, Alloy Steel,<br>Carbide, TDC Coating,<br>Diamond Coating in | Dissecting Tools: Stainless<br>Steel, Tool Steel, Alloy Steel,<br>Carbide, TDC Coating,<br>Diamond Coating in Nickel<br>Substrate, Titanium Nitride |
| Feature/<br>Attribute | Subject<br>Devices<br>Midas<br>Rex™<br>Legend™<br>Depth<br>Stop | Electric Drill<br>Expanded Indications<br>(K170312) | Pneumatic Drill<br>Expanded Indications<br>(K163182) |
| | | Nickel Substrate,<br>Titanium Nitride | |
| Surgical<br>Dissecting<br>Tools - Tip<br>Style | Twist Drill | Round/Acorn, Match<br>Head, Ball, Cylinder,<br>Oval, Tapered/Side<br>Cutting, Metal<br>Cutting, Twist Drill,<br>Hole Maker/Saw, | Round/Acorn, Match Head,<br>Ball, Cylinder, Oval,<br>Tapered/Side Cutting, Metal<br>Cutting, Twist Drill, Hole<br>Maker/Saw, Reverse Tapered |
| Surgical<br>Dissecting<br>Tool -<br>Overall<br>Length | Surgical<br>Dissecting<br>Tool:<br>6.7-8.7cm | Surgical Dissecting<br>Tool:<br>3-42cm | Surgical Dissecting Tool:<br>3-42cm |
| Surgical<br>Dissecting<br>Tool - Head<br>Diameter | Surgical<br>Dissecting<br>Tool:<br>2.5 - 7.5mm | Surgical Dissecting<br>Tool:<br>0.5-25mm | Surgical Dissecting Tool:<br>0.5-25mm |
| Attachment<br>Configuration | Depth Stop | Straight, Angled,<br>Footed, Contra Angled,<br>Right Angled, Metal<br>Cutting, Depth limiting<br>Drill Guides, Perforator,<br>Jacob Chuck<br>Attachments, Wire/Pin<br>Collet Attachments | Straight, Angled, Footed,<br>Contra Angled, Right Angled,<br>Metal Cutting, Depth limiting<br>Drill Guides, Perforator, Jacob<br>Chuck Attachments, Wire/Pin<br>Collet Attachments |
| Attachment<br>Length | ASDS01<br>13.7cm -<br>14.8cm in<br>1mm<br>increments | 2-40cm | 2-40cm |
| Drill System<br>Operating<br>Principle | Electric<br>powered by<br>IPC and<br>Pneumatic<br>powered by<br>Pneumatic<br>Pressure | Electric powered by IPC | Pneumatic powered by<br>Pneumatic Pressure…